Placebo-controlled trial of oral laquinimod for multiple sclerosis.

PubMed

Comi, Giancarlo; Jeffery, Douglas; Kappos, Ludwig; Montalban, Xavier; Boyko, Alexey; Rocca, Maria A; Filippi, Massimo

2012-03-15

Two proof-of-concept clinical trials have provided evidence that laquinimod reduces disease activity in patients with relapsing-remitting multiple sclerosis. We conducted a randomized, double-blind, phase 3 study at 139 sites in 24 countries. A total of 1106 patients with relapsing-remitting multiple sclerosis were randomly assigned in a 1:1 ratio to receive oral laquinimod at a dose of 0.6 mg once daily or placebo for 24 months. The primary end point was the annualized relapse rate during the 24-month period. Secondary end points included confirmed disability progression (defined as an increase in the score on the Expanded Disability Status Scale that was sustained for at least 3 months) and the cumulative number of gadolinium-enhancing lesions and new or enlarging lesions on T(2)-weighted magnetic resonance imaging. Treatment with laquinimod as compared with placebo was associated with a modest reduction in the mean (±SE) annualized relapse rate (0.30±0.02 vs. 0.39±0.03, P=0.002) and with a reduction in the risk of confirmed disability progression (11.1% vs. 15.7%; hazard ratio, 0.64; 95% confidence interval, 0.45 to 0.91; P=0.01). The mean cumulative numbers of gadolinium-enhancing lesions and new or enlarging lesions on T(2)-weighted images were lower for patients receiving laquinimod than for those receiving placebo (1.33±0.14 vs. 2.12±0.22 and 5.03±0.08 vs. 7.14±0.07, respectively; P<0.001 for both comparisons). Transient elevations in alanine aminotransferase levels to greater than three times the upper limit of the normal range were observed in 24 patients receiving laquinimod (5%) and 8 receiving placebo (2%). In this phase 3 study, oral laquinimod administered once daily slowed the progression of disability and reduced the rate of relapse in patients with relapsing-remitting multiple sclerosis. (Funded by Teva Pharmaceutical Industries; ClinicalTrials.gov number, NCT00509145.).

Safety of multiple stereotactic radiosurgery treatments for multiple brain lesions.

PubMed

Hillard, Virany H; Shih, Lynn L; Chin, Shing; Moorthy, Chitti R; Benzil, Deborah L

2003-07-01

Stereotactic radiosurgery (SRS) is a widely used therapy for multiple brain lesions, and studies have clearly established the safety and efficacy of single-dose SRS. However, as patient survival has increased, the recurrence of tumors and the development of metastases to new sites within the brain have made it desirable to repeat treatments over time. The cumulative toxicity of multi-isocenter, multiple treatments has not been well defined. We have retrospectively studied 10 patients who received multiple SRS treatments for multiple brain lesions to assess the cumulative toxicity of these treatments. In a retrospective review of all patients treated with SRS using the X-knife (Radionics, Burlington, MA) at Westchester Medical Center/New York Medical College between December 1995 and December 2000, 10 patients were identified who received at least two treatments to at least 3 isocenters and had a minimum follow-up period of 6 months. Image fusion technique was used to determine cumulative doses to targeted lesions, whole brain and critical brain structures. Toxicities and complications were identified by chart and radiological review. The average of the maximum doses (cGy) to a point within the whole brain was 2402 (range 1617-3953); to the brainstem, 1059 (range 48-4126); to the right optic nerve, 223 (range 14-1012); to the left optic nerve, 159 (range 17-475); and to the optic chiasm, 219 (range 15-909). There were no focal neurological toxicities, including visual disturbances, cranial nerve palsies, or ataxia in any of the 10 patients. There were also no global toxicities, including cognitive decline or secondary tumors. Only one patient developed seizures that were difficult to control in association with radiation necrosis. Multiple SRS treatments at the cumulative doses used in our study are a safe therapy for patients with multiple brain lesions.

Duplicative medications in patients who visit multiple medical institutions among the insured of a corporate health insurance society in Japan.

PubMed

Kinoshita, Hiroki; Kobayashi, Yasuki; Fukuda, Takashi

2008-01-01

The objective of this paper is to describe the frequency of duplicative medication use and to estimate the drug cost associated with duplicative medications in patients who visit multiple medical institutions in Japan. The subjects of this study were insurants of a corporate health insurance society. We examined claims of insurants who received prescriptions from multiple medical institutions in April 2002. We examined characteristics of insurants who received duplicative medications and calculated the cost of duplicated drugs. 8.8% received drugs with the same mechanism of action for overlapping administration periods. In terms of comparison among three age groups, 0-19 years old, 20-69 years old, and 70 years old or older, the percentage was higher in 0-19-year-old patients than in the other age groups. The cost of duplicated drugs was found to be 0.7% or 0.5% of the total drug cost, when calculated with higher-priced drugs and lower-priced drugs, respectively. This study suggests that pediatric and teenage patients as well as elderly patients require prudent management of medication to avoid duplicative medications and that at least an estimated 5.2-7.2 billion yen may be saved if duplicative medications can be completely eliminated nationwide.

Potential Benefits of Rib Fracture Fixation in Patients with Flail Chest and Multiple Non-flail Rib Fractures.

PubMed

Qiu, Meiguang; Shi, Zhanjun; Xiao, Jun; Zhang, Xuming; Ling, Shishui; Ling, Hao

2016-12-01

The purpose of this study is to evaluate the potential benefits of rib fracture fixation in patients with flail chest and multiple non-flail rib fractures versus conventional treatment modalities. A retrospective reviewed study compared 86 cases which received surgical treatment between June 2009 and May 2013 to 76 cases which received conservative treatment between January 2006 and May 2009. The patients were divided into the flail chest ( n  = 38) and multiple non-flail rib fracture groups ( n  = 124). In the flail chest group, the mechanical ventilation time, ICU monitoring time, tracheostomies, thoracic deformity, and impaired pulmonary function and return to full-time employment were compared. In the multiple non-flail rib fracture group, fracture healing, visual analog scale (VAS) pain score, inpatient length of stay, atelectatic, pulmonary complications, and normal activity-returning time were compared. Patients in the flail chest operative fixation group had significantly shorter ICU stay, decreased ventilator requirements, fewer tracheostomies, less thoracic deformity and impaired pulmonary function, and more returned to full-time employment. Patients in the multiple non-flail rib fracture operative fixation had shorter hospital stay, less pain, earlier return to normal activity, more fracture healing, less atelectasis, and fewer pulmonary infections. This study demonstrates the potential benefits of surgical stabilization of flail chest and multiple non-flail rib fractures with plate fixation. When compared with conventional conservative management, operatively managed patients demonstrated improved clinical outcomes.

Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

PubMed

Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

2013-12-01

The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

Efficacy of single-agent bortezomib vs. single-agent thalidomide in patients with relapsed or refractory multiple myeloma: a systematic comparison

PubMed Central

Prince, H Miles; Adena, Michael; Smith, Dell Kingsford; Hertel, Judy

2007-01-01

Objective: To conduct a systematic review of the efficacy of single-agent bortezomib vs. single-agent thalidomide in patients with relapsed/refractory multiple. Methods: Publications in English from 1966 to June 2005 (MEDLINE, EMBASE, Cochrane library), publication reference lists, Janssen-Cilag data-on-file and abstracts from recent multiple myeloma conferences were reviewed. Prospective studies containing at least a single arm of either treatment group with n ≥ 30 were included. Studies adding dexamethasone for non-responders were excluded. Statistical pooling was performed for response rate and overall survival. Results: One bortezomib study (n = 333, NEJM 2005, 352; 2487–98) and 15 thalidomide (n = 1007) studies met these criteria and were included. Patient baseline characteristics including age, gender, IgG:IgA, disease duration and beta-2 microglobulin were well matched except that 48% of bortezomib patients had received prior thalidomide. Response rate, defined as serum M-protein reduction ≥ 50%, was 53% for patients receiving bortezomib vs. 32% for thalidomide (P < 0.001, n = 10 studies). Response rate determined by European Group for Blood and Marrow Transplantation (EBMT) criteria was 41% for patients receiving bortezomib vs. 22% for thalidomide (P < 0.001, n = 4 studies). Conclusion: Bortezomib was associated with a significantly higher response rate and complete remission rate using both M-protein and EBMT criteria. PMID:17608711

Clinical and Endoscopic Features of Metastatic Tumors in the Stomach

PubMed Central

Kim, Ga Hee; Ahn, Ji Yong; Jung, Hwoon-Yong; Park, Young Soo; Kim, Min-Ju; Choi, Kee Don; Lee, Jeong Hoon; Choi, Kwi-Sook; Kim, Do Hoon; Lim, Hyun; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho

2015-01-01

Background/Aims Metastasis to the stomach is rare. The aim of this study was to describe and analyze the clinical outcomes of cancers that metastasized to the stomach. Methods We reviewed the clinicopathological aspects of patients with gastric metastases from solid organ tumors. Thirty-seven cases were identified, and we evaluated the histology, initial presentation, imaging findings, lesion locations, treatment courses, and overall patient survival. Results Endoscopic findings indicated that solitary lesions presented more frequently than multiple lesions and submucosal tumor-like tumors were the most common appearance. Malignant melanoma was the tumor that most frequently metastasized to the stomach. Twelve patients received treatments after the diagnosis of gastric metastasis. The median survival period from the diagnosis of gastric metastasis was 3.0 months (interquartile range, 1.0 to 11.0 months). Patients with solitary lesions and patients who received any treatments survived longer after the diagnosis of metastatic cancer than patients with multiple lesions and patients who did not any receive any treatments. Conclusions Proper treatment with careful consideration of the primary tumor characteristics can increase the survival period in patients with tumors that metastasize to the stomach, especially in cases with solitary metastatic lesions in endoscopic findings. PMID:25473071

Carfilzomib-dexamethasone versus subcutaneous or intravenous bortezomib in relapsed or refractory multiple myeloma: secondary analysis of the phase 3 ENDEAVOR study.

PubMed

Goldschmidt, Hartmut; Moreau, Philippe; Ludwig, Heinz; Niesvizky, Ruben; Chng, Wee-Joo; Joshua, Douglas; Weisel, Katja; Spencer, Andrew; Orlowski, Robert Z; Feng, Shibao; Iskander, Karim S; Dimopoulos, Meletios A

2018-06-01

This is a secondary analysis of the phase 3 ENDEAVOR study comparing relapsed and/or refractory multiple myeloma (RRMM) patients receiving carfilzomib-dexamethasone (Kd) with those receiving subcutaneous (SC) bortezomib with dexamethasone (Vd) or intravenous (IV) Vd. Of Kd-treated patients, 356 Kd were pre-selected (by physician prior to randomization if to be randomized to Vd) for SC Vd (Kd [SC Vd]) and 108 for IV Vd (Kd [IV Vd], respectively. Of Vd-treated patients, 360 received SC Vd and 75 IV Vd. Kd (SC Vd) median PFS was not reached; SC Vd was 9.5 months. Median PFS for Kd (IV Vd) and IV Vd were 22.2 and 8.5 months, respectively. Median PFS was significantly longer and response rates were higher for Kd versus retreatment with bortezomib (SC or IV Vd) and in bortezomib naive patients. Overall, Kd was superior to Vd in RRMM regardless of route of bortezomib administration or prior bortezomib exposure.

A prospective, randomized study of cryotherapy during administration of high-dose melphalan to decrease the severity and duration of oral mucositis in patients with multiple myeloma undergoing autologous peripheral blood stem cell transplantation.

PubMed

Lilleby, K; Garcia, P; Gooley, T; McDonnnell, P; Taber, R; Holmberg, L; Maloney, D G; Press, O W; Bensinger, W

2006-06-01

Forty patients with multiple myeloma scheduled to receive melphalan 200 mg/m(2) followed by autologous stem cell transplantation were randomly assigned to receive oral cryotherapy or room temperature normal saline rinses 30 min before and for 6 h after high-dose therapy. Patients were evaluated for the development of mucositis using the National Cancer Institute grading system as well as evaluation of secondary measures such as days of total parenteral nutrition (TPN), narcotic use, hospitalization, weight loss and resumption of oral caloric intake for 28 days after transplant. Patients self-scored their pain, swallowing, drinking, eating, sleeping and taste alterations for 28 days. The primary end point of this trial was the incidence of grades 3-4 mucositis. Compared to the normal saline group, patients using cryotherapy experienced less grade 3-4 mucositis, 14 vs 74%, P=0.0005. Patients receiving cryotherapy also had statistically lower uses of narcotics and TPN, although there were no differences in length of hospitalization or weight loss. Patient-reported pain was significantly lower and activities were significantly better in the cryotherapy group.

Physician practices of bone density testing and drug prescribing to prevent or treat osteoporosis during androgen deprivation therapy.

PubMed

Tanvetyanon, Tawee

2005-01-15

Androgen deprivation therapy (ADT) is a strong risk factor for osteoporosis. The current study identified physician practices in preventing or treating osteoporosis during ADT. The practices of interest are the uses of dual-energy X-ray absorptiometry (DXA) scans, bisphosphonates, calcium or vitamin D supplement, calcitonin, or estrogen. A retrospective medical record review was conducted. Patients were included if they had received ADT with goserelin injection for >/= 1 year. Multivariable logistic regression analysis was performed to identify independent predictors of receiving at least one intervention. Analyses included 184 patients. Most were the elderly with multiple risk factors for osteoporosis. Only 8.7% (95% confidence interval [CI], 4.6-13.0%) of patients received a DXA scan at least once during the past 3 years. Oral and intravenous bisphosphonates were prescribed in 4.9% (95%CI, 1.8-8.0%) and 0.5% (95%CI, 0-2.0%) of patients, respectively, during the past year. Overall, 14.7% of patients (95%CI, 9.5-20.0%) received at least one intervention. Concurrent risk factors for osteoporosis, including smoking, alcoholism, advanced age, low body mass index, long duration of ADT, multiple comorbidities, history of fractures, and steroid use, were not independent predictors of having received interventions. However, bone metastasis was, with a hazard ratio of 5.6 (95%CI, 1.99-15.6%). Primary care physicians provided the greatest number of interventions and cancer-related specialists provided the fewest. The majority of patients with prostate carcinoma undergoing ADT did not receive interventions to prevent or treat osteoporosis. Having other concurrent risk factors for osteoporosis was not predictive of receiving these few interventions. (c) 2004 American Cancer Society.

Comparison of interferon beta products and azathioprine in the treatment of relapsing-remitting multiple sclerosis.

PubMed

Etemadifar, M; Janghorbani, M; Shaygannejad, V

2007-12-01

We compared the relative efficacy of interferon beta (IFNbeta) products and azathioprine (AZA) in the treatment of relapsing- remitting multiple sclerosis (RRMS). Ninety-four previously untreated patients of short duration with RRMS were randomly allocated to the two treatment groups. The first group received IFNbeta products (Betaferon,Avonex or Rebif); the second group received AZA for 12 months. Response to treatment was assessed at 3, 6, and 12 months after starting therapy. The mean number of relapse during one year of the study was lower in the AZA group than in the IFNbeta products group (0.28 vs. 0.64, P < 0.05). After 12 months, 57.4% of patients receiving IFNbeta products remained relapse free compared with 76.6% of those given AZA. The Expanded Disability Status Scale (EDSS) decreased by 0.30 units in IFNbeta-treated patients (P < 0.05) and 0.46 in AZAtreated patients (P < 0.001). Treatment with IFNbeta products and AZA significantly reduces the relapse rate and EDSS score in patients with RRMS, while AZA is more effective than the IFNbeta formulations.

BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma.

PubMed

Niesvizky, Ruben; Jayabalan, David S; Christos, Paul J; Furst, Jessica R; Naib, Tara; Ely, Scott; Jalbrzikowski, Jessica; Pearse, Roger N; Zafar, Faiza; Pekle, Karen; Larow, April; Lent, Richard; Mark, Tomer; Cho, Hearn J; Shore, Tsiporah; Tepler, Jeffrey; Harpel, John; Schuster, Michael W; Mathew, Susan; Leonard, John P; Mazumdar, Madhu; Chen-Kiang, Selina; Coleman, Morton

2008-02-01

This trial determined the safety and efficacy of the combination regimen clarithromycin (Biaxin), lenalidomide (Revlimid), and dexamethasone (BiRD) as first-line therapy for multiple myeloma. Patients received BiRD in 28-day cycles. Dexamethasone (40 mg) was given orally once weekly, clarithromycin (500 mg) was given orally twice daily, and lenalidomide (25 mg) was given orally daily on days 1 to 21. Objective response was defined by standard criteria (ie, decrease in serum monoclonal protein [M-protein] by at least 50%, and a decrease in urine M-protein by at least 90%). Of the 72 patients enrolled, 65 had an objective response (90.3%). A combined stringent and conventional complete response rate of 38.9% was achieved, and 73.6% of the patients achieved at least a 90% decrease in M-protein levels. This regimen did not interfere with hematopoietic stem-cell harvest. Fifty-two patients who did not go on to receive transplants received continued therapy (complete response, 37%; very good partial response, 33%). The major adverse events were thromboembolic events, corticosteroid-related morbidity, and cytopenias. BiRD is an effective regimen with manageable side effects in the treatment of symptomatic, newly diagnosed multiple myeloma. This trial was registered at www.clinicaltrials.gov as #NCT00151203.

Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study

PubMed Central

Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

2015-01-01

The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV. PMID:25533447

Coexistence of multiple sclerosis and ankylosing spondylitis: Report of four cases from Russia and review of the literature.

PubMed

Fominykh, Vera; Shevtsova, Tatyana; Arzumanian, Narine; Brylev, Lev

2017-10-01

Multiple sclerosis is a chronic demyelinating disorder of the central nervous system. There are many cases of multiple sclerosis - like syndrome and demyelinating disorders in systemic lupus erythematosus, Sjogren disease, Behcet disease and other autoimmune conditions. Coexistence of ankylosing spondylitis and multiple sclerosis usually is rare but in this article we report 4 Russian patients with concomitant multiple sclerosis and ankylosing spondylitis diseases. None of these patients received anti-tumor necrosis factor alpha therapy prior to diagnosis of multiple sclerosis. Pathogenesis, diagnostic and treatment challenges are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Treatment of candidosis in severely injured adults with short-course, low-dose amphotericin B.

PubMed

Rosemurgy, A S; Drost, T F; Murphy, C G; Kearney, R E; Albrink, M H

1990-12-01

Thirty-three (0.7%) of 4,818 trauma patients admitted between January 1, 1987, and July 1, 1989, developed invasive candidosis requiring IV antifungal therapy. All patients were seriously traumatized. Before developing candidosis, all patients had documented bacterial infections. These infections were generally polymicrobial and were treated with multiple broad-spectrum antibiotics (an average of 5.4 antibiotics for 17.2 days). Twenty-eight (85%) of 33 patients received enteral feedings for an average of 11 days +/- 1.5 (SEM) before developing candidosis and 24 (73%) received NG/oral nystatin for an average of 7.6 days +/- 0.9 before developing candidosis. All patients with candidosis were treated with intravenous amphotericin B: cumulative dose of 157.3 mg +/- 31.3 mg given over 10 days +/- 1.1. One patient developed recurrent candidosis despite NG/oral prophylaxis and enteral feedings. Six patients (18%) died due to sepsis and multiple organ failure. The patients who died did not objectively differ from the survivors. Candidosis is an infrequent infection in severely injured patients. Candidosis was invariably preceded by treatment with multiple broad-spectrum antibiotics for a variety of polymicrobial bacterial infections. NG/oral nystatin and enteral feedings did not prevent candidosis, in contrast to widely accepted beliefs. Amphotericin B therapy was safe. Recurrent candidosis was unusual. Candida infections had a high mortality rate associated with multiple blood transfusions and prolonged hospitalization. Candidosis represents a sign of severe injury and illness but can be amenable to prompt, aggressive treatment.

Outcomes of unrelated cord blood transplantation in patients with multiple myeloma: a survey on behalf of Eurocord, the Cord Blood Committee of Cellular Therapy and Immunobiology Working Party, and the Chronic Leukemia Working Party of the EBMT.

PubMed

Paviglianiti, Annalisa; Xavier, Erick; Ruggeri, Annalisa; Ceballos, Patrice; Deconinck, Eric; Cornelissen, Jan J; Nguyen-Quoc, Stephanie; Maillard, Natacha; Sanz, Guillermo; Rohrlich, Pierre-Simon; Garderet, Laurent; Volt, Fernanda; Rocha, Vanderson; Kroeger, Nicolaus; Gluckman, Eliane; Fegueux, Nathalie; Mohty, Mohamad

2016-09-01

Although allogeneic stem cell transplantation is not a standard therapy for multiple myeloma, some patients can benefit from this intense therapy. There are few reports on outcomes after umbilical cord blood transplantation in multiple myeloma, and investigation of this procedure is warranted. We retrospectively analyzed 95 patients, 85 with multiple myeloma and 10 with plasma cell leukemia, receiving single or double umbilical cord blood transplantation from 2001 to 2013. Median follow up was 41 months. The majority of patients received a reduced intensity conditioning. The cumulative incidence of neutrophil engraftment was 97%±3% at 60 days, and that of 100-day acute graft-versus-host disease grade II-IV was 41%±5%. Chronic graft-versus-host disease at two years was 22%±4%. Relapse and non-relapse mortality was 47%±5% and 29%±5% at three years, respectively. Three-year progression-free survival and overall survival were 24%±5% and 40%±5%, respectively. Anti-thymocyte globulin was associated with decreased incidence of acute graft-versus-host disease, higher non-relapse mortality, decreased overall and progression-free survival. Patients with high cytogenetic risk had higher relapse, and worse overall and progression-free survival. In conclusion, umbilical cord blood transplantation is feasible for multiple myeloma patients. Copyright© Ferrata Storti Foundation.

Dexamethasone, all trans retinoic acid and interferon alpha 2a in patients with refractory multiple myeloma.

PubMed

Avilés, A; Rosas, A; Huerta-Guzmán, J; Talavera, A; Cleto, S

1999-02-01

Few effective regimen are available for patients with refractory multiple myeloma (RMM). Generally, responses are scarce and disease free survival is very short. We developed a new therapeutic option in these patients using dexamethasone (40 mg/m2, i.v., daily, days 1 to 4), all-trans retinoic acid (45 mg/m2, po, daily, days 5 to 14) and interferon alpha 2a (9.0 MU, daily, subcutaneously, days 5 to 14). The treatment was administered every 21 days for 6 cycles. In a pilot study, 12 patients, heavily treated with chemotherapy and radiotherapy and in some cases with interferon, were allocated to receive the afore mentioned treatment. Response was observed in 10 patients (83%). With a median follow-up of 36.1 months (range 27 to 41), seven patients remain alive and disease-free without any treatment. Two patients were failures and have died due to tumor progression. Toxicity was mild and all patients received treatment according to the planned doses of drugs. The use of biological modifiers in combination with dexamethasone offer a safe and effective therapeutic option in patients with refractory multiple myeloma. More studies are warranted to define the role of this type of treatment.

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

PubMed

Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

2014-04-01

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

Abdominal injuries in a low trauma volume hospital - a descriptive study from northern Sweden

PubMed Central

2014-01-01

Background Abdominal injuries occur relatively infrequently during trauma, and they rarely require surgical intervention. In this era of non-operative management of abdominal injuries, surgeons are seldom exposed to these patients. Consequently, surgeons may misinterpret the mechanism of injury, underestimate symptoms and radiologic findings, and delay definite treatment. Here, we determined the incidence, diagnosis, and treatment of traumatic abdominal injuries at our hospital to provide a basis for identifying potential hazards in non-operative management of patients with these injuries in a low trauma volume hospital. Methods This retrospective study included prehospital and in-hospital assessments of 110 patients that received 147 abdominal injuries from an isolated abdominal trauma (n = 70 patients) or during multiple trauma (n = 40 patients). Patients were primarily treated at the University Hospital of Umeå from January 2000 to December 2009. Results The median New Injury Severity Score was 9 (range: 1–57) for 147 abdominal injuries. Most patients (94%) received computed tomography (CT), but only 38% of patients with multiple trauma were diagnosed with CT < 60 min after emergency room arrival. Penetrating trauma caused injuries in seven patients. Solid organ injuries constituted 78% of abdominal injuries. Non-operative management succeeded in 82 patients. Surgery was performed for 28 patients, either immediately (n = 17) as result of operative management or later (n = 11), due to non-operative management failure; the latter mainly occurred with hollow viscus injuries. Patients with multiple abdominal injuries, whether associated with multiple trauma or an isolated abdominal trauma, had significantly more non-operative failures than patients with a single abdominal injury. One death occurred within 30 days. Conclusions Non-operative management of patients with abdominal injuries, except for hollow viscus injuries, was highly successful in our low trauma volume hospital, even though surgeons receive low exposure to these patients. However, a growing proportion of surgeons lack experience in decision-making and performing trauma laparotomies. Quality assurance programmes must be emphasized to ensure future competence and quality of trauma care at low trauma volume hospitals. PMID:25124882

Evaluation of an every-other-day palonosetron schedule to control emesis in multiple-day high-dose chemotherapy.

PubMed

Mirabile, Aurora; Celio, Luigi; Magni, Michele; Bonizzoni, Erminio; Gianni, Alessandro Massimo; Di Nicola, Massimo

2014-12-01

Efficacy of intermittent palonosetron dosing in patients undergoing multiple-day, high-dose chemotherapy (HDC) was investigated. Fifty-eight patients received palonosetron (0.25 mg intravenous [iv.]) every other day plus daily dexamethasone (8 mg iv. twice daily) dosing. The primary end point was complete control (CC; no emesis, no rescue anti-emetics, and no more than mild nausea) in the overall acute-period (until 24 h after chemotherapy completion). Acute-period CC occurred in 81% and 50% of patients receiving palonosetron and ondansetron (historical control cohort), respectively. Palonosetron (odds ratio [OR]: 4.37; p = 0.001) and a longer duration of HDC regimen (OR: 3.47; p = 0.011) independently predicted a better anti-emetic outcome. Palonosetron every other day plus daily dexamethasone is an effective anti-emetic coverage in patients undergoing HDC.

Different clinical response to interferon beta and glatiramer acetate related to the presence of oligoclonal IgM bands in CSF in multiple sclerosis patients.

PubMed

Casanova, Bonaventura; Lacruz, Laura; Villar, María Luisa; Domínguez, José Andrés; Gadea, María Carcelén; Gascón, Francisco; Mallada, Javier; Hervás, David; Simó-Castelló, María; Álvarez-Cermeño, José Carlos; Calles, Carmen; Olascoaga, Javier; Ramió-Torrentà, Lluís; Alcalá, Carmen; Cervelló, Angeles; Boscá, Isabel; Pérez-Mirallles, Francisco Carlos; Coret, Francisco

2018-06-07

To study the efficacy of interferon beta (IFNβ) and glatiramer acetate (GA) related to the presence of oligoclonal M bands (OCMB) in the cerebrospinal fluid in relapsing-remitting multiple sclerosis (RRMS). This is an observational, multicenter and retrospective study with prospectively collected data of patients that started treatment with IFNβ or GA. Treatment decision was made blinded to the OCMB status. Time to first attack after starting therapy was compared by using Kaplan-Meier curves, and adjustment by Cox regression analysis was performed. Two hundred and fifty-six patients entered in the study (141-55% received IFNβ; 115-45% received GA). After a mean follow-up of 41 and 65 months, 54.7% of patients remained free from further attacks (RF). The proportion of RF patients was higher in the GA group than in the IFNβ group (72.2 vs. 40.4%, p < 0.001). The IFNβ patients with OCMB+ presented the poorest response, 31.3% RF vs. 48.1% in IFNβ without OCMB, p = 0.03. OCMB in CSF could be a biomarker of treatment response in multiple sclerosis.

Staging resection of multiple primary esophageal cancer by endoscopic submucosal dissection and esophagectomy: A case report.

PubMed

Yao, Yufeng; Wu, Yimin; Chai, Ying

2018-05-01

Multiple primary esophageal cancer pose great risks to patients and are always challenging to resect surgically. In order to reduce the risk of postoperative complication and meet the needs of minimally invasive and precision medicine, new treatment plans have been always developed for patients with multiple primary esophageal cancer. A 75-year-old man was admitted to our hospital for aggravated dysphagia. No significant abnormalities were identified on physical examination. Endoscopic examination detected 3 masses in the esophagus and biopsy confirmed multiple primary esophageal cancer. The patient received a new staging treatment procedure firstly and an innovative single-position, minimally invasive Ivor Lewis esophagectomy in our hospital. This patient discharged one week after the surgery and enjoyed a good health during our follow up for 30 month. We believe our procedure provides a beneficial new alternative approach for patients with multiple primary esophageal cancer.

Natalizumab plus interferon beta-1a reduces lesion formation in relapsing multiple sclerosis.

PubMed

Radue, Ernst-Wilhelm; Stuart, William H; Calabresi, Peter A; Confavreux, Christian; Galetta, Steven L; Rudick, Richard A; Lublin, Fred D; Weinstock-Guttman, Bianca; Wynn, Daniel R; Fisher, Elizabeth; Papadopoulou, Athina; Lynn, Frances; Panzara, Michael A; Sandrock, Alfred W

2010-05-15

The SENTINEL study showed that the addition of natalizumab improved outcomes for patients with relapsing multiple sclerosis (MS) who had experienced disease activity while receiving interferon beta-1a (IFNbeta-1a) alone. Previously unreported secondary and tertiary magnetic resonance imaging (MRI) measures are presented here. Patients received natalizumab 300 mg (n=589) or placebo (n=582) intravenously every 4 weeks plus IFNbeta-1a 30 microg intramuscularly once weekly. Annual MRI scans allowed comparison of a range of MRI end points versus baseline. Over 2 years, 67% of patients receiving natalizumab plus IFNbeta-1a remained free of new or enlarging T2-lesions compared with 30% of patients receiving IFNbeta-1a alone. The mean change from baseline in T2 lesion volume over 2 years decreased in patients receiving natalizumab plus IFNbeta-1a and increased in those receiving IFNbeta-1a alone (-277.5mm(3) versus 525.6mm(3); p<0.001). Compared with IFNbeta-1a alone, add-on natalizumab therapy resulted in a smaller increase in mean T1-hypointense lesion volume after 2 years (1821.3mm(3) versus 2210.5mm(3); p<0.001), a smaller mean number of new T1-hypointense lesions over 2 years (2.3 versus 4.1; p<0.001), and a slower rate of brain atrophy during the second year of therapy (-0.31% versus -0.40%; p=0.020). Natalizumab add-on therapy reduced gadolinium-enhancing, T1-hypointense, and T2 MRI lesion activity and slowed brain atrophy progression in patients with relapsing MS who experienced disease activity despite treatment with IFNbeta-1a alone. Copyright 2010 Elsevier B.V. All rights reserved.

A Teaching Hospital Medical Clinic: Secondary Rather than Primary Care.

ERIC Educational Resources Information Center

Fletcher, Suzanne; And Others

1979-01-01

A review of 287 patient visits to a teaching hospital polyclinic shows that most patients had multiple problems that required the help of subspecialists. However, the patients' needs for accessibility, comprehensiveness, coordination, and continuity are as great as those of patients receiving primary care. Implications for academic internal…

Management of chemotherapy-induced nausea and vomiting in patients receiving multiple-day highly or moderately emetogenic chemotherapy: role of transdermal granisetron.

PubMed

Coluzzi, Flaminia; Mattia, Consalvo

2016-08-01

Granisetron transdermal delivery system (GTDS) is the first 5-HT3 drug to be transdermally delivered and represents a convenient alternative to oral and intravenous antiemetics for the treatment of chemotherapy-induced nausea and vomiting. GTDS is effective and well tolerated in patients receiving multiple-day moderate-to-highly emetogenic chemotherapy. In this setting noninferiority studies showed similar efficacy when GTDS was compared with intravenous and oral granisetron and intravenous palonosetron. GTDS has shown good cardiovascular safety; however, special caution is needed in patients at risk for developing excessive QTc interval prolongation and arrhythmias. So far, GTDS has been investigated for intravenous prevention in comparison with granisetron and palonosetron; however, further prospects open the route to future clinical investigations.

Palatability and oral cavity tolerability of THC:CBD oromucosal spray and possible improvement measures in multiple sclerosis patients with resistant spasticity: a pilot study.

PubMed

Lus, Giacomo; Cantello, Roberto; Danni, Maura Chiara; Rini, Agusto; Sarchielli, Paola; Tassinari, Tiziana; Signoriello, Elisabetta

2018-04-01

Complaints about Δ 9 -tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex ® ; GW Pharma Ltd, Salisbury, UK) in the management of multiple sclerosis spasticity include unpleasant taste and oral mucosal anomalies. This pilot study assessed the use of sugar-free chewing gum and/or a refrigerated bottle of THC:CBD oromucosal spray to mitigate these effects. Patients with multiple sclerosis spasticity (n = 52) at six sites in Italy who were receiving THC:CBD oromucosal spray and had associated oral mucosal effects were randomized into Group A (chewing gum; n = 15); Group B (cold bottle; n = 20); and Group C (cold bottle + chewing gum; n = 17). Taste perception in patients receiving chewing gum ± cold bottle intervention (Groups A and C combined) was significantly (p = 0.0001) improved from baseline to week 4 while maintaining spasticity control. Patient comfort, satisfaction and treatment adherence may benefit from these interventions.

Comparative analysis of Micrococcus luteus isolates from blood cultures of patients with pulmonary hypertension receiving epoprostenol continuous infusion.

PubMed

Hirata, Yoshinori; Sata, Makoto; Makiuchi, Yuko; Morikane, Keita; Wada, Akihito; Okabe, Nobuhiko; Tomoike, Hitonobu

2009-12-01

During the period 2002-2008, at the National Cardiovascular Center, Osaka, 28 Micrococcus luteus isolates and one Kocuria spp. isolate were obtained from blood cultures of pulmonary hypertension (PH) patients who were receiving continuous infusion therapy with epoprostenol. Pulsed-field gel electrophoresis patterns of the isolates were unrelated, suggesting that the infections had multiple origins. The preparation of epoprostenol solution by patients themselves was thought to be a risk factor.

Incidence of Exposure of Patients in the United States to Multiple Drugs for Which Pharmacogenomic Guidelines Are Available.

PubMed

Samwald, Matthias; Xu, Hong; Blagec, Kathrin; Empey, Philip E; Malone, Daniel C; Ahmed, Seid Mussa; Ryan, Patrick; Hofer, Sebastian; Boyce, Richard D

2016-01-01

Pre-emptive pharmacogenomic (PGx) testing of a panel of genes may be easier to implement and more cost-effective than reactive pharmacogenomic testing if a sufficient number of medications are covered by a single test and future medication exposure can be anticipated. We analysed the incidence of exposure of individual patients in the United States to multiple drugs for which pharmacogenomic guidelines are available (PGx drugs) within a selected four-year period (2009-2012) in order to identify and quantify the incidence of pharmacotherapy in a nation-wide patient population that could be impacted by pre-emptive PGx testing based on currently available clinical guidelines. In total, 73 024 095 patient records from private insurance, Medicare Supplemental and Medicaid were included. Patients enrolled in Medicare Supplemental age > = 65 or Medicaid age 40-64 had the highest incidence of PGx drug use, with approximately half of the patients receiving at least one PGx drug during the 4 year period and one fourth to one third of patients receiving two or more PGx drugs. These data suggest that exposure to multiple PGx drugs is common and that it may be beneficial to implement wide-scale pre-emptive genomic testing. Future work should therefore concentrate on investigating the cost-effectiveness of multiplexed pre-emptive testing strategies.

Multiple-, But Not Single-, Dose of Parecoxib Reduces Shoulder Pain after Gynecologic Laparoscopy

PubMed Central

Zhang, Hufei; Shu, Haihua; Yang, Lu; Cao, Minghui; Zhang, Jingjun; Liu, Kexuan; Xiao, Liangcan; Zhang, Xuyu

2012-01-01

Background: The aim of this study was to investigate effect of single- and multiple-dose of parecoxib on shoulder pain after gynecologic laparoscopy. Methods: 126 patients requiring elective gynecologic laparoscopy were randomly allocated to three groups. Group M (multiple-dose): receiving parecoxib 40mg at 30min before the end of surgery, at 8 and 20hr after surgery, respectively; Group S (single-dose): receiving parecoxib 40mg at 30min before the end of surgery and normal saline at the corresponding time points; Group C (control): receiving normal saline at the same three time points. The shoulder pain was evaluated, both at rest and with motion, at postoperative 6, 24 and 48hr. The impact of shoulder pain on patients' recovery (activity, mood, walking and sleep) was also evaluated. Meanwhile, rescue analgesics and complications were recorded. Results: The overall incidence of shoulder pain in group M (37.5%) was lower than that in group C (61.9%) (difference=-24.4%; 95% CI: 3.4~45.4%; P=0.023). Whereas, single-dose regimen (61.0%) showed no significant reduction (difference with control=-0.9%; 95% CI: -21.9~20.0%; P=0.931). Moreover, multiple-dose regimen reduced the maximal intensity of shoulder pain and the impact for activity and mood in comparison to the control. Multiple-dose of parecoxib decreased the consumption of rescue analgesics. The complications were similar among all groups and no severe complications were observed. Conclusions: Multiple-, but not single-, dose of parecoxib may attenuate the incidence and intensity of shoulder pain and thereby improve patients' quality of recovery following gynecologic laparoscopy. PMID:23136538

Utility of bortezomib retreatment in relapsed or refractory multiple myeloma patients: a multicenter case series.

PubMed

Wolf, Jeffrey; Richardson, Paul G; Schuster, Michael; LeBlanc, Annette; Walters, Ian B; Battleman, David S

2008-10-01

Bortezomib therapy has become an important part of the standard of care for patients with relapsed multiple myeloma, and preliminary clinical evidence suggests that bortezomib retreatment in patients previously treated with the drug may prolong disease control. This retrospective study was designed to clarify the utility of bortezomib as a repeat therapy. We reviewed records from 3 major cancer centers that had participated in the phase II (SUMMIT or CREST) or phase III (APEX) registration studies to identify patients who were subsequently retreated off protocol with bortezomib-based therapy. We found 22 patients who received bortezomib retreatment following a 60 or more day gap between bortezomib treatments. Twelve patients had intervening therapy between initial bortezomib treatment and bortezomib retreatment. During retreatment, 14 of 22 patients received bortezomib in combination with another antineoplastic agent. The overall response rate for bortezomib retreatment was 50% (9% complete responses). The median length of retreatment was 5.1 months in responding patients and 2.4 months in nonresponding patients. Therapy was terminated due to unmanageable toxicity in 2 patients during retreatment, compared with 6 patients during initial treatment. During retreatment, no patients required dose reduction due to peripheral neuropathy, compared to 4 patients during their initial treatment. Thus, bortezomib retreatment appears to be safe and effective. Favorable observed response rates with bortezomib retreatment suggest that it may be a viable option for relapsed or refractory multiple myeloma, even in patients previously exposed to bortezomib.

[Tandem transplantation with peripheral autologous hematopoietic blood stem cells in treatment of oncologic and hematologic malignancies. Initial results of the Donauspital, Vienna].

PubMed

Ruckser, R; Kier, P; Sebesta, C; Kittl, E; Kurz, M; Selleny, S; Höniger, S; Scherz, M; Habertheuer, K H; Zelenka, P

1995-01-01

10 patients were subjected to tandem transplantation for breast cancer (n = 3), ovarian cancer (n = 2) and multiple myeloma (n = 5), at the Second Department of Medicine, Donauspital, Vienna. The breast cancer patients were in stages 2 and 3, respectively, at diagnosis and entered complete remission thereafter. 2 of them developed lymph node metastasis and additional local recurrence, the 3rd patient presented with distant metastasis. The 2 patients with ovarian cancer were in stages Figo III and IV, respectively, at the time of diagnosis, and showed minimal residual disease at second-look-operation. 5 patients with multiple myeloma were in stage 3 pretransplant. Peripheral stem cells were obtained after either high-dose cyclophosphamide or FEC induction and application of cytokines. In 4 patients, tandem transplantation has been completed. 1 patient with multiple myeloma, who had received total body irradiation in combination with chemotherapy for the 2nd transplant, succumbed from idiopathic interstitial pneumonia. No severe clinical complications were observed in all other patients. All patients with solid tumors entered complete remission after the 1st transplantation. 3 of them completed tandem transplantation. Of these, 2 remain in continuous complete remission, the 3rd patient relapsed in lymph nodes day 485. In patients who received only 1 course of high dose chemotherapy with stem cell transplantation, relapses occurred on days 29 and 75, respectively. All patients with multiple myeloma entered only partial remission. We conclude that supralethal chemotherapy with peripheral blood stem cell support is a safe procedure that may at least induce prolonged remissions in solid tumors and hematologic malignancies.(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing-remitting multiple sclerosis: the CLARITY Extension study.

PubMed

Comi, Giancarlo; Cook, Stuart; Rammohan, Kottil; Soelberg Sorensen, Per; Vermersch, Patrick; Adeniji, Abidemi K; Dangond, Fernando; Giovannoni, Gavin

2018-01-01

The CLARITY and CLARITY Extension studies demonstrated that treatment of relapsing-remitting multiple sclerosis (RRMS) with cladribine tablets (CT) results in significant clinical improvements, compared with placebo. This paper presents the key magnetic resonance imaging (MRI) findings from the CLARITY Extension study. Patients who received a cumulative dose of either CT 3.5 or 5.25 mg/kg in CLARITY were rerandomized to either placebo or CT 3.5 mg/kg in CLARITY Extension. Patients from the arm that received placebo in CLARITY were assigned to CT 3.5 mg/kg. MRI assessments were carried out when patients entered CLARITY Extension and after Weeks 24, 48, 72 and 96, and in a supplemental follow-up period. At CLARITY Extension baseline, patients who received placebo during CLARITY had more T1 gadolinium-enhanced (Gd+) lesions than patients who received CT during CLARITY. These patients, who were then exposed to cladribine 3.5 mg/kg during the extension, experienced a 90.4% relative reduction (median difference -0.33, 97.5% confidence interval -0.33-0.00; p < 0.001) in T1 Gd+ lesions at the end of the extension compared with the end of CLARITY. Overall, the majority of patients in each treatment group remained free from T1 Gd+ lesions throughout CLARITY Extension. However, a small proportion of patients who were treated with cladribine in CLARITY and received placebo in CLARITY Extension showed evidence of increased MRI activity, and this was associated with a prolonged treatment gap between CLARITY and CLARITY Extension. A 2-year treatment with CT 3.5 mg/kg has a durable effect on MRI outcomes in the majority of patients, an effect that was sustained in patients who were not retreated in the subsequent 2 years after initial treatment. ClinicalTrials.gov identifier: NCT00641537 .

Long-term effects of cladribine tablets on MRI activity outcomes in patients with relapsing–remitting multiple sclerosis: the CLARITY Extension study

PubMed Central

Comi, Giancarlo; Cook, Stuart; Rammohan, Kottil; Soelberg Sorensen, Per; Vermersch, Patrick; Adeniji, Abidemi K.; Dangond, Fernando; Giovannoni, Gavin

2018-01-01

Background The CLARITY and CLARITY Extension studies demonstrated that treatment of relapsing–remitting multiple sclerosis (RRMS) with cladribine tablets (CT) results in significant clinical improvements, compared with placebo. This paper presents the key magnetic resonance imaging (MRI) findings from the CLARITY Extension study. Methods Patients who received a cumulative dose of either CT 3.5 or 5.25 mg/kg in CLARITY were rerandomized to either placebo or CT 3.5 mg/kg in CLARITY Extension. Patients from the arm that received placebo in CLARITY were assigned to CT 3.5 mg/kg. MRI assessments were carried out when patients entered CLARITY Extension and after Weeks 24, 48, 72 and 96, and in a supplemental follow-up period. Results At CLARITY Extension baseline, patients who received placebo during CLARITY had more T1 gadolinium-enhanced (Gd+) lesions than patients who received CT during CLARITY. These patients, who were then exposed to cladribine 3.5 mg/kg during the extension, experienced a 90.4% relative reduction (median difference −0.33, 97.5% confidence interval −0.33–0.00; p < 0.001) in T1 Gd+ lesions at the end of the extension compared with the end of CLARITY. Overall, the majority of patients in each treatment group remained free from T1 Gd+ lesions throughout CLARITY Extension. However, a small proportion of patients who were treated with cladribine in CLARITY and received placebo in CLARITY Extension showed evidence of increased MRI activity, and this was associated with a prolonged treatment gap between CLARITY and CLARITY Extension. Conclusion A 2-year treatment with CT 3.5 mg/kg has a durable effect on MRI outcomes in the majority of patients, an effect that was sustained in patients who were not retreated in the subsequent 2 years after initial treatment. ClinicalTrials.gov identifier: NCT00641537 PMID:29399054

Travelling for treatment; does distance and deprivation affect travel for intensity-modulated radiotherapy in the rural setting for head and neck cancer?

PubMed

Cosway, B; Douglas, L; Armstrong, N; Robson, A

2017-06-01

NHS England has commissioned intensity-modulated radiotherapy for head and neck cancers from Newcastle hospitals for patients in North Cumbria. This study assessed whether travel distances affected the decision to travel to Newcastle (to receive intensity-modulated radiotherapy) or Carlisle (to receive conformal radiotherapy). All patients for whom the multidisciplinary team recommended intensity-modulated radiotherapy between December 2013 and January 2016 were included. Index of multiple deprivation scores and travel distances were calculated. Patients were also asked why they chose their treating centre. Sixty-nine patients were included in this study. There were no significant differences in travel distance (p = 0.53) or index of multiple deprivation scores (p = 0.47) between patients opting for treatment in Carlisle or Newcastle. However, 29 of the 33 patients gave travel distance as their main reason for not travelling for treatment. Quantitatively, travel distance and deprivation does not impact on whether patients accept intensity-modulated radiotherapy. However, patients say distance is a major barrier for access. Future research should explore how to reduce this.

[The efficiency of emergency therapy in patients with head-brain, multiple injury. Quality assurance in emergency medicine].

PubMed

Schüttler, J; Schmitz, B; Bartsch, A C; Fischer, M

1995-12-01

For cardio-pulmonary resuscitation there are standardized treatment concepts, but there have been few prospective investigations examining the efficacy of prehospital advanced trauma life support and its effect on the outcome in patients with severe head injury and multiple trauma treated within the German emergency system. The results of this study underline the importance of intensive prehospital treatment and highlight some problems that should be taken into account in future in the training of emergency physicians. METHODS. A total of 179 patients with cerebral trauma were investigated. Data obtained included demographic and logistic data of the patients and the emergency physicians, diagnoses and treatment at the scene of the accident and state of the patient on admission in each case. Having divided the patients into three groups by severity of the trauma, we distinguished between sufficient and insufficient treatment and assessed infusion therapy, ventilatory support, positioning and immobilization, and analgesic and sedative therapy. For statistical analysis of the data we used chi 2-test and Fisher's exact test. P < 0.05 was considered significant. RESULTS. There were 102 patients who had sustained a cerebral trauma without other life-threatening lesions (score 1), 40 with multiple trauma (score 2) and 37 with multiple trauma (score 3). On average 2.4 IV lines were established and the patients received 1186 +/- 765 cc of crystalloid in addition to 801 +/- 411 cc of colloid fluids. In all groups, patients who received adequate infusion therapy had a better outcome; even in the group with score 1 significantly fewer had a fatal outcome. In all, 167 (93%) patients had endotracheal tubes placed, and in 150 cases (84%) ventilatory therapy was considered sufficient. The proportion of score 1 patients with sufficient ventilatory support who had a fatal outcome was significantly lower than that in the group with insufficient treatment. In patients with multiple trauma we could not separate the benefits of sufficient respiratory therapy and infusion therapy. In only 54% of the cases a vacuum mattress was used and in only 41% the patients were positioned with the upper part of the body elevated by 30 degrees. These were 28 patients (16%) who received neither analgesics nor sedatives. Regardless of the quality of prehospital treatment of isolated head injury, a Glasgow Coma Scale (GCS) score lower than 5 involved a very high mortality and all patients with a GCS score of 9 or more survived. In the group with GCS scores between 5 and 8, however, significantly more of the patients who received adequate treatment survived (82.5% vs 40%). CONCLUSIONS. The present study confirms that sufficient advanced trauma life support can improve the outcome of trauma victims with cerebral trauma. Adequate infusion and respiratory therapy reduce the mortality among such patients significantly. In patients with multiple trauma a clear positive effect of generous infusion therapy also is evident. The clearest effect of sufficient prehospital treatment is seen in patients with isolated cerebral trauma and a GCS score between 5 and 8. These results demonstrate the importance of advanced trauma life support and show emphatically that the so-called scoop-and-run strategy should be abandoned when resources are available for extended preclinical emergency treatment. On the other hand, we detected some problem areas in the prehospital treatment of trauma victims, such as positioning, immobilization and drug therapy with analgesics and sedatives. These findings allow us to pinpoint specific points that should be stressed in the training of emergency physicians and paramedics.

What is the benefit of treatment with multiple lines of chemotherapy for patients with metastatic breast cancer? A retrospective cohort study.

PubMed

Bakker, J L; Wever, K; van Waesberghe, J H; Beeker, A; Meijers-Heijboer, H; Konings, I R; Verheul, H M W

2015-12-01

Despite the extensive clinical experience, it is still under debate to what extent patients with metastatic breast cancer (MBC) benefit from multiple lines of chemotherapy beyond standard first or second line treatment. Selection of patients with MBC who will benefit from treatment is crucial to improve outcome and reduce unnecessary toxicity. In this retrospective study, systemic treatment outcome for patients with metastatic MBC is being evaluated. We evaluated to what extent the clinical benefit of prior chemotherapy can predict the success of a subsequent treatment line. Ninety-one patients treated with chemotherapy for MBC between January 2005 and January 2009 were included in this study. Clinical characteristics of patients, choices of chemotherapy and response at first evaluation of every treatment line was evaluated based on radiologic and clinical data. Patients received multiple systemic cytotoxic and biological (combination) therapies. 30% of these patients received more than five consecutive systemic (combination) treatments. First line chemotherapy was mostly anthracycline-based, followed by taxanes, capecitabine and vinorelbine. The response rate (RR, complete response plus partial response according to RECIST 1.1) decreased from 20% (95% CI 11-28%) upon first line of treatment to 0% upon the fourth line. The clinical benefit rate (combining RR and stable disease) decreased from 85% (95% CI 78-93%) in the first to 54% (95% CI 26-67) upon the fourth line. 24% of the patients with clinical benefit at first evaluation did not receive a subsequent line of treatment when progressive disease occurred, while sixty-one percent of the patients with progressive disease at first evaluation of a treatment did not receive a subsequent line of chemotherapy. When applied, the efficacy of a subsequent line of treatment was similar for patients independent of previous treatment benefit. The clinical benefit at first evaluation from systemic treatment in MBC does not predict for subsequent treatment benefit in this retrospective analysis. The fact that 61% of patients did not receive subsequent treatment after previous treatment failure suggests that either clinical judgement is of critical value in selection of patients to prevent them from unnecessary toxicity or, alternatively indicates that based on the assumption that prior treatment failure predicts for lack of benefit undertreatment of patients occurs. Therefore, a more adequate clinical judgement tool or predictive biomarkers for response are urgently needed to improve treatment outcome. Copyright © 2015. Published by Elsevier Ltd.

[Outcomes of treatment of chemotherapy drugs different manufacturers tuberculosis patients with multiple drug resistance].

PubMed

2014-09-01

The article is devoted to studying the effectiveness of treatment of tuberculosis (TB) patients with multidrug-resistant TB drugs 2 number of different manufacturers. To assess the effectiveness of treatment of second-line drugs were taken to study two groups of patients: Group 1 - 164 patients who received anti-TB drugs from the Global Fund and Group 2 174 patients who received anti-TB drugs for the national program. Comparative evaluation showed high efficiency second-line drugs from the Global Fund, as evidenced by the high level of 95,8 % abacillation in a short time in this patient group.

The Applicability of the International Staging System in Chinese Patients with Multiple Myeloma Receiving Bortezomib or Thalidomide-Based Regimens as Induction Therapy: A Multicenter Analysis

PubMed Central

Lu, Jing; Lu, Jin; Liu, Aijun; Fu, Weijun; Du, Juan; Huang, Xiaojun; Chen, Wenming; Hou, Jian

2015-01-01

The International Staging System (ISS) is the most important prognostic system for multiple myeloma (MM). It was identified in the era of conventional agents. The outcome of MM has significantly changed by novel agents. Thus the applicability of ISS system in the era of novel agents in Chinese patients needs to be demonstrated. We retrospectively analyzed the clinical outcomes and prognostic significance of ISS system in 1016 patients with newly diagnosed multiple myeloma in Chinese patients between 2008 and 2012, who received bortezomib- or thalidomide-based regimens as first-line therapy. The median overall survival (OS) of patients for ISS stages I/II/III was not reached/55.4 months/41.7 months (p < 0.001), and the median progression-free survival (PFS) was 30/29.5/25 months (p = 0.072), respectively. Statistically significant difference in survival was confirmed among three ISS stages in thalidomide-based group, but not between ISS stages I and II in bortezomib-based group. These findings suggest that ISS system can predict the survival in the era of novel agents in Chinese MM patients, and bortezomib may have the potential to partially overcome adverse effect of risk factors on survival, especially in higher stage of ISS system. PMID:26640799

Thalidomide, clarithromycin, lenalidomide and dexamethasone therapy in newly diagnosed, symptomatic multiple myeloma.

PubMed

Mark, Tomer M; Bowman, Isaac A; Rossi, Adriana C; Shah, Manan; Rodriguez, Melissa; Quinn, Ryann; Pearse, Roger N; Zafar, Faiza; Pekle, Karen; Jayabalan, David; Ely, Scott; Coleman, Morton; Chen-Kiang, Selina; Niesvizky, Ruben

2014-12-01

We studied T-BiRD (thalidomide [Thalomid(®)], clarithromycin [Biaxin(®)], lenalidomide [Revlimid(®)] and dexamethasone) in symptomatic, newly diagnosed multiple myeloma. In 28-day cycles, patients received dexamethasone 40 mg/day on days 1, 8, 15, 22, clarithromycin 500 mg twice daily on days 1-28; lenalidomide 25 mg/day on days 1-21; and thalidomide 100 mg/day (50 mg/day on days 1-7 of cycle 1 only) on days 1-28. Twenty-six patients received a median of 6 cycles (range 0-41). Overall response rate (ORR) was 80% for the group and 100% in 11 patients who underwent autologous stem cell transplantation as part of first-line therapy. The 4-year overall survival rate was 74.9%, and the median progression-free survival was 35.6 months. Eight patients discontinued due to regimen toxicity. Grade 3 non hematologic toxicity affected 12 patients (46.2%). T-BiRD is a highly active regimen with potential toxicity limitations. ClinicalTrials.gov identifier: NCT00538733.

Hemorrhage and Subsequent Allogenic Red Blood Cell Transfusion are Associated With Characteristic Monocyte Messenger RNA Expression Patterns in Patients After Multiple Injury—A Genome Wide View

PubMed Central

Bogner, Viktoria; Baker, Henry V.; Kanz, Karl-Georg; Moldawer, L. L.; Mutschler, Wolf; Biberthaler, Peter

2014-01-01

Introduction As outcome to severe trauma is frequently affected by massive blood loss and consecutive hemorrhagic shock, replacement of red blood cell (RBC) units remains indispensable. Administration of RBC units is an independent risk factor for adverse outcome in patients with trauma. The impact of massive blood transfusion or uncrossmatched blood transfusion on the patients’ immune response in the early posttraumatic period remains unclear. Material Thirteen patients presenting with blunt multiple injuries (Injury Severity Score >16) were studied. Monocytes were obtained on admission and at 6, 12, 24, 48, and 72 hours after trauma. Biotinylated complementary RNA targets were hybridized to Affymetrix HG U 133A microarrays. The data were analyzed by a supervised analysis based on whether the patients received massive blood transfusions, and then subsequently, by hierarchical clustering, and by Ingenuity pathway analysis. Results Supervised analysis identified 224 probe sets to be differentially expressed (p < 0.001) in patients who received massive blood transfusion, when compared with those who did not. In addition, 331 probe sets were found differentially expressed (p < 0.001) in patients who received uncrossmatched RBC units in comparison with those who exclusively gained crossmatched ones. Functional pathway analysis of the respectively identified gene expression profiles suggests a contributory role by the AKT/PI3Kinase pathway, the mitogen-activated protein-kinase pathway, the Ubiquitin pathway, and the diverse inflammatory networks. Conclusion We exhibited for the first time a serial, sequential screening analysis of monocyte messenger RNA expression patterns in patients with multiple trauma indicating a strongly significant association between the patients’ genomic response in blood monocytes and massive or uncross-matched RBC substitution. PMID:19820587

VANTAGE 095: An International, Multicenter, Open-Label Study of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Relapsed and Refractory Multiple Myeloma.

PubMed

Siegel, David S; Dimopoulos, Meletios; Jagannath, Sundar; Goldschmidt, Hartmut; Durrant, Simon; Kaufman, Jonathan L; Leleu, Xavier; Nagler, Arnon; Offner, Fritz; Graef, Thorsten; Eid, Joseph E; Houp, Jennifer; Gause, Christine; Vuocolo, Scott; Anderson, Kenneth C

2016-06-01

The present global, open-label, single-arm, multicenter, phase IIb study was designed to determine the efficacy and tolerability of oral vorinostat combined with standard doses of bortezomib in patients with multiple myeloma considered refractory to novel myeloma agents. Eligible patients were age ≥ 18 years, had received ≥ 2 previous regimens, had disease refractory to ≥ 1 previous bortezomib-containing regimen, and had received ≥ 1 dose of an immunomodulatory drug (thalidomide or lenalidomide)-based regimen. The patients received 21-day cycles of bortezomib (1.3 mg/m(2) intravenously on days 1, 4, 8, and 11) plus oral vorinostat (400 mg/d on days 1-14). Oral dexamethasone, 20 mg, on the day of and the day after each dose of bortezomib could be added for patients with progressive disease after 2 cycles or no change after 4 cycles. The primary endpoint was the objective response rate. The objective response rate was 11.3% (95% confidence interval, 6.6%-17.7%), and the median duration of response was 211 days (range, 64-550 days). The median overall survival duration was 11.2 months (95% confidence interval, 8.5-14.4 months), with a 2-year survival rate of 32%. The frequently reported adverse events were thrombocytopenia (69.7%), nausea (57.0%), diarrhea (53.5%), anemia (52.1%), and fatigue (48.6%); the overall safety profile was consistent with that of bortezomib and vorinostat. The combination of vorinostat and bortezomib is active in patients with multiple myeloma refractory to novel treatment modalities and offers a new therapeutic option for this difficult-to-treat patient population (ClinicalTrials.gov identifier, NCT00773838). Copyright © 2016 Elsevier Inc. All rights reserved.

Effect of alpha-lipoic acid on asymmetric dimethylarginine and disability in multiple sclerosis patients: A randomized clinical trial.

PubMed

Khalili, Mohammad; Soltani, Madjid; Moghadam, Shirin Amiri; Dehghan, Parvin; Azimi, Amirreza; Abbaszadeh, Omid

2017-07-01

Multiple Sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system. Oxidative stress plays a major role in the onset and progression of MS. Asymmetric dimethylarginine (ADMA) formation is dependent on oxidative stress status. We examined whether alpha-lipoic acid (ALA) as a potent antioxidant could improve the Expanded Disability Status Scale (EDSS) and decrease plasma level of ADMA in multiple sclerosis patients. In a randomized, double-blinded clinical trial conducted at Sina Hospital in Tehran, Iran, from September 2009 to July 2011, 24 patients with relapsing-remitting MS were divided into a treatment group receiving ALA (1200mg/day) for 12 weeks and a control group receiving placebo. Then patients' EDSS and Plasma levels of ADMA were measured at baseline and 12 weeks later. Statistical analysis was done by SPSS software version 16 using the K-S test, Chi square, Mann-Whitney U-test and Wilcoxon test. The plasma levels of ADMA in the intervention group were decreased significantly (p=0.04). Also, no patient had increased EDSS score in the supplement group, where 2 out of 12 patients in the placebo group experienced so. Comparing the serum level of ADMA between the two groups failed to show any significant change in the supplement group compared with the control group. Considering that ADMA is produced by oxidative stress in MS patients and leads to increase of inflammation, ALA may have the potential of beneficial effects in them, in part, by decreasing the plasma level of ADMA and stopping progression. The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: No. IRCT138812222602N2. The authors received no financial support for the research, authorship, and/or publication of this article.

Correction of anemia in a transfusion-dependent patient with primary myelofibrosis receiving iron chelation therapy with deferasirox (Exjade®, ICL670)

PubMed Central

Di Tucci, Anna Angela; Murru, Roberta; Alberti, Daniele; Rabault, Bertrand; Deplano, Simona; Angelucci, Emanuele

2007-01-01

Transfusional iron overload in patients with chronic anemias can result in multiple organ failure. Experience in the management of iron overload in patients with myelodysplastic syndromes is limited, as many do not receive chelation therapy due to short-life expectancy and the difficulties associated with the administration of the current reference standard chelator, deferoxamine. There have, however, been some reports of reduced transfusion requirement associated with chelation therapy in patients with myelodysplastic syndromes and myelofibrosis. Here, we discuss a patient with primary myelofibrosis and related transfusion-dependent anemia who received chelation therapy with the once-daily oral iron chelator, deferasirox. In addition to the reduced iron levels, the patient demonstrated an unexpected reduction in blood transfusion requirement, ultimately resulting in long-lasting transfusion-free survival. PMID:17391307

Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study.

PubMed

Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

2015-03-01

The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV. © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Evaluation of neutrophil-to-lymphocyte ratio in newly diagnosed patients receiving borte- zomib-based therapy for multiple myeloma.

PubMed

Zhou, Xin; Wang, Jing; Xia, Jun; Cheng, Feng; Mao, Jingjue; Zhu, Jianwei; Guo, Hongfeng

2018-01-01

The neutrophil-to-lymphocyte ratio (NLR) at diagnosis has been identified as an independent prognostic marker in several malignancies. Recently, a few studies have reported that an elevated pretreatment NLR is associated with poor survival among multiple myeloma (MM) patients. However, the role of NLR at diagnosis in patients with MM treated with regimens containing bortezomib has been less explored. We aimed to investigate the relationships between NLR and overall survival (OS) in newly diagnosed patients receiving bortezomib-based therapy for MM. A total of 76 newly diagnosed patients with MM treated with bortezomib-based regimes were analyzed retrospectively. NLR was calculated from whole blood counts prior to therapy and subsequently correlated with OS. Complete remission (CR) was seen in 39.2% of patients with NLR < 2.95 compared to 20% in the group with NLR ⩾ 2.95 (P= 0.094). NLR was lower in CR patients in comparison to Non-CR subjects (P= 0.044). Patients with a NLR ⩾ 2.95 experienced inferior median survival compared to those with NLR < 2.95 (4-year OS rates were 30.9% and 64.8%, respectively, P= 0.029). In multivariate analysis, only elevated LDH and IgA MM were factors predicting inferior OS. Elevated NLR was associated with poor OS in MM patients receiving induction therapy with bortezomib-based regimens, but it was not an independent prognostic factor in this patient cohort.

An Evaluation of Stereoscopic Digital Mammography for Earlier Detection of Breast Cancer and Reduced Rate of Recall

DTIC Science & Technology

2008-08-01

in the Right breast, for which she received a lumpectomy, radiation therapy , and chemotherapy. Figure 6. Clinical history... receive . A high -risk patient who returns for yearly or accelerated screening examinations will be eligible for multiple enrollments in the study...based on all the available information. You will receive a letter or phone call from the Breast Imaging

Mass screening of multiple abdominal solid organs using mobile helical computed tomography scanner--a preliminary report.

PubMed

Ishikawa, Susumu; Aoki, Jun; Ohwada, Susumu; Takahashi, Toru; Morishita, Yasuo; Ueda, Keisuke

2007-04-01

The possibility of a new screening procedure for multiple abdominal solid organs using a mobile helical computed tomography (CT) scanner was evaluated. A total of 4,543 residents, who were 40 years of age or older, received CT scanning without contrast medium. The mean age of participants was 64 years including 2,022 males and 2,521 females. A total of 2,105 abnormal findings were uniquely detected in 1,594 participants. Liver and kidney diseases including ureter occupied around 30% of total abnormal findings, respectively. Besides frequent cystic or calcified lesions, solid tumours were suspected in 56 lesions, which received further examination by specialized physicians. Five (9%) of them were confirmed as being malignant tumours including pancreatic cancer in two patients, and liver, lung and ovary cancers in one patient each, respectively. All five patients with each malignant lesion received curative operations. Small-sized abdominal aortic aneurysms and heart valve diseases were uniquely found in 22 and two patients, respectively. Qualitative diagnoses of solid tumours were difficult using CT findings without contrast medium. CT screening procedures require further investigation in aspect of the selection of examinees, CT scanning procedure, sensitivity and specificity, and cost-effectiveness.

SU-E-T-79: Comparison of Doses Received by the Hippocampus in Patients Treated with Single Vs Multiple Isocenter Based Stereotactic Radiation Therapy to the Brain for Multiple Brain Metastases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Algan, O; Giem, J; Young, J

Purpose: To investigate the doses received by the hippocampus and normal brain tissue during a course of stereotactic radiotherapy utilizing a single isocenter (SI) versus multiple isocenter (MI) in patients with multiple intracranial metastases. Methods: Seven patients imaged with MRI including SPGR sequence and diagnosed with 2–3 brain metastases were included in this retrospective study. Two sets of stereotactic IMRT treatment plans, (MI vs SI), were generated. The hippocampus was contoured on SPGR sequences and doses received by the hippocampus and whole brain were calculated. The prescribed dose was 25Gy in 5 fractions. The two groups were compared using t-testmore » analysis. Results: There were 17 lesions in 7 patients. The median tumor, right hippocampus, left hippocampus and brain volumes were: 3.37cc, 2.56cc, 3.28cc, and 1417cc respectively. In comparing the two treatment plans, there was no difference in the PTV coverage except in the tail of the DVH curve. All tumors had V95 > 99.5%. The only statistically significant parameter was the V100 (72% vs 45%, p=0.002, favoring MI). All other evaluated parameters including the V95 and V98 did not reveal any statistically significant differences. None of the evaluated dosimetric parameters for the hippocampus (V100, V80, V60, V40, V20, V10, D100, D90, D70, D50, D30, D10) revealed any statistically significant differences (all p-values > 0.31) between MI and SI plans. The total brain dose was slightly higher in the SI plans, especially in the lower dose regions, although this difference was not statistically significant. Utilizing brain-sub-PTV volumes did not change these results. Conclusion: The use of SI treatment planning for patients with up to 3 brain metastases produces similar PTV coverage and similar normal tissue doses to the hippocampus and the brain compared to MI plans. SI treatment planning should be considered in patients with multiple brain metastases undergoing stereotactic treatment.« less

The Management of Superior Mesenteric Artery Aneurysm: Experience with 16 Cases in a Single Center.

PubMed

Zilun, Li; Henghui, Yin; Yang, Zhao; Mian, Wang; Guangqi, Chang; Shenming, Wang

2017-07-01

Superior mesenteric artery aneurysm (SMAA) represents a rare but potentially fatal condition. This study aimed to present the individual management protocol of SMAA in our center and to discuss a potential preliminary treatment algorithm. SMAA patients treated in our center between January 2007 and December 2014 were retrospectively reviewed on January 2015. Sixteen patients with SMAA were identified, including 1 female and 15 males, with a mean age of 48.9 ± 12.9 years. Three patients (3/16, 18.8%) were treated by multiple overlapping bare stents and one (1/16, 6.3%) initially by a single bare stent. Two cases (2/16, 12.5%) were treated by a covered stent implantation, but one of those suffered from SMAA rupture 7 days later, whereas the other had inner-stent thrombosis one month after discharge and died from multiple organ-dysfunction syndrome. Nine patients (9/16, 56.2%) received conservative therapy, one of who received multiple overlapping bare stents implantations for persistent abdominal pain. One patient underwent open surgery. There were 2 major complications, with no death during hospitalization and 1 death during follow-up. SMAA treatment needs to be individually prescribed, based on clinical manifestation, anatomy, and etiology. Multiple overlapping bare stents are safe and effective in selective patients with SMAA, and covered stents should be used with caution to avoid covering proximal branches; open surgery should be reserved for patients with suspected intestinal necrosis. Copyright © 2017 Elsevier Inc. All rights reserved.

The evolution of computed tomography from organ-selective to whole-body scanning in managing unconscious patients with multiple trauma: A retrospective cohort study.

PubMed

Hong, Zhi-Jie; Chen, Cheng-Jueng; Yu, Jyh-Cherng; Chan, De-Chuan; Chou, Yu-Ching; Liang, Chia-Ming; Hsu, Sheng-Der

2016-09-01

We aimed to evaluate the benefit of whole-body computed tomography (WBCT) scanning for unconscious adult patients suffering from high-energy multiple trauma compared with the conventional stepwise approach of organ-selective CT.Totally, 144 unconscious patients with high-energy multiple trauma from single level I trauma center in North Taiwan were enrolled from January 2009 to December 2013. All patients were managed by a well-trained trauma team and were suitable for CT examination. The enrolled patients are all transferred directly from the scene of an accident, not from other medical institutions with a definitive diagnosis. The scanning regions of WBCT include head, neck, chest, abdomen, and pelvis. We analyzed differences between non-WBCT and WBCT groups, including gender, age, hospital stay, Injury Severity Score, Glasgow Coma Scale, Revised Trauma Score, time in emergency department (ED), medical cost, and survival outcome.Fifty-five patients received the conventional approach for treating trauma, and 89 patients received immediate WBCT scanning after an initial examination. Patients' time in ED was significantly shorter in the WBCT group in comparison with the non-WBCT group (158.62 ± 80.13 vs 216.56 ± 168.32 min, P = 0.02). After adjusting for all possible confounding factors, we also found that survival outcome of the WBCT group was better than that of the non-WBCT group (odds ratio: 0.21, 95% confidence interval: 0.06-0.75, P = 0.016).Early performing WBCT during initial trauma management is a better approach for treating unconscious patients with high-energy multiple trauma.

Carfilzomib, lenalidomide and dexamethasone in patients with heavily pretreated multiple myeloma: A phase 1 study in Japan.

PubMed

Suzuki, Kenshi; Ri, Masaki; Chou, Takaaki; Sugiura, Isamu; Takezako, Naoki; Sunami, Kazutaka; Ishida, Tadao; Izumi, Tohru; Ozaki, Shuji; Shumiya, Yoshihisa; Ota, Kenji; Iida, Shinsuke

2017-03-01

This is the first study in which the carfilzomib, lenalidomide and dexamethasone (KRd) regimen was evaluated in heavily pretreated multiple myeloma. This study is a multicenter, open-label phase 1 study of KRd in Japanese patients with relapsed or refractory multiple myeloma (RRMM) patients. The objectives were to evaluate the safety, tolerability, efficacy and pharmacokinetics of the regimen. Carfilzomib was administrated intravenously over 10 min on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. In cycle 1, the dosage for days 1 and 2 was 20 mg/m 2 , followed by 27 mg/m 2 . Lenalidomide and dexamethasone were administered at 25 mg (days 1-21) and 40 mg (days 1, 8, 15 and 22), respectively. Twenty-six patients were enrolled. Patients had received a median of four prior regimens and 88.5% and 61.5% received previous bortezomib and lenalidomide, respectively. High-risk cytogenetics were seen in 53.8% of patients. The overall response rate was 88.5%. A higher rate of hyperglycemia was observed than in a previous carfilzomib monotherapy study, but this was attributed to dexamethasone. Carfilzomib pharmacokinetics were not affected by lenalidomide and dexamethasone. The KRd regimen was well tolerated and showed efficacy in Japanese RRMM patients. © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

Low-dose right unilateral electroconvulsive therapy (ECT): effectiveness of the first treatment.

PubMed

Lapidus, Kyle A B; Shin, Joseph S W; Pasculli, Rosa M; Briggs, Mimi C; Popeo, Dennis M; Kellner, Charles H

2013-06-01

Electroconvulsive therapy (ECT) is a widely used, highly effective antidepressant treatment. Except for the most severely ill patients, right unilateral (RUL) electrode placement is the most frequent initial treatment choice. In current practice, RUL ECT is administered at several multiples of seizure threshold (ST) based on reports that lower stimulus intensity results in lower response/remission rates. Many patients, as part of an initial dose titration to determine ST, will receive a single treatment with low-dose RUL ECT and subsequent treatments with a stimulus at a multiple of ST. To assess response to the first ECT. A retrospective analysis of charts from clinical practice at Mount Sinai Medical Center was performed. A single treatment with low-dose (presumably near ST) RUL ECT had a significant and immediate antidepressant effect in our sample of patients with major depression. We determined that this response is similar to that of patients receiving a single initial treatment with high-dose RUL ECT (at a multiple of ST). These data suggest, contrary to commonly held belief, that RUL ECT may be effective at a low stimulus dose. This argues against restimulating at 6 times ST in the initial session, based on the belief that the near-threshold seizure has no antidepressant efficacy. Our findings suggest a need for further investigation of cases in which low-dose RUL ECT may be an effective antidepressant treatment. Further prospective studies, including larger numbers of patients who receive randomized treatment with low- or high-dose RUL with longer follow-up, are indicated.

Demyelination during tumour necrosis factor antagonist therapy for psoriasis: a case report and review of the literature.

PubMed

Mahil, Satveer K; Andrews, Thomasin C; Brierley, Charlotte; Barker, Jonathan N; Smith, Catherine H

2013-02-01

Central nervous system (CNS) demyelination in a patient receiving tumour necrosis factor alpha (TNF-α) antagonist therapy in our practice prompted a search of the literature to assess the evidence for a causal relationship between TNF antagonist therapy and demyelination. We summarise clinical data extracted on 65 reported cases of CNS demyelination in patients receiving TNF antagonist therapy and show that the data are consistent with a drug-related aetiology given the temporal relationship between TNF antagonist initiation and symptoms, de-challenge-re-challenge phenomenon and the later age of disease onset compared with sporadic multiple sclerosis. Research on TNF signalling pathways also suggests a plausible causative role of TNF antagonist therapy in demyelination. However to date, controlled trial and pharmacovigilance data do not show an increased risk of demyelination in patients receiving TNF antagonist therapy. These data may be underpowered to exclude such a risk and pooled, collaborative data from multiple registries are warranted. Given the uncertainty in this area, clinicians should adhere to existing clinical guidance advising avoidance of TNF antagonist therapy in patients with a personal or family history of demyelination, and ensure all suitable patients are enrolled in long term safety registries in countries where these are established.

Minimum effective volume of mepivacaine for ultrasound-guided supraclavicular block

PubMed Central

Song, Jae Gyok; Kang, Bong Jin; Park, Kee Keun

2013-01-01

Background The aim of this study was to estimate the minimum effective volume (MEV) of 1.5% mepivacaine for ultrasound-guided supraclavicular block by placing the needle near the lower trunk of brachial plexus and multiple injections. Methods Thirty patients undergoing forearm and hand surgery received ultrasound-guided supraclavicular block with 1.5% mepivacaine. The initial volume of local anesthetic injected was 24 ml, and local anesthetic volume for the next patient was determined by the response of the previous patient. The next patient received a 3 ml higher volume in the case of the failure of the previous case. If the previous block was successful, the next volume was 3 ml lower. MEV was estimated by the Dixon and Massey up and down method. MEV in 95, 90, and 50% of patients (MEV95, MEV90, and MEV50) were calculated using probit transformation and logistic regression. Results MEV95 of 1.5% mepivacaine was 17 ml (95% confidence interval [CI], 13-42 ml), MEV90 was 15 ml (95% CI, 12-34 ml), and MEV50 was 9 ml (95% CI, 4-12 ml). Twelve patients had a failed block. Three patients received general anesthesia. Nine patients could undergo surgery with sedation only. Only one patient showed hemi-diaphragmatic paresis. Conclusions MEV95 was 17 ml, MEV90 was 15 ml, and MEV50 was 9 ml. However, needle location near the lower trunk of brachial plexus and multiple injections should be performed. PMID:23904937

Tandem Autologous Stem Cell Transplantation for Multiple Myeloma Patients Based on Response to Their First Transplant—A Prospective Phase II Study

PubMed Central

Byrne, Michael; Salmasinia, Donya; Leather, Helen; Cogle, Christopher R; Davis, Amy; Hsu, Jack W; Wiggins, Laura; Chang, Myron N; An, Qi; Wingard, John R; Moreb, Jan S

2014-01-01

In this prospective phase II clinical trial, multiple myeloma (MM) patients were randomized to receive a second (tandem) autologous stem cell transplantation (ASCT) based on whether they achieved a partial response or worse (≤PR) following initial ASCT (ASCT1). Patients who achieved a very good partial response or better (≥VGPR) had salvage ASCT at relapse. Seventy-five patients received conditioning therapy and ASCT1. A total of 44 patients (59%) achieved ≥VGPR, whereas 31 patients entered ≤PR and were offered tandem ASCT. In all, 20 patients agreed to tandem ASCT. Demographic and clinical characteristics were similar between the two cohorts except for median lactate dehydrogenase (LDH) (P = 0.0141) and percentage of marrow plasma cells before ASCT1 (P = 0.0047), both lower in the ≥VGPR group. Intent to treat analysis showed that patients who achieved ≥VGPR to ASCT1 had a trend toward improved progression-free survival (PFS) (37 vs. 26 months, P = 0.078) and superior overall survival (OS) (not reached vs. 50 months, P = 0.0073). Patients with ≤PR who declined tandem transplantation had shortened PFS (20 vs. 28 months, P = 0.05) but similar OS (53 vs. 57.5 months, P = 0.29) compared to those who received it. Thus, a favorable clinical response to ASCT1 identifies a low-risk group with superior long-term prognosis despite similar PFS. PMID:25232286

Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis.

PubMed

Panitch, Hillel S; Thisted, Ronald A; Smith, Richard A; Wynn, Daniel R; Wymer, James P; Achiron, Anat; Vollmer, Timothy L; Mandler, Raul N; Dietrich, Dennis W; Fletcher, Malcolm; Pope, Laura E; Berg, James E; Miller, Ariel

2006-05-01

To evaluate the efficacy and safety of DM/Q (capsules containing dextromethorphan [DM] and quinidine [Q]) compared with placebo, taken twice daily, for the treatment of pseudobulbar affect over a 12-week period in multiple sclerosis patients. A total of 150 patients were randomized in a double-blind, placebo-controlled study to assess pseudobulbar affect with the validated Center for Neurologic Study-Lability Scale. Each patient also recorded the number of episodes experienced between visits, estimated quality of life and quality of relationships on visual analog scales, and completed a pain rating scale. Patients receiving DM/Q had greater reductions in Center for Neurologic Study-Lability Scale scores than those receiving placebo (p < 0.0001) at all clinic visits (days 15, 29, 57, and 85). All secondary end points also favored DM/Q, including the number of crying or laughing episodes (p

The incidence and risk factors of febrile neutropenia in chemotherapy-naïve lung cancer patients receiving etoposide plus platinum.

PubMed

Fujiwara, Takumi; Kenmotsu, Hirotsugu; Naito, Tateaki; Kawamura, Takahisa; Mamesaya, Nobuaki; Kotake, Mie; Kobayashi, Haruki; Omori, Shota; Nakashima, Kazuhisa; Wakuda, Kazushige; Ono, Akira; Taira, Tetsuhiko; Murakami, Haruyasu; Omae, Katsuhiro; Mori, Keita; Endo, Masahiro; Takahashi, Toshiaki

2017-06-01

This study was to determine the incidence and risk factors of febrile neutropenia in chemotherapy-naïve Japanese patients treated systemically with etoposide plus platinum for lung cancer. The study was a retrospective analysis of 244 patients who were monitored for febrile neutropenia through multiple cycles of the combination of etoposide with platinum, and the associations between incidence of febrile neutropenia and patient characteristics were evaluated. Eighty-eight patients were treated with etoposide plus cisplatin and 156 were treated with etoposide plus carboplatin. Of the 244 patients treated, 198 (81.1%) completed 4 cycles for chemotherapy. Febrile neutropenia was observed in 48 of 244 patients (19.7%), including 18 of 88 (20.5%) patients who received etoposide plus cisplatin and 30 of 156 (19.2%) patients who received etoposide plus carboplatin. Grade 3 or 4 of neutropenia was experienced by a total of 208 patients (85.2%); 79 of 88 (89.8%) receiving etoposide plus cisplatin and 129 of 156 (82.7%) receiving etoposide plus carboplatin. Male gender and previous radiotherapy were identified by multivariate analysis as independent risk factors for febrile neutropenia. These results contrast with findings in Western patients and suggest that ethnic differences exist in the incidence of febrile neutropenia in patients receiving etoposide plus platinum chemotherapy. In addition, our results suggest that primary prophylaxis with granulocyte colony-stimulating factor should be considered for patients with these risk factors for febrile neutropenia prior to treatment with etoposide plus platinum.

A Telerehabilitation Program Improves Postural Control in Multiple Sclerosis Patients: A Spanish Preliminary Study

PubMed Central

Ortiz-Gutiérrez, Rosa; Cano-de-la-Cuerda, Roberto; Galán-del-Río, Fernando; Alguacil-Diego, Isabel María; Palacios-Ceña, Domingo; Miangolarra-Page, Juan Carlos

2013-01-01

Postural control disorders are among the most frequent motor disorder symptoms associated with multiple sclerosis. This study aims to demonstrate the potential improvements in postural control among patients with multiple sclerosis who complete a telerehabilitation program that represents a feasible alternative to physical therapy for situations in which conventional treatment is not available. Fifty patients were recruited. Control group (n = 25) received physiotherapy treatment twice a week (40 min per session). Experimental group (n = 25) received monitored telerehabilitation treatment via videoconference using the Xbox 360® and Kinect console. Experimental group attended 40 sessions, four sessions per week (20 min per session).The treatment schedule lasted 10 weeks for both groups. A computerized dynamic posturography (Sensory Organization Test) was used to evaluate all patients at baseline and at the end of the treatment protocol. Results showed an improvement over general balance in both groups. Visual preference and the contribution of vestibular information yielded significant differences in the experimental group. Our results demonstrated that a telerehabilitation program based on a virtual reality system allows one to optimize the sensory information processing and integration systems necessary to maintain the balance and postural control of people with multiple sclerosis. We suggest that our virtual reality program enables anticipatory PC and response mechanisms and might serve as a successful therapeutic alternative in situations in which conventional therapy is not readily available. PMID:24185843

How to determine bortezomib-based regimen for elderly patients with multiple myeloma: PAD versus CBd, an observational study.

PubMed

Huang, Bin-Tao; Tan, Yan; Zhao, Wei-Hong; Zeng, Qing-Chun; Li, Bing-Sheng; Chen, Rui-Lin

2014-02-01

This was an open-label, observational, prospective assessment. We conducted an analysis of the impact of bortezomib-based therapy (PAD: bortezomib, doxorubicin, high-dose dexamethasone vs. CBd: cyclophosphamide bortezomib, low-dose dexamethasone) on the survival rates and adverse events in elderly patients with newly diagnosed multiple myeloma (MM). Out of 303 patients, 128 received the PAD regimen and the other 175 patients received the CBd induction therapy (age 65-89 years). Baseline patient characteristics between the two cohorts were balanced in age (P = 0.69), international staging system (ISS) prognostic stages (P = 0.90), serum calcium (P = 0.70), and serum creatinine (P = 0.52). Overall response (OS) after the induction chemotherapy was achieved in 214 of 303 patients (70.6 %), with no significant differences observed between the two treatment groups (71.9 vs. 69.7 %, P = 0.68). Patients with ISS stage 2 reached the same 5-year OS advantages compared to patients with ISS stage 1, because they received bortezomib-based PAD or CBd treatments. Patients receiving CBd protocol gained similar satisfactory progression-free survival (PFS) results when compared to the PAD regimen group: PFS at 5 years reached 58.2 versus 58.9 % (P = 0.85). Five-year OS in the CBd arm had significant advantages compared to the PAD group, 79.9 versus 49.9 % (P < 0.05). The overall safety profiles showed that 26 of 128 (20.3 %) patients died in the PAD arm, while 13 of 175 patients died (7.4 %) in the CBd group (P < 0.01). Similarly, the PAD arm had a higher serious infection rate than that of the CBd arm (39.2 vs. 13.1 %, P < 0.01). Bortezomib benefits elderly patients with newly diagnosed MM; they achieve satisfactory treatment responses and survival advantages. Further, patients treated with CBd have superior treatment advantages, with a predictable safety profile, when compared to the PAD regimen.

The evolution of computed tomography from organ-selective to whole-body scanning in managing unconscious patients with multiple trauma

PubMed Central

Hong, Zhi-Jie; Chen, Cheng-Jueng; Yu, Jyh-Cherng; Chan, De-Chuan; Chou, Yu-Ching; Liang, Chia-Ming; Hsu, Sheng-Der

2016-01-01

Abstract We aimed to evaluate the benefit of whole-body computed tomography (WBCT) scanning for unconscious adult patients suffering from high-energy multiple trauma compared with the conventional stepwise approach of organ-selective CT. Totally, 144 unconscious patients with high-energy multiple trauma from single level I trauma center in North Taiwan were enrolled from January 2009 to December 2013. All patients were managed by a well-trained trauma team and were suitable for CT examination. The enrolled patients are all transferred directly from the scene of an accident, not from other medical institutions with a definitive diagnosis. The scanning regions of WBCT include head, neck, chest, abdomen, and pelvis. We analyzed differences between non-WBCT and WBCT groups, including gender, age, hospital stay, Injury Severity Score, Glasgow Coma Scale, Revised Trauma Score, time in emergency department (ED), medical cost, and survival outcome. Fifty-five patients received the conventional approach for treating trauma, and 89 patients received immediate WBCT scanning after an initial examination. Patients’ time in ED was significantly shorter in the WBCT group in comparison with the non-WBCT group (158.62 ± 80.13 vs 216.56 ± 168.32 min, P = 0.02). After adjusting for all possible confounding factors, we also found that survival outcome of the WBCT group was better than that of the non-WBCT group (odds ratio: 0.21, 95% confidence interval: 0.06–0.75, P = 0.016). Early performing WBCT during initial trauma management is a better approach for treating unconscious patients with high-energy multiple trauma. PMID:27631215

Cost savings of home bortezomib injection in patients with multiple myeloma treated by a combination care in Outpatient Hospital and Hospital care at Home.

PubMed

Touati, Mohamed; Lamarsalle, Ludovic; Moreau, Stéphane; Vergnenègre, Françoise; Lefort, Sophie; Brillat, Catherine; Jeannet, Laetitia; Lagarde, Aline; Daulange, Annick; Jaccard, Arnaud; Vergnenègre, Alain; Bordessoule, Dominique

2016-12-01

At home injectable chemotherapy for patients receiving treatment for hematological diseases is still in debate. Given the expense of new innovative medicines, at home treatment has been proposed as a suitable option for improving patient quality of life and decreasing treatment costs. We decided to assess the cost of bortezomib administration in France among multiple myeloma patients from an economic standpoint. Patients in this study were treated within a regional hematological network combining outpatient hospital care and Hospital care at Home administration. To make the cost comparison, our team simulated outpatient hospital care expenses. Fifty-four consecutive multiple myeloma patients who received at least one injection of bortezomib in Hospital care at Home from January 2009 to December 2011 were included in the study. The median number of injections was 12 (range 1-44) at home and 6 (range 0-30) in the outpatient care unit. When compared with the cost simulation of outpatient hospital care alone, bortezomib administration with combined care was significantly less expensive for the National Health Insurance (NHI) budget. The mean total cost per patient and per injection was 954.20 € for combined outpatient and Hospital care at Home vs 1143.42 € for outpatient hospital care alone. This resulted in an estimated 16.5 % cost saving (Wilcoxon signed-rank test, p < 0.0001). The greatest savings were observed in administration costs (37.5 % less) and transportation costs (68.1 % less). This study reflects results for a regionally implemented program for multiple myeloma patients treated with bortezomib in routine practice in a large rural area.

Do patients with neurogenic bladder treated with clean intermittentcatheterization need antibacterial prophylaxis?

PubMed

Akil, İpek; Özen, Çınar; Cengiz, Beyhan

2016-06-23

In this study, we investigated the effectiveness of antibiotic prophylaxis (ABP) with respect to the incidence of symptomatic urinary tract infections (UTIs) and evaluated the development of renal scarring in patients treated with clean intermittent catheterization (CIC). A total of 22 patients were included in the study. The patients were administered ABP in the first year (the ABP-received period) but not in the second year (the ABP-discontinued period). Twenty-eight of all cultures taken in the ABP-received period (18.2%) and 25 (16.2%) of the ABP-discontinued cultures were considered to be indicative of symptomatic UTIs (P = 0.65). The multiple antibiotic resistance rate of microorganisms in cultures taken during the ABP-discontinued period (47; 30.5%) was lower than that in those taken in the ABP-received period (62; 40.3%), (P = 0.07). There was no difference between the ABP-received and ABP-discontinued periods with respect to the development of new lesions according to dimercaptosuccinic acid results (P = 0.14). Routine ABP usage is not protective against the development of symptomatic UTIs and new lesions in neurogenic bladder patients receiving CIC. Furthermore, the growth of resistant microorganisms increased in the ABP-received period.

Stereotactic ablative radiotherapy: a potentially curable approach to early stage multiple primary lung cancer.

PubMed

Chang, Joe Y; Liu, Yung-Hsien; Zhu, Zhengfei; Welsh, James W; Gomez, Daniel R; Komaki, Ritsuko; Roth, Jack A; Swisher, Stephen G

2013-09-15

Surgical resection has been the standard treatment for early stage multiple primary lung cancer (MPLC). However, a significant proportion of patients with MPLC cannot undergo surgery. For this report, the authors explored the role of stereotactic ablative radiotherapy (SABR) for patients with MPLC. Patients with MPLC who received SABR (50 grays [Gy] in 4 fractions or 70 Gy in 10 fractions) for the second tumor were reviewed. Four-dimensional, computed tomography-based, planning/volumetric image-guided treatment was used for all patients. Treatment outcomes/toxicities were analyzed. For the 101 patients who received SABR, at a median follow-up of 36 months and with a median overall survival (OS) of 46 months, the 2-year and 4-year in-field local control rates were 97.4% and 95.7%, respectively. The 2-year and 4-year OS rates were 73.2% and 47.5%, respectively; and the progression-free survival (PFS) rates were 67% and 58%, respectively. Patients who had metachronous tumors had better OS and PFS than patients who had synchronous tumors (2-year OS: 80.6% metachronous vs 61.5% synchronous; 4-year OS: 52.7% vs 39.7%, respectively; P = .047; 2-year PFS: 84.7% vs 49.4%, respectively; 4-year PFS: 75.6% vs 30.4%, respectively; P = .0001). For patients who either underwent surgery or received SABR for an index tumor, the incidence of grade ≥ 3 radiation pneumonitis was 3% (2 of 71 patients); however, this increased to 17% (5 of 30 patients) for those who received conventional radiotherapy for an index tumor. Other grade ≥ 3 toxicities included grade 3 chest wall pain (3 of 101 patients; 3%) and grade 3 skin toxicity (1 of 101 patients; 1%). SABR achieves promising long-term tumor control and survival and may be a potential curative treatment for early stage MPLC. © 2013 American Cancer Society.

Interest in Providing Multiple Sclerosis Care and Subspecializing in Multiple Sclerosis Among Neurology Residents

PubMed Central

Teixeira-Poit, Stephanie; Kane, Heather L.; Frost, A. Corey; Keating, Michael; Olmsted, Murrey

2014-01-01

Background: Although detailed knowledge regarding treatment options for multiple sclerosis (MS) patients is largely limited to neurologists, shortages in the neurologist workforce, including MS subspecialists, are predicted. Thus, MS patients may have difficulties in gaining access to appropriate care. No systematic evaluation has yet been performed of the number of neurology residents planning to pursue MS subspecialization. This study identifies factors affecting interest in providing MS patient care or MS subspecialization among current neurology residents. Methods: We randomly selected half of all Accreditation Council of Graduate Medical Education–certified neurology residency programs in the continental United States to receive the neurology resident survey. Completed surveys were received from 218 residents. Results: Residents were significantly more likely to have increased interest in MS care when they participated in MS research, were interested in teaching, and indicated that the “ability to improve patient outcomes and quality of life” was a positive factor influencing their desire to provide MS patient care. Residents who were interested in providing MS care, interested in teaching, and indicated that “research opportunities” was a positive factor for providing MS patient care were significantly more likely to express interest in MS subspecialization. Conclusions: Increasing opportunities to interact with MS patients, learn about MS care, and participate in MS research may increase interest in MS care and subspecialization among neurology residents. Opportunities to educate residents regarding MS patient care may affect residents’ attitudes. PMID:24688352

An important discovery on combination of irreversible electroporation and allogeneic natural killer cell immunotherapy for unresectable pancreatic cancer

PubMed Central

Liang, Shuzhen; Wang, Xiaohua; Liang, Yinqing; Zhang, Mingjie; Chen, Jibing; Niu, Lizhi; Xu, Kecheng

2017-01-01

Purpose To study the safety and clinical efficacy on combination of irreversible electroporation and allogeneic natural killer cell therapy for treating Stage III/IV pancreatic cancer, evaluating median progression free survival (PFS), and overall survival (OS). Results Adverse events of all patients were limited to grades 1 and 2, including local (mainly tussis 13.4%, nausea and emesis 7.1%, pain of puncture point 29.6% and duodenum and gastric retention 4.3%) and systemic (mainly fatigue 22.3%, fever 31.6%, and transient reduction of intraoperative blood pressure 25.1% and white cell count reduction 18.3%) reactions, fever was the most frequent. The serum amylase level at 24 h and 7 d after IRE was not significantly changed compared to those before IRE (P > 0.05). CA19–9 value was lower in IRE-NK group than in IRE at 1 month after treatment (P < 0.05). After a median follow-up of 7.4 months (3.6–11.2 months): in stage III group, median PFS was higher in IRE-NK group (9.3 months) than in IRE group (8.1 months, P = 0.0465), median OS was higher in IRE-NK (13.2 months) than in IRE (11.4 months, P = 0.0411), and median PFS was higher in who received multiple NK than single NK (9.8 months vs.8.1 months, P = 0.0423, respectively), median OS who received multiple NK was higher than single NK (13.9 months vs.12.3 months, P = 0.0524, respectively), the RR in IRE-NK (63.2%) was higher than in IRE (50.0%, P < 0.05); in stage IV group, median OS was higher in IRE-NK (9.8 months) than in IRE (8.7 months, P = 0.0397), the DCR in IRE-NK (66.7%) was higher than in IRE (42.9%, P < 0.05). Materials and Methods Between July 2016 and May 2017, we enrolled 71 patients who met the enrollment criteria. The patients were divided into stage III (32 patients, 17 patients received only IRE and 15 patients received IRE-NK (Irreversible electroporation- natural killer): 8 patients underwent a course of NK and 7 patients underwent ≥ 3 courses) and stage IV (39 patients, 22 patients received only IRE and 17 patients received IRE-NK: 9 patients underwent a course of NK and 8 patients underwent ≥ 3 courses). The safety and short-term effects were evaluated firstly, then the median PFS, median OS, response rate (RR) and disease control rate (DCR) were assessed. Conclusions Combination of irreversible electroporation and allogeneic natural killer cell immunotherapy significantly increased median PFS and median OS in stage III pancreatic cancer and extended the median OS of stage IV pancreatic cancer. Multiple allogeneic natural killer cells infusion was associated with better prognosis to stage III pancreatic cancer. PMID:29254205

Stem cell transplantation and mesenchymal cells to treat autoimmune diseases.

PubMed

Tyndall, Alan; van Laar, Jacob M

2016-06-01

Since the start of the international stem cell transplantation project in 1997, over 2000 patients have received a haematopoietic stem cell transplant (HSCT), mostly autologous, as treatment for a severe autoimmune disease, the majority being multiple sclerosis (MS), systemic sclerosis (SSc) and Crohn's disease. There was an overall 85% 5-year survival and 43% progression-free survival. Around 30% of patients in all disease subgroups had a complete response, often durable despite full immune reconstitution. In many cases, e.g. systemic sclerosis, morphological improvement such as reduction of skin collagen and normalization of microvasculature was documented, beyond any predicted known effects of intense immunosuppression alone. It is hoped that the results of the three running large prospective randomized controlled trials will allow modification of the protocols to reduce the high transplant-related mortality which relates to regimen intensity, age of patient, and comorbidity. Mesenchymal stromal cells (MSC), often incorrectly called stem cells, have been the intense focus of in vitro studies and animal models of rheumatic and other diseases over more than a decade. Despite multiple plausible mechanisms of action and a plethora of positive in vivo animal studies, few randomised controlled clinical trials have demonstrated meaningful clinical benefit in any condition so far. This could be due to confusion in cell product terminology, complexity of clinical study design and execution or agreement on meaningful outcome measures. Within the rheumatic diseases, SLE and rheumatoid arthritis (RA) have received most attention. Uncontrolled multiple trial data from over 300 SLE patients have been published from one centre suggesting a positive outcome; one single centre comparative study in 172 RA was positive. In addition, small numbers of patients with Crohn's disease, multiple sclerosis, primary Sjögren's disease, polymyositis/dermatomyositis and type II diabetes mellitus have received MSC therapeutically. The possible reasons for this apparent mismatch between expectation and clinical reality will be discussed. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Early malnutrition screening and low cost protein supplementation in elderly patients admitted to a skilled nursing facility.

PubMed

Harding, Krystal M; Dyo, Melissa; Goebel, Joy R; Gorman, Nik; Levine, Julia

2016-08-01

Malnutrition among skilled nursing facility (SNF) patients can lead to hospital readmissions and multiple complications. To evaluate the effect of an existing malnutrition screening and management program on prealbumin levels of patients in skilled nursing facilities. A retrospective design was used to evaluate baseline admission data including a prealbumin level. Patients with malnutrition received an oral protein supplement according to protocol. A comparison prealbumin level was obtained at 30days. Nearly half of the patients were severely malnourished on admission. Patients receiving the prescribed protocol had significantly increased prealbumin levels at 30days than those patients that did not receive the protocol as prescribed. A prealbumin level upon admission at a SNF could represent a reliable tool to evaluate malnutrition. Initiation of an early malnutrition screening and protein supplement program in this setting is essential to identifying and treating at-risk patients before complications occur. Copyright © 2015 Elsevier Inc. All rights reserved.

Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis.

PubMed

Moreau, Philippe; Dimopoulos, Meletios A; Richardson, Paul G; Siegel, David S; Cavo, Michele; Corradini, Paolo; Weisel, Katja; Delforge, Michel; O'Gorman, Peter; Song, Kevin; Chen, Christine; Bahlis, Nizar; Oriol, Albert; Hansson, Markus; Kaiser, Martin; Anttila, Pekka; Raymakers, Reinier; Joao, Cristina; Cook, Gordon; Sternas, Lars; Biyukov, Tsvetan; Slaughter, Ana; Hong, Kevin; Herring, Jennifer; Yu, Xin; Zaki, Mohamed; San-Miguel, Jesus

2017-09-01

Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs are important to ensure patients continue therapy long enough to receive the best clinical benefit. Data from the MM-002, MM-003, and MM-010 trials were pooled to further characterize the safety profile of pomalidomide plus low-dose dexamethasone and AE management. This analysis included 1088 patients who received ≥ 2 prior therapies, including lenalidomide and bortezomib, and progressed ≤ 60 days of last therapy. Patients received 28-day cycles of pomalidomide 4 mg/day on days 1-21 and low-dose dexamethasone 40 mg (20 mg if aged > 75 years) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. The most common grade 3/4 AEs were neutropenia (56.2%), anemia (32.3%), and thrombocytopenia (25.8%), which occurred within the first few cycles of treatment. Grade 3/4 infections occurred in 33.7% patients, of whom 13.9% had pneumonia, and 40.3% had neutropenia. Pomalidomide dose reductions or interruptions were reported in 24.2% and 66.0% of patients, respectively. AEs were managed by dose modifications and/or supportive care. Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Gut microbiota in multiple sclerosis: possible influence of immunomodulators.

PubMed

Cantarel, Brandi L; Waubant, Emmanuelle; Chehoud, Christel; Kuczynski, Justin; DeSantis, Todd Z; Warrington, Janet; Venkatesan, Arun; Fraser, Claire M; Mowry, Ellen M

2015-06-01

Differences in gut bacteria have been described in several autoimmune disorders. In this exploratory pilot study, we compared gut bacteria in patients with multiple sclerosis and healthy controls and evaluated the influence of glatiramer acetate and vitamin D treatment on the microbiota. Subjects were otherwise healthy white women with or without relapsing-remitting multiple sclerosis who were vitamin D insufficient. Patients with multiple sclerosis were untreated or were receiving glatiramer acetate. Subjects collected stool at baseline and after 90 days of vitamin D3 (5000 IU/d) supplementation. The abundance of operational taxonomic units was evaluated by hybridization of 16S rRNA to a DNA microarray. While there was overlap of gut bacterial communities, the abundance of some operational taxonomic units, including Faecalibacterium, was lower in patients with multiple sclerosis. Glatiramer acetate-treated patients with multiple sclerosis showed differences in community composition compared with untreated subjects, including Bacteroidaceae, Faecalibacterium, Ruminococcus, Lactobacillaceae, Clostridium, and other Clostridiales. Compared with the other groups, untreated patients with multiple sclerosis had an increase in the Akkermansia, Faecalibacterium, and Coprococcus genera after vitamin D supplementation. While overall bacterial communities were similar, specific operational taxonomic units differed between healthy controls and patients with multiple sclerosis. Glatiramer acetate and vitamin D supplementation were associated with differences or changes in the microbiota. This study was exploratory, and larger studies are needed to confirm these preliminary results.

Preventing Facial Pressure Ulcers in Acute Respiratory Distress Syndrome (ARDS).

PubMed

Kim, Ruth S; Mullins, Kimberly

2016-01-01

In patients with acute lung injury and/or severe acute respiratory distress syndrome (ARDS), prone positioning is a therapeutic intervention to improve oxygenation. Positioning a patient in a prone position increases the risk of medical device-related pressure ulcers in the facial area. This article summarizes experience with 4 patients with ARDS. Two did not receive pressure ulcer preventive measures and subsequently developed multiple necrotic facial pressure ulcers related to prone positioning for treatment of ARDS. The other 2 patients were managed on a thin silicone foam dressing; neither of these patients developed facial pressure ulcers during pronation therapy. The use of thin soft silicone foam dressings may prevent the development of facial deep tissue injuries in patients receiving prolonged pronation therapy.

Erythrocyte membrane fatty acids in multiple sclerosis patients and hot-nature dietary intervention with co-supplemented hemp-seed and evening-primrose oils.

PubMed

Rezapour-Firouzi, Soheila; Arefhosseini, Seyed Rafie; Ebrahimi-Mamaghani, Mehrangiz; Farhoudi, Mehdi; Baradaran, Behzad; Ali, Torbati Mohammad; Zamani, Fatemeh

2013-01-01

The risk of developing multiple sclerosis (MS) is associated with increased dietary intake of saturated fatty acids. For many years it has been suspected that this disease might be associated with an imbalance between unsaturated and saturated fatty acids. We determined erythrocyte membrane fatty acids levels in Hot nature dietary intervention with co-supplemented hemp seed and evening primrose oils in multiple sclerosis patients. To determine the erythrocyte membrane fatty acids levels and correlate it with expanded disability status scale (EDSS) at baseline after 6 months intervention in MS patients by gas chromatography, in this double blind, randomized trial, 100 RRMS patients with EDSS<6 were allocated into three groups: "Group A" that received co-supplemented hemp seed and evening primrose oils with advised Hot nature diet. "Group B" received olive oil and "Group C" received the co-supplemented oils. The results showed that the mean follow-up was 180 ± 2.9SD days (N=65, 23 M and 42 F aged 34.25 ± 8.07 years with disease duration of 6.80 ± 4.33 years). There was no significant difference in the study parameters at baseline. After 6 months, EDSS, Immunological parameters and the erythrocyte cell membrane with regard to specific fatty acids showed improvement in the group A and C, whereas there was worsening condition for the group B after the intervention. We concluded that Hot-nature dietary intervention with co-supplemented hemp seed and evening primrose oils caused an increase PUFAs in MS patients and improvement in the erythrocyte membrane fatty acids composition. This could be an indication of restored plasma stores, and a reflection of disease severity reduction.

Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study.

PubMed

Lisi, Franco; Carfagna, Piero; Oliva, Mario Montanino; Rago, Rocco; Lisi, Rosella; Poverini, Roberta; Manna, Claudio; Vaquero, Elena; Caserta, Donatella; Raparelli, Valeria; Marci, Roberto; Moscarini, Massimo

2012-07-23

Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n=50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients.

Phage idiotype vaccination: first phase I/II clinical trial in patients with multiple myeloma

PubMed Central

2014-01-01

Background Multiple myeloma is characterized by clonal expansion of B cells producing monoclonal immunoglobulins or fragments thereof, which can be detected in the serum and/or urine and are ideal target antigens for patient-specific immunotherapies. Methods Using phage particles as immunological carriers, we employed a novel chemically linked idiotype vaccine in a clinical phase I/II trial including 15 patients with advanced multiple myeloma. Vaccines composed of purified paraproteins linked to phage were manufactured successfully for each patient. Patients received six intradermal immunizations with phage idiotype vaccines in three different dose groups. Results Phage idiotype was well tolerated by all study participants. A subset of patients (80% in the middle dose group) displayed a clinical response indicated by decrease or stabilization of paraprotein levels. Patients exhibiting a clinical response to phage vaccines also raised idiotype-specific immunoglobulins. Induction of a cellular immune response was demonstrated by a cytotoxicity assay and delayed type hypersensitivity tests. Conclusion We present a simple, time- and cost-efficient phage idiotype vaccination strategy, which represents a safe and feasible patient-specific therapy for patients with advanced multiple myeloma and produced promising anti-tumor activity in a subset of patients. PMID:24885819

[Effects of pamidronate disodium (Bonin) combined with chemotherapy on bone pain in multiple myeloma].

PubMed

Leng, Yun; Chen, Shi-lun; Shi, Hong-zhi

2002-10-01

Objective. To evaluate the therapeutic effects of Disodium Pamidronate (Bonin) on bone pain in multiple myeloma. Method. 18 patients received only chemotherapy and 16 patients with addition of Bonin were compared. Result. The bone pain was significantly relieved both in chemotherapy alone group and in the combination group of Bonin with chemotherapy after treatment (P<0.01, as compared with before therapy). However, the effects of combination group were more dramatical than that of the other group (P<0.05). No obvious side-effects were observed except mild fever in one patient in the combination group. Conclusion. Bonin, as a safe and effective Bisphosphonates preparation, could relieve bone pain in multiple myeloma more effectively when combined with chemotherapy.

[The results of a randomized open multicenter comparative study on the tolerability and safety of gilenya (fingolimod) in patients with remitting multiple sclerosis].

PubMed

Popova, E V; Boyko, A N; Boyko, O V

2015-01-01

At the present time, disease modifying drugs (DMD) for treatment of patients with multiple sclerosis are used to reduce the risk of exacerbations and, consequently, slowing the progression of disability in accordance to treatment standards. However, the application of the first line of this therapy is not always successful. In these situations, patients receive second-line DMD. Fingolimod is one of the second-line drugs in Russia. To gain experience in using fingolimod in routine neurological practice, we have conducted a post-marketing research - GIMN.

Retreatment with bortezomib alone or in combination for patients with multiple myeloma following an initial response to bortezomib.

PubMed

Sood, Raman; Carloss, Harry; Kerr, Robert; Lopez, Jose; Lee, Martin; Druck, Mark; Walters, Ian B; Noga, Stephen J

2009-10-01

This clinical trial was conducted to determine the safety and efficacy of bortezomib retreatment in patients with multiple myeloma (MM) who had previously responded to bortezomib. Patients with progressive MM who had previously tolerated bortezomib as a single agent or in combination with other drugs, with a minimum of partial response (PR; >or=50% M-protein reduction) for >or=4 months, who had not received intervening MM therapy, were retreated with bortezomib (days 1, 4, 8, and 11 of a 21-day cycle) with a starting dose being the dose at which the patient ended the initial treatment. Patients were allowed to receive bortezomib on retreatment in combination with dexamethasone, thalidomide, or doxorubicin. Thirty-two patients received bortezomib retreatment (most with added dexamethasone). The median treatment-free interval (last dose of initial bortezomib treatment to first dose of retreatment) was 9.9 (range 2.5-34.0) months. The median duration of retreatment was 2.8 (<1-7.9) months; median total duration of bortezomib treatment was 6.7 (2.5-19.8) months. Based on the investigators' assessment of best response, the overall response rate (complete plus PR) was 50%. The median time from start of retreatment to progressive disease (PD) was 6.6 (95% confidence interval: 5.1-9.6) months. Thirteen patients (41%) experienced PN; bortezomib-related SAEs were reported in four patients. Retreatment with bortezomib alone or in combination is effective and well tolerated in patients with MM who have responded to their initial bortezomib treatment. (c) 2009 Wiley-Liss, Inc.

Multiple Testing, Cumulative Radiation Dose, and Clinical Indications in Patients Undergoing Myocardial Perfusion Imaging

PubMed Central

Einstein, Andrew J.; Weiner, Shepard D.; Bernheim, Adam; Kulon, Michal; Bokhari, Sabahat; Johnson, Lynne L.; Moses, Jeffrey W.; Balter, Stephen

2013-01-01

Context Myocardial perfusion imaging (MPI) is the single medical test with the highest radiation burden to the US population. While many patients undergoing MPI receive repeat MPI testing, or additional procedures involving ionizing radiation, no data are available characterizing their total longitudinal radiation burden and relating radiation burden with reasons for testing. Objective To characterize procedure counts, cumulative estimated effective doses of radiation, and clinical indications, for patients undergoing MPI. Design, Setting, Patients Retrospective cohort study evaluating, for 1097 consecutive patients undergoing index MPI during the first 100 days of 2006 at Columbia University Medical Center, all preceding medical imaging procedures involving ionizing radiation undergone beginning October 1988, and all subsequent procedures through June 2008, at that center. Main Outcome Measures Cumulative estimated effective dose of radiation, number of procedures involving radiation, and indications for testing. Results Patients underwent a median (interquartile range, mean) of 15 (6–32, 23.9) procedures involving radiation exposure; 4 (2–8, 6.5) were high-dose (≥3 mSv, i.e. one year's background radiation), including 1 (1–2, 1.8) MPI studies per patient. 31% of patients received cumulative estimated effective dose from all medical sources >100mSv. Multiple MPIs were performed in 39% of patients, for whom cumulative estimated effective dose was 121 (81–189, 149) mSv. Men and whites had higher cumulative estimated effective doses, and there was a trend towards men being more likely to undergo multiple MPIs than women (40.8% vs. 36.6%, Odds ratio 1.29, 95% confidence interval 0.98–1.69). Over 80% of initial and 90% of repeat MPI exams were performed in patients with known cardiac disease or symptoms consistent with it. Conclusion In this institution, multiple testing with MPI was very common, and in many patients associated with very high cumulative estimated doses of radiation. PMID:21078807

What is different about workers' compensation patients? Socioeconomic predictors of baseline disability status among patients with lumbar radiculopathy.

PubMed

Atlas, Steven J; Tosteson, Tor D; Hanscom, Brett; Blood, Emily A; Pransky, Glenn S; Abdu, William A; Andersson, Gunnar B; Weinstein, James N

2007-08-15

Combined analysis of 2 prospective clinical studies. To identify socioeconomic characteristics associated with workers' compensation in patients with an intervertebral disc herniation (IDH) or spinal stenosis (SpS). Few studies have compared socioeconomic differences between those receiving or not receiving workers' compensation with the same underlying clinical conditions. Patients were identified from the Spine Patient Outcomes Research Trial (SPORT) and the National Spine Network (NSN) practice-based outcomes study. Patients with IDH and SpS within NSN were identified satisfying SPORT eligibility criteria. Information on disability and work status at baseline evaluation was used to categorize patients into 3 groups: workers' compensation, other disability compensation, or work-eligible controls. Enrollment rates of patients with disability in a clinical efficacy trial (SPORT) and practice-based network (NSN) were compared. Independent socioeconomic predictors of baseline workers' compensation status were identified in multivariate logistic regression models controlling for clinical condition, study cohort, and initial treatment designation. Among 3759 eligible patients (1480 in SPORT and 2279 in NSN), 564 (15%) were receiving workers' compensation, 317 (8%) were receiving other disability compensation, and 2878 (77%) were controls. Patients receiving workers' compensation were less common in SPORT than NSN (9.2% vs. 18.8%, P < 0.001), but patients receiving other disability compensation were similarly represented (8.9% vs. 7.7%, P = 0.19). In univariate analyses, many socioeconomic characteristics significantly differed according to baseline workers' compensation status. In multiple logistic regression analyses, gender, educational level, work characteristics, legal action, and expectations about ability to work without surgery were independently associated with receiving workers' compensation. Clinical trials involving conditions commonly seen in patients with workers' compensation may need special efforts to ensure adequate representation. Socioeconomic characteristics markedly differed between patients receiving and not receiving workers' compensation. Identifying the independent effects of workers' compensation on outcomes will require controlling for these baseline characteristics and other clinical features associated with disability status.

Twice-weekly ixazomib in combination with lenalidomide-dexamethasone in patients with newly diagnosed multiple myeloma.

PubMed

Richardson, Paul G; Hofmeister, Craig C; Rosenbaum, Cara A; Htut, Myo; Vesole, David H; Berdeja, Jesus G; Liedtke, Michaela; Chari, Ajai; Smith, Stephen D; Lebovic, Daniel; Raje, Noopur; Byrne, Catriona; Liao, Eileen; Gupta, Neeraj; Bacco, Alessandra Di; Estevam, Jose; Berg, Deborah; Baz, Rachid

2018-06-25

Weekly ixazomib with lenalidomide-dexamethasone (Rd) is feasible and has shown activity in newly diagnosed multiple myeloma (NDMM) patients. This phase 1/2 study (NCT01383928) evaluated the recommended phase 2 dose (RP2D), pharmacokinetics, safety and efficacy of twice-weekly ixazomib plus Rd in NDMM; 64 patients were enrolled across both phases. Patients received twice-weekly oral ixazomib 3·0 or 3·7 mg plus lenalidomide 25 mg and dexamethasone 20 mg (10 mg in cycles 9-16) for up to sixteen 21-day cycles, followed by maintenance with twice-weekly ixazomib alone. No dose-limiting toxicities were reported in cycle 1; the RP2D was 3·0 mg based on overall tolerability across multiple cycles. In 62 evaluable patients, the confirmed overall response rate was 94% (68% ≥very good partial response; 24% complete response). Median progression-free survival was 24·9 months. Responses (median duration 36·9 months for patients receiving the RP2D) deepened during treatment. Grade 3 drug-related adverse events (AEs) occurred in 64% of patients, including: rash, 13%; peripheral neuropathy, 8%; hyperglycaemia, 8%. There were no grade 4 drug-related AEs. Thirteen patients discontinued due to AEs. Twice-weekly ixazomib-Rd offers substantial activity with promising long-term outcomes in NDMM patients but may be associated with greater toxicity compared with weekly ixazomib-Rd in this setting. © 2018 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd on behalf of British Society for Haematology.

Patterns of relapse and outcome of elderly multiple myeloma patients treated as front-line therapy with novel agents combinations☆

PubMed Central

Lopez, Aurelio; Mateos, Maria-Victoria; Oriol, Albert; Valero, Marta; Martínez, Joaquín; Lorenzo, Jose Ignacio; Perez, Montserrat; Martinez, Rafael; de Paz, Raquel; Granell, Miguel; De Arriba, Felipe; Blanchard, M. Jesús; Peñalver, Francisco Javier; Bello, Jose Luis; Martin, Maria Luisa; Bargay, Joan; Blade, Joan; Lahuerta, Juan Jose; San Miguel, Jesús F.; de la Rubia, Javier

2015-01-01

We report the characteristics of relapse, treatment response, and outcomes of 145 elderly patients with multiple myeloma in first relapse after front-line treatment with VMP or VTP. Reappearance of CRAB symptoms (113 patients) and more aggressive forms of disease (32 patients) were the most common patterns of relapse. After second-line therapy, 75 (51.7%) patients achieved at partial response and 16 (11%) complete response (CR). Overall survival was longer among patients receiving VMP as front-line induction (21.4 vs. 14.4 months, P=0.037), in patients achieving CR (28.3 vs. 14.8 months; P=0.04), and in patients without aggressive relapse (28.6 vs. 7.6 months; P=0.0007). PMID:26500850

Management of cystinuric patients: an observational, retrospective, single-centre analysis.

PubMed

Ahmed, Kamran; Khan, Mohammad Shamim; Thomas, Kay; Challacombe, Ben; Bultitude, Matthew; Glass, Jonathan; Tiptaft, Richard; Dasgupta, Prokar

2008-01-01

A critical appraisal of the management of patients with cystine stones treated in our unit in the past 6 years and to analyze the outcome of multimodality therapies. An observational, single-centre retrospective study. We reviewed the records of all patients with stones referred to our centre over a 6-year period from 1998 to 2005. Data recorded included demographic details, medical therapies received/prescribed, compliance with medical therapies, mode of treatment, stone clearance and any recurrence during this period of study. A total of 30 cystinuric patients were treated in our institution over the period of 6 years from 1998 to early 2005. Of these 16 were males and 14 females with an average age at last follow-up of 39 years (range 15-70). Two patients were successfully managed medically. The remaining patients (n = 28) underwent a total of 237 procedures (pre- and postreferral to our unit), with an average of 7.9 procedures per patient for 126 stone episodes (4.2 episodes/patient). The modes of treatment included extracorporeal shockwave lithotripsy (n = 143), ureterorenoscopy and intracorporeal lithotripsy (n = 50), percutaneous nephrolithotomy (n = 28) and open procedures (n = 16). Two patients needed open surgery at our unit. Prior to referral to our dedicated unit, patients had received treatment with extracorporeal shockwave lithotripsy (multiple sessions), ureteroscopy (n = 14), percutaneous nephrolithotomy (n = 4) and open stone removal (n = 14). Most of the stones at our unit were managed using minimally invasive therapies. Compliance of cystinuric patients with medical treatment is often poor and patients experience recurrent stone episodes requiring multiple interventions. Modern management of cystine calculi should be with staged minimally invasive procedures to avoid the complications of multiple open procedures wherever possible along with appropriate medical prophylaxis.

What Is Different About Worker’s Compensation Patients?

PubMed Central

Atlas, Steven J.; Tosteson, Tor D.; Hanscom, Brett; Blood, Emily A.; Pransky, Glenn S.; Abdu, William A.; Andersson, Gunnar B.; Weinstein, James N.

2010-01-01

Study Design Combined analysis of 2 prospective clinical studies. Objective To identify socioeconomic characteristics associated with workers’ compensation in patients with an intervertebral disc herniation (IDH) or spinal stenosis (SpS). Summary of Background Data Few studies have compared socioeconomic differences between those receiving or not receiving workers’ compensation with the same underlying clinical conditions. Methods Patients were identified from the Spine Patient Outcomes Research Trial (SPORT) and the National Spine Network (NSN) practice-based outcomes study. Patients with IDH and SpS within NSN were identified satisfying SPORT eligibility criteria. Information on disability and work status at baseline evaluation was used to categorize patients into 3 groups: workers’ compensation, other disability compensation, or work-eligible controls. Enrollment rates of patients with disability in a clinical efficacy trial (SPORT) and practice-based network (NSN) were compared. Independent socioeconomic predictors of baseline workers’ compensation status were identified in multivariate logistic regression models controlling for clinical condition, study cohort, and initial treatment designation. Results Among 3759 eligible patients (1480 in SPORT and 2279 in NSN), 564 (15%) were receiving workers’ compensation, 317 (8%) were receiving other disability compensation, and 2878 (77%) were controls. Patients receiving workers’ compensation were less common in SPORT than NSN (9.2% vs. 18.8%, P < 0.001), but patients receiving other disability compensation were similarly represented (8.9% vs. 7.7%, P = 0.19). In univariate analyses, many socioeconomic characteristics significantly differed according to baseline workers’ compensation status. In multiple logistic regression analyses, gender, educational level, work characteristics, legal action, and expectations about ability to work without surgery were independently associated with receiving workers’ compensation. Conclusion Clinical trials involving conditions commonly seen in patients with workers’ compensation may need special efforts to ensure adequate representation. Socioeconomic characteristics markedly differed between patients receiving and not receiving workers’ compensation. Identifying the independent effects of workers’ compensation on outcomes will require controlling for these baseline characteristics and other clinical features associated with disability status. PMID:17700451

Glaucoma filtration surgery following sustained elevation of intraocular pressure secondary to intravitreal anti-VEGF injections.

PubMed

Skalicky, Simon E; Ho, Ivan; Agar, Ashish; Bank, Allan

2012-07-01

To document cases of sustained elevation of intraocular pressure (IOP) while receiving intravitreal anti-vascular endothelial growth factor (VEGF) agents and subsequent management. A retrospective series of all cases managed by the authors and colleagues was performed. Six patients developed sustained elevated IOP; five received ranibizumab and one bevacizumab. Four received unilateral and two received bilateral injections. Two had preexisting primary open-angle glaucoma and one had pseudoexfoliative glaucoma, all with stable IOP prior to anti-VEGF treatment. Angles were open in all cases. Peak IOP averaged 43 mm Hg (range: 34 to 60 mm Hg). The mean number of injections preceding the IOP increase was 10 (range: 1 to 20). Four patients required trabeculectomy, one selective laser trabeculoplasty, and one multiple topical medications. A sustained increase in IOP requiring glaucoma filtering surgery is a rare but important treatment complication for patients receiving intravitreal anti-VEGF therapy, especially those with preexisting glaucoma or glaucoma risk factors. Copyright 2012, SLACK Incorporated.

Prediction of peripheral neuropathy in multiple myeloma patients receiving bortezomib and thalidomide: a genetic study based on a single nucleotide polymorphism array.

PubMed

García-Sanz, Ramón; Corchete, Luis Antonio; Alcoceba, Miguel; Chillon, María Carmen; Jiménez, Cristina; Prieto, Isabel; García-Álvarez, María; Puig, Noemi; Rapado, Immaculada; Barrio, Santiago; Oriol, Albert; Blanchard, María Jesús; de la Rubia, Javier; Martínez, Rafael; Lahuerta, Juan José; González Díaz, Marcos; Mateos, María Victoria; San Miguel, Jesús Fernando; Martínez-López, Joaquín; Sarasquete, María Eugenia

2017-12-01

Bortezomib- and thalidomide-based therapies have significantly contributed to improved survival of multiple myeloma (MM) patients. However, treatment-induced peripheral neuropathy (TiPN) is a common adverse event associated with them. Risk factors for TiPN in MM patients include advanced age, prior neuropathy, and other drugs, but there are conflicting results about the role of genetics in predicting the risk of TiPN. Thus, we carried out a genome-wide association study based on more than 300 000 exome single nucleotide polymorphisms in 172 MM patients receiving therapy involving bortezomib and thalidomide. We compared patients developing and not developing TiPN under similar treatment conditions (GEM05MAS65, NCT00443235). The highest-ranking single nucleotide polymorphism was rs45443101, located in the PLCG2 gene, but no significant differences were found after multiple comparison correction (adjusted P = .1708). Prediction analyses, cytoband enrichment, and pathway analyses were also performed, but none yielded any significant findings. A copy number approach was also explored, but this gave no significant results either. In summary, our study did not find a consistent genetic component associated with TiPN under bortezomib and thalidomide therapies that could be used for prediction, which makes clinical judgment essential in the practical management of MM treatment. Copyright © 2016 John Wiley & Sons, Ltd.

Evaluation of TNF-α serum level in patients with recalcitrant multiple common warts, treated by lipid garlic extract.

PubMed

Kenawy, Soha; Mohammed, Ghada Farouk; Younes, Soha; Elakhras, Atef Ibrahim

2014-01-01

No universal consensus about optimal modality for treating the recalcitrant multiple common warts (RMCW). The objective of the study was to evaluate the immunological mechanisms and clinical therapeutic effect of using lipid garlic extract (LGE) in the treatment of RMCW. The study included 50 patients with RMCW. They were randomly assigned into two groups: the first group (25 patients) received LGE, and the second group (25 patients) received saline as a control group. In both groups, treatments were made to single lesions, or largest wart in case of multiple lesions, until complete clearance of lesions or for a maximum of 4 weeks. Blood serum was taken at pre-study and at the fourth week to measure tumor necrosis factor alpha (TNF-α) level. A significant difference was found between the therapeutic responses of RMCW to LGE antigen and saline control group (p < 0.001). In the LGE group, complete response was achieved in 96% of patients presenting with RMCW. There was a statistically nonsignificant increase in TNF-α of LGE group versus saline group. No recurrence was observed in the LGE group. LGE as an immunotherapy is an inexpensive, effective, and safe modality with good cure rates for treatment of RMCWs, when other topical or physical therapies have failed. © 2014 Wiley Periodicals, Inc.

Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial.

PubMed

Gandolfi, Marialuisa; Munari, Daniele; Geroin, Christian; Gajofatto, Alberto; Benedetti, Maria Donata; Midiri, Alessandro; Carla, Fontana; Picelli, Alessandro; Waldner, Andreas; Smania, Nicola

2015-10-01

Impaired sensory integration contributes to balance disorders in patients with multiple sclerosis (MS). The objective of this paper is to compare the effects of sensory integration balance training against conventional rehabilitation on balance disorders, the level of balance confidence perceived, quality of life, fatigue, frequency of falls, and sensory integration processing on a large sample of patients with MS. This single-blind, randomized, controlled trial involved 80 outpatients with MS (EDSS: 1.5-6.0) and subjective symptoms of balance disorders. The experimental group (n = 39) received specific training to improve central integration of afferent sensory inputs; the control group (n = 41) received conventional rehabilitation (15 treatment sessions of 50 minutes each). Before, after treatment, and at one month post-treatment, patients were evaluated by a blinded rater using the Berg Balance Scale (BBS), Activities-specific Balance Confidence Scale (ABC), Multiple Sclerosis Quality of Life-54, Fatigue Severity Scale (FSS), number of falls and the Sensory Organization Balance Test (SOT). The experimental training program produced greater improvements than the control group training on the BBS (p < 0.001), the FSS (p < 0.002), number of falls (p = 0.002) and SOT (p < 0.05). Specific training to improve central integration of afferent sensory inputs may ameliorate balance disorders in patients with MS. Clinical Trial Registration (NCT01040117). © The Author(s), 2015.

Antimalarial Activity of KAF156 in Falciparum and Vivax Malaria.

PubMed

White, Nicholas J; Duong, Tran T; Uthaisin, Chirapong; Nosten, François; Phyo, Aung P; Hanboonkunupakarn, Borimas; Pukrittayakamee, Sasithon; Jittamala, Podjanee; Chuthasmit, Kittiphum; Cheung, Ming S; Feng, Yiyan; Li, Ruobing; Magnusson, Baldur; Sultan, Marc; Wieser, Daniela; Xun, Xiaolei; Zhao, Rong; Diagana, Thierry T; Pertel, Peter; Leong, F Joel

2016-09-22

KAF156 belongs to a new class of antimalarial agents (imidazolopiperazines), with activity against asexual and sexual blood stages and the preerythrocytic liver stages of malarial parasites. We conducted a phase 2, open-label, two-part study at five centers in Thailand and Vietnam to assess the antimalarial efficacy, safety, and pharmacokinetic profile of KAF156 in adults with acute Plasmodium vivax or P. falciparum malaria. Assessment of parasite clearance rates in cohorts of patients with vivax or falciparum malaria who were treated with multiple doses (400 mg once daily for 3 days) was followed by assessment of the cure rate at 28 days in a separate cohort of patients with falciparum malaria who received a single dose (800 mg). Median parasite clearance times were 45 hours (interquartile range, 42 to 48) in 10 patients with falciparum malaria and 24 hours (interquartile range, 20 to 30) in 10 patients with vivax malaria after treatment with the multiple-dose regimen and 49 hours (interquartile range, 42 to 54) in 21 patients with falciparum malaria after treatment with the single dose. Among the 21 patients who received the single dose and were followed for 28 days, 1 had reinfection and 7 had recrudescent infections (cure rate, 67%; 95% credible interval, 46 to 84). The mean (±SD) KAF156 terminal elimination half-life was 44.1±8.9 hours. There were no serious adverse events in this small study. The most common adverse events included sinus bradycardia, thrombocytopenia, hypokalemia, anemia, and hyperbilirubinemia. Vomiting of grade 2 or higher occurred in 2 patients, 1 of whom discontinued treatment because of repeated vomiting after receiving the single 800-mg dose. More adverse events were reported in the single-dose cohort, which had longer follow-up, than in the multiple-dose cohorts. KAF156 showed antimalarial activity without evident safety concerns in a small number of adults with uncomplicated P. vivax or P. falciparum malaria. (Funded by Novartis and others; ClinicalTrials.gov number, NCT01753323 .).

Clinical outcomes of venous thromboembolism with dalteparin therapy in multiple myeloma patients.

PubMed

Lee, Sung-Eun; Jeon, Young-Woo; Yoon, Jae-Ho; Cho, Byung-Sik; Eom, Ki-Seong; Kim, Yoo-Jin; Kim, Hee-Je; Lee, Seok; Cho, Seok-Goo; Kim, Dong-Wook; Lee, Jong Wook; Min, Woo-Sung; Kim, Myungshin; Min, Chang-Ki

2015-11-01

This study focused on the clinical outcomes in multiple myeloma (MM) patients with venous thromboembolism (VTE) who received low-molecular-weight heparin (dalteparin) therapy. Changes in D-dimer levels before and after VTE were also evaluated. Among 549 patients treated with various chemotherapeutic agents, a total of 52 (9.47%) patients including 32 newly diagnosed with MM and 16 with relapsed/refractory MM developed VTE, 48 of whom received dalteparin. Among the 48 treated patients, 37 (77%) had proximal deep vein thrombosis (DVT), four had (8%) pulmonary embolism (PE), and seven (15%) had both DVT and PE. In 32 patients with available paired samples (at baseline and VTE occurrence), significant conversion of D-dimer levels from 2.2 ± 0.4 mg/L to 11.8 ± 1.6 mg/L (P < 0.001) was observed, which decreased from 10.9 ± 0.4 mg/L to 1.9 ± 0.6 mg/L one month after initiating dalteparin therapy. A total of 44 patients received dalteparin with a median duration of 4.2 months (range, 2.7-9.4), and four patients were discontinued early due to death (n = 3) and major bleeding (n = 1). After a median follow-up of 9.0 months (range, 0.7-35.8) since the first VTE episode, five patients showed recurrence of VTE with a cumulative incidence of 17.5 ± 7.9%. Major bleeding occurred in three patients. In summary, dalteparin seems to be a promising drug for the treatment of VTE in MM. In addition, the significant difference in D-dimer levels observed before occurrence of VTE and after dalteparin treatment may suggest the usefulness of D-dimer testing as a surrogate marker for VTE in MM patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

Comparison of the safety and efficacy of conventional monopolar and 2-micron laser transurethral resection in the management of multiple nonmuscle-invasive bladder cancer.

PubMed

Liu, H; Wu, J; Xue, S; Zhang, Q; Ruan, Y; Sun, X; Xia, S

2013-08-01

To compare the safety and efficacy of conventional monopolar transurethral resection of bladder tumour (TURBT) and 2-micron continuous-wave laser resection (2-µm laser) techniques in the management of multiple nonmuscle-invasive bladder cancer (NMIBC), and to investigate long-term effects on tumour recurrence. Patients with multiple NMIBC were randomized to receive TURBT or 2-µm laser in a nonblinded manner. All patients received intravesical chemotherapy with epirubicin (40 mg/40 ml) for 8 weeks, beginning 1 week after surgery, followed with monthly maintenance therapy for 12 months. Three-year follow-up data of preoperative, operative and postoperative management were recorded. In total, 120 patients were included: 56 in the TURBT group and 64 in the 2-µm laser group. Intra- and postoperative complications (including bladder perforation, bleeding and irritation) were less frequently observed in the 2-µm laser group compared with the TURBT group. There were no significant differences in first time to recurrence, overall recurrence or occurrence of urethral strictures. The 2-µm laser resection method was more effective than TURBT in reducing rates of intra- and postoperative complications, but offered no additional benefit regarding tumour recurrence.

Explore Transplant at Home: a randomized control trial of an educational intervention to increase transplant knowledge for Black and White socioeconomically disadvantaged dialysis patients.

PubMed

Waterman, Amy D; McSorley, Anna-Michelle M; Peipert, John D; Goalby, Christina J; Peace, Leanne J; Lutz, Patricia A; Thein, Jessica L

2015-08-28

Compared to others, dialysis patients who are socioeconomically disadvantaged or Black are less likely to receive education about deceased donor kidney transplant (DDKT) and living donor kidney transplant (LDKT) before they reach transplant centers, often due to limited availability of transplant education within dialysis centers. Since these patients are often less knowledgeable or ready to pursue transplant, educational content must be simplified, made culturally sensitive, and presented gradually across multiple sessions to increase learning and honor where they are in their decision-making about transplant. The Explore Transplant at Home (ETH) program was developed to help patients learn more about DDKT and LDKT at home, with and without telephone conversations with an educator. In this randomized controlled trial (RCT), 540 low-income Black and White dialysis patients with household incomes at or below 250 % of the federal poverty line, some of whom receive financial assistance from the Missouri Kidney Program, will be randomly assigned to one of three education conditions: (1) standard-of-care transplant education provided by the dialysis center, (2) patient-guided ETH (ETH-PG), and (3) health educator-guided ETH (ETH-EG). Patients in the standard-of-care condition will only receive education provided in their dialysis centers. Those in the two ETH conditions will receive four video and print modules delivered over an 8 month period by mail, with the option of receiving supplementary text messages weekly. In addition, patients in the ETH-EG condition will participate in multiple telephonic educational sessions with a health educator. Changes in transplant knowledge, decisional balance, self-efficacy, and informed decision making will be captured with surveys administered before and after the ETH education. At the conclusion of this RCT, we will have determined whether an education program administered to socioeconomically disadvantaged dialysis patients, over several months directly in their homes, can help more individuals learn about the options of DDKT and LDKT. We also will be able to examine the efficacy of different educational delivery approaches to further understand whether the addition of a telephone educator is necessary for increasing transplant knowledge. ClinicalTrials.gov, NCT02268682.

[Clinical course of multiple sclerosis in patients treated with cytostatic drugs for cancer].

PubMed

Santos-García, D; Prieto, J M; Lema, M

The risk of side effects secondary to global and non-specific immune suppression has limited the systematic application of immunosuppressive therapy in multiple sclerosis (MS). However, when a patient with MS develops a cancer, cytostatic drugs as treatment for the neoplastic process may induce improvement not only of the cancer but also of MS. We present a series of four women with clinically defined MS and subjected to cytostatic therapy (cisplatin, 5-fluorouracil, leukovorin, adriamycin, tamoxifen and anastrozole) after the development of cancer: two presented breast cancer, one colon cancer, and the fourth parotid gland malignancy. Their clinical and neuroimaging course is described, following chemotherapy for the malignant disease. None of the patients have suffered further MS outbreaks. The four women have improved and remain clinically stable after neoplastic treatment. Magnetic resonance imaging showed persistence of the same lesion burden in three patients, and reduction in the other. At the present one patient receives weekly intramuscular interferon-beta 1a, whereas the other did not received any treatment. Probably there are no specific cytostatics for MS. Immunosuppressive therapy could be a therapeutic option among patients with an aggressive clinical course.

Comparative Efficacy of Daratumumab Monotherapy and Pomalidomide Plus Low-Dose Dexamethasone in the Treatment of Multiple Myeloma: A Matching Adjusted Indirect Comparison.

PubMed

Van Sanden, Suzy; Ito, Tetsuro; Diels, Joris; Vogel, Martin; Belch, Andrew; Oriol, Albert

2018-03-01

Daratumumab (a human CD38-directed monoclonal antibody) and pomalidomide (an immunomodulatory drug) plus dexamethasone are both relatively new treatment options for patients with heavily pretreated multiple myeloma. A matching adjusted indirect comparison (MAIC) was used to compare absolute treatment effects of daratumumab versus pomalidomide + low-dose dexamethasone (LoDex; 40 mg) on overall survival (OS), while adjusting for differences between the trial populations. The MAIC method reduces the risk of bias associated with naïve indirect comparisons. Data from 148 patients receiving daratumumab (16 mg/kg), pooled from the GEN501 and SIRIUS studies, were compared separately with data from patients receiving pomalidomide + LoDex in the MM-003 and STRATUS studies. The MAIC-adjusted hazard ratio (HR) for OS of daratumumab versus pomalidomide + LoDex was 0.56 (95% confidence interval [CI], 0.38-0.83; p  = .0041) for MM-003 and 0.51 (95% CI, 0.37-0.69; p  < .0001) for STRATUS. The treatment benefit was even more pronounced when the daratumumab population was restricted to pomalidomide-naïve patients (MM-003: HR, 0.33; 95% CI, 0.17-0.66; p  = .0017; STRATUS: HR, 0.41; 95% CI, 0.21-0.79; p  = .0082). An additional analysis indicated a consistent trend of the OS benefit across subgroups based on M-protein level reduction (≥50%, ≥25%, and <25%). The MAIC results suggest that daratumumab improves OS compared with pomalidomide + LoDex in patients with heavily pretreated multiple myeloma. This matching adjusted indirect comparison of clinical trial data from four studies analyzes the survival outcomes of patients with heavily pretreated, relapsed/refractory multiple myeloma who received either daratumumab monotherapy or pomalidomide plus low-dose dexamethasone. Using this method, daratumumab conferred a significant overall survival benefit compared with pomalidomide plus low-dose dexamethasone. In the absence of head-to-head trials, these indirect comparisons provide useful insights to clinicians and reimbursement authorities around the relative efficacy of treatments. © AlphaMed Press 2017.

Comparison of doses received by the hippocampus in patients treated with single isocenter– vs multiple isocenter–based stereotactic radiation therapy to the brain for multiple brain metastases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Algan, Ozer, E-mail: oalgan@ouhsc.edu; Giem, Jared; Young, Julie

To investigate the doses received by the hippocampus and normal brain tissue during a course of stereotactic radiation therapy using a single isocenter (SI)–based or multiple isocenter (MI)–based treatment planning in patients with less than 4 brain metastases. In total, 10 patients with magnetic resonance imaging (MRI) demonstrating 2-3 brain metastases were included in this retrospective study, and 2 sets of stereotactic intensity-modulated radiation therapy (IMRT) treatment plans (SI vs MI) were generated. The hippocampus was contoured on SPGR sequences, and doses received by the hippocampus and the brain were calculated and compared between the 2 treatment techniques. A totalmore » of 23 lesions in 10 patients were evaluated. The median tumor volume, the right hippocampus volume, and the left hippocampus volume were 3.15, 3.24, and 2.63 mL, respectively. In comparing the 2 treatment plans, there was no difference in the planning target volume (PTV) coverage except in the tail for the dose-volume histogram (DVH) curve. The only statistically significant dosimetric parameter was the V{sub 100}. All of the other measured dosimetric parameters including the V{sub 95}, V{sub 99}, and D{sub 100} were not significantly different between the 2 treatment planning techniques. None of the dosimetric parameters evaluated for the hippocampus revealed any statistically significant difference between the MI and SI plans. The total brain doses were slightly higher in the SI plans, especially in the lower dose region, although this difference was not statistically different. The use of SI-based treatment plan resulted in a 35% reduction in beam-on time. The use of SI treatments for patients with up to 3 brain metastases produces similar PTV coverage and similar normal tissue doses to the hippocampus and the brain when compared with MI plans. SI treatment planning should be considered in patients with multiple brain metastases undergoing stereotactic treatment.« less

Comparison of doses received by the hippocampus in patients treated with single isocenter- vs multiple isocenter-based stereotactic radiation therapy to the brain for multiple brain metastases.

PubMed

Algan, Ozer; Giem, Jared; Young, Julie; Ali, Imad; Ahmad, Salahuddin; Hossain, Sabbir

2015-01-01

To investigate the doses received by the hippocampus and normal brain tissue during a course of stereotactic radiation therapy using a single isocenter (SI)-based or multiple isocenter (MI)-based treatment planning in patients with less than 4 brain metastases. In total, 10 patients with magnetic resonance imaging (MRI) demonstrating 2-3 brain metastases were included in this retrospective study, and 2 sets of stereotactic intensity-modulated radiation therapy (IMRT) treatment plans (SI vs MI) were generated. The hippocampus was contoured on SPGR sequences, and doses received by the hippocampus and the brain were calculated and compared between the 2 treatment techniques. A total of 23 lesions in 10 patients were evaluated. The median tumor volume, the right hippocampus volume, and the left hippocampus volume were 3.15, 3.24, and 2.63mL, respectively. In comparing the 2 treatment plans, there was no difference in the planning target volume (PTV) coverage except in the tail for the dose-volume histogram (DVH) curve. The only statistically significant dosimetric parameter was the V100. All of the other measured dosimetric parameters including the V95, V99, and D100 were not significantly different between the 2 treatment planning techniques. None of the dosimetric parameters evaluated for the hippocampus revealed any statistically significant difference between the MI and SI plans. The total brain doses were slightly higher in the SI plans, especially in the lower dose region, although this difference was not statistically different. The use of SI-based treatment plan resulted in a 35% reduction in beam-on time. The use of SI treatments for patients with up to 3 brain metastases produces similar PTV coverage and similar normal tissue doses to the hippocampus and the brain when compared with MI plans. SI treatment planning should be considered in patients with multiple brain metastases undergoing stereotactic treatment. Copyright © 2015 American Association of Medical Dosimetrists. Published by Elsevier Inc. All rights reserved.

Novel therapy in multiple myeloma.

PubMed

Avilés, Agustin; Neri, Natividad; Nambo, M Jesús; Cleto, Sergio; Castañeda, Claudia; González, Martha; Talavera, Alejandra; Huerta-Guzmán, Judith

2005-10-01

Treatment in patients with multiple myeloma remain to be defined. Younger patients (defined as a cut-off level < 65 years old) will be treated with chemotherapy and transplant procedures. However, most patients > 65 years old are not candidates for this therapeutic approach and the use of intensive chemotherapy could be associated to severe toxicity. We developed an new, not-cytotoxic regimen with dexamethasone 30 mg/m(2), iv, days 1 to 4, all trans retinoic acid 45 mg/m(2), po, days 5 to 14 and interferon alfa 2a 4.5 MU, sc, daily, days 5 to 14 (DAI regimen) administered every 28 days in number of 6 cycles, at this point patients were restaging, if they showed complete response, objective response or partial response they were conducted to received thalidomide 100-200 mg po, daily and dexamethasone 10 mg/2, po days 1 to 4 at monthly intervals, for 18 months. Forty one patients were enrolled in an Phase II study. In an intent to treat analysis all patients were evaluable. Complete response was observed in 18 cases (43%), objective response in 10 patients (24%) and partial response in 5 patients (12%), overall response rate was 80%. Eight patients were considered failures. At an median of 36 months, no relapse of progression disease has been observed, thus actuarial curves at 3-years showed that event free survival is 100% and overall survival is 91%. Toxicity was mild, all patients received the planned dose in time. This regimen appear to be useful in older patients with multiple myeloma, the response rate is higher and toxicity was mild. Controlled clinical trials comparing with conventional chemotherapy will be conducted to define the role of this therapeutic approach.

Efficacy of Stereotactic Radiosurgery in Patients with Multiple Metastases: Importance of Volume Rather Than Number of Lesions.

PubMed

Dahshan, Basem A; Mattes, Malcolm D; Bhatia, Sanjay; Palek, Mary Susan; Cifarelli, Christopher P; Hack, Joshua D; Vargo, John A

2017-12-19

The role of stereotactic radiosurgery (SRS) in the treatment of multiple brain metastases is controversial. While whole brain radiation therapy (WBRT) has historically been the mainstay of treatment, its value is increasingly being questioned as emerging data supports that SRS alone can provide comparable therapeutic outcomes for limited (one to three) intracranial metastases with fewer adverse effects, including neurocognitive decline. Multiple recent studies have also demonstrated that patients with multiple (> 3) intracranial metastases with a low overall tumor volume have a favorable therapeutic response to SRS, with no significant difference compared to patients with limited metastases. Herein, we present a patient with previously controlled breast cancer who presented with multiple recurrences of intracranial metastases but low total intracranial tumor volume each time. This patient underwent SRS alone for a total of 40 metastatic lesions over three separate procedures with good local control and without any significant cognitive toxicity. The patient eventually opted for enrollment in the NRG-CC001 clinical trial after multiple cranial recurrences. She received conventional WBRT with six months of memantine and developed significant neurocognitive side effects. This case highlights the growing body of literature supporting the role of SRS alone in the management of multiple brain metastases and the importance of maximizing neurocognition as advances in systemic therapies prolong survival in Stage IV cancer.

Efficacy of Stereotactic Radiosurgery in Patients with Multiple Metastases: Importance of Volume Rather Than Number of Lesions

PubMed Central

Mattes, Malcolm D; Bhatia, Sanjay; Palek, Mary Susan; Cifarelli, Christopher P; Hack, Joshua D; Vargo, John A

2017-01-01

The role of stereotactic radiosurgery (SRS) in the treatment of multiple brain metastases is controversial. While whole brain radiation therapy (WBRT) has historically been the mainstay of treatment, its value is increasingly being questioned as emerging data supports that SRS alone can provide comparable therapeutic outcomes for limited (one to three) intracranial metastases with fewer adverse effects, including neurocognitive decline. Multiple recent studies have also demonstrated that patients with multiple (> 3) intracranial metastases with a low overall tumor volume have a favorable therapeutic response to SRS, with no significant difference compared to patients with limited metastases. Herein, we present a patient with previously controlled breast cancer who presented with multiple recurrences of intracranial metastases but low total intracranial tumor volume each time. This patient underwent SRS alone for a total of 40 metastatic lesions over three separate procedures with good local control and without any significant cognitive toxicity. The patient eventually opted for enrollment in the NRG-CC001 clinical trial after multiple cranial recurrences. She received conventional WBRT with six months of memantine and developed significant neurocognitive side effects. This case highlights the growing body of literature supporting the role of SRS alone in the management of multiple brain metastases and the importance of maximizing neurocognition as advances in systemic therapies prolong survival in Stage IV cancer. PMID:29492355

Inhibition of Interferon-beta Responses in Multiple Sclerosis Immune Cells Associated With High-Dose Statins

PubMed Central

Feng, Xuan; Han, Diana; Kilaru, Bharat K.; Franek, Beverly S.; Niewold, Timothy B.; Reder, Anthony T.

2014-01-01

Objective To determine whether statins affect type 1 interferon responses in relapsing-remitting multiple sclerosis (RRMS). Design Study effects of atorvastatin on type 1 interferon responses in Jurkat cells, mononuclear cells (MNCs) from therapy-naive patients with RRMS in vitro, and MNCs from interferon-treated RRMS patients in vivo in 4 conditions: no drug, statin only, interferon-beta only, and statin added on to interferon-beta therapy. Patients The study examined clinically stable patients with RRMS: 21 therapy-naive patients and 14 patients receiving interferon-beta with a statin. Interventions Statin effects on in vitro and in vivo interferon-beta–induced STAT1 transcription factor activation, expression of interferon-stimulated proteins in MNCs, and serum type 1 interferon activity. Results In vitro, atorvastatin dose dependently inhibited expression of interferon-stimulated P-Y-STAT1 by 44% (P< .001), interferon regulatory factor 1 protein by 30% (P= .006), and myxovirus resistance 1 protein by 32% (P=.004) compared with no-statin control in MNCs from therapy-naive RRMS patients. In vivo, 9 of 10 patients who received high-dose statins (80 mg) had a significant reduction in interferon-beta therapy–induced serum interferon-α/β activity, whereas only 2 of 4 patients who received medium-dose statins (40 mg) had reductions. High-dose add-on statin therapy significantly blocked interferon-beta function, with less P-Y-STAT1 transcription factor activation, and reduced myxovirus resistance 1 protein and viperin protein production. Medium doses of statins did not change STAT1 activation. Conclusions High-dose add-on statin therapy significantly reduces interferon-beta function and type 1 interferon responses in RRMS patients. These data provide a putative mechanism for how statins could counteract the beneficial effects of interferon-beta and worsen disease. PMID:22801747

Phase IV study of retention on fingolimod versus injectable multiple sclerosis therapies: a randomized clinical trial.

PubMed

Cree, Bruce A C; Arnold, Douglas L; Cascione, Mark; Fox, Edward J; Williams, Ian M; Meng, Xiangyi; Schofield, Lesley; Tenenbaum, Nadia

2018-01-01

In relapsing-remitting multiple sclerosis (RRMS), suboptimal adherence to injectable disease-modifying therapies (iDMTs; interferon β-1a/b, glatiramer acetate) is common, reducing their effectiveness. Patient retention on oral fingolimod and iDMTs was evaluated in PREFER MS , a randomized, parallel-group, active-controlled, open-label, 48-week study. Patients were included if they had RRMS, were aged 18-65 years and had Expanded Disability Status Scale score up to 6, enrolled at 117 US study sites, were treatment naïve or had received only one iDMT class. Patients were randomized 1:1 (fingolimod 0.5 mg/day; preselected iDMT) by interactive voice-and-web-response system without blinding, followed up quarterly, and allowed one study-approved treatment switch after 12 weeks, or earlier for efficacy or safety reasons. The primary outcome was patient retention on randomized treatment over 48 weeks. Secondary endpoints included patient-reported outcomes, brain volume loss (BVL), and cognitive function. Analysis of 433/436 patients receiving fingolimod and 428/439 receiving iDMTs showed that patient retention rate was significantly higher with fingolimod than with iDMTs [352 (81.3%) versus 125 (29.2%); 95% confidence interval 46.4-57.8%; p < 0.0001]. The most common treatment switch was from iDMT to fingolimod for injection-related reasons. Patient satisfaction was greater and BVL less with fingolimod than with iDMTs, with no difference in cognitive function. Adverse events were consistent with established tolerability profiles for each treatment. In RRMS, fingolimod was associated with better treatment retention, patient satisfaction and BVL outcomes than iDMTs. Patients may persist with iDMTs, but many may switch treatment if permitted. Treatment satisfaction fosters adherence, a prerequisite for optimal outcomes.

Radiation Dose-rate Reduction Pattern in Well-differentiated Thyroid Cancer Treated with I-131.

PubMed

Khan, Shahbaz Ahmad; Khan, Muhammad Saqib; Arif, Muhammad; Durr-e-Sabih; Rahim, Muhammad Kashif; Ahmad, Israr

2015-07-01

To determine the patterns of dose rate reduction in single and multiple radioiodine (I-131) therapies in cases of well differentiated thyroid cancer patients. Analytical series. Department of Nuclear Medicine and Radiation Physics, Multan Institute of Nuclear Medicine and Radiotherapy (MINAR), Multan, Pakistan, from December 2006 to December 2013. Ninety three patients (167 therapies) with well differentiated thyroid cancer treated with different doses of I-131 as an in-patient were inducted. Fifty four patients were given only single I-131 therapy dose ranging from 70 mCi (2590 MBq) to 150 mCi (5550 MBq). Thirty nine patients were treated with multiple I-131 radioisotope therapy doses ranging from 80 mCi (2960 MBq) to 250 mCi (9250 MBq). T-test was applied on the sample data showed statistically significant difference between the two groups with p-value (p < 0.01) less than 0.05 taken as significant. There were 68 females and 25 males with an age range of 15 to 80 years. Mean age of the patients were 36 years. Among the 93 cases of first time Radio Active Iodine (RAI) therapy, 59 cases (63%) were discharged after 48 hours. Among 39 patients who received RAI therapy second time or more, most were discharged earlier after achieving acceptable discharge dose rate i.e 25 µSv/hour; 2 out of 39 (5%) were discharged after 48 hours. In 58% patients, given single I-131 therapy dose, majority of these were discharged after 48 hours without any major complications. For well differentiated thyroid cancer patients, rapid dose rate reduction is seen in patients receiving second or subsequent radioiodine (RAI) therapy, as compared to first time receiving RAI therapy.

The use of a low dose hydrocortisone to prevent pulmonary embolism in patients with multiple trauma.

PubMed

Chaari, Anis; Ghadhoune, Hatem; Chakroune, Olfa; Abid, Hanen; Turki, Olfa; Bahloul, Mabrouk; Bouaziz, Mounir

2013-08-01

Venous thromboembolism events are common in trauma patients. Immediate acute inflammation following injury triggers coagulation cascade and may increase the risk of pulmonary embolism (PE) in this population. We aimed to evaluate whether early low-dose steroids prevent symptomatic PE onset in multiple trauma patients. The medical surgical intensive care unit of Habib Bourguiba University Hospital (Sfax--Tunisia). Comparative study of two cohorts: a retrospective cohort of patients who didn't receive early low-dose steroids (steroid (-) group) and a prospective cohort of patients who received hydrocortisone with a dose of 100 mg/8 h for a scheduled period of 7 days (steroid (+) group). All adult patients admitted in our intensive care unit (ICU) for multiple trauma with predicted duration of mechanical ventilation over 48 h were included. Evaluation of the impact of low-dose steroids on the incidence of symptomatic PE. We included 175 patients: 92 in the steroids (-) group and 83 in the steroids (+) group. PE was diagnosed in 15 patients (8.5 %). The incidence of PE was significantly lower in steroid (+) group (3.6 vs 13 %; p = 0.013). In multivariate analysis, independent factors predicting PE onset were meningeal hemorrhage [OR = 14.7; 95 % CI (2.2-96.3); p = 0.013] and pelvic ring trauma [OR = 8; 95 % CI (1.8-36.4); p = 0.007] whereas low-dose steroids were significantly associated with a protective effect [OR = 0.2; 95 % CI (0.05-0.77); p = 0.019]. There was no significant difference between steroids (+) and steroids (-) groups neither in terms of mean ICU length of stay (LOS) (respectively 11 ± 9.7 and 12.3 ± 10.7 days; p = 0.372) nor in terms of ICU mortality (respectively 29.3 and 24.1 %; p = 0.434). Steroids are effective in reducing the incidence of PE in multiple trauma patients. However, no significant benefice was found on ICU mortality.

Legionnaire's Disease and Immunosuppressive Drugs.

PubMed

Htwe, Tin Han; Khardori, Nancy M

2017-03-01

Immunosuppressive agents predispose patients to legionnaire's disease. Patients receiving tumor necrosis factor antagonists are generally not severely immunocompromised by the underlying disease. In patients with malignancy receiving immunosuppressive therapies, it is difficult to balance the underlying disease versus the therapy used. Transplant recipients are often on multiple drugs, including immunosuppressants. It seems that immunosuppressive drugs add to the risk for legionella infection. The index of suspicion should be high for legionella infection early during a compatible clinical syndrome. The control of Legionella species and prevention of transmission should be the foremost goal in protecting susceptible populations from Legionnaire's disease. Copyright © 2016 Elsevier Inc. All rights reserved.

Hypofractionated Whole-Brain Radiotherapy for Multiple Brain Metastases From Transitional Cell Carcinoma of the Bladder

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rades, Dirk, E-mail: Rades.Dirk@gmx.ne; Department of Radiation Oncology, University of Hamburg; Meyners, Thekla

2010-10-01

Purpose: Brain metastases in bladder cancer patients are extremely rare. Most patients with multiple lesions receive longer-course whole-brain radiotherapy (WBRT) with 10 x 3 Gy/2 weeks or 20 x 2 Gy/4 weeks. Because its radiosensitivity is relatively low, metastases from bladder cancer may be treated better with hypofractionated radiotherapy. This study compared short-course hypofractionated WBRT (5 x 4 Gy/1 week) to longer-course WBRT. Methods and Materials: Data for 33 patients receiving WBRT alone for multiple brain metastases from transitional cell bladder carcinoma were retrospectively analyzed. Short-course WBRT with 5 x 4 Gy (n = 12 patients) was compared to longer-coursemore » WBRT with 10 x 3 Gy/20 x 2 Gy (n = 21 patients) for overall survival (OS) and local (intracerebral) control (LC). Five additional potential prognostic factors were investigated: age, gender, Karnofsky performance score (KPS), number of brain metastases, and extracranial metastases. The Bonferroni correction for multiple tests was used to adjust the p values derived from the multivariate analysis. p values of <0.025 were considered significant. Results: At 6 months, OS was 42% after 5 x 4 Gy and 24% after 10 x 3/20 x 2 Gy (p = 0.31). On univariate analysis, improved OS was associated with less than four brain metastases (p = 0.021) and almost associated with a lack of extracranial metastases (p = 0.057). On multivariate analysis, both factors were not significant. At 6 months, LC was 83% after 5 x 4 Gy and 27% after 10 x 3/20 x 2 Gy (p = 0.035). Improved LC was almost associated with a KPS of {>=}70 (p = 0.051). On multivariate analysis, WBRT regimen was almost significant (p = 0.036). KPS showed a trend (p = 0.07). Conclusions: Short-course WBRT with 5 x 4 Gy should be seriously considered for most patients with multiple brain metastases from bladder cancer, as it resulted in improved LC.« less

Implementation of an Interorganizational System: The Case of Medical Insurance E-Clearance

ERIC Educational Resources Information Center

Bose, Indranil; Liu, Han; Ye, Alex

2012-01-01

The patients receiving treatment from a hospital need to interact with multiple entities when claiming reimbursements. The complexities of the medical service supply chain can be simplified with an electronic clearance management system that allows hospitals, medical insurance bureau, bank, and patients to interact in a seamless and cashless…

Cochlear implantation and clinical features in patients with Noonan syndrome and Noonan syndrome with multiple lentigines caused by a mutation in PTPN11.

PubMed

van Nierop, Josephine W I; van Trier, Dorothée C; van der Burgt, Ineke; Draaisma, Jos M T; Mylanus, Emmanuel A M; Snik, Ad F; Admiraal, Ronald J C; Kunst, Henricus P M

2017-06-01

Existing literature only reports a few patients with Noonan syndrome (NS) and Noonan syndrome with multiple lentigines (NSML) who underwent cochlear implantation (CI). The present study describes four NS patients and one NSML patient with a PTPN11 mutation. They all had severe to profound hearing loss, and they received a CI. The age at which the CI surgery occurred ranged from 1 to 13 years old, and the audiological results in all five patients improved after the CI. Otological and audiological examinations in NS and NSML are important, and for those with severe hearing loss, the CI surgery improved the audiological outcome regardless of age. Published by Elsevier B.V.

Clomiphene citrate combined with metformin versus letrozole for induction of ovulation in clomiphene-resistant polycystic ovary syndrome: a randomized clinical trial.

PubMed

Rezk, Mohamed; Shaheen, Abd-Elhamid; Saif El-Nasr, Ibrahim

2018-04-01

A total of 202 patients with clomiphene citrate (CC) -resistant polycystic ovary syndrome (PCOS) were randomly allocated into two arms of induction of ovulation; the first group (n = 102) received CC 100 mg and metformin 500 mg while the second group (n = 100) received letrozole 2.5 mg with ovulation rate, clinical pregnancy rate, adverse effects, and acceptability were assessed. Patients in the letrozole arm experienced higher rate of ovulation (82% versus 43.1%, p < .001), more dominant follicles (p < .05), better endometrial thickness (p < .001), higher clinical pregnancy rate (36% versus 9.8%, p < .001), higher multiple pregnancy rate (p < .05), lesser adverse effects (p < .05) and higher acceptability (p < .001) compared to patients in the CC and metformin arm. In conclusion; letrozole is better and more acceptable than combined CC and metformin for inducing ovulation in patients with CC-resistant PCOS with higher clinical pregnancy rate and unexpectedly higher multiple pregnancy rate.

Effectiveness of a combination of ezetimibe and statins in patients with acute coronary syndrome and multiple comorbidities: A 6-year population-based cohort study.

PubMed

Lin Wu, Fe-Lin; Wang, Jui; Ho, Wei; Chou, Chia-Hung; Wu, Yi-Jung; Choo, Dan-Wei; Wang, Yu-Wen; Chen, Po-Yu; Chien, Kuo-Liong; Lin, Zhen-Fang

2017-04-15

The clinical benefits of a combination of statins and ezetimibe in patients with acute coronary syndrome (ACS) were observed in a clinical trial. However, little is known regarding the effectiveness of using statins with or without ezetimibe in patients with ACS and multiple comorbidities in real-world clinical practice. This is a nationwide population-based cohort study using Taiwan National Health Insurance Research Database. A total of 212,110 patients with ACS who had been discharged after their first ACS events between 2006 and 2010 were enrolled. A propensity score matching approach was used to create matched cohorts for adjusting potential confounders. Cox proportional hazards regressions were performed to estimate the risk of re-hospitalization for ACS and revascularization. Patients in the statins-plus-ezetimibe group had a significantly lower risk of re-hospitalization for ACS (adjusted hazard ratio [HR]=0.64, 95% confidence interval [CI]: 0.60-0.69) and revascularization (HR=0.69, 95% CI: 0.63-0.76) than those in the statins-alone group. In the statins-plus-ezetimibe group, female patients had a lower risk of re-hospitalization for ACS than male patients did, and patients without diabetes mellitus had a lower risk of re-hospitalization for ACS than did patients with diabetes mellitus. Patients with ACS and multiple comorbidities receiving a combination therapy of statins and ezetimibe had a lower risk of re-hospitalization for ACS and revascularization than those receiving statins alone. Significant interaction effects were observed between combination with ezetimibe, sex, and diabetes mellitus. Copyright © 2017 Elsevier B.V. All rights reserved.

Radiotherapy in the treatment of multiple myeloma.

PubMed

Bosch, A; Frias, Z

1988-12-01

Fifty-nine patients with multiple myeloma referred for treatment of painful bony lesions received irradiation to 95 local areas, and 16 of the 59 were irradiated using hemibody techniques. Pain relief was obtained in practically all of the irradiated regions. Most local areas were treated to doses of 3000 cGy in 10 to 15 fractions. Patients with generalized pain due to multiple site involvement were treated with single dose hemibody irradiation, to doses of 600 cGy to the upper hemibody, and of 800 cGy to the lower hemibody. This treatment was well tolerated and side effects minimal. Median survival from diagnosis was 30 months and the survival at 1, 3, and 5 years was 80%, 42%, and 12% respectively. Key articles on radiation therapy of multiple myeloma are reviewed and discussed. Since all patients eventually relapse after chemotherapy, the role of radiotherapy using present techniques should be fully evaluated and considered as an alternative in the primary treatment of multiple myeloma.

Effects of Cinacalcet on Fracture Events in Patients Receiving Hemodialysis: The EVOLVE Trial.

PubMed

Moe, Sharon M; Abdalla, Safa; Chertow, Glenn M; Parfrey, Patrick S; Block, Geoffrey A; Correa-Rotter, Ricardo; Floege, Jürgen; Herzog, Charles A; London, Gerard M; Mahaffey, Kenneth W; Wheeler, David C; Dehmel, Bastian; Goodman, William G; Drüeke, Tilman B

2015-06-01

Fractures are frequent in patients receiving hemodialysis. We tested the hypothesis that cinacalcet would reduce the rate of clinical fractures in patients receiving hemodialysis using data from the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events trial, a placebo-controlled trial that randomized 3883 hemodialysis patients with secondary hyperparathyroidism to receive cinacalcet or placebo for ≤64 months. This study was a prespecified secondary analysis of the trial whose primary end point was all-cause mortality and non-fatal cardiovascular events, and one of the secondary end points was first clinical fracture event. Clinical fractures were observed in 255 of 1935 (13.2%) patients randomized to placebo and 238 of 1948 (12.2%) patients randomized to cinacalcet. In an unadjusted intention-to-treat analysis, the relative hazard for fracture (cinacalcet versus placebo) was 0.89 (95% confidence interval [95% CI], 0.75 to 1.07). After adjustment for baseline characteristics and multiple fractures, the relative hazard was 0.83 (95% CI, 0.72 to 0.98). Using a prespecified lag-censoring analysis (a measure of actual drug exposure), the relative hazard for fracture was 0.72 (95% CI, 0.58 to 0.90). When participants were censored at the time of cointerventions (parathyroidectomy, transplant, or provision of commercial cinacalcet), the relative hazard was 0.71 (95% CI, 0.58 to 0.87). Fracture rates were higher in older compared with younger patients and the effect of cinacalcet appeared more pronounced in older patients. In conclusion, using an unadjusted intention-to-treat analysis, cinacalcet did not reduce the rate of clinical fracture. However, when accounting for differences in baseline characteristics, multiple fractures, and/or events prompting discontinuation of study drug, cinacalcet reduced the rate of clinical fracture by 16%-29%. Copyright © 2015 by the American Society of Nephrology.

Andrographis paniculata decreases fatigue in patients with relapsing-remitting multiple sclerosis: a 12-month double-blind placebo-controlled pilot study.

PubMed

Bertoglio, J C; Baumgartner, M; Palma, R; Ciampi, E; Carcamo, C; Cáceres, D D; Acosta-Jamett, G; Hancke, J L; Burgos, R A

2016-05-23

Andrographis paniculata (A. paniculata), a medicinal plant, has shown anti-inflammatory, neuroprotective and antifibrotic effects in animal models as well as clinical efficacy in different studies, including an anti-fatigue effect in autoimmune diseases such as rheumatoid arthritis. In multiple sclerosis (MS), fatigue is rated as one of the most common and disabling symptoms. In the present trial, we investigated the effect of A. paniculata on relapse rate and fatigue in relapsing-remitting MS (RRMS) patients receiving interferon beta. A randomised double-blind placebo-controlled trial assessed the effects of 170 mg of A. paniculata dried extract tablet b.i.d. p.o. on relapse rate and fatigue using the Fatigue Severity Scores (FSS) over 12 months in RRMS patients receiving interferon. The Expanded Disability Status Scale (EDSS) score, inflammatory parameters and radiological findings were also investigated. Twenty-five patients were enrolled, and twenty-two patients were ultimately analysed and randomised to the active or placebo group. Patients treated with A. paniculata showed a significant reduction in their FSS score as compared to the placebo, equivalent to a 44 % reduction at 12 months. No statistically significant differences were observed for relapse rate, EDSS or inflammatory parameters, with a trend in reducing new lesions among the A. paniculata group. One patient in the A. paniculata group presented with a mild and transient skin rash, which was alleviated with anti-histamine treatment for three weeks. A. paniculata was well tolerated in patients and no changes in clinical parameters were observed. A. paniculata significantly reduces fatigue in patients with RRMS receiving interferon beta in comparison to placebo and only interferon beta treatment. ClinicalTrials.gov Identifier: NCT02280876 ; Trial registration date: 20.10.2014.

Influence of multiple antenatal counselling sessions on modern contraceptive uptake in Nigeria.

PubMed

Adanikin, Abiodun I; Onwudiegwu, Uche; Loto, Olabisi M

2013-10-01

To determine the influence of multiple contraceptive counselling sessions during antenatal care on use of modern postpartum contraception. A total of 216 eligible pregnant women were randomised into antenatal and postnatal counselling groups. The 'Antenatal group' received one-to-one antenatal contraceptive counselling on several occasions while the 'Postnatal group' received a single one-to-one contraceptive counselling session at the sixth week postnatal check, as is routinely practised. All participants were contacted six months postpartum by telephone or personal visit, and questioned about their contraceptive use, if any. More women who had multiple antenatal contraceptive counselling sessions used modern contraceptive methods than those who had a single postnatal counselling session (57% vs. 35%; p = 0.002). There was also a significantly more frequent use of contraception among previously undecided patients in the Antenatal group (p = 0.014). Multiple antenatal contraceptive counselling sessions improve the use of modern postpartum contraception.

Can Patient Navigation Improve Receipt of Recommended Breast Cancer Care? Evidence From the National Patient Navigation Research Program

PubMed Central

Ko, Naomi Y.; Darnell, Julie S.; Calhoun, Elizabeth; Freund, Karen M.; Wells, Kristin J.; Shapiro, Charles L.; Dudley, Donald J.; Patierno, Steven R.; Fiscella, Kevin; Raich, Peter; Battaglia, Tracy A.

2014-01-01

Purpose Poor and underserved women face barriers in receiving timely and appropriate breast cancer care. Patient navigators help individuals overcome these barriers, but little is known about whether patient navigation improves quality of care. The purpose of this study is to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care. Patients and Methods Women with breast cancer who participated in the national Patient Navigation Research Program were examined to determine whether the care they received included the following: initiation of antiestrogen therapy in patients with hormone receptor–positive breast cancer; initiation of postlumpectomy radiation therapy; and initiation of chemotherapy in women younger than age 70 years with triple-negative tumors more than 1 cm. This is a secondary analysis of a multicenter quasi-experimental study funded by the National Cancer Institute to evaluate patient navigation. Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants. Results Among participants eligible for antiestrogen therapy, navigated participants (n = 380) had a statistically significant higher likelihood of receiving antiestrogen therapy compared with non-navigated controls (n = 381; odds ratio [OR], 1.73; P = .004) in a multivariable analysis. Among the participants eligible for radiation therapy after lumpectomy, navigated participants (n = 255) were no more likely to receive radiation (OR, 1.42; P = .22) than control participants (n = 297). Conclusion We demonstrate that navigated participants were more likely than non-navigated participants to receive antiestrogen therapy. Future studies are required to determine the full impact patient navigation may have on ensuring that vulnerable populations receive quality care. PMID:25071111

Multiple courses of pulse corticosteroid therapy for alopecia areata.

PubMed

Yoshimasu, Takashi; Kanazawa, Nobuo; Yamamoto, Yuki; Furukawa, Fukumi

2016-09-01

Various systemic corticosteroid therapies are used for alopecia areata (AA). Pulse therapy using methylprednisolone is a treatment approach for AA. The efficacy of multiple courses of pulse therapy for various severities of AA was evaluated. AA patients with less than 50% hair loss, less than or equal to 6 months after AA onset, needed 1.9 courses of pulse therapy for vellus hair to develop. On the other hand, AA patients with more than 50% hair loss, less than 6 months after AA onset, needed more courses of pulse therapy for vellus hair to develop. Regardless of the disease duration, AA patients with less than 50% hair loss showed a good response rate (100%) after both a short period and a long period after therapy. After receiving multiple courses of pulse therapy, the AA patients with more than 50% hair loss also showed improvement with limited adverse reactions. © 2016 Japanese Dermatological Association.

Safety Outcomes of Apixaban Compared With Warfarin in Patients With End-Stage Renal Disease.

PubMed

Sarratt, Stefanie C; Nesbit, Ross; Moye, Robert

2017-06-01

Current guidelines make no specific recommendations on the selection of direct oral anticoagulants for the prevention and treatment of venous thromboembolism in patients with end-stage renal disease (ESRD) receiving hemodialysis. Based on these guidelines, warfarin remains the anticoagulant of choice in these patients. To compare bleeding rates in patients receiving apixaban or warfarin with ESRD undergoing chronic hemodialysis. This was a single-center, retrospective, institutional review board-approved cohort analysis. Patients with ESRD undergoing chronic hemodialysis and receiving anticoagulation therapy with either apixaban or warfarin were included in this study. All data were collected from paper charts and electronic medical records and included documentation of bleeding events and related interventions. The primary outcome of this study was clinically relevant major bleeding events. Secondary outcomes included clinically relevant nonmajor bleeding events and minor bleeding events. A total of 160 patients were included in this study (warfarin group, n = 120; apixaban group, n = 40). There were 7 major bleeding events in the warfarin group compared with zero in the apixaban group ( P = 0.34). There were similar rates of clinically relevant nonmajor bleeding events (12.5% vs 5.8%, P = 0.17) and minor bleeding (2.5% vs 2.5%, P = 0.74) events in patients receiving apixaban and warfarin. There were no observed differences in bleeding rates in patients receiving apixaban compared with those receiving warfarin. Apixaban may be a cautious consideration in hemodialysis patients until there is further insight into the effect of subsequent, multiple doses on drug accumulation and clinical outcomes.

Posterior paramedian subrhomboidal analgesia versus thoracic epidural analgesia for pain control in patients with multiple rib fractures.

PubMed

Shelley, Casey L; Berry, Stepheny; Howard, James; De Ruyter, Martin; Thepthepha, Melissa; Nazir, Niaman; McDonald, Tracy; Dalton, Annemarie; Moncure, Michael

2016-09-01

Rib fractures are common in trauma admissions and are associated with an increased risk of pulmonary complications, intensive care unit admissions, and mortality. Providing adequate pain control in patients with multiple rib fractures decreases the risk of adverse events. Thoracic epidural analgesia is currently the preferred method for pain control. This study compared outcomes in patients with multiple acute rib fractures treated with posterior paramedian subrhomboidal (PoPS) analgesia versus thoracic epidural analgesia (TEA). This prospective study included 30 patients with three or more acute rib fractures admitted to a Level I trauma center. Thoracic epidural analgesia or PoPS catheters were placed, and local anesthesia was infused. Data were collected including patients' pain level, adjunct morphine equivalent use, adverse events, length of stay, lung volumes, and discharge disposition. Nonparametric tests were used and two-sided p < 0.05 were considered statistically significant. Nineteen (63%) of 30 patients received TEA and 11 (37%) of 30 patients received PoPS. Pain rating was lower in the PoPS group (2.5 vs. 5; p = 0.03) after initial placement. Overall, there was no other statistically significant difference in pain control or use of oral morphine adjuncts between the groups. Hypotension occurred in eight patients, 75% with TEA and only 25% with PoPS. No difference was found in adverse events, length of stay, lung volumes, or discharge disposition. In patients with rib fractures, PoPS analgesia may provide pain control equivalent to TEA while being less invasive and more readily placed by a variety of hospital staff. This pilot study is limited by its small sample size, and therefore additional studies are needed to prove equivalence of PoPS compared to TEA. Therapeutic study, level IV.

Relapse outcomes, safety, and treatment patterns in patients diagnosed with relapsing-remitting multiple sclerosis and initiated on subcutaneous interferon β-1a or dimethyl fumarate: a real-world study.

PubMed

Ernst, Frank R; Barr, Peri; Elmor, Riad; Wong, Schiffon L

2017-12-01

To estimate real-world treatment patterns, safety, and relapse outcomes of subcutaneous (sc) interferon (IFN) β-1a (Rebif) vs dimethyl fumarate (DMF; Tecfidera), to treat relapsing-remitting multiple sclerosis (RRMS). A US retrospective chart review of 450 randomly selected adults newly diagnosed with RRMS who received sc IFN β-1a (n = 143) or DMF (n = 307) was conducted. Patients were either (a) treatment-naïve, initiating first-line treatment with sc IFN β-1a or DMF, or (b) previously treated, switching to sc IFN β-1a or DMF. Two years' follow-up data were captured. Patient characteristics, persistence, and adverse events between treatment groups were compared using t-tests or Chi-square tests. Kaplan-Meier curves with log-rank tests and Cox proportional hazards models were used to compare time to, and risk of non-persistence. Annualized Relapse Rates (ARR) were calculated using a robust variance Poisson model adjusting for covariates. Propensity scores were used to address possible selection bias. One hundred and twelve patients became non-persistent, most commonly due to an adverse event (n = 37). No difference was observed in time to overall non-persistence between sc IFN β-1a and DMF patients. Among treatment-naïve patients, those receiving DMF had 2.4-times the risk (HR = 2.439, 95% CI = 1.007-5.917, p = .0483) of experiencing a discontinuation than patients receiving sc IFN β-1a. Non-persistent patients receiving DMF had 2.3-times the risk (HR = 2.311, 95% CI = 1.350-3.958, p = .0023) of experiencing an adverse event at a given time point than patients prescribed sc IFN β-1a. No differences in relapse risk or ARR between sc IFN β-1a- and DMF-treated patients were observed. sc IFN β-1a-treated patients had comparable persistence and relapse outcomes, and better safety outcomes vs DMF-treated patients across 2 years.

A quality improvement project to reduce the intraoperative use of single-dose fentanyl vials across multiple patients in a pediatric institution.

PubMed

Buck, David; Subramanyam, Rajeev; Varughese, Anna

2016-01-01

The use of a single-dose vial across multiple patients presents a risk to sterility and is against CDC guidelines. We initiated a quality improvement (QI) project to reduce the intraoperative use of single-dose vials of fentanyl across multiple patients at Cincinnati Children's Hospital Medical Center (CCHMC). The initial step of the improvement project was the development of a Key Driver Diagram. The diagram has the SMART aim of the project, key drivers inherent to the process we are trying to improve, and specific interventions targeting the key drivers. The number of patients each week receiving an IV dose of fentanyl, from a vial previously accessed for another patient was tracked in a high turnover operating room (OR). The improvement model used was based on the concept of building Plan-Do-Study-Act (PDSA) cycles. Tests of change included provider education, provision of an increased number of fentanyl vials, alternate wasting processes, and provision of single-use fentanyl syringes by the pharmacy. Prior to initiation of this project, it was common for a single fentanyl vial to be accessed for multiple patients. Our data showed an average percentage of failures of just over 50%. During the end of the project, after 7 months, the mean percentage failures had dropped to 5%. Preparation of 20 mcg single-use fentanyl syringes by pharmacy, combined with education of providers on appropriate use, was successful in reducing failures to below our goal of 25%. Appropriately sized fentanyl syringes prepared by pharmacy, education on correct use of single-dose vials, and reminders in the OR, reduced the percentage of patients receiving a dose of fentanyl from a vial previously accessed for another patient in a high-volume otolaryngology room. © 2015 John Wiley & Sons Ltd.

Efficacy of natalizumab therapy in patients of African descent with relapsing multiple sclerosis: analysis of AFFIRM and SENTINEL data.

PubMed

Cree, Bruce A C; Stuart, William H; Tornatore, Carlo S; Jeffery, Douglas R; Pace, Amy L; Cha, Choon H

2011-04-01

Patients with multiple sclerosis (MS) who are of African descent experience a more aggressive disease course than patients who are of white race/ethnicity. In phase 3 clinical trials (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] and Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis [SENTINEL]), natalizumab use significantly improved clinical and magnetic resonance imaging outcomes over 2 years in patients with relapsing MS. Because patients of African descent may be less responsive to interferon beta treatment than patients of white race/ethnicity, the efficacy of natalizumab therapy in this population is clinically important. To evaluate the efficacy of natalizumab use in patients of African descent with relapsing MS. Post hoc analysis. Academic research. Patients of African descent with relapsing MS who received natalizumab or placebo in the phase 3 AFFIRM study and those who received natalizumab plus intramuscular interferon beta-1a or placebo plus intramuscular interferon beta-1a in the phase 3 SENTINEL study. Efficacy of natalizumab use in patients of African descent with relapsing MS who participated in the AFFIRM or SENTINEL trial. Forty-nine patients of African descent participated in AFFIRM (n = 10) or SENTINEL (n = 39). Demographic and baseline disease characteristics were similar between patients treated with natalizumab (n = 21) or placebo (n = 28). Natalizumab therapy significantly reduced the annualized MS relapse rate by 60% (0.21 vs 0.53 in the placebo group, P = .02). Compared with placebo use, natalizumab therapy also significantly reduced the accumulation of lesions observed on magnetic resonance imaging over 2 years: the mean number of gadolinium-enhancing lesions was reduced by 79% (0.19 vs 0.91, P = .03), and the mean number of new or enlarged T2-weighted lesions was reduced by 90% (0.88 vs 8.52, P = .008). Natalizumab therapy significantly improved the relapse rate and accumulation of brain lesions in patients of African descent with relapsing MS.

Referral patterns of special needs patients at the Royal Dental Hospital of Melbourne, Victoria, Australia.

PubMed

Mohamed Rohani, M; Calache, H; Borromeo, G L

2017-06-01

Special Needs Dentistry (SND) has been recognized as a dental specialty in Australia since 2003 but there have been no studies addressing the profile of patients for specialist care. The purpose of this study is to identify, via referrals received, the profile of patients and quality of referrals at the largest public SND unit in Victoria, Australia. All referrals received over a 6-month period (1 January-30 June 2013) by the integrated SND unit (ISNU) were reviewed prior to allocation to the outpatient clinic (OP), domiciliary (DOM) or general anaesthetic (GA) services. Six-hundred and eighty-eight referrals were received with the majority for the OP clinic (68.3%), followed by DOM (22.4%) and GA services (9.3%) (χ 2  = 360.2, P < 0.001). A referral may have specified more than one special needs condition with the most common category being those who were medically compromised (81.7%). The reasons for referral included lack of compliance (27.2%), further management due to multiple medical conditions or GA services required (9.9%), or for multiple other reasons (62.9%). A diverse pattern of SND patients was referred to the ISNU with a majority of referrals having no specific referral reason cited, suggesting poor quality of referrals. © 2016 Australian Dental Association.

Subcutaneous interferon β-1a in pediatric patients with multiple sclerosis: Regional differences in clinical features, disease management, and treatment outcomes in an international retrospective study.

PubMed

Krupp, Lauren B; Pohl, Daniela; Ghezzi, Angelo; Boyko, Alexey; Tenembaum, Silvia; Chen, Liang; Aycardi, Ernesto; Banwell, Brenda

2016-04-15

To further understand management of pediatric patients with multiple sclerosis (MS), we examined disease features, clinical practice patterns, and response to treatment in the United States (US) and seven other countries ('rest of World'; ROW). Anonymized data, recorded as part of routine clinical practice, were obtained from medical records (1997-2009) of study participants (who received subcutaneous interferon β-1a before age 18 years) from the US and ROW. Samples were stratified by age (preadolescents [<12 years] and adolescents [12-17 years]). US adolescents had a higher mean body mass index versus ROW adolescents (BMI; 27.2 versus 22.5 kg/m(2)), started disease-modifying therapy (DMT) earlier after the first relapse, were more likely to have received a DMT before initiating subcutaneous interferon β-1a, had a higher relapse rate, and were more likely to switch from subcutaneous interferon β-1a to another DMT before the end of the observation period. This retrospective analysis of a multinational sample of pediatric MS patients who received subcutaneous interferon β-1a found that those from the US had higher BMI, relapsed more frequently, and were managed differently, compared with ROW patients. Future prospective studies are needed to confirm these observations and ascertain their clinical significance. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Assessment of National Practice for Palliative Radiation Therapy for Bone Metastases Suggests Marked Underutilization of Single-Fraction Regimens in the United States

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rutter, Charles E., E-mail: charles.rutter@yale.edu; Yale Cancer Center, New Haven, Connecticut; Yu, James B.

2015-03-01

Purpose: To characterize temporal trends in the application of various bone metastasis fractionations within the United States during the past decade, using the National Cancer Data Base; the primary aim was to determine whether clinical practice in the United States has changed over time to reflect the published randomized evidence and the growing movement for value-based treatment decisions. Patients and Methods: The National Cancer Data Base was used to identify patients treated to osseous metastases from breast, prostate, and lung cancer. Utilization of single-fraction versus multiple-fraction radiation therapy was compared according to demographic, disease-related, and health care system details. Results: Wemore » included 24,992 patients treated during the period 2005-2011 for bone metastases. Among patients treated to non-spinal/vertebral sites (n=9011), 4.7% received 8 Gy in 1 fraction, whereas 95.3% received multiple-fraction treatment. Over time the proportion of patients receiving a single fraction of 8 Gy increased (from 3.4% in 2005 to 7.5% in 2011). Numerous independent predictors of single-fraction treatment were identified, including older age, farther travel distance for treatment, academic treatment facility, and non-private health insurance (P<.05). Conclusions: Single-fraction palliative radiation therapy regimens are significantly underutilized in current practice in the United States. Further efforts are needed to address this issue, such that evidence-based and cost-conscious care becomes more commonplace.« less

Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial.

PubMed

San-Miguel, Jesús F; Hungria, Vania T M; Yoon, Sung-Soo; Beksac, Meral; Dimopoulos, Meletios A; Elghandour, Ashraf; Jedrzejczak, Wieslaw W; Günther, Andreas; Nakorn, Thanyaphong N; Siritanaratkul, Noppadol; Schlossman, Robert L; Hou, Jian; Moreau, Philippe; Lonial, Sagar; Lee, Jae H; Einsele, Hermann; Sopala, Monika; Bengoudifa, Bourras-Rezki; Binlich, Florence; Richardson, Paul G

2016-11-01

Panobinostat plus bortezomib and dexamethasone significantly increased median progression-free survival compared with placebo plus bortezomib and dexamethasone in the phase 3 PANORAMA 1 trial. Here, we present the final overall survival analysis for this trial. PANORAMA 1 is a randomised, placebo-controlled, double-blind, phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma with one to three previous treatments. Patients were randomly assigned (1:1) to receive panobinostat (20 mg orally) or placebo, with bortezomib (1·3 mg/m 2 intravenously) and dexamethasone (20 mg orally), over two distinct treatment phases. In treatment phase 1 (eight 3-week cycles), patients received: panobinostat or placebo on days 1, 3, 5, 8, 10, and 12; bortezomib on days 1, 4, 8, and 11; and dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. During treatment phase 2 (four 6-week cycles with a 2 weeks on, 1 week off schedule), panobinostat or placebo was given three times a week, bortezomib was administered once a week, and dexamethasone was given on the days of and following bortezomib administration. The primary endpoint was progression-free survival; overall survival was a key secondary endpoint. This study is registered at ClinicalTrials.gov, NCT01023308. Between Jan 21, 2010, and Feb 29, 2012, 768 patients were enrolled into the study and randomly assigned to receive either panobinostat (n=387) or placebo (n=381), plus bortezomib and dexamethasone. At data cutoff (June 29, 2015), 415 patients had died. Median overall survival was 40·3 months (95% CI 35·0-44·8) in those who received panobinostat, bortezomib, and dexamethasone versus 35·8 months (29·0-40·6) in those who received placebo, bortezomib, and dexamethasone (hazard ratio [HR] 0·94, 95% CI 0·78-1·14; p=0·54). Of patients who had received at least two previous regimens including bortezomib and an immunomodulatory drug, median overall survival was 25·5 months (95% CI 19·6-34·3) in 73 patients who received panobinostat, bortezomib, and dexamethasone versus 19·5 months (14·1-32·5) in 74 who received placebo (HR 1·01, 95% CI 0·68-1·50). The overall survival benefit with panobinostat over placebo with bortezomib and dexamethasone was modest. However, optimisation of the regimen could potentially prolong treatment duration and improve patients' outcomes, although further trials will be required to confirm this. Novartis Pharmaceuticals. Copyright © 2016 Elsevier Ltd. All rights reserved.

Reducing Unnecessary Portable Pelvic Radiographs in Trauma Patients: A Resident-Driven Quality Improvement Initiative.

PubMed

Langer, Jessica M; Tsai, Emily B; Luhar, Aarti; McWilliams, Justin; Motamedi, Kambiz

2015-09-01

Quality improvement is increasingly important in the changing health care climate. We aim to establish a methodology and identify critical factors leading to successful implementation of a resident-led radiology quality improvement intervention at the institutional level. Under guidance of faculty mentors, the first-year radiology residents developed a quality improvement initiative to decrease unnecessary STAT pelvic radiographs (PXRs) in hemodynamically stable trauma patients who would additionally receive STAT pelvic CT scans. Development and implementation of this initiative required multiple steps, including: establishing resident and faculty leadership, gathering evidence from published literature, cultivating multidisciplinary support, and developing and implementing an institution-wide ordering algorithm. A visual aid and brief questionnaire were distributed to clinicians for use during treatment of trauma cases to ensure sustainability of the initiative. At multiple time points, pre- and post-intervention, residents performed a retrospective chart review to evaluate changes in imaging-ordering trends for trauma patients. Chart review showed a decline in the number of PXRs for hemodynamically stable trauma patients, as recommended in the ordering algorithm: 78% of trauma patients received both a PXR and a pelvic CT scan in the first 24 hours of the initiative, compared with 26% at 1 month; 24% at 6 months; and 18% at 10 to 12 months postintervention. The resident-led radiology quality improvement initiative created a shift in ordering culture at an institutional level. Development and implementation of this algorithm exemplified the impact of a multidisciplinary collaborative effort involving multiple departments and multiple levels of the medical hierarchy. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Opioid Overdose Outbreak - West Virginia, August 2016.

PubMed

Massey, Joel; Kilkenny, Michael; Batdorf, Samantha; Sanders, Sarah K; Ellison, Debra; Halpin, John; Gladden, R Matthew; Bixler, Danae; Haddy, Loretta; Gupta, Rahul

2017-09-22

On August 15, 2016, the Mayor's Office of Drug Control Policy in Huntington, West Virginia, notified the Cabell-Huntington Health Department (CHHD) of multiple calls regarding opioid overdose received by the emergency medical system (EMS) during 3 p.m.-8 p.m. that day. A public health investigation and response conducted by the West Virginia Bureau for Public Health (BPH) and CHHD identified 20 opioid overdose cases within a 53-hour period in Cabell County; all cases included emergency department (ED) encounters. EMS personnel, other first responders, and ED providers administered the opioid antidote naloxone to 16 (80%) patients, six of whom were administered multiple doses, suggesting exposure to a highly potent opioid. No patients received referral for recovery support services. In addition to the public health investigation, a public safety investigation was conducted; comprehensive opioid toxicology testing of clinical specimens identified the synthetic opioid fentanyl* and novel fentanyl analogs, including carfentanil, † which had been used by patients who overdosed in Huntington. Results of these two investigations highlight the importance of collaboration between public health and public safety agencies to provide in-depth surveillance data from opioid overdose outbreaks that involve high-potency fentanyl analogs. These data facilitated a public health response through increased awareness of powerful opioid substances requiring multiple naloxone doses for reversal, and improved patient linkage to recovery support services and a harm reduction program from the ED after opioid overdose.

Microdose gonadotropin-releasing hormone agonist flare-up protocol versus multiple dose gonadotropin-releasing hormone antagonist protocol in poor responders undergoing intracytoplasmic sperm injection-embryo transfer cycle.

PubMed

Kahraman, Korhan; Berker, Bulent; Atabekoglu, Cem Somer; Sonmezer, Murat; Cetinkaya, Esra; Aytac, Rusen; Satiroglu, Hakan

2009-06-01

To compare the efficacy of microdose GnRH agonist (GnRH-a) flare-up and multiple dose GnRH antagonist protocols in patients who have a poor response to a long luteal GnRH-a protocol. Prospective, randomized, clinical study. University hospital. Forty-two poor responder patients undergoing intracytoplasmic sperm injection (ICSI)-embryo transfer cycle. Twenty-one patients received microdose leuprolide acetate (LA) (50 microg twice daily) starting on the second day of withdrawal bleeding. The other 21 patients received 0.25 mg of cetrorelix daily when the leading follicle reached 14 mm in diameter. Serum E(2) levels, number of growing follicles and mature oocytes, embryo quality, dose of gonadotropin used, cancellation, fertilization, implantation rate and pregnancy rate (PR). The mean serum E(2) concentration on the day of hCG administration was significantly higher in the microdose GnRH-a group than in the GnRH antagonist group (1,904 vs. 1,362 pg/mL). The clinical PRs per started cycle of microdose GnRH-a and GnRH antagonist groups were 14.2% and 9.5%, respectively. There were no statistically significant differences in the other ovulation induction characteristics, fertilization and implantation rates. Microdose GnRH-a flare-up protocol and multiple dose GnRH antagonist protocol seem to have similar efficacy in improving treatment outcomes of poor responder patients.

Adverse events in patients in home healthcare: a retrospective record review using trigger tool methodology

PubMed Central

Schildmeijer, Kristina Görel Ingegerd; Unbeck, Maria; Ekstedt, Mirjam; Lindblad, Marléne; Nilsson, Lena

2018-01-01

Objective Home healthcare is an increasingly common part of healthcare. The patients are often aged, frail and have multiple diseases, and multiple caregivers are involved in their treatment. This study explores the origin, incidence, types and preventability of adverse events (AEs) that occur in patients receiving home healthcare. Design A study using retrospective record review and trigger tool methodology. Setting and methods Ten teams with experience of home healthcare from nine regions across Sweden reviewed home healthcare records in a two-stage procedure using 38 predefined triggers in four modules. A random sample of records from 600 patients (aged 18 years or older) receiving home healthcare during 2015 were reviewed. Primary and secondary outcome measures The cumulative incidence of AEs found in patients receiving home healthcare; secondary measures were origin, types, severity of harm and preventability of the AEs. Results The patients were aged 20–79 years, 280 men and 320 women. The review teams identified 356 AEs in 226 (37.7%; 95% CI 33.0 to 42.8) of the home healthcare records. Of these, 255 (71.6%; 95% CI 63.2 to 80.8) were assessed as being preventable, and most (246, 69.1%; 95% CI 60.9 to 78.2) required extra healthcare visits or led to a prolonged period of healthcare. Most of the AEs (271, 76.1%; 95% CI 67.5 to 85.6) originated in home healthcare; the rest were detected during home healthcare but were related to care outside home healthcare. The most common AEs were healthcare-associated infections, falls and pressure ulcers. Conclusions AEs in patients receiving home healthcare are common, mostly preventable and often cause temporary harm requiring extra healthcare resources. The most frequent types of AEs must be addressed and reduced through improvements in interprofessional collaboration. This is an important area for future studies. PMID:29301764

Treatment of Pediatric Septic Shock With the Surviving Sepsis Campaign Guidelines and PICU Patient Outcomes.

PubMed

Workman, Jennifer K; Ames, Stefanie G; Reeder, Ron W; Korgenski, E Kent; Masotti, Susan M; Bratton, Susan L; Larsen, Gitte Y

2016-10-01

The Surviving Sepsis Campaign recommends rapid recognition and treatment of severe sepsis and septic shock. Few reports have evaluated the impact of these recommendations in pediatrics. We sought to determine if outcomes in patients who received initial care compliant with the Surviving Sepsis Campaign time goals differed from those treated more slowly. Single center retrospective cohort study. Emergency department and PICU at an academic children's hospital. Three hundred twenty-one patients treated for septic shock in the emergency department and admitted directly to the PICU. None. The exposure was receipt of emergency department care compliant with the Surviving Sepsis Campaign recommendations (delivery of IV fluids, IV antibiotics, and vasoactive infusions within 1 hr of shock recognition). The primary outcome was development of new or progressive multiple organ dysfunction syndrome. Secondary outcomes included mortality, need for mechanical ventilation or vasoactive medications, and hospital and PICU length of stay. Of the 321 children studied, 117 received Surviving Sepsis Campaign compliant care in the emergency department and 204 did not. New or progressive multiple organ dysfunction syndrome developed in nine of the patients (7.7%) who received Surviving Sepsis Campaign compliant care and 25 (12.3%) who did not (p = 0.26). There were 17 deaths; overall mortality rate was 5%. There were no significant differences between groups in any of the secondary outcomes. Although only 36% of patients met the Surviving Sepsis Campaign guideline recommendation of bundled care within 1 hour of shock recognition, 75% of patients received the recommended interventions in less than 3 hours. Treatment for pediatric septic shock in compliance with the Surviving Sepsis Campaign recommendations was not associated with better outcomes compared with children whose initial therapies in the emergency department were administered more slowly. However, all patients were treated rapidly and we report low morbidity and mortality. This underscores the importance of rapid recognition and treatment of septic shock.

Can patient navigation improve receipt of recommended breast cancer care? Evidence from the National Patient Navigation Research Program.

PubMed

Ko, Naomi Y; Darnell, Julie S; Calhoun, Elizabeth; Freund, Karen M; Wells, Kristin J; Shapiro, Charles L; Dudley, Donald J; Patierno, Steven R; Fiscella, Kevin; Raich, Peter; Battaglia, Tracy A

2014-09-01

Poor and underserved women face barriers in receiving timely and appropriate breast cancer care. Patient navigators help individuals overcome these barriers, but little is known about whether patient navigation improves quality of care. The purpose of this study is to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care. Women with breast cancer who participated in the national Patient Navigation Research Program were examined to determine whether the care they received included the following: initiation of antiestrogen therapy in patients with hormone receptor-positive breast cancer; initiation of postlumpectomy radiation therapy; and initiation of chemotherapy in women younger than age 70 years with triple-negative tumors more than 1 cm. This is a secondary analysis of a multicenter quasi-experimental study funded by the National Cancer Institute to evaluate patient navigation. Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants. Among participants eligible for antiestrogen therapy, navigated participants (n = 380) had a statistically significant higher likelihood of receiving antiestrogen therapy compared with non-navigated controls (n = 381; odds ratio [OR], 1.73; P = .004) in a multivariable analysis. Among the participants eligible for radiation therapy after lumpectomy, navigated participants (n = 255) were no more likely to receive radiation (OR, 1.42; P = .22) than control participants (n = 297). We demonstrate that navigated participants were more likely than non-navigated participants to receive antiestrogen therapy. Future studies are required to determine the full impact patient navigation may have on ensuring that vulnerable populations receive quality care. © 2014 by American Society of Clinical Oncology.

Impact of Neoadjuvant Chemotherapy on Breast Reconstruction

PubMed Central

Hu, Yue-Yung; Weeks, Christine M.; In, Haejin; Dodgion, Christopher M.; Golshan, Mehra; Chun, Yoon S.; Hassett, Michael J.; Corso, Katherine A.; Gu, Xiangmei; Lipsitz, Stuart R.; Greenberg, Caprice C.

2011-01-01

BACKGROUND With advances in oncologic treatment, cosmesis after mastectomy has assumed a pivotal role in patient and provider decision making. Multiple studies have confirmed the safety of both chemotherapy before breast surgery and immediate reconstruction. Little has been written about the effect of neoadjuvant chemotherapy on decisions about reconstruction. METHODS The authors identified 665 patients with stage I through III breast cancer who received chemotherapy and underwent mastectomy at Dana-Farber/Brigham & Women’s Cancer Center from 1997 to 2007. By using multivariate logistic regression, reconstruction rates were compared between patients who received neoadjuvant chemotherapy (n = 180) and patients who underwent mastectomy before chemotherapy (n = 485). The rate of postoperative complications after mastectomy was determined for patients who received neoadjuvant chemotherapy compared with those who did not. RESULTS Reconstruction was performed immediately in 44% of patients who did not receive neoadjuvant chemotherapy but in only 23% of those who did. Twenty-one percent of neoadjuvant chemotherapy recipients and 14% of adjuvant-only chemotherapy recipients underwent delayed reconstruction. After controlling for age, receipt of radiotherapy, and disease stage, neoadjuvant recipients were less likely to undergo immediate reconstruction (odds ratio [OR], 0.57; 95% confidence interval [CI], 0.37, 0.87) but were no more likely to undergo delayed reconstruction (OR, 1.29; 95% CI, 0.75, 2.20). Surgical complications occurred in 30% of neoadjuvant chemotherapy recipients and in 31% of adjuvant chemotherapy recipients. CONCLUSIONS The current results suggest that patients who receive neoadjuvant chemotherapy are less likely to undergo immediate reconstruction and are no more likely to undergo delayed reconstruction than patients who undergo surgery before they receive chemotherapy. PMID:21264833

A Phase III Study of Conventional Radiation Therapy Plus Thalidomide Versus Conventional Radiation Therapy for Multiple Brain Metastases (RTOG 0118)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Knisely, Jonathan P.S.; Berkey, Brian; Chakravarti, Arnab

2008-05-01

Purpose: To compare whole-brain radiation therapy (WBRT) with WBRT combined with thalidomide for patients with brain metastases not amenable to resection or radiosurgery. Patients and Methods: Patients with Zubrod performance status 0-1, MRI-documented multiple (>3), large (>4 cm), or midbrain brain metastases arising from a histopathologically confirmed extracranial primary tumor, and an anticipated survival of >8 weeks were randomized to receive WBRT to a dose of 37.5 Gy in 15 fractions with or without thalidomide during and after WBRT. Prerandomization stratification used Radiation Therapy Oncology Group (RTOG) Recursive Partitioning Analysis (RPA) Class and whether post-WBRT chemotherapy was planned. Endpoints includedmore » overall survival, progression-free survival, time to neurocognitive progression, the cause of death, toxicities, and quality of life. A protocol-planned interim analysis documented that the trial had an extremely low probability of ever showing a significant difference favoring the thalidomide arm given the results at the time of the analysis, and it was therefore closed on the basis of predefined statistical guidelines. Results: Enrolled in the study were 332 patients. Of 183 accrued patients, 93 were randomized to receive WBRT alone and 90 to WBRT and thalidomide. Median survival was 3.9 months for both arms. No novel toxicities were seen, but thalidomide was not well tolerated in this population. Forty-eight percent of patients discontinued thalidomide because of side effects. Conclusion: Thalidomide provided no survival benefit for patients with multiple, large, or midbrain metastases when combined with WBRT; nearly half the patients discontinued thalidomide due to side effects.« less

Comparison of Personal Resources in Patients Who Differently Estimate the Impact of Multiple Sclerosis.

PubMed

Wilski, Maciej; Tomczak, Maciej

2017-04-01

Discrepancies between physicians' assessment and patients' subjective representations of the disease severity may influence physician-patient communication and management of a chronic illness, such as multiple sclerosis (MS). For these reasons, it is important to recognize factors that distinguish patients who differently estimate the impact of MS. The purpose of this study was to verify if the patients who overestimate or underestimate the impact of MS differ in their perception of personal resources from individuals presenting with a realistic appraisal of their physical condition. A total of 172 women and 92 men diagnosed with MS completed Multiple Sclerosis Impact Scale, University of Washington Self Efficacy Scale, Rosenberg Self-Esteem Scale, Body Esteem Scale, Brief Illness Perception Questionnaire, Treatment Beliefs Scale, Actually Received Support Scale, and Socioeconomic resources scale. Physician's assessment of health status was determined with Expanded Disability Status Scale. Linear regression analysis was conducted to identify the subsets of patients with various patterns of subjective health and Expanded Disability Status Scale (EDSS) scores. Patients overestimating the impact of their disease presented with significantly lower levels of self-esteem, self-efficacy in MS, and body esteem; furthermore, they perceived their condition more threatening than did realists and underestimators. They also assessed anti-MS treatment worse, had less socioeconomic resources, and received less support than underestimators. Additionally, underestimators presented with significantly better perception of their disease, self, and body than did realists. Self-assessment of MS-related symptoms is associated with specific perception of personal resources in coping with the disease. These findings may facilitate communication with patients and point to new directions for future research on adaptation to MS.

Specialized Community-Based Care: An Evidence-Based Analysis

PubMed Central

2012-01-01

Background Specialized community-based care (SCBC) refers to services that manage chronic illness through formalized links between primary and specialized care. Objectives The objectives of this evidence-based analysis (EBA) were as follows: to summarize the literature on SCBC, also known as intermediate care to synthesize the evidence from previous Medical Advisory Secretariat (now Health Quality Ontario) EBAs on SCBC for heart failure, diabetes, chronic obstructive pulmonary disease (COPD), and chronic wounds to examine the role of SCBC in family practice Results Part 1: Systematic Review of Intermediate Care Seven systematic reviews on intermediate care since 2008 were identified. The literature base is complex and difficult to define. There is evidence to suggest that intermediate care is effective in improving outcomes; however, the effective interventions are still uncertain. Part 2: Synthesis of Evidence in Intermediate Care Mortality • Heart failure Significant reduction in patients receiving SCBC • COPD Nonsignificant reduction in patients receiving SCBC Hospitalization • Heart failure Nonsignificant reduction in patients receiving SCBC • COPD Significant reduction in patients receiving SCBC Emergency Department Visits • Heart failure Nonsignificant reduction in patients receiving SCBC • COPD Significant reduction in patients receiving SCBC Disease-Specific Patient Outcomes • COPD Nonsignificant improvement in lung function in patients receiving SCBC • Diabetes Significant reduction in hemoglobin A1c (HbA1c) and systolic blood pressure in patients receiving SCBC • Chronic wounds Significant increase in the proportion of healed wounds in patients receiving SCBC Quality of Life • Heart failure Trend toward improvement in patients receiving SCBC • COPD Significant improvement in patients receiving SCBC Part 3: Intermediate Care in Family Practice—Evidence-Based Analysis Five randomized controlled trials were identified comparing SCBC to usual care in family practice. Inclusion criteria were 1) the presence of multiple chronic conditions, and 2) interventions that included 2 or more health care professions. The GRADE quality of the evidence was assessed as low for all outcomes due to the inconsistency and indirectness of the results. Limitations This review did not look at disease-specific studies on intermediate care in family practice. Conclusions Specialized community-based care effectively improves outcomes in patients with heart failure, COPD, and diabetes. The effectiveness of SCBC in family practice is unclear. PMID:23226812

The role of shock index as a predictor of multiple-trauma patients' pathways.

PubMed

Toccaceli, Andrea; Giampaoletti, Andrea; Dignani, Lucia; Lucertini, Carla; Petrucci, Cristina; Lancia, Loreto

2016-03-01

This research was conducted with the aim of investigating the accuracy of the shock index (SI) in distinguishing which multiple-trauma patients should be admitted to an intensive care unit (ICU) after treatment in an emergency room (ER). The SI is an easily obtained indicator, as it corresponds to an arithmetic ratio between the two parameters that are always measured during the first-aid treatment of multiple-trauma patients: heart rate (HR) and systolic blood pressure (SBP). There are many studies examining the SI in the multiple-trauma patients as a possible predictor of the destination unit. The SI is evaluated both at the trauma scene (pre-hospital SI-pH) and in the emergency room (SI-ER). An observational study with a retrospective approach was conducted on 158 adult patients with multiple trauma. The mean SI-pH and SI-ER values were higher in ICU patients than in-patients discharged or admitted to a normal ward, but the difference between these two patient groups was significant only for the SI-ER. Analysis of the receiver operating characteristic (ROC) curves confirmed that only the SI-ER is significant as a reliable indicator for ICU admission with a best cut-off of 1·05. However, a threshold value of 0·75 was still able to establish the correct type of destination for multiple-trauma patients, with a sensitivity of 57·3% and a specificity of 62·5%. This research showed that the SI-pH and SI-ER values are correlated, but only the SI-ER has shown statistical significance in terms of distinguishing the type of destination of multiple-trauma patient (ICU, ordinary ward or discharge) after initial treatment in the ER. The results of this study suggest the possibility of using SI in multiple-trauma patients as a triage indicator to assess the patients' care complexity and to guide the choice of proper clinical paths. © 2015 British Association of Critical Care Nurses.

Salicylate-induced enzymuria: comparison with other anti-inflammatory agents.

PubMed

Proctor, R A; Kunin, C M

1978-12-01

N-acetyl-beta glucosaminidase (NAG) enzymuria was used as a marker of renal injury in patients with rheumatic disease. An elevated NAG level was particularly common in patients receiving gold or aspirin therapy. The multiplicity of drugs received and the unknown role of underlying disease in these patients led to a study in healthy volunteers. Customary therapeutic doses of aspirin, choline salicylate, ibuprofen, indomethacin and acetaminophen did not produce enzymuria. Large single doses of salicylates equivalent to 6 tablets of aspirin consistently did produce enzymuria. The size of the individual dose in relation to body weight was more important than the total daily dose. NAG enzymuria appears to be a sensitive tool for identifying potentially nephrotoxic drugs.

Kinetic therapy in multiple trauma patients with severe blunt chest trauma: an analysis at a level-1 trauma center.

PubMed

Zeckey, C; Wendt, K; Mommsen, P; Winkelmann, M; Frömke, C; Weidemann, J; Stübig, T; Krettek, C; Hildebrand, F

2015-01-01

Chest trauma is a relevant risk factor for mortality after multiple trauma. Kinetic therapy (KT) represents a potential treatment option in order to restore pulmonary function. Decision criteria for performing kinetic therapy are not fully elucidated. The purpose of this study was to investigate the decision making process to initiate kinetic therapy in a well defined multiple trauma cohort. A retrospective analysis (2000-2009) of polytrauma patients (age > 16 years, ISS ⩾ 16) with severe chest trauma (AIS(Chest) ⩾ 3) was performed. Patients with AIS(Head) ⩾ 3 were excluded. Patients receiving either kinetic (KT+) or lung protective ventilation strategy (KT-) were compared. Chest trauma was classified according to the AIS(Chest), Pulmonary Contusion Score (PCS), Wagner Jamieson Score and Thoracic Trauma Severity Score (TTS). There were multiple outcome parameters investigated included mortality, posttraumatic complications and clinical data. A multivariate regression analysis was performed. Two hundred and eighty-three patients were included (KT+: n=160; KT-: n=123). AIS(Chest), age and gender were comparable in both groups. There were significant higher values of the ISS, PCS, Wagner Jamieson Score and TTS in group KT+. The incidence of posttraumatic complications and mortality was increased compared to group KT- (p< 0.05). Despite that, kinetic therapy failed to be an independent risk factor for mortality in multivariate logistic regression analysis. Kinetic therapy is an option in severely injured patients with severe chest trauma. Decision making is not only based on anatomical aspects such as the AIS(Chest), but on overall injury severity, pulmonary contusions and physiological deterioration. It could be assumed that the increased mortality in patients receiving KT is primarily caused by these factors and does not reflect an independent adverse effect of KT. Furthermore, KT was not shown to be an independent risk factor for mortality.

Pretreatment with oral contraceptives in infertile anovulatory patients with polycystic ovary syndrome who receive gonadotropins for controlled ovarian stimulation.

PubMed

Palomba, Stefano; Falbo, Angela; Orio, Francesco; Russo, Tiziana; Tolino, Achille; Zullo, Fulvio

2008-06-01

This study was intended to assess the effects of oral contraceptives given before treatment in infertile anovulatory patients with polycystic ovary syndrome who receive gonadotropins for controlled ovarian stimulation. Pretreatment with oral contraceptives increased the mono-ovulatory cycles, the duration of stimulation for noncanceled cycles, and the number of vials of gonadotropins used. It also reduced the number of dominant follicles and the peak E(2) levels for dominant follicles. No effect was observed in rates of cycle cancellation, pregnancy, abortion, live birth, multiple pregnancies, and ovarian hyperstimulation syndrome.

Multiple sclerosis, brain radiotherapy, and risk of neurotoxicity: The Mayo Clinic experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Miller, Robert C.; Lachance, Daniel H.; Lucchinetti, Claudia F.

2006-11-15

Purpose: The aim of this study was a retrospective assessment of neurotoxicity in patients with multiple sclerosis (MS) receiving external beam radiotherapy (EBRT) to the brain. Methods and Materials: We studied 15 consecutively treated patients with MS who received brain EBRT. Neurologic toxicity was assessed with the Common Toxicity Criteria v.3.0. Results: Median follow-up for the 5 living patients was 6.0 years (range, 3.3-27.4 years). No exacerbation of MS occurred in any patient during EBRT. Five patients had Grade 4 neurologic toxicity and 1 had possible Grade 5 toxicity. Kaplan-Meier estimated risk of neurotoxicity greater than Grade 4 at 5more » years was 57% (95% confidence interval, 27%-82%). Toxicity occurred at 37.5 to 54.0 Gy at a median of 1.0 year (range, 0.2-4.3 years) after EBRT. Univariate analysis showed an association between opposed-field irradiation of the temporal lobes, central white matter, and brainstem and increased risk of neurotoxicity (p < 0.04). Three of 6 cases of toxicity occurred in patients treated before 1986. Conclusions: External beam radiotherapy of the brain in patients with MS may be associated with an increased risk of neurotoxicity compared with patients without demyelinating illnesses. However, this risk is associated with treatment techniques that may not be comparable to modern, conformal radiotherapy.« less

Impact of whole-body rehabilitation in patients receiving chronic mechanical ventilation.

PubMed

Martin, Ubaldo J; Hincapie, Luis; Nimchuk, Mark; Gaughan, John; Criner, Gerard J

2005-10-01

To evaluate the prevalence and magnitude of weakness in patients receiving chronic mechanical ventilation and the impact of providing aggressive whole-body rehabilitation on conventional weaning variables, muscle strength, and overall functional status. Retrospective analysis of 49 consecutive patients. Multidisciplinary ventilatory rehabilitation unit in an academic medical center. Forty-nine consecutive chronic ventilator-dependent patients referred to a tertiary care hospital ventilator rehabilitation unit. None. Patients were 58 +/- 7 yrs old with multiple etiologies for respiratory failure. On admission, all patients were bedridden and had severe weakness of upper and lower extremities measured by a 5-point muscle strength score and a 7-point Functional Independence Measurement. Postrehabilitation, patients had increases in upper and lower extremity strength (p < .05) and were able to stand and ambulate. All weaned from mechanical ventilation, but three required subsequent intermittent support. Six patients died before hospital discharge. Upper extremity strength on admission inversely correlated with time to wean from mechanical ventilation (R = .72, p < .001). : Patients receiving chronic ventilation are weak and deconditioned but respond to aggressive whole-body and respiratory muscle training with an improvement in strength, weaning outcome, and functional status. Whole-body rehabilitation should be considered a significant component of their therapy.

Role of 3D animation in periodontal patient education: a randomized controlled trial.

PubMed

Cleeren, Gertjan; Quirynen, Marc; Ozcelik, Onur; Teughels, Wim

2014-01-01

This randomized controlled parallel trial investigates the effect of 3D animation on the increase and recall of knowledge on periodontitis by patients with periodontitis. The effects of a 3D animation (3D animation group) were compared with narration and drawing (control group) for periodontal patient education. A total of 68 periodontitis patients were stratified according to educational level and then randomly allocated to control or 3D animation groups. All patients received: (1) a pre-test (baseline knowledge), (2) a patient education video (3D animation or control video), (3) a post-test (knowledge immediately after looking at the video), and (4) a follow-up test (knowledge recall after 2 weeks). Each test contained 10 multiple-choice questions. There was no significant difference in baseline knowledge. Patients receiving the 3D animations had significantly higher scores for both the post-test and the follow-up test, when compared with patients receiving sketch animations. 3D animations are more effective than real-time drawings for periodontal patient education in terms of knowledge recall. 3D animations may be a powerful tool for assisting in the information process. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Pretreatment with myo-inositol in non polycystic ovary syndrome patients undergoing multiple follicular stimulation for IVF: a pilot study

PubMed Central

2012-01-01

Background Aim of this pilot study is to examine the effects of myo-inositol administration on ovarian response and oocytes and embryos quality in non PolyCystic Ovary Syndrome (PCOS) patients undergoing multiple follicular stimulation and in vitro insemination by conventional in vitro fertilization or by intracytoplasmic sperm injection. Methods One hundred non-PCOS women aged <40 years and with basal FSH <10 mUI/ml were down-regulated with triptorelin acetate from the mid-luteal phase for 2 weeks, before starting the stimulation protocol for oocytes recovery. All patients received rFSH, at a starting dose of 150 IU for 6 days. The dose was subsequently adjusted according to individual response. Group B (n = 50) received myo-inositol and folic acid for 3 months before the stimulation period and then during the stimulation itself. Group A (n-50) received only folic acid as additional treatment in the 3 months before and through treatment. Results Total length of the stimulation was similar between the two groups. Nevertheless, total amount of gonadotropins used to reach follicular maturation was found significantly lower in group B. In addition, the number of oocytes retrieved was significantly reduced in the group pretreated with myo-inositol. Clinical pregnancy and implantation rate were not significantly different in the two groups. Conclusions Our findings suggest that the addition of myo-inositol to folic acid in non PCOS-patients undergoing multiple follicular stimulation for in-vitro fertilization may reduce the numbers of mature oocytes and the dosage of rFSH whilst maintaining clinical pregnancy rate. Further, a trend in favor of increased incidence of implantation in the group pretreated with myo-inositol was apparent in this study. Further investigations are warranted to clarify this pharmacological approach, and the benefit it may hold for patients. PMID:22823904

Predictors of chemoradiation related febrile neutropenia prophylaxis in older adults - Experience from a limited resource setting.

PubMed

Gangopadhyay, Aparna

2018-01-01

To identify risk factors that lower efficacy of antibiotic prophylaxis of febrile neutropenia among older patients on chemoradiation. Audit of institutional data showed that older adults are at higher risk of febrile neutropenia during chemoradiation. In limited resource settings widespread use of Granulocyte-Colony Stimulating Factor (G-CSF) is not economically feasible and antibiotics are used commonly. Despite compliance with antibiotics, prophylaxis is inadequate in many patients owing to patient and tumor related factors. Data from records of 219 older patients receiving antibiotic prophylaxis during chemoradiation were studied. Baseline assessment data and predisposing factors for febrile neutropenia were recorded. All patients received prophylactic fluoroquinolones. Incidence of febrile neutropenia and association with predisposing factors at baseline was analyzed by multiple logistic regression. 38.4% developed febrile neutropenia despite compliance. Multiple logistic regression revealed geriatric assessment (G8) score and tumor stage to be significant predictors of febrile neutropenia while on antibiotics ( p  < 0.0001). Odds ratios for two significant predictors G8 score and tumor stage, respectively, were 2.9 (95% CI 1.8036-4.6815) and 2.7 (95% CI 1.7501-4.1318). Correlation between these two significant predictors was found to be low in our cohort (Spearman's coefficient of rank correlation (rho) - 0.431, p  < 0.0001). G8 score and tumor burden are significant predictors of efficacy of antibiotic prophylaxis among older adults receiving chemoradiation. In older patients having poor G8 scores and advanced tumors, antibiotic prophylaxis is unsuitable. Interestingly, co-morbidities and poor performance status did not impact efficacy of antibiotic prophylaxis among our elderly patients.

Disease-modifying drug initiation patterns in commercially insured multiple sclerosis patients: a retrospective cohort study

PubMed Central

2011-01-01

Background The goal of this research was to compare the demographics, clinical characteristics and treatment patterns for newly diagnosed multiple sclerosis (MS) patients in a commercial managed care population who received disease-modifying drug (DMD) therapy versus those not receiving DMD therapy. Methods A retrospective cohort study using US administrative healthcare claims identified individuals newly diagnosed with MS (no prior MS diagnosis 12 months prior using ICD-9-CM 340) and ≥ 18 years old during 2001-2007 to characterize them based on demographics, clinical characteristics, and pharmacologic therapy for one year prior to and a minimum of one year post-index. The index date was the first MS diagnosis occurring in the study period. Follow-up of subjects was done by ICD-9-CM code identification and not by actual chart review. Multivariate analyses were conducted to adjust for confounding variables. Results Patients were followed for an average of 35.7 ± 17.5 months after their index diagnosis. Forty-three percent (n = 4,462) of incident patients received treatment with at least one of the DMDs during the post-index period. Treated patients were primarily in the younger age categories of 18-44 years of age, with DMD therapy initiated an average of 5.3 ± 9.1 months after the index diagnosis. Once treatment was initiated, 27.7% discontinued DMD therapy after an average of 17.6 ± 14.6 months, and 16.5% had treatment gaps in excess of 60 days. Conclusions Nearly 60% of newly-diagnosed MS patients in this commercial managed care population remained untreated while over a quarter of treated patients stopped therapy and one-sixth experienced treatment gaps despite the risk of disease progression or a return of pre-treatment disease activity. PMID:21974973

Vorinostat or placebo in combination with bortezomib in patients with multiple myeloma (VANTAGE 088): a multicentre, randomised, double-blind study.

PubMed

Dimopoulos, Meletios; Siegel, David S; Lonial, Sagar; Qi, Junyuan; Hajek, Roman; Facon, Thierry; Rosinol, Laura; Williams, Catherine; Blacklock, Hilary; Goldschmidt, Hartmut; Hungria, Vania; Spencer, Andrew; Palumbo, Antonio; Graef, Thorsten; Eid, Joseph E; Houp, Jennifer; Sun, Linda; Vuocolo, Scott; Anderson, Kenneth C

2013-10-01

We aimed to assess efficacy and tolerability of vorinostat in combination with bortezomib for treatment of patients with relapsed or refractory multiple myeloma. In our randomised, double-blind, placebo-controlled, phase 3 trial, we enrolled adults (≥18 years) at 174 university hospitals in 31 countries worldwide. Eligible patients had to have non-refractory multiple myeloma that previously responded to treatment (one to three regimens) but were currently progressing, ECOG performance statuses of 2 or less, and no continuing toxic effects from previous treatment. We excluded patients with known resistance to bortezomib. We randomly allocated patients (1:1) using an interactive voice response system to receive 21 day cycles of bortezomib (1·3 mg/m(2) intravenously on days 1, 4, 8, and 11) in combination with oral vorinostat (400 mg) or matching placebo once-daily on days 1-14. We stratified patients by baseline tumour stage (International Staging System stage 1 or stage ≥2), previous bone-marrow transplantation (yes or no), and number of previous regimens (1 or ≥2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed adverse events in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number 00773747. Between Dec 24, 2008, and Sept 8, 2011, we randomly allocated 317 eligible patients to the vorinostat group (315 of whom received at least one dose) and 320 to the placebo group (all of whom received at least one dose). Median PFS was 7·63 months (95% CI 6·87-8·40) in the vorinostat group and 6·83 months (5·67-7·73) in the placebo group (hazard ratio [HR] 0·77, 95% CI 0·64-0·94; p=0·0100). 312 (99%) of 315 patients in the vorinostat group and 315 (98%) of 320 patients in the placebo group had adverse events (300 [95%] adverse events in the vorinostat group and 282 [88%] in the control group were regarded as related to treatment). The most common grade 3-4 adverse events were thrombocytopenia (143 [45%] patients in the vorinostat group vs 77 [24%] patients in the placebo group), neutropenia (89 [28%] vs 80 [25%]), and anaemia (53 [17%] vs 40 [13%]). Although the combination of vorinostat and bortezomib prolonged PFS relative to bortezomib and placebo, the clinical relevance of the difference in PFS between the two groups is not clear. Different treatment schedules of bortezomib and vorinostat might improve tolerability and enhance activity. Merck. Copyright © 2013 Elsevier Ltd. All rights reserved.

Where Do Patients With Cancer in Iowa Receive Radiation Therapy?

PubMed Central

Ward, Marcia M.; Ullrich, Fred; Matthews, Kevin; Rushton, Gerard; Tracy, Roger; Goldstein, Michael A.; Bajorin, Dean F.; Kosty, Michael P.; Bruinooge, Suanna S.; Hanley, Amy; Jacobson, Geraldine M.; Lynch, Charles F.

2014-01-01

Purpose: Multiple studies have shown survival benefits in patients with cancer treated with radiation therapy, but access to treatment facilities has been found to limit its use. This study was undertaken to examine access issues in Iowa and determine a methodology for conducting a similar national analysis. Patients and Methods: All Iowa residents who received radiation therapy regardless of where they were diagnosed or treated were identified through the Iowa Cancer Registry (ICR). Radiation oncologists were identified through the Iowa Physician Information System (IPIS). Radiation facilities were identified through IPIS and classified using the Commission on Cancer accreditation standard. Results: Between 2004 and 2010, 113,885 invasive cancers in 106,603 patients, 28.5% of whom received radiation treatment, were entered in ICR. Mean and median travel times were 25.8 and 20.1 minutes, respectively, to the nearest facility but 42.4 and 29.1 minutes, respectively, to the patient's chosen treatment facility. Multivariable analysis predicting travel time showed significant relationships for disease site, age, residence location, and facility category. Residents of small and isolated rural towns traveled nearly 3× longer than urban residents to receive radiation therapy, as did patients using certain categories of facilities. Conclusion: Half of Iowa patients could reach their nearest facility in 20 minutes, but instead, they traveled 30 minutes on average to receive treatment. The findings identified certain groups of patients with cancer who chose more distant facilities. However, other groups of patients with cancer, namely those residing in rural areas, had less choice, and some had to travel considerably farther to radiation facilities than urban patients. PMID:24443730

Quality of life in Brazilian patients with treated or untreated chronic hepatitis C

PubMed Central

Perlin, Cássio Marques; Ferreira, Vinicius Lins; Borba, Helena Hiemisch Lobo; Wiens, Astrid; Ivantes, Cláudia Alexandra Pontes; Lenzi, Luana; Pontarolo, Roberto

2017-01-01

ABSTRACT Introduction: Multiple factors negatively affect the quality of life of patients infected with hepatitis C virus. This study aims to evaluate the effect of pharmacological treatment on the quality of life of these individuals. Methods: This is a cross-sectional study conducted in two Southern Brazilian centers that used two instruments (a generic and a specific one) for measuring the quality of life in patients with chronic hepatitis C: the Short Form-36 (SF-36); and the Chronic Liver Disease Questionnaire (CLDQ) for liver disease. We included patients from two centers without any treatment (control group), or receiving medication (peginterferon + ribavirin ± telaprevir or boceprevir, i.e., respectively, dual, and triple therapies). Results: One hundred and forty-seven patients were included. Patients under treatment (n = 86) had a lower score in 7 of the 8 SF-36 domains, with statistical significance (p<0.05) only for the emotional function domain. Patients who were not treated (n = 58) had higher scores in 4 of the 6 (p<0.05) CLDQ domains. A comparison of patients, receiving dual or triple therapies for both questionnaires, was only significant in the Vitality domain from CLDQ. Conclusions: Treatment can affect the subjective perception of patients regarding quality of life. Due to the complexity of the disease, each patient must be evaluated in multiple dimensions. Thus, the results may be useful for understanding the patient's perceptions during treatment, and it can also serve as a reference for care instructions. PMID:29267589

Exploring the Impact of Language Services on Utilization and Clinical Outcomes for Diabetics

PubMed Central

Hacker, Karen; Choi, Yoon Susan; Trebino, Lisa; Hicks, LeRoi; Friedman, Elisa; Blanchfield, Bonnie; Gazelle, G. Scott

2012-01-01

Background Significant health disparities exist between limited English proficient and English-proficient patients. Little is known about the impact of language services on chronic disease outcomes such as for diabetes. Methods/Principal Findings To determine whether the amount and type of language services received during primary care visits had an impact on diabetes-related outcomes (hospitalization, emergency room utilization, glycemic control) in limited English proficient patients, a retrospective cohort design was utilized. Hospital and medical record data was examined for 1425 limited English proficient patients in the Cambridge Health Alliance diabetes registry. We categorized patients receiving usual care into 7 groups based on the amount and combination of language services (language concordant providers, formal interpretation and nothing) received at primary care visits during a 9 month period. Bivariate analyses and multiple logistic regression were used to determine relationships between language service categories and outcomes in the subsequent 6 months. Thirty-one percent of patients (445) had no documentation of interpreter use or seeing a language concordant provider in any visits. Patients who received 100% of their primary care visits with language concordant providers were least likely to have diabetes-related emergency department visits compared to other groups (p<0001) in the following 6 months. Patients with higher numbers of co-morbidities were more likely to receive formal interpretation. Conclusions/Significance Language concordant providers may help reduce health care utilization for limited English proficient patients with diabetes. However, given the lack of such providers in sufficient numbers to meet patients' communication needs, strategies are needed to both increase their numbers and ensure that the highest risk patients receive the most appropriate language services. In addition, systems serving diverse populations must clarify why some limited English proficient patients do not receive language services at some or all of their visits and whether this has an impact on quality of care. PMID:22675571

Paratesticular Liposarcoma; a Case Report

PubMed Central

Omidvari, Shapour; Hamedi, Seyyed Hasan; Moaddab-Shoar, Leila; Nasrollahi, Hamid; Daneshbod, Yahya; Mosleh-Shirazi, Mohammad Amin; Ansrai, Mansour; Mohammadianpanah, Mohammad; Ahmadloo, Niloofar; Mosalaei, Ahmad

2014-01-01

Paratesticular sarcomas have happened rarely. Due to the infrequency of this malignant disease and its diverse histopathologic subtypes, no standard treatment would be available. Multiple treatments have reported in literature with different results. We have reported a 55 years old man with a 30 years history of paratesticular mass. After multiple operations, radical orchiectomy has revealed liposarcoma. The patient has been receiving 50 Gy radiation to the scrotum and inguinal area. After 18 months follow up, the patient was well and disease free. He has shown good response to surgery and radiotherapy, so we have reported the disease and its clinical course. PMID:25628845

Paratesticular liposarcoma; a case report.

PubMed

Omidvari, Shapour; Hamedi, Seyyed Hasan; Moaddab-Shoar, Leila; Nasrollahi, Hamid; Daneshbod, Yahya; Mosleh-Shirazi, Mohammad Amin; Ansrai, Mansour; Mohammadianpanah, Mohammad; Ahmadloo, Niloofar; Mosalaei, Ahmad

2014-01-01

Paratesticular sarcomas have happened rarely. Due to the infrequency of this malignant disease and its diverse histopathologic subtypes, no standard treatment would be available. Multiple treatments have reported in literature with different results. We have reported a 55 years old man with a 30 years history of paratesticular mass. After multiple operations, radical orchiectomy has revealed liposarcoma. The patient has been receiving 50 Gy radiation to the scrotum and inguinal area. After 18 months follow up, the patient was well and disease free. He has shown good response to surgery and radiotherapy, so we have reported the disease and its clinical course.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Predictive factors for moderate or severe exacerbations in asthma patients receiving outpatient care.

PubMed

Gutiérrez, Francisco Javier Álvarez; Galván, Marta Ferrer; Gallardo, Juan Francisco Medina; Mancera, Marta Barrera; Romero, Beatriz Romero; Falcón, Auxiliadora Romero

2017-05-02

Asthma exacerbations are important events that affect disease control, but predictive factors for severe or moderate exacerbations are not known. The objective was to study the predictive factors for moderate (ME) and severe (SE) exacerbations in asthma patients receiving outpatient care. Patients aged > 12 years with asthma were included in the study and followed-up at 4-monthly intervals over a 12-month period. Clinical (severity, level of control, asthma control test [ACT]), atopic, functional, inflammatory, SE and ME parameters were recorded. Univariate analysis was used to compare data from patients presenting at least 1 SE or ME during the follow-up period vs no exacerbations. Statistically significant (p <0.1) factors were then subjected to multiple analysis by binary logistic regression. A total of 330 patients completed the study, most of whom were atopic (76%), women (nearly 70%), with moderate and mild persistent asthma (>80%). Twenty-seven patients (8%) had a SE and 183 had a ME (58.5%) during follow-up. In the case of SEs, the only predictive factor identified in the multiple analysis was previous SE (baseline visit OR 4.218 95% CI 1.53-11.58, 4-month follow-up OR 6.88 95% CI 2.018-23.51) and inhalation technique (OR 3.572 95% CI 1.324-9.638). In the case of MEs, the only predictive factor found in the multiple analysis were previous ME (baseline visit OR 2.90 95% CI 1.54-5.48, 4-month follow- up OR 1.702 95% CI 1.146-2.529). The primary predictive factor for SE or ME is prior SE or ME, respectively. SEs seem to constitute a specific patient "phenotype", in which the sole predictive factor is prior SEs.

The European Medicines Agency Review of Carfilzomib for the Treatment of Adult Patients with Multiple Myeloma Who Have Received at Least One Prior Therapy.

PubMed

Tzogani, Kyriaki; Camarero Jiménez, Jorge; Garcia, Isabel; Sancho-López, Arantxa; Martin, Marc; Moreau, Alexandre; Demolis, Pierre; Salmonson, Tomas; Bergh, Jonas; Laane, Edward; Ludwig, Heinz; Gisselbrecht, Christian; Pignatti, Francesco

2017-11-01

On November 19, 2015, a marketing authorization valid through the European Union was issued for carfilzomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.In a phase III trial in patients with relapsed MM, median progression-free survival (PFS) for patients treated with carfilzomib in combination with lenalidomide and dexamethasone (CRd) was 26.3 months versus 17.6 months for those receiving lenalidomide and dexamethasone alone (hazard ratio = 0.69; 95% confidence interval, 0.57-0.83; one-sided log-rank p value < .0001). The most frequently observed toxicity (grade ≥3, treatment arm vs. control arm) in the phase III trial included neutropenia (29.6% vs. 26.5%), anemia (17.9% vs. 17.7%), thrombocytopenia (16.8% vs. 12.3%), pneumonia (12.5% vs. 10.5%), fatigue (7.7% vs. 6.4%), hypertension (4.6% vs. 2.1%), diarrhea (3.8% vs. 4.1%), and respiratory tract infection (4.1% vs. 2.1%).The objective of this article is to summarize the scientific review of the application leading to regulatory approval in the European Union. The scientific review concluded that the gain in PFS of 8.7 months observed with the combination of CRd was considered clinically meaningful and was supported by a clear trend in overall survival benefit, although the data were not mature. The delay in disease progression appeared superior to available alternatives in the setting of relapsed MM at the time of the marketing authorization of carfilzomib. Therefore, given the overall accepted safety profile, which was considered manageable in the current context, the benefit risk for CRd was considered positive. Carfilzomib (Kyprolis) was approved in the European Union in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The addition of carfilzomib to lenalidomide and dexamethasone resulted in a clinically meaningful and statistically significant improvement of progression-free survival compared with lenalidomide and dexamethasone, which was supported by a clear trend in overall survival benefit, although the data were not mature. At the time of the marketing authorization of carfilzomib, the delay in disease progression appeared superior to available alternatives in the setting of relapsed multiple myeloma. In terms of safety, the overall accepted safety profile was considered manageable. © AlphaMed Press 2017.

Repeated onabotulinumtoxin-a injections provide better results than single injection in treatment of painful bladder syndrome.

PubMed

Kuo, Hann-Chorng

2013-01-01

Onabotulinumtoxin-A (BoNT-A) is effective for the treatment of interstitial cystitis/painful bladder syndrome (IC/PBS). However, long-term follow-up does not show successful outcome after a single injection. To evaluate the efficacy and safety of repeated intravesical BoNT-A injections for treatment of IC/PBS and compare the success rates among patient groups receiving different injection numbers. Prospective interventional study. Tertiary medical center. Intravesical injection of 100 U of BoNT-A was performed in 81 patients every 6 months for up to 4 times or until patients' symptoms significantly improved. Patients who received a single injection served as active controls. Measured parameters included O'Leary-Sant symptom indexes (ICSI) and problem indexes (ICPI), visual analogue score (VAS) for pain, voiding diary variables, urodynamic parameters, maximal bladder capacity under anesthesia, glomerulation grade, and global response assessment. Multiple measurements and Kaplan-Meier analysis were used for comparison of consecutive data and success rates among groups. Among 81 patients, 20 received single injections, 19 received 2 injections, 12 received 3 injections, and 30 received 4 injections. The mean (± standard deviation) of ICSI, ICPI, total scores, VAS, functional bladder capacity, and daytime frequency all showed significant improvement after repeated BoNT-A treatment with different injections. Significantly better success rates were noted in patients who received 4 repeated injections (P = 0.0242) and 3 injections (P = 0.050), compared to those who received a single injection. However, there was no significant difference of long-term success rates among patients who received 2, 3, and 4 injections. Lack of placebo control group is the main limitation. Repeated intravesical BoNT-A injections were safe and effective for pain relief and they increased bladder capacity and provided a better long-term success rate than a single injection did for treatment of IC/PBS.

Fulfilment of knowledge expectations and emotional state among people undergoing hip replacement: a multi-national survey.

PubMed

Johansson Stark, Asa; Ingadottir, Brynja; Salanterä, Sanna; Sigurdardottir, Arun; Valkeapää, Kirsi; Bachrach-Lindström, Margareta; Unosson, Mitra

2014-11-01

Patient education in connection with hip replacement is intended to prepare patients for surgery, discharge and postoperative recovery. Patients experience symptoms and emotions due to disease or upcoming surgery which can affect how their knowledge expectations are fulfilled. To describe the differences between received and expected knowledge in patients undergoing elective hip replacement in three Nordic countries, and to analyse how these differences are related to patients' characteristics, preoperative symptoms and emotions. A descriptive, prospective survey with two data collection points; before admission and at hospital discharge after surgery. Two Finnish, three Icelandic and two Swedish hospitals. The population consisted of patients on a waiting list for hip replacement. Of the consecutively included patients, 320 answered questionnaires both before admission and at discharge and were included in the study. The mean age of the patients was 64 years, and 55% were women. Structured questionnaires were used; the knowledge expectations of hospital patients scale and self-reported scales for symptoms and emotions before admission and received knowledge of hospital patients scale at discharge. Fulfilment of knowledge expectation was assessed by calculating the difference between received and expected knowledge with a paired sample t-test. A multiple stepwise regression model was used to explain the variance of fulfilled knowledge expectations. Patients expected more knowledge than they received (p<0.001) and 77% of them had unfulfilled knowledge expectations. Patients with a higher level of education were more likely to have unfulfilled knowledge expectations. A higher level of education was also related to a greater difference between received and expected knowledge. The difference was more correlated with patients' emotions than their symptoms. A depressive state was the major predictor of the variance in the difference between received and expected knowledge. In order to better support patients by education it is necessary to assess their emotional state, educational level and knowledge expectations before surgery. Copyright © 2014 Elsevier Ltd. All rights reserved.

Disparities in the Utilization of Laparoscopic Surgery for Colon Cancer in Rural Nebraska: A Call for Placement and Training of Rural General Surgeons

PubMed Central

Gruber, Kelli; Soliman, Amr S.; Schmid, Kendra; Rettig, Bryan; Ryan, June; Watanabe-Galloway, Shinobu

2015-01-01

Background Advances in medical technology are changing surgical standards for colon cancer treatment. The laparoscopic colectomy is equivalent to the standard open colectomy while providing additional benefits. It is currently unknown what factors influence utilization of laparoscopic surgery in rural areas and if treatment disparities exist. The objectives of this study were to examine demographic and clinical characteristics associated with receiving laparoscopic colectomy and to examine the differences between rural and urban patients who received either procedure. Methods This study utilized a linked dataset of Nebraska Cancer Registry and hospital discharge data on colon cancer patients diagnosed and treated in the entire state of Nebraska from 2008–2011 (N=1,062). Multiple logistic regression analysis was performed to identify predictors of receiving the laparoscopic treatment. Results Rural colon cancer patients were 40% less likely to receive laparoscopic colectomy compared to urban patients. Independent predictors of receiving laparoscopic colectomy were younger age (<60), urban residence, ≥3 comorbidities, elective admission, smaller tumor size, and early stage at diagnosis. Additionally, rural patients varied demographically compared to urban patients. Conclusions Laparoscopic surgery is becoming the new standard of treatment for colon cancer and important disparities exist for rural cancer patients in accessing the specialized treatment. As cancer treatment becomes more specialized, the importance of training and placement of general surgeons in rural communities must be a priority for health care planning and professional training institutions. PMID:25951881

Prevention and treatment of recurrent laryngeal nerve injury in thyroid surgery

PubMed Central

Jiang, Yan; Gao, Bo; Zhang, Xiaohua; Zhao, Jianjie; Chen, Jinping; Zhang, Shu; Luo, Donglin

2014-01-01

Aim: To summary the experience for prevention and treatment of recurrent laryngeal nerve (RLN) injury in thyroid surgery. Methods: Clinical features of 623 patients who received thyroid surgery from January 2010 to December 2012 were analyzed retrospectively, and the features of RLN injury and intraoperative as well as postoperative treatments were reviewed. Results: RLN injury occurred in 31 patients (4.98%), in which, unilateral RLN injury occurred in 27 patients and bilateral RLN injuries occurred in 4 patients (temporary injury in 28 patients and permanent injury in 3 patients). 6 patients underwent RLN anastomosis during surgery and exhibited transient hoarseness after surgery. RLN exploration and decompression was given in 1 patient and the patient got normal vocal cord motion 2 months after surgery. 1 patient with bilateral injuries received tracheotomy and CO2 laser resection of arytenoid cartilage and achieved recovery 1 year later. Conclusions: In order to prevent RLN injury, the anatomic variations of RLN should be mastered. Routine exposure of RLN can effectively prevent the injury in patients receiving the second or multiple surgeries. Early interventions for RLN injury include mainly early discovery, early exploration and early anastomosis, and the function of RLN in some patients can recover completely. Subsequent treatments mainly focus on the improvement of the voice, expansion of glottis and melioration of dyspnea. PMID:24482694

Thiazolidinediones and congestive heart failure in veterans with type 2 diabetes.

PubMed

Toprani, A; Fonseca, V

2011-03-01

The thiazolidinedione (TZD) class of antihyperglycaemic agents has been shown to improve glycaemic control by improving peripheral insulin sensitivity but may worsen or precipitate congestive heart failure (CHF). Randomized controlled trials have shown an increased risk of CHF in patients treated with TZDs. The use of TZDs in clinical practice has the potential to increase morbidity and health care costs. The purpose of this study was to compare the incidence of CHF in TZD and non-TZD-treated patients in a clinical setting. A retrospective cohort study of all male patients with type 2 diabetes seen in the South Central US Veterans Administration health care network between 1 October 1996 and 31 December 2004. We constructed a Cox proportional hazards model to evaluate the impact of TZD therapy on time to incidence of CHF. Of 3956 patients, 29% (n = 1157) developed CHF during the study period. The incidence of CHF was higher in patients who received TZD medications than in those who received TZDs. After adjustment for multiple cardiac risk factors, the hazard ratio for the development of CHF for TZD versus non-TZD-treated patients was 0.69 with a 95% confidence interval of 0.60-0.79. Patients in this cohort who received TZD medications had a lower incidence of heart failure than patients who did not receive TZDs. © 2011 Blackwell Publishing Ltd.

Prognostic factors affecting survival after whole brain radiotherapy in patients with brain metastasized lung cancer.

PubMed

Tsakonas, Georgios; Hellman, Fatou; Gubanski, Michael; Friesland, Signe; Tendler, Salomon; Lewensohn, Rolf; Ekman, Simon; de Petris, Luigi

2018-02-01

Whole-brain radiotherapy (WBRT) has been the standard of care for multiple NSCLC brain metastases but due to its toxicity and lack of survival benefit, its use in the palliative setting is being questioned. This was a single institution cohort study including brain metastasized lung cancer patients who received WBRT at Karolinska University Hospital. Information about Recursive Partitioning Analysis (RPA) and Graded Prognostic Assessment (GPA) scores, demographics, histopathological results and received oncological therapy were collected. Predictors of overall survival (OS) from the time of received WBRT were identified by Cox regression analyses. OS between GPA and RPA classes were compared by pairwise log rank test. A subgroup OS analysis was performed stratified by RPA class. The cohort consisted of 280 patients. RPA 1 and 2 classes had better OS compared to class 3, patients with GPA <1.5 points had better OS compared to GPA≥ 1.5 points and age >70 years was associated with worse OS (p< .0001 for all comparisons). In RPA class 2 subgroup analysis GPA ≥1.5 points, age ≤70 years and CNS surgery before salvage WBRT were independent positive prognostic factors. RPA class 3 patients should not receive WBRT, whereas RPA class 1 patients should receive WBRT if clinically indicated. RPA class 2 patients with age ≤70 years and GPA ≥1.5 points should be treated as RPA 1. WBRT should be omitted in RPA 2 patients with age >70. In RPA 2 patients with age ≤70 years and GPA <1.5 points WBRT could be a reasonable option.

Vitiligo-like lesions occurring in patients receiving anti-programmed cell death-1 therapies are clinically and biologically distinct from vitiligo.

PubMed

Larsabal, Maiana; Marti, Aurélie; Jacquemin, Clément; Rambert, Jérôme; Thiolat, Denis; Dousset, Léa; Taieb, Alain; Dutriaux, Caroline; Prey, Sorilla; Boniface, Katia; Seneschal, Julien

2017-05-01

The use of anti-programmed cell death (PD)-1 therapies in metastatic tumors is associated with cutaneous side effects including vitiligo-like lesions. We sought to characterize clinically and biologically vitiligo-like lesions occurring in patients receiving anti-PD-1 therapies by studying a case series of 8 patients with metastatic tumors and 30 control subjects with vitiligo. Eight patients receiving anti-PD-1 therapies with features of vitiligo-like lesions seen in our department were recruited. Clinical features and photographs were analyzed. For some patients, skin and blood samples were obtained. Results were compared with the vitiligo group. All patients developed lesions localized on photoexposed areas with a specific depigmentation pattern consisting of multiple flecked lesions without Koebner phenomenon. In contrast to vitiligo, patients receiving anti-PD-1 therapies who developed vitiligo-like lesions did not report any personal or family histories of vitiligo, thyroiditis, or other autoimmune disorders. Analysis of blood and skin samples revealed increased C-X-C motif ligand 10 levels in serum of patients developing vitiligo-like lesions, associated with skin infiltration of CD8 T-cells expressing C-X-C motif receptor 3 and producing elevated levels of interferon-γ and tumor necrosis factor-alfa. This cross-sectional study concerned a single center. Clinical and biological patterns of vitiligo-like lesions occurring in patients receiving anti-PD-1 therapies differ from vitiligo, suggesting a different mechanism. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Real-world outcome and healthcare costs of relapsed or refractory multiple myeloma: A retrospective analysis from the Chinese experience.

PubMed

Zhou, Xin; Xia, Jun; Mao, Jingjue; Cheng, Feng; Qian, Xifeng; Guo, Hongfeng

2016-06-01

Our aim was to retrospectively investigate the real-world outcome and healthcare costs associated with the treatment of patients with relapsed or refractory multiple myeloma (RRMM) in a Chinese single center. A retrospective study was conducted for 93 patients between January 2008 and December 2013 in a Chinese hematology department. Total monthly costs attributable to each cost component were described across all regimens and for bortezomib-based treatment regimens. Mean total cost per patient-month ($1139.85) varied depending on the sequence of therapy (range: mean $51.63-$6600.96). Drugs and hospital visit were the most and the least consumed resource (65.48% and 2.87%, respectively). Mean total monthly costs were $2071.96 (range: $679.73-$6600.96) and $551.14 (range: $51.63-$1698.59) for patients receiving bortezomib and patients not receiving bortezomib, respectively. Differences between the two groups were significant for drugs; drugs costs were higher for patients treated with bortezomib. Kaplan-Meier curves showed a longer overall survival (mean [median] 31.43 [25] vs. 21.93 [18] months) for patients treated with bortezomib. Real-world costs during treatment of RRMM varied greatly. Total costs during bortezomib-based regimens are significantly higher compared with non-bortezomib regimens. Further multi-center studies are needed to assess the cost-effectiveness of bortezomib for the treatment of RRMM in China.

Immunomodulatory effects of the Agaricus blazei Murrill-based mushroom extract AndoSan in patients with multiple myeloma undergoing high dose chemotherapy and autologous stem cell transplantation: a randomized, double blinded clinical study.

PubMed

Tangen, Jon-Magnus; Tierens, Anne; Caers, Jo; Binsfeld, Marilene; Olstad, Ole Kristoffer; Trøseid, Anne-Marie Siebke; Wang, Junbai; Tjønnfjord, Geir Erland; Hetland, Geir

2015-01-01

Forty patients with multiple myeloma scheduled to undergo high dose chemotherapy with autologous stem cell support were randomized in a double blinded fashion to receive adjuvant treatment with the mushroom extract AndoSan, containing 82% of Agaricus blazei Murrill (19 patients) or placebo (21 patients). Intake of the study product started on the day of stem cell mobilizing chemotherapy and continued until the end of aplasia after high dose chemotherapy, a period of about seven weeks. Thirty-three patients were evaluable for all study endpoints, while all 40 included patients were evaluable for survival endpoints. In the leukapheresis product harvested after stem cell mobilisation, increased percentages of Treg cells and plasmacytoid dendritic cells were found in patients receiving AndoSan. Also, in this group, a significant increase of serum levels of IL-1ra, IL-5, and IL-7 at the end of treatment was found. Whole genome microarray showed increased expression of immunoglobulin genes, Killer Immunoglobulin Receptor (KIR) genes, and HLA genes in the Agaricus group. Furthermore, AndoSan displayed a concentration dependent antiproliferative effect on mouse myeloma cells in vitro. There were no statistically significant differences in treatment response, overall survival, and time to new treatment. The study was registered with Clinicaltrials.gov NCT00970021.

Immunomodulatory Effects of the Agaricus blazei Murrill-Based Mushroom Extract AndoSan in Patients with Multiple Myeloma Undergoing High Dose Chemotherapy and Autologous Stem Cell Transplantation: A Randomized, Double Blinded Clinical Study

PubMed Central

Tierens, Anne; Caers, Jo; Binsfeld, Marilene; Olstad, Ole Kristoffer; Trøseid, Anne-Marie Siebke; Wang, Junbai; Tjønnfjord, Geir Erland; Hetland, Geir

2015-01-01

Forty patients with multiple myeloma scheduled to undergo high dose chemotherapy with autologous stem cell support were randomized in a double blinded fashion to receive adjuvant treatment with the mushroom extract AndoSan, containing 82% of Agaricus blazei Murrill (19 patients) or placebo (21 patients). Intake of the study product started on the day of stem cell mobilizing chemotherapy and continued until the end of aplasia after high dose chemotherapy, a period of about seven weeks. Thirty-three patients were evaluable for all study endpoints, while all 40 included patients were evaluable for survival endpoints. In the leukapheresis product harvested after stem cell mobilisation, increased percentages of Treg cells and plasmacytoid dendritic cells were found in patients receiving AndoSan. Also, in this group, a significant increase of serum levels of IL-1ra, IL-5, and IL-7 at the end of treatment was found. Whole genome microarray showed increased expression of immunoglobulin genes, Killer Immunoglobulin Receptor (KIR) genes, and HLA genes in the Agaricus group. Furthermore, AndoSan displayed a concentration dependent antiproliferative effect on mouse myeloma cells in vitro. There were no statistically significant differences in treatment response, overall survival, and time to new treatment. The study was registered with Clinicaltrials.gov NCT00970021. PMID:25664323

Cumulative effective radiation dose received by blunt trauma patients arriving to a military level I trauma center from point of injury and interhospital transfers.

PubMed

Van Arnem, Kerri A; Supinski, David P; Tucker, Jonathan E; Varney, Shawn

2016-12-01

Trauma patients sustaining blunt injuries are exposed to multiple radiologic studies. Evidence indicates that the risk of cancer from exposure to ionizing radiation rises in direct proportion to the cumulative effective dose (CED) received. The purpose of this study is to quantify the amount of ionizing radiation accumulated when arriving directly from point of injury to San Antonio Military Medical Center (SAMMC), a level I trauma center, compared with those transferred from other facilities. A retrospective record review was conducted from 1st January 2010 through 31st December 2012. The SAMMC trauma registry, electronic medical records, and the digital radiology imaging system were searched for possible candidates. The medical records were then analyzed for sex, age, mechanism of injury, received directly from point of injury (direct group), transfer from another medical facility (transfer group), computed tomographic scans received, dose-length product, CED of radiation, and injury severity score. A diagnostic imaging physicist then calculated the estimated CED each subject received based on the dose-length product of each computed tomographic scan. A total of 300 patients were analyzed, with 150 patients in the direct group and 150 patients in the transfer group. Both groups were similar in age and sex. Patients in the transfer group received a significantly greater CED of radiation compared with the direct group (mean, 37.6 mSv vs 28 mSv; P=.001). The radiation received in the direct group correlates with a lifetime attributable risk (LAR) of 1 in 357 compared with the transfer group with an increase in LAR to 1 in 266. Patients transferred to our facility received a 34% increase in ionizing radiation compared with patients brought directly from the injury scene. This increased dose of ionizing radiation contributes to the LAR of cancer and needs to be considered before repeating imaging studies. III. Published by Elsevier Inc.

Timing of Chemotherapy After MammoSite Radiation Therapy System Breast Brachytherapy: Analysis of the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Haffty, Bruce G.; Vicini, Frank A.; Beitsch, Peter

2008-12-01

Purpose: To evaluate cosmetic outcome and radiation recall in the American Society of Breast Surgeons registry trial, as a function of the interval between accelerated partial breast irradiation (APBI) and initiation of chemotherapy (CTX). Methods and Materials: A total of 1440 patients at 97 institutions participated in this trial. After lumpectomy for early-stage breast cancer, patients received APBI (34 Gy in 10 fractions) with MammoSite RTS brachytherapy. A total of 148 patients received CTX within 90 days of APBI. Cosmetic outcome was evaluated at each follow-up visit and dichotomized as excellent/good or fair/poor. Results: Chemotherapy was initiated at a meanmore » of 3.9 weeks after the final MammoSite procedure and was administered {<=}3 weeks after APBI in 54 patients (36%) and >3 weeks after APBI in 94 patients (64%). The early and delayed groups were well balanced with respect to multiple factors that may impact on cosmetic outcome. There was a superior cosmetic outcome in those receiving chemotherapy >3 weeks after APBI (excellent/good in 72.2% at {<=}3 weeks vs. excellent/good in 93.8% at >3 weeks; p = 0.01). Radiation recall in those receiving CTX at {<=}3 weeks was 9 of 50 (18%), compared with 6 of 81(7.4%) in those receiving chemotherapy at >3 weeks (p = 0.09). Conclusion: The majority of patients receiving CTX after APBI have excellent/good cosmetic outcomes, with a low rate of radiation recall. Chemotherapy initiated >3 weeks after the final MammoSite procedure seems to be associated with a better cosmetic outcome and lower rate of radiation recall. An excellent/good cosmetic outcome in patients receiving CTX after 3 weeks was similar to the cosmetic outcome of the overall patient population who did not receive CTX.« less

Smoldering multiple myeloma requiring treatment: time for a new definition?

PubMed Central

Stewart, A. Keith; Chanan-Khan, Asher; Rajkumar, S. Vincent; Kyle, Robert A.; Fonseca, Rafael; Kapoor, Prashant; Bergsagel, P. Leif; McCurdy, Arleigh; Gertz, Morie A.; Lacy, Martha Q.; Lust, John A.; Russell, Stephen J.; Zeldenrust, Steven R.; Reeder, Craig; Roy, Vivek; Buadi, Francis; Dingli, David; Hayman, Suzanne R.; Leung, Nelson; Lin, Yi; Mikhael, Joseph; Kumar, Shaji K.

2013-01-01

Smoldering multiple myeloma (SMM) bridges the gap between monoclonal gammopathy of undetermined significance (a mostly premalignant disorder) and active multiple myeloma (MM). Until recently, no interventional study in patients with SMM showed improved overall survival (OS) with therapy as compared with observation. A report from the PETHEMA-GEM (Programa Español de Tratamientos en Hematologica) group described both fewer myeloma-related events and better OS among patients with high-risk SMM who were treated with lenalidomide and dexamethasone. This unique study prompted us to review current knowledge about SMM and address the following questions: (1) Are there patients currently defined as SMM who should be treated routinely? (2) Should the definitions of SMM and MM be reconsidered? (3) Has the time come when not treating is more dangerous than treating? (4) Could unintended medical harm result from overzealous intervention? Our conclusion is that those patients with the highest-risk SMM (extreme bone marrow plasmacytosis, extremely abnormal serum immunoglobulin free light chain ratio, and multiple bone lesions detected only by modern imaging) should be reclassified as active MM so that they can receive MM-appropriate therapy and the paradigm of careful observation for patients with SMM can be preserved. PMID:24144641

Cumulative effective dose associated with radiography and CT of adolescents with spinal injuries.

PubMed

Lemburg, Stefan P; Peters, Soeren A; Roggenland, Daniela; Nicolas, Volkmar; Heyer, Christoph M

2010-12-01

The purpose of this study was to analyze the quantity and distribution of cumulative effective doses in diagnostic imaging of adolescents with spinal injuries. At a level 1 trauma center from July 2003 through June 2009, imaging procedures during initial evaluation and hospitalization and after discharge of all patients 10-20 years old with spinal fractures were retrospectively analyzed. The cumulative effective doses for all imaging studies were calculated, and the doses to patients with spinal injuries who had multiple traumatic injuries were compared with the doses to patients with spinal injuries but without multiple injuries. The significance level was set at 5%. Imaging studies of 72 patients (32 with multiple injuries; average age, 17.5 years) entailed a median cumulative effective dose of 18.89 mSv. Patients with multiple injuries had a significantly higher total cumulative effective dose (29.70 versus 10.86 mSv, p < 0.001) mainly owing to the significantly higher CT-related cumulative effective dose to multiple injury patients during the initial evaluation (18.39 versus 2.83 mSv, p < 0.001). Overall, CT accounted for 86% of the total cumulative effective dose. Adolescents with spinal injuries receive a cumulative effective dose equal to that of adult trauma patients and nearly three times that of pediatric trauma patients. Areas of focus in lowering cumulative effective dose should be appropriate initial estimation of trauma severity and careful selection of CT scan parameters.

Risks and burden of viral respiratory tract infections in patients with multiple myeloma in the era of immunomodulatory drugs and bortezomib: experience at an Australian Cancer Hospital.

PubMed

Teh, Benjamin W; Worth, Leon J; Harrison, Simon J; Thursky, Karin A; Slavin, Monica A

2015-07-01

Infections are a leading cause of morbidity and mortality in patients with multiple myeloma. The epidemiology, risk factors and outcomes of viral respiratory tract infections (vRTI) are not well described in patients with multiple myeloma managed with novel agents, the current standard of care. Patients with myeloma from 2009 to 2012 who tested positive on respiratory virus multiplex polymerase chain reaction had clinical, radiological and microbiological records reviewed. The Fourth European Conference on Infections in Leukaemia (ECIL-4) definitions of RTI were applied. Univariate and multivariate regression analysis of risk factors was performed using vRTI as the evaluable outcome. Of 330 patients, 75 (22.7%) tested positive for a total of 100 vRTI episodes. All patients received thalidomide, lenalidomide or bortezomib in combination with myeloma therapies (median of three treatment regimens). vRTI occurred most commonly in patients with progressive disease, and receipt of more than three lines of myeloma therapy was associated with an increased risk of vRTI (p < 0.01). Amongst key respiratory pathogens, influenza was associated with the highest hospital admission rate (66.7%), ICU admission rate (41.6%) and mortality (33.3%) whilst RSV was associated with prolonged hospital stay. Patients with multiple myeloma and advanced disease managed with multiple lines of therapy are at risk for vRTI, and targeted interventions for prevention/treatment are required.

Patient expectations and experiences of multiple sclerosis interferon β-1a treatment: a longitudinal, observational study in routine UK clinical practice

PubMed Central

Syed, Mehmood; Rog, David; Parkes, Laura; Shepherd, Gillian L

2014-01-01

Background Premature discontinuation and poor treatment adherence are problems in chronic conditions, such as multiple sclerosis in which patients must take long-term treatment in order to receive maximum benefit from their medication. The Assessing needs In Multiple Sclerosis (AIMS) study explored factors related to premature treatment discontinuation and patients’ experiences of subcutaneous (sc) interferon (IFN) β-1a treatment in the UK. Methods A questionnaire-based survey was integrated into the Bupa Home Healthcare patient-support program, which delivers sc IFN β-1a to patients in their home. Data were collected via patient questionnaires incorporated into routine clinical care and administered upon registration of a new patient by the coordinator, following initial delivery of treatment, prior to each delivery during therapy and at the end of treatment. Univariate and multivariate analyses were performed to identify factors associated with premature discontinuation. Results Data were collected from 2,390 patients (1,267 new; 1,123 existing) from 59 UK prescribing centers (November 2006–April 2011). Following the first delivery of sc IFN β-1a, 94% (1,149/1,225) of patients had received training, and 73% (818/1,120) reported that they had no concerns. In total, 24% of new patients discontinued therapy by the end of the study. In the univariate model, none of the candidate variables tested were significant predictors of treatment discontinuation. The strongest predictors of discontinuation in multivariate analyses were lack of information prior to starting treatment and patients feeling unwell on treatment and geographic region (P<0.05 for each variable). Conclusion This study suggests that patients feeling well on treatment and provision of high-quality information are the main determinants of persistence with sc IFN β-1a therapy. A package of care that targets these issues should therefore be considered when initiating sc IFN β-1a therapy. PMID:24570582

Development of mediastinal lymphoma after radiotherapy for concurrent medulloblastoma and PNET in a patient with Gorlin syndrome.

PubMed

Jiang, Tao; Wang, Junmei; Wang, Ying; Li, Chunde

2016-08-12

Very young children with Gorlin syndrome are at risk for developing medulloblastoma. Patients with Gorlin syndrome may have multiple system abnormalities, including basal cell carcinomas, jaw cysts, desmoplastic medulloblastoma, palmar/plantar pits, rib abnormalities, and intracranial falx calcification. The early diagnosis of Gorlin syndrome in desmoplastic medulloblastoma patients is very important because these patients should receive chemotherapy as a first-line treatment and should avoid radiotherapy as much as possible. In the present study, a 5-year-old male patient had a concurrent cerebellar desmoplastic medulloblastoma and temporal primitive neuroectodermal tumor. Examinations of this patient revealed multiple café-au-lait spots, a jaw cyst, and a bifid rib. A molecular classification analysis revealed that the patient's cerebellar tumor was of the sonic hedgehog subtype. Twenty-seven months after tumor resection and cerebrospinal irradiation were performed, mediastinal lymphoma was found in the patient. The patient ultimately died of lymphoma. To the best of our knowledge, this is the first report of a concurrent medulloblastoma and primitive neuroectodermal tumor and the fourth report of multiple café-au-lait spots in a patient with Gorlin syndrome. This report is also the first account of the development of mediastinal lymphoma after spinal irradiation in a patient with Gorlin syndrome. Chemotherapy should be the first-line treatment for medulloblastoma patients with Gorlin syndrome. Young patients with medulloblastoma of the desmoplastic subtype and multiple café-au-lait spots should be thoroughly examined for Gorlin syndrome.

Do patient preferences for health information vary by health literacy or numeracy? A qualitative assessment.

PubMed

Gaglio, Bridget; Glasgow, Russell E; Bull, Sheana S

2012-01-01

Seeking health information can be a complicated process for a patient. Patients must know the topic of interest, where to look or ask, how to assess and comprehend, and how to evaluate the credibility and trustworthiness of the sources. In this study, the authors describe preferences of patients with multiple risk factors for cardiovascular disease with varying health literacy and numeracy abilities for receiving health information. Participants were recruited from 2 health care systems. Health literacy and numeracy were assessed and participants completed an orally administered survey consisting of open-ended questions about obtaining health information and preferences for health information. In-depth interviews were conducted with a subset of participants. A diverse sample of 150 individuals (11.3% Latino, 37.3% African American, 44.7% with income less than $15,000/year) participated. Most participants had adequate functional health literacy, while 65% had low numeracy skills. Regardless of health literacy or numeracy ability, participants overwhelmingly preferred to receive health information during a face-to-face conversation with their health care provider. While individuals with adequate functional health literacy identified a variety of health information sources, actions are needed to ensure multiple modalities are available and are in plain, clear language that reinforces patients' understanding and application of information to health behavior.

What Is the Prevalence of Symptomatic Obstructive Sleep Apnea Syndrome in Chronic Spinal Pain Patients? An Assessment of the Correlation of OSAS with Chronic Opioid Therapy, Obesity, and Smoking.

PubMed

Pampati, Sanjana; Manchikanti, Laxmaiah

2016-05-01

In modern medicine, obstructive sleep apnea syndrome (OSAS) is a commonly described sleep disorder with airway obstruction, disrupted sleep, and excessive daytime sleepiness. Since its description in 1976 by Guilleminault et al, numerous epidemiologic studies and systematic reviews, with multiple comorbidities related to cardiovascular sequelae, altered cognitive function, and multiple other potential complications have been described. Multiple risk factors have been identified included obesity, smoking, alcohol consumption, and other factors. Chronic pain and chronic opioid therapy also have been described to contribute to a large proportion of patients with OSAS. Chronic pain, obesity, smoking, and chronic opioid therapy are often found together, yet there is a paucity of literature describing OSAS in chronic pain patients. To assess the prevalence of symptomatic OSAS in chronic spinal pain patients receiving chronic opioid therapy and determine the association of OSAS with multiple risk factors and comorbidities. A retrospective assessment of patients who attend a single interventional pain management practice from January 1, 2010to December 31, 2014. A private interventional pain management practice in the United States. The data were collected from 4,036 consecutive patients presenting for assessment to a pain management center from January 1, 2010 to December 31, 2014. All assessments were comprehensive and performed by 2 physicians. The comprehensive assessment included a complete history, a physical examination, and a review of records. The prevalence of OSAS in patients with chronic spinal pain was 13.8%. The results showed a higher prevalence in males compared to females (15.1% versus 12.8%), a higher prevalence in those aged 45 or older compared to those 25-45 years and those 18-25 years (16.3% versus 10.7% or 2.5%), higher prevalence in Hispanics and Asians compared to African Americans and whites (23.7% versus 16.2% versus 13.4%), higher prevalence in patients with combined back and neck pain compared to patients with thoracic pain only or back pain only (16.3% versus 8.2% to 11%). Prevalence also varied by body mass index (BMI): 32.4% in morbidly obese patients, 20.3% in severely obese patients, 15.7% in obese patients, 9.2% in those who were overweight, and only 5.7% in those with normal weight. A significant correlation with OSAS was also observed in patients smoking more than 40 pack years and multiple respiratory symptoms except for chronic bronchitis and multiple cardiovascular ailments. The retrospective nature of the assessment. This retrospective assessment of over 4,000 patients suffering from chronic pain and receiving chronic opioid therapy indicated a prevalence of sleep apnea syndrome as 13.8%. Multiple risk factors including obesity, chronic obstructive pulmonary disease (COPD), chronic sinus and nasal discharge, and multiple comorbidities including cardiovascular and related ailments have been identified. Obstructive sleep apnea syndrome, chronic pain, chronic spinal pain, chronic opioid therapy, obesity, smoking, cardiovascular risk factors, pulmonary risk factors.

[Multiple myeloma: Maintenance therapy after autologous hematopoietic stem cell transplantation, depending on minimal residual disease].

PubMed

Solovyev, M V; Mendeleeva, L P; Pokrovskaya, O S; Nareyko, M V; Firsova, M V; Galtseva, I V; Davydova, Yu O; Kapranov, N M; Kuzmina, L A; Gemdzhian, E G; Savchenko, V G

To determine the efficiency of maintenance therapy with bortezomib in patients with multiple myeloma (MM) who have achieved complete remission (CR) after autologous hematopoietic stem cell (auto-HSCT), depending on the presence of minimal residual disease (MRD). In January 2014 to February 2016, fifty-two MM patients (19 men and 33 women) aged 24 to 66 years (median 54 years), who had achieved CR after auto-HSCT, were randomized to perform maintenance therapy with bortezomib during a year. On day 100 after auto-HSCT, all the patients underwent immunophenotyping of bone marrow plasma cells by 6-color flow cytometry to detect MRD. Relapse-free survival (RFS) was chosen as a criterion for evaluating the efficiency of maintenance therapy. After auto-HSCT, MRD-negative patients had a statistically significantly higher 2-year RFS rate than MRD-positive patients: 52.9% (95% confidence interval (CI), 35.5 to 70.5%) versus 37.2% (95% CI, 25.4 to 49.3%) (p=0.05). The presence of MRD statistically significantly increased the risk of relapse (odds ratio 1.7; 95% CI, 1.2 to 3.4; p=0.05). Two-year cumulative risk of relapse (using the Kaplan-Meier) after auto-HSCT did not statistically significantly differ in MRD-negative patients receiving (n=15) and not receiving (n=10) maintenance therapy with bortezomib (p=0.58). After completion of maintenance treatment, 42% of the MRD-positive patients achieved a negative status. In the MRD-positive patients who had received maintenance therapy, the average time to recurrence was 5 months longer than that in the naïve patients: 17.3 versus 12.3 months. The MRD status determined in MM patients who have achieved CR after auto-HSCT is an important factor for deciding on the use of maintenance therapy.

Using digital notifications to improve attendance in clinic: systematic review and meta-analysis.

PubMed

Robotham, Dan; Satkunanathan, Safarina; Reynolds, John; Stahl, Daniel; Wykes, Til

2016-10-24

Assess the impact of text-based electronic notifications on improving clinic attendance, in relation to study quality (according to risk of bias), and to assess simple ways in which notifications can be optimised (ie, impact of multiple notifications). Systematic review, study quality appraisal assessing risk of bias, data synthesised in meta-analyses. MEDLINE, EMBASE, PsycINFO, Web of Science and Cochrane Database of Systematic Reviews (01.01.05 until 25.4.15). A systematic search to discover all studies containing quantitative data for synthesis into meta-analyses. Studies examining the effect of text-based electronic notifications on prescheduled appointment attendance in healthcare settings. Primary analysis included experimental studies where randomisation was used to define allocation to intervention and where a control group consisting of 'no reminders' was used. Secondary meta-analysis included studies comparing text reminders with voice reminders. Studies lacking sufficient information for inclusion (after attempting to contact study authors) were excluded. Primary outcomes were rate of attendance/non-attendance at healthcare appointments. Secondary outcome was rate of rescheduled and cancelled appointments. 26 articles were included. 21 included in the primary meta-analysis (8345 patients receiving electronic text notifications, 7731 patients receiving no notifications). Studies were included from Europe (9), Asia (7), Africa (2), Australia (2) and America (1). Patients who received notifications were 23% more likely to attend clinic than those who received no notification (risk ratio=1.23, 67% vs 54%). Those receiving notifications were 25% less likely to 'no show' for appointments (risk ratio=.75, 15% vs 21%). Results were similar when accounting for risk of bias, region and publication year. Multiple notifications were significantly more effective at improving attendance than single notifications. Voice notifications appeared more effective than text notifications at improving attendance. Electronic text notifications improve attendance and reduce no shows across healthcare settings. Sending multiple notifications could improve attendance further. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit-Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA.

PubMed

Ziemssen, Tjalf; Lang, Michael; Tackenberg, Björn; Schmidt, Stephan; Albrecht, Holger; Klotz, Luisa; Haas, Judith; Lassek, Christoph; Medin, Jennie; Cornelissen, Christian

2018-01-01

The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of fingolimod treatment. Patients were divided into 2 cohorts: fingolimod starter [first received fingolimod in PANGAEA (n = 3315)] and previous study [received fingolimod before enrollment in PANGAEA in RCTs (n = 875), some of whom also had baseline data at entry into RCTs (n = 505)]. At PANGAEA baseline, patients in the fingolimod starter versus the previous study cohort had a higher annualized relapse rate [ARR (95% confidence interval): 1.79 (1.75-1.83) vs 1.32 (1.25-1.40)] and Expanded Disability Status Scale score [3.11 (3.04-3.17) vs 2.55 (2.44-2.66)]. A greater proportion in the fingolimod starter versus previous study cohort had diabetes (2.0% vs 0.7%). After 12 months of fingolimod, ARRs were lower than in the 12 months before PANGAEA enrollment in the fingolimod starter [0.386 (0.360-0.414)] and previous study [0.276 (0.238-0.320)] cohorts. Expanded Disability Status Scale scores were stable versus baseline. Adverse events were experienced by similar proportions in both cohorts during fingolimod treatment. Relevant differences exist in disease activity and comorbidities between patients receiving fingolimod in clinical practice versus RCTs. Irrespective of baseline differences indicating a higher proportion at an advanced stage of multiple sclerosis in the real world versus RCTs, fingolimod remains effective, with a manageable safety profile.

Effectiveness and Safety of Tigecycline Compared with Other Broad-Spectrum Antimicrobials in Abdominal Solid Organ Transplant Recipients with Polymicrobial Intraabdominal Infections.

PubMed

Liebenstein, Tyler; Schulz, Lucas T; Viesselmann, Chris; Bingen, Emma; Musuuza, Jackson; Safdar, Nasia; Rose, Warren E

2017-02-01

Because patients with abdominal solid organ transplants (SOTs) are at increased risk of polymicrobial intraabdominal infections (IAIs) following transplantation, the objective of this study was to compare the effectiveness and adverse event profile of tigecycline with those of other broad-spectrum therapies for polymicrobial IAIs in this population. Retrospective cohort study. Large academic medical center with multiple outpatient clinics. A total of 81 adult SOT recipients were included who were treated for confirmed or suspected polymicrobial IAIs from 2007-2012. Of these patients, 27 received tigecycline and 54 received comparator therapy with a broad-spectrum β-lactam (e.g., piperacillin-tazobactam, cefepime, or meropenem) with or without glycopeptide or lipopeptide gram-positive therapy (vancomycin or daptomycin) (comparator group). Patients in the comparator group were matched to tigecycline-treated patients based on transplant type (kidney, combined kidney-pancreas, combined kidney-liver, or solitary pancreas) in a 1:2 ratio (tigecycline-to-other broad-spectrum antibiotics). Data on patient demographics, comorbidities, and clinical variables were collected and compared by using bivariate analyses. Clinical outcomes-clinical cure, improvement or failure, and disease recurrence-as well as death within 1 year were analyzed by bivariate analyses and logistic regression. Clinical cure was lower in the tigecycline group versus the comparator group (40.7% vs 72.2%, p=0.008), but cure combined with improvement was similar between the two groups (85.2% vs 88.9%, p=0.724). Multiple logistic regression analysis showed that treatment with comparator antibiotics increased the odds of cure (odds ratio [OR] 1.37, 95% confidence interval [CI] 0.15-12.27) and reduced the odds of treatment failure (OR 0.59, 95% CI 0.07-4.55) and death within 1 year (OR 0.79, 95% CI 0.22-2.86); however, patients receiving comparator antibiotics were more likely to have disease recurrence (OR 1.45, 95% CI 0.33-6.36). Patients receiving tigecycline experienced a higher rate of adverse events than those receiving comparator antibiotics (29.6% vs 9.3%, p=0.026). Patients receiving tigecycline were less likely to achieve optimal clinical outcomes and had more adverse events. Alternative regimens should be selected over tigecycline for the treatment of polymicrobial IAIs in abdominal SOT recipients until additional studies are completed to examine its role in this population. © 2016 Pharmacotherapy Publications, Inc.

Verbal communication of families with cancer patients at end of life: A questionnaire survey with bereaved family members.

PubMed

Nakazato, Kazuhiro; Shiozaki, Mariko; Hirai, Kei; Morita, Tatsuya; Tatara, Ryuhei; Ichihara, Kaori; Sato, Shinichi; Simizu, Megumi; Tsuneto, Satoru; Shima, Yasuo; Miyasita, Mitsunori

2018-01-01

To clarify the verbal communication of feelings between families and patients in Japanese palliative care units from the perspective of bereaved family members by examining (1) proportions of families' and patients' verbalization of six feelings (gratitude, love, seeking forgiveness, giving forgiveness, wishes after death, and continuing bonds), (2) recognition of receiving these feelings through verbalization from the family's perspective, and (3) the specific attitudes of family members that influence their verbalizations. In 2010, a cross-sectional survey was conducted with 968 bereaved families of cancer patients in palliative care units across Japan. Five hundred thirty-seven responses were analyzed. (1) "Gratitude" was verbalized most often (families: 47%; patients: 61%), and "expressing forgiveness" least often (families: 16%; patients: 11%). (2) Even if the words were not used, 81.2% to 88.2% of families answered that they had received the patient's feelings, and 71.8% to 85.4% of families felt the patient had received their feelings. (3) Multiple logistic regression analyses indicated that the strongest attitudes determining verbalizing were "not wanting to say farewell without conveying feelings," "a daily basis of expressing," and "heart-to-heart communication" (ishin-denshin). For both families and patients, verbalizing feelings was difficult. Our results showed that families' and patients' verbalizing and receiving of feelings must be aligned to understand their communication at the end of life in Japan. Future research is needed to verify how attitude helps promote or inhibit verbalization. Copyright © 2017 John Wiley & Sons, Ltd.

Early physical and functional rehabilitation of trauma patients in the Médecins Sans Frontières trauma centre in Kunduz, Afghanistan: luxury or necessity?

PubMed Central

Gohy, Bérangère; Ali, Engy; Van den Bergh, Rafael; Schillberg, Erin; Nasim, Masood; Naimi, Muhammad Mahmood; Cheréstal, Sophia; Falipou, Pauline; Weerts, Eric; Skelton, Peter; Van Overloop, Catherine; Trelles, Miguel

2016-01-01

Background In Afghanistan, Médecins Sans Frontières provided specialised trauma care in Kunduz Trauma Centre (KTC), including physiotherapy. In this study, we describe the development of an adapted functional score for patient outcome monitoring, and document the rehabilitation care provided and patient outcomes in relation to this functional score. Methods A descriptive cohort study was done, including all patients admitted in the KTC inpatient department (IPD) between January and June 2015. The adapted functional score was collected at four points in time: admission and discharge from both IPD and outpatient department (OPD). Results Out of the 1528 admitted patients, 92.3% (n = 1410) received at least one physiotherapy session. A total of 1022 patients sustained either lower limb fracture, upper limb fracture, traumatic brain injury or multiple injury. Among them, 966 patients received physiotherapy in IPD, of whom 596 (61.7%) received IPD sessions within 2 days of admission; 696 patients received physiotherapy in OPD. Functional independence increased over time; among patients having a functional score taken at admission and discharge from IPD, 32.2% (172/535) were independent at discharge, and among patients having a functional score at OPD admission and discharge, 79% (75/95) were independent at discharge. Conclusions The provision of physiotherapy was feasible in this humanitarian setting, and the tailored functional score appeared to be relevant. PMID:27738078

Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma

PubMed Central

Suvannasankha, Attaya; Fay, Joseph W.; Arnulf, Bertrand; Kaufman, Jonathan L.; Ifthikharuddin, Jainulabdeen J.; Weiss, Brendan M.; Krishnan, Amrita; Lentzsch, Suzanne; Comenzo, Raymond; Wang, Jianping; Nottage, Kerri; Chiu, Christopher; Khokhar, Nushmia Z.; Ahmadi, Tahamtan; Lonial, Sagar

2017-01-01

Daratumumab plus pomalidomide and dexamethasone (pom-dex) was evaluated in patients with relapsed/refractory multiple myeloma with ≥2 prior lines of therapy who were refractory to their last treatment. Patients received daratumumab 16 mg/kg at the recommended dosing schedule, pomalidomide 4 mg daily for 21 days of each 28-day cycle, and dexamethasone 40 mg weekly. Safety was the primary end point. Overall response rate (ORR) and minimal residual disease (MRD) by next-generation sequencing were secondary end points. Patients (N = 103) received a median (range) of 4 (1-13) prior therapies; 76% received ≥3 prior therapies. The safety profile of daratumumab plus pom-dex was similar to that of pom-dex alone, with the exception of daratumumab-specific infusion-related reactions (50%) and a higher incidence of neutropenia, although without an increase in infection rate. Common grade ≥3 adverse events were neutropenia (78%), anemia (28%), and leukopenia (24%). ORR was 60% and was generally consistent across subgroups (58% in double-refractory patients). Among patients with a complete response or better, 29% were MRD negative at a threshold of 10−5. Among the 62 responders, median duration of response was not estimable (NE; 95% confidence interval [CI], 13.6-NE). At a median follow-up of 13.1 months, the median progression-free survival was 8.8 (95% CI, 4.6-15.4) months and median overall survival was 17.5 (95% CI, 13.3-NE) months. The estimated 12-month survival rate was 66% (95% CI, 55.6-74.8). Aside from increased neutropenia, the safety profile of daratumumab plus pom-dex was consistent with that of the individual therapies. Deep, durable responses were observed in heavily treated patients. The study was registered at www.clinicaltrials.gov as #NCT01998971. PMID:28637662

Thrombocytopenia following implantation of the stentless biological sorin freedom SOLO valve.

PubMed

Gersak, Borut; Gartner, Urska; Antonic, Miha

2011-07-01

Stentless biological valves have proven advantages in hemodynamic performance and left ventricular function compared to stented biological valves. Following a marked postoperative fall in the platelet count of patients after implantation of the Freedom SOLO valve, the study aim was to confirm clinical observations that this effect was more severe in patients receiving Freedom SOLO valves than in those receiving St. Jude Medical (SJM) mechanical aortic valves. Preoperative and postoperative platelet counts were compared in two groups of patients who underwent aortic valve replacement (AVR) without any concomitant procedures between January and December 2007. Patients received either a Freedom SOLO valve (n = 28) or a SJM mechanical valve (n = 41). Mean values of platelet counts were compared using three multiple linear regression models. Platelet counts were significantly lower in the Freedom SOLO group than in the SJM group from the first postoperative day (POD 1) up to POD 6 (p <0.001). In three patients of the Freedom SOLO group the platelet count fell below 30x10(9)/l, while the lowest level in the SJM group was 75x10(9)/l. Based on multiple linear regression models, the type of valve implanted had a statistically significant influence on postoperative platelet counts on POD 1, POD 3, and POD 5 (p <0.001). Whilst the reason for this phenomenon is unknown, the use of consistent monitoring should prevent severe falls in platelet count from becoming dangerous for the patient. Further studies are required to investigate the phenomenon since, despite a shorter cardiopulmonary bypass time, the fall in platelet count was more profound in the Freedom SOLO group.

Non-observance of guidelines for surgical antimicrobial prophylaxis and surgical-site infections.

PubMed

Lallemand, S; Thouverez, M; Bailly, P; Bertrand, X; Talon, D

2002-06-01

A prospective multicentre study was conducted to assess major aspects of surgical prophylaxis and to determine whether inappropriate antimicrobial prophylaxis was a factor associated (risk or protective factor) with surgical site infection (SSI). Surgical prophylaxis practices were assessed by analysing four variables: indication, antimicrobial agent, timing and duration. Univariate and multivariate analyses were carried out to identify predictors of SSI among patient-specific, operation-specific and antimicrobial prophylaxis-specific factors. The frequency of SSI was 2.7% (13 SSI in 474 observations). Total compliance of the prescription with guidelines was observed in 41.1% of cases (195 prescriptions). Of the 139 patients who received an inappropriate drug, 126 (90.6%) received a drug with a broader spectrum than the recommended drug. Prophylaxis was prolonged in 71 (87.7%) of the 81 patients who received prophylaxis for inappropriate lengths of time and 43 (61.4%) of the 70 patients who did not receive prophylaxis at the optimal moment were treated too late. Multivariate analysis clearly demonstrated that SSI was associated with multiple procedures (relative risk 8.5), short duration of prophylaxis (relative risk 12.7) and long-term therapy with antimicrobial agents during the previous year (relative risk 8.8). The ecological risk of the emergence of resistance associated with the frequent use of broad-spectrum antibiotics and prophylaxis for longer periods was not offset by individual benefit to the patients who received inappropriate prophylaxis.

Demographic and Clinical Profile of Patients With Dementia Receiving Electroconvulsive Therapy: A Case-Control Study.

PubMed

Zhang, Qing-E; Sha, Sha; Ungvari, Gabor S; Chiu, Helen F K; Ng, Chee H; He, Hong-Bo; Forester, Brent P; Xiang, Yu-Tao

2016-09-01

Little is known about the clinical characteristics of patients with dementia receiving electroconvulsive therapy (ECT) for the treatment of behavioral symptoms. This study examined the demographic and clinical profile of patients with dementia receiving ECT in China. This was a retrospective, case-control study. The sample was composed of 23 patients with dementia treated with ECT and 71 sex- and age-matched controls treated for a period of 8 years (2007-2014) at the National Clinical Research Centre of Mental Disorders, China. Sociodemographic and clinical data were collected from the electronic chart management system. Multiple logistic regression analysis revealed that ECT was independently associated with high risk for suicide at admission. The recorded indications for ECT included both high risk for suicide and aggressive behavior. Most patients responded to ECT satisfactorily (56.5%) or partially (34.8%) with only mild-moderate transient memory impairment (30.4%). Although this is a preliminary study limited by the retrospective design and small sample size, findings suggest that ECT is an effective and safe therapeutic intervention to reduce the risk for suicide and aggressive behavior in dementia.

Effect of travel distance and time to radiotherapy on likelihood of receiving mastectomy.

PubMed

Goyal, Sharad; Chandwani, Sheenu; Haffty, Bruce G; Demissie, Kitaw

2015-04-01

Breast-conserving surgery (BCS) followed by adjuvant radiation therapy (RT) is the standard of care for women with early-stage breast cancer as an alternative to mastectomy. The purpose of this study was to examine the relationship between receipt of mastectomy and travel distance and time to RT facility in New Jersey (NJ). Data were collected from a cohort of 634 NJ women diagnosed with early-stage breast cancer. In patients receiving RT, the precise RT facility was used, whereas in patients not receiving RT, surgeons were contacted to determine the location of RT referral. Travel distance and time to RT facility from the patients' residential address were modeled separately using multiple binomial regression to examine their association with choice of surgery while adjusting for clinical and sociodemographic factors. Overall, 58.5 % patients underwent BCS with median travel distance to the radiation facility of 4.8 miles (vs. 6.6 miles for mastectomy) and median travel time of 12.0 min (vs. 15.0 min for mastectomy). Patients residing > 9.2 miles compared with ≤ 9.2 miles from radiation facility were 44 % more likely to receive mastectomy. Additionally, patients requiring > 19 min compared with ≤ 19 min of travel time were 36 % more likely to receive mastectomy. These data found that travel distance and time from RT facility act as barriers to undergoing BCS in women with early-stage breast cancer. Despite being in an urban region, a significant number of women in NJ with early-stage breast cancer did not receive BCS.

Quantifying the Benefits of Dimethyl Fumarate Over β Interferon and Glatiramer Acetate Therapies on Work Productivity Outcomes in MS Patients.

PubMed

Lee, Andrew; Pike, James; Edwards, Michael R; Petrillo, Jennifer; Waller, John; Jones, Eddie

2017-06-01

Dimethyl fumarate (DMF) is a novel oral therapy used for the treatment of relapse-remitting multiple sclerosis (RRMS). In two 2-year pivotal Phase 3 trials in patients with RRMS, DMF significantly reduced disease activity based on both clinical and magnetic resonance imaging (MRI) findings and demonstrated an acceptable safety profile. However, there is currently a lack of comparative data which explore the relationship between work productivity and health-related quality of life (HRQoL) outcomes in RRMS and how these differ among RRMS therapies, including DMF. We explored this relationship through patient-reported data from the EuroQol Five-Dimensions (EQ-5D) tool, Work Productivity and Activity Impairment Questionnaire (WPAI), and the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) using the Adelphi MS DSP® dataset. Our data demonstrated that patients receiving DMF experienced better outcomes, relative to patients receiving beta (β)interferons or glatiramer acetate, in all WPAI subscales [overall; average treatment effect (ATE) -13.92, 95% confidence interval (CI) -18.87 to -7.08; p < 0.001], EQ-5D (ATE +0.075, 95% Cl 0.014-0.136; p = 0.016) and HAQUAMS [ATE -0.45, 95% Cl -0.61 to -0.29; p < 0.001]. The EQ-5D and HAQUAMS were used with WPAI to determine the relationship between HRQoL outcomes and work productivity. Multiple linear regression analyses were performed, adjusting for age, sex, body mass index, ethnicity and number of comorbid conditions. These data demonstrate that therapy with DMF was associated with increased work productivity and HRQoL for patients with RRMS and that these outcomes were consistently improved compared to outcomes with interferon and glatiramer acetate therapies.

A placebo-controlled, double-blind, dose-escalation study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of single and multiple intravenous infusions of AZD9773 in patients with severe sepsis and septic shock

PubMed Central

2012-01-01

Introduction Tumor necrosis factor-alpha (TNF-α), an early mediator in the systemic inflammatory response to infection, is a potential therapeutic target in sepsis. The primary objective of this study was to determine the safety and tolerability of AZD9773, an ovine, polyclonal, anti-human TNF-α Fab preparation, in patients with severe sepsis. Secondary outcomes related to pharmacokinetic (PK) and pharmacodynamic (PD) parameters. Methods In this double-blind, placebo-controlled, multicenter Phase IIa study, patients were sequentially enrolled into five escalating-dose cohorts (single doses of 50 or 250 units/kg; multiple doses of 250 units/kg loading and 50 units/kg maintenance, 500 units/kg loading and 100 units/kg maintenance, or 750 units/kg loading and 250 units/kg maintenance). In each cohort, patients were randomized 2:1 to receive AZD9773 or placebo. Results Seventy patients received AZD9773 (n = 47) or placebo (n = 23). Baseline characteristics were similar across cohorts. Mean baseline APACHE score was 25.9. PK data demonstrated an approximately proportional increase in concentration with increasing dose and a terminal half-life of 20 hours. For the multiple-dose cohorts, serum TNF-α concentrations decreased to near-undetectable levels within two hours of commencing AZD9773 infusion. This suppression was maintained in most patients for the duration of treatment. AZD9773 was well tolerated. Most adverse events were of mild-to-moderate intensity and considered by the reporting investigator as unrelated to study treatment. Conclusions The safety, PK and PD data support the continued evaluation of AZD9773 in larger Phase IIb/III studies. PMID:22340283

Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma.

PubMed

Lonial, Sagar; Dimopoulos, Meletios; Palumbo, Antonio; White, Darrell; Grosicki, Sebastian; Spicka, Ivan; Walter-Croneck, Adam; Moreau, Philippe; Mateos, Maria-Victoria; Magen, Hila; Belch, Andrew; Reece, Donna; Beksac, Meral; Spencer, Andrew; Oakervee, Heather; Orlowski, Robert Z; Taniwaki, Masafumi; Röllig, Christoph; Einsele, Hermann; Wu, Ka Lung; Singhal, Anil; San-Miguel, Jesus; Matsumoto, Morio; Katz, Jessica; Bleickardt, Eric; Poulart, Valerie; Anderson, Kenneth C; Richardson, Paul

2015-08-13

Elotuzumab, an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7), showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma. In this phase 3 study, we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone (elotuzumab group) or lenalidomide and dexamethasone alone (control group). Coprimary end points were progression-free survival and the overall response rate. Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival. Overall, 321 patients were assigned to the elotuzumab group and 325 to the control group. After a median follow-up of 24.5 months, the rate of progression-free survival at 1 year in the elotuzumab group was 68%, as compared with 57% in the control group; at 2 years, the rates were 41% and 27%, respectively. Median progression-free survival in the elotuzumab group was 19.4 months, versus 14.9 months in the control group (hazard ratio for progression or death in the elotuzumab group, 0.70; 95% confidence interval, 0.57 to 0.85; P<0.001). The overall response rate in the elotuzumab group was 79%, versus 66% in the control group (P<0.001). Common grade 3 or 4 adverse events in the two groups were lymphocytopenia, neutropenia, fatigue, and pneumonia. Infusion reactions occurred in 33 patients (10%) in the elotuzumab group and were grade 1 or 2 in 29 patients. Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease progression or death. (Funded by Bristol-Myers Squibb and AbbVie Biotherapeutics; ELOQUENT-2 ClinicalTrials.gov number, NCT01239797.).

Development of a clinical practice guideline for testing nasogastric tube placement.

PubMed

Peter, Sue; Gill, Fenella

2009-01-01

A Perth metropolitan hospital group standardized changes to nasogastric tube placement, including removal of the "whoosh test" and litmus paper, and introduction of pH testing. Two audits were conducted: bedside data collection at a pediatric hospital and a point-prevalence audit across seven hospitals. Aspirate was obtained for 97% of all tests and pH was < or = 5.5 for 84%, validating the practice changes. However, patients on continuous feeds and/or receiving acid-inhibiting medications had multiple pH testing fails. Nasogastric tube placement continues to present a challenge for those high-risk patients on continuous feeds and/or receiving acid-inhibiting medications.

Endometrial scratch injury before intrauterine insemination: is it time to re-evaluate its value? Evidence from a systematic review and meta-analysis of randomized controlled trials.

PubMed

Vitagliano, Amerigo; Noventa, Marco; Saccone, Gabriele; Gizzo, Salvatore; Vitale, Salvatore Giovannni; Laganà, Antonio Simone; Litta, Pietro Salvatore; Saccardi, Carlo; Nardelli, Giovanni Battista; Di Spiezio Sardo, Attilio

2018-01-01

To assess the impact of endometrial scratch injury (ESI) on the outcomes of intrauterine insemination (IUI) stimulated cycles. Systematic review and meta-analysis. Not applicable. Infertile women undergoing one or more IUI stimulated cycles. Randomized controlled trials (RCTs) were identified by searching electronic databases. We included RCTs comparing ESI (i.e., intervention group) during the course of IUI stimulated cycle (C-ESI) or during the menstrual cycle preceding IUI treatment (P-ESI) with controls (no endometrial scratch). The summary measures were reported as odds ratio (OR) with 95% confidence-interval (CI). Clinical pregnancy rate, ongoing pregnancy rate, multiple pregnancy rate, ectopic pregnancy rate, miscarriage rate. Eight trials were included in the meta-analysis, comprising a total of 1,871 IUI cycles. Endometrial scratch injury was associated with a higher clinical pregnancy rate (OR 2.27) and ongoing pregnancy rate (OR 2.04) in comparison with the controls. No higher risk of multiple pregnancy (OR 1.09), miscarriage (OR 0.80), or ectopic pregnancy (OR 0.82) was observed in patients receiving ESI. Subgroup analysis based on ESI timing showed higher clinical pregnancy rate (OR 2.57) and ongoing pregnancy rate (OR 2.27) in patients receiving C-ESI and no advantage in patients receiving P-ESI. Available data suggest that ESI performed once, preferably during the follicular phase of the same cycle of IUI with flexible aspiration catheters, may improve clinical pregnancy and ongoing pregnancy rates in IUI cycles. Endometrial scratch injury does not appear to increase the risk of multiple pregnancy, miscarriage, or ectopic pregnancy. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Short-term, high-dose glucocorticoid treatment does not contribute to reduced bone mineral density in patients with multiple sclerosis.

PubMed

Olsson, A; Oturai, D B; Sørensen, P S; Oturai, P S; Oturai, A B

2015-10-01

Patients with multiple sclerosis (MS) are at increased risk of reduced bone mineral density (BMD). A contributing factor might be treatment with high-dose glucocorticoids (GCs). The objective of this paper is to assess bone mass in patients with MS and evaluate the importance of short-term, high-dose GC treatment and other risk factors that affect BMD in patients with MS. A total of 260 patients with MS received short-term high-dose GC treatment and had their BMD measured by dual x-ray absorptiometry. BMD was compared to a healthy age-matched reference population (Z-scores). Data regarding GCs, age, body mass index (BMI), serum 25(OH)D, disease duration and severity were collected retrospectively and analysed in a multiple linear regression analysis to evaluate the association between each risk factor and BMD. Osteopenia was present in 38% and osteoporosis in 7% of the study population. Mean Z-score was significantly below zero, indicating a decreased BMD in our MS patients. Multiple linear regression analysis showed no significant association between GCs and BMD. In contrast, age, BMI and disease severity were independently associated with both lumbar and femoral BMD. Reduced BMD was prevalent in patients with MS. GC treatment appears not to be the primary underlying cause of secondary osteoporosis in MS patients. © The Author(s), 2015.

[The application of high-frequency and iTBS transcranial magnetic stimulation for the treatment of spasticity in the patients presenting with secondary progressive multiple sclerosis].

PubMed

Korzhova, J E; Chervyakov, A V; Poydasheva, A G; Kochergin, I A; Peresedova, A V; Zakharova, M N; Suponeva, N A; Chernikova, L A; Piradov, M A

Spasticity is considered to be a common manifestation of multiple sclerosis. Muscle relaxants are not sufficiently effective; more than that, some of them often cause a variety of adverse reactions. Transcranial magnetic stimulation (TMS) can be a promising new tool for the treatment of spasticity. The objective of the present study was to compare the effectiveness of the two TMS protocols: rhythmic (high-frequency) TMS (rTMS) and stimulation with the theta bursts (iTBS) in terms of their ability to reduce spasticity in the patients presenting with multiple sclerosis. Twenty two patients with secondary-progressive multiple sclerosis were pseudo-randomized into two groups: those in the first (high-frequency) group received the treatment with the use of rTMS therapy at a frequency of 10 Hz; the patients of the second group, underwent stimulation with the theta bursts (iTBS). All the patients received 10 sessions of either stimulation applied to the primary motor area (M1) of both legs. The effectiveness of TMS protocols was evaluated before therapy and after 10 sessions of stimulation based on the Modified Ashworth scale (MAS), the expanded disability status scale (EDSS), and the Kurtzke functional scale (Kfs). In addition, the patients were interviewed before treatment, after 10 rTMS sessions, immediately after and within 2 and 12 weeks after the completion of the treatment using questionnaires for the evaluation of spasticity (SESS) , fatigue, and dysfunction of the pelvic organs (severity of defecation and urination disorders), fatigue. The study has demonstrated a significant reduction in spasticity in the patients of both groups at the end of the TMS protocol based on the MAS scale. There was no significant difference between the outcomes of the two protocols. Both had positive effect on the concomitant «non-motor» symptoms (fatigue, dysfunction of the pelvic organs). High-frequency transcranial magnetic stimulation (10 sessions of rTMS therapy at a frequency of 10 Hz) and stimulation with the theta-bursts applied to the M1 area in both legs can be an effective alternative treatment of spasticity in the patients with secondary-progressive multiple sclerosis. Further research is needed to detect more accurately the differences between the outcomes of the two stimulation protocols and the development of indications for their application on an individual basis.

Unexpected dramatic increase in CD4+ cell count in a patient with AIDS after enfuvirtide treatment despite persistent viremia and resistance mutations.

PubMed

Soria, Alessandro; Cavarelli, Mariangela; Sala, Stefania; Alessandrini, Anna Ida; Scarlatti, Gabriella; Lazzarin, Adriano; Castagna, Antonella

2008-06-01

An unexpected dramatic immune recovery was observed in a patient with full-blown AIDS receiving enfuvirtide-based antiretroviral therapy after multiple treatment failures. A complex interplay of viral and host factors, including the control of X4 viruses and proviral burden, may favor immune restoration with HIV neutralizing activity, despite persistent viremia.

Stereotactic body radiotherapy (SBRT) for multiple pulmonary oligometastases: Analysis of number and timing of repeat SBRT as impact factors on treatment safety and efficacy.

PubMed

Klement, R J; Hoerner-Rieber, J; Adebahr, S; Andratschke, N; Blanck, O; Boda-Heggemann, J; Duma, M; Eble, M J; Eich, H C; Flentje, M; Gerum, S; Hass, P; Henkenberens, C; Hildebrandt, G; Imhoff, D; Kahl, K H; Klass, N D; Krempien, R; Lohaus, F; Petersen, C; Schrade, E; Wendt, T G; Wittig, A; Guckenberger, M

2018-03-03

Stereotactic body radiotherapy (SBRT) for oligometastatic disease is characterized by an excellent safety profile; however, experiences are mostly based on treatment of one single metastasis. It was the aim of this study to evaluate safety and efficacy of SBRT for multiple pulmonary metastases. This study is based on a retrospective database of the DEGRO stereotactic working group, consisting of 637 patients with 858 treatments. Cox regression and logistic regression were used to analyze the association between the number of SBRT treatments or the number and the timing of repeat SBRT courses with overall survival (OS) and the risk of early death. Out of 637 patients, 145 patients were treated for multiple pulmonary metastases; 88 patients received all SBRT treatments within one month whereas 57 patients were treated with repeat SBRT separated by at least one month. Median OS for the total patient population was 23.5 months and OS was not significantly influenced by the overall number of SBRT treatments or the number and timing of repeat SBRT courses. The risk of early death within 3 and 6 months was not increased in patients treated with multiple SBRT treatments, and no grade 4 or grade 5 toxicity was observed in these patients. In appropriately selected patients, synchronous SBRT for multiple pulmonary oligometastases and repeat SBRT may have a comparable safety and efficacy profile compared to SBRT for one single oligometastasis. Copyright © 2018 Elsevier B.V. All rights reserved.

Pharmacodynamic Effects of Single and Multiple Doses of Empagliflozin in Patients With Type 2 Diabetes.

PubMed

Heise, Tim; Jordan, Jens; Wanner, Christoph; Heer, Martina; Macha, Sreeraj; Mattheus, Michaela; Lund, Søren S; Woerle, Hans J; Broedl, Uli C

2016-10-01

Our aim was to investigate the effects of the sodium glucose cotransporter 2 inhibitor empagliflozin on urinary and serum glucose and electrolytes, urinary volume, osmolality, and the renin-angiotensin system in patients with type 2 diabetes. In an open-label study, 22 patients receiving metformin (median age 56 years; range 40-65 years) received empagliflozin 25 mg once daily for 5 days. Food, fluid, and sodium intake were standardized for 3 days before and during treatment. Twenty patients completed treatment. After single and multiple doses of empagliflozin, mean (SE) changes from baseline in 24-hour urinary glucose excretion were 463.3 (57.3) mmol/d and 599.5 (60.0) mmol/d, respectively (83.5 [10.3] g/d and 108.0 [10.8] g/d, respectively) (both P < 0.001), and in fasting serum glucose concentration were -1.8 (0.4) mmol/L and -1.1 (0.3) mmol/L, respectively (both P < 0.001). After a single dose, mean (SE) change from baseline in urine sodium excretion was 45.3 (9.6) mmol/d (P < 0.001), and in urine volume was 341.0 (140.5) g/d (P = 0.025), but there were no changes compared with baseline in either parameter after multiple doses. There were no changes in plasma renin or serum aldosterone with single or multiple doses of empagliflozin. There was a nonsignificant reduction in weight after a single dose of empagliflozin and a mean (SE) change of -1.4 (0.5) kg after multiple doses (P = 0.020). Empagliflozin 25 mg increased urinary glucose excretion and decreased serum glucose and weight with transient natriuresis and increases in urine volume, without significant changes in the renin-angiotensin system. Clinicaltrials.gov Identifier: NCT01276288. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

G-CSF plus preemptive plerixafor vs hyperfractionated CY plus G-CSF for autologous stem cell mobilization in multiple myeloma: effectiveness, safety and cost analysis.

PubMed

Antar, A; Otrock, Z K; Kharfan-Dabaja, M A; Ghaddara, H A; Kreidieh, N; Mahfouz, R; Bazarbachi, A

2015-06-01

The optimal stem cell mobilization regimen for patients with multiple myeloma (MM) remains undefined. We retrospectively compared our experience in hematopoietic cell mobilization in 83 MM patients using fractionated high-dose CY and G-CSF with G-CSF plus preemptive plerixafor. All patients in the CY group (n=56) received fractionated high-dose CY (5 g/m(2) divided into five doses of 1 g/m(2) every 3 h) with G-CSF. All patients in the plerixafor group (n=27) received G-CSF and plerixafor preemptively based on an established algorithm. Compared with plerixafor, CY use was associated with higher total CD34+ cell yield (7.5 × 10(6) vs 15.5 × 10(6) cells/kg, P=0.005). All patients in both groups yielded ⩾4 × 10(6) CD34+ cells/kg. Conversely, CY use was associated with high frequency of febrile neutropenia, blood and platelet transfusions need and hospitalizations. The average total cost of mobilization in Lebanon was slightly higher in the plerixafor group ($7886 vs $7536; P=0.16). Our data indicate robust stem cell mobilization in MM patients with either fractionated high-dose CY and G-CSF or G-CSF alone with preemptive plerixafor. The chemo-mobilization approach was associated with twofold stem cell yield, slightly lower cost but significantly increased toxicity.

'Postconditioning' the human heart: multiple balloon inflations during primary angioplasty may confer cardioprotection.

PubMed

Darling, Chad E; Solari, Patrick B; Smith, Craig S; Furman, Mark I; Przyklenk, Karin

2007-05-01

Growing evidence from experimental models suggests that relief of myocardial ischemia in a stuttering manner (i.e., 'postconditioning' [PostC] with brief cycles of reperfusion-reocclusion) limits infarct size. However, the potential clinical efficacy of PostC has, to date,been largely unexplored. Using a retrospective study design, our aim was to test the hypothesis that creatine kinase release (CK: clinical surrogate of infarct size) would be attenuated in ST-segment elevation myocardial infarction (STEMI) patients requiring multiple balloon inflations-deflations during primary angioplasty versus STEMI patients who received minimal balloon inflations and/or direct stenting. To investigate this concept, we reviewed the records of all STEMI patients with single vessel occlusion who presented to our institution from November 2004 - April 2006 for primary angioplasty. Exclusion criteria were: previous MI, cardiogenic shock, patients resuscitated from cardiac arrest, or pre-infarct angina. Patients were prospectively divided into two subsets: those receiving 1-3 balloon inflations (considered the minimum range to achieve patency and stent placement) versus those in whom 4 or more inflations were applied. Peak CK release was significantly lower in patients requiring > or =4 versus 1-3 inflations (1655 versus 2272 IU/L; p<0.05), an outcome consistent with the concept that relief of sustained ischemia in a stuttered manner (analogous to postconditioning) may evoke cardioprotection in the clinical setting.

Perirenal space blocking restores gastrointestinal function in patients with severe acute pancreatitis

PubMed Central

Sun, Jun-Jun; Chu, Zhi-Jie; Liu, Wei-Feng; Qi, Shi-Fang; Yang, Yan-Hui; Ge, Peng-Lei; Zhang, Xiao-Hui; Li, Wen-Sheng; Yang, Cheng; Zhang, Yu-Ming

2013-01-01

AIM: To investigate effects of perirenal space blocking (PSB) on gastrointestinal function in patients with severe acute pancreatitis (SAP). METHODS: Forty patients with SAP were randomly allocated to receive PSB or no PSB (NPSB). All the SAP patients received specialized medical therapy (SMT). Patients in the PSB group received PSB + SMT when hospitalized and after diagnosis, whereas patients in the NPSB group only received SMT. A modified gastrointestinal failure (GIF) scoring system was used to assess the gastrointestinal function in SAP patients after admission. Pain severity (visual analog scale, 0 to 100) was monitored every 24 h for 72 h. RESULTS: Modified GIF score decreased in both groups during the 10-d study period. The median score decrease was initially significantly greater in the PSB group than in the NPSB group after PSB was performed. During the 72-h study period, pain intensity decreased in both groups. The median pain decrease was significantly greater in the PSB group than in the NPSB group at single time points. Patients in the PSB group had significantly lower incidences of hospital mortality, multiple organ dysfunction syndrome, systemic inflammatory response syndrome, and pancreatic infection, and stayed in the intensive care unit for a shorter duration. However, no difference in terms of operation incidence was found between the two groups. CONCLUSION: PSB could ameliorate gastrointestinal dysfunction or failure during the early stage of SAP. Moreover, PSB administration could improve prognosis and decrease the mortality of SAP patients. PMID:24379596

Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development.

PubMed

Brookes, Sara T; Macefield, Rhiannon C; Williamson, Paula R; McNair, Angus G; Potter, Shelley; Blencowe, Natalie S; Strong, Sean; Blazeby, Jane M

2016-08-17

Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders. Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria. Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3-22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65-82 % agreement for peer-only feedback versus 74-94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group. In the development of a core outcome or information set, providing feedback within Delphi questionnaires from all stakeholder groups separately may influence the final core set and improve consensus between the groups. Further work is needed to better understand how participants rate and re-rate items within a Delphi process. The three randomized controlled trials reported here were each nested within the development of a core information or outcome set to investigate processes in core outcome and information set development. Outcomes were not health-related and therefore trial registration was not applicable.

Advances in the treatment of neutropenia.

PubMed

Dale, David C

2009-09-01

The present review updates treatment of neutropenia from articles published from January 2008 through April 2009. Chemotherapy-induced neutropenia occurs most commonly in the first cycle of treatment. Older patients, patients with multiple comorbidities, and those receiving more myelotoxic drugs are prone to develop neutropenia and its complications. Current guidelines recommend the prophylactic use of the myeloid growth factors for the first cycle of chemotherapy for patients with more than a 20% risk of febrile neutropenia. Meta analysis from randomized trials shows that granulocyte colony-stimulating factor prophylaxis is associated with patients receiving more intensive chemotherapy, having better survival, but also having a higher risk of secondary acute myeloid leukemia. Antibiotics are standard treatment of febrile neutropenia and are increasingly used for prophylaxis in 'low-risk' patients. The myeloid growth factor granulocyte colony-stimulating factor has radically changed our approach to the prevention of febrile neutropenia. Antibiotics remain the mainstay of treatment of febrile neutropenia.

Patient Decision Making in Vestibular Schwannoma: A Survey of the Acoustic Neuroma Association.

PubMed

Moshtaghi, Omid; Goshtasbi, Khodayar; Sahyouni, Ronald; Lin, Harrison W; Djalilian, Hamid R

2018-05-01

Objective To assess the decision-making process of patients with vestibular schwannoma (VS). Study Design Patients with VS completed a voluntary survey over a 3-month period. Setting Surveys were distributed online through email, Facebook, and member website. Subjects and Methods All patients had a diagnosis of VS and were members of the Acoustic Neuroma Association (ANA). A total of 789 patients completed the online survey. Results Of the 789 participants, 474 (60%) cited physician recommendation as a significant influential factor in deciding treatment. In our sample, 629 (80%) saw multiple VS specialists and 410 (52%) sought second opinions within the same specialty. Of those who received multiple consults, 242 (59%) of patients reported receiving different opinions regarding treatment. Those undergoing observation spent significantly less time with the physician (41 minutes) compared to surgery (68 minutes) and radiation (60 minutes) patients ( P < .001). A total of 32 (4%) patients stated the physician alone made the decision for treatment, and 29 (4%) felt they did not understand all possible treatment options before final decision was made. Of the 414 patients who underwent surgery, 66 (16%) felt they were pressured by the surgeon to choose surgical treatment. Conclusion Deciding on a proper VS treatment for patients can be complicated and dependent on numerous clinical and individual factors. It is clear that many patients find it important to seek second opinions from other specialties. Moreover, second opinions within the same specialty are common, and the number of neurotologists consulted correlated with higher decision satisfaction.

Multiple myeloma in Niger Delta, Nigeria: complications and the outcome of palliative interventions

PubMed Central

Nwabuko, Ogbonna Collins; Igbigbi, Elizabeth Eneikido; Chukwuonye, Innocent Ijezie; Nnoli, Martin Anazodo

2017-01-01

Background Multiple myeloma (MM) is one of the hematological malignancies that require palliative care. This is because of the life-threatening nature and the suffering associated with the illness. The aim of this study is to bring to the fore the complications experienced by people living with MM in the Niger-Delta region of Nigeria and the outcome of various palliative interventions. Methods This was a 10-year multi-center retrospective study of 26 patients diagnosed and managed in three major centers in the Niger-Delta region of Nigeria from January 2003 to December 2012. Information on the clinical, laboratory, radiological data, and palliative treatment was obtained at presentation and subsequently at intervals of 3 months until the patient was lost to follow-up. Result The mean duration from onset of symptoms to diagnosis was 13.12 months (95% CI, 6.65–19.58). A total of 16 (61.5%), eight (30.8%), and two subjects (7.7%) presented in Durie–Salmon (DS) stages III, II, and I, respectively. The complications presented by patients at diagnoses included bone pain (84.6%), anemia (61.5%), nephropathy (23.1%), and hemiplegia (35%). All the patients received analgesics, while 50.0% received blood transfusion, 56.7% had surgery performed, 19% had hemodialysis, and 3.8% received radiotherapy. A total of 10 (38%) patients benefited from bisphosphonates (BPs). A total of 57.6% of patients were on melphalan–prednisone (MP) double regimen, while 19% and 8% patients were on MP–thalidomide and MP–bortezomib triple regimens, respectively. A total of 3.8% of patients at DS stage IIIB disease had autologous stem-cell transplantation (ASCT). Only 7.6% of the myeloma patients survived up to 5 years post diagnosis. The overall mean survival interval was 39.7 months (95% CI, 32.1–47.2). Conclusion Late diagnosis and inadequate palliative care account for major complications encountered by MM patients in the Niger-Delta region of Nigeria. This could be responsible for the poor prognostic outcome and low survival interval of MM individuals in this region. There is, therefore, a need to improve the quality of palliative care received by myeloma patients in this region. This is achievable via provision of relevant and affordable health care facilities for diagnosis and treatment of the disease. PMID:28579833

Radiation recall dermatitis, panniculitis, and myositis following cyclophosphamide therapy: histopathologic findings of a patient affected by multiple myeloma.

PubMed

Borroni, Giovanni; Vassallo, Camilla; Brazzelli, Valeria; Martinoli, Sara; Ardigò, Marco; Alessandrino, Paolo Emilio; Borroni, Riccardo Giovanni; Franchini, Pietro

2004-06-01

Radiation recall dermatitis is one of the skin sequelae that may affect oncology patients. It occurs in a previously irradiated field, when subsequent chemotherapy is given. The eruption may be elicited by chemotherapy, even several months after radiotherapy. Its mechanism is poorly understood, and the histopathologic findings have received, to date, only sketchy descriptions. A 55-year-old male affected by multiple myeloma received radiation therapy both on his left coxofemoral area, and lumbar region (D11-L1). After cyclophosphamide administration, he developed 2 well defined square-shaped, infiltrated erythematoviolaceous plaques in the prior irradiated fields. Histopathologic findings revealed a diffusely fibrosclerosing process, involving deep dermis, hypodermis, as well as the underlying muscle, while sparing the epidermis and superficial-mid dermis. Histopathology was indistinguishable from deep radio-dermatitis, panniculitis, and myositis. This is the first case providing clear evidence of the causative role of cyclophosphamide in inducing a cutaneous and subcutaneous radiation recall reaction.

DCEP as a bridge to ongoing therapies for advanced relapsed and/or refractory multiple myeloma.

PubMed

Yuen, Hiu Lam Agnes; Low, Michael Sze Yuan; Fedele, Pasquale; Kalff, Anna; Walker, Patricia; Bergin, Krystal; Coutsouvelis, John; Grigoriadis, George; Spencer, Andrew

2018-04-04

There is limited data describing dexamethasone, cyclophosphamide, etoposide, and cisplatin (DCEP) in relapsed refractory multiple myeloma (RRMM). We reviewed 65 patients with RRMM receiving DCEP between 2005 and 2017 in two Melbourne Hospitals. Patients had received a mean of three prior treatment lines (range, 1-11). The mean number of cycles of DCEP was two (range, 1-4). Overall response rate (ORR) was 55% whilst 19% achieved MR and SD. Median overall survival (OS) was 9.6 months. Those bridged to autologous stem cell transplant (ASCT) had significantly improved OS compared to those who were not (median 32.8 vs. 10.7 months, p=.0004). Significant treatment-related mortality (TRM) was observed (9.7%), mostly attributable to grade 3-4 neutropenia and febrile neutropenia. Mandatory use of G-CSF is, therefore, warranted to prevent septic complications. In heavily pretreated RRMM, DCEP is an effective bridge to definitive therapy but in the absence of the latter, its value is questionable.

A Comparison of Self-Hypnosis Versus Progressive Muscle Relaxation in Patients With Multiple Sclerosis and Chronic Pain1

PubMed Central

Jensen, Mark P.; Barber, Joseph; Romano, Joan M.; Molton, Ivan R.; Raichle, Katherine A.; Osborne, Travis L.; Engel, Joyce M.; Stoelb, Brenda L.; Kraft, George H.; Patterson, David R.

2009-01-01

Twenty-two patients with multiple sclerosis (MS) and chronic pain we recruited into a quasi-experimental trial comparing the effects of self-hypnosis training (HYP) with progressive muscle relaxation (PMR) on pain intensity and pain interference; 8 received HYP and the remaining 14 participants were randomly assigned to receive either HYP or PMR. HYP-condition participants reported significantly greater pre- to postsession as well as pre- to posttreatment decreases in pain and pain interference than PMR-condition participants, and gains were maintained at 3-month follow-up. Most of the participants in both conditions reported that they continued to use the skills they learned in treatment and experienced pain relief when they did so. General hypnotizability was not significantly related to treatment outcome, but treatment-outcome expectancy assessed before and after the first session was. The results support the efficacy of self-hypnosis training for the management of chronic pain in persons with MS. PMID:19234967

Chronic Pain: How Challenging Are DDIs in the Analgesic Treatment of Inpatients with Multiple Chronic Conditions?

PubMed Central

Siebenhuener, Klarissa; Eschmann, Emmanuel; Kienast, Alexander; Schneider, Dominik; Minder, Christoph E.; Saller, Reinhard; Zimmerli, Lukas; Blaser, Jürg; Battegay, Edouard

2017-01-01

Background Chronic pain is common in multimorbid patients. However, little is known about the implications of chronic pain and analgesic treatment on multimorbid patients. This study aimed to assess chronic pain therapy with regard to the interaction potential in a sample of inpatients with multiple chronic conditions. Methods and Findings We conducted a retrospective study with all multimorbid inpatients aged ≥18 years admitted to the Department of Internal Medicine of University Hospital Zurich in 2011 (n = 1,039 patients). Data were extracted from the electronic health records and reviewed. We identified 433 hospitalizations of patients with chronic pain and analyzed their combinations of chronic conditions (multimorbidity). We then classified all analgesic prescriptions according to the World Health Organization (WHO) analgesic ladder. Furthermore, we used a Swiss drug-drug interactions knowledge base to identify potential interactions between opioids and other drug classes, in particular coanalgesics and other concomitant drugs. Chronic pain was present in 38% of patients with multimorbidity. On average, patients with chronic pain were aged 65.7 years and had a mean number of 6.6 diagnoses. Hypertension was the most common chronic condition. Chronic back pain was the most common painful condition. Almost 90% of patients were exposed to polypharmacotherapy. Of the chronic pain patients, 71.1% received opioids for moderate to severe pain, 43.4% received coanalgesics. We identified 3,186 potential drug-drug interactions, with 17% classified between analgesics (without coanalgesics). Conclusions Analgesic drugs-related DDIs, in particular opioids, in multimorbid patients are often complex and difficult to assess by using DDI knowledge bases alone. Drug-multimorbidity interactions are not sufficiently investigated and understood. Today, the scientific literature is scarce for chronic pain in combination with multiple coexisting medical conditions and medication regimens. Our work may provide useful information to enable further investigations in multimorbidity research within the scope of potential interactions and chronic pain. PMID:28046033

Chronic Pain: How Challenging Are DDIs in the Analgesic Treatment of Inpatients with Multiple Chronic Conditions?

PubMed

Siebenhuener, Klarissa; Eschmann, Emmanuel; Kienast, Alexander; Schneider, Dominik; Minder, Christoph E; Saller, Reinhard; Zimmerli, Lukas; Blaser, Jürg; Battegay, Edouard; Holzer, Barbara M

2017-01-01

Chronic pain is common in multimorbid patients. However, little is known about the implications of chronic pain and analgesic treatment on multimorbid patients. This study aimed to assess chronic pain therapy with regard to the interaction potential in a sample of inpatients with multiple chronic conditions. We conducted a retrospective study with all multimorbid inpatients aged ≥18 years admitted to the Department of Internal Medicine of University Hospital Zurich in 2011 (n = 1,039 patients). Data were extracted from the electronic health records and reviewed. We identified 433 hospitalizations of patients with chronic pain and analyzed their combinations of chronic conditions (multimorbidity). We then classified all analgesic prescriptions according to the World Health Organization (WHO) analgesic ladder. Furthermore, we used a Swiss drug-drug interactions knowledge base to identify potential interactions between opioids and other drug classes, in particular coanalgesics and other concomitant drugs. Chronic pain was present in 38% of patients with multimorbidity. On average, patients with chronic pain were aged 65.7 years and had a mean number of 6.6 diagnoses. Hypertension was the most common chronic condition. Chronic back pain was the most common painful condition. Almost 90% of patients were exposed to polypharmacotherapy. Of the chronic pain patients, 71.1% received opioids for moderate to severe pain, 43.4% received coanalgesics. We identified 3,186 potential drug-drug interactions, with 17% classified between analgesics (without coanalgesics). Analgesic drugs-related DDIs, in particular opioids, in multimorbid patients are often complex and difficult to assess by using DDI knowledge bases alone. Drug-multimorbidity interactions are not sufficiently investigated and understood. Today, the scientific literature is scarce for chronic pain in combination with multiple coexisting medical conditions and medication regimens. Our work may provide useful information to enable further investigations in multimorbidity research within the scope of potential interactions and chronic pain.

The combination of amoxicillin-clavulanic acid and ketoconazole in the treatment of Madurella mycetomatis eumycetoma and Staphylococcus aureus co-infection.

PubMed

Mhmoud, Najwa A; Fahal, Ahmed Hassan; Mahgoub, El Sheikh; van de Sande, Wendy W J

2014-06-01

Eumycetoma is a chronic progressive disabling and destructive inflammatory disease which is commonly caused by the fungus Madurella mycetomatis. It is characterized by the formation of multiple discharging sinuses. It is usually treated by antifungal agents but it is assumed that the therapeutic efficiency of these agents is reduced by the co-existence of Staphylococcus aureus co-infection developing in these sinuses. This prospective study was conducted to investigate the safety, efficacy and clinical outcome of combined antibiotic and antifungal therapy in eumycetoma patients with superimposed Staphylococcus aureus infection. The study enrolled 337 patients with confirmed M. mycetomatis eumycetoma and S. aureus co-infection. Patients were allocated into three groups; 142 patients received amoxicillin-clavulanic acid and ketoconazole, 93 patients received ciprofloxacin and ketoconazole and 102 patients received ketoconazole only. The study showed that, patients who received amoxicillin-clavulanic acid and ketoconazole treatment had an overall better clinical outcome compared to those who had combined ciprofloxacin and ketoconazole or to those who received ketoconazole only. In this study, 60.6% of the combined amoxicillin-clavulanic acid/ketoconazole group showed complete or partial clinical response to treatment compared to 30.1% in the ciprofloxacin/ketoconazole group and 36.3% in the ketoconazole only group. The study also showed that 64.5% of the patients in the ciprofloxacin/ketoconazole group and 59.8% in the ketoconazole only group had progressive disease and poor outcome. This study showed that the combination of amoxicillin-clavulanic acid and ketoconazole treatment is safe and offers good clinical outcome and it is therefore recommended to treat eumycetoma patients with Staphylococcus aureus co-infection.

Outcomes of microvascular flap reconstruction of the head and neck in patients receiving systemic immunosuppressive therapy for organ transplantation.

PubMed

Schaverien, Mark V; Dean, Riley A; Myers, Jeffrey N; Fang, Lin; Largo, Rene D; Yu, Peirong

2018-05-03

For organ transplant recipients, cancer secondary to immunosuppressive therapy threatens long-term survival. The associated multiple comorbidities make major free flap reconstruction following cancer surgery a complicated event. This study evaluates the outcomes of free flap reconstruction in this population. A retrospective chart review of all head and neck free flap cases in patients with a history of organ transplantation receiving systemic immunosuppressive therapy between 2005 and 2017 at a single-institution was conducted. Of 57 organ transplant patients, 25 patients (28 flaps) were included. Flaps used included the anterolateral thigh (n = 17), radial forearm (n = 4), latissimus dorsi (n = 3), fibula (n = 2), lateral arm (n = 1), and thoracodorsal artery perforator (n = 1) flaps. The most common organ transplant was kidney, then lung, liver, and heart. Mean inpatient stay was 8.2 days (range, 4-28). Complications occurred in 15 patients, with no total or partial flap losses. Major head and neck free flap reconstructive surgery can be performed safely in organ transplant patients receiving immunosuppressive therapy. Meticulous multidisciplinary care is required to achieve consistently successful outcomes. © 2018 Wiley Periodicals, Inc.

A novel nano-immunoassay method for quantification of proteins from CD138-purified myeloma cells: biological and clinical utility

PubMed Central

Misiewicz-Krzeminska, Irena; Corchete, Luis Antonio; Rojas, Elizabeta A.; Martínez-López, Joaquín; García-Sanz, Ramón; Oriol, Albert; Bladé, Joan; Lahuerta, Juan-José; Miguel, Jesús San; Mateos, María-Victoria; Gutiérrez, Norma C.

2018-01-01

Protein analysis in bone marrow samples from patients with multiple myeloma has been limited by the low concentration of proteins obtained after CD138+ cell selection. A novel approach based on capillary nano-immunoassay could make it possible to quantify dozens of proteins from each myeloma sample in an automated manner. Here we present a method for the accurate and robust quantification of the expression of multiple proteins extracted from CD138-purified multiple myeloma samples frozen in RLT Plus buffer, which is commonly used for nucleic acid preservation and isolation. Additionally, the biological and clinical value of this analysis for a panel of 12 proteins essential to the pathogenesis of multiple myeloma was evaluated in 63 patients with newly diagnosed multiple myeloma. The analysis of the prognostic impact of CRBN/Cereblon and IKZF1/Ikaros mRNA/protein showed that only the protein levels were able to predict progression-free survival of patients; mRNA levels were not associated with prognosis. Interestingly, high levels of Cereblon and Ikaros proteins were associated with longer progression-free survival only in patients who received immunomodulatory drugs and not in those treated with other drugs. In conclusion, the capillary nano-immunoassay platform provides a novel opportunity for automated quantification of the expression of more than 20 proteins in CD138+ primary multiple myeloma samples. PMID:29545347

A novel nano-immunoassay method for quantification of proteins from CD138-purified myeloma cells: biological and clinical utility.

PubMed

Misiewicz-Krzeminska, Irena; Corchete, Luis Antonio; Rojas, Elizabeta A; Martínez-López, Joaquín; García-Sanz, Ramón; Oriol, Albert; Bladé, Joan; Lahuerta, Juan-José; Miguel, Jesús San; Mateos, María-Victoria; Gutiérrez, Norma C

2018-05-01

Protein analysis in bone marrow samples from patients with multiple myeloma has been limited by the low concentration of proteins obtained after CD138 + cell selection. A novel approach based on capillary nano-immunoassay could make it possible to quantify dozens of proteins from each myeloma sample in an automated manner. Here we present a method for the accurate and robust quantification of the expression of multiple proteins extracted from CD138-purified multiple myeloma samples frozen in RLT Plus buffer, which is commonly used for nucleic acid preservation and isolation. Additionally, the biological and clinical value of this analysis for a panel of 12 proteins essential to the pathogenesis of multiple myeloma was evaluated in 63 patients with newly diagnosed multiple myeloma. The analysis of the prognostic impact of CRBN /Cereblon and IKZF1 /Ikaros mRNA/protein showed that only the protein levels were able to predict progression-free survival of patients; mRNA levels were not associated with prognosis. Interestingly, high levels of Cereblon and Ikaros proteins were associated with longer progression-free survival only in patients who received immunomodulatory drugs and not in those treated with other drugs. In conclusion, the capillary nano-immunoassay platform provides a novel opportunity for automated quantification of the expression of more than 20 proteins in CD138 + primary multiple myeloma samples. Copyright © 2018 Ferrata Storti Foundation.

Signs and symptoms associated with the metabolic syndrome in psychiatric inpatients receiving antipsychotics: a retrospective chart review.

PubMed

Goethe, John W; Szarek, Bonnie L; Caley, Charles F; Woolley, Stephen B

2007-01-01

The metabolic syndrome has been recognized as a major health risk for patients taking atypical antipsychotics. Few studies, however, have examined large samples of psychiatric patients to explore the prevalence of the signs and symptoms associated with this condition. The investigators retrospectively identified all inpatient admissions at the study site who were treated with antipsychotics during 2003 (N = 1691) and extracted demographic and clinical data (including measures associated with the syndrome: body mass index > 30 kg/m2, dyslipidemia, diagnosis of hypertension or diabetes). Stepwise logistic regression was used to identify variables associated with each correlate of the syndrome. In the majority of this sample (69.3%), at least 1 correlate of the metabolic syndrome was present. The odds that a patient would have 1 or more of these measures were approximately 8 times greater for those receiving clozapine than for those receiving another anti-psychotic medication. These patients also had increased odds (odds ratio = 2.5) of having hypertension or diabetes. In the subsample of patients with documentation for all 5 correlates of the metabolic syndrome (N = 362), 18.8% had > or = 3 of 5. The prevalence of at least 3 correlates in psychiatric inpatients receiving antipsychotics is probably an underestimate, because diagnosis was substituted for the blood pressure and glucose measures. Nonetheless, these findings support the call for routine screening for metabolic symptoms in patients receiving antipsychotics. The risk for these symptoms may be particularly high in some subgroups identified, such as patients older than 50 years and those taking clozapine or multiple antipsychotics.

Physiotherapy for poliomyelitis: a descriptive study in the Republic of Congo.

PubMed

Mancini, Silvia; Coldiron, Matthew E; Nicholas, Sarala; Llosa, Augusto E; Mouniaman-Nara, Isabelle; Ngala, Joseph; Grais, Rebecca F; Porten, Klaudia

2014-10-23

A large poliomyelitis outbreak occurred in 2010 in the Republic of Congo. This paper describes the demographic and clinical characteristics of poliomyelitis cases and their outcomes following physiotherapy. Demographic and clinical data were collected on 126 individuals between November 23, 2010 and March 23, 2011. The male/female ratio was 2.5 and the median age was 19 years (IQR: 13.5-23). The most severe forms of the disease were more common in older patients, 81 of the 126 patients (64.3%) had multiple evaluations of muscle strength. Among patients with multiple evaluations, 38.1% had improved strength at final evaluation, 48.3% were stable and 13.6% had decreased strength. Most acute poliomyelitis patients receiving physiotherapy had improved or stable muscle strength at their final evaluation. These descriptive results highlight the need for further research into the potential benefits of physiotherapy in polio affected patients.

Double hemibody irradiation (DHBI) in the management of relapsed and primary chemoresistant multiple myeloma.

PubMed

McSweeney, E N; Tobias, J S; Blackman, G; Goldstone, A H; Richards, J D

1993-01-01

In view of increasing controversy regarding the role of double hemibody irradiation (DHBI) in the treatment of multiple myeloma, we have analysed the use of this technique at our institution over a 6-year period. Fifty-five patients with multiple myeloma were treated with both upper and lower hemibody irradiation between January 1985 and January 1991; 42 had relapsed post-plateau and 13 were chemoresistant to initial therapy. Fifteen patients received alpha IFN-2b maintenance therapy post-DHBI, at a dose of 3 Mu three times per week, as part of a randomized trial. Ninety-five per cent of patients experienced symptomatic improvement in bone pain post-DHBI, 21% of whom discontinued opiate analgesics altogether; 63% had a minor biochemical response and 38% had a partial biochemical response. The overall survival (OS) and progression free survivals (PFS) in all patients were 11 months and 8 months respectively. No significant difference was noted in either OS or PFS, according to whether patients were chemoresistant or had relapsed post-plateau. alpha IFN did not appear to prolong survival (OS or PFS) post-DHBI. Cytopenia was a significant problem, such that only 60% of patients had counts adequate enough to be eligible for alpha IFN. We conclude that DHBI is an effective treatment in patients with relapsed multiple myeloma and in those who are chemoresistant to initial therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical outcome of high-dose-rate interstitial brachytherapy in vulvar cancer: A single institutional experience.

PubMed

Mahantshetty, Umesh; Naga, Pushpa; Engineer, Reena; Sastri, Supriya; Ghadi, Yogesh; Upreti, Udita; Somesan, Vijaya; Kadam, Sudarshan; Kohle, Satish; Deshpande, Deepak; Shrivastava, Shyam Kishore

With an aim to evaluate and report high dose date interstitial brachytherapy (HDR-ISBT) in vulvar cancers, we undertook this retrospective analysis. Histologically proven vulvar cancers treated with HDR-ISBT between 2001 and 2016 were analyzed. Radiotherapy details, clinical outcome in terms of local control rates, survivals, and toxicities were evaluated. A total of 38 patients received HDR-ISBT, with definitive radiation in 29 (76.3%), adjuvant postoperative in six (15.8%) and salvage radiation in three (7.9%) patients. Of them, 29 patients received brachytherapy boost and nine patients ISBT alone. BT procedure included freehand plastic tube technique in 23 (single [n = 5] or multiple plane [n = 18]), 13 patients with template based and two patients combined approach. Patients with brachytherapy alone received median EQD2 of 38.4 Gy 10 (35.5-46.7 Gy 10 ), as boost received median 23.3 Gy 10 (13-37.3 Gy 10 ). At 3-month post-treatment response evaluation, 30 patients achieved clinically complete response, two patients partial response and six maintained postoperative status. With a median follow-up of 30 months, 29 (76.3%) were disease free, and 9 (23.7%) patients had relapsed disease with four patients expired due to disease and two died of other causes. The 5-year overall survival, disease free survival, and local control rates were 82%, 51%, and 77%, respectively. HDR-ISBT in vulvar cancer is a feasible and a viable option with acceptable and comparable outcomes. Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Treatment patterns and health care resource use in patients receiving multiple lines of therapy for metastatic squamous cell carcinoma of the head and neck in the United Kingdom.

PubMed

La, Elizabeth M; Smyth, Emily Nash; Talbird, Sandra E; Li, Li; Kaye, James A; Lin, Aimee Bence; Bowman, Lee

2018-06-21

This study evaluated the patterns of care and health care resource use (HCRU) in patients with metastatic squamous cell carcinoma of the head and neck (SCCHN) who received ≥3 lines of systemic therapy in the United Kingdom (UK). Oncologists (n = 40) abstracted medical records for patients with metastatic SCCHN who initiated third-line systemic therapy during 1 January 2011-30 August 2014 (n = 220). Patient characteristics, treatment patterns and SCCHN-related HCRU were summarised descriptively for the metastatic period; exploratory multivariable regression analyses were conducted on select HCRU outcomes. At metastatic diagnosis, most patients had an Eastern Cooperative Oncology Group performance status (PS) of 0/1 (95%). For patients with PS 0/1, the most common first-line treatment was cisplatin+5-fluorouracil (5-FU); docetaxel was the most common second- and third-line treatment. For patients with PS ≥ 2, the most common first-, second-, and third-line treatments were carboplatin+5-FU, cetuximab, and methotrexate, respectively. Most patients received supportive care during (85%) and after (89%) therapy. This study provides useful information, prior to the availability of immunotherapy, on patient characteristics, treatment patterns, HCRU, and survival in a real-world UK population with metastatic SCCHN receiving ≥3 lines of systemic therapy. Patterns of care and HCRU varied among patients with metastatic SCCHN; specific systemic therapies varied by patient PS. © 2018 Eli Lilly and Company. European Journal of Cancer Care published by John Wiley & Sons Ltd.

Memory rehabilitation for the working memory of patients with multiple sclerosis (MS).

PubMed

Mousavi, Shokoufeh; Zare, Hossein; Etemadifar, Masoud; Taher Neshatdoost, Hamid

2018-05-01

The main cognitive impairments in multiple sclerosis (MS) affect the working memory, processing speed, and performances that are in close interaction with one another. Cognitive problems in MS are influenced to a lesser degree by disease recovery medications or treatments,but cognitive rehabilitation is considered one of the promising methods for cure. There is evidence regarding the effectiveness of cognitive rehabilitation for MS patients in various stages of the disease. Since the impairment in working memory is one of the main MS deficits, a particular training that affects this cognitive domain can be of a great value. This study aims to determine the effectiveness of memory rehabilitation on the working memory performance of MS patients. Sixty MS patients with cognitive impairment and similar in terms of demographic characteristics, duration of disease, neurological problems, and mental health were randomly assigned to three groups: namely, experimental, placebo, and control. Patients' cognitive evaluation incorporated baseline assessments immediately post-intervention and 5 weeks post-intervention. The experimental group received a cognitive rehabilitation program in one-hour sessions on a weekly basis for 8 weeks. The placebo group received relaxation techniques on a weekly basis; the control group received no intervention. The results of this study showed that the cognitive rehabilitation program had a positive effect on the working memory performance of patients with MS in the experimental group. These results were achieved in immediate evaluation (post-test) and follow-up 5 weeks after intervention. There was no significant difference in working memory performance between the placebo group and the control group. According to the study, there is evidence for the effectiveness of a memory rehabilitation program for the working memory of patients with MS. Cognitive rehabilitation can improve working memory disorders and have a positive effect on the working memory performance of these patients.

Reduced Antiplatelet Effect of Aspirin Does Not Predict Cardiovascular Events in Patients With Stable Coronary Artery Disease.

PubMed

Larsen, Sanne Bøjet; Grove, Erik Lerkevang; Neergaard-Petersen, Søs; Würtz, Morten; Hvas, Anne-Mette; Kristensen, Steen Dalby

2017-08-05

Increased platelet aggregation during antiplatelet therapy may predict cardiovascular events in patients with coronary artery disease. The majority of these patients receive aspirin monotherapy. We aimed to investigate whether high platelet-aggregation levels predict cardiovascular events in stable coronary artery disease patients treated with aspirin. We included 900 stable coronary artery disease patients with either previous myocardial infarction, type 2 diabetes mellitus, or both. All patients received single antithrombotic therapy with 75 mg aspirin daily. Platelet aggregation was evaluated 1 hour after aspirin intake using the VerifyNow Aspirin Assay (Accriva Diagnostics) and Multiplate Analyzer (Roche; agonists: arachidonic acid and collagen). Adherence to aspirin was confirmed by serum thromboxane B 2 . The primary end point was the composite of nonfatal myocardial infarction, ischemic stroke, and cardiovascular death. At 3-year follow-up, 78 primary end points were registered. The primary end point did not occur more frequently in patients with high platelet-aggregation levels (first versus fourth quartile) assessed by VerifyNow (hazard ratio: 0.5 [95% CI, 0.3-1.1], P =0.08) or Multiplate using arachidonic acid (hazard ratio: 1.0 [95% CI, 0.5-2.1], P =0.92) or collagen (hazard ratio: 1.4 [95% CI, 0.7-2.8], P =0.38). Similar results were found for the composite secondary end point (nonfatal myocardial infarction, ischemic stroke, stent thrombosis, and all-cause death) and the single end points. Thromboxane B 2 levels did not predict any end points. Renal insufficiency was the only clinical risk factor predicting the primary and secondary end points. This study is the largest to investigate platelet aggregation in stable coronary artery disease patients receiving aspirin as single antithrombotic therapy. We found that high platelet-aggregation levels did not predict cardiovascular events. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

MTHFR, TS and XRCC1 genetic variants may affect survival in patients with myelodysplastic syndromes treated with supportive care or azacitidine.

PubMed

Visani, G; Loscocco, F; Ruzzo, A; Galimberti, S; Graziano, F; Voso, M T; Giacomini, E; Finelli, C; Ciabatti, E; Fabiani, E; Barulli, S; Volpe, A; Magro, D; Piccaluga, P; Fuligni, F; Vignetti, M; Fazi, P; Piciocchi, A; Gabucci, E; Rocchi, M; Magnani, M; Isidori, A

2017-12-05

We evaluated the impact of genomic polymorphisms in folate-metabolizing, DNA synthesis and DNA repair enzymes on the clinical outcome of 108 patients with myelodysplastic syndromes (MDS) receiving best supportive care (BSC) or azacitidine. A statistically significant association between methylenetetrahydrofolate reductase (MTHFR) 677T/T, thymidylate synthase (TS) 5'-untranslated region (UTR) 3RG, TS 3'-UTR -6 bp/-6 bp, XRCC1 399G/G genotypes and short survival was found in patients receiving BSC by multivariate analysis (P<0.001; P=0.026; P=0.058; P=0.024). MTHFR 677T/T, TS 3'-UTR -6 bp/-6 bp and XRCC1 399G/G genotypes were associated with short survival in patients receiving azacitidine by multivariate analysis (P<0.001; P=0.004; P=0.002). We then performed an exploratory analysis to evaluate the effect of the simultaneous presence of multiple adverse variant genotypes. Interestingly, patients with ⩾1 adverse genetic variants had a short survival, independently from their International Prognostic Scoring System (IPSS) and therapy received. To our knowledge, this is the first study showing that polymorphisms in folate-metabolizing pathway, DNA synthesis and DNA repair genes could influence survival of MDS patients.The Pharmacogenomics Journal advance online publication, 5 December 2017; doi:10.1038/tpj.2017.48.

Evolution of multi-drug resistant HCV clones from pre-existing resistant-associated variants during direct-acting antiviral therapy determined by third-generation sequencing

NASA Astrophysics Data System (ADS)

Takeda, Haruhiko; Ueda, Yoshihide; Inuzuka, Tadashi; Yamashita, Yukitaka; Osaki, Yukio; Nasu, Akihiro; Umeda, Makoto; Takemura, Ryo; Seno, Hiroshi; Sekine, Akihiro; Marusawa, Hiroyuki

2017-03-01

Resistance-associated variant (RAV) is one of the most significant clinical challenges in treating HCV-infected patients with direct-acting antivirals (DAAs). We investigated the viral dynamics in patients receiving DAAs using third-generation sequencing technology. Among 283 patients with genotype-1b HCV receiving daclatasvir + asunaprevir (DCV/ASV), 32 (11.3%) failed to achieve sustained virological response (SVR). Conventional ultra-deep sequencing of HCV genome was performed in 104 patients (32 non-SVR, 72 SVR), and detected representative RAVs in all non-SVR patients at baseline, including Y93H in 28 (87.5%). Long contiguous sequences spanning NS3 to NS5A regions of each viral clone in 12 sera from 6 representative non-SVR patients were determined by third-generation sequencing, and showed the concurrent presence of several synonymous mutations linked to resistance-associated substitutions in a subpopulation of pre-existing RAVs and dominant isolates at treatment failure. Phylogenetic analyses revealed close genetic distances between pre-existing RAVs and dominant RAVs at treatment failure. In addition, multiple drug-resistant mutations developed on pre-existing RAVs after DCV/ASV in all non-SVR cases. In conclusion, multi-drug resistant viral clones at treatment failure certainly originated from a subpopulation of pre-existing RAVs in HCV-infected patients. Those RAVs were selected for and became dominant with the acquisition of multiple resistance-associated substitutions under DAA treatment pressure.

Genetic variants in VEGF pathway genes in neoadjuvant breast cancer patients receiving bevacizumab: Results from the randomized phase III GeparQuinto study.

PubMed

Hein, Alexander; Lambrechts, Diether; von Minckwitz, Gunter; Häberle, Lothar; Eidtmann, Holger; Tesch, Hans; Untch, Michael; Hilfrich, Jörn; Schem, Christian; Rezai, Mahdi; Gerber, Bernd; Dan Costa, Serban; Blohmer, Jens-Uwe; Schwedler, Kathrin; Kittel, Kornelia; Fehm, Tanja; Kunz, Georg; Beckmann, Matthias W; Ekici, Arif B; Hanusch, Claus; Huober, Jens; Liedtke, Cornelia; Mau, Christine; Moisse, Matthieu; Müller, Volkmar; Nekljudova, Valentina; Peuteman, Gilian; Rack, Brigitte; Rübner, Matthias; Van Brussel, Thomas; Wang, Liewei; Weinshilboum, Richard M; Loibl, Sibylle; Fasching, Peter A

2015-12-15

Studies assessing the effect of bevacizumab (BEV) on breast cancer (BC) outcome have shown different effects on progression-free and overall survival, suggesting that a subgroup of patients may benefit from this treatment. Unfortunately, no biomarkers exist to identify these patients. Here, we investigate whether single nucleotide polymorphisms (SNPs) in VEGF pathway genes correlate with pathological complete response (pCR) in the neoadjuvant GeparQuinto trial. HER2-negative patients were randomized into treatment arms receiving either BEV combined with standard chemotherapy or chemotherapy alone. In a pre-planned biomarker study, DNA was collected from 729 and 724 patients, respectively from both treatment arms, and genotyped for 125 SNPs. Logistic regression assessed interaction between individual SNPs and both treatment arms to predict pCR. Five SNPs may be associated with a better response to BEV, but none of them remained significant after correction for multiple testing. The two SNPs most strongly associated, rs833058 and rs699947, were located upstream of the VEGF-A promoter. Odds ratios for the homozygous common, heterozygous and homozygous rare rs833058 genotypes were 2.36 (95% CI, 1.49-3.75), 1.20 (95% CI, 0.88-1.64) and 0.61 (95% CI, 0.34-1.12). Notably, some SNPs in VEGF-A exhibited a more pronounced effect in the triple-negative subgroup. Several SNPs in VEGF-A may be associated with improved pCR when receiving BEV in the neoadjuvant setting. Although none of the observed effects survived correction for multiple testing, our observations are consistent with previous studies on BEV efficacy in BC. Further research is warranted to clarify the predictive value of these markers. © 2015 UICC.

Low symptomatic premature stent occlusion of multiple plastic stents for benign biliary strictures: comparing standard and prolonged stent change intervals.

PubMed

Lawrence, Christopher; Romagnuolo, Joseph; Payne, K Mark; Hawes, Robert H; Cotton, Peter B

2010-09-01

Benign biliary strictures are typically managed endoscopically whereby an increasing size or number of plastic stents is placed at ERCP. Stents are often changed every 3 to 4 months based on the known median patency of a single biliary stent, but patency data for multiple biliary stents are lacking. To assess the incidence of occlusion-free survival of multiple plastic biliary stents and the rate of premature occlusion if left in longer than 6 months. Retrospective. Tertiary-care medical center (Charleston, SC). Consecutive patients who received multiple plastic stents for benign nonhilar biliary strictures from 1994 to 2008 were identified. Exchange of multiple plastic biliary stents within 6 months (group 1) or 6 months or longer (group 2) after placement. Symptomatic stent occlusion. Seventy-nine patients with nonhilar extrahepatic benign biliary stricture underwent 125 ERCPs with multiple plastic biliary stents. Stents were scheduled for removal/exchange within 6 months in 52 patients (86 ERCPs) compared with after 6 months in 22 patients (26 ERCPs). The median interval between multiple stent placement and removal/exchange was 90 days for group 1 and 242 days for group 2. Premature stent occlusion occurred in 4 of 52 (7.7%) patients in group 1 versus 1 of 22 (4.5%) in group 2, with significantly longer occlusion-free survival in group 2 (log-rank P < .0001). Retrospective study at a single tertiary referral center. Multiple plastic biliary stents for benign nonhilar strictures were associated with a low rate of premature symptomatic stent occlusion at more than 6 months and a longer occlusion-free survival. Copyright 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Human Trafficking, Sexual Assault, or Something Else? A Complicated Case With an Unexpected Outcome.

PubMed

Scott-Tilley, Donna; Crites, Heather

This case report presents a patient who presented multiple times with vaginal injuries and bleeding, reporting sexual assault with a foreign object. Findings from her history and physical examination were consistent with sexual assault and human trafficking. The outcome of this case was not what we initially expected when the patient first presented for care. However, the patient ultimately received the care she needed. This case illuminates the need for excellent continuing education, interdisciplinary communication, and continuity of care.

Fatty emaciation: a case report of suspected fat overload syndrome in oral refeeding.

PubMed

Macher, Arielle D; Palazuelos, Daniel; Maviglia, Saverio M

2012-07-01

Refeeding syndrome has been observed in patients receiving nutrition after a prolonged period of malnourishment and is characterized by multiple metabolic derangements. Besides hypophosphatemia and hypoglycemia, lipemia has been described in association with parenteral nutrition administration to the malnourished. The authors describe one anorexic patient who developed lipemia during oral refeeding, followed by a precipitous drop in hematocrit suggestive of fat overload syndrome.

Analysis of neutralizing antibodies to therapeutic interferon-beta in multiple sclerosis patients: a comparison of three methods in a large Australasian cohort.

PubMed

McKay, Fiona; Schibeci, Stephen; Heard, Robert; Stewart, Graeme; Booth, David

2006-03-20

Persistent high-titre neutralizing antibodies (NAB) to therapeutic interferon-beta(IFNbeta)in multiple sclerosis patients reduce therapeutic efficacy. Difficulties in standardization of cell-based bioactivity assays have hindered interlaboratory comparison of NAB titres and the determination of a clinically relevant definition of seropositivity. We determined NAB status in Australasian multiple sclerosis patients receiving IFNbetausing both the antiviral cytopathic effect (CPE) assay (n = 227) and the more specific ELISA for the type I interferon-inducible MxA protein (n = 350). While the log(10) titres determined in the two assays were highly correlated (p < 0.0001; r = 0.967) with similar distributions, the MxA assay was more sensitive, detecting lower concentrations of NAB than the CPE assay. The range of titres determined in the CPE assay was 10 to >7290; and 9 to 53,700 in the MxA assay, with ranked titre distribution highlighting the arbitrary nature of currently accepted definitions of NAB seropositivity. Bioactivity of injected IFNbetawas significantly reduced in NAB-positive patients (p = 0.006; NAB MxA titres = 184 to 5340) compared to NAB-negative patients as assessed ex vivo using real-time RT-PCR analysis of MxA gene induction. The range of MxA mRNA levels in healthy controls was remarkably consistent with previously published results, regardless of the assay standardization method [Gilli, F., Sala, A., Marnetto, F., Lindberg, R.L., Leppert, D. and Bertolotto, A. (2003) Comparison of IFNbeta bioavailability evaluations by MxA mRNA using two independent quantification methods. Abstract, ECTRIMS Meeting, Milan, Italy; Pachner, A., Narayan, K., Price, N., Hurd, M. and Dail, D. (2003a) MxA Gene Expression Analysis as an Interferon-beta Bioactivity Measurement in Patients with Multiple Sclerosis and the Identification of Antibody-Mediated Decreased Bioactivity. Mol. Diagn. 7, 17-25]. Assessment of IFNbetaresponse ex vivo accounts for both circulating factors and the cellular response to IFNbeta, and the data support the development of the MxA gene induction assay for the routine screening of patients receiving IFNbeta.

Incidence of neutropenia and use of granulocyte colony-stimulating factors in multiple myeloma: is current clinical practice adequate?

PubMed

Leleu, Xavier; Gay, Francesca; Flament, Anne; Allcott, Kim; Delforge, Michel

2018-03-01

Although immunomodulatory drugs, alkylating agents, corticosteroids, protease inhibitors, and therapeutic monoclonal antibodies improve multiple myeloma outcomes, treatment burden is still an issue. Neutropenia is a known complication of cytotoxic cancer therapy and is often associated with infections; it is an important consideration in myeloma given the fact that patients often have a weakened immune system. The risk of febrile neutropenia increases with severe and persisting neutropenia. Recombinant granulocyte colony-stimulating factors (G-CSFs) are commonly used to reduce the incidence, duration, and severity of febrile neutropenia. Here, we review the risk and management of neutropenia associated with new and commonly used anti-myeloma agents. Few papers report the use of G-CSF in patients with multiple myeloma receiving anti-cancer treatments, and fewer describe whether G-CSF was beneficial. None of the identified studies reported G-CSF primary prophylaxis. Further studies are warranted to evaluate the need for G-CSF prophylaxis in multiple myeloma. Prophylaxis may be particularly useful in patients at high risk of prolonged severe neutropenia.

Translating research into practice: the role of provider-based research networks in the diffusion of an evidence-based colon cancer treatment innovation.

PubMed

Carpenter, William R; Meyer, Anne-Marie; Wu, Yang; Qaqish, Bahjat; Sanoff, Hanna K; Goldberg, Richard M; Weiner, Bryan J

2012-08-01

Provider-based research networks (PBRNs)--collaborative research partnerships between academic centers and community-based practitioners--are a promising model for accelerating the translation of research into practice; however, empirical evidence of accelerated translation is limited. Oxaliplatin in adjuvant combination chemotherapy is an innovation with clinical trial-proven survival benefit compared with prior therapies. The goal of this study is to examine the diffusion of oxaliplatin into community practice, and whether affiliation with the National Cancer Institute's (NCI's) Community Clinical Oncology Program (CCOP)--a nationwide cancer-focused PBRN--is associated with accelerated innovation adoption. This retrospective observational study used linked Surveillance, Epidemiology, and End Results-Medicare and NCI CCOP data to examine Medicare participants with stage III colon cancer initiating treatment in 2003 through 2006, the years surrounding oxaliplatin's Food and Drug Administration approval. A fixed-effects analysis examined chemotherapy use among patients treated outside academic centers at CCOP-affiliated practices compared with non-CCOP practices. Two-group modeling controlled for multiple levels of clustering, year of chemotherapy initiation, tumor characteristics, patient age, race, comorbidity, Medicaid dual-eligibility status, and education. Of 4055 community patients, 35% received 5-fluoruracil, 20% received oxaliplatin, 7% received another chemotherapy, and 38% received no chemotherapy. Twenty-five percent of CCOP patients received oxaliplatin, compared with 19% of non-CCOP patients. In multivariable analysis, CCOP exposure was associated with higher odds of receiving guideline-concordant treatment in general, and oxaliplatin specifically. These findings contribute to a growing set of evidence linking PBRNs with a greater probability of receiving treatment innovations and high-quality cancer care, with implications for clinical and research policy.

Relationships between received and perceived social support and health-related quality of life among patients receiving methadone maintenance treatment in Mainland China.

PubMed

Zhou, Kaina; Li, Hengxin; Wei, Xiaoli; Yin, Juan; Liang, Peifeng; Zhang, Hongmei; Kou, Lingling; Hao, Mengmeng; You, Lijuan; Li, Xiaomei; Zhuang, Guihua

2017-06-26

Social support has been considered one of the most important factors of health-related quality of life (HRQoL) evaluations among different populations; however, few studies have explored the relationships of both received and perceived social support to HRQoL among patients undergoing methadone maintenance treatment (MMT). Thus, the purpose of this cross-sectional study was to clarify these relationships. Participants were patients admitted at the two largest privately and publicly funded MMT clinics in Xi'an. The main explanatory variable was social support, both received (i.e., social network support and professional support services) and perceived (Multidimensional Scale of Perceived Social Support). The outcome was HRQoL, which was evaluated using the Short-Form 36 Health Survey version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0). We carried out independent samples t-tests and multiple linear regression analysis to examine the relationships between received and perceived social support and HRQoL. The study findings revealed that patients with good social support had significantly higher scores on the SF-36v2 and QOL-DAv2.0 (p < 0.05). After controlling for individual characteristics, the significant factors predicting HRQoL were good family relationships, usually communicating with others, a convenient service time, appropriate treatment charges, and good perceived social support (p < 0.05). Our results suggest that received and perceived social support influences HRQoL among individuals receiving MMT. Thus, these variables should be considered during health management efforts and interventions directed at this patient population.

Prospective, randomized, controlled trial using best-selling smoking-cessation book.

PubMed

Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

2017-07-01

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

Predictors of psychological well-being in a diverse sample of HIV-positive patients receiving highly active antiretroviral therapy.

PubMed

Safren, Steven A; Radomsky, Adam S; Otto, Michael W; Salomon, Elizabeth

2002-01-01

The purpose of the present study was to identify variables relevant to psychological well-being in HIV patients receiving highly active antiretroviral therapy (HAART). Multiple stressors accompany living with HIV while managing a HAART regimen. However, a variety of cognitive and behavioral variables can protect against or augment the deleterious effects of stress in this population. The authors hypothesized that satisfaction with social support, coping styles, and maladaptive attributions about HIV would explain more variance in psychological well-being than stressful life events per se. Participants were individuals with HIV receiving antiretroviral therapy-either starting a new HAART regimen or having difficulties adhering to their current regimen. Satisfaction with social support, coping styles, and punishment beliefs about HIV were uniquely associated with depression, quality of life, and self-esteem over and above the effects of stressful life events. These results provide support for continued psychosocial interventions that target these variables among patients with HIV.

Treatment Patterns, Survival, and Healthcare Costs of Patients with Malignant Gliomas in a Large US Commercially Insured Population

PubMed Central

Ray, Saurabh; Bonafede, Machaon M.; Mohile, Nimish A.

2014-01-01

Background Glioblastoma multiforme is the most common malignant primary brain tumor in adults and is associated with poor survival rates. Symptoms often include headaches; nausea and vomiting; and progressive memory, personality, or neurologic deficits. The treatment remains a challenge, and despite the approval of multiple new therapies in the past decade, survival has not improved. Objective To describe treatment patterns, survival, and healthcare costs of patients with incident glioblastoma in a large US population. Methods For this population-based study, adult patients (aged ≥18 years) with incident malignant brain neoplasm who had undergone brain surgery between January 1, 2006, and December 31, 2010, were identified in the Truven Health Analytics MarketScan Research Databases. The patients were stratified into 4 cohorts based on the use of temozolomide and/or external beam radiation therapy within 90 days after brain surgery (ie, the index event). Treatment patterns, survival, and healthcare costs were assessed until patient death, disenrollment, or the end-of-study period. Results A total of 2272 patients met the inclusion criteria; of these, 37% received temozolomide and radiation therapy, 13.8% received radiation alone, 3.9% received temozolomide alone, and 45.3% of patients received neither. The average patient age ranged from 55.3 years to 59.8 years across the study cohorts; between 29.8% and 44% of patients in each cohort were female. The duration of temozolomide use was similar between the temozolomide-only cohort and patients receiving temozolomide with external beam radiation; approximately 76% of patients received temozolomide at least 60 days, dropping to 48.1% and 23% at 180 days and 360 days of follow-up, respectively. The median survival was 456 days, ranging from 331 days in the temozolomide-only cohort to 529 days in the cohort that received neither temozolomide nor external beam radiation. The average total costs in the 6 months postindex were $106,896, from $79,099 for patients who received neither temozolomide nor radiation to $138,767 for those who received both therapies. Conclusion The survival patterns of patients with glioblastoma seen in this real-world study of current treatments in a clinical setting is similar to the survival rate reported in clinical trials. However, further cost-effectiveness and quality-of-life analyses will be critical to better understand the role of temozolomide therapy in this patient population, considering its considerable cost burden and potential negative impact on survival seen in this study. PMID:24991398

Sirolimus alternative to blood transfusion as a life saver in blue rubber bleb nevus syndrome

PubMed Central

Wang, Ke-Ling; Ma, Shu-Fang; Pang, Ling-Yu; Zhang, Meng-Na; Hu, Lin-Yan; Liu, Meng-Jia; Zou, Li-Ping

2018-01-01

Abstract Rationale: Blue rubber bleb nevus syndrome (BRBNS) is a rare disease characterized by multiple venous malformations. The gastrointestinal bleeding and secondary iron deficiency anemia are the most common complications. There are currently no effective treatments for BRBNS. Here, we report a case of successful treatment with a small dose of sirolimus of a BRBN patient with a de novo gene mutation. Patient concerns: A 12-year-old female was admitted to our hospital with multiple hemangiomas for 12 years. The patient often displayed melena; she recently received transfusion of 2 units of red blood cells once every 2 weeks. Multiple fist-sized hemangiomas were piled up on both sides and back of the neck, and were also noted on the arms, legs, chest, back, and on the tip of the tongue. The laboratory findings demonstrated severe anemia. Blood sample sequencing detected a heterozygous de novo mutation c.2545C > Tin the TEK gene. Diagnoses: Based on these findings, final diagnosis of Blue rubber bleb nevus syndrome (BRBNS) was made. Interventions: After the diagnosis, low-dose sirolimus was orally administered. Outcomes: The patient's hemoglobin was increased after treatment with sirolimus for 1 month. Since the initial treatment with sirolimus, she had not received any blood transfusions. The skin and mucosal hemangioma decreased significantly, and new digestive tract hemorrhage, muscle hematoma, or adverse drug reactions were not observed. Lessons: we report a case of a mutation in exon 15 of the TEK gene leading to BRBN. It was successfully treated with a small dose of sirolimus as an alternative to blood transfusion in order to save the of BRBN patient's life. PMID:29465551

Incremental Benefit of a Home Visit Following Discharge for Patients with Multiple Chronic Conditions Receiving Transitional Care

PubMed Central

Jackson, Carlos; Kasper, Elizabeth W.; Williams, Christianna

2016-01-01

Abstract Transitional care management is effective at reducing hospital readmissions among patients with multiple chronic conditions, but evidence is lacking on the relative benefit of the home visit as a component of transitional care. The sample included non-dual Medicaid recipients with multiple chronic conditions enrolled in Community Care of North Carolina (CCNC), with a hospital discharge between July 2010 and December 2012. Using claims data and care management records, this study retrospectively examined whether home visits reduced the odds of 30-day readmission compared to less intensive transitional care support, using multivariate logistic regression to control for demographic and clinical characteristics. Additionally, the researchers examined group differences within clinical risk strata on inpatient admissions and total cost of care in the 6 months following hospital discharge. Of 35,174 discharges receiving transitional care from a CCNC care manager, 21% (N = 7468) included a home visit. In multivariate analysis, home visits significantly reduced the odds of readmission within 30 days (odds ratio = 0.52, 95% confidence interval 0.48–0.57). At the 6-month follow-up, home visits were associated with fewer inpatient admissions within 4 of 6 clinical risk strata, and lower total costs of care for highest risk patients (average per member per month cost difference $970; P < 0.01). For complex chronic patients, home visits reduced the likelihood of a 30-day readmission by almost half compared to less intensive forms of nurse-led transitional care support. Higher risk patients experienced the greatest benefit in terms of number of inpatient admissions and total cost of care in the 6 months following discharge. (Population Health Management 2016;19:163–170) PMID:26431255

The influence of serial fecal sampling on the diagnosis of giardiasis in humans, dogs, and cats.

PubMed

Uchôa, Flávia Fernandes de Mendonça; Sudré, Adriana Pittella; Macieira, Daniel de Barros; Almosny, Nádia Regina Pereira

2017-08-24

Giardia infection is a common clinical problem in humans and pets. The diagnosis of giardiasis is challenging as hosts intermittently excrete protozoan cysts in their feces. In the present study, we comparatively evaluated two methods of serial fecal sampling in humans, dogs, and cats from Rio de Janeiro, Brazil. The Faust et al. technique was used to examine fecal specimens collected in triplicate from 133 patients (52 humans, 60 dogs, and 21 cats). Specimens from 74 patients were received from the group assigned to carry out sampling on consecutive days - 34 humans, 35 dogs, and 5 cats, and specimens from 59 patients were received from the group assigned to carry out sampling on non-consecutive, separate days - 18 human beings, 25 dogs, and 16 cats. G. duodenalis cysts were found in stools of 30 individuals. Multiple stool sampling resulted in an increase in the number of samples that were positive for Giardia in both groups. The authors therefore conclude that multiple stool sampling increases the sensitivity of the Faust et al . technique to detect G. duodenalis cysts in samples from humans, cats and dogs.

Endothelial stress products and coagulation markers in patients with multiple myeloma treated with lenalidomide plus dexamethasone: an observational study

PubMed Central

Rosovsky, Rachel; Hong, Fangxin; Tocco, Deanna; Connell, Brendan; Mitsiades, Constantine; Schlossman, Robert; Ghobrial, Irene; Lockridge, Leslie; Warren, Diane; Bradwin, Gary; Doyle, Mary; Munshi, Nikhil; Soiffer, Robert J.; Anderson, Kenneth C.; Weller, Edie; Richardson, Paul

2014-01-01

Summary In this prospective study of patients with relapsed and/or refractory multiple myeloma (MM) treated with lenalidomide and dexamethasone, relationships between markers of endothelial stress and drug administration and incidence of venous thromboembolism (VTE) were assessed. Of 33 enrolled patients, laboratory and treatment data were available for 32 patients. Of these, 23 received pulsed dexamethasone (40 mg/day on days 1–4, 9–12, and 17–21 of each 28-day cycle) and 9 received weekly dexamethasone (40 mg/day on days 1, 8, 15, and 21 of each cycle). The overall incidence of VTE was 9%. A decreasing trend in markers values was observed with intercellular adhesion molecule (P = 0·05), fibrinogen (P = 0·008), plasminogen activator inhibitor-1 (P < 0·001), homocysteine (P = 0·002), and P-selectin (P < 0·001) during therapy. Compared with weekly dexamethasone, pulsed dexamethasone was associated with significantly greater variation in mean adjusted relative values of fibrinogen, P-selectin, and vascular endothelial growth factor (P < 0·001 for all comparisons), although there was no apparent association with VTE incidence. Lenalidomide plus dexamethasone affects endothelial stress marker levels in patients with advanced MM. The higher variation seen with pulsed dexamethasone suggests greater endothelial stress with this approach. PMID:23240658

Cognitive and physical functions related to the level of supervision and dependence in the toileting of stroke patients.

PubMed

Sato, Atsushi; Okuda, Yutaka; Fujita, Takaaki; Kimura, Norihiko; Hoshina, Noriyuki; Kato, Sayaka; Tanaka, Shigenari

2016-01-01

This study aimed to clarify which cognitive and physical factors are associated with the need for toileting assistance in stroke patients and to calculate cut-off values for discriminating between independent supervision and dependent toileting ability. This cross-sectional study included 163 first-stroke patients in nine convalescent rehabilitation wards. Based on their FIM Ⓡ instrument score for toileting, the patients were divided into an independent-supervision group and a dependent group. Multiple logistic regression analysis and receiver operating characteristic analysis were performed to identify factors related to toileting performance. The Minimental State Examination (MMSE); the Stroke Impairment Assessment Set (SIAS) score for the affected lower limb, speech, and visuospatial functions; and the Functional Assessment for Control of Trunk (FACT) were analyzed as independent variables. The multiple logistic regression analysis showed that the FIM Ⓡ instrument score for toileting was associated with the SIAS score for the affected lower limb function, MMSE, and FACT. On receiver operating characteristic analysis, the SIAS score for the affected lower limb function cut-off value was 8/7 points, the MMSE cut-off value was 25/24 points, and the FACT cut-off value was 14/13 points. Affected lower limb function, cognitive function, and trunk function were related with the need for toileting assistance. These cut-off values may be useful for judging whether toileting assistance is needed in stroke patients.

Gamma Knife Radiosurgery as a Therapeutic Strategy for Intracranial Sarcomatous Metastases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Flannery, Thomas; Department of Radiation Oncology, University of Pittsburgh School of Medicine and the University of Pittsburgh Medical Center, Pittsburgh, PA; Department of Neurosurgery, Royal Hospitals Trust, Belfast, Northern Ireland

2010-02-01

Purpose: To determine the indication and outcomes for Gamma Knife stereotactic radiosurgery (GKSRS) in the care of patients with intracranial sarcomatous metastases. Methods and Materials: Data from 21 patients who underwent radiosurgery for 60 sarcomatous intracranial metastases (54 parenchymal and 6 dural-based) were studied. Nine patients had radiosurgery for solitary tumors and 12 for multiple tumors. The primary pathology was metastatic leiomyosarcoma (4 patients), osteosarcoma (3 patients), soft-tissue sarcoma (5 patients), chondrosarcoma (2 patients), alveolar soft part sarcoma (2 patients), and rhabdomyosarcoma, Ewing's sarcoma, liposarcoma, neurofibrosarcoma, and synovial sarcoma (1 patient each). Twenty patients received multimodality management for their primarymore » tumor, and 1 patient had no evidence of systemic disease. The mean tumor volume was 6.2 cm{sup 3} (range, 0.07-40.9 cm{sup 3}), and a median margin dose of 16 Gy was administered. Three patients had progressive intracranial disease despite fractionated whole-brain radiotherapy before SRS. Results: A local tumor control rate of 88% was achieved (including patients receiving boost, up-front, and salvage SRS). New remote brain metastases developed in 7 patients (33%). The median survival after diagnosis of intracranial metastasis was 16 months, and the 1-year survival rate was 61%. Conclusions: Gamma Knife radiosurgery was a well-tolerated and initially effective therapy in the management of patients with sarcomatous intracranial metastases. However, many patients, including those who also received fractionated whole-brain radiotherapy, developed progressive new brain disease.« less

How does measurement of platelet P-selectin compare with other methods of measuring platelet function as a means of determining the effectiveness of antiplatelet therapy?

PubMed

Fox, Susan C; May, Jane A; Dovlatova, Natalia; Glenn, Jackie R; Johnson, Andrew; White, Ann E; Radhakrishnan, Ashwin; Heptinstall, Stan

2018-02-20

Measurement of P-selectin on activated platelets as a means of measuring platelet function utilizing the technology described here has the advantage of not requiring immediate access to specialist equipment and expertise. Blood samples are activated, fixed, stored, and transported to a central laboratory for flow cytometric analysis. Here we have compared P-selectin with other more traditional approaches to measuring platelet function in blood and/or platelet-rich plasma (PRP) from patients with acute coronary syndromes on treatment for at least 1 month with either aspirin and clopidogrel or aspirin with prasugrel. The comparators were light transmission aggregometry (LTA), VerifyNow and Multiplate aggregometry (for determining the effects of aspirin) and LTA, VerifyNow and Multiplate together with the BioCytex VASP phosphorylation assay (for the P2Y 12 antagonists). The P-selectin Aspirin Test revealed substantial inhibition of platelet function in all but three of 96 patients receiving aspirin with clopidogrel and in none of 51 patients receiving aspirin and prasugrel. The results were very similar to those obtained using LTA. There was only one patient with high residual platelet aggregation and low P-selectin expression. The same patients identified as "non-responders" to aspirin also presented with the highest residual platelet activity as measured using the VerifyNow system, although not quite as well separated from the other values. With the Multiplate test only one of these patients clearly stood out from the others. The results obtained using the P-selectin P2Y 12 Test in 102 patients taking aspirin and clopidogrel were similar to the more traditional approaches in that a wide scatter of results was obtained. Generally, high values seen with the P-selectin P2Y 12 Test were also high with the LTA, VerifyNow, Multiplate, and BioCytex VASP P2Y 12 Tests. Similarly, low residual platelet function using the P2Y 12 test was seen irrespective of the testing procedure used. However, there were differences in some patients. Prasugrel was always more effective than clopidogrel in inhibiting platelet function with none of 56 patients (P-selectin and VerifyNow), only 2 of 56 patients (Multiplate) and only 3 of 56 patients (Biocytex VASP) demonstrating high on-treatment residual platelet reactivity (HRPR) defined using previously published cut-off values. The exception was LTA where there were 11 of 56 patients with HRPR. It remains to be seen which experimental approach provides the most useful information regarding outcomes after adjusting therapies in treated patients.

Physiotherapy in Primary Care Triage - the effects on utilization of medical services at primary health care clinics by patients and sub-groups of patients with musculoskeletal disorders: a case-control study.

PubMed

Bornhöft, Lena; Larsson, Maria E H; Thorn, Jörgen

2015-01-01

Primary Care Triage is a patient sorting system used in some primary health care clinics (PHCCs) in Sweden where patients with musculoskeletal disorders (MSD) are triaged directly to physiotherapists. The purpose of this study was to investigate whether sorting/triaging patients seeking a PHCC for MSD directly to physiotherapists affects their utilization of medical services at the clinic for the MSD and to determine whether the effects of the triaging system vary for different sub-groups of patients. A retrospective case-control study design was used at two PHCCs. At the intervention clinic, 656 patients with MSD were initially triaged to physiotherapists. At the control clinic, 1673 patients were initially assessed by general practitioners (GPs). The main outcome measures were the number of patients continuing to visit GPs after the initial assessment, the number of patients receiving referrals to specialists/external examinations, doctors' notes for sick-leave or prescriptions for analgesics during one year, all for the original MSD. Significantly fewer patients triaged to physiotherapists required multiple GP visits for the MSD or received MSD-related referrals to specialists/external examinations, sick-leave recommendations or prescriptions during the following year compared to the GP-assessed group. This applies to all sub-groups except for the group with lower extremity disorders, which did not reach significance for either multiple GP visits or sick-leave recommendations. The reduced utilization of medical services by patients with MSD who were triaged to physiotherapists at a PHCC is likely due to altered management of MSD with initial assessment by physiotherapists.

Gorlin-Goltz syndrome and neoplasms: a case study.

PubMed

Lopes, Nilza N F; Caran, Eliana M; Lee, Maria Lucia; Silva, Nasjla Saba; Rocha, André Caroli; Macedo, Carla R D

2010-01-01

Gorlin syndrome is a rare autosomal dominant disorder exhibiting high penetrance and variable expressivity. It is characterized by facial dysmorphism, skeletal anomalies, multiple basal cell carcinomas, odontogenic keratocysts (OKC), palmar and plantar pits, bifid ribs, vertebral anomalies and a variety of other malformations. Various neoplasms, such as medulloblastomas, meningiomas, ovarian and cardiac fibromas are also found in this syndrome. To describe a twelve-year-old patient with Gorlin-Goltz syndrome, with basal cell carcinomas and promyelocytic leukemia developed after receiving craniospinal radiation for a medulloblastoma. Bifid ribs as well as mandibular and maxillar OKC were also diagnosed Conclusion: The patient with Gorlin-Goltz syndrome should receive close follow-up for early detection of malformations nd malignant neoplasias.

Methicillin-resistant Staphylococcus aureus prolongs intensive care unit stay in ventilator-associated pneumonia, despite initially appropriate antibiotic therapy.

PubMed

Shorr, Andrew F; Combes, Alain; Kollef, Marin H; Chastre, Jean

2006-03-01

To determine the impact of methicillin-resistant Staphylococcus aureus (MRSA) on length of stay in the intensive care unit (ICU) for patients with ventilator-associated pneumonia (VAP) and to control for the effect of initially inappropriate antibiotic treatment on outcomes by focusing only on persons who were given appropriate antibiotic therapy for their infection. Retrospective analysis of pooled, patient-level data from multiple clinical trials in VAP. Multiple ICUs in France. Persons with bronchoscopically confirmed VAP due to either MRSA or methicillin-susceptible S. aureus (MSSA) and who received initially appropriate antibiotic treatment. All persons with MRSA VAP received vancomycin (15 mg/kg intravenously, twice daily). None. We compared patients with MRSA VAP to persons with MSSA VAP. ICU length of stay represented the primary end point and ICU-free days served as a secondary end point. We recorded information regarding multiple confounders, including demographics, reasons for ICU admission and mechanical ventilation (MV), severity of illness at both ICU admission and time of diagnosis of VAP, and duration of mechanical ventilation before and following the onset of VAP. The final cohort included 107 patients, and one third of cases were due to MRSA. Despite receiving initially appropriate antibiotic treatment, median ICU length of stay was significantly longer for persons with MRSA infection (33 days vs. 22 days; p=.047). The median number of ICU-free days was concomitantly lower in MRSA VAP (0 days vs. 5 days; p=.011). Survival analysis employing a Cox proportional hazards model identified several predictors of remaining in the ICU: Pao2/Fio2 ratio at diagnosis of VAP, duration of MV before VAP, duration of MV after diagnosis of VAP, and reason for MV. Additionally, infection with MRSA as opposed MSSA doubled the probability of needing continued ICU care (hazard ratio, 2.08; 95% confidence interval, 1.09-3.95; p=.025). MRSA VAP independently prolongs the duration of ICU hospitalization, and in turn, increases overall costs, even for patients initially given appropriate antibiotic treatment. Confronting the adverse impact of MRSA will require efforts that address more than the initial antibiotic prescription.

Exploring Occupational Therapy Students' Meaning of Feedback during Fieldwork Experiences

ERIC Educational Resources Information Center

Rathgeber, Karen Lynne

2014-01-01

Researchers have revealed that students' confidence and performance improve after they receive feedback from clinical supervisors regarding the delivery of quality patient care. Multiple studies of feedback have focused on the provision and acceptance of feedback; however, it was not known if or how students internalized feedback to promote…

Influence of Preoperative Peripheral Parenteral Nutrition with Micronutrients after Colorectal Cancer Patients

PubMed Central

Tang, Hsiu-Chih; Hu, Shu-Hui; Yang, Hui-Lan

2015-01-01

Background. The inflammatory reactions are stronger after surgery of malnourished preoperative patients. Many studies have shown vitamin and trace element deficiencies appear to affect the functioning of immune cells. Enteral nutrition is often inadequate for malnourished patients. Therefore, total parenteral nutrition (TPN) is considered an effective method for providing preoperative nutritional support. TPN needs a central vein catheter, and there are more risks associated with TPN. However, peripheral parenteral nutrition (PPN) often does not provide enough energy or nutrients. Purpose. This study investigated the inflammatory response and prognosis for patients receiving a modified form of PPN with added fat emulsion infusion, multiple vitamins (MTV), and trace elements (TE) to assess the feasibility of preoperative nutritional support. Methods. A cross-sectional design was used to compare the influence of PPN with or without adding MTV and TE on malnourished abdominal surgery patients. Results. Both preoperative groups received equal calories and protein, but due to the lack of micronutrients, patients in preoperative Group B exhibited higher inflammation, lower serum albumin levels, and higher anastomotic leak rates and also required prolonged hospital stays. Conclusion. Malnourished patients who receive micronutrient supplementation preoperatively have lower postoperative inflammatory responses and better prognoses. PPN with added fat emulsion, MTV, and TE provides valid and effective preoperative nutritional support. PMID:26000296

Influence of preoperative peripheral parenteral nutrition with micronutrients after colorectal cancer patients.

PubMed

Liu, Ming-Yi; Tang, Hsiu-Chih; Hu, Shu-Hui; Yang, Hui-Lan; Chang, Sue-Joan

2015-01-01

The inflammatory reactions are stronger after surgery of malnourished preoperative patients. Many studies have shown vitamin and trace element deficiencies appear to affect the functioning of immune cells. Enteral nutrition is often inadequate for malnourished patients. Therefore, total parenteral nutrition (TPN) is considered an effective method for providing preoperative nutritional support. TPN needs a central vein catheter, and there are more risks associated with TPN. However, peripheral parenteral nutrition (PPN) often does not provide enough energy or nutrients. This study investigated the inflammatory response and prognosis for patients receiving a modified form of PPN with added fat emulsion infusion, multiple vitamins (MTV), and trace elements (TE) to assess the feasibility of preoperative nutritional support. Methods. A cross-sectional design was used to compare the influence of PPN with or without adding MTV and TE on malnourished abdominal surgery patients. Both preoperative groups received equal calories and protein, but due to the lack of micronutrients, patients in preoperative Group B exhibited higher inflammation, lower serum albumin levels, and higher anastomotic leak rates and also required prolonged hospital stays. Malnourished patients who receive micronutrient supplementation preoperatively have lower postoperative inflammatory responses and better prognoses. PPN with added fat emulsion, MTV, and TE provides valid and effective preoperative nutritional support.

Characterization of skin reactions and pain reported by patients receiving radiation therapy for cancer at different sites.

PubMed

Gewandter, Jennifer S; Walker, Joanna; Heckler, Charles E; Morrow, Gary R; Ryan, Julie L

2013-12-01

Skin reactions and pain are commonly reported side effects of radiation therapy (RT). To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain. A self-report survey-adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire--assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity or pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain. Survey respondents (N = 106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (P < or = .007). Patients receiving head/neck/brain RT reported increased skin problems (P < .0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (P = .066 and P = .122, respectively). Small sample size, exploratory analyses, and nonvalidated measure. Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site while patients receiving head/neck/brain RT had increased skin problems but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain and that interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients.

Cyclophosphamide, bortezomib and dexamethasone (CyBorD) induction for newly diagnosed multiple myeloma: High response rates in a phase II clinical trial

PubMed Central

Reeder, Craig B.; Reece, Donna E.; Kukreti, Vishal; Chen, Christine; Trudel, Suzanne; Hentz, Joseph; Noble, Brie; Pirooz, Nicholas A.; Spong, Jacy E.; Piza, Jesus G.; Zepeda, Victor H. Jimenez; Mikhael, Joseph R.; Leis, Jose F.; Bergsagel, P. Leif; Fonseca, Rafael; Stewart, A. Keith

2009-01-01

We have studied a three drug combination with bortezomib, cyclophosphamide and dexamethasone (CyBorD) on a 28 day cycle in the treatment of newly diagnosed multiple myeloma patients to assess response and toxicity. The primary endpoint of response was evaluated after four cycles. Thirty-three newly diagnosed, symptomatic patients with multiple myeloma received bortezomib 1.3 mg/m2 intravenously on days 1, 4, 8, 11, cyclophosphamide 300 mg/m2 orally days 1, 8, 15, 22 and dexamethasone 40 mg orally days 1-4, 9-12, 17-20 on a 28 day cycle for four cycles. Responses were rapid with a mean 80% decline in the sentinel monoclonal protein at the end of two cycles. The overall intent to treat response rate (≥ partial response) was 88% with 61% ≥VGPR and 39% CR/nCR. For the 28 patients that completed all 4 cycles of therapy the CR/nCR rate was 46% and ≥VGPR rate 71%. All patients undergoing stem cell harvest had a successful collection. Twenty three patients underwent SCT and are evaluable through day 100 with CR/nCR documented in 70% and ≥VGPR in 74%. In conclusion, CyBorD produces a rapid and profound response in patients with newly diagnosed multiple myeloma with manageable toxicity. PMID:19225538

The Effect of Antifibrinolytic Prophylaxis on Postoperative Outcomes in Patients Undergoing Cardiac Operations

PubMed Central

Koul, Abhinav; Ferraris, Victor; Davenport, Daniel L; Ramaiah, Chandrashekhar

2012-01-01

Antifibrinolytic agents such as aprotinin and epsilon aminocaproic acid limit postoperative bleeding and blood transfusion in patients undergoing cardiac operations using cardiopulmonary bypass (CPB). Recent evidence suggests that these agents have adverse side effects that influence operative mortality and morbidity. We studied postoperative bleeding, transfusion rates, and operative outcomes in our patients in order to assess the efficacy of these agents during cardiac operations requiring CPB. We reviewed records of 520 patients undergoing a variety of cardiac operations between January 2005 and May 2009. We measured multiple variables including pre-operative risk factors, antifibrinolytic agent used, and outcomes of operation, such as measures of bleeding and blood transfusion, as well as serious operative morbidity and mortality. Postoperative bleeding rates varied significantly between patients receiving aprotinin and those receiving aminocaproic acid (P < 0.05). There was an associated 12% decrease in operative site bleeding in aprotinin-treated patients compared with aminocaproic acid. There was no significant difference in the transfusion rates of packed red blood cells between patients receiving aminocaproic acid or aprotinin (P > 0.05), though individuals in the aprotinin group did receive FFP more frequently than patients in the aminocaproic acid group (P < 0.05). There was no significant difference in morbidity and mortality rates between patients in either drug group (P > 0.05). Our study shows that aprotinin is more effective at controlling operative site bleeding than aminocaproic acid. Reduced operative site bleeding did not portend better outcome or differences in transfusion requirements. Aminocaproic acid remains a safe and cost-effective option for antifibrinolytic prophylaxis because of unavailability of aprotinin. PMID:23101999

Paclitaxel-carboplatin induced radiation recall colitis.

PubMed

Kundak, Isil; Oztop, Ilhan; Soyturk, Mujde; Ozcan, Mehmet Ali; Yilmaz, Ugur; Meydan, Nezih; Gorken, Ilknur Bilkay; Kupelioglu, Ali; Alakavuklar, Mehmet

2004-01-01

Some chemotherapeutic agents can "recall" the irradiated volumes by skin or pulmonary reactions in cancer patients who previously received radiation therapy. We report a recall colitis following the administration of paclitaxel-containing regimen in a patient who had been irradiated for a carcinoma of the uterine cervix. A 63-year-old woman underwent a Wertheim operation because of uterine cervix carcinoma. After 8 years of follow-up, a local recurrence was observed and she received curative external radiotherapy (45 Gy) to the pelvis. No significant adverse events were observed during the radiotherapy. Approximately one year later, she was hospitalized because of metastatic disease with multiple pulmonary nodules, and a chemotherapy regimen consisting of paclitaxel and carboplatin was administered. The day after the administration of chemotherapy the patient had diarrhea and rectal bleeding. Histological examination of the biopsy taken from rectal hyperemic lesions showed a radiation colitis. The symptoms reappeared after the administration of each course of chemotherapy and continued until the death of the patient despite the interruption of the chemotherapy. In conclusion, the probability of recall phenomena should be kept in mind in patients who received previously with pelvic radiotherapy and treated later with cytotoxic chemotherapy.

Factors Predictive of Receiving Adjuvant Radiotherapy in High-Intermediate-Risk Stage I Endometrial Cancer.

PubMed

McGunigal, Mary; Pollock, Ariel; Doucette, John T; Liu, Jerry; Chadha, Manjeet; Kalir, Tamara; Gupta, Vishal

2018-06-01

Randomized trials have shown a local control benefit with adjuvant radiotherapy (RT) in high-intermediate-risk endometrial cancer patients, although not all such patients receive RT. We reviewed the National Cancer Data Base to investigate which patient/tumor-related factors are associated with delivery of adjuvant RT. The National Cancer Data Base was queried for patients diagnosed with International Federation of Gynecology and Obstetrics 2009 stage I endometrioid adenocarcinoma from 1998 to 2012 who underwent surgery +/- adjuvant RT. Exclusion criteria were unknown stage/grade, nonsurgical primary therapy, less than 30 days' follow-up, RT of more than 6 months after surgery, or palliative treatment. High-intermediate risk was defined based on Post Operative Radiation Therapy in Endometrial Carcinoma 2 criteria: older than 60 years with stage IA grade 3 or stage IB grade 1-2. Seventeen thousand five hundred twenty-four met inclusion criteria, and the 13,651 patients with complete data were subjected to a multiple logistic regression analysis; 7814 (57.2%) received surgery alone, and 5837 (42.8%) received surgery + RT. Receipt of adjuvant RT was more likely among black women and women with higher income, Northeastern residence, diagnosis after 2010, greater than 50% myometrial invasion, and receipt of adjuvant chemotherapy (P < 0.05). Patients older than 80 years or those undergoing lymph node dissection were less likely to receive adjuvant RT (P < 0.05). Of those treated with RT, 44.0% received external beam therapy, 54.8% received vaginal cuff brachytherapy, and 0.6% received both. Among irradiated women, patients older than 80 years and those with Northeastern residence, treatment at academic facilities, diagnosis after 2004, and lymph node dissection were more likely to undergo brachytherapy over external beam radiation therapy (P < 0.05). Overall use of adjuvant RT was 28.8% between 1998 and 2004, 42.0% between 2005 and 2010, and 43.4% between 2011 and 2012; the difference between 1998-2004 and 2005-2010 was not statistically significant. Fewer than half of patients with high-intermediate-risk endometrial cancer by Post Operative Radiation Therapy in Endometrial Carcinoma 2 criteria received adjuvant RT despite evidence demonstrating improved local control. Both patient- and tumor-related factors are associated with delivery of adjuvant RT and the modality selected.

Metoprolol improves survival in severe traumatic brain injury independent of heart rate control.

PubMed

Zangbar, Bardiya; Khalil, Mazhar; Rhee, Peter; Joseph, Bellal; Kulvatunyou, Narong; Tang, Andrew; Friese, Randall S; O'Keeffe, Terence

2016-02-01

Multiple prior studies have suggested an association between survival and beta-blocker administration in patients with severe traumatic brain injury (TBI). However, it is unknown whether this benefit of beta-blockers is dependent on heart rate control. The aim of this study was to assess whether rate control affects survival in patients receiving metoprolol with severe TBI. Our hypothesis was that improved survival from beta-blockade would be associated with a reduction in heart rate. We performed a 7-y retrospective analysis of all blunt TBI patients at a level-1 trauma center. Patients aged >16 y with head abbreviated injury scale 4 or 5, admitted to the intensive care unit (ICU) from the operating room or emergency room (ER), were included. Patients were stratified into two groups: metoprolol and no beta-blockers. Using propensity score matching, we matched the patients in two groups in a 1:1 ratio controlling for age, gender, race, admission vital signs, Glasgow coma scale, injury severity score, mean heart rate monitored during ICU admission, and standard deviation of heart rate during the ICU admission. Our primary outcome measure was mortality. A total of 914 patients met our inclusion criteria, of whom 189 received beta-blockers. A propensity-matched cohort of 356 patients (178: metoprolol and 178: no beta-blockers) was created. Patients receiving metoprolol had higher survival than those patients who did not receive beta-blockers (78% versus 68%; P = 0.04); however, there was no difference in the mean heart rate (89.9 ± 13.9 versus 89.9 ± 15; P = 0.99). Nor was there a difference in the mean of standard deviation of the heart rates (14.7 ± 6.3 versus 14.4 ± 6.5; P = 0.65) between the two groups. In Kaplan-Meier survival analysis, patients who received metoprolol had a survival advantage (P = 0.011) compared with patients who did not receive any beta-blockers. Our study shows an association with improved survival in patients with severe TBI receiving metoprolol, and this effect appears to be independent of any reduction in heart rate. We suggest that beta-blockers should be administered to all severe TBI patients irregardless of any perceived beta-blockade effect on heart rate. Published by Elsevier Inc.

Best Practice for the Administration of Daratumumab in Multiple Myeloma: Australian Myeloma Nurse Expert Opinion

PubMed Central

King, Tracy; Jagger, Jacqueline; Wood, Jodie; Woodrow, Carmel; Snowden, Alicia; Haines, Sally; Crosbie, Christina; Houdyk, Kristen

2018-01-01

Patients with multiple myeloma (MM) are typically of an advanced age and may have significant co-existing medical conditions. They have often had multiple lines of therapy and as such experience disease-related effects alongside associated treatment toxicities. Daratumumab is a monoclonal antibody approved for the treatment of MM in the relapsed/refractory setting. Clinical studies found that daratumumab showed good tolerability as a monotherapy and in combination with current standard therapies. However, the administration of daratumumab does require specific management considerations. It is administered as an intravenous infusion and infusion-related reactions (IRRs) may occur. Daratumumab also interferes with routine blood transfusion tests, giving false positives for the indirect antiglobulin test. This article highlights key nursing care considerations and practical management aspects to improve the treatment experience of patients receiving daratumumab infusions. Pretreatment aspects, patient education, pre- and post-medication, daratumumab administration, and the management of IRRs are discussed. An IRR management sheet that could be used by nurses and a patient information sheet are located at the end of this article.

Analysis of medical litigation among patients with medical disputes in cosmetic surgery in Taiwan.

PubMed

Lyu, Shu-Yu; Liao, Chuh-Kai; Chang, Kao-Ping; Tsai, Shang-Ta; Lee, Ming-Been; Tsai, Feng-Chou

2011-10-01

This study aimed to investigate the key factors in medical disputes (arguments) among female patients after cosmetic surgery in Taiwan and to explore the correlates of medical litigation. A total of 6,888 patients (3,210 patients from two hospitals and 3,678 patients from two clinics) received cosmetic surgery from January 2001 to December 2009. The inclusion criteria specified female patients with a medical dispute. Chi-square testing and multiple logistic regression analysis were used to analyze the data. Of the 43 patients who had a medical dispute (hospitals, 0.53%; clinics, 0.73%), 9 plaintiffs eventually filed suit against their plastic surgeons. Such an outcome exhibited a decreasing annual trend. The hospitals and clinics did not differ significantly in terms of patient profiles. The Chi-square test showed that most patients with a medical dispute (p < 0.05) were older than 30 years, were divorced or married, had received operations under general anesthesia, had no economic stress, had a history of medical litigation, and eventually did not sue the surgeons. The test results also showed that the surgeon's seniority and experience significantly influenced the possibility of medical dispute and nonlitigation. Multiple logistical regression analysis further showed that the patients who did decide to enter into litigation had two main related factors: marital stress (odds ratio [OR], 10.67; 95% confidence interval [CI], 1.20-94.73) and an education level below junior college (OR, 9.33; 95% CI, 1.01-86.36). The study findings suggest that the key characteristics of patients and surgeons should be taken into consideration not only in the search for ways to enhance pre- and postoperative communication but also as useful information for expert testimony in the inquisitorial law system.

Brain-Only Metastases Seen on FDG PET as First Relapse of Papillary Thyroid Carcinoma Two Years Post-Thyroidectomy.

PubMed

Naddaf, Sleiman Y; Syed, Ghulam Mustafa Shah; Hadb, Abdulrahman; Al-Thaqfi, Saif

2016-09-01

We report a case of a 60-year-old man diagnosed with papillary thyroid cancer who had a relapse seen only in the brain at FDG PET on standard images. Total thyroidectomy was performed in July 2013 after initial diagnosis. Patient received I ablation in December 2013, followed by external beam radiotherapy to the neck. In September 2015, the patient presented with neurological symptoms. Brain MRI showed multiple brain metastases later confirmed on histopathology. An FDG PET/CT scan was performed to evaluate the whole body in November 2015. Multiple hypermetabolic lesions were identified in the brain with no other lesion up to mid thighs.

Does aerobic training alleviate fatigue and improve societal participation in patients with multiple sclerosis? A randomized controlled trial.

PubMed

Heine, Martin; Verschuren, Olaf; Hoogervorst, Erwin Lj; van Munster, Erik; Hacking, Hub Ga; Visser-Meily, Anne; Twisk, Jos Wr; Beckerman, Heleen; de Groot, Vincent; Kwakkel, Gert

2017-10-01

Evidence supporting the effectiveness of aerobic training, specific for fatigue, in severely fatigued patients with multiple sclerosis (MS) is lacking. To estimate the effectiveness of aerobic training on MS-related fatigue and societal participation in ambulant patients with severe MS-related fatigue. Patients ( N = 90) with severe MS-related fatigue were allocated to 16-week aerobic training or control intervention. Primary outcomes were perceived fatigue (Checklist Individual Strength (CIS20r) fatigue subscale) and societal participation. An improvement of ⩾8 points on the CIS20r fatigue subscale was considered clinically relevant. Outcomes were assessed by a blinded observer at baseline, 2, 4, 6 and 12 months. Of the 89 patients that started treatment (median Expanded Disability Status Scale (interquartile range), 3.0 (2.0-3.6); mean CIS20r fatigue subscale (standard deviation (SD)), 42.6 (8.0)), 43 received aerobic training and 46 received the control intervention. A significant post-intervention between-group mean difference (MD) on the CIS20r fatigue subscale of 4.708 (95% confidence interval (CI) = 1.003-8.412; p  = 0.014) points was found in favour of aerobic training that, however, was not sustained during follow-up. No effect was found on societal participation. Aerobic training in MS patients with severe fatigue does not lead to a clinically meaningful reduction in fatigue or societal participation when compared to a low-intensity control intervention.

The role of single-shot metronidazole in the prevention of Clostridium difficile infection following ileostomy reversal surgery.

PubMed

Fernandes, Roland; Robinson, Paul; Rangarajan, Karan; Scott, Sophie; Angco, Laura

2017-05-01

Symptomatic infection with Clostridium difficile is strongly linked to antibiotic use and rates are higher for colorectal surgery. In February 2015, trust policy for antibiotic prophylaxis of ileostomy reversal surgery was changed from three doses of metronidazole plus cefuroxime to single-dose metronidazole, in a bid to reduce rates of Clostridium difficile infection. A retrospective cohort study was conducted at a single, large hospital trust between February 2014 and February 2016, before and after change in antimicrobial policy. Theatre data, clinical notes and pathology results were all reviewed. Outcome data, patient age, gender, length of operation and hospital stay were extracted. One hundred three patients underwent ileostomy reversal surgery between February 2014 and February 2015. All received cefuroxime together with metronidazole at induction of anaesthesia followed by two further post-operative doses as operative prophylaxis. Ninety-six patients underwent ileostomy reversal surgery between February 2015 and February 2016. All received single-dose metronidazole at induction as prophylaxis. Post-operative diarrhoea was significantly reduced in patients given single-dose metronidazole compared with patients managed with multiple dose, dual antibiotic therapy (32 vs 12.5%, P 0.001). Rates of CDI were also significantly reduced in patients given single-dose metronidazole (6.8 vs 1%, P 0.038). Single-dose, pre-operative metronidazole is effective at reducing post-operative diarrhoea and CDI in ileostomy reversal surgery compared with multiple-dose cefuroxime plus metronidazole. Metronidazole may be effective as a prophylactic antibiotic against CDI in colonic surgery.

Effective quality improvement of thromboprophylaxis in acute medicine.

PubMed

Clark, Barbara M; d'Ancona, Grainne; Kinirons, Mark; Hunt, Beverley J; Hopper, Adrian

2011-05-01

The Health Select Committee Report on the prevalence of venous thromboembolism (VTE) in 2005 suggested that poor awareness of the risks of VTE contributed significantly to mortality and morbidity in hospitalised patients. It recommended that all hospitalised patients should undergo a VTE risk assessment. In 2006, an audit in medical patients at Guy's and St Thomas' NHS Foundation Trust (GSTFT) revealed a lack of documentation of VTE risk assessment and poor use of thromboprophylaxis in 'at risk' patients. In 2007, the GSTFT 'Venous Thromboembolism in Adult Medical Inpatients' guideline was approved. The aim was to achieve a thromboprophylaxis culture within Acute Medicine and, in doing so, achieve a high adherence rate. The guideline was launched and implemented using a multidisciplinary and multiple intervention approach involving education and feedback, IT intervention, verbal and written reminders, regular audit and process redesign. An audit in 2008 showed that the rate of adherence had increased from 56% preguideline to 96%. However, a repeat audit in 2009 suggested that even though the majority of patients were receiving appropriate thromboprophylaxis, risk assessment documentation was poor. This resulted in treatment being provided to some low-risk patients when it was not required. In conclusion, the most effective means of achieving VTE guideline adherence is to establish a thromboprophylaxis culture. This can be accomplished through a multiple intervention and continuous feedback approach. However, it is essential to ensure that a comprehensive VTE risk assessment is carried out to ensure that those not requiring treatment do not receive it unnecessarily.

Sequential Use of Anaplastic Lymphoma Kinase Inhibitors in Japanese Patients With ALK-Rearranged Non-Small-Cell Lung Cancer: A Retrospective Analysis.

PubMed

Asao, Tetsuhiko; Fujiwara, Yutaka; Itahashi, Kota; Kitahara, Shinsuke; Goto, Yasushi; Horinouchi, Hidehito; Kanda, Shintaro; Nokihara, Hiroshi; Yamamoto, Noboru; Takahashi, Kazuhisa; Ohe, Yuichiro

2017-07-01

Second-generation anaplastic lymphoma kinase (ALK) inhibitors, such as alectinib and ceritinib, have recently been approved for treatment of ALK-rearranged non-small-cell lung cancer (NSCLC). An optimal strategy for using 2 or more ALK inhibitors has not been established. We sought to investigate the clinical impact of sequential use of ALK inhibitors on these tumors in clinical practice. Patients with ALK-rearranged NSCLC treated from May 2010 to January 2016 at the National Cancer Center Hospital were identified, and their outcomes were evaluated retrospectively. Fifty-nine patients with ALK-rearranged NSCLC had been treated and 37 cases were assessable. Twenty-six received crizotinib, 21 received alectinib, and 13 (35.1%) received crizotinib followed by alectinib. Response rates and median progression-free survival (PFS) on crizotinib and alectinib (after crizotinib failure) were 53.8% (95% confidence interval [CI], 26.7%-80.9%) and 38.4% (95% CI, 12.0%-64.9%), and 10.7 (95% CI, 5.3-14.7) months and 16.6 (95% CI, 2.9-not calculable), respectively. The median PFS of patients on sequential therapy was 35.2 months (95% CI, 12.7 months-not calculable). The 5-year survival rate of ALK-rearranged patients who received 2 sequential ALK inhibitors from diagnosis was 77.8% (95% CI, 36.5%-94.0%). The combined PFS and 5-year survival rates in patients who received sequential ALK inhibitors were encouraging. Making full use of multiple ALK inhibitors might be important to prolonging survival in patients with ALK-rearranged NSCLC. Copyright © 2016 Elsevier Inc. All rights reserved.

Whole Abdominopelvic Intensity-Modulated Radiation Therapy for Desmoplastic Small Round Cell Tumor After Surgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pinnix, Chelsea C.; Fontanilla, Hiral P.; Hayes-Jordan, Andrea

2012-05-01

Purpose: Desmoplastic small round cell tumor (DSCRT) is an uncommon pediatric tumor with a poor prognosis. Aggressive multimodality therapy is the current treatment approach; however. treatment toxicity is of concern. We report our results with whole abdominopelvic intensity-modulated radiation therapy (WAP-IMRT) as a component of multimodality therapy for DSCRT at a single institution. Materials/Methods: Medical records of all patients with DSCRT who received WAP-IMRT as part of definitive treatment at MD Anderson (2006-2010) were identified and reviewed. Results: Eight patients with DSRCT received WAP-IMRT with a median follow-up of 15.2 months. All patients received multiple courses of chemotherapy followed bymore » surgical debulking of intra-abdominal disease; seven also had intraoperative hyperthermic cisplatin. WAP-IMRT was delivered to a total dose of 30 Gy postoperatively; four patients received a simultaneous boost (6-10 Gy) to sites of gross residual disease. Seven patients received concurrent chemotherapy during WAP-IMRT. No Radiation Therapy Oncology Group Grade 4 nausea, vomiting, or diarrhea occurred during RT. Red-cell transfusions were given to two patients to maintain hemoglobin levels >10 g/dL. Grade 4 cytopenia requiring growth factor support occurred in only one patient; no other significant cytopenias were noted. WAP-IMRT resulted in 25% lower radiation doses to the lumbosacral vertebral bodies and pelvic bones than conventional RT plans. The median time to local or distant failure after WAP-IMRT was 8.73 months in seven patients. One patient who had completed RT 20 months before the last follow-up remains alive without evidence of disease. Five patients (63%) experienced treatment failure in the abdomen. Distant failure occurred in three patients (37.5%). Conclusions: WAP-IMRT with concurrent radiosensitizing chemotherapy was well tolerated after aggressive surgery for DSCRT. Enhanced bone sparing with IMRT probably accounts for the low hematologic toxicity (vs. conventional WAP-RT). This modality should be considered as an additional local-regional control option for DSRCT.« less

Socioeconomic status and the utilization of diagnostic imaging in an urban setting

PubMed Central

Demeter, Sandor; Reed, Martin; Lix, Lisa; MacWilliam, Leonard; Leslie, William D.

2005-01-01

Background In publicly funded health care systems, the utilization of health care services should be equitable, irrespective of socioeconomic status (SES). Although the association between SES and health care utilization has been examined in Canada relative to surgical, cardiac and preventive health care services, no published studies have specifically explored the association between SES and diagnostic imaging. Methods We examined over 300 000 diagnostic imaging claims made in the Winnipeg Regional Health Authority between Apr. 1, 2001, and Mar. 31, 2002. Using patient postal codes, we assigned SES on the basis of average household incomes in Canada's 1996 census. Using multiple regression, we examined the association between income quintile, patient age group (≤16, 17–64, ≥ 65 years), patient morbidity level according to the Johns Hopkins University Adjusted Clinical Group method (high, moderate, low), and imaging modality (general radiology, vascular, computed tomography, magnetic resonance, and general and obstetric ultrasound). Results Relative rates (RR) of diagnostic imaging utilization (highest v. lowest income quintile) were significantly increased in pediatric and adult patient groups at all morbidity levels receiving general radiology (highest RR 2.47, 95% confidence interval [CI] 2.07–2.93); pediatric and adult patient groups at high and low morbidity levels and elderly patient groups at low morbidity levels receiving general ultrasound (highest RR 2.26, 95% CI 1.20–4.26); pediatric and adult patient groups at all morbidity levels and elderly patients at high and moderate morbidity levels receiving magnetic resonance imaging (highest RR 2.51, 95% CI 1.78– 3.52); and adult patient groups at all morbidity levels receiving computed tomography (highest RR 1.46, 95% CI 1.35– 1.59). A lower RR of diagnostic imaging utilization in the highest income quintile was found only among patients receiving obstetric ultrasound (RR 0.80, 95% CI 0.73–0.87). No significant associations were found among elderly patients receiving general radiology or computed tomography or adult patients receiving vascular imaging. Interpretation We found a pattern of increased diagnostic imaging utilization in patient groups with a higher SES. Further research is needed to better understand the nature of this finding and how it contributes to health outcomes. PMID:16275968

The Influence of Prednisone on the Efficacy of Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer.

PubMed

Buonerba, Carlo; Sonpavde, Guru; Vitrone, Francesca; Bosso, Davide; Puglia, Livio; Izzo, Michela; Iaccarino, Simona; Scafuri, Luca; Muratore, Margherita; Foschini, Francesca; Mucci, Brigitta; Tortora, Vincenzo; Pagliuca, Martina; Ribera, Dario; Riccio, Vittorio; Morra, Rocco; Mosca, Mirta; Cesarano, Nicola; Di Costanzo, Ileana; De Placido, Sabino; Di Lorenzo, Giuseppe

2017-01-01

Background: Cabazitaxel is a second-generation taxane that is approved for use with concomitant low dose daily prednisone in metastatic castration resistant prostate cancer (mCRPC) after docetaxel failure. Since the role of daily corticosteroids in improving cabazitaxel efficacy or ameliorating its safety profile has not been adequately investigated so far, we compared outcomes of patients receiving cabazitaxel with or without daily corticosteroids in a retrospective single-Institution cohort of mCRPC patients. Patients and methods: Medical records of deceased patients with documented mCRPC treated with cabazitaxel following prior docetaxel between January, 2011 and January, 2017 were reviewed at the single participating center. Patients who were receiving daily doses of systemic corticosteroids other than low dose daily prednisone or prednisolone (<= 10 mg a day) were excluded. The primary end point of this analysis was overall survival (OS). Secondary end-points were exposure to cabazitaxel as well as incidence of grade 3-4 adverse events. Univariable and multivariable Cox proportional hazards regression was used to evaluate prednisone use and other variables as potentially prognostic for overall survival. Results: Overall, among 91 patients, 57 patients received cabazitaxel concurrently with low dose prednisone and 34 patients did not receive concurrent prednisone. The median overall survival of the population was 9.8 months (interquartile range, 9 to 14). Patients receiving prednisone had an overall survival of 9 months (interquartile range, 8 to 12) vs.14 months (interquartile range, 9.4 to 16.7) for patients not treated with prednisone. Approximately 45% of patients had a >30% PSA decline at 12 weeks. Prednisone use was not significantly prognostic for overall survival or PSA decline ≥30% rates on regression analyses. Importantly, a >30% PSA decline at 12, but not at 3, 6, 9 weeks, was prognostic for improved survival at multivariate analysis Conclusions: The data presented here support the hypothesis that omitting daily corticosteroids in cabazitaxel-treated patients has no negative impact on either survival or safety profile. In the large prospective trial CABACARE, cabazitaxel-treated patients will be randomized to receive or not receive daily prednisone. The CABACARE (EudraCT n. 2016-003646-81) study is currently ongoing at University Federico II of Naples and at other multiple participating centers in Italy.

The Influence of Prednisone on the Efficacy of Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer

PubMed Central

Buonerba, Carlo; Sonpavde, Guru; Vitrone, Francesca; Bosso, Davide; Puglia, Livio; Izzo, Michela; Iaccarino, Simona; Scafuri, Luca; Muratore, Margherita; Foschini, Francesca; Mucci, Brigitta; Tortora, Vincenzo; Pagliuca, Martina; Ribera, Dario; Riccio, Vittorio; Morra, Rocco; Mosca, Mirta; Cesarano, Nicola; Di Costanzo, Ileana; De Placido, Sabino; Di Lorenzo, Giuseppe

2017-01-01

Background: Cabazitaxel is a second-generation taxane that is approved for use with concomitant low dose daily prednisone in metastatic castration resistant prostate cancer (mCRPC) after docetaxel failure. Since the role of daily corticosteroids in improving cabazitaxel efficacy or ameliorating its safety profile has not been adequately investigated so far, we compared outcomes of patients receiving cabazitaxel with or without daily corticosteroids in a retrospective single-Institution cohort of mCRPC patients. Patients and methods: Medical records of deceased patients with documented mCRPC treated with cabazitaxel following prior docetaxel between January, 2011 and January, 2017 were reviewed at the single participating center. Patients who were receiving daily doses of systemic corticosteroids other than low dose daily prednisone or prednisolone (<= 10 mg a day) were excluded. The primary end point of this analysis was overall survival (OS). Secondary end-points were exposure to cabazitaxel as well as incidence of grade 3-4 adverse events. Univariable and multivariable Cox proportional hazards regression was used to evaluate prednisone use and other variables as potentially prognostic for overall survival. Results: Overall, among 91 patients, 57 patients received cabazitaxel concurrently with low dose prednisone and 34 patients did not receive concurrent prednisone. The median overall survival of the population was 9.8 months (interquartile range, 9 to 14). Patients receiving prednisone had an overall survival of 9 months (interquartile range, 8 to 12) vs.14 months (interquartile range, 9.4 to 16.7) for patients not treated with prednisone. Approximately 45% of patients had a >30% PSA decline at 12 weeks. Prednisone use was not significantly prognostic for overall survival or PSA decline ≥30% rates on regression analyses. Importantly, a >30% PSA decline at 12, but not at 3, 6, 9 weeks, was prognostic for improved survival at multivariate analysis Conclusions: The data presented here support the hypothesis that omitting daily corticosteroids in cabazitaxel-treated patients has no negative impact on either survival or safety profile. In the large prospective trial CABACARE, cabazitaxel-treated patients will be randomized to receive or not receive daily prednisone. The CABACARE (EudraCT n. 2016-003646-81) study is currently ongoing at University Federico II of Naples and at other multiple participating centers in Italy. PMID:28928853

Thromboembolism in patients with pericardial valves in the absence of chronic anticoagulation: 12 years' experience.

PubMed

García-Bengoechea, J B; González-Juanatey, J R; Rubio, J; Durán, D; Sierra, J

1991-01-01

Between January 1977 and January 1989, 465 pericardial bioprostheses were implanted in 424 patients. The mean age of patients was 59.1 years (range 16-81 y.) At the time of surgery, 68% of the patients suffered from chronic atrial fibrillation. Mitral valve replacement was performed in 167 patients, aortic valve replacement in 216, multiple replacement in 40 (36 mitral and aortic, 3 mitral and tricuspid, and 1 mitral, aortic and tricuspid), and 1 pulmonary valve replacement. The different types of pericardial valve used were: Ionescu-Shiley 408, Mitral Medical 23, Bioflo 30, and Hancock 4. Hospital mortality was 10.1% with an attrition rate of 1.8 episodes per 100 patients/year. The 12-year actuarial survival rate was 65.1%. No patient underwent long-term anticoagulant treatment. The first 144 patients undergoing mitral and multiple valve replacements received temporary anticoagulation for the first 8 weeks after surgery. There was no valve thrombosis observed. Altogether 19 thromboembolic events (6 early and 13 late) were clinically documented. One patient died after an embolic event. The linearized rates of thromboembolism were 1.64 episodes per 100 patients/year for mitral and multiple valve replacements and 0.33 episodes per 100 patients/year for aortic valve replacement, with an overall rate of 1.0 episodes per 100 patients/year. Excluding early thromboembolism, the linearized rate was 1.02 episodes per 100 patients/year overall. The actuarial freedom from embolism was 92.4% overall, 88.2% for the mitral and multiple valve replacement group, and 97.6% for the aortic valve replacement group at a maximum follow-up of 12 years.(ABSTRACT TRUNCATED AT 250 WORDS)

Malignant melanoma brain metastases. Review of Roswell Park Memorial Institute experience.

PubMed

Madajewicz, S; Karakousis, C; West, C R; Caracandas, J; Avellanosa, A M

1984-06-01

One-hundred twenty five of 700 patients with malignant melanoma treated at Roswell Park Memorial Institute from 1972 to 1978 were found to have brain metastases. Seventy-three percent of the patients had multiple brain metastases. Male to female ratio was 1.9:1. The median survival of the untreated group of patients was 3 weeks as compared with that of 6 weeks for the patients maintained on steroids only, 9 weeks for those who received radiotherapy, 11 weeks for the patients treated with intraarterial chemotherapy, and 26 weeks for the patients who underwent successful surgical excision of a solitary lesion.

Safety and efficacy of dual-lead thalamic deep brain stimulation for patients with treatment-refractory multiple sclerosis tremor: a single-centre, randomised, single-blind, pilot trial.

PubMed

Oliveria, Seth F; Rodriguez, Ramon L; Bowers, Dawn; Kantor, Daniel; Hilliard, Justin D; Monari, Erin H; Scott, Bonnie M; Okun, Michael S; Foote, Kelly D

2017-09-01

Efficacy in previous studies of surgical treatments of refractory multiple sclerosis tremor using lesioning or deep brain stimulation (DBS) has been variable. The aim of this study was to investigate the safety and efficacy of dual-lead thalamic DBS (one targeting the ventralis intermedius-ventralis oralis posterior nucleus border [the VIM lead] and one targeting the ventralis oralis anterior-ventralis oralis posterior border [the VO lead]) for the treatment of multiple sclerosis tremor. We did a single centre, single-blind, prospective, randomised pilot trial at the University of Florida Center for Movement Disorders and Neurorestoration clinic (Gainesville, FL, USA). We recruited adult patients with a clinical diagnosis of multiple sclerosis tremor refractory to previous medical therapy. Before surgery to implant both leads, we randomly assigned patients (1:1) to receive 3 months of optimised single-lead DBS-either VIM or VO. We did the randomisation with a computer-generated sequence, using three blocks of four patients, and independent members of the Center did the assignment. Patients and all clinicians other than the DBS programming nurse were masked to the choice of lead. Patients underwent surgery 1 month after their baseline visit for implantation of the dual lead DBS system. A pulse generator and two extension cables were implanted in a second surgery 3-4 weeks later. Patients then received an initial 3-month period of continuous stimulation of either the VIM or VO lead followed by blinded safety assessment of their tremor with the Tolosa-Fahn-Marin Tremor Rating Scale (TRS) during optimised VIM or VO lead stimulation at the end of the 3 months. After this visit, both leads were activated in all patients for an additional 3 months, and optimally programmed during serial visits as dictated by a prespecified programming algorithm. At the 6-month follow-up visit, TRS score was measured, and mood and psychological batteries were administered under four stimulation conditions: VIM on, VO on, both on, and both off (the order of testing was chosen by a computer-generated random sequence, assigned by independent members of the centre, and enacted by an unmasked DBS programming nurse). Each of four stimulation settings were tested over 4 consecutive days, with stimulation settings held constant for at least 12 h before testing. The primary outcome was change in mean total TRS score at the 6-month postoperative assessment with both leads activated, compared with the preoperative baseline mean TRS score. Analysis was by intention to treat. Safety was analysed in all patients who received the surgical implantation except in one patient who discontinued before the safety assessment. This trial is registered with ClinicalTrials.gov, number NCT00954421. Between Jan 16, 2007, and Dec 17, 2013, we enrolled 12 patients who were randomly assigned either to 3 initial months of VIM-only or VO-only stimulation. One patient from the VO-only group developed an infection necessitating DBS explantation, and was excluded from the assessment of the primary outcome. Compared with the mean baseline TRS score of 57·0 (SD 10·2), the mean score at 6 months decreased to 40·1 (17·6), -29·6% reduction; t=-0·28, p=0·03. Three of 11 patients did not respond to surgical intervention. One patient died suddenly 2 years after surgery, but this was judged to be unrelated to DBS implantation. Serious adverse events included a superficial wound infection in one patient that resolved with antibiotic therapy, and transient altered mental status and late multiple sclerosis exacerbation in another patient. The most common non-serious adverse events were headache and fatigue. Dual lead thalamic DBS might be a safe and effective option for improving severe, refractory multiple sclerosis tremor. Larger studies are necessary to show whether this technique is widely applicable, safe in the long-term, and effective in treating multiple sclerosis tremor or other severe tremor disorders. US National Institutes of Health, the Cathy Donnellan, Albert E Einstein, and Birdie W Einstein Fund, and the William Merz Professorship. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evidence of intermetastatic heterogeneity for pathological response and genetic mutations within colorectal liver metastases following preoperative chemotherapy.

PubMed

Sebagh, Mylène; Allard, Marc-Antoine; Bosselut, Nelly; Dao, Myriam; Vibert, Eric; Lewin, Maïté; Lemoine, Antoinette; Cherqui, Daniel; Adam, René; Sa Cunha, Antonio

2016-04-19

In patients receiving preoperative chemotherapy, colorectal liver metastases (CLM) are expected to demonstrate a similar behaviour because of similar organ microenvironment and tumour cell chemosensitivity. We focused on the occurrence of pathological and genetic heterogeneity within CLM. Patients resected for multiple CLM between 2004 and 2011 after > three cycles of chemotherapy were included. Pathological heterogeneity was arbitrarily defined as a > 50% difference in the percentage of remaining tumour cells between individual CLM. In patients with pathological heterogeneity, the mutational genotyping (KRAS, NRAS, BRAF and PIK3CA) was determined from the most heterogeneous CLM. Pathological heterogeneity was observed in 31 of 157 patients with multiple CLM (median = 4, range, 2-32) (19.7%). In 72.4% of them, we found a concordance of the mutation status between the paired CLM: both wild-type in 55%, and both mutated in 17.2%. We observed a discordance of the mutation status of 27.6% between CLM: one mutated and the other wild-type. The mutated CLM was the less florid one in 75% of patients with genetic heterogeneity. Pathological heterogeneity is present in 19.7% of patients with multiple CLM. Genetic heterogeneity is present in 27.6% of patients with pathological heterogeneity. Heterogeneity could refine guide management for tissue sampling.

Rehabilitation and multiple limb amputations: A clinical report of patients injured in combat.

PubMed

Melcer, Ted; Pyo, Jay; Walker, Jay; Quinn, Kimberly; Lebedda, Martin; Neises, Kamaran; Nguyen, Christina; Galarneau, Michael

2016-01-01

This clinical report describes the outpatient rehabilitation program for patients with multiple limb amputations enrolled in the Comprehensive Combat and Complex Casualty Care facility at the Naval Medical Center San Diego. Injury-specific data for 29 of these patients wounded by blast weaponry in Afghanistan in 2010 or 2011 were captured by the Expeditionary Medical Encounter Database at the Naval Health Research Center and were reviewed for this report. Their median Injury Severity Score was 27 (N = 29; range, 11-54). Patients averaged seven moderate to serious injuries (Abbreviated Injury Scale scores ≥2), including multiple injuries to lower limbs and injuries to the torso and/or upper limbs. All patients received care from numerous clinics, particularly physical therapy during the first 6 mo postinjury. Clinic use generally declined after the first 6 mo with the exception of prosthetic devices and repairs. The clinical team implemented the Mayo-Portland Adaptability Inventory, 4th Revision (MPAI-4) to assess functioning at outpatient program initiation and discharge (n = 23). At program discharge, most patients had improved scores for the MPAI-4 items assessing mobility, pain, and transportation, but not employment. Case reports described rehabilitation for two patients with triple amputations and illustrated multispecialty care and contrasting solutions for limb prostheses.

Incidence and mitigation of gastrointestinal events in patients with relapsing-remitting multiple sclerosis receiving delayed-release dimethyl fumarate: a German phase IV study (TOLERATE).

PubMed

Gold, Ralf; Schlegel, Eugen; Elias-Hamp, Birte; Albert, Christian; Schmidt, Stephan; Tackenberg, Björn; Xiao, James; Schaak, Tom; Salmen, Hans Christian

2018-01-01

Gastrointestinal (GI) events are common adverse events (AEs) associated with delayed-release dimethyl fumarate (DMF), an approved treatment for relapsing-remitting multiple sclerosis (RRMS). The objective of the TOLERATE study was to evaluate GI tolerability and GI mitigation via symptomatic therapies in patients initiating DMF in a real-world clinical setting in Germany. TOLERATE was a multicentre, open-label, single-arm study performed at 25 German sites. Endpoints were frequency, severity, duration (all primary) and mitigation of GI-related events (secondary). Patients were instructed to take DMF according to the prescribing information for up to 12 weeks and to document GI events and intake of GI-symptomatic therapy on numerical rating scales, using eDiaries. A total of 211 patients were included in the safety population (71% female; mean age 40 ± 11 years). Of these, 185 patients (87.7%) reported GI-related events, out of which nearly half received GI-symptomatic therapy (84/185; 45.4%). The most frequently reported GI events were upper abdominal pain, flatulence and nausea. GI-related events peaked during the first 3 weeks of therapy and rapidly decreased thereafter. The severity of GI events over 12 weeks according to the Modified Overall Gastrointestinal Symptom Scale were mild to moderate in the majority of patients reporting GI-related events and taking symptomatic GI medication (53.6%). Only 10% of all patients discontinued study treatment due to AEs in general, while 6.6% discontinued due to GI-related events. The severity of GI-related events decreased over time in patients who received symptomatic treatment with one or more medications (e.g. acid secretion blockers, antidiarrhoeals or antiemetics). Gastrointestinal events associated with delayed-release DMF were mainly mild to moderate in severity. Prevalence of GI events peaked during the first 3 weeks of therapy and rapidly faded thereafter. Although 44.9% of patients experiencing GI events used common GI symptomatic therapies, only 6.6% of patients discontinued DMF because of GI events, suggesting that GI events could be managed well with common symptomatic therapy.

The use of lipid-lowering therapy for secondary prevention in patients undergoing percutaneous coronary intervention

PubMed Central

Ma, Jessica M; Jackevicius, Cynthia A; Genus, Uchenwa; Dzavik, Vladimir

2006-01-01

BACKGROUND Recent literature suggests that lipid-lowering therapy may have an early beneficial effect among patients undergoing percutaneous coronary intervention (PCI) because the therapy decreases cardiac mortality, morbidity and possibly restenosis. OBJECTIVE The primary objective of the present study was to determine the proportion of PCI patients receiving lipid-lowering therapy at a large, tertiary-care referral centre. METHODS Patients undergoing a first PCI between August 2000 and August 2002 with corresponding inpatient medication information were included in the study. Patient demographics, procedural variables, and lipid-lowering and other evidence-based cardiac medication data were collected. A multiple logistical regression model was constructed to evaluate the factors associated with the use of lipid-lowering therapy. RESULTS Of the 3254 cases included in the analyses, 52% were elective, 44% were urgent or salvage, and 4% were emergent. The mean patient age was 63 years, and 73% of patients were male. Over 76% of patients were receiving lipid-lowering therapy at the time of PCI. Patient use of other medications was as follows: acetylsalicylic acid in 96%, beta-blocker in 80% and angiotensin-converting enzyme inhibitor in 59%. In the multiple regression analysis, variables significantly associated with lipid-lowering therapy use included hypercholesterolemia, beta-blocker use, angiotensin-converting enzyme inhibitor use, case urgency, prior coronary artery bypass graft surgery, age and sex. CONCLUSION Lipid-lowering therapy use rates exceeded those previously reported in the literature. Women and patients undergoing elective procedures appear to be treated less often with lipid-lowering therapy. There remains an opportunity to further optimize use in this high-risk cohort at time of PCI. PMID:16639478

Ustekinumab in Pediatric Crohn Disease Patients.

PubMed

Bishop, Casey; Simon, Hayley; Suskind, David; Lee, Dale; Wahbeh, Ghassan

2016-09-01

We describe the use of ustekinumab for 4 patients with pediatric Crohn disease treated at the Seattle Children's Hospital Inflammatory Bowel Disease Center. A retrospective chart review was done to identify patients' clinical data, disease phenotype, treatment history, and laboratory and growth parameters before treatment with ustekinumab and at last follow-up. Adverse events while on ustekinumab were also recorded. Four adolescent patients with Crohn disease at our center received ustekinumab. All had previously received corticosteroids, methotrexate, azathioprine/6-mercaptopurine, and both infliximab and adalimumab. Patients had varying disease phenotypes. Ages at ustekinumab initiation were 12, 13, 16, and 17 years. Weight ranged from 40.5 to 57.8 kg, mean 49.5 kg. Two patients showed clinical response and remain on ustekinumab. Two patients discontinued therapy because of continued symptoms and disease complications and required multiple hospitalizations. Ustekinumab was used in 4 children with pediatric Crohn disease with 2 of 4 patients showing clinical response (1 with persistently elevated C-reactive protein). A prospective study is needed to define its efficacy, safety, and placement in managing pediatric Crohn disease in the future.

Predictive Value of Glasgow Coma Score and Full Outline of Unresponsiveness Score on the Outcome of Multiple Trauma Patients.

PubMed

Baratloo, Alireza; Shokravi, Masumeh; Safari, Saeed; Aziz, Awat Kamal

2016-03-01

The Full Outline of Unresponsiveness (FOUR) score was developed to compensate for the limitations of Glasgow coma score (GCS) in recent years. This study aimed to assess the predictive value of GCS and FOUR score on the outcome of multiple trauma patients admitted to the emergency department. The present prospective cross-sectional study was conducted on multiple trauma patients admitted to the emergency department. GCS and FOUR scores were evaluated at the time of admission and at the sixth and twelfth hours after admission. Then the receiver operating characteristic (ROC) curve, sensitivity, specificity, as well as positive and negative predictive value of GCS and FOUR score were evaluated to predict patients' outcome. Patients' outcome was divided into discharge with and without a medical injury (motor deficit, coma or death). Finally, 89 patients were studied. Sensitivity and specificity of GCS in predicting adverse outcome (motor deficit, coma or death) were 84.2% and 88.6% at the time of admission, 89.5% and 95.4% at the sixth hour and 89.5% and 91.5% at the twelfth hour, respectively. These values for the FOUR score were 86.9% and 88.4% at the time of admission, 89.5% and 100% at the sixth hour and 89.5% and 94.4% at the twelfth hour, respectively. Findings of this study indicate that the predictive value of FOUR score and GCS on the outcome of multiple trauma patients admitted to the emergency department is similar.

Multiple Free Internal Limiting Membrane Flap Insertion in the Treatment of Macular Hole-Associated Retinal Detachment in High Myopia.

PubMed

Chen, San-Ni; Hsieh, Yi-Ting; Yang, Chung-May

2018-06-06

The aim of this paper was to evaluate the efficacy of multiple free internal limiting membrane (ILM) flap insertion in the management of macular hole-associated retinal detachment in high myopia. Eyes receiving operation for macular hole-associated retinal detachment were retrospectively recruited. Those in the study group received ILM peeling and multiple free ILM flap insertion, while those in the control group received ILM peeling only. Postoperative anatomical outcomes and best-corrected visual acuity were compared between the 2 groups. Twenty-seven eyes of 27 patients were recruited in this study (13 in the study group, 14 in the control group). After the operation, the retina was reattached in all cases in both groups. The macular hole closure rate was 100% in the study group but only 42.9% in the control group (adjusted p < 0.001). The eyes in the study group had better visual improvement (logMAR -0.58 ± 0.43) than those in the control group (logMAR -0.31 ± 0.50) with borderline significance (adjusted p = 0.078). For macular hole-associated retinal detachment in highly myopic eyes, the multiple free ILM flap insertion technique offers an effective way to close macular holes. Whether this result also means better visual outcome remains to be seen. © 2018 S. Karger AG, Basel.

Determinants of complications after multiple transrectal core biopsies of the prostate.

PubMed

Norberg, M; Holmberg, L; Häggman, M; Magnusson, A

1996-01-01

Transrectal ultrasound-guided biopsies of the prostate were performed on 347 consecutive men. All patients were given prophylactic antibiotics. The first 199 patients received 400 mg norfloxacin immediately after the biopsies were performed and 400 mg the same evening. The second group of 148 patients received 400 mg of norfloxacin 1 h before the examination followed by five doses administered twice daily. A total of 15 major complications were noted. In the first group the complication rate was 6.5% and in the second group 1.4%. The different regimes of prophylactic antibiotic treatment were the only parameters shown to have a statistically significant impact on the complication rate. The number of complications decreased, but were not eliminated, when prophylactic treatment with norfloxacin was given before the biopsies were taken and continued for a total of 3 days.

Blood Transfusion During Total Ankle Arthroplasty Is Associated With Increased In-Hospital Complications and Costs.

PubMed

Ewing, Michael A; Huntley, Samuel R; Baker, Dustin K; Smith, Kenneth S; Hudson, Parke W; McGwin, Gerald; Ponce, Brent A; Johnson, Michael D

2018-04-01

Total ankle arthroplasty (TAA) is an increasingly used, effective treatment for end-stage ankle arthritis. Although numerous studies have associated blood transfusion with complications following hip and knee arthroplasty, its effects following TAA are largely unknown. This study uses data from a large, nationally representative database to estimate the association between blood transfusion and inpatient complications and hospital costs following TAA. Using the Nationwide Inpatient Sample (NIS) database from 2004 to 2014, 25 412 patients who underwent TAA were identified, with 286 (1.1%) receiving a blood transfusion. Univariate analysis assessed patient and hospital factors associated with blood transfusion following TAA. Patients requiring blood transfusion were more likely to be female, African American, Medicare recipients, and treated in nonteaching hospitals. Average length of stay for patients following transfusion was 3.0 days longer, while average inpatient cost was increased by approximately 50%. Patients who received blood transfusion were significantly more likely to suffer from congestive heart failure, peripheral vascular disease, hypothyroidism, coagulation disorder, or anemia. Acute renal failure was significantly more common among patients receiving blood transfusion ( P < .001). Blood transfusions following TAA are infrequent and are associated with multiple medical comorbidities, increased complications, longer hospital stays, and increased overall cost. Level III: Retrospective, comparative study.

Hypersensitivity reactions in patients receiving hemodialysis.

PubMed

Butani, Lavjay; Calogiuri, Gianfranco

2017-06-01

To describe hypersensitivity reactions in patients receiving maintenance hemodialysis. PubMed search of articles published during the past 30 years with an emphasis on publications in the past decade. Case reports and review articles describing hypersensitivity reactions in the context of hemodialysis. Pharmacologic agents are the most common identifiable cause of hypersensitivity reactions in patients receiving hemodialysis. These include iron, erythropoietin, and heparin, which can cause anaphylactic or pseudoallergic reactions, and topical antibiotics and anesthetics, which lead to delayed-type hypersensitivity reactions. Many hypersensitivity reactions are triggered by complement activation and increased bradykinin resulting from contact system activation, especially in the context of angiotensin-converting enzyme inhibitor use. Several alternative pharmacologic preparations and dialyzer membranes are available, such that once an etiology for the reaction is established, recurrences can be prevented without affecting the quality of care provided to patients. Although hypersensitivity reactions are uncommon in patients receiving hemodialysis, they can be life-threatening. Moreover, considering the large prevalence of the end-stage renal disease population, the implications of such reactions are enormous. Most reactions are pseudoallergic and not mediated by immunoglobulin E. The multiplicity of potential exposures and the complexity of the environment to which patients on dialysis are exposed make it challenging to identify the precise cause of these reactions. Great diligence is needed to investigate hypersensitivity reactions to avoid recurrence in this high-risk population. Copyright © 2017 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Analysis and Simulation of Disadvantaged Receivers for Multiple-Input Multiple-Output Communications Systems

DTIC Science & Technology

2010-09-01

SIMULATION OF DISADVANTAGED RECEIVERS FOR MULTIPLE-INPUT MULTIPLE- OUTPUT COMMUNICATIONS SYSTEMS by Tracy A. Martin September 2010 Thesis...DATE September 2010 3. REPORT TYPE AND DATES COVERED Master’s Thesis 4. TITLE AND SUBTITLE Analysis and Simulation of Disadvantaged Receivers...Channel State Information at the Transmitter (CSIT). A disadvantaged receiver is subsequently introduced to the system lacking the optimization enjoyed

A randomised phase II study of sialyl-Tn and DETOX-B adjuvant with or without cyclophosphamide pretreatment for the active specific immunotherapy of breast cancer.

PubMed

Miles, D W; Towlson, K E; Graham, R; Reddish, M; Longenecker, B M; Taylor-Papadimitriou, J; Rubens, R D

1996-10-01

Studies in animal models of mouse mammary carcinoma have shown that ovine submaxillary mucin, which carries multiple sialyl-Tn (STn) epitopes, is effective in stimulating an immune response and inhibiting tumour growth. In similar studies using carbohydrate antigens, pretreatment with low-dose cyclophosphamide has been shown to be important in modulating the immune response to antigen possibly by inhibiting suppresser T-cell activity. In a clinical trial assessing the efficacy and toxicity of synthetic STn, patients with metastatic breast cancer were randomised to receive 100 micrograms STn linked to keyhole limpet haemocyanin (KLH) with DETOX-B adjuvant given by subcutaneous injection at weeks 0, 2, 5 and 9 with or without low-dose cyclophosphamide (CTX, 300 mg m-2) pretreatment, 3 days before the start of immunotherapy. Patients with responding or stable disease after the first four injections were eligible to receive STn-KLH at 4 week intervals. The main toxicity noted was the development of subcutaneous granulomata at injection sites. Of 23 patients randomised, 18 received four injections, 5 patients having developed progressive disease during the initial 12 week period. Two minor responses were noted in the 18 patients who received four active specific immunotherapy (ASI) injections and a further five patients had stable disease. Six patients continued ASI at 4 week intervals and a partial response was noted in a patient who had previously had stable disease. All patients developed IgG and IgM responses to sialyl-Tn and levels of IgM antibodies were significantly higher in those patients who were pretreated with CTX. Measurable tumour responses have been recorded following ASI with STn-KLH plus DETOX and the immunomodulatory properties of low-dose CTX have been confirmed.

A randomised phase II study of sialyl-Tn and DETOX-B adjuvant with or without cyclophosphamide pretreatment for the active specific immunotherapy of breast cancer.

PubMed Central

Miles, D. W.; Towlson, K. E.; Graham, R.; Reddish, M.; Longenecker, B. M.; Taylor-Papadimitriou, J.; Rubens, R. D.

1996-01-01

Studies in animal models of mouse mammary carcinoma have shown that ovine submaxillary mucin, which carries multiple sialyl-Tn (STn) epitopes, is effective in stimulating an immune response and inhibiting tumour growth. In similar studies using carbohydrate antigens, pretreatment with low-dose cyclophosphamide has been shown to be important in modulating the immune response to antigen possibly by inhibiting suppresser T-cell activity. In a clinical trial assessing the efficacy and toxicity of synthetic STn, patients with metastatic breast cancer were randomised to receive 100 micrograms STn linked to keyhole limpet haemocyanin (KLH) with DETOX-B adjuvant given by subcutaneous injection at weeks 0, 2, 5 and 9 with or without low-dose cyclophosphamide (CTX, 300 mg m-2) pretreatment, 3 days before the start of immunotherapy. Patients with responding or stable disease after the first four injections were eligible to receive STn-KLH at 4 week intervals. The main toxicity noted was the development of subcutaneous granulomata at injection sites. Of 23 patients randomised, 18 received four injections, 5 patients having developed progressive disease during the initial 12 week period. Two minor responses were noted in the 18 patients who received four active specific immunotherapy (ASI) injections and a further five patients had stable disease. Six patients continued ASI at 4 week intervals and a partial response was noted in a patient who had previously had stable disease. All patients developed IgG and IgM responses to sialyl-Tn and levels of IgM antibodies were significantly higher in those patients who were pretreated with CTX. Measurable tumour responses have been recorded following ASI with STn-KLH plus DETOX and the immunomodulatory properties of low-dose CTX have been confirmed. PMID:8883420

Opioid-Prescribing Patterns of Emergency Physicians and Risk of Long-Term Use

PubMed Central

Barnett, Michael L.; Olenski, Andrew R.; Jena, Anupam B.

2017-01-01

BACKGROUND Increasing overuse of opioids in the United States may be driven in part by physician prescribing. However, the extent to which individual physicians vary in opioid prescribing and the implications of that variation for long-term opioid use and adverse outcomes in patients are unknown. METHODS We performed a retrospective analysis involving Medicare beneficiaries who had an index emergency department visit in the period from 2008 through 2011 and had not received prescriptions for opioids within 6 months before that visit. After identifying the emergency physicians within a hospital who cared for the patients, we categorized the physicians as being high-intensity or low-intensity opioid prescribers according to relative quartiles of prescribing rates within the same hospital. We compared rates of long-term opioid use, defined as 6 months of days supplied, in the 12 months after a visit to the emergency department among patients treated by high-intensity or low-intensity prescribers, with adjustment for patient characteristics. RESULTS Our sample consisted of 215,678 patients who received treatment from low-intensity prescribers and 161,951 patients who received treatment from high-intensity prescribers. Patient characteristics, including diagnoses in the emergency department, were similar in the two treatment groups. Within individual hospitals, rates of opioid prescribing varied widely between low-intensity and high-intensity prescribers (7.3% vs. 24.1%). Long-term opioid use was significantly higher among patients treated by high-intensity prescribers than among patients treated by low-intensity prescribers (adjusted odds ratio, 1.30; 95% confidence interval, 1.23 to 1.37; P<0.001); these findings were consistent across multiple sensitivity analyses. CONCLUSIONS Wide variation in rates of opioid prescribing existed among physicians practicing within the same emergency department, and rates of long-term opioid use were increased among patients who had not previously received opioids and received treatment from high-intensity opioid prescribers. (Funded by the National Institutes of Health.) PMID:28199807

Prevalence and characteristics of patients with metastatic cancer who receive no anticancer therapy.

PubMed

Small, Alexander C; Tsao, Che-Kai; Moshier, Erin L; Gartrell, Benjamin A; Wisnivesky, Juan P; Godbold, James H; Smith, Cardinale B; Sonpavde, Guru; Oh, William K; Galsky, Matthew D

2012-12-01

A subset of patients who present with metastatic solid tumors never receive anticancer therapy. Reasons may include poor functional status, comorbidities, and patient preference. To the authors' knowledge, the prevalence and characteristics of this population have not previously been described. The National Cancer Data Base was queried for patients diagnosed with metastatic (stage IV according to the American Joint Committee on Cancer) solid tumors (including those of the breast, cervix, colon, and kidney; small cell and nonsmall cell lung cancer [NSCLC]; and tumors of the prostate, rectum, and uterus) who received neither radiotherapy nor systemic therapy. Log-binomial regression analysis was used to estimate prevalence ratios (PRs) for the percentage of untreated to treated patients with stage IV cancer. Between 2000 and 2008, 773,233 patients with stage IV cancer were identified, 159,284 of whom (20.6%; 95% confidence interval, 20.5%-20.7%) received no anticancer therapy. Patients with NSCLC accounted for 55% of the untreated population. Patients with cancers of the kidney and lung had the highest rates of no treatment at 25.5% and 24.0%, respectively, whereas patients with prostate cancer had the lowest rate of no treatment at 11.1%. Across all cancer types, older age (PR range, 1.37-1.49; all P < .001), black race (PR range, 1.05-1.32; all P < .001), lack of medical insurance (PR range, 1.47-2.46; all P < .001), and lower income (except for cancer of the uterus; PR range, 0.91-0.98 for every $10,000-increase in income [all P < .001]) were associated with a lack of treatment. Approximately 20% of patients who present with stage IV solid tumors do not receive anticancer therapy. Although there are likely multiple reasons for this lack of treatment, including appropriate indications, these findings have potential implications with regard to health care policy and access to care. Copyright © 2012 American Cancer Society.

[A Correlational Study of the Recovery Process in Patients With Mental Illness].

PubMed

Huang, Yao-Hui; Lin, Yao-Yu; Lee, Shih-Kai; Lee, Ming-Feng; Lin, Ching-Lan Esther

2018-04-01

The ideology of recovery addresses the autonomy of patients with mental illness and their ability to reconstruct a normal life. Empirical knowledge of this process of recovery and related factors remains unclear. To assess the process of recovery and related factors in patients with mental illness. This cross-sectional, correlational study was conducted on a convenience sample in a psychiatric hospital. Two-hundred and fifty patients with mental illness were recruited and were assessed using 3 instruments: Questionnaire about the Process of Recovery (QPR), Perceived Psychiatric Stigma Scale (PPSS), and Personal and Social Performance Scale (PSP). Data were analyzed using descriptive statistics, χ 2 , analysis of variance, and multiple linear regression analysis. Most of the participants were male, middle-aged, unmarried, educated to the senior high school level, employed, receiving home-care treatment, and diagnosed with schizophrenia. Those who were unemployed, living in a community rehabilitative house, and living in the community, respectively, earned relatively higher recovery scores (p < .05). The total scores of QPR and the 3 subscales were negatively correlated with PPSS (p < .01) and positively correlated with PSPS (p < .01; p < .05). Multiple regression analysis indicated that the factors of education, employment, having received community rehabilitative models, and stigma, respectively, significantly explained the recovery capacity of patients with mental illness. Community psychiatric nurses should provide care to help employed patients adapt to stresses in the workplace, strengthen their stigma-coping strategies, and promote public awareness of mental health issues by increasing public knowledge and acceptance of mental illness in order to minimize patient-perceived stigma and facilitate their recovery.

Autologous hematopoietic cell transplantation for multiple myeloma patients with renal insufficiency: A Center for International Blood and Marrow Transplant Research Analysis

PubMed Central

Mahindra, Anuj; Hari, Parameswaran; Fraser, Raphael; Fei, Mingwei; Huang, Jiaxing; Berdeja, Jesus; Callander, Natalie; Costa, Luciano; Diaz, Miguel Angel; Freytes, Cesar; Gale, Robert Peter; Girnius, Saulius; Holmberg, Leona; Kharfan-Dabaja, Mohamad; Kumar, Shaji; Kyle, Robert; Lazarus, Hillard; Lee, Cindy; Maiolino, Angelo; Moreb, Jan; Nishihori, Taiga; Pawarode, Attaphol; Saad, Ayman; Savani, Bipin N.; Schriber, Jeffrey; William, Basem; Wirk, Baldeep M.; Krishnan, Amrita; Nieto, Yago; D’Souza, Anita

2017-01-01

Autologous hematopoietic cell transplantation (AHCT) in multiple myeloma (MM) patients with renal insufficiency (RI) is controversial. Patients who underwent AHCT for MM between 2008-2013 were identified (N =1492) and grouped as normal/mild (≥60 ml/min), N=1240, moderate (30-59), N=185 and severe RI (<30), N=67 based on MDRD. Multivariate analysis of non-relapse mortality (NRM), relapse, progression-free survival (PFS) and overall survival (OS) was performed. Of the 67 patients with severe RI, 35 were on dialysis prior to AHCT. Patients received melphalan 200 mg/m2 (Mel200) in 92% (normal/mild), 75% (moderate) and 33% (severe) RI; remainder received 140 mg/m2 (Mel140). Thirty four of 35 patients with severe RI achieved post-AHCT dialysis independence. The 5-year PFS for normal, moderate and severe RI was 35 (95% CI, 31-38)%, 40 (31-49)% and 27 (15-40)% respectively, (p=0·42); 5-year OS for normal, mod and severe RI was 68 (65-71)%, 68 (60-76)% and 60 (46-74)% respectively, (p=0·69). With moderate RI, 5-year PFS for HDM 140 mg/m2 was 18 (6-35)% and for Mel200 was 46 (36-57)% (p=0·009). With severe RI, 5-year PFS Mel140 was 25 (11-41) % and for Mel200 was 32 (11-58)% (p=0·37). We conclude that AHCT is safe and effective in patients with MM with RI. PMID:28920949

29 Year Old Man with Multiple Sclerosis and Schizophrenia: A Case Report.

PubMed

Noorani, Nahid; Hadi, Fateme; Ahmadkhaniha, Hamid Reza

2016-12-01

Multiple sclerosis (MS) is the most common debilitating neurological disease that affects adults, whether young adults or middle-aged. Although, most attention is toward the neurological signs of the disease, the neuropsychiatric signs are not uncommon. This case report presents a 29 year old male with a record of obsessive-compulsive disorder (OCD) without psychotic disorder, which coincides with the diagnosis MS, has been stricken to auditory hallucinations and reference delusion. The patient received some antipsychotic drugs such as Haloperidol and Perphenazine irregularly, but any psychotic signs of the patient were never in control. During this period he had several active episodes of MS disease, wherein the symptoms had subsided due to hospitalization and received corticosteroids pulse. The first time the patient was submitted to the emergency unit of Rasoul Akram Hospital, there was the possibility of schizophrenia which was confirmed in subsequent visits. The signs of the patient were not controllable for a long time and finally fully controlled by a combination of Aripiprazole (abilizol), Risperidone and Sertraline, and currently, for almost 3 years, both psychotic symptoms and MS disease have been under control. Our patient seems to catch the MS disease and schizophrenia simultaneously. There was no relation between MS and psychosis episodes and the MS attacks. Since the onset the patient had several acute MS attacks of MS, and hospitalization several times. These findings and characteristics regarding our patient made him completely different from other reported cases of MS along with neuropsychiatric signs which may help doctors in diagnosis and managment of similar cases.

The Association of CD81 Polymorphisms with Alloimmunization in Sickle Cell Disease

PubMed Central

Tatari-Calderone, Zohreh; Tamouza, Ryad; Le Bouder, Gama P.; Dewan, Ramita; Luban, Naomi L. C.; Lasserre, Jacqueline; Maury, Jacqueline; Lionnet, François; Krishnamoorthy, Rajagopal; Girot, Robert

2013-01-01

The goal of the present work was to identify the candidate genetic markers predictive of alloimmunization in sickle cell disease (SCD). Red blood cell (RBC) transfusion is indicated for acute treatment, prevention, and abrogation of some complications of SCD. A well-known consequence of multiple RBC transfusions is alloimmunization. Given that a subset of SCD patients develop multiple RBC allo-/autoantibodies, while others do not in a similar multiple transfusional setting, we investigated a possible genetic basis for alloimmunization. Biomarker(s) which predicts (predict) susceptibility to alloimmunization could identify patients at risk before the onset of a transfusion program and thus may have important implications for clinical management. In addition, such markers could shed light on the mechanism(s) underlying alloimmunization. We genotyped 27 single nucleotide polymorphisms (SNPs) in the CD81, CHRNA10, and ARHG genes in two groups of SCD patients. One group (35) of patients developed alloantibodies, and another (40) had no alloantibodies despite having received multiple transfusions. Two SNPs in the CD81 gene, that encodes molecule involved in the signal modulation of B lymphocytes, show a strong association with alloimmunization. If confirmed in prospective studies with larger cohorts, the two SNPs identified in this retrospective study could serve as predictive biomarkers for alloimmunization. PMID:23762099

Evaluation of Bortezomib-Induced Neuropathy Using Total Neuropathy Score (Reduced and Clinical Versions) and NCI CTCAE v4.0 in Newly Diagnosed Patients With Multiple Myeloma Receiving Bortezomib-Based Induction.

PubMed

Lakshman, Arjun; Modi, Manish; Prakash, Gaurav; Malhotra, Pankaj; Khadwal, Alka; Jain, Sanjay; Kumari, Savita; Varma, Neelam; Varma, Subhash

2017-08-01

Bortezomib-induced peripheral neuropathy (BiPN) is a dose-limiting adverse effect of bortezomib-based therapy for multiple myeloma (MM). The reporting of BiPN is variable because of the use of different neuropathy scales. Most investigators use the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). We prospectively evaluated the incidence of BiPN in treatment-naive patients with MM receiving weekly cyclophosphamide, bortezomib, and dexamethasone (CyBorD) in 28-day cycles using 3 neuropathy scores: Total Neuropathy Score-reduced (TNSr) and -clinical (TNSc), and NCI CTCAE v4.0. Twenty-six patients received CyBorD. Twenty patients completed follow-up. The rates of occurrence of BiPN were as follows: TNSr - 55% (n = 11), TNSc - 40% (n = 8), and NCI CTCAE - 45% (n = 9). All 3 scales showed worsening after treatment (P < .01). When compared to BiPN by TNSr, sensitivities for NCI CTCAE and TNSc were 77.8% and 88.9%, respectively. Specificity was 63.3% for both NCI CTCAE and TNSc. Among 12 patients who did not have BiPN by NCI CTCAE scale, 41.7% (n = 5) and 16.7% (n = 2) patients satisfied the criteria for BiPN by TNSr and TNSc, respectively. The higher detection rate of neuropathy by TNSr and TNSc is probably due to increment in scores that are allotted for increase in anatomic extent of sensorimotor involvement, unlike the NCI CTCAE scale, which requires functional limitation for increase in grade. NCI CTCAE may be suboptimal in comparison to TNSr and TNSc in assessment of BiPN because it may miss worsening neuropathy without functional limitation. Copyright © 2017 Elsevier Inc. All rights reserved.

Cluster bomb ocular injuries.

PubMed

Mansour, Ahmad M; Hamade, Haya; Ghaddar, Ayman; Mokadem, Ahmad Samih; El Hajj Ali, Mohamad; Awwad, Shady

2012-01-01

To present the visual outcomes and ocular sequelae of victims of cluster bombs. This retrospective, multicenter case series of ocular injury due to cluster bombs was conducted for 3 years after the war in South Lebanon (July 2006). Data were gathered from the reports to the Information Management System for Mine Action. There were 308 victims of clusters bombs; 36 individuals were killed, of which 2 received ocular lacerations and; 272 individuals were injured with 18 receiving ocular injury. These 18 surviving individuals were assessed by the authors. Ocular injury occurred in 6.5% (20/308) of cluster bomb victims. Trauma to multiple organs occurred in 12 of 18 cases (67%) with ocular injury. Ocular findings included corneal or scleral lacerations (16 eyes), corneal foreign bodies (9 eyes), corneal decompensation (2 eyes), ruptured cataract (6 eyes), and intravitreal foreign bodies (10 eyes). The corneas of one patient had extreme attenuation of the endothelium. Ocular injury occurred in 6.5% of cluster bomb victims and 67% of the patients with ocular injury sustained trauma to multiple organs. Visual morbidity in civilians is an additional reason for a global ban on the use of cluster bombs.

Effect of blood transfusion on outcome after major burn injury: a multicenter study.

PubMed

Palmieri, Tina L; Caruso, Daniel M; Foster, Kevin N; Cairns, Bruce A; Peck, Michael D; Gamelli, Richard L; Mozingo, David W; Kagan, Richard J; Wahl, Wendy; Kemalyan, Nathan A; Fish, Joel S; Gomez, Manuel; Sheridan, Robert L; Faucher, Lee D; Latenser, Barbara A; Gibran, Nicole S; Klein, Robert L; Solem, Lynn D; Saffle, Jeffrey R; Morris, Stephen E; Jeng, James C; Voigt, David; Howard, Pamela A; Molitor, Fred; Greenhalgh, David G

2006-06-01

To delineate blood transfusion practices and outcomes in patients with major burn injury. Patients with major burn injury frequently require multiple blood transfusions; however, the effect of blood transfusion after major burn injury has had limited study. Multicenter retrospective cohort analysis. Regional burn centers throughout the United States and Canada. Patients admitted to a participating burn center from January 1 through December 31, 2002, with acute burn injuries of >or=20% total body surface area. Outcome measurements included mortality, number of infections, length of stay, units of blood transfused in and out of the operating room, number of operations, and anticoagulant use. A total of 21 burn centers contributed data on 666 patients; 79% of patients survived and received a mean of 14 units of packed red blood cells during their hospitalization. Mortality was related to patient age, total body surface area burn, inhalation injury, number of units of blood transfused outside the operating room, and total number of transfusions. The number of infections per patient increased with each unit of blood transfused (odds ratio, 1.13; p<.001). Patients on anticoagulation during hospitalization received more blood than patients not on anticoagulation (16.3+/-1.5 vs. 12.3+/-1.5, p<.001). The number of transfusions received was associated with mortality and infectious episodes in patients with major burns even after factoring for indices of burn severity. The utilization of blood products in the treatment of major burn injury should be reserved for patients with a demonstrated physiologic need.

Association Between Medication Use for Attention-Deficit/Hyperactivity Disorder and Risk of Motor Vehicle Crashes.

PubMed

Chang, Zheng; Quinn, Patrick D; Hur, Kwan; Gibbons, Robert D; Sjölander, Arvid; Larsson, Henrik; D'Onofrio, Brian M

2017-06-01

Motor vehicle crashes (MVCs) are a major public health problem. Research has demonstrated that individuals with attention-deficit/hyperactivity disorder (ADHD) are more likely to experience MVCs, but the effect of ADHD medication treatment on the risk of MVCs remains unclear. To explore associations between ADHD medication use and risk of MVCs in a large cohort of patients with ADHD. For this study, a US national cohort of patients with ADHD (n = 2 319 450) was identified from commercial health insurance claims between January 1, 2005, and December 31, 2014, and followed up for emergency department visits for MVCs. The study used within-individual analyses to compare the risk of MVCs during months in which patients received ADHD medication with the risk of MVCs during months in which they did not receive ADHD medication. Dispensed prescription of ADHD medications. Emergency department visits for MVCs. Among 2 319 450 patients identified with ADHD, the mean (SD) age was 32.5 (12.8) years, and 51.7% were female. In the within-individual analyses, male patients with ADHD had a 38% (odds ratio, 0.62; 95% CI, 0.56-0.67) lower risk of MVCs in months when receiving ADHD medication compared with months when not receiving medication, and female patients had a 42% (odds ratio, 0.58; 95% CI, 0.53-0.62) lower risk of MVCs in months when receiving ADHD medication. Similar reductions were found across all age groups, across multiple sensitivity analyses, and when considering the long-term association between ADHD medication use and MVCs. Estimates of the population-attributable fraction suggested that up to 22.1% of the MVCs in patients with ADHD could have been avoided if they had received medication during the entire follow-up. Among patients with ADHD, rates of MVCs were lower during periods when they received ADHD medication. Considering the high prevalence of ADHD and its association with MVCs, these findings warrant attention to this prevalent and preventable cause of mortality and morbidity.

Immunomodulatory and therapeutic effects of Hot-nature diet and co-supplemented hemp seed, evening primrose oils intervention in multiple sclerosis patients.

PubMed

Rezapour-Firouzi, Soheila; Arefhosseini, Seyed Rafie; Mehdi, Farhoudi; Mehrangiz, Ebrahimi-Mamaghani; Baradaran, Behzad; Sadeghihokmabad, Elyar; Mostafaei, Somaiyeh; Fazljou, Seyed Mohammad Bagher; Torbati, Mohammad-ali; Sanaie, Sarvin; Zamani, Fatemeh

2013-10-01

Multiple sclerosis (MS) is the most chronic and inflammatory disorder. Because of limited efficacy and adverse side effects, identifying novel therapeutic and protective agents is important. This study was aimed to assess the potential therapeutic effects of hemp seed and evening primrose oils as well as Hot-nature dietary intervention on RRMS patients. In this double blind, randomized trial, 100 MS patients with EDSS<6 were allocated into 3 groups: "Group A" who received co-supplemented hemp seed and evening primrose oils with advised Hot-nature diet, "Group B" who received olive oil, "Group C" who received the co-supplemented oils. Mizadj, clinically EDSS and relapse rate as well as immunological factors (IL-4, IFN-γ and IL-17) were assessed at baseline and after 6 months. Mean follow-up was 180±2.9 SD days (N=65, 23 M and 42 F aged 34.25±8.07 years with disease duration 6.80±4.33 years). There was no significant difference in studies parameters at baseline. After 6 months, significant improvements in Mizadj, EDSS and relapse rate were found in the groups A and C, while the group B showed a border significant decrease in relapse rate. Immunological parameters showed improvement in groups A and C, whereas there was worsening condition for group B after the intervention. The co-supplemented hemp seed and evening primrose oils with Hot-nature diet have beneficial effects in improving of clinical score in RRMS patients which were confirmed by immunological findings. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure.

PubMed

Spencer, Andrew; Prince, H Miles; Roberts, Andrew W; Prosser, Ian W; Bradstock, Kenneth F; Coyle, Luke; Gill, Devinder S; Horvath, Noemi; Reynolds, John; Kennedy, Nola

2009-04-10

Thalidomide is effective in the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM). However, the role of thalidomide in the post-autologous stem cell transplantation (ASCT) context remains unclear. This study assessed whether the addition of thalidomide consolidation following ASCT would improve the durability of responses achieved and overall survival. Between January 2002 and March 2005, 269 patients with newly diagnosed MM who achieved disease stabilization or better with conventional induction chemotherapy received a single high-dose melphalan conditioned ASCT. Post-ASCT, 129 patients were randomly assigned to receive indefinite prednisolone maintenance therapy (control group) and 114 to receive the same in addition to 12 months of thalidomide consolidation (thalidomide group). The primary study end points were progression-free survival (PFS) and overall survival (OS). The secondary end point was tolerability. After a median follow-up of 3 years, the postrandomization 3-year PFS rates were 42% and 23% (P < .001; hazard ratio [HR], 0.5; 95% CI, 0.35 to 0.71) and the OS rates were 86% and 75% (P = .004; HR, 0.41; 95% CI, 0.22 to 0.76) in the thalidomide and control groups, respectively. There was no difference in survival between groups 12 months after disease progression (79% v 77%; P = .237). Neurological toxicities were more common in the thalidomide arm but there were no differences between arms for thromboembolic events. Consolidation therapy with 12 months of thalidomide combined with prednisolone prolongs survival when used after a single high-dose therapy supported ASCT in patients with newly diagnosed MM. Furthermore, thalidomide consolidation therapy did not adversely impact on survival in the subsequent salvage setting.

Parsimonious model for blood glucose level monitoring in type 2 diabetes patients.

PubMed

Zhao, Fang; Ma, Yan Fen; Wen, Jing Xiao; DU, Yan Fang; Li, Chun Lin; Li, Guang Wei

2014-07-01

To establish the parsimonious model for blood glucose monitoring in patients with type 2 diabetes receiving oral hypoglycemic agent treatment. One hundred and fifty-nine adult Chinese type 2 diabetes patients were randomized to receive rapid-acting or sustained-release gliclazide therapy for 12 weeks. Their blood glucose levels were measured at 10 time points in a 24 h period before and after treatment, and the 24 h mean blood glucose levels were measured. Contribution of blood glucose levels to the mean blood glucose level and HbA1c was assessed by multiple regression analysis. The correlation coefficients of blood glucose level measured at 10 time points to the daily MBG were 0.58-0.74 and 0.59-0.79, respectively, before and after treatment (P<0.0001). The multiple stepwise regression analysis showed that the blood glucose levels measured at 6 of the 10 time points could explain 95% and 97% of the changes in MBG before and after treatment. The three blood glucose levels, which were measured at fasting, 2 h after breakfast and before dinner, of the 10 time points could explain 84% and 86% of the changes in MBG before and after treatment, but could only explain 36% and 26% of the changes in HbA1c before and after treatment, and they had a poorer correlation with the HbA1c than with the 24 h MBG. The blood glucose levels measured at fasting, 2 h after breakfast and before dinner truly reflected the change 24 h blood glucose level, suggesting that they are appropriate for the self-monitoring of blood glucose levels in diabetes patients receiving oral anti-diabetes therapy. Copyright © 2014 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

Phase I Trial of Anti-CS1 Monoclonal Antibody Elotuzumab in Combination With Bortezomib in the Treatment of Relapsed/Refractory Multiple Myeloma

PubMed Central

Jakubowiak, Andrzej J.; Benson, Don M.; Bensinger, William; Siegel, David S.D.; Zimmerman, Todd M.; Mohrbacher, Ann; Richardson, Paul G.; Afar, Daniel E.H.; Singhal, Anil K.; Anderson, Kenneth C.

2012-01-01

Purpose To evaluate the maximum-tolerated dose (MTD), safety, and efficacy of elotuzumab in combination with bortezomib in patients with relapsed or relapsed and refractory multiple myeloma (MM). Patients and Methods Elotuzumab (2.5, 5.0, 10, or 20 mg/kg intravenously [IV]) and bortezomib (1.3 mg/m2 IV) were administered on days 1 and 11 and days 1, 4, 8, and 11, respectively, in 21-day cycles by using a 3 + 3 dose-escalation design. Patients with stable disease or better after four cycles could continue treatment until disease progression or unexpected toxicity. Responses were assessed during each cycle by using European Group for Blood and Marrow Transplantation (EBMT) criteria. Results Twenty-eight patients with a median of two prior therapies were enrolled; three patients each received 2.5, 5.0, and 10 mg/kg of elotuzumab and 19 received 20 mg/kg (six during dose escalation and 13 during an expansion phase). No dose-limiting toxicities were observed during cycle 1 of the dose-escalation phase, and the MTD was not reached up to the maximum planned dose of 20 mg/kg. The most frequent grade 3 to 4 adverse events (AEs) were lymphopenia (25%) and fatigue (14%). Two elotuzumab-related serious AEs of chest pain and gastroenteritis occurred in one patient. An objective response (a partial response or better) was observed in 13 (48%) of 27 evaluable patients and in two (67%) of three patients refractory to bortezomib. Median time to progression was 9.46 months. Conclusion The combination of elotuzumab and bortezomib was generally well-tolerated and showed encouraging activity in patients with relapsed/refractory MM. PMID:22291084

Effect of 13q deletion on IL-6 production in patients with multiple myeloma: a hypothesis may hold true.

PubMed

Neemat, Kassem; Rania, Khalifa; Tarek, Mohamed; Hamdy, Abdel Azim

2014-01-01

Numerous studies have shown a correlation between 13q deletion and poor prognosis in multiple myeloma (MM), but the mechanisms are not fully understood. Earlier studies suggest that this lesion involves large segments or the entire long arm involving the retinoblastoma (Rb) gene. In myeloma, Rb gene is believed to down regulate interleukin-6 (IL-6) which plays a central role in the pathogenesis of MM. Therefore, it has been hypothesized that loss of the Rb gene might be associated with very high expression of IL-6 and subsequent bad prognosis. Hence this study evaluates IL-6 production in MM patients with and without 13q deletions and assesses their response to conventional and new therapeutic regimens. Forty MM patients and 20 matched controls were included in this study. Interphase fluorescence in situ hybridization (FISH) analysis was performed using LSI 13q14-specific probe. Serum levels of IL-6 were determined by ELISA. All patients received conventional chemotherapy. Refractory patients received other therapeutic regimens of Thalidomide or Bortezomib. Significant increase (p < 0.001) of IL-6 production was recorded in patients with a 13q deletion compared to patients with normal chromosome 13q status. These patients were also refractory to conventional chemotherapy but showed striking response to Thalidomide or Bortezomib. This study suggests that 13q deletions are associated with increased production of IL-6 in MM and this could be a possible cause of the associated bad prognosis. In addition, the results also show the potential to improve responses in patients with refractory MM with the introduction of novel therapies.

Impact of deploying multiple point-of-care tests with a 'sample first' approach on a sexual health clinical care pathway. A service evaluation.

PubMed

Harding-Esch, Emma M; Nori, Achyuta V; Hegazi, Aseel; Pond, Marcus J; Okolo, Olanike; Nardone, Anthony; Lowndes, Catherine M; Hay, Phillip; Sadiq, S Tariq

2017-09-01

To assess clinical service value of STI point-of-care test (POCT) use in a 'sample first' clinical pathway (patients providing samples on arrival at clinic, before clinician consultation). Specific outcomes were: patient acceptability; whether a rapid nucleic acid amplification test (NAAT) for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) could be used as a POCT in practice; feasibility of non-NAAT POCT implementation for Trichomonas vaginalis (TV) and bacterial vaginosis (BV); impact on patient diagnosis and treatment. Service evaluation in a south London sexual health clinic. Symptomatic female and male patients and sexual contacts of CT/NG-positive individuals provided samples for diagnostic testing on clinic arrival, prior to clinical consultation. Tests included routine culture and microscopy; CT/NG (GeneXpert) NAAT; non-NAAT POCTs for TV and BV. All 70 (35 males, 35 females) patients approached participated. The 'sample first' pathway was acceptable, with >90% reporting they were happy to give samples on arrival and receive results in the same visit. Non-NAAT POCT results were available for all patients prior to leaving clinic; rapid CT/NG results were available for only 21.4% (15/70; 5 males, 10 females) of patients prior to leaving clinic. Known negative CT/NG results led to two females avoiding presumptive treatment, and one male receiving treatment directed at possible Mycoplasma genitalium infection causing non-gonococcal urethritis. Non-NAAT POCTs detected more positives than routine microscopy (TV 3 vs 2; BV 24 vs 7), resulting in more patients receiving treatment. A 'sample first' clinical pathway to enable multiple POCT use was acceptable to patients and feasible in a busy sexual health clinic, but rapid CT/NG processing time was too long to enable POCT use. There is need for further development to improve test processing times to enable POC use of rapid NAATs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

The costs of fluid overload in the adult intensive care unit: is a small-volume infusion model a proactive solution?

PubMed Central

Child, Debra L; Cao, Zhun; Seiberlich, Laura E; Brown, Harold; Greenberg, Jordan; Swanson, Anne; Sewall, Martha R; Robinson, Scott B

2015-01-01

Purpose Fluid overload (FO) in critically ill patients remains a challenging clinical dilemma, and many continuous intravenous (IV) medications in the US are being delivered as a dilute solution, adding significantly to a patient’s daily intake. This study describes the costs and outcomes of FO in patients receiving multiple continuous infusions. Materials and methods A retrospective study was conducted using a hospital administrative database covering >500 US hospitals. An FO cohort included adult intensive care unit (ICU) patients with a central line receiving IV loop diuretics and 2+ continuous IV infusions on 50%+ of their ICU days; a directly matched non-FO cohort included patients without IV diuretic use. The primary outcome of the study was total hospitalization costs per visit. Additional outcomes were ICU costs, mortality, total and ICU length of stay (LOS), 30-day readmission rates, and ventilator use. Unadjusted descriptive analysis was performed using chi-squared or paired t-tests to compare outcomes between the two cohorts. Results A total of 63,974 patients were identified in each cohort. The total hospitalization cost per visit for the FO cohort was US$15,344 higher than the non-FO cohort (US$42,386 vs US$27,042), and the ICU cost for the FO cohort was US$5,243 higher than the non-FO cohort (US$10,902 vs US$5,659). FO patients had higher mortality (20% vs 16.8%), prolonged LOS (11.5 vs 8.0 days), longer ICU LOS (6.2 vs 3.6 days), higher risk of 30-day readmission (21.8% vs 21.3%), and ventilator usage (47.7% vs 28.3%) than the non-FO cohort (all P<0.05). Conclusion In patients receiving multiple continuous infusions, FO is associated with increased health care resources and costs. Maximally concentrating medications and proactively providing continuous medications in small-volume infusions (SVI) could be a potential solution to prevent iatrogenic FO in critically ill patients. Further prospective research is warranted to assess the impact of the SVI dispensing model on patient outcomes and health care costs. PMID:25548524

"Why Is This Patient Being Sent Here?": Communication from Urgent Care to the Emergency Department.

PubMed

Gardner, Rebekah; Choo, Esther K; Gravenstein, Stefan; Baier, Rosa R

2016-03-01

Despite patients' increasing use of urgent care centers (UCC), little is known about how urgent care clinicians communicate with the emergency department (ED). To assess ED clinicians' perceptions of the quality and consistency of communication when patients are referred from UCCs to EDs. Emergency medicine department chairs distributed a brief, electronic survey to a statewide sample of ED clinicians via e-mail. The survey included multiple-choice and free-text questions focused on types of communication desired and received from UCCs, types of test results available on transfer, and suggestions for improvement. Of 199 ED clinicians, 102 (51.3%) responded. More than four out of five respondents "somewhat" or "strongly agreed" that each of the following would be helpful: a telephone call, the reason for referral, specific concern, a copy of the chart, and UCC contact information. However, ED clinicians reported not consistently receiving these: only a fifth (21.6%) of clinicians reported receiving the specific concern for their last 5 patients transferred from a UCC, and 34.3% recalled receiving a copy of the chart. Overall, 54.9% reported receiving laboratory test results "often or almost always," 49.0% electrocardiograms, and 44.1% imaging reports. Qualitative analysis revealed several themes: incomplete data when patients are referred; barriers to discussion between ED and urgent care clinicians; and possible solutions to improve communication. Our findings highlight variation in communication from UCCs to EDs, indicating a need to improve communication standards and practices. We identify several potential ways to improve this clinical information hand-off. Copyright © 2016 Elsevier Inc. All rights reserved.

Tumor Cell Gene Expression Changes Following Short-term In vivo Exposure to Single Agent Chemotherapeutics are Related to Survival in Multiple Myeloma

PubMed Central

Burington, Bart; Barlogie, Bart; Zhan, Fenghuang; Crowley, John; Shaughnessy, John D.

2013-01-01

Changes in global gene expression patterns in tumor cells following in vivo therapy may vary by treatment and provide added or synergistic prognostic power over pretherapy gene expression profiles (GEP). This molecular readout of drug-cell interaction may also point to mechanisms of action/resistance. In newly diagnosed patients with multiple myeloma (MM), microarray data were obtained on tumor cells prior to and 48 hours after in vivo treatment using dexamethasone (n = 45) or thalidomide (n = 42); in the case of relapsed MM, microarray data were obtained prior to (n = 36) and after (n = 19) lenalidomide administration. Dexamethasone and thalidomide induced both common and unique GEP changes in tumor cells. Combined baseline and 48-hour changes in GEP in a subset of genes, many related to oxidative stress and cytoskeletal dynamics, were predictive of outcome in newly diagnosed MM patients receiving tandem transplants. Thalidomide-altered genes also changed following lenalidomide exposure and predicted event-free and overall survival in relapsed patients receiving lenalidomide as a single agent. Combined with baseline molecular features, changes in GEP following short-term single-agent exposure may help guide treatment decisions for patients with MM. Genes whose drug-altered expression were found to be related to survival may point to molecular switches related to response and/or resistance to different classes of drugs. PMID:18676754

The Esophageal Anastomotic Stricture Index (EASI) for the management of esophageal atresia.

PubMed

Sun, Linda Yi-Chan; Laberge, Jean-Martin; Yousef, Yasmine; Baird, Robert

2015-01-01

Anastomotic stricture is the most common complication following repair of esophageal atresia. An Esophageal Anastomotic Stricture Index (EASI) based on the postoperative esophagram may identify patients at high risk of stricture formation. Digital images of early postoperative esophagrams of patients undergoing EA repair from 2005 to 2013 were assessed. Demographics and outcomes including dilations were prospectively collected. Upper (U-EASI) and lower (L-EASI) pouch ratios were generated using stricture diameter divided by maximal respective pouch diameter. Score performances were evaluated with area under the receiver operator curves (AUC) and the Fisher's exact test for single and multiple (>3) dilatations. Interrater agreement was evaluated using the intraclass correlation coefficient (ICC). Forty-five patients had esophagrams analyzed; 28 (62%) required dilatation and 19 received >3 (42%). U-EASI and L-EASI ratios ranged from 0.17 to 0.70, with L-EASI outperforming the U-EASI as follows: L-EASI AUC: 0.66 for a single dilatation, 0.65 for >3 dilatations; U-EASI AUC: 0.56 for a single dilatation, 0.67 for >3 dilatations. All patients with an L-EASI ratio of ≤0.30 (n=8) required multiple esophageal dilatations, p=0.0006. The interrater ICC was 0.87. The EASI is a simple, reproducible tool to predict the development and severity of anastomotic stricture after esophageal atresia repair and can direct postoperative surveillance. Copyright © 2015 Elsevier Inc. All rights reserved.

Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol.

PubMed

Ray, Kausik K; Landmesser, Ulf; Leiter, Lawrence A; Kallend, David; Dufour, Robert; Karakas, Mahir; Hall, Tim; Troquay, Roland P T; Turner, Traci; Visseren, Frank L J; Wijngaard, Peter; Wright, R Scott; Kastelein, John J P

2017-04-13

In a previous study, a single injection of inclisiran, a chemically synthesized small interfering RNA designed to target PCSK9 messenger RNA, was found to produce sustained reductions in low-density lipoprotein (LDL) cholesterol levels over the course of 84 days in healthy volunteers. We conducted a phase 2, multicenter, double-blind, placebo-controlled, multiple-ascending-dose trial of inclisiran administered as a subcutaneous injection in patients at high risk for cardiovascular disease who had elevated LDL cholesterol levels. Patients were randomly assigned to receive a single dose of placebo or 200, 300, or 500 mg of inclisiran or two doses (at days 1 and 90) of placebo or 100, 200, or 300 mg of inclisiran. The primary end point was the change from baseline in LDL cholesterol level at 180 days. Safety data were available through day 210, and data on LDL cholesterol and proprotein convertase subtilisin-kexin type 9 (PCSK9) levels were available through day 240. A total of 501 patients underwent randomization. Patients who received inclisiran had dose-dependent reductions in PCSK9 and LDL cholesterol levels. At day 180, the least-squares mean reductions in LDL cholesterol levels were 27.9 to 41.9% after a single dose of inclisiran and 35.5 to 52.6% after two doses (P<0.001 for all comparisons vs. placebo). The two-dose 300-mg inclisiran regimen produced the greatest reduction in LDL cholesterol levels: 48% of the patients who received the regimen had an LDL cholesterol level below 50 mg per deciliter (1.3 mmol per liter) at day 180. At day 240, PCSK9 and LDL cholesterol levels remained significantly lower than at baseline in association with all inclisiran regimens. Serious adverse events occurred in 11% of the patients who received inclisiran and in 8% of the patients who received placebo. Injection-site reactions occurred in 5% of the patients who received injections of inclisiran. In our trial, inclisiran was found to lower PCSK9 and LDL cholesterol levels among patients at high cardiovascular risk who had elevated LDL cholesterol levels. (Funded by the Medicines Company; ORION-1 ClinicalTrials.gov number, NCT02597127 .).

Sirolimus alternative to blood transfusion as a life saver in blue rubber bleb nevus syndrome: A case report.

PubMed

Wang, Ke-Ling; Ma, Shu-Fang; Pang, Ling-Yu; Zhang, Meng-Na; Hu, Lin-Yan; Liu, Meng-Jia; Zou, Li-Ping

2018-02-01

Blue rubber bleb nevus syndrome (BRBNS) is a rare disease characterized by multiple venous malformations. The gastrointestinal bleeding and secondary iron deficiency anemia are the most common complications. There are currently no effective treatments for BRBNS. Here, we report a case of successful treatment with a small dose of sirolimus of a BRBN patient with a de novo gene mutation. A 12-year-old female was admitted to our hospital with multiple hemangiomas for 12 years. The patient often displayed melena; she recently received transfusion of 2 units of red blood cells once every 2 weeks. Multiple fist-sized hemangiomas were piled up on both sides and back of the neck, and were also noted on the arms, legs, chest, back, and on the tip of the tongue. The laboratory findings demonstrated severe anemia. Blood sample sequencing detected a heterozygous de novo mutation c.2545C > Tin the TEK gene. Based on these findings, final diagnosis of Blue rubber bleb nevus syndrome (BRBNS) was made. After the diagnosis, low-dose sirolimus was orally administered. The patient's hemoglobin was increased after treatment with sirolimus for 1 month. Since the initial treatment with sirolimus, she had not received any blood transfusions. The skin and mucosal hemangioma decreased significantly, and new digestive tract hemorrhage, muscle hematoma, or adverse drug reactions were not observed. we report a case of a mutation in exon 15 of the TEK gene leading to BRBN. It was successfully treated with a small dose of sirolimus as an alternative to blood transfusion in order to save the of BRBN patient's life.

Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting over multiple cycles of moderately or highly emetogenic chemotherapy.

PubMed

Rapoport, Bernardo; Schwartzberg, Lee; Chasen, Martin; Powers, Dan; Arora, Sujata; Navari, Rudolph; Schnadig, Ian

2016-04-01

Rolapitant, a novel neurokinin-1 receptor antagonist (RA), was shown to protect against delayed chemotherapy-induced nausea and vomiting (CINV) during the first cycle of moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) in randomized, double-blind trials. This analysis explored the efficacy and safety of rolapitant in preventing CINV over multiple cycles of MEC or HEC. Patients in one phase III MEC, one phase II HEC, and two phase III HEC clinical trials were randomized to receive oral rolapitant (180 mg) or placebo in combination with a 5-hydroxytryptamine type 3 RA and dexamethasone. Regardless of response in cycle 1, patients could continue the same antiemetic treatment for up to six cycles. On days 6-8 of each subsequent chemotherapy cycle, patients reported the incidence of emesis and/or nausea interfering with normal daily life. Post hoc analyses of pooled safety and efficacy data from the four trials were performed for cycles 2-6. Significantly more patients receiving rolapitant than control reported no emesis or interfering nausea (combined measure) in cycles 2 (p = 0.006), 3 (p < 0.001), 4 (p = 0.001), and 5 (p = 0.021). Over cycles 1-6, time-to-first emesis was significantly longer with rolapitant than with control (p < 0.001). The incidence of treatment-related adverse events during cycles 2-6 was similar in rolapitant (5.5%) and control (6.8%) arms. No cumulative toxicity was observed. Over multiple cycles of MEC or HEC, rolapitant provided superior CINV protection and reduced emesis and nausea interfering with daily life compared with control and remained well tolerated. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Gut microbiota in MS: possible influence of immunomodulators

PubMed Central

Cantarel, Brandi L.; Waubant, Emmanuelle; Chehoud, Christel; Kuczynski, Justin; DeSantis, Todd Z.; Warrington, Janet; Venkatesan, Arun; Fraser, Claire M.; Mowry, Ellen M.

2015-01-01

Objectives Differences in gut bacteria have been described in several autoimmune disorders. In this exploratory pilot study, we compared gut bacteria in multiple sclerosis patients and healthy controls and evaluated the influence of glatiramer acetate and vitamin D treatment on the microbiota. Methods Subjects were otherwise healthy white women with or without relapsing-remitting multiple sclerosis who were vitamin D insufficient. Multiple sclerosis patients were untreated or were receiving glatiramer acetate. Subjects collected stool at baseline and after 90 days of vitamin D3 (5,000 IU/day) supplementation. The abundance of operational taxonomic units was evaluated by hybridization of 16S rRNA to a DNA microarray. Results While there was overlap of gut bacterial communities, the abundance of some operational taxonomic units, including Faecalibacterium, was lower in multiple sclerosis patients. Glatiramer acetate-treated MS subjects showed differences in community composition compared to untreated subjects, including Bacteroidaceae, Faecalibacterium, Ruminococcus, Lactobacillaceae, Clostridium, and Other Clostridiales. Compared to the other groups, untreated multiple sclerosis subjects had an increase in the Akkermansia, Faecalibacterium, and Coprococcus genera after vitamin D supplementation. Conclusions While overall bacterial communities were similar, specific operational taxonomic units differed between healthy and multiple sclerosis subjects. Glatiramer acetate and vitamin D supplementation were associated with differences or changes in the microbiota. This study was exploratory, and larger studies are needed to confirm these preliminary results. PMID:25775034

Prevalence and factors leading to unemployment in MS (multiple sclerosis) patients undergoing immunomodulatory treatment in Poland

PubMed Central

Król, Joanna; Nocoń, Danuta; Kubaszewski, Przemysław; Rzepa, Teresa; Nowacki, Przemysław

2018-01-01

Multiple Sclerosis (MS) is the most common, primary neurogenic cause of disability among young adults. We investigated demographic and clinical factors associated with unemployment on the example of 150 MS patients receiving immunomodulatory treatment in Poland. This study was based on clinical evaluation and collection of self-reported questionnaires, with an attention to self-motivation, severe fatigue and moderate disability. Patients who were unemployed (40% of all patients) had a mean disease duration of almost 5 years. Older (p<0.001), less educated (p = 0.007) and more severely disabled patients (p<0,001) were most likely to be unemployed. Moderate disability (OR = 11.089 95% CI: 4.11–34.201, p<0,001), severe fatigue (OR = 2.625 95% CI: 1.02–6.901, p = 0,046) and lower level of self-motivation (KNS) (OR = 0.947, 95% CI: 0.896–0.006, p = 0.042) were independently associated with unemployment. PMID:29634737

Electroacupuncture reduces duration of postoperative ileus after laparoscopic surgery for colorectal cancer.

PubMed

Ng, Simon S M; Leung, Wing Wa; Mak, Tony W C; Hon, Sophie S F; Li, Jimmy C M; Wong, Cherry Y N; Tsoi, Kelvin K F; Lee, Janet F Y

2013-02-01

We investigated the efficacy of electroacupuncture in reducing the duration of postoperative ileus and hospital stay after laparoscopic surgery for colorectal cancer. We performed a prospective study of 165 patients undergoing elective laparoscopic surgery for colonic and upper rectal cancer, enrolled from October 2008 to October 2010. Patients were assigned randomly to groups that received electroacupuncture (n = 55) or sham acupuncture (n = 55), once daily from postoperative days 1-4, or no acupuncture (n = 55). The acupoints Zusanli, Sanyinjiao, Hegu, and Zhigou were used. The primary outcome was time to defecation. Secondary outcomes included postoperative analgesic requirement, time to ambulation, and length of hospital stay. Patients who received electroacupuncture had a shorter time to defecation than patients who received no acupuncture (85.9 ± 36.1 vs 122.1 ± 53.5 h; P < .001) and length of hospital stay (6.5 ± 2.2 vs 8.5 ± 4.8 days; P = .007). Patients who received electroacupuncture also had a shorter time to defecation than patients who received sham acupuncture (85.9 ± 36.1 vs 107.5 ± 46.2 h; P = .007). Electroacupuncture was more effective than no or sham acupuncture in reducing postoperative analgesic requirement and time to ambulation. In multiple linear regression analysis, an absence of complications and electroacupuncture were associated with a shorter duration of postoperative ileus and hospital stay after the surgery. In a clinical trial, electroacupuncture reduced the duration of postoperative ileus, time to ambulation, and postoperative analgesic requirement, compared with no or sham acupuncture, after laparoscopic surgery for colorectal cancer. ClinicalTrials.gov number, NCT00464425. Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

Ionizing diagnostic radiation exposure in patients with Crohn's disease: A retrospective study in a medium hospital and its predictive factors.

PubMed

Merino Rodríguez, Esther; Carrera Alonso, Elisa; Torralba González de Suso, Miguel; Sánchez da Silva, Marta; Martínez López, María; Sánchez-Tembleque Zarandona, María Dolores

2018-02-01

It is estimated that diagnostic medical radiation exposure may be responsable for 0.5-2% of cancers worldwide. Because of the relapsing course of Crohn's disease (CD), these patients usually requiere multiple ionizing radiation test. Stimating the total cumulative effective dose received by our CD patients and identifying the risk factors associated with the exposure to a cumulative effective dose due to the disease (CEED) > 50mSv. Retrospective cohort study (2001-2014). patients with CD. Risk dose >50mSv. For calculating de cumulative effective dose and the CEED, all the ionizing test done were taken. For identifying predictive factors for receiving a CEDD >50mSv, an univariate and a multivariate logistic regression analyses were performed using a >50mSv dose as dependent variable. Of the 267 patients analyzed the 24.6% of them received a cumulative effective dose > 50mSv and the 15.2% a CEED>50mSv. In the multivariate analysis, the following variables were identified as independent predictors associated with a CEDD >50mSv: major surgery (OR= 2.1; IC 95% [1.1-3.8]; p=.019) and severity (OR= 20.6; IC 95% [4.5-94.8]; p<.01). Patients with CD are more at risk of receiving risk CEED, so it would be advisable to monitor the cumulative effective dose received to anticipate our intervention in order to avoid reaching that dose. The ultrasounds and abdominal resonance enterography are alternatives in these cases, although their accessibility is limited in some centers. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Methylene blue is associated with poor outcomes in vasoplegic shock.

PubMed

Weiner, Menachem M; Lin, Hung-Mo; Danforth, Dennis; Rao, Srikar; Hosseinian, Leila; Fischer, Gregory W

2013-12-01

The purpose of this study was to investigate whether patients who received methylene blue as treatment for vasoplegia during cardiac surgery with cardiopulmonary bypass had decreased morbidity and mortality. Retrospective analysis. Single tertiary care university hospital. Adult patients who suffered from vasoplegia and underwent all types of cardiac surgery with cardiopulmonary bypass at this institution between 2007 and 2008. With IRB approval, the authors reviewed the charts of the identified patients and divided them into 2 groups based on whether they had received methylene blue. Two hundred twenty-six patients were identified who met the inclusion criteria for the study. Fifty-seven of these patients had received methylene blue for vasoplegia. The authors collected data on preoperative and intraoperative variables as well as outcomes. The patients who received methylene blue had higher rates of in-hospital mortality, a compilation of morbidities, as well as renal failure and hyperbilirubinemia. A multiple logistic regression model demonstrated that receiving methylene blue was an independent predictor of in-hospital mortality (p value: 0.007, OR 4.26, 95% CI: 1.49-12.12), compilation of morbidities (p value: 0.001, OR 4.80, 95% CI: 1.85-12.43), and hyperbilirubinemia (p value:<0.001, OR 6.58, 95% CI: 2.91-14.89). Using propensity score matching, the association with morbidity was again seen but the association with mortality was not found. The current study identified the use of methylene blue as treatment for vasoplegia to be independently associated with poor outcomes. While further studies are required, a thorough risk-benefit analysis should be applied before using methylene blue and, perhaps, it should be relegated to rescue use and not as first-line therapy. Copyright © 2013 Elsevier Inc. All rights reserved.

Characterization of skin reactions and pain reported by patients receiving radiation therapy for cancer at different sites

PubMed Central

Gewandter, Jennifer S.; Walker, Joanna; Heckler, Charles E.; Morrow, Gary R.; Ryan, Julie L.

2015-01-01

Background Skin reactions and pain are commonly reported side effects of radiation therapy (RT). Objective To characterize RT-induced symptoms according to treatment site subgroups and identify skin symptoms that correlate with pain. Methods A self-report survey, adapted from the MD Anderson Symptom Inventory and the McGill Pain Questionnaire, assessed RT-induced skin problems, pain, and specific skin symptoms. Wilcoxon Sign Ranked tests compared mean severity of pre- and post-RT pain and skin problems within each RT-site subgroup. Multiple linear regression (MLR) investigated associations between skin symptoms and pain. Results Survey respondents (n=106) were 58% female and on average 64 years old. RT sites included lung, breast, lower abdomen, head/neck/brain, and upper abdomen. Only patients receiving breast RT reported significant increases in treatment site pain and skin problems (p≤0.007). Patients receiving head/neck/brain RT reported increased skin problems (p<0.0009). MLR showed that post-RT skin tenderness and tightness were most strongly associated with post-RT pain (p=0.066 and p=0.122, respectively). Limitations Small sample size, exploratory analyses, and non-validated measure. Conclusions Only patients receiving breast RT reported significant increases in pain and skin problems at the RT site, while patients receiving head/neck/brain RT had increased skin problems, but not pain. These findings suggest that the severity of skin problems is not the only factor that contributes to pain, and interventions should be tailored to specifically target pain at the RT site, possibly by targeting tenderness and tightness. These findings should be confirmed in a larger sampling of RT patients. PMID:24645338

Clinical study evaluating the effect of bevacizumab on the severity of zoledronic acid-related osteonecrosis of the jaw in cancer patients.

PubMed

Lescaille, Géraldine; Coudert, Amélie E; Baaroun, Vanessa; Ostertag, Agnès; Charpentier, Emmanuel; Javelot, Marie-José; Tolédo, Rafael; Goudot, Patrick; Azérad, Jean; Berdal, Ariane; Spano, Jean-Philippe; Ruhin, Blandine; Descroix, Vianney

2014-01-01

This study aimed to evaluate the effect of bevacizumab (BVZ) on the severity of osteonecrosis of the jaw (ONJ) in a cohort of cancer patients treated with intravenous zoledronic acid (ZA). We reviewed 42 oncologic patients with ONJ between 2007 and 2010. Only patients with solids tumors and who had received ZA were included. Data analyses included age, sex, underlying disease, ZA and BVZ dosages, dental history and ONJ characteristics. Of the 42 ONJ patients treated with ZA, 10 also received BVZ. In the 10 ZA/BVZ patients, the mean duration of ZA treatment at the time of ONJ diagnosis was 12.4 months (±6.8), compared to 22.9 months (±4.8) in the 32 patients who received ZA only (p<0.05). Cox's model analysis of the delay to ONJ diagnosis confirmed the impact of BVZ on ONJ diagnosis. In the ZA/BVZ-treated group, 7 (70%) patients developed spontaneous osteonecrosis. Multiple logistic regression analysis showed that ZA/BVZ is associated with increased risk of developing spontaneous ONJ (OR 6.07; 95% CI, [1.3-28.2], p<0.05). And finally, the number of ONJ lesions was increased in the ZA/BVZ-treated group compared to the ZA group (p<0.01). Other clinical conditions as type of tumor (prostate, breast…), cancer severity or other chemotherapy drugs also could be involved in ONJ evolution. However, this study demonstrates for the first time the potential negative influence of BVZ on the incidence and severity of ONJ in patients receiving ZA. Within the study limits, our results suggest that combination ZA/BVZ treatment may possibly predispose to the development of spontaneous and earlier ONJ. © 2013.

Optimal initiation of Helicobacter pylori eradication in patients with peptic ulcer bleeding.

PubMed

Yoon, Hyuk; Lee, Dong Ho; Jang, Eun Sun; Kim, Jaihwan; Shin, Cheol Min; Park, Young Soo; Hwang, Jin-Hyeok; Kim, Jin-Wook; Jeong, Sook-Hayng; Kim, Nayoung

2015-02-28

To evaluate when Helicobacter pylori (H. pylori) eradication therapy (ET) should be started in patients with peptic ulcer bleeding (PUB). Clinical data concerning adults hospitalized with PUB were retrospectively collected and analyzed. Age, sex, type and stage of peptic ulcer, whether endoscopic therapy was performed or not, methods of H. pylori detection, duration of hospitalization, and specialty of the attending physician were investigated. Factors influencing the confirmation of H. pylori infection prior to discharge were determined using multiple logistic regression analysis. The H. pylori eradication rates of patients who received ET during hospitalization and those who commenced ET as outpatients were compared. A total of 232 patients with PUB were evaluated for H. pylori infection by histology and/or rapid urease testing. Of these patients, 53.7% (127/232) had confirmed results of H. pylori infection prior to discharge. In multivariate analysis, duration of hospitalization and ulcer stage were factors independently influencing whether H. pylori infection was confirmed before or after discharge. Among the patients discharged before confirmation of H. pylori infection, 13.3% (14/105) were lost to follow-up. Among the patients found to be H. pylori-positive after discharge, 41.4% (12/29) did not receive ET. There was no significant difference in the H. pylori eradication rate between patients who received ET during hospitalization and those who commenced ET as outpatients [intention-to-treat: 68.8% (53/77) vs 60% (12/20), P=0.594; per-protocol: 82.8% (53/64) vs 80% (12/15), P=0.723]. Because many patients with PUB who were discharged before H. pylori infection status was confirmed lost an opportunity to receive ET, we should confirm H. pylori infection and start ET prior to discharge.

Patients' level of satisfaction and self-reports of intention to comply following consultation with nurses and midwives with prescriptive authority: a cross-sectional survey.

PubMed

Drennan, Jonathan; Naughton, Corina; Allen, Deirdre; Hyde, Abbey; O'Boyle, Kathy; Felle, Patrick; Treacy, Margaret Pearl; Butler, Michelle

2011-07-01

Prescriptive authority for nurses and midwives was introduced in Ireland in 2007. This allows nurses and midwives who have completed a prescribing preparation programme to independently prescribe a wide-range of medications. To date little is known of patient outcomes such as satisfaction with the consultation process and intention to comply as a consequence of the introduction of nurse and midwife prescribing. There are four principal objectives within this study: (1) to measure the level of patients' satisfaction with education and advice received from a nurse or midwife with a prescribing remit; (2) to measure patients' satisfaction with the consultation process; (3) to measure patients' self-reports of their intention to comply with the prescriber's prescription and advice; and (4) to identify the variables that predict patients' intention to comply with the prescription and advice provided by a nurse or midwife with prescriptive authority. Cross-sectional descriptive survey. A total of one hundred and forty respondents completed the survey. Respondents consisted of adult patients who had received a prescription from a nurse prescriber in a general hospital, women who had received a prescription from a midwife in a maternity hospital and parents whose child received a prescription from a nurse in a children's hospital. Instruments used to measure patient outcomes included the Consultation Satisfaction Questionnaire (CSQ) and the compliance intent subscale of the Medical Interview Satisfaction Scale (MISS). A linear multiple regression model was performed to identify the variables that predicted patients' intent to comply. Patients and parents surveyed were highly satisfied with the care they received from nurses and midwives with prescriptive authority. Respondents also reported that they received comprehensive education and advice. Predictors of compliance intent included patient satisfaction with the time spent with the nurse or midwife during the prescribing consultation, overall satisfaction with the consultation process and patients' health status. Extending a prescribing remit to nurses and midwives has been an effective addition to the provision of health care. Providing patients with time to address their questions and concerns during the consultation process impacts positively on patient outcomes and develops a philosophy of concordance between the patient and nurse/midwife prescriber. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Multiple myeloma and HIV infection: report of 3 cases].

PubMed

Elira Dokekias, A; Moutschen, M; Purhuence, M F; Malanda, F; Moyikoua, A

2004-02-01

HIV infection rages at the endemic state in Sub Saharan African and especially in Congo Brazzaville. We report the observation of three female patients infected with HIV and developing multiple myeloma. The three patients were treated at the University hospital of Brazzaville between 2000 and 2002. In two cases multiple myeloma was discovered after the diagnosis of HIV infection. In the other case, the diagnosis of HIV infection was posterior to the occurrence of multiple myeloma. HIV infection was symptomatic in two cases who received consequently antiviral treatment. Multiple myeloma was diagnosed at an advanced stage in the three cases. The paraprotein was an IgG in two cases and an IgA in the other one. The CD4 counts before treatment were around 200/mm3 in two cases and within normal limits in the third case. Viral load was not measured. VMCP and VAMCP regimens were administered without major complications and under anti-infectious prophylaxis. The follow-up is still insufficient to assess the medium-term evolution and to determine the prognosis of multiple myeloma. The description of these three cases confirms the involvement of HIV in B cell lymphoma genesis.

Upfront plerixafor plus G-CSF versus cyclophosphamide plus G-CSF for stem cell mobilization in multiple myeloma: efficacy and cost analysis study.

PubMed

Afifi, S; Adel, N G; Devlin, S; Duck, E; Vanak, J; Landau, H; Chung, D J; Lendvai, N; Lesokhin, A; Korde, N; Reich, L; Landgren, O; Giralt, S; Hassoun, H

2016-04-01

Cyclophosphamide plus G-CSF (C+G-CSF) is one of the most widely used stem cell (SC) mobilization regimens for patients with multiple myeloma (MM). Plerixafor plus G-CSF (P+G-CSF) has demonstrated superior SC mobilization efficacy when compared with G-CSF alone and has been shown to rescue patients who fail mobilization with G-CSF or C+G-CSF. Despite the proven efficacy of P+G-CSF in upfront SC mobilization, its use has been limited, mostly due to concerns of high price of the drug. However, a comprehensive comparison of the efficacy and cost effectiveness of SC mobilization using C+G-CSF versus P+G-CSF is not available. In this study, we compared 111 patients receiving C+G-CSF to 112 patients receiving P+G-CSF. The use of P+G-CSF was associated with a higher success rate of SC collection defined as ⩾5 × 10(6) CD34+ cells/kg (94 versus 83%, P=0.013) and less toxicities. Thirteen patients in the C+G-CSF arm were hospitalized owing to complications while none in the P+G-CSF group. C+G-CSF was associated with higher financial burden as assessed using institutional-specific costs and charges (P<0.001) as well as using Medicare reimbursement rates (P=0.27). Higher rate of hospitalization, increased need for salvage mobilization, and increased G-CSF use account for these differences.

Peritoneal small solute transport rate is related to the malnutrition inflammation score in peritoneal dialysis patients.

PubMed

Sezer, Siren; Elsurer, Rengin; Afsar, Baris; Arat, Zubeyde; Ozdemir, Nurhan F; Haberal, Mehmet

2007-01-01

A high peritoneal membrane transport status and peritoneal albumin leakage are determinants of morbidity and mortality in patients receiving continuous ambulatory peritoneal dialysis. In this study, we analyzed the relationship between the malnutrition inflammation score, peritoneal transport status, and 24-hour peritoneal albumin leakage in patients receiving peritoneal dialysis. Sixty-six patients receiving peritoneal dialysis (male-female ratio 30/36; age 46.2 +/- 14.1 years; mean duration of peritoneal dialysis 32.4 +/- 23.9 months) who had experienced no attacks of peritonitis within the prior 6 months were included. The malnutrition inflammation score was positively correlated with the serum C-reactive protein concentration, dialysate/plasma creatinine ratio, and 24-hour peritoneal albumin leakage. Triceps and biceps skinfold thicknesses and serum concentrations of prealbumin, total cholesterol, and triglyceride were negatively correlated with the malnutrition inflammation score. Multiple linear regression analysis showed that the malnutrition inflammation score was independently associated with the dialysate/plasma creatinine ratio (p = 0.039) and 24-hour peritoneal albumin amount (p = 0.005). High peritoneal transport status and peritoneal albumin leakage are significantly associated with the malnutrition inflammation score. (c) 2007 S. Karger AG, Basel

Multidisciplinary decision-making on chemotherapy for colorectal cancer: an age-based comparison.

PubMed

Hamaker, Marije E; van Rixtel, Bert; Thunnissen, Peter; Oberndorff, Ardi H; Smakman, Niels; Ten Bokkel Huinink, Daan

2015-05-01

With the ageing of society, optimising decision-making for older patients with cancer becomes increasingly important. A first step is awareness of current clinical practice. We analysed how treatment decisions regarding chemotherapy for older and younger patients with colorectal cancer are currently being made by the multidisciplinary team, the oncologist and the patient. A total of 316 patients with colorectal cancer (median age 68.3 years), discussed at the multidisciplinary gastrointestinal oncology team meetings between 2010 and 2013, were reviewed to select patients for whom guidelines recommended chemotherapy. Multidisciplinary decision-making and subsequent clinical course were extracted from medical files. The multidisciplinary team recommended chemotherapy in 97% of younger patients treated with curative intent, compared to 65% of older patients; 86% of younger patients and 42% of older patients subsequently received chemotherapy. In a palliative setting, the multidisciplinary team recommended chemotherapy in 98% of younger and 69% of older patients and 81% and 45%, respectively, subsequently received this treatment. In addition to comorbidity and the patient's physical condition, chronological age was an important reason for withholding chemotherapy. When older patients did receive chemotherapy, reduced intensity regimens were often effectuated. Multidisciplinary decision-making regarding chemotherapy for older patients with colorectal cancer is still frequently based on clinical impressions, preconceptions or chronological age alone. Rather, treatment decisions should be made after thorough evaluation of the patient's health status across multiple domains, either by a geriatrician or within the oncology team itself. Given the preference-sensitive nature of chemotherapy decisions in the elderly, shared decision-making should be strived for whenever possible. Copyright © 2015 Elsevier Inc. All rights reserved.

Desire for Information in the Elderly: Interactions with Patients, Family, and Physicians.

PubMed

Gironés, Regina

2015-12-01

Lung cancer chemotherapy decisions in patients≥70 years old are complex. To assess the modes of communication with older lung cancer patients, we prospectively collected data. We assessed patients' level of knowledge about diagnosis and prognosis. Eighty-three patients diagnosed with lung cancer from January 2006 to February 2008 were recruited from a single center. Logistic regression and multiple imputation methods were used to assess associations between patient information and independent variables. Families received the diagnosis of lung cancer (92.8%). Family was more protective when the patients were elderly (p 0.036), depressed (p 0.054), had dementia (p 0.03), had poor performance status (p 0.03), or complied with frailty criteria (p 0.014). Physicians who gave cancer diagnoses were not oncologists and they usually gave cancer diagnosis preferably to family members. Only 27.7% of patients were informed that they had tumors. A 73.5% of patients actively solicited information; however, elderly and frail patients tended to do so less. A large proportion of elderly lung cancer patients do not receive adequate information about their disease prior to contact with oncologists. However, they do actively ask for information and speak about cancer with oncologists.

Empirical-Based Typology of Health Care Utilization by Medicare Eligible Veterans.

PubMed

Vaughan Sarrazin, Mary; Rosenthal, Gary E; Turvey, Carolyn L

2018-06-12

Up to 70 percent of patients who receive care through Veterans Health Administration (VHA) facilities also receive care from non-VA providers. Using applied classification techniques, this study sought to improve understanding of how elderly VA patients use VA services and complementary use of non-VA care. The study included 1,721,900 veterans age 65 and older who were enrolled in VA and Medicare during 2013 with at least one VA encounter during 2013. Outpatient and inpatient encounters and medications received in VA were classified, and mutually exclusive patient subsets distinguished by patterns of VA service use were derived empirically using latent class analysis (LCA). Patient characteristics and complementary use of non-VA care were compared by patient subset. Five patterns of VA service use were identified that were distinguished by quantity of VA medical and specialty services, medication complexity, and mental health services. Low VA Medical users tend to be healthier and rely on non-VA services, while High VA users have multiple high cost illnesses and concentrate their care in the VA. VA patients distinguished by patterns of VA service use differ in illness burden and the use of non-VA services. This information may be useful for framing efforts to optimize access to care and care coordination for elderly VA patients. © Health Research and Educational Trust.

Comparison of primary and reoperative surgery in patients with Crohns disease.

PubMed

Heimann, T M; Greenstein, A J; Lewis, B; Kaufman, D; Heimann, D M; Aufses, A H

1998-04-01

This study was performed to determine the clinical results of patients with Crohns disease who require surgical resection. The outcome of patients undergoing initial surgery was compared with those having reoperation. One hundred sixty-four patients undergoing intestinal resection for Crohns disease at The Mount Sinai Hospital from 1976 to 1989 were studied prospectively. The mean duration of follow-up was 72 months. Ninety patients (55%) underwent initial intestinal resection whereas 74 patients (45%) underwent reoperation for recurrent disease. Patients undergoing reoperation were older (33.4 vs. 38.7 years), had longer durations of disease (8.7 vs. 15.2 years), had shorter resections (60 vs. 46 cm), and were more likely to require ileostomy. Forty-seven percent of the patients with multiple previous resections required an ileostomy. This group also received a mean of 2.3 U blood in the perioperative period and showed a trend to increased symptomatic recurrence (49% vs. 71% at 5 years). Patients with Crohns disease undergoing first and second reoperation have outcomes similar to those in patients undergoing primary resection. Patients requiring multiple reoperations are more likely to require blood transfusions and permanent ileostomy and to show a greater trend to early symptomatic recurrence.

Effect of time to infusion of autologous stem cells (24 vs. 48 h) after high-dose melphalan in patients with multiple myeloma.

PubMed

Talamo, Giampaolo; Rakszawski, Kevin L; Rybka, Witold B; Dolloff, Nathan G; Malysz, Jozef; Berno, Tamara; Zangari, Maurizio

2012-08-01

High-dose melphalan (HD-Mel) is considered the current standard of care among the preparative regimens used in autologous peripheral blood stem cell transplantation (SCT) for multiple myeloma (MM), but optimal time and schedule of administration is not defined. We retrospectively analyzed outcomes and toxicities of HD-Mel administered on day -2 vs. day -1 before autologous stem cells infusion. A total of 138 consecutive MM patients treated at Penn State Hershey Cancer Institute between 2007 and 2010 were included in this study. No difference in time to hematopoietic recovery, common SCT-related toxicities, and clinical outcomes was seen between patients who received HD-Mel on day -2 (group A, n = 47), and those who received it on day -1 (group B, n = 91). Prompt and full hematopoietic recovery occurred even when stem cells were infused between 8 and 24 h after completion of chemotherapy. In the absence of prospective and randomized data, we conclude that a single I.V. infusion of HD-Mel on day -1 is a safe and effective practice, and the so-called 'day of rest' before the transplant appears not to be necessary. © 2012 John Wiley & Sons A/S.

Advantages with prophylactic PEG-rhG-CSF versus rhG-CSF in breast cancer patients receiving multiple cycles of myelosuppressive chemotherapy: an open-label, randomized, multicenter phase III study.

PubMed

Xie, Jie; Cao, Jun; Wang, Jing-Fen; Zhang, Bai-Hong; Zeng, Xiao-Hua; Zheng, Hong; Zhang, Yang; Cai, Li; Wu, Yu-Dong; Yao, Qiang; Zhao, Xiao-Chun; Mao, Wei-Dong; Jiang, Ai-Mei; Chen, Shao-Shui; Yang, Shun-E; Wang, Shu-Sen; Wang, Jian-Hong; Pan, Yue-Yin; Ren, Bi-Yong; Chen, Yan-Ju; Ouyang, Li-Zhi; Lei, Kai-Jian; Gao, Jing-Hua; Huang, Wen-He; Huang, Zhan; Shou, Tao; He, Yan-Ling; Cheng, Jing; Sun, Yang; Li, Wei-Ming; Cui, Shu-de; Wang, Xin; Rao, Zhi-Guo; Ma, Hu; Liu, Wei; Wu, Xue-Yong; Shen, Wei-Xi; Cao, Fei-Lin; Xiao, Ze-Min; Wu, Biao; Tian, Shu-Yan; Meng, Dong; Shen, Peng; Wang, Bi-Yun; Wang, Zhonghua; Zhang, Jian; Wang, Leiping; Hu, Xi-Chun

2018-04-01

PEG-rhG-CSF reduces neutropenia and improves chemotherapy safety. In China's registration trial (CFDA: 2006L01305), we assessed its efficacy and safety against rhG-CSF, and prospectively explored its value over multiple cycles of chemotherapy. In this open-label, randomized, multicenter phase 3 study, breast cancer patients (n = 569) were randomized to receive PEG-rhG-CSF 100 µg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 µg/kg/d after chemotherapy. The primary endpoints were the incidence and duration of grade 3/4 neutropenia during cycle 1. Secondary endpoints included the incidence and duration of grade 3/4 neutropenia during cycles 2-4, the incidence of febrile neutropenia, and the safety. A once-per-cycle PEG-rhG-CSF at either 100 µg/kg or 6 mg was not different from daily injections of rhG-CSF for either incidence or duration of grade 3/4 neutropenia. Interestingly, a substantial difference was noted during cycle 2, and the difference became bigger over cycles 3-4, reaching a statistical significance at cycle 4 in either incidence (P = 0.0309) or duration (P = 0.0289) favoring PEG-rhG-CSF. A significant trend toward a lower incidence of all-grade adverse events was noted at 129 (68.98%), 142 (75.53%), and 160 (82.47%) in the PEG-rhG-CSF 100 µg/kg and 6 mg and rhG-CSF groups, respectively (P = 0.0085). The corresponding incidence of grade 3/4 drug-related adverse events was 2/187 (1.07%), 1/188 (0.53%), and 8/194 (4.12%), respectively (P = 0.0477). Additionally, PFS in metastatic patients preferred PEG-rhG-CSF to rhG-CSF despite no significance observed by Kaplan-Meier analysis (n = 49, P = 0.153). PEG-rhG-CSF is a more convenient and safe formulation and a more effective prophylactic measure in breast cancer patients receiving multiple cycles of chemotherapy.

Localized primary gastrointestinal diffuse large B cell lymphoma received a surgical approach: an analysis of prognostic factors and comparison of staging systems in 101 patients from a single institution.

PubMed

Zhang, Shengting; Wang, Li; Yu, Dong; Shen, Yang; Cheng, Shu; Zhang, Li; Qian, Ying; Shen, Zhixiang; Li, Qinyu; Zhao, Weili

2015-08-15

Diffuse large B cell lymphoma (DLBCL) represents the most common histological subtype of primary gastrointestinal lymphoma and is a heterogeneous group of disease. Prognostic characterization of individual patients is an essential prerequisite for a proper risk-based therapeutic choice. Clinical and pathological prognostic factors were identified, and predictive value of four previously described prognostic systems were assessed in 101 primary gastrointestinal DLBCL (PG-DLBCL) patients with localized disease, including Ann Arbor staging with Musshoff modification, International Prognostic Index (IPI), Lugano classification, and Paris staging system. Univariate factors correlated with inferior survival time were clinical parameters [age>60 years old, multiple extranodal/gastrointestinal involvement, elevated serum lactate dehydrogenase and β2-microglobulin, and decreased serum albumin], as well as pathological parameters (invasion depth beyond serosa, involvement of regional lymph node or adjacent tissue, Ki-67 index, and Bcl-2 expression). Major independent variables of adverse outcome indicated by multivariate analysis were multiple gastrointestinal involvement. In patients unfit for Rituximab but received surgery, radical surgery significantly prolonged the survival time, comparing with alleviative surgery. Addition of Rituximab could overcome the negative prognostic effect of alleviative surgery. Among the four prognostic systems, IPI and Lugano classification clearly separated patients into different risk groups. IPI was able to further stratify the early-stage patients of Lugano classification into groups with distinct prognosis. Radical surgery might be proposed for the patients unfit for Rituximab treatment, and a combination of clinical and pathological staging systems was more helpful to predict the disease outcome of PG-DLBCL patients.

Multicenter, Phase I, Dose-Escalation Trial of Lenalidomide Plus Bortezomib for Relapsed and Relapsed/Refractory Multiple Myeloma

PubMed Central

Richardson, Paul G.; Weller, Edie; Jagannath, Sundar; Avigan, David E.; Alsina, Melissa; Schlossman, Robert L.; Mazumder, Amitabha; Munshi, Nikhil C.; Ghobrial, Irene M.; Doss, Deborah; Warren, Diane L.; Lunde, Laura E.; McKenney, Mary; Delaney, Carol; Mitsiades, Constantine S.; Hideshima, Teru; Dalton, William; Knight, Robert; Esseltine, Dixie-Lee; Anderson, Kenneth C.

2009-01-01

Purpose Lenalidomide and bortezomib are active in relapsed and relapsed/refractory multiple myeloma (MM). In preclinical studies, lenalidomide sensitized MM cells to bortezomib and dexamethasone. This phase I, dose-escalation study (ie, NCT00153933) evaluated safety and determined the maximum-tolerated dose (MTD) of lenalidomide plus bortezomib in patients with relapsed or with relapsed and refractory MM. Patients and Methods Patients received lenalidomide 5, 10, or 15 mg/d on days 1 through 14 and received bortezomib 1.0 or 1.3 mg/m2 on days 1, 4, 8, and 11 of 21-day cycles. Dexamethasone (20mg or 40 mg on days 1, 2, 4, 5, 8, 9, 11, and 12) was added for progressive disease after two cycles. Primary end points were safety and MTD determination. Results Thirty-eight patients were enrolled across six dose cohorts. The MTD was lenalidomide 15 mg/d plus bortezomib 1.0 mg/m2. Dose-limiting toxicities (n = 1 for each) were grade 3 hyponatremia and herpes zoster reactivation and grade 4 neutropenia. The most common treatment-related, grades 3 to 4 toxicities included reversible neutropenia, thrombocytopenia, anemia, and leukopenia. Among 36 response-evaluable patients, 61% (90% CI, 46% to 75%) achieved minimal response or better. Among 18 patients who had dexamethasone added, 83% (90% CI, 62% to 95%) achieved stable disease or better. Median overall survival was 37 months. Conclusion Lenalidomide plus bortezomib was well tolerated and showed promising activity with durable responses in patients with relapsed and relapsed/refractory MM, including patients previously treated with lenalidomide, bortezomib, and/or thalidomide. The combination of lenalidomide, bortezomib, and dexamethasone is being investigated in a phase II study in this setting and in newly diagnosed MM. PMID:19786667

Outcome of hematopoietic cell transplantation for DNA double-strand break repair disorders.

PubMed

Slack, James; Albert, Michael H; Balashov, Dmitry; Belohradsky, Bernd H; Bertaina, Alice; Bleesing, Jack; Booth, Claire; Buechner, Jochen; Buckley, Rebecca H; Ouachée-Chardin, Marie; Deripapa, Elena; Drabko, Katarzyna; Eapen, Mary; Feuchtinger, Tobias; Finocchi, Andrea; Gaspar, H Bobby; Ghosh, Sujal; Gillio, Alfred; Gonzalez-Granado, Luis I; Grunebaum, Eyal; Güngör, Tayfun; Heilmann, Carsten; Helminen, Merja; Higuchi, Kohei; Imai, Kohsuke; Kalwak, Krzysztof; Kanazawa, Nubuo; Karasu, Gülsün; Kucuk, Zeynep Y; Laberko, Alexandra; Lange, Andrzej; Mahlaoui, Nizar; Meisel, Roland; Moshous, D; Muramatsu, Hideki; Parikh, Suhag; Pasic, Srdjan; Schmid, Irene; Schuetz, Catharina; Schulz, Ansgar; Schultz, Kirk R; Shaw, Peter J; Slatter, Mary A; Sykora, Karl-Walter; Tamura, Shinobu; Taskinen, Mervi; Wawer, Angela; Wolska-Kuśnierz, Beata; Cowan, Morton J; Fischer, Alain; Gennery, Andrew R

2018-01-01

Rare DNA breakage repair disorders predispose to infection and lymphoreticular malignancies. Hematopoietic cell transplantation (HCT) is curative, but coadministered chemotherapy or radiotherapy is damaging because of systemic radiosensitivity. We collected HCT outcome data for Nijmegen breakage syndrome, DNA ligase IV deficiency, Cernunnos-XRCC4-like factor (Cernunnos-XLF) deficiency, and ataxia-telangiectasia (AT). Data from 38 centers worldwide, including indication, donor, conditioning regimen, graft-versus-host disease, and outcome, were analyzed. Conditioning was classified as myeloablative conditioning (MAC) if it contained radiotherapy or alkylators and reduced-intensity conditioning (RIC) if no alkylators and/or 150 mg/m 2 fludarabine or less and 40 mg/kg cyclophosphamide or less were used. Fifty-five new, 14 updated, and 18 previously published patients were analyzed. Median age at HCT was 48 months (range, 1.5-552 months). Twenty-nine patients underwent transplantation for infection, 21 had malignancy, 13 had bone marrow failure, 13 received pre-emptive transplantation, 5 had multiple indications, and 6 had no information. Twenty-two received MAC, 59 received RIC, and 4 were infused; information was unavailable for 2 patients. Seventy-three of 77 patients with DNA ligase IV deficiency, Cernunnos-XLF deficiency, or Nijmegen breakage syndrome received conditioning. Survival was 53 (69%) of 77 and was worse for those receiving MAC than for those receiving RIC (P = .006). Most deaths occurred early after transplantation, suggesting poor tolerance of conditioning. Survival in patients with AT was 25%. Forty-one (49%) of 83 patients experienced acute GvHD, which was less frequent in those receiving RIC compared with those receiving MAC (26/56 [46%] vs 12/21 [57%], P = .45). Median follow-up was 35 months (range, 2-168 months). No secondary malignancies were reported during 15 years of follow-up. Growth and developmental delay remained after HCT; immune-mediated complications resolved. RIC HCT resolves DNA repair disorder-associated immunodeficiency. Long-term follow-up is required for secondary malignancy surveillance. Routine HCT for AT is not recommended. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Healthcare resource utilization among patients with relapsed multiple myeloma in the UK, France, and Italy.

PubMed

Gonzalez-McQuire, Sebastian; Yong, Kwee; Leleu, Henri; Mennini, Francesco S; Flinois, Alain; Gazzola, Carlotta; Schoen, Paul; Campioni, Marco; DeCosta, Lucy; Fink, Leah

2018-05-01

To assess the real-world healthcare resource utilization (HRU) and costs associated with different treatment regimens used in the management of patients with relapsed multiple myeloma in the UK, France, and Italy. Retrospective medical chart review of characteristics, time to progression, level of response, HRU during treatment, and adverse events (AEs). Data collection started on June 1, 2015 and was completed on July 15, 2015. In the 3 months before record abstraction, eligible patients had either disease progression after receiving one of their country's most commonly prescribed regimens or had received the best supportive care and died. Costs were calculated based on HRU and country-specific diagnosis-related group and/or unit reference costs, amongst other standard resources. Physicians provided data for 1,282 patients (387 in the UK, 502 in France, 393 in Italy) who met the inclusion criteria. Mean [median] total healthcare costs associated with a single line of treatment were €51,717 [35,951] in the UK, €37,009 [32,538] for France, and €34,496 [42,342] for Italy, driven largely by anti-myeloma medications costs (contributing 95.0%, 90.0%, and 94.2% of total cost, respectively). During active treatment, the highest costs were associated with lenalidomide- and pomalidomide-based regimens. Mean cost per month was lowest for patients achieving a very good partial response or better. Unscheduled events (i.e. not considered part of routine management, whether or not related to multiple myeloma, such as unscheduled hospitalization, AEs, fractures) accounted for 1-9% of total costs and were highest for bendamustine. The use of retrospective data means that clinical practice (e.g. use of medical procedures, evaluation of treatment response) is not standardized across participating countries/centers, and some data (e.g. low-grade AEs) may be incomplete or differently adjudicated/reported. The centers involved may not be fully representative of national practice. Drug costs are the main contributor to total HRU costs associated with multiple myeloma. The duration of active treatment may influence the average total costs, as well as response, associated with a single line of therapy. Improved treatment outcomes, and reductions in unscheduled events and concomitant medication use may, therefore, reduce the overall HRU and related costs of care in multiple myeloma.

Testicular carcinoma: a study of knowledge, awareness, and practice of testicular self-examination in male soldiers and military physicians.

PubMed

Singer, A J; Tichler, T; Orvieto, R; Finestone, A; Moskovitz, M

1993-10-01

Multiple-choice questionnaires devised to evaluate knowledge and awareness of testicular carcinoma and the practice of testicular self-examination (TSE) were distributed to 717 male soldiers and 200 military physicians in the Israeli army. Twenty-one percent of the soldiers had received explanations about the importance of TSE; 16% actually received instruction on TSE; yet only 2% practiced TSE regularly. Seventy percent of physicians had been taught how to examine testicles, but only 10% of physicians examined testicles in their routine physical exams. TSE was practiced most frequently among soldiers who had received instruction in the technique. Physicians should encourage their young male patients to practice TSE.

Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma.

PubMed

Dimopoulos, Meletios A; Oriol, Albert; Nahi, Hareth; San-Miguel, Jesus; Bahlis, Nizar J; Usmani, Saad Z; Rabin, Neil; Orlowski, Robert Z; Komarnicki, Mieczyslaw; Suzuki, Kenshi; Plesner, Torben; Yoon, Sung-Soo; Ben Yehuda, Dina; Richardson, Paul G; Goldschmidt, Hartmut; Reece, Donna; Lisby, Steen; Khokhar, Nushmia Z; O'Rourke, Lisa; Chiu, Christopher; Qin, Xiang; Guckert, Mary; Ahmadi, Tahamtan; Moreau, Philippe

2016-10-06

Daratumumab showed promising efficacy alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed or refractory multiple myeloma. In this phase 3 trial, we randomly assigned 569 patients with multiple myeloma who had received one or more previous lines of therapy to receive lenalidomide and dexamethasone either alone (control group) or in combination with daratumumab (daratumumab group). The primary end point was progression-free survival. At a median follow-up of 13.5 months in a protocol-specified interim analysis, 169 events of disease progression or death were observed (in 53 of 286 patients [18.5%] in the daratumumab group vs. 116 of 283 [41.0%] in the control group; hazard ratio, 0.37; 95% confidence interval [CI], 0.27 to 0.52; P<0.001 by stratified log-rank test). The Kaplan-Meier rate of progression-free survival at 12 months was 83.2% (95% CI, 78.3 to 87.2) in the daratumumab group, as compared with 60.1% (95% CI, 54.0 to 65.7) in the control group. A significantly higher rate of overall response was observed in the daratumumab group than in the control group (92.9% vs. 76.4%, P<0.001), as was a higher rate of complete response or better (43.1% vs. 19.2%, P<0.001). In the daratumumab group, 22.4% of the patients had results below the threshold for minimal residual disease (1 tumor cell per 10 5 white cells), as compared with 4.6% of those in the control group (P<0.001); results below the threshold for minimal residual disease were associated with improved outcomes. The most common adverse events of grade 3 or 4 during treatment were neutropenia (in 51.9% of the patients in the daratumumab group vs. 37.0% of those in the control group), thrombocytopenia (in 12.7% vs. 13.5%), and anemia (in 12.4% vs. 19.6%). Daratumumab-associated infusion-related reactions occurred in 47.7% of the patients and were mostly of grade 1 or 2. The addition of daratumumab to lenalidomide and dexamethasone significantly lengthened progression-free survival among patients with relapsed or refractory multiple myeloma. Daratumumab was associated with infusion-related reactions and a higher rate of neutropenia than the control therapy. (Funded by Janssen Research and Development; POLLUX ClinicalTrials.gov number, NCT02076009 .).

[Survival of patients with primary central nervous system diffuse large B-cell lymphoma: impact of gene aberrations and protein overexpression of bcl-2 and C-MYC, and selection of chemotherapy regimens].

PubMed

Yin, W J; Zhu, X; Yang, H Y; Sun, W Y; Wu, M J

2018-01-08

Objective: To investigate the impact of clinicopathological features, gene rearrangements and protein expression of bcl-6, bcl-2, C-MYC and chemotherapy regime on the prognosis of patients with primary central nervous system diffuse large B-cell lymphoma (PCNS-DLBCL). Methods: Thirty-three cases of PCNS-DLBCL diagnosed from January 2006 to December 2016 at Zhejiang Cancer Hospital were collected. The expression of CD10, bcl-6, bcl-2, MUM1 and MYC were detected by immunohistochemical staining (IHC). The presence of EB virus was detected by in situ hybridization(EBER). Copy number variation (ICN) and translocation status of bcl-6, bcl-2 and C-MYC genes were detected by fluorescence in situ hybridization (FISH). The relationship between the above indexes and the prognosis was analyzed by univariate, bivariate survival analysis and multiple Cox hazard regression analysis. Results: The study included 33 patients of PCNS-DLBCL, without evidence of primary or secondary immunodeficient disease. Male to female ratio was 1.36∶1.00, and the average age was 56 years. Twenty cases had single lesion while 13 had multiple lesions. Deep brain involvement was seen in 12 cases. All patients underwent partial or total tumor resection. Five patients received whole brain post-surgery radiotherapy, nine patients received high-dose methotrexate (HD-MTX) based chemotherapy, and 12 patients received whole-brain radiotherapy combined with HD-MTX based chemotherapy. Severn patients received no further treatment and rituximab was used in 8 patients. According to the Hans model, 27 cases were classified as non-GCB subtypes (81.8%). Bcl-2 was positive in 25 cases (75.8%, 25/33) and highly expressed in 8 (24.2%). MYC was positive in 12 cases (36.4%) and double expression of bcl-2 and MYC was seen in 6 cases. EBER positive rate was 10.0%(3/30), all of which had multiple lesions. Two bcl-6 gene translocations and 3 amplifications were found in 28 patients. Two translocations, 3 ICN or with both bcl-2 gene translocation and ICN were found in 30 patients. Four ICNs of C-MYC gene were found in 28 patients. Elevated protein in cerebrospinal fluid (CSF) was found in 13 patients. LDH increased in 10 cases. Follow-up period was 2-90 months with the average survival time of (23.0±3.7) months and two-year survival rate of 39.0%. Univariate survival analysis showed that overexpression of bcl-2 protein (≥70%) and MYC protein (≥40%), bcl-2 gene abnormality (including copy number increase and translocation), C-MYC gene copy number increased were adverse factors for survival. C-MYC/ bcl-2 gene double hit was seen in 2 cases. Bivariate survival analysis found that of bcl-2/MYC protein double expression and bcl-2 and C-MYC genes double aberration were significantly associated with adverse outcomes. Cox multivariate risk regression analysis found that gender, cerebrospinal fluid protein increasing, and ICN of C-MYC gene were independent poor prognostic factors. DH-MTX based comprehensive chemotherapy was associated with better prognosis. Conclusions: Double hit at genomic level (copy number variations and gene rearrangements) and double protein expression of bcl-2 and C-MYC in PCNS-DLBCL are significantly associated with an adverse outcome. DH-MTX based comprehensive treatment may prolong the patient survival.

Primary and Secondary Spontaneous Pneumothorax: Prevalence, Clinical Features, and In-Hospital Mortality

PubMed Central

Ueda, Sho; Yamaoka, Masatoshi; Sekiya, Yoshiaki; Yamada, Hitoshi; Kawakami, Naoki; Araki, Yuichi; Wakai, Yoko; Saito, Kazuhito; Inagaki, Masaharu; Matsumiya, Naoki

2017-01-01

Background. Optimal treatment practices and factors associated with in-hospital mortality in spontaneous pneumothorax (SP) are not fully understood. We evaluated prevalence, clinical characteristics, and in-hospital mortality among Japanese patients with primary or secondary SP (PSP/SSP). Methods. We retrospectively reviewed and stratified 938 instances of pneumothorax in 751 consecutive patients diagnosed with SP into the PSP and SSP groups. Factors associated with in-hospital mortality in SSP were identified by multiple logistic regression analysis. Results. In the SSP group (n = 327; 34.9%), patient age, requirement for emergency transport, and length of stay were greater (all, p < 0.001), while the prevalence of smoking (p = 0.023) and number of surgical interventions (p < 0.001) were lower compared to those in the PSP group (n = 611; 65.1%). Among the 16 in-hospital deceased patients, 12 (75.0%) received emergency transportation and 10 (62.5%) exhibited performance status (PS) of 3-4. In the SSP group, emergency transportation was an independent factor for in-hospital mortality (odds ratio 16.37; 95% confidence interval, 4.85–55.20; p < 0.001). Conclusions. The prevalence and clinical characteristics of PSP and SSP differ considerably. Patients with SSP receiving emergency transportation should receive careful attention. PMID:28386166

Assessing anxiety and depression with respect to the quality of life in cancer inpatients receiving palliative care.

PubMed

Bužgová, Radka; Jarošová, Darja; Hajnová, Erika

2015-12-01

The study aimed at assessing the presence of anxiety and depression in cancer inpatients receiving palliative care at an oncology department using the Hospital Anxiety and Depression Scale (HADS) and determining whether anxiety and depression contribute to a lower quality of life controlled for pain and illness severity. This cross-sectional study comprised 225 advanced cancer inpatients (a mean age of 65.1 years). Data were collected with the HADS, EORTC QLQ-C30 and Karnofsky Performance Status scale. Anxiety (HADS-a ≥8) was found in 33.9% and depression (HADS-d ≥8) in 47.6% of patients. Higher anxiety scores were observed in patients living with a partner (p = 0.042) and non-religious patients (p = 0.045). Correlations were found between anxiety, depression and all quality of life dimensions (r = 0.31-0.63). Multiple regression analysis showed that anxiety and depression contribute to lower physical and emotional functioning. Patients with anxiety (HADS-a ≥8) and depression (HADS-d ≥8) reported a lower total quality of life (p < 0.01). Management of anxiety and depression in cancer patients receiving palliative care may contribute to improvement in certain quality of life dimensions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Does aerobic training alleviate fatigue and improve societal participation in patients with multiple sclerosis? A randomized controlled trial

PubMed Central

Heine, Martin; Verschuren, Olaf; Hoogervorst, Erwin LJ; van Munster, Erik; Hacking, Hub GA; Visser-Meily, Anne; Twisk, Jos WR; Beckerman, Heleen; de Groot, Vincent; Kwakkel, Gert

2017-01-01

Background: Evidence supporting the effectiveness of aerobic training, specific for fatigue, in severely fatigued patients with multiple sclerosis (MS) is lacking. Objective: To estimate the effectiveness of aerobic training on MS-related fatigue and societal participation in ambulant patients with severe MS-related fatigue. Methods: Patients (N = 90) with severe MS-related fatigue were allocated to 16-week aerobic training or control intervention. Primary outcomes were perceived fatigue (Checklist Individual Strength (CIS20r) fatigue subscale) and societal participation. An improvement of ⩾8 points on the CIS20r fatigue subscale was considered clinically relevant. Outcomes were assessed by a blinded observer at baseline, 2, 4, 6 and 12 months. Results: Of the 89 patients that started treatment (median Expanded Disability Status Scale (interquartile range), 3.0 (2.0–3.6); mean CIS20r fatigue subscale (standard deviation (SD)), 42.6 (8.0)), 43 received aerobic training and 46 received the control intervention. A significant post-intervention between-group mean difference (MD) on the CIS20r fatigue subscale of 4.708 (95% confidence interval (CI) = 1.003–8.412; p = 0.014) points was found in favour of aerobic training that, however, was not sustained during follow-up. No effect was found on societal participation. Conclusion: Aerobic training in MS patients with severe fatigue does not lead to a clinically meaningful reduction in fatigue or societal participation when compared to a low-intensity control intervention. PMID:28528566

Effect of visual biofeedback cycling training on gait in patients with multiple sclerosis.

PubMed

Hochsprung, A; Granja Domínguez, A; Magni, E; Escudero Uribe, S; Moreno García, A

2017-09-06

Gait alterations are present in a high percentage of patients with multiple sclerosis (MS). They appear from early stages of the disease and can limit patients' capacity to perform basic activities of daily living, affecting their quality of life. Visual biofeedback cycling training appears to be a useful tool in treating these impairments. This study aims to evaluate the short-term effect of visual biofeedback cycling training on gait in patients with MS. A total of 61 patients with mild to moderate MS were randomly assigned to a control group and an intervention group. The intervention group received visual biofeedback cycling training (MOTOmed viva2 system) once per week for 3 months, and a home exercise program. The control group only received the home exercise program. Both groups were evaluated using the GAITRite ® Walkway gait assessment system before the intervention, during the first month of the programme, and after the intervention. In the intervention group, the analysis revealed statistically significant differences between Functional Ambulation Profile (FAP) scores before and during the intervention (P=.014), and before and after the intervention (P=.002). A statistically significant improvement was observed in step length in the intervention group between pre- and post-intervention scores (P=.001) and between first-month and post-intervention scores (P=.004). Visual biofeedback cycling training improved specific gait parameters in the short term and appears to be a therapeutic option for gait retraining in patients with MS. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

A trauma-informed examination of the hardships experienced by abortion fund patients in the United States.

PubMed

Ely, Gretchen E; Hales, Travis; Jackson, D Lynn; Bowen, Elizabeth A; Maguin, Eugene; Hamilton, Greer

2017-11-01

Researchers describe hardships experienced by abortion patients, examining administrative health cases from 2010 to 2015 in the United States. All patients received financial assistance from an abortion fund to help pay for abortion. Case data were analyzed to assess types and numbers of hardships experienced by age, race, and geographic origin. Hardships ranged from homelessness to parenting multiple children. Patients from the geographic South experienced the most hardships, followed by those from the Midwest. Hardships experienced by abortion fund patients are like those reported in other samples of abortion patients; hardships potentially cause or exacerbate trauma. Results are discussed in the context of a trauma-informed perspective.

The efficacy of radiation therapy in the treatment of Graves' orbitopathy.

PubMed

Matthiesen, Chance; Thompson, J Spencer; Thompson, David; Farris, Bradley; Wilkes, Byron; Ahmad, Salahuddin; Herman, Terence; Bogardus, Carl

2012-01-01

To review our institutional outcomes of patients treated with radiation therapy (RT) for Graves' orbitopathy (GO), assess the role of orbital reirradiation, and identify prognostic factors of complete response (CR). This is a retrospective review of 211 patients who presented with a diagnosis of GO and received RT between January 2000-2010. RT dose was 20 Gy in 10 fractions. Patient median age was 51 years (range, 15-84 years), median follow-up was 11 months (range, 1-88 months). Patient symptoms included any combination of proptosis (90.9%), extraocular muscle dysfunction (78.9%), soft tissue signs (68.4%), and diplopia (58.4%). Corticosteroids were used as first-line therapy in 20.6% of patients. Among those who achieved either CR or partial response (PR), prognostic factors were evaluated. Stabilization of disease without recurrence was clinically achieved overall in 202 patients (96.7%). At the completion of RT, 176 patients (84.2%) reported a symptomatic improvement of pretreatment symptoms. CR of GO symptoms was achieved using multiple treatment modalities, including RT by 93 patients (44.5%), of which 32 patients received RT only. Corticosteroids were discontinued in 97.8% of patients who received them as initial therapy. Surgical intervention following radiotherapy was required for 144 (68.9%) of all patients. Fourteen patients received orbital reirradiation for persistent or recurrent symptoms. Five of these achieved a CR, and the other nine achieved disease stabilization but retained persistent ocular symptoms. Long-term side effects of RT included dry eyes (12%). Of the prognostic factors we investigated, only gender predicted CR, which was less common in men (33.9%) than in women (49.7%) p = 0.0471. Orbital radiation for GO is an established treatment modality for patients. Orbital reirradiation is beneficial for patients who do not respond to initial RT or experience symptom recurrence without an apparent risk of increased morbidity. Copyright © 2012 Elsevier Inc. All rights reserved.

Impact of systemic targeted agents on the clinical outcomes of patients with brain metastases

PubMed Central

Johnson, Adam G.; Ruiz, Jimmy; Hughes, Ryan; Page, Brandi R.; Isom, Scott; Lucas, John T.; McTyre, Emory R.; Houseknecht, Kristin W.; Ayala-Peacock, Diandra N.; Bourland, Daniel J.; Hinson, William H.; Laxton, Adrian W.; Tatter, Stephen B.; Debinski, Waldemar; Watabe, Kounosuke; Chan, Michael D.

2015-01-01

Background To determine the clinical benefits of systemic targeted agents across multiple histologies after stereotactic radiosurgery (SRS) for brain metastases. Methods Between 2000 and 2013, 737 patients underwent upfront SRS for brain metastases. Patients were stratified by whether or not they received targeted agents with SRS. 167 (23%) received targeted agents compared to 570 (77%) that received other available treatment options. Time to event data were summarized using Kaplan-Meier plots, and the log rank test was used to determine statistical differences between groups. Results Patients who received SRS with targeted agents vs those that did not had improved overall survival (65% vs. 30% at 12 months, p < 0.0001), improved freedom from local failure (94% vs 90% at 12 months, p = 0.06), improved distant failure-free survival (32% vs. 18% at 12 months, p = 0.0001) and improved freedom from whole brain radiation (88% vs. 77% at 12 months, p = 0.03). Improvement in freedom from local failure was driven by improvements seen in breast cancer (100% vs 92% at 12 months, p < 0.01), and renal cell cancer (100% vs 88%, p = 0.04). Multivariate analysis revealed that use of targeted agents improved all cause mortality (HR = 0.6, p < 0.0001). Conclusions Targeted agent use with SRS appears to improve survival and intracranial outcomes. PMID:26087184

Methotrexate-associated lymphoproliferative disorder complicated by severe acute respiratory failure and ileal perforation: a case report.

PubMed

Suzuki, Eiji; Kanno, Takashi; Kimura, Satoru; Irie, Takumi; Odajima, Hajime; Migita, Kiyoshi

2018-06-19

Lymphoproliferative disorder (LPD) is a potentially severe adverse effect of methotrexate (MTX) administration in patients with rheumatoid arthritis (RA). We report a case of MTX-associated LPD (MTX-LPD) in a patient with RA who developed severe pulmonary failure complicated by perforation of the terminal ileum. A 61-year-old woman with RA receiving MTX complained of dyspnea and abdominal pain. She was diagnosed with intestinal perforation and peritonitis, and underwent immediate abdominal surgery. Pathological examinations of the specimen obtained from the resected ileum and a bone marrow aspirate revealed diffuse large B-cell lymphoma. Steroid therapy failed to improve her respiratory failure, but her condition improved after abdominal surgery and suspension of MTX. MTX-LPD can result in multiple life-threatening conditions; however, the symptoms are highly variable. RA patients receiving MTX should thus be monitored carefully, and MTX administration should be stopped immediately on suspicion of MTX-LPD.

Clinical effects of laser immunotherapy on metastatic cancer patients

NASA Astrophysics Data System (ADS)

Naylor, Mark F.; Lam, Anh K.; Bahavar, Cody F.; Nordquist, Robert E.; Chen, Wei R.

2016-03-01

Clinical trials of late-stage breast cancer patients and late-stage melanoma patients treated by laser immunotherapy (LIT) have shown promising results. In a 2010 study of Li et al, eleven late-stage melanoma patients received LIT in one or multiple 6-week treatment cycles applied to a 200-cm2 treatment site, which usually contained multiple cutaneous metastases. Long-term, positive response was observed in six patients. All lesions in the treatment area of the patients responded to LIT, eight of which achieved complete local response (CLR). CLR was observed in the non-treatment site (regional) lesions in four patients. Five patients were still alive at the time of last follow-up. The probability of 12-month overall survival was 70%.2 In 2011, Li et al, treated ten late stage breast cancer patients with LIT.1 In 8 patients available for evaluation, the objective response rate was 62.5% and the clinical beneficial response rate was 75%.1 This review demonstrates that LIT is safe and well tolerated, so it can be easily applied on an outpatient basis and can be combined with other pharmaceutical modalities to improve the therapeutic response of metastatic cancers.

Two cases of multiple ossifying fibromas in the jaws

PubMed Central

2014-01-01

Background The clinicopathologic characteristics of multiple ossifying fibroma (OF) are unclear due to the condition’s rarity, making diagnosis challenging. Sporadic multiple OFs must be distinguished from hyperparathyroidism-jaw tumour syndrome (HPT-JT) related OF and other fibro-osseous lesions. Methods Multiple OF cases were identified from ossifying fibroma cases. Clinical data including age, sex, anatomic site, radiographic features, clinical impression, treatment and available follow-up data as well as serum calcium, phosphorus, and parathyroid hormone (PTH) were recorded. GNAS and HRPT2 genetic mutations were examined in the two present cases. Case reports of sporadic multiple ossifying fibroma and HPT-JT-related OF were also reviewed. Results The two present cases were confirmed as sporadic multiple OF, with no genetic GNAS and HRPT2 mutations found. The incidence of sporadic multiple ossifying fibroma was 2.0% (2/102). The total 18 sporadic multiform OF cases were characterized as followed: 13 (72.2%) female; 5 (27.8%) male; mean age 28.6 years; 2/16 (11.1%) cases only in the mandible; 4/18 (22.2%) cases only in the maxilla; and 12/18 (66.7%) cases in both the maxilla and mandible. Radiographically, the lesions were radiolucent in 5/18 (27.8%) cases and mixed density in 13/18 (72.2%) cases. Along with 24 cases of HPT-JT related OF were reviewed, sixteen (66.7%) patients were diagnosed with a single lesion, and 8 patients (33.3%) were diagnosed with multiple jaw lesions. Conclusions Sporadic multiple OFs are very rare, but must be distinguished from HPT-JT related OF. We strongly recommend that patients diagnosed with multiple ossifying fibromas receive serum PTH testing and mutation screening of HRPT2. Virtual slides http://www.diagnosticpathology.diagnomx.eu/vs/1194507146115753 PMID:24678936

Implementing Routine Palliative Care Consultation Before LVAD Implantation: A Single Center Experience.

PubMed

Salomon, Say; Frankel, Hilary; Chuang, Elizabeth; Eti, Serife; Selwyn, Peter

2018-05-01

Left ventricular assist devices (LVADs) are increasingly used to improve quality of life for end-stage heart failure patients. The Joint Commission now requires preimplantation palliative care assessment; however, many palliative care teams have little experience providing this service. To describe the integration of palliative services at one Center of Excellence for Heart and Vascular Care. This is a retrospective chart review of all patients receiving LVADs at a single urban academic medical center from January 2015 to September 2016. Palliative care needs and services provided are described. Two case presentations illustrate the collaboration between the cardiothoracic and palliative care teams. Fifty one patients were included. Of those, 28 received a palliative care consultation during this roll-out period. The rate of consultation rose from 35% to 71% as workflows improved with institutional commitment. Symptom assessment, psychosocial assessment, and advance care planning (ACP) were always performed (n = 28; 100%). More than half of the patients were evaluated for dyspnea (n = 20; 71%), fatigue (n = 18; 64%), and pain (n = 16; 57%). Consults centered around ACP, and very few patients (n = 7; 25%) required palliative care follow-up. Palliative consultation did not delay LVAD placement. Although palliative care consultants provided initial evaluation and management of multiple symptoms, there was not a large ongoing need. Integration of palliative services into the care of patients receiving LVADs can be incorporated into the workflow of the cardiothoracic and palliative care teams, resulting in improved ACP for all patients receiving LVADs and better care coordination for patients at the end of life. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Long-term outcomes of patients receiving a massive transfusion after trauma.

PubMed

Mitra, Biswadev; Gabbe, Belinda J; Kaukonen, Kirsi-Maija; Olaussen, Alexander; Cooper, David J; Cameron, Peter A

2014-10-01

Resuscitation of patients presenting with hemorrhagic shock after major trauma has evolved to incorporate multiple strategies to maintain tissue perfusion and oxygenation while managing coagulation disorders. We aimed to study changes across time in long-term outcomes in patients with major trauma. A retrospective observational study in a single major trauma center in Australia was conducted. We included all patients with major trauma and massive blood transfusion within the first 24 h during a 6-year period (from 2006 to 2011). The main outcome measures were Glasgow Outcome Score-Extended (GOSE) and work capacity at 6 and 12 months. There were 5,915 patients with major trauma of which 365 (6.2%; 95% confidence interval [95% CI], 5.6 - 6.8) received a massive transfusion. The proportion of major trauma patients receiving a massive transfusion decreased across time from 8.2% to 4.4% (P < 0.01). There were statistically significant trends toward lower volumes of red blood cell transfusion and higher ratios of fresh-frozen plasma to red blood cells (P < 0.01). Among massively transfused patients, there was no significant change in measured outcomes during the study period, with a persistent 23% mortality in hospital, 52% unfavorable GOSE at 6 months, and 44% unfavorable GOSE at 12 months. Massive transfusion was independently associated with unfavorable outcomes at 6 months after injury (adjusted odds ratio, 1.56; 95% CI, 1.05 - 2.31) but not at 12 months (adjusted odds ratio, 0.85; 95% CI, 0.72 - 1.01). A significant reduction in massive transfusion rates was observed. Unfavorable long-term outcomes among patients receiving a massive transfusion after trauma were frequent with a substantial proportion of survivors experiencing poor functional status 1 year after injury.

Outcomes and toxicities in patients with intermediate-risk prostate cancer treated with brachytherapy alone or brachytherapy and supplemental external beam radiation therapy.

PubMed

Schlussel Markovic, Emily; Buckstein, Michael; Stone, Nelson N; Stock, Richard G

2018-05-01

To evaluate the cancer control outcomes and long-term treatment-related morbidity of brachytherapy as well as combination brachytherapy and external beam radiation therapy (EBRT) in patients with intermediate-risk prostate cancer. A retrospective review was conducted in a prospectively collected database of patients with intermediate-risk prostate cancer who were treated either with brachytherapy or brachytherapy and EBRT, with or without androgen deprivation therapy (ADT), in the period 1990-2014. Urinary and erectile dysfunction symptoms were measured using the International Prostate Symptom Score (IPSS), the Mount Sinai erectile function scale and the Sexual Health Inventory for Men (SHIM). Cancer control endpoints included biochemical failure and development of distant metastases. All statistical analyses were carried out using the Statistical Package for Social Science (SPSS). Survival curves were calculated using Kaplan-Meier actuarial methods and compared using log-rank tests. Cox regression multivariate analyses were used to test the effect of multiple variables on treatment outcomes. A total of 902 patients were identified, with a median follow-up of 91 months. Of these, 390 received brachytherapy and 512 received combination therapy with EBRT. In patients with one intermediate-risk factor, the addition of EBRT did not significantly affect freedom from biochemical failure or distant metastases. Among patients with two or three intermediate-risk factors, added EBRT did not improve freedom from biochemical failure. Significant differences in late toxicity between patients treated with brachytherapy vs combination brachytherapy and EBRT were identified including urge incontinence (P < 0.001), haematuria (P < 0.001), dysuria (P < 0.001), and change in quality-of-life IPSS (P = 0.002). These symptoms were reported by patients at any point during treatment follow-up. Analysis of patients who were potent before treatment using actuarial methods showed that patients receiving combination therapy more frequently experienced loss of potency, as measured by the Mount Sinai erectile function scale (P = 0.040). Brachytherapy monotherapy results in equal biochemical and distant control in both patients with one and more than one intermediate-risk features. While no significant benefit was shown, we believe that the addition of EBRT may prevent recurrence in patients with multiple intermediate-risk features and should be considered. © 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.

Non-inflammatory causes of emergency consultation in patients with multiple sclerosis.

PubMed

Rodríguez de Antonio, L A; García Castañón, I; Aguilar-Amat Prior, M J; Puertas, I; González Suárez, I; Oreja Guevara, C

2018-05-26

To describe non-relapse-related emergency consultations of patients with multiple sclerosis (MS): causes, difficulties in the diagnosis, clinical characteristics, and treatments administered. We performed a retrospective study of patients who attended a multiple sclerosis day hospital due to suspected relapse and received an alternative diagnosis, over a 2-year period. Demographic data, clinical characteristics, final diagnosis, and treatments administered were evaluated. Patients who were initially diagnosed with pseudo-relapse and ultimately diagnosed with true relapse were evaluated specifically. As an exploratory analysis, patients who consulted with non-inflammatory causes were compared with a randomly selected cohort of patients with true relapses who attended the centre in the same period. The study included 50 patients (33 were women; mean age 41.4±11.7years). Four patients (8%) were initially diagnosed with pseudo-relapse and later diagnosed as having a true relapse. Fever and vertigo were the main confounding factors. The non-inflammatory causes of emergency consultation were: neurological, 43.5% (20 patients); infectious, 15.2% (7); psychiatric, 10.9% (5); vertigo, 8.6% (4); trauma, 10.9% (5); and miscellaneous, 10.9% (5). MS-related symptoms constituted the most frequent cause of non-inflammatory emergency consultations. Close follow-up of relapse and pseudo-relapse is necessary to detect incorrect initial diagnoses, avoid unnecessary treatments, and relieve patients' symptoms. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Therapy satisfaction and adherence in patients with relapsing–remitting multiple sclerosis: the THEPA-MS survey

PubMed Central

Haase, Rocco; Kullmann, Jennifer S.; Ziemssen, Tjalf

2016-01-01

Background: Improved clinical effectiveness and therefore positive modification of multiple sclerosis (MS) with basic therapy can be achieved by long-term regular intake of drugs as prescribed but investigations have shown that a high percentage of patients do not take their medications as prescribed. Objectives: We assessed the satisfaction and adherence of patients with MS with their current disease-modifying treatment under clinical practice conditions. We compared different facets of satisfaction as well as their internal relationship and identified predictors in an exploratory manner. Methods: Therapy satisfaction in patients with relapsing–remitting multiple sclerosis (THEPA-MS) was a noninterventional, prospective cross-sectional study performed throughout Germany in 2013 and 2014, and included patients with clinically isolated syndrome or relapsing–remitting MS. We applied a standardized approach to document satisfaction and adherence by patient-reported outcomes (Treatment Satisfaction Questionnaire for Medication) as well as by physician ratings. Results: Of 3312 patients with a mean age of 43.7 years, 73.3% were women and the mean level of disability according to the Expanded Disability Status Scale was 2.29; 13.3% did not receive any medication at the time of documentation, 21.3% received interferon β1a intramuscularly, 20.7% had interferon β1a subcutaneously, 17.0% had interferon β1b subcutaneously and 23.7% had glatiramer acetate. Adherence rates varied between 60% (lifetime) and 96.5% (current medication). Differences between current medications were found for side effects and convenience scores but not for effectiveness, satisfaction and adherence. Higher global satisfaction and effectiveness were associated with fewer relapses, longer duration of medication, lower disability score and the absence of several side effects. Conclusion: In a connected model of patient satisfaction, effectiveness, side effects, convenience and adherence, patients’ individual needs and concerns have to be addressed. Most differences were found with respect to side effects and convenience of treatment. Therefore, an improvement in these two domains seems to be the most promising proximate approach to elevate adherence levels. PMID:27366231

Impact of stress-induced diabetes on outcomes in severely burned children.

PubMed

Finnerty, Celeste C; Ali, Arham; McLean, Josef; Benjamin, Nicole; Clayton, Robert P; Andersen, Clark R; Mlcak, Ronald P; Suman, Oscar E; Meyer, Walter; Herndon, David N

2014-04-01

Post-burn hyperglycemia leads to graft failure, multiple organ failure, and death. A hyperinsulinemic-euglycemic clamp is used to keep serum glucose between 60 and 110 mg/dL. Because of frequent hypoglycemic episodes, a less-stringent sliding scale insulin protocol is used to maintain serum glucose levels between 80 and 160 mg/dL after elevations >180 mg/dL. We randomized pediatric patients with massive burns into 2 groups, patients receiving sliding scale insulin to lower blood glucose levels (n = 145) and those receiving no insulin (n = 98), to determine the differences in morbidity and mortality. Patients 0 to 18 years old with burns covering ≥ 30% of the total body surface area and not randomized to receive anabolic agents were included in this study. End points included glucose levels, infections, resting energy expenditure, lean body mass, bone mineral content, fat mass, muscle strength, and serum inflammatory cytokines, hormones, and liver enzymes. Maximal glucose levels occurred within 6 days of burn injury. Blood glucose levels were age dependent, with older children requiring more insulin (p < 0.05). Daily maximum and daily minimum, but not 6 am, glucose levels were significantly different based on treatment group (p < 0.05). Insulin significantly increased resting energy expenditure and improved bone mineral content (p < 0.05). Each additional wound infection increased incidence of hyperglycemia (p = 0.004). There was no mortality in patients not receiving insulin, only in patients who received insulin (p < 0.004). Muscle strength was increased in patients receiving insulin (p < 0.05). Burn-induced hyperglycemia develops in a subset of severely burned children. Length of stay was reduced in the no insulin group, and there were no deaths in this group. Administration of insulin positively impacted bone mineral content and muscle strength, but increased resting energy expenditure, hypoglycemic episodes, and mortality. New glucose-lowering strategies might be needed. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

75 FR 82402 - Proposed Consolidated Vaccine Information Materials for Multiple Infant Vaccines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... number of shots your baby needs by combining several vaccines in one shot. These combination vaccines are... to any patient (or to the parent or legal representative in the case of a child) receiving vaccines... United States who intends to administer one of these covered vaccines is required to provide copies of...

Multidrug-resistant bacteria infection and nursing quality management application in the department of physical examination.

PubMed

Xu, Li; Luo, Qiang; Chen, Liangzhen; Jiao, Lingmei

2017-09-01

The main problem of clinical prevention and control of multi drug resistant bacteria infection is to strengthen the monitoring of pathogenic bacteria spectrum, this study research on the multi drug-resistant bacteria infection and nursing quality management application in the department of physical examination. The results of this study showed that the number of patients with multiple drug resistant infections showed an increasing trend. Therefore, once the patients with multiple drug-resistant bacteria infection are found, the prevention and control of the patients with multiple drug-resistant bacteria should be strictly followed, and the patient's medication care should be highly valued. Also, the nurses need to be classified based on the knowledge and skill characteristics of the nurses in the department of physical examination, and compare the nursing effect before and after classification and grouping. The physicians and individuals receiving physical examinations in the department of physical examination had a higher degree of satisfaction for nursing effect after classification compared with those before classification. Classification and grouping management helps improve the nursing quality and overall quality of the nurses in the department of physical examination.

EMA Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple Myeloma.

PubMed

Tzogani, Kyriaki; van Hennik, Paula; Walsh, Ita; De Graeff, Pieter; Folin, Annika; Sjöberg, Jan; Salmonson, Tomas; Bergh, Jonas; Laane, Edward; Ludwig, Heinz; Gisselbrecht, Christian; Pignatti, Francesco

2018-05-01

On August 28, 2015, a marketing authorization valid through the European Union was issued for panobinostat, in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD).Panobinostat is an orally available histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDAC proteins at nanomolar concentrations. HDAC proteins catalyze the removal of acetyl groups from the lysine residues of histones and some nonhistone proteins. Inhibition of HDAC activity results in increased acetylation of histone proteins, an epigenetic alteration that results in a relaxing of chromatin, leading to transcriptional activation. The recommended starting dose of panobinostat is 20 mg, taken orally in a cyclical manner for up to 48 weeks.The use of panobinostat in combination with bortezomib and dexamethasone was studied in a randomized, double-blind, placebo-controlled, multicenter phase III study (PANORAMA I) in 768 patients with relapsed or relapsed and refractory multiple myeloma who had received one to three prior lines of therapies. In the subgroup of patients who have received at least two prior regimens including bortezomib and an IMiD, there was a difference of 7.8 months in the progression-free survival in favor of the experimental arm (12.5 months for panobinostat + bortezomib + dexamethasone vs. 4.7 months for placebo + bortezomib + dexamethasone; hazard ratio = 0.47, 95% confidence interal 0.31-0.72; log-rank p value = .0003). The incidence of grade 3-4 adverse events suspected to be related to study drug was 76.9% vs. 51.2%, for the panobinostat and the placebo group, respectively. The most common side effects (grade 3-4) associated with panobinostat included diarrhea (18.9%), fatigue (14.7%), nausea (4.5%), vomiting (5.5%), thrombocytopenia (43.6%), anemia (7.9%), neutropenia (16.5%) and lymphopenia (8.1%).This article summarizes the scientific review of the application leading to regulatory approval in the European Union. The full scientific assessment report and product information, including the Summary of Product Characteristics, are available on the European Medicines Agency website (http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landing_page.jsp&mid=). Farydak was approved in the European Union in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD). The addition of panobinostat to bortezomib and dexamethasone resulted in a clinically meaningful and statistically significant improvement of progression-free survival compared with bortezomib and dexamethasone, and an additional therapeutic option with a new mechanism of action was considered valuable. Although the toxicity associated with panobinostat combination was significant, at the time of the marketing authorization of panobinostat, it was considered that it was acceptable and that it should be left to the clinician and the patient to decide whether the panobinostat combination is the preferred treatment option or not. © AlphaMed Press 2017.

Understanding and meeting injection device needs in multiple sclerosis: a survey of patient attitudes and practices

PubMed Central

Verdun di Cantogno, Elisabetta; Russell, Susan; Snow, Tom

2011-01-01

Background: All established disease-modifying drugs for multiple sclerosis require parenteral administration, which can cause difficulties for some patients, sometimes leading to suboptimal adherence. A new electronic autoinjection device has been designed to address these issues. Methods: Patients with relapsing multiple sclerosis currently receiving subcutaneous or intramuscular interferon beta-1a, interferon beta-1b, or glatiramer acetate completed an online questionnaire (July 4–25, 2008) that surveyed current injection practices, experiences with current injection methods, and impressions and appeal of the new device. Results: In total, 422 patients completed the survey, of whom 44% used autoinjectors, 43% prefilled syringes, and 13% syringes and vials; overall, 66% currently self-injected. Physical and psychological barriers to self-injection included difficulty with injections, needle phobia, and concerns over correct injection technique. Only 40% of respondents were “very satisfied” with their current injection method. The new electronic autoinjector was rated as “very appealing” by 65% of patients. The benefits of the new device included the ability to customize injection settings and to review dosing history. Conclusion: New technologies may help patients overcome physical and psychological barriers to self-injection. The combination of a reliable and flexible autoinjection device with dose-monitoring technology may improve communication between health care professionals and patients, and improve treatment adherence. PMID:21573048

Dynamics of multiple resistance mechanisms in plasma DNA during EGFR-targeted therapies in non-small cell lung cancer.

PubMed

Tsui, Dana Wai Yi; Murtaza, Muhammed; Wong, Alvin Seng Cheong; Rueda, Oscar M; Smith, Christopher G; Chandrananda, Dineika; Soo, Ross A; Lim, Hong Liang; Goh, Boon Cher; Caldas, Carlos; Forshew, Tim; Gale, Davina; Liu, Wei; Morris, James; Marass, Francesco; Eisen, Tim; Chin, Tan Min; Rosenfeld, Nitzan

2018-06-01

Tumour heterogeneity leads to the development of multiple resistance mechanisms during targeted therapies. Identifying the dominant driver(s) is critical for treatment decision. We studied the relative dynamics of multiple oncogenic drivers in longitudinal plasma of 50 EGFR -mutant non-small-cell lung cancer patients receiving gefitinib and hydroxychloroquine. We performed digital PCR and targeted sequencing on samples from all patients and shallow whole-genome sequencing on samples from three patients who underwent histological transformation to small-cell lung cancer. In 43 patients with known EGFR mutations from tumour, we identified them accurately in plasma of 41 patients (95%, 41/43). We also found additional mutations, including EGFR T790M (31/50, 62%), TP53 (23/50, 46%), PIK3CA (7/50, 14%) and PTEN (4/50, 8%). Patients with both TP53 and EGFR mutations before treatment had worse overall survival than those with only EGFR Patients who progressed without T790M had worse PFS during TKI continuation and developed alternative alterations, including small-cell lung cancer-associated copy number changes and TP53 mutations, that tracked subsequent treatment responses. Longitudinal plasma analysis can help identify dominant resistance mechanisms, including non-druggable genetic information that may guide clinical management. © 2018 The Authors. Published under the terms of the CC BY 4.0 license.

Analysis of Trends and Factors in Breast Multiple Primary Malignant Neoplasms

PubMed Central

Motuzyuk, Igor; Sydorchuk, Oleg; Kovtun, Natalia; Palian, Zinaida; Kostiuchenko, Yevhenii

2018-01-01

Background: The study aims to evaluate the current state and tendencies in multiple primary breast cancer incidence, behavior, and treatment in Ukraine. Methods: A total of 2032 patients who received special treatment at the Department of Breast Tumors and Reconstructive Surgery of the National Cancer Institute from 2008 to 2015 were included in the study. Among them, there were 195 patients with multiple primary malignant neoplasms: 54.9% patients with synchronous cancer and 45.1% patients with metachronous cancer. The average age of patients was 46.6 years, and the percentage of postmenopausal women was 63.1%. Among patients with synchronous cancer, there were 56.1% patients with only breast localizations and 43.9% with combination of breast and other localizations, and among patients with metachronous cancer, there were 46.6% patients with only breast localizations and 53.4% with combination of breast and other localizations. All the patients were evaluated in terms of aggressiveness of the disease, survival rates, as well as risk factors and treatment options. Results: A more aggressive course of breast cancer is observed in patients exposed to radiation from the Chernobyl accident under the age of 30 years (P < .01). The clinical course of disease in patients with synchronous cancer is worse and prognostically unfavorable compared with metachronous cancer (P < .01). The course of the disease in patients who underwent mastectomy is worse compared with patients who underwent breast-conserving surgery (P < .01). Plastic and reconstructive surgery in patients with synchronous cancer was proven to be reasonable in terms of increase in survival (P < .01). Conclusions: The patients with multiple primary breast cancer should have attentive management and treatment. Multidisciplinary team should concern all the risk factors and provide the most sufficient option of management. This is crucial to continue research in this oncological area. PMID:29531473

Music Therapy for Symptom Management After Autologous Stem Cell Transplantation: Results From a Randomized Study.

PubMed

Bates, Debbie; Bolwell, Brian; Majhail, Navneet S; Rybicki, Lisa; Yurch, Melissa; Abounader, Donna; Kohuth, Joseph; Jarancik, Shannon; Koniarczyk, Heather; McLellan, Linda; Dabney, Jane; Lawrence, Christine; Gallagher, Lisa; Kalaycio, Matt; Sobecks, Ronald; Dean, Robert; Hill, Brian; Pohlman, Brad; Hamilton, Betty K; Gerds, Aaron T; Jagadeesh, Deepa; Liu, Hien D

2017-09-01

High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is frequently performed in patients with hematologic malignancies. ASCT can result in significant nausea, pain, and discomfort. Supportive care has improved, and pharmacologic therapies are frequently used, but with limitations. Music has been demonstrated to improve nausea and pain in patients undergoing chemotherapy, but little data are available regarding the effects of music therapy in the transplantation setting. In a prospective study, patients with lymphoma or multiple myeloma undergoing ASCT were randomized to receive either interactive music therapy with a board-certified music therapist or no music therapy. The music therapy arm received 2 music therapy sessions on days +1 and +5. Primary outcomes were perception of pain and nausea measured on a visual analog scale. Secondary outcomes were narcotic pain medication use from day -1 to day +5 and impact of ASCT on patient mood as assessed by Profile of Mood States (POMS) on day +5. Eighty-two patients were enrolled, with 37 in the music therapy arm and 45 in the no music therapy arm. Patients who received MT had slightly increased nausea by day +7 compared with the no music therapy patients. The music therapy and no music therapy patients had similar pain scores; however, the patients who received music therapy used significantly less narcotic pain medication (median, 24 mg versus 73 mg; P = .038). Music therapy may be a viable nonpharmacologic method of pain management for patients undergoing ASCT; the music therapy patients required significantly fewer morphine equivalent doses compared with the no music therapy patients. Additional research is needed to better understand the effects of music therapy on patient-perceived symptoms, such as pain and nausea. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Usefulness and safety of oral cryotherapy in the prevention of oral mucositis after conditioning regimens with high-dose melphalan for autologous stem cell transplantation for lymphoma and myeloma.

PubMed

Batlle, Montserrat; Morgades, Mireia; Vives, Susana; Ferrà, Christelle; Oriol, Albert; Sancho, Juan-Manuel; Xicoy, Blanca; Moreno, Miriam; Magallón, Laura; Ribera, Josep-Maria

2014-12-01

Oral mucositis (OM) is a common complication of conditioning regimens with high-dose melphalan (HDmel). This retrospective cohort study analyzes the impact of oral cryotherapy (OC) or room temperature saline rinses on the prevention of OM in patients with multiple myeloma (MM) or lymphoid neoplasias submitted to autologous stem cell transplantation (ASCT) in a single center. From August 2006 to July 2011, 134 consecutive patients were enrolled. Two consecutive groups were included: Non-OC (August 2006 to April 2009, 68 patients) and OC (May 2009 to July 2011, 66 cases). MM cases (78, 58%) received HDmel as the conditioning regimen and 56 patients (42%) with lymphoma received BEAM. The non-OC and OC groups were comparable for the main clinicobiologic features and type of neoplasia. OM was more frequent and severe in patients receiving BEAM as the conditioning therapy. The group of OC showed less frequent and less severe mucositis and fewer days on antibiotics. No differences were observed in the duration of OM, need for parenteral nutrition and narcotics, and the length of hospital stay on comparison with the OC and non-OC groups. By multivariate analyses, OC was an independent favorable prognostic factor for OM development. This study shows that OC is more effective than saline rinses in the prevention of OM in patients with lymphoma and myeloma receiving conditioning regimens with HDmel for ASCT. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Exploration of the recurrence in radiation brain necrosis after bevacizumab discontinuation.

PubMed

Zhuang, Hongqing; Yuan, Xiangkun; Chang, Joe Y; Song, Yongchun; Wang, Junjie; Yuan, Zhiyong; Wang, Xiaoguang; Wang, Ping

2016-07-26

The aim of the paper was to investigate the recurrence and its causes of radiation brain necrosis following bevacizumab discontinuation. This study included 14 patients with radiation brain necrosis (confirmed through imaging) after stereotactic radiotherapy for a primary or metastatic brain tumor and who received bevacizumab treatment from June 2011 through December 2014. The patients received bevacizumab at 5 mg/kg, q3-4w, for at least 3 cycles. The T1 signal intensity from enhanced MRI images was used as the evaluation criteria for the brain necrosis treatment efficacy. brain necrosis improved in 13 of the 14 cases (92.9%). However, during follow-up, 10 of the 13 responsive patients (76.9%) exhibited a recurrence in brain necrosis, and a multiple linear regression analysis shows that brain necrosis recurrence was related to the follow-up time after the initial bevacizumab treatment discontinuation. bevacizumab produced good short-term effects for radiation brain necrosis; however, most of the patients would recurrence after bevacizumab is discontinued. Thus, brain necrosis was irreversible.

Hodgkin's lymphoma rectosigmoid in a patient with ulcerative colitis on long-term azathioprine therapy

PubMed Central

Khuroo, Mehnaaz S

2014-01-01

Hodgkin's lymphoma complicating chronic ulcerative colitis is extremely rare. We report a case of extranodal Hodgkin's lymphoma involving rectosigmoid in a patient of chronic ulcerative colitis on long-term azathioprine. A 67-year-old man presented with extensive ulcerative colitis, on follow-up since September 2005. He received long-term steroids, mesalamine and azathioprine. Serial surveillance colonoscopic examinations and colonic biopsies were performed. Surveillance colonoscopy performed 8 years after the onset of disease showed multiple deep ulcers and nodular masses involving the rectum and sigmoid colon. Histological examination of rectosigmoid biopsies showed classic Hodgkin's disease. Azathioprine was withdrawn. He received mechlorethamine, vincristine, procarbazine and prednisone (MOPP) chemotherapy protocol and was planned for total colectomy in follow-up. We believe patients with ulcerative colitis on long-term azathioprine should be on vigil for development of lymphomas by protocol surveillance colonoscopic examinations and biopsies. The risk of lymphoma in such patients is small and outweighs the benefits of long-term azathioprine therapy. PMID:24849639

Prognostic value of Sequential Organ Failure Assessment and Simplified Acute Physiology II Score compared with trauma scores in the outcome of multiple-trauma patients.

PubMed

Fueglistaler, Philipp; Amsler, Felix; Schüepp, Marcel; Fueglistaler-Montali, Ida; Attenberger, Corinna; Pargger, Hans; Jacob, Augustinus Ludwig; Gross, Thomas

2010-08-01

Prospective data regarding the prognostic value of the Sequential Organ Failure Assessment (SOFA) score in comparison with the Simplified Acute Physiology Score (SAPS II) and trauma scores on the outcome of multiple-trauma patients are lacking. Single-center evaluation (n = 237, Injury Severity Score [ISS] >16; mean ISS = 29). Uni- and multivariate analysis of SAPS II, SOFA, revised trauma, polytrauma, and trauma and ISS scores (TRISS) was performed. The 30-day mortality was 22.8% (n = 54). SOFA day 1 was significantly higher in nonsurvivors compared with survivors (P < .001) and correlated well with the length of intensive care unit stay (r = .50, P < .001). Logistic regression revealed SAPS II to have the best predictive value of 30-day mortality (area under the receiver operating characteristic = .86 +/- .03). The SOFA score significantly added prognostic information with regard to mortality to both SAPS II and TRISS. The combination of critically ill and trauma scores may increase the accuracy of mortality prediction in multiple-trauma patients. 2010 Elsevier Inc. All rights reserved.

From the Children’s Oncology Group: Evidence-based recommendations for PEG-asparaginase nurse monitoring, hypersensitivity reaction management, and patient/family education

PubMed Central

Woods, Deborah; Winchester, Kari; Towerman, Alison; Gettinger, Katie; Carey, Christina; Timmermann, Karen; Langley, Rachel; Browne, Emily

2017-01-01

PEG-aspariginase is a backbone chemotherapy agent in pediatric acute lymphoblastic leukemia and in some non-Hodgkin lymphoma therapies. Nurses lack standardized guidelines for monitoring patients receiving PEG-asparaginase and for educating patients/families about hypersensitivity reaction risks. An electronic search of six databases using publication years 2000–2015 and multiple professional organizations and clinical resources was conducted. Evidence sources were reviewed for topic applicability. Each of the final 23 sources was appraised by two team members. The GRADE system was used to assign a quality and strength rating for each recommendation. Multiple recommendations were developed: four relating to nurse monitoring of patients during and after drug administration, eight guiding hypersensitivity reaction management, and four concerning patient/family educational content. These strong recommendations were based on moderate, low, or very-low quality evidence. Several recommendations relied upon generalized drug hypersensitivity guidelines. Additional research is needed to safely guide PEG-asparaginase monitoring, hypersensitivity reaction management and patient/family education. Nurses administering PEG-asparaginase play a critical role in the early identification and management of hypersensitivity reactions. PMID:28602129

Oligoclonal and monoclonal bands after single autologous stem cell transplant in patients with multiple myeloma: impact on overall survival and progression-free survival.

PubMed

Jimenez-Zepeda, Victor H; Reece, Donna E; Trudel, Suzanne; Franke, Norman; Winter, Andrew; Chen, Christine; Tiedemann, Rodger; Kukreti, Vishal

2014-10-01

Abstract Recently, the occurrence of oligoclonal and monoclonal bands (OB/MB) unrelated to the original clone has been reported in patients with multiple myeloma who undergo autologous stem cell transplant (ASCT) and/or receive treatment with novel agents. The aim of our study was to assess the impact of OB/MB occurrence on overall (OS) and progression-free survival (PFS) for patients with MM undergoing single ASCT at our institution. All consecutive patients with documented MM undergoing single ASCT from January 2000 to December 2012 were evaluated. Ninety-nine patients (11.8%) developed OB/MB at day 100 post-ASCT (32.3%, OB and 67.7%, MB). Multivariate analysis identified the development of OBs/MBs as an independent favorable prognostic factor for OS and PFS (p = 0.008 and 0.012, respectively). In conclusion, the occurrence of OB/MB is an important prognostic factor in patients with MM who undergo ASCT. Its impact on clinical outcomes should be prospectively validated and its biological significance further elucidated.

Extracorporeal therapies in pediatric severe sepsis: findings from the pediatric health-care information system.

PubMed

Ruth, Amanda; McCracken, Courtney E; Fortenberry, James D; Hebbar, Kiran B

2015-11-10

Pediatric severe sepsis (PSS) continues to be a major health problem. Extracorporeal therapies (ETs), defined as extracorporeal membrane oxygenation (ECMO) and RRenal replacement therapyenal replacement therapy (RRT), are becoming more available for utilization in a variety of health conditions. We aim to describe (1) rates of utilization of ET in PSS, (2) outcomes for PSS patients receiving ET, and (3) epidemiologic characteristics of patients receiving ET. We conducted a retrospective review of a prospectively collected database. Data from the Pediatric Health Information System (PHIS) database collected by the Children's Hospital Association (CHA) from 2004-2012 from 43 US children's hospitals' pediatric intensive care units (PICUs) were used. Patients with PSS were defined by (1) International Classification of Diseases, 9th Revision (ICD-9) codes reflecting severe sepsis and septic shock and (2) ICD-9 codes of infection and organ dysfunction as defined by updated Angus criteria. Among the patients with PSS, those with a PHIS flag of ECMO or RRT were identified further as our main cohort. From 2004 to 2012, 636,842 patients were identified from 43 hospitals, and PSS prevalence was 7.7 % (49,153 patients). Nine point eight percent (4795 patients) received at least one form of ET, and the associated mortality rate was 39 %. Mortality rates were 47.8 % for those who received ECMO, 32.3 % in RRT, and 58.0 % in RRT + ECMO. Underlying co-morbidities were found in 3745 patients (78.1 %) who received ET (81 % for ECMO, 77.9 % in RRT, and 71.2 % in those who received both). There was a statistically significant increase in ECMO utilization in patients with at least three organ dysfunctions from 2004 to 2012 (6.9 % versus 10.3 %, P < 0.001) while RRT use declined (24.5 % versus 13.2 %, P < 0.001). After 2009, there was a significant increase in ECMO utilization (3.6 % in 2004-2008 versus 4.0 % in 2009-2012, P = 0.004). ECMO and RRT were used simultaneously in only 500 patients with PSS (1 %). ETs were used in a significant portion of PSS patients with multiple organ dysfunction syndrome (MODS) during this time period. Mortality was significant and increased with increasing organ failure. ECMO use in PSS patients with MODS increased from 2004 to 2012. Further evaluation of ET use in PSS is warranted.

Retrospective comparison of filgrastim plus plerixafor to other regimens for remobilization after primary mobilization failure: clinical and economic outcomes.

PubMed

Perkins, Janelle B; Shapiro, Jamie F; Bookout, Ryan N; Yee, Gary C; Anasetti, Claudio; Janssen, William E; Fernandez, Hugo F

2012-07-01

We performed a retrospective analysis to evaluate clinical and economic outcomes in patients receiving remobilization therapy after primary mobilization failure. Our primary endpoint was to compare filgrastim plus plerixafor to other regimens in their ability to collect a target cell dose of at least 2 million CD34+ cells/kg (cumulative). Of 96 consecutive patients who failed their primary mobilization therapy and in whom a second mobilization was attempted, remobilization consisted of filgrastim plus plerixafor (n = 38), filgrastim with or without sargramostim (n = 43), or chemotherapy plus filgrastim (n = 15), 84% of filgrastim/plerixafor patients were able to collect at least 2 million CD34+ cells/kg from both mobilizations, compared to 60% of patients mobilized with chemotherapy/filgrastim and 79% of the filgrastim ± sargramostim patients (P = 0.17). However, when combined with cells collected from the first mobilization, 53% of filgrastim/plerixafor patients reached the target of 2 million CD34+ cells in one apheresis, compared to 20% of those receiving chemotherapy/filgrastim and 28% of those receiving filgrastim ± sargramostim (P = 0.02). Resource utilization, mobilization drug costs, clinical care costs, and total costs were significantly different. We conclude that while filgrastim/plerixafor is the most efficient remobilization strategy, those clinical benefits may not translate into lower cost, especially when multiple days of plerixafor administration are required. Copyright © 2012 Wiley Periodicals, Inc.

Clinical Trial Enrollment is Associated With Improved Follow-up Rates Among Survivors of Childhood Cancer.

PubMed

Hutchins, Kelley K; Savaşan, Süreyya; Thomas, Ronald L; Strathdee, Laura A; Wang, Zhihong J; Taub, Jeffrey W

2018-04-17

Fortunately >80% of children diagnosed with cancer become long-term survivors; however, this population is at a significantly increased risk of morbidity and mortality as a result of their previous cancer therapy, and long-term follow-up (LTFU) is critical. Multiple barriers to receiving adequate LTFU care have been studied. We investigated whether lack of enrollment in a therapeutic clinical trial may be a barrier to receiving LTFU care. We conducted a review of 353 patient records at the Children's Hospital of Michigan enrolled in our Children's Oncology Group registry between January 1, 2005 and December 31, 2010. In total, 71 patients were excluded (death before follow-up, n=61; currently receiving therapy, n=5; known transfer of care, n=4; insufficient information, n=1). In total, 158 (56%) patients were enrolled in a therapeutic clinical trial. Follow-up rates at 1-, 2- and 5-years following completion of therapy for patients enrolled in a therapeutic clinical trial were 96.8% (153/158), 93.7% (148/158), and 81.7% (103/126), respectively, compared with 83.1% (103/124; P<0.001), 74.2% (92/124; P<0.001), and 66.7% (72/108; P=0.001) for patients not enrolled. Our findings suggest patients enrolled in a therapeutic clinical trial have better LTFU rates and supports the importance of patient enrollment in therapeutic clinical trials when possible. Additional resources may be warranted to improve LTFU for patients not enrolled.

DNA damage in blood cells in relation to chemotherapy and nutritional status in colorectal cancer patients-A pilot study.

PubMed

Kværner, Ane Sørlie; Minaguchi, Jun; Yamani, Naouale El; Henriksen, Christine; Ræder, Hanna; Paur, Ingvild; Henriksen, Hege Berg; Wiedswang, Gro; Smeland, Sigbjørn; Blomhoff, Rune; Collins, Andrew Richard; Bøhn, Siv Kjølsrud

2018-03-01

DNA damage can be considered as a biomarker for toxicity and response to chemotherapy. It is not known whether the chemotherapy-induced genotoxicity is associated with malnutrition. In this pilot study, we assess genotoxicity by means of DNA damage in patients with lymph-node positive colorectal cancer (CRC) and explore associations with chemotherapy treatment and nutritional status. DNA damage was compared between patients receiving chemotherapy (n = 24) and those not receiving chemotherapy (n = 20). DNA damage was measured in frozen whole blood by the comet assay. Associations between DNA damage and various indicators of malnutrition were also explored, including Patient-Generated Subjective Global Assessment (PG-SGA), bioelectrical impedance analysis (BIA) and anthropometric measurements, using multiple linear regression models. Patients on chemotherapy have higher levels of DNA damage in blood cells than patients not receiving chemotherapy (median of 16.9 and 7.9% tail DNA respectively, p = 0.001). The moderately malnourished patients (PG-SGA category B), representing 41% of the patients, have higher levels of cellular DNA damage than patients with good nutritional status (mean difference of 7.5% tail DNA, p = 0.033). In conclusion, adjuvant chemotherapy and malnutrition are both associated with increased levels of DNA damage in blood cells of CRC patients. Carefully controlled longitudinal studies or randomized controlled trials should be performed to determine whether good nutritional status may protect against chemotherapy-induced genotoxicity and enhance compliance to therapy in CRC patients. Copyright © 2018 Elsevier B.V. All rights reserved.

Use of gastroprotection in patients discharged from hospital on nonsteroidal anti-inflammatory drugs.

PubMed

Coté, Gregory A; Norvell, John P; Rice, John P; Bulsiewicz, William J; Howden, Colin W

2008-01-01

Gastrointestinal (GI) hemorrhage is responsible for 200-400,000 hospitalizations in the United States annually. Nonsteroidal anti-inflammatory drugs (NSAIDs) are responsible for > or =30% of admissions due to GI hemorrhage. Misoprostol reduces the number of NSAID-related upper GI events while proton pump inhibitors (PPIs) reduce the incidence of endoscopic ulcers. To measure the utilization of GI prophylaxis in patients discharged from hospital on ulcerogenic medicines. We performed a medical record review of all 480 patients discharged from the medical service over a 3-month period on aspirin or nonaspirin NSAIDs. Use of gastroprotection was recorded, particularly among those patients not previously prescribed a PPI or misoprostol. Patients with a different indication for PPI therapy were excluded. In all, 480 patients were identified, and 142 were excluded. Of the 338 remaining patients, 154 (46%) were prescribed GI prophylaxis. In particular, 240 patients had not been receiving a PPI or misoprostol at the time of admission (gastroprotection naive). Of these, 23.3% received a new prescription for GI prophylaxis at discharge. Use of gastroprotection increased among patients older than 60 years compared with those 60 years and younger (P = 0.008), but there was no difference among patients with higher baseline comorbidity or those receiving multiple agents of interest. Although hospitalization offers an opportunity to recognize patients at high risk of developing upper GI complications from NSAIDs, utilization of appropriate gastroprotection seemed suboptimal. Educational efforts directed at physicians may help them recognize risk factors for GI hemorrhage and current indications for prophylaxis.

Supportive care needs and psychological distress and/or quality of life in ambulatory advanced colorectal cancer patients receiving chemotherapy: a cross-sectional study.

PubMed

Sakamoto, Nobuhiro; Takiguchi, Shuji; Komatsu, Hirokazu; Okuyama, Toru; Nakaguchi, Tomohiro; Kubota, Yosuke; Ito, Yoshinori; Sugano, Koji; Wada, Makoto; Akechi, Tatsuo

2017-12-01

Although currently many advanced colorectal cancer patients continuously receive chemotherapy, there are very few findings with regard to the supportive care needs of such patients. The purposes of this study were to investigate the patients' perceived needs and the association with psychological distress and/or quality of life, and to clarify the characteristics of patients with a high degree of unmet needs. Ambulatory colorectal cancer patients who were receiving chemotherapy were asked to complete the Short-Form Supportive Care Needs Survey questionnaire, which covers five domains of need (health system and information, psychological, physical, care and support, and sexuality needs), the Hospital Anxiety and Depression Scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Complete data were available for 100 patients. Almost all of the top 10 most common unmet needs belonged to the psychological domain. The patients' total needs were significantly associated with both psychological distress (r = 0.65, P < 0.001) and quality of life (r = -0.38, P < 0.001). A multiple regression analysis revealed that the female gender was significantly associated with higher total needs. The moderate to strong associations that exist between patients' needs and psychological distress and/or quality of life suggest that interventions that respond to patients' needs may be one possible strategy for ameliorating psychological distress and enhancing quality of life. Female patients' needs should be evaluated more carefully. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Current role of radiation therapy for multiple myeloma.

PubMed

Talamo, Giampaolo; Dimaio, Christopher; Abbi, Kamal K S; Pandey, Manoj K; Malysz, Jozef; Creer, Michael H; Zhu, Junjia; Mir, Muhammad A; Varlotto, John M

2015-01-01

Radiation therapy (RT) is a treatment modality traditionally used in patients with multiple myeloma (MM), but little is known regarding the role and effectiveness of RT in the era of novel agents, i.e., immunomodulatory drugs and proteasome inhibitors. We retrospectively reviewed data from 449 consecutive MM patients seen at our institute in 2010-2012 to assess indications for RT as well as its effectiveness. Pain response was scored similarly to RTOG 0631 and used the Numerical Rating Pain Scale. Among 442 evaluable patients, 149 (34%) patients and 262 sites received RT. The most common indication for RT was palliation of bone pain (n = 109, 42%), followed by prevention/treatment of pathological fractures (n = 73, 28%), spinal cord compression (n = 26, 10%), and involvement of vital organs/extramedullary disease (n = 25, 10%). Of the 55 patients evaluable for pain relief, complete and partial responses were obtained in 76.4 and 7.2%, respectively. Prior RT did not significantly decrease the median number of peripheral blood stem cells collected for autologous transplant, even when prior RT was given to both the spine and pelvis. Inadequacy of stem cell collection for autologous stem cell transplant (ASCT) was not significantly different and it occurred in 9 and 15% of patients receiving no RT and spine/pelvic RT, respectively. None of the three cases of therapy-induced acute myelogenous leukemia/MDS occurred in the RT group. Despite the introduction of novel effective agents in the treatment of MM, RT remains a major therapeutic component for the management in 34% of patients, and it effectively provides pain relief while not interfering with successful peripheral blood stem cell collection for ASCT.

Current Role of Radiation Therapy for Multiple Myeloma

PubMed Central

Talamo, Giampaolo; Dimaio, Christopher; Abbi, Kamal K. S.; Pandey, Manoj K.; Malysz, Jozef; Creer, Michael H.; Zhu, Junjia; Mir, Muhammad A.; Varlotto, John M.

2015-01-01

Background: Radiation therapy (RT) is a treatment modality traditionally used in patients with multiple myeloma (MM), but little is known regarding the role and effectiveness of RT in the era of novel agents, i.e., immunomodulatory drugs and proteasome inhibitors. Methods: We retrospectively reviewed data from 449 consecutive MM patients seen at our institute in 2010–2012 to assess indications for RT as well as its effectiveness. Pain response was scored similarly to RTOG 0631 and used the Numerical Rating Pain Scale. Results: Among 442 evaluable patients, 149 (34%) patients and 262 sites received RT. The most common indication for RT was palliation of bone pain (n = 109, 42%), followed by prevention/treatment of pathological fractures (n = 73, 28%), spinal cord compression (n = 26, 10%), and involvement of vital organs/extramedullary disease (n = 25, 10%). Of the 55 patients evaluable for pain relief, complete and partial responses were obtained in 76.4 and 7.2%, respectively. Prior RT did not significantly decrease the median number of peripheral blood stem cells collected for autologous transplant, even when prior RT was given to both the spine and pelvis. Inadequacy of stem cell collection for autologous stem cell transplant (ASCT) was not significantly different and it occurred in 9 and 15% of patients receiving no RT and spine/pelvic RT, respectively. None of the three cases of therapy-induced acute myelogenous leukemia/MDS occurred in the RT group. Conclusion: Despite the introduction of novel effective agents in the treatment of MM, RT remains a major therapeutic component for the management in 34% of patients, and it effectively provides pain relief while not interfering with successful peripheral blood stem cell collection for ASCT. PMID:25741475

Strict sequential catheter ablation strategy targeting the pulmonary veins and superior vena cava for persistent atrial fibrillation.

PubMed

Yoshiga, Yasuhiro; Shimizu, Akihiko; Ueyama, Takeshi; Ono, Makoto; Fukuda, Masakazu; Fumimoto, Tomoko; Ishiguchi, Hironori; Omuro, Takuya; Kobayashi, Shigeki; Yano, Masafumi

2018-08-01

An effective catheter ablation strategy, beyond pulmonary vein isolation (PVI), for persistent atrial fibrillation (AF) is necessary. Pulmonary vein (PV)-reconduction also causes recurrent atrial tachyarrhythmias. The effect of the PVI and additional effect of a superior vena cava (SVC) isolation (SVCI) was strictly evaluated. Seventy consecutive patients with persistent AF who underwent a strict sequential ablation strategy targeting the PVs and SVC were included in this study. The initial ablation strategy was a circumferential PVI. A segmental SVCI was only applied as a repeat procedure when patients demonstrated no PV-reconduction. After the initial procedure, persistent AF was suppressed in 39 of 70 (55.7%) patients during a median follow-up of 32 months. After multiple procedures, persistent AF was suppressed in 46 (65.7%) and 52 (74.3%) patients after receiving the PVI alone and PVI plus SVCI strategies, respectively. In 6 of 15 (40.0%) patients with persistent AF resistant to PVI, persistent AF was suppressed. The persistent AF duration independently predicted persistent AF recurrences after multiple PVI alone procedures [HR: 1.012 (95% confidence interval: 1.006-1.018); p<0.001] and PVI plus SVCI strategies [HR: 1.018 (95% confidence interval: 1.011-1.025); p<0.001]. A receiver-operating-characteristic analysis for recurrent persistent AF indicated an optimal cut-off value of 20 and 32 months for the persistent AF duration using the PVI alone and PVI plus SVCI strategies, respectively. The outcomes of the PVI plus SVCI strategy were favorable for patients with shorter persistent AF durations. The initial SVCI had the additional effect of maintaining sinus rhythm in some patients with persistent AF resistant to PVI. Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Continuous subcutaneous insulin infusion preserves axonal function in type 1 diabetes mellitus.

PubMed

Kwai, Natalie; Arnold, Ria; Poynten, Ann M; Lin, Cindy S-Y; Kiernan, Matthew C; Krishnan, Arun V

2015-02-01

Diabetic peripheral neuropathy is a common and debilitating complication of diabetes mellitus. Although strict glycaemic control may reduce the risk of developing diabetic peripheral neuropathy, the neurological benefits of different insulin regimens remain relatively unknown. In the present study, 55 consecutive patients with type 1 diabetes mellitus underwent clinical neurological assessment. Subsequently, 41 non-neuropathic patients, 24 of whom were receiving multiple daily insulin injections (MDII) and 17 receiving continuous subcutaneous insulin infusion (CSII), underwent nerve excitability testing, a technique that assesses axonal ion channel function and membrane potential in human nerves. Treatment groups were matched for glycaemic control, body mass index, disease duration and gender. Neurophysiological parameters were compared between treatment groups and those taken from age and sex-matched normal controls. Prominent differences in axonal function were noted between MDII-treated and CSII-treated patients. Specifically, MDII patients manifested prominent abnormalities when compared with normal controls in threshold electrotonus (TE) parameters including depolarizing TE(10-20ms), undershoot and hyperpolarizing TE (90-100 ms) (P < 0.05). Additionally, recovery cycle parameters superexcitability and subexcitability were also abnormal (P < 0.05). In contrast, axonal function in CSII-treated patients was within normal limits when compared with age-matched controls. The differences between the groups were noted in cross-sectional analysis and remained at longitudinal follow-up. Axonal function in type 1 diabetes is maintained within normal limits in patients treated with continuous subcutaneous insulin infusion and not with multiple daily insulin injections. This raises the possibility that CSII therapy may have neuroprotective potential in patients with type 1 diabetes. Copyright © 2014 John Wiley & Sons, Ltd.

Do physicians’ recommendations pull patients away from their preferred treatment options?

PubMed Central

Mendel, Rosmarie; Traut‐Mattausch, Eva; Frey, Dieter; Bühner, Markus; Berthele, Achim; Kissling, Werner; Hamann, Johannes

2011-01-01

Abstract Context and objective  Shared decision making is especially advocated for preference‐sensitive decisions. We investigated whether physicians’ recommendations pull patients away from their preferred treatment option when making a preference‐sensitive decision. Design, participants and methods  Inpatients (N = 102 with schizophrenia, N = 101 with multiple sclerosis) were presented with a hypothetical scenario (the choice between two drugs). They were first asked about their preferences concerning the two drugs and then they received a (fictitious) clinician’s recommendation that was contrary to their preferences. Subsequently they made a final choice between the two drugs. Main outcome measures  The main outcome measure was whether the patient followed the physician’s advice in the hypothetical scenario. Thereby patient’s (pre‐recommendation) preferences served as a baseline. Results  In the decision scenario, about 48% of the patients with schizophrenia and 26% of the patients with multiple sclerosis followed the advice of their physician and thus chose the treatment option that went against their initial preferences. Patients who followed their physician’s advice were less satisfied with their decision than patients not following their physician’s advice (schizophrenia: t = 2.61, P = 0.01; multiple sclerosis: t = 2.67, P = 0.009). Discussion and conclusions  When sharing decisions with patients, physicians should be aware that their advice might influence patients’ decisions away from their preferred treatment option. They should encourage their patients to identify their own preferences and help to find the treatment option most consistent with them. PMID:21323824

Pre- and Postoperative Predictors of Infection-Related Complications in Patients Undergoing Percutaneous Nephrolithotomy.

PubMed

Rivera, Marcelino; Viers, Boyd; Cockerill, Patrick; Agarwal, Deepak; Mehta, Ramila; Krambeck, Amy

2016-09-01

We aim to describe pre- and postoperative predictors of infection-related complications in individuals undergoing percutaneous nephrolithotomy (PCNL). Patients treated with PCNL from 2009 to 2013 were reviewed. Patients with positive urine or stone cultures received extended antimicrobial treatment. All others received 7 days of empirical therapy preoperatively and postoperatively. Pre- and postoperative predictors of infectious complication were identified. We identified 227 patients who underwent primary PCNL with infectious complications occurring in 37 (16%): 11 (5%) urinary tract infection/pyelonephritis, 21 (9%) systemic inflammatory response syndrome (SIRS), and 2 (0.9%) sepsis. There were no significant differences between those with and without infectious complication with regard to age, gender, stone size, presence of diabetes, or procedure duration. Those with infectious complication were more likely to have a positive intraoperative stone culture (p = 0.01), struvite stone composition (p < 0.01), staghorn calculi (p < 0.001), and multiple stones (p = 0.02). Preoperatively, on multivariable analysis, only the presence of a staghorn calculus remained independently associated with increased risks of fever/SIRS/sepsis (odds ratio [OR] 3.14; p = 0.02) and total infectious complications (OR 2.53; p = 0.02) following PCNL. After controlling for pre- and post-PCNL risk factors, again, only staghorn calculi remained significantly associated with fever/SIRS/sepsis (OR 3.41; p = 0.01) and total infectious complications (OR 2.91; p = 0.01), with presence of multiple stones approaching significance (OR 4.2, confidence interval [CI]: 0.96, 18.6; p = 0.06). In individuals undergoing PCNL on preoperative antibiotics, risk of SIRS/sepsis was low. The presence of a staghorn calculus confers a greater than threefold increased risk of postoperative infection with multiple stones approaching a significant risk. Patients with large stone burdens should be counseled appropriately regarding these risks.

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

PubMed

Huo, Jian; Liu, Li-Sha; Jian, Wen-Yuan; Zeng, Jie-Ping; Duan, Jun-Guo; Lu, Xue-Jing; Yin, Shuo

2018-06-18

Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

Cost Averted With Timely Fecal Microbiota Transplantation in the Management of Recurrent Clostridium difficile Infection in Alberta, Canada.

PubMed

Waye, Arianna; Atkins, Kerry; Kao, Dina

2016-10-01

Fecal microbiota transplantation (FMT) is highly effective in treating recurrent Clostridium difficile infection (RCDI). However, the ideal timing for offering FMT remains to be determined. Furthermore, the direct medical costs averted with timely FMT have not been examined. A retrospective review of the Edmonton FMT program database included patients who received FMT for RCDI (October 2012 to September 2014). They were divided into 2 groups: those who received FMT after 2 recurrences (the timely FMT group) and those who received FMT after at least 3 recurrences (the delayed FMT group). The primary outcome was the difference in direct medical costs related to hospital admissions and emergency room visits due to CDI between the 2 groups. The secondary outcomes were RCDI cure rate and duration of RCDI in each group. A total of 75 patients were included: 30 received timely FMT, whereas 45 received delayed FMT. The mean difference in hospital length of stay and emergency room visits related to CDI were 13.8 days shorter and 1.3 visits fewer with timely FMT, associated with a mean cost saving of $29,842 per patient. Sensitivity analysis was performed to examine the effect of outliers and comorbities on the differential costs, and it was found that the differences in average cost per patient were more pronounced in those with Charlson comorbidity index ≥3 compared with those with scores of 0 to 2. The cure rate was 94% (timely FMT group) and 93% (delayed FMT group). The mean duration of RCDI was 109 days (timely FMT group) and 281 days (delayed FMT group). Timely FMT can provide significant cost savings to health-care systems, especially for patients with multiple comorbidities.

Patient-Reported Expedited Partner Therapy for Gonorrhea in the United States: Findings of the STD Surveillance Network 2010-2012.

PubMed

Stenger, Mark R; Kerani, Roxanne P; Bauer, Heidi M; Burghardt, Nicole; Anschuetz, Greta L; Klingler, Ellen; Schumacher, Christina M; Simon, Julie; Golden, Matthew

2015-09-01

Expedited partner therapy (EPT) has been shown to prevent reinfection in persons with gonorrhea and to plausibly reduce incidence. The Centers for Disease Control and Prevention recommends EPT as an option for treating sex partners of heterosexual patients. Few studies that examine how the reported use of this valuable intervention differs by patient and provider characteristics and by geography across multiple jurisdictions in the United States are currently available. Case and patient interview data were obtained for a random sample of reported cases from 7 geographically disparate US jurisdictions participating in the Sexually Transmitted Disease (STD) Surveillance Network. These data were weighted to be representative of all reported gonorrhea cases in the 7 study sites. Patient receipt of EPT was estimated, and multivariate models were constructed separately to examine factors associated with receipt of EPT for heterosexuals and for men who have sex with men. Overall, 5.4% of patients diagnosed and reported as having gonorrhea reported receiving EPT to treat their sex partners. Heterosexual patients were more likely to have received EPT than men who have sex with men at 6.6% and 2.6% of patients, respectively. Receipt of EPT did not vary significantly by race, Hispanic ethnicity, or age for either group, although significant variation was observed in different provider settings, with patients from family planning/reproductive health and STD clinic settings more likely to report receiving EPT. Jurisdiction variations were also observed with heterosexual patients in Washington State most likely (35.5%), and those in New York City, Connecticut, and Philadelphia least likely to report receiving EPT (<2%). With the exception of one jurisdiction in the STD Surveillance Network actively promoting EPT use, patient-reported receipt of the intervention remains suboptimal across the network. Additional efforts to promote EPT, especially for patients diagnosed in private provider and hospital settings, are needed to realize the full potential of this valuable gonorrhea control intervention.

BiRd (clarithromycin, lenalidomide, dexamethasone): an update on long-term lenalidomide therapy in previously untreated patients with multiple myeloma.

PubMed

Rossi, Adriana; Mark, Tomer; Jayabalan, David; Christos, Paul; Zafar, Faiza; Pekle, Karen; Pearse, Roger; Chen-Kiang, Selina; Coleman, Morton; Niesvizky, Ruben

2013-03-14

The combination of clarithromycin, lenalidomide, and dexamethasone (BiRd) was evaluated as therapy for treatment-naive symptomatic multiple myeloma (MM), with overall response at 2 years of 90%. We reviewed the long-term follow-up of initial BiRd therapy. Seventy-two patients were given dexamethasone 40 mg weekly, clarithromycin 500 mg twice daily, and lenalidomide 25 mg daily on days 1 to 21 of a 28-day cycle. After a median follow-up of 6.6 years, overall response rates were 93%, with a very good partial response or better of 68%. Median progression-free survival was 49 months. Evaluation for the development of second primary malignancies (SPMs) was conducted, and no increase in incidence was noted in our cohort of patients who received frontline immunomodulatory therapy. BiRd remains a highly potent and safe regimen for frontline therapy in patients with MM without apparent increase in risk of SPMs. This trial was registered at www.clinicaltrials.gov as #NCT00151203.

BiRd (clarithromycin, lenalidomide, dexamethasone): an update on long-term lenalidomide therapy in previously untreated patients with multiple myeloma

PubMed Central

Rossi, Adriana; Mark, Tomer; Jayabalan, David; Christos, Paul; Zafar, Faiza; Pekle, Karen; Pearse, Roger; Chen-Kiang, Selina; Coleman, Morton

2013-01-01

The combination of clarithromycin, lenalidomide, and dexamethasone (BiRd) was evaluated as therapy for treatment-naive symptomatic multiple myeloma (MM), with overall response at 2 years of 90%. We reviewed the long-term follow-up of initial BiRd therapy. Seventy-two patients were given dexamethasone 40 mg weekly, clarithromycin 500 mg twice daily, and lenalidomide 25 mg daily on days 1 to 21 of a 28-day cycle. After a median follow-up of 6.6 years, overall response rates were 93%, with a very good partial response or better of 68%. Median progression-free survival was 49 months. Evaluation for the development of second primary malignancies (SPMs) was conducted, and no increase in incidence was noted in our cohort of patients who received frontline immunomodulatory therapy. BiRd remains a highly potent and safe regimen for frontline therapy in patients with MM without apparent increase in risk of SPMs. This trial was registered at www.clinicaltrials.gov as #NCT00151203. PMID:23299315

The impact of extended longitudinal observation on the assessment of personality disorders.

PubMed

Pedersen, G; Karterud, S; Hummelen, B; Wilberg, T

2013-11-01

Multiple sources of information are necessary for a valid assessment of personality disorders (PDs). This study investigates the impact of longitudinal observation. The sample comprised 1217 patients from 15 different treatment units. PDs were assessed at admission to treatment using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) and additional clinical information (best estimate diagnosis). After approximately 18 weeks of treatment, the SCID-II protocols were re-examined at clinical conferences and the diagnostic status reassessed on the basis of longitudinal observations in multiple group situations (longitudinal, expert, all data principle). Using this procedure, 78% of the patients' diagnostic criteria sets were changed, and 32% of patients' diagnostic statuses were changed. Many (32%) patients who were evaluated initially as not having a PD received a PD diagnosis after re-examination. The information provided by customary clinical assessment has important limitations, and longitudinal observation provides additional information that may change the diagnostic status in approximately one-third of PD cases. Copyright © 2013 John Wiley & Sons, Ltd.

Prophylactic plasma transfusion for surgical patients with abnormal preoperative coagulation tests: a single-institution propensity-adjusted cohort study.

PubMed

Jia, Qing; Brown, Michael J; Clifford, Leanne; Wilson, Gregory A; Truty, Mark J; Stubbs, James R; Schroeder, Darrell R; Hanson, Andrew C; Gajic, Ognjen; Kor, Daryl J

2016-03-01

Perioperative haemorrhage negatively affects patient outcomes and results in substantial consumption of health-care resources. Plasma transfusions are often administered to address abnormal preoperative coagulation tests, with the hope to mitigate bleeding complications. We aimed to assess the associations between preoperative plasma transfusion and bleeding complications in patients with elevated international normalised ratio (INR) undergoing non-cardiac surgery. We did an observational study in a consecutive sample of adult patients undergoing non-cardiac surgery with preoperative INR greater than or equal to 1·5. The exposure of interest was transfusion of preoperative plasma for elevated INR. The primary outcome was WHO grade 3 bleeding in the early perioperative period (from entry into the operating room until 24 h following exit from operating room). Hypotheses were tested with univariate and propensity-matched analyses. We did multiple sensitivity analyses to further evaluate the robustness of study findings. Between Jan 1, 2008, and Dec 31, 2011, we identified 1234 (8·4%) of 14 743 patients who had an INR of 1·5 or above and were included in this investigation. Of 1234 study participants, 139 (11%) received a preoperative plasma transfusion. WHO grade 3 bleeding occurred in 73 (53%) of 139 patients who received preoperative plasma compared with 350 (32%) of 1095 patients who did not (odds ratio [OR] 2·35, 95% CI 1·65-3·36; p<0·0001). Among the propensity-matched cohort, 65 (52%) of 125 plasma recipients had WHO grade 3 bleeding compared with 97 (40%) of 242 of those who did not receive preoperative plasma (OR 1·75, 95% CI 1·09-2·81; p=0·021). Results from multiple sensitivity analyses were qualitatively similar. Preoperative plasma transfusion for elevated international normalised ratios was associated with an increased frequency of perioperative bleeding complications. Findings were robust in the sensitivity analyses, suggestive that more conservative management of abnormal preoperative international normalised ratios is warranted. Mayo Clinic, National Institutes of Health. Copyright © 2016 Elsevier Ltd. All rights reserved.

Estimation of energy requirements for mechanically ventilated, critically ill patients using nutritional status

PubMed Central

Kan, Mee-Nin; Chang, Han-Hsin; Sheu, Woei-Fen; Cheng, Chien-Hsiang; Lee, Bor-Jen; Huang, Yi-Chia

2003-01-01

Background There is very little information on what is considered an adequate energy intake for mechanically ventilated, critically ill patients. The purpose of the present study was to determine this energy requirement by making use of patients' nutritional status. Methods The study was conducted in a multidisciplinary intensive care unit of Taichung Veterans General Hospital, Taiwan. Patients were hemodynamically stable and not comatose, and were requiring at least 7 days of mechanical ventilation. Fifty-four patients successfully completed this study. The resting energy expenditure was measured using indirect calorimetry. The total energy requirement was considered 120% of the measured energy expenditure. The daily nutrient intake was recorded. Nutritional status was assessed using single and multiple parameters, nitrogen balance, and medical records, and was performed within 24 hours of admission and after 7 days in the intensive care unit. Results Fifteen patients were being underfed (<90% of total energy requirement), 20 patients were in the appropriate feeding (AF) group (within ± 10% of total energy requirement), and 19 patients received overfeeding (>110% of total energy requirement). Patients in the underfeeding group received only 68.3% of their energy requirement, while the overfeeding group patients received up to 136.5% of their required calories. Only patients in the AF group had a positive nitrogen balance (0.04 ± 5.1) on day 7. AF group patients had a significantly higher Nutritional Risk Index value at day 7 than at day 1. Conclusion AF patients had more improvement in nutritional status than patients in the other feeding groups. To provide at least 120% of the resting energy expenditure seemed adequate to meet the caloric energy needs of hemodynamically stable, mechanically ventilated, critically ill patients. PMID:12974978

Interstitial pneumonia with autoimmune features: an additional risk factor for ARDS?

PubMed

Grasselli, Giacomo; Vergnano, Beatrice; Pozzi, Maria Rosa; Sala, Vittoria; D'Andrea, Gabriele; Scaravilli, Vittorio; Mantero, Marco; Pesci, Alberto; Pesenti, Antonio

2017-09-18

Interstitial pneumonia with autoimmune features (IPAF) identifies a recently recognized autoimmune syndrome characterized by interstitial lung disease and autoantibodies positivity, but absence of a specific connective tissue disease diagnosis or alternative etiology. We retrospectively reviewed the clinical presentation, diagnostic workup and management of seven critically ill patients who met diagnostic criteria for IPAF. We compared baseline characteristics and clinical outcome of IPAF patients with those of the population of ARDS patients admitted in the same period. Seven consecutive patients with IPAF admitted to intensive care unit for acute respiratory distress syndrome (ARDS) were compared with 78 patients with ARDS secondary to a known risk factor and with eight ARDS patients without recognized risk factors. Five IPAF patients (71%) survived and were discharged alive from ICU: Their survival rate was equal to that of patients with a known risk factor (71%), while the subgroup of patients without risk factors had a markedly lower survival (38%). According to the Berlin definition criteria, ARDS was severe in four IPAF patients and moderate in the remaining three. All had multiple organ dysfunction at presentation. The most frequent autoantibody detected was anti-SSA/Ro52. All patients required prolonged mechanical ventilation (median duration 49 days, range 10-88); four received extracorporeal membrane oxygenation and one received low-flow extracorporeal CO 2 removal. All patients received immunosuppressive therapy. This is the first description of a cohort of critical patients meeting the diagnostic criteria for IPAF presenting with ARDS. This diagnosis should be considered in any critically ill patient with interstitial lung disease of unknown origin. While management is challenging and level of support high, survival appears to be good and comparable to that of patients with ARDS associated with a known clinical insult.

Propensity for home death among Taiwanese cancer decedents in 2001-2006, determined by services received at end of life.

PubMed

Tang, Siew Tzuh; Huang, Ean-Wen; Liu, Tsang-Wu; Rau, Kun-Ming; Hung, Yen-Ni; Wu, Shiao-Chi

2010-10-01

The discrepancy between patients' preferred and actual place of death highlights the dilemma inherent in achieving their preferences for home death. Research on determinants of home death has been limited largely by focusing on individual-level factors and somewhat on health care resources at the primary hospital and regional levels. To investigate factors associated with home death, specifically, services received by cancer patients at the end of life (EOL). This was a retrospective cohort study using administrative data from 201,201 Taiwanese cancer decedents in the period 2001-2006. Rates of home death decreased significantly over time (from 35.67% to 32.39%). Dying at home was associated with patient demographics (gender, age, and marital status) and disease characteristics (cancer type, metastatic status, postdiagnosis survival time, and comorbidity level). Taiwanese cancer patients were less likely to die at home if they received care from a medical oncologist and in hospitals or regions with abundant health care resources. Furthermore, Taiwanese cancer patients were less likely to die at home if they used life-sustaining treatments (intensive care unit care, cardiopulmonary resuscitation, intubation, and mechanical ventilation) in the last month of life. However, multiple emergency room visits in the last month of life and receiving hospice care increased Taiwanese cancer patients' propensity to die at home. Despite the causal ambiguity in interpreting our research findings, they indicate that using life-sustaining treatments at EOL not only exacts a substantial toll from patients, family members, and society, but also decreases the likelihood of dying at home. Copyright © 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Prognostic impact of the pretreatment aspartate transaminase/alanine transaminase ratio in patients treated with first-line systemic tyrosine kinase inhibitor therapy for metastatic renal cell carcinoma.

PubMed

Kang, Minyong; Yu, Jiwoong; Sung, Hyun Hwan; Jeon, Hwang Gyun; Jeong, Byong Chang; Park, Se Hoon; Jeon, Seong Soo; Lee, Hyun Moo; Choi, Han Yong; Seo, Seong Il

2018-05-13

To examine the prognostic role of the pretreatment aspartate transaminase/alanine transaminase or De Ritis ratio in patients with metastatic renal cell carcinoma receiving first-line systemic tyrosine kinase inhibitor therapy. We retrospectively searched the medical records of 579 patients with metastatic renal cell carcinoma who visited Samsung Medical Center, Seoul, Korea, from January 2001 through August 2016. After excluding 210 patients, we analyzed 360 patients who received first-line tyrosine kinase inhibitor therapy. Cancer-specific survival and overall survival were defined as the primary and secondary end-points, respectively. A multivariate Cox proportional hazards regression model was used to identify independent prognosticators of survival outcomes. The overall population was divided into two groups according to the pretreatment De Ritis ratio as an optimal cut-off value of 1.2, which was determined by a time-dependent receiver operating characteristic curve analysis. Patients with a higher pretreatment De Ritis ratio (≥1.2) had worse cancer-specific survival and overall survival outcomes, compared with those with a lower De Ritis ratio (<1.2). Notably, a higher De Ritis ratio (≥1.2) was found to be an independent predictor of both cancer-specific survival (hazard ratio 1.61, 95% confidence interval 1.13-2.30) and overall survival outcomes (hazard ratio 1.69, 95% confidence interval 1.19-2.39), along with male sex, multiple metastasis (≥2), non-clear cell histology, advanced pT stage (≥3), previous metastasectomy and the Memorial Sloan Kettering Cancer Center risk classification. Our findings show that the pretreatment De Ritis ratio can provide valuable information about the survival outcomes of metastatic renal cell carcinoma patients receiving first-line tyrosine kinase inhibitor therapy. © 2018 The Japanese Urological Association.

Performance measurement for people with multiple chronic conditions: conceptual model.

PubMed

Giovannetti, Erin R; Dy, Sydney; Leff, Bruce; Weston, Christine; Adams, Karen; Valuck, Tom B; Pittman, Aisha T; Blaum, Caroline S; McCann, Barbara A; Boyd, Cynthia M

2013-10-01

Improving quality of care for people with multiple chronic conditions (MCCs) requires performance measures reflecting the heterogeneity and scope of their care. Since most existing measures are disease specific, performance measures must be refined and new measures must be developed to address the complexity of care for those with MCCs. To describe development of the Performance Measurement for People with Multiple Chronic Conditions (PM-MCC) conceptual model. Framework development and a national stakeholder panel. We used reviews of existing conceptual frameworks of performance measurement, review of the literature on MCCs, input from experts in the multistakeholder Steering Committee, and public comment. The resulting model centers on the patient and family goals and preferences for care in the context of multiple care sites and providers, the type of care they are receiving, and the national priority domains for healthcare quality measurement. This model organizes measures into a comprehensive framework and identifies areas where measures are lacking. In this context, performance measures can be prioritized and implemented at different levels, in the context of patients' overall healthcare needs.

IgD multiple myeloma a descriptive report of 17 cases: survival and response to therapy

PubMed Central

2012-01-01

Background Immunoglobulin D multiple myeloma (MM) is rare and has a poorer prognosis than other MM isotypes. Design and methods Seventeen patients (pts) diagnosed from 1993 to 2009 with IgD MM were selected from six institutions of Multiple Myeloma Latium-Region GIMEMA Working Group. Results Median age was 55 years, 14 patients had bone lesions, eight had renal impairment with estimated glomerular filtration rate (eGFR) < 50 ml/min, one serum calcium ≥ 12 mg/dl, 11 had lambda light chains, five stage III of ISS, six with chromosomal abnormalities. Six pts received conventional chemotherapy (CT): five melphalan + steroids based regimens. Eleven underwent high-doses of chemotherapy with autologous stem cell transplantation (HDT/ASCT), five single and six tandem ASCT: six received bortezomib and/or thalidomide as induction therapy and five VAD. Thalidomide maintenance was used in two pts: one in HDT/ASCT and one in CT group; bortezomib was used in one patient after HDT/ASCT. At a median follow up of 38 (range 19-60) and 50 months (range 17-148) for pts treated with CT and HDT/ASCT, respectively, the overall response rate (ORR) was 83% and 90%. In the group of patients treated with CT, median overall survival (OS) was 34 months (95% CI 15- 54 months), median progression free survival (PFS) was 18 months (95% CI 3-33 months) and median duration of response (DOR) was 7 months (95% CI 5-9 months). Median OS, PFS and DOR were not reached at the time of this analysis in the HDT/ASCT group of patients. Death was observed in 27.3% of pts treated with HDT/ASCT and in 66.7% undergone CT. Conclusions Despite the retrospective analysis and the small number of pts our study showed that the use of HDT/ASCT seems to improve also the prognosis of IgD MM patients. Treatment options including new drugs, before and after stem cell transplantation, may further improve the outcomes of these patients. PMID:22381082

Insulin pump patient characteristics and glucose control in the hospitalized setting.

PubMed

Kannan, Subramanian; Satra, Ankita; Calogeras, Ellen; Lock, Patricia; Lansang, M Cecilia

2014-05-01

Patients' knowledge of their insulin pumps and glucose control during hospitalization has not been studied. The aim was to study the determinants of glycemic control in patients using continuous subcutaneous insulin infusion (CSII) in the hospital. Three groups of patients were identified: those who did not need any inpatient education and continued on CSII (gorup A), those who received education then continued on CSII (group B), and those for whom CSII was not appropriate and were treated with multiple daily insulin injections (gorup C). We compared the measures of glycemic control between the 3 groups and analyzed which variables impacted glucose control. There were 50 patients, with 51 hospital admissions, 57% males, mean age 48 ± 13 years, 86% had type 1 diabetes (T1DM). The mean DM duration was 26 ± 14 years, mean duration of CSII use was 8.7 ± 6 years, and mean HbA1c was 7.6 ± 1.4%. The mean duration of hospital stay was 5.6 ± 4.6 days. Mean blood glucose (BG) and frequency of hyperglycemia and hypoglycemic events among the 3 groups adjusted for their duration of hospital stay were not statistically different. None of the patients developed diabetic ketoacidosis while using their pump. Stepwise multivariate analysis revealed knowledge of hypoglycemia correction was the single most important predictor of mean BG (P < .001). Patients who received inpatient education performed similarly to patients who did not need inpatient education. Patients who receive inpatient education on CSII fare similar as patients who did not require inpatient education. © 2014 Diabetes Technology Society.

Long-term colonization with single and multiple strains of Helicobacter pylori assessed by DNA fingerprinting.

PubMed Central

Taylor, N S; Fox, J G; Akopyants, N S; Berg, D E; Thompson, N; Shames, B; Yan, L; Fontham, E; Janney, F; Hunter, F M

1995-01-01

The gastric pathogen Helicobacter pylori establishes long-term chronic infections that can lead to gastritis, peptic ulcers, and cancer. The species is so diverse that distinctly different strains are generally recovered from each patient. To better understand the dynamics of long-term carriage, we characterized H. pylori isolates from initial and follow-up biopsy specimens from a patient population at high risk of H. pylori infection and gastric cancer. Eighty-five isolates were obtained from 23 patients and were analyzed by genomic restriction enzyme analysis, arbitrarily primed PCR fingerprinting, (random amplified polymorphic DNA analysis), and/or restriction of specific PCR-amplified genes (restriction fragment length polymorphism analysis). A single strain was found in sequential biopsy specimens from 12 of 15 patients (80%) receiving sucralfate. In the remaining three patients treated with sucralfate, two strains were identified in two patients and three strains were identified in the third patient. In contrast, a single strain was found in sequential biopsy specimens from only three of eight patients (37%) receiving bismuth, metronidazole, and nitrofurantoin. Two strains were identified in five other patients receiving bismuth-antibiotic (63%). Immunoglobulin G antibodies to H. pylori were present in the sera of all patients. Thus, H. pylori colonization can persist for long periods (up to at least 4 years), despite high titers of immunoglobulin G antibodies in serum. Resistance to metronidazole was noted in some strains before and/or after treatment, but all strains remained susceptible to amoxicillin, tetracycline, and nitrofurantoin.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7790461

Risk perception in natalizumab-treated multiple sclerosis patients and their neurologists.

PubMed

Heesen, Christoph; Kleiter, Ingo; Nguyen, Franziska; Schäffler, Nina; Kasper, Jürgen; Köpke, Sascha; Gaissmaier, Wolfgang

2010-12-01

Natalizumab is associated with the potentially life-threatening side-effect progressive multifocal leukoencephalopathy (PML). Little is known about patients' and physicians' risk estimates and attitudes towards natalizumab treatment. Consecutive natalizumab-treated patients (n = 69) and neurologists (n = 66) in two centres and cooperating private practices received an evidence-based three-page information leaflet about natalizumab-associated PML and an evaluation sheet. After reading the information, patients were significantly more likely than physicians to intend continuation of natalizumab treatment and willing to accept higher risks of PML: 49% of physicians would stop treatment at a PML risk of 2:10,000 or lower, while only 17% of patients would do so (p < 0.001). This difference could not be explained by risk calculation abilities or lack of understanding. Both groups overestimated natalizumab treatment effects. Patients had a significantly worse perception of multiple sclerosis as a malignant disease. We conclude that patients were willing to accept a higher risk of PML than neurologists. Coherent with their perception of risks and benefits, patients were also more willing to continue treatment. Open information about treatment-related risks is appreciated and might support shared decision making.

Out-of-hospital and emergency department management of epidemic scombroid poisoning.

PubMed

Eckstein, M; Serna, M; DelaCruz, P; Mallon, W K

1999-09-01

To report two epidemic outbreaks of scombroid food poisoning and their emergency medical services (EMS) response and emergency department (ED) treatment, analyzing the impact of early physician involvement and on-line medical control. Retrospective case series of two multiple-casualty incidents (MCIs) involving scombroid food poisoning. A total 57 patients were treated from two separate incidents, with 30 patients transported to area hospitals. One patient required treatment with a cardiac medication in the field and another patient eventually required hospital admission. On-scene medical control (incident 1) and early identification of the index case (incident 2) were instrumental to out-of-hospital care interventions and conservation of resources. Patient triage, field treatment, and hospital transport were expedited, with some patients treated and released from the scene. Immediate diagnosis of a food-borne illness in the out-of-hospital setting allows rapid treatment at the scene and allows for the efficient transport of multiple patients to a single receiving facility. EMS medical directors should be able to immediately respond to such incidents to make presumptive diagnoses and accurately direct patient care. When this is not possible, early identification of the index case facilitates early diagnosis and treatment.

One Size Does Not Fit All: Using Qualitative Methods to Inform the Development of an Internet Portal for Multiple Sclerosis Patients

PubMed Central

Atreja, Ashish; Mehta, Neil; Miller, Deborah; Moore, Shirley; Nichols, Karen; Miller, Holly; Harris, C Martin

2005-01-01

Disabled and elderly populations are the fastest growing segment of Internet usage. However, these people face an “Inverse Information law”- access to appropriate information is particularly difficult to those who need it the most. Our tertiary care Multiple Sclerosis (MS) center received funding to develop a MS specific patient portal linked to web messaging system so as to empower patients to become more active participants in their health care. In order to design an effective portal, we conducted a qualitative study using focus groups and direct observation techniques. The study explores the perceptions, expectations and interactions of MS patients with the portal and underscores the many challenges MS patients face in getting quality health information on the Internet. Many of the patient barriers were due to inappropriate font sizes, low contrast, cluttering of web page and use of dynamic and flashing objects. Some of these issues are not addressed by Section 508 accessibility guidelines. We believe that any future patient portal or health information web site needs to address these issues and educate the patients about accessibility options to enhance utilization and user satisfaction. PMID:16778993

Alterations in bone marrow and blood mononuclear cell polyamine and methylglyoxal bis(guanylhydrazone) levels: phase I evaluation of alpha-difluoromethylornithine and methylglyoxal bis(guanylhydrazone) treatment of human hematological malignancies.

PubMed

Maddox, A M; Freireich, E J; Keating, M J; Haddox, M K

1988-03-01

Nine patients with hematological malignancies were treated with difluoromethylornithine and methylglyoxal bis(guanylhydrazone). The number of circulating blast cells decreased in all of the patients treated with DFMO and MGBG for longer than 1 wk. Morphological evidence of myeloid maturation was evident in four patients with leukemia and the circulating M Protein decreased in one patient with multiple myeloma. The polyamine content of the mononuclear cells in both the peripheral blood and bone marrow was transiently increased after the initial MGBG dose. During administration of DFMO decreases were achieved in the peripheral blood mononuclear cell putrescine levels in 7 patients, spermidine levels in 5 patients, and spermine levels in 4 patients. Alterations in bone marrow mononuclear cell polyamine levels were similar to those which occurred in the peripheral cells. An average of 9 days of DFMO treatment was required to lower mononuclear cell polyamine levels. Three of the 4 evaluable patients receiving multiple MGBG doses had an increased mononuclear cell content of MGBG after DFMO pretreatment. Enhancement of cellular MGBG levels was not directly correlated to the degree of cellular polyamine depletion.

Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study.

PubMed

Bendaly, Edmond; Dalal, Anand A; Culver, Kenneth; Galebach, Philip; Bocharova, Iryna; Foster, Rebekah; Sasane, Medha; Macalalad, Alexander R; Guérin, Annie

2017-05-01

This study aimed to provide the first real-world description of the characteristics, treatments, dosing patterns, and early outcomes of patients with ALK-positive non-small cell lung cancer (NSCLC) who received ceritinib in US clinical practice. US oncologists provided data from medical charts of adult patients diagnosed with locally advanced or metastatic ALK-positive NSCLC who received ceritinib following crizotinib. Patient characteristics, treatment patterns, ceritinib dosing, early outcomes, and occurrence of gastrointestinal adverse events (AEs) by dose and instructions on food intake were assessed, and Kaplan-Meier analysis was used to describe clinician-defined progression-free survival (PFS) on ceritinib. Medical charts of 58 ALK-positive NSCLC patients treated with ceritinib were reviewed (median age 63 years; 41% male; 21% with prior chemotherapy experience). At ceritinib initiation, 44 patients had multiple distant metastases, most commonly in the liver (60%), bone (53%), and brain (38%). Initial ceritinib dose varied: 71% received 750 mg, 19% 600 mg, and 10% 450 mg. Although median follow-up after ceritinib initiation was short (3.8 months), most patients achieved either a complete or partial response (69%) on ceritinib, regardless of metastatic sites present at initiation or initial dose. Median PFS on ceritinib was 12.9 months. 17% of patients had a gastrointestinal AE reported during follow-up. The majority of events occurred in patients instructed to fast; no patients instructed to take a lower dose of ceritinib with food reported gastrointestinal AEs. These early findings of ceritinib use in clinical practice suggest that ceritinib is effective at treating crizotinib-experienced ALK-positive NSCLC patients, regardless of metastatic sites or initial dose, and dosing ceritinib with food may lead to fewer gastrointestinal AEs. Future studies with larger sample size and longer follow-up are warranted, including an ongoing randomized trial to assess the gastrointestinal tolerability of ceritinib 450 and 600 mg with low-fat meals. Novartis Pharmaceutical Corporation.

Cardiopulmonary Resuscitation in Patients With Terminal Illness: An Evidence-Based Analysis

PubMed Central

Sehatzadeh, S

2014-01-01

Background Cardiopulmonary resuscitation (CPR) was first introduced in 1960 for people who unexpectedly experience sudden cardiac arrest. Over the years, it became routine practice in all institutions to perform CPR for all patients even though, for some patients with fatal conditions, application of CPR only prolongs the dying process through temporarily restoring cardiac function. Objectives This analysis aims to systematically review the literature to provide an accurate estimate of survival following CPR in patients with terminal health conditions. Data Sources A literature search was performed for studies published from January 1, 2004, until January 10, 2014. The search was updated monthly to March 1, 2014. Review Methods Abstracts and full text of studies that met eligibility criteria were reviewed. Reference lists were also examined for any additional relevant studies not identified through the search. Results Cancer patients have lower survival rates following CPR than patients with conditions other than cancer, and cancer patients who receive CPR in intensive care units have one-fifth the rate of survival to discharge of cancer patients who receive CPR in general wards. While the meta-analysis of studies published between 1967 and 2005 reported a lower survival to discharge for cancer patients (6.2%), more recent studies reported higher survival to discharge or to 30-day survival for these patients. Higher survival rates in more recent studies could originate with more “do not attempt resuscitation” orders for patients with end-stage cancer in recent years. Older age does not significantly decrease the rate of survival following CPR while the degree, the type, and the number of chronic health conditions; functional dependence; and multiple CPRs (particularly in advanced age) do reduce survival rates. Emergency Medical Services response time have a significant impact on survival following out-of-hospital CPR. Conclusions Survival after CPR depends on the severity of illness, type and number of health conditions, functional dependence, and multiple CPRs. PMID:26339301

Cardiopulmonary Resuscitation in Patients With Terminal Illness: An Evidence-Based Analysis.

PubMed

Sehatzadeh, S

2014-01-01

Cardiopulmonary resuscitation (CPR) was first introduced in 1960 for people who unexpectedly experience sudden cardiac arrest. Over the years, it became routine practice in all institutions to perform CPR for all patients even though, for some patients with fatal conditions, application of CPR only prolongs the dying process through temporarily restoring cardiac function. This analysis aims to systematically review the literature to provide an accurate estimate of survival following CPR in patients with terminal health conditions. A literature search was performed for studies published from January 1, 2004, until January 10, 2014. The search was updated monthly to March 1, 2014. Abstracts and full text of studies that met eligibility criteria were reviewed. Reference lists were also examined for any additional relevant studies not identified through the search. Cancer patients have lower survival rates following CPR than patients with conditions other than cancer, and cancer patients who receive CPR in intensive care units have one-fifth the rate of survival to discharge of cancer patients who receive CPR in general wards. While the meta-analysis of studies published between 1967 and 2005 reported a lower survival to discharge for cancer patients (6.2%), more recent studies reported higher survival to discharge or to 30-day survival for these patients. Higher survival rates in more recent studies could originate with more "do not attempt resuscitation" orders for patients with end-stage cancer in recent years. Older age does not significantly decrease the rate of survival following CPR while the degree, the type, and the number of chronic health conditions; functional dependence; and multiple CPRs (particularly in advanced age) do reduce survival rates. Emergency Medical Services response time have a significant impact on survival following out-of-hospital CPR. Survival after CPR depends on the severity of illness, type and number of health conditions, functional dependence, and multiple CPRs.

No evidence of disease activity in patients receiving fingolimod at private or academic centers in clinical practice: a retrospective analysis of the multiple sclerosis, clinical, and magnetic resonance imaging outcomes in the USA (MS-MRIUS) study.

PubMed

Zivadinov, Robert; Khan, Nasreen; Korn, Jonathan R; Lathi, Ellen; Silversteen, Jason; Calkwood, Jonathan; Kolodny, Scott; Silva, Diego; Medin, Jennie; Weinstock-Guttman, Bianca

2018-04-12

The impact of multiple sclerosis (MS) center type on outcomes has not been investigated. This study aimed to evaluate baseline characteristics and clinical and magnetic resonance imaging (MRI) outcomes in patients with MS receiving fingolimod over 16 months' follow-up at private or academic centers in the USA. Clinical and MRI data collected in clinical practice from patients initiating fingolimod were stratified by center type and retrospectively analyzed. No evidence of disease activity (NEDA-3) was defined as patients with no new/enlarged T2/gadolinium-enhancing lesions, no relapses, and no disability progression (Expanded Disability Status Scale scores). Data were collected for 398 patients from 25 private centers and 192 patients from eight academic centers. Patients were older (median age = 43 vs 41 years; p = .0047) and had a numerically shorter median disease duration (7.0 vs 8.5 years; p = .0985) at private vs academic centers. Annualized relapse rate (ARR) was higher in patients at private than academic centers in the pre-index (0.40 vs 0.29; p = .0127) and post-index (0.16 vs 0.08; p = .0334) periods. The opposite was true for T2 lesion volume in the pre-index (2.86 vs 5.23 mL; p = .0002) and post-index (2.86 vs 5.11 mL; p = .0016) periods; other MRI outcomes were similar between center types. After initiating fingolimod, ARRs were reduced, disability and most MRI outcomes remained stable, and a similar proportion of patients achieved NEDA-3 at private and academic centers (64.1% vs 56.1%; p = .0659). Patient characteristics differ between private and academic centers. Over 55% of patients achieved NEDA-3 during fingolimod treatment at both center types.

Cysticercal encephalitis presenting with a "starry sky" appearance on neuroimaging.

PubMed

Patil, Tushar B; Gulhane, Ragini V

2015-01-01

A lady in her early forties was brought to our hospital in an unconscious state with history of generalized tonic-clonic seizures for last 6 h. She had multiple episodes of seizures in last 4 months, but did not receive any treatment. Relatives also gave a history of fever, headache, and vomiting for last 1 week. Her seizures were controlled with intravenous lorazepam and valproate. Clinical examination revealed a delirious patient with bilateral papilledema, brisk deep tendon reflexes, and extensor plantars. She had aspirated and had bilateral coarse crepitations on chest auscultation. Computed tomography (CT) of brain showed multiple small hyperdense calcific lesions extending throughout both the cerebral hemispheres leading to a "starry sky" appearance, suggestive of cysticercal encephalitis. The patient succumbed to progressive aspiration pneumonitis on the 6(th) day after hospitalization.

Clinical effectiveness of multiple-drug injection treatment in unruptured ectopic pregnancies: a retrospective study.

PubMed

Dai, Quan; Wang, Lu-Lu; Shao, Xiao-Hui; Wang, Si-Ming; Dong, Xiao-Qiu

2012-10-01

To study the effect of local interventional treatment of unruptured ectopic pregnancies with multiple-drug injection guided by color Doppler sonography. In this retrospective analysis, 49 patients with an unruptured ectopic pregnancy were treated with two different local injection methods administered under sonographic guidance. The patients were divided into single-drug (n = 23) and multiple-drug (n = 26) injection groups, and they received a locally administered injection of methotrexate alone or a combination including methotrexate, hemocoagulase, antibiotics, and anti-inflammatory drugs, respectively. Overall, local injection treatment was successful in 44 patients. The 5 patients with failed treatment underwent laparotomy about 1 week after single-drug injection. Serum β-human chorionic gonadotropin (β-hCG ) levels, ectopic pregnancy mass sizes, blood flow at various points after treatment, the incidence of pelvic bleeding, and the time for serum β-hCG levels to return to normal and the mass to resolve were analyzed in the remaining 44 patients. Single-drug treatment was successful in 18 patients; 10 of 23 had low to moderate pelvic bleeding after treatment, and 5 were referred for surgery. All 26 patients were successfully treated by multiple-drug injection. Only 2 patients had a small amount of pelvic bleeding. Differences between groups were statistically significant (P < .05) for surgery rates, the incidence of pelvic bleeding, transient increases in serum β-hCG levels, mean days to normal β-hCG levels, mean days of mass resolution, and mean mass diameters 1 to 6 weeks after treatment. Local multiple-drug injection under color Doppler guidance is a new, safe, and effective method for treating unruptured ectopic pregnancies. It accelerates the serum β-hCG decline and facilitates mass resolution. This regimen is associated with a very low rate of pelvic bleeding, improves the success rate of conservative treatment, and, therefore, has value as an important clinical application.

Extravasation of liposomal daunorubicin in patients with AIDS-associated Kaposi's sarcoma: a report of four cases.

PubMed

Cabriales, S; Bresnahan, J; Testa, D; Espina, B M; Scadden, D T; Ross, M; Gill, P S

1998-01-01

To report on four patients with AIDS-related Kaposi's sarcoma who were treated with liposomal daunorubicin (DaunoXome, NeXstar Pharmaceuticals, Inc., San Dimas, CA) as part of phase I/II and phase III clinical trials and who experienced extravasation during IV infusion. All patients were treated with ice as an immediate intervention. In addition, two patients received treatment with multiple subcutaneous injections of steroids. Two patients experienced erythema, swelling, and pain after the extravasation. Two patients who were treated aggressively reported erythema and swelling without pain. Three patients observed changes in the texture of their skin that was accompanied by decreased sensation, which developed after 8-16 weeks. These changes completely resolved in all patients receiving intervention after six months. None of the patients suffered tissue necrosis. Extravasation with liposomal daunorubicin is notable for the absence of tissue necrosis that typically is observed with anthracyclines. Long-term effects were limited to skin discoloration and decreased sensation, both of which resolved in all patients. The lack of observed skin necrosis with daunorubicin suggests a treatment advantage with a reduction in the required aggressive extravasation procedures for free anthracyclines as well as increased safety for the patient. Additional data is needed to confirm these observations.

Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients.

PubMed

Mulvaney, Sean W; Lynch, James H; Hickey, Matthew J; Rahman-Rawlins, Tabassum; Schroeder, Matthew; Kane, Shawn; Lipov, Eugene

2014-10-01

Report the successful use of stellate ganglion blocks (SGBs) in 166 active duty service members with multiple combat deployments experiencing anxiety symptoms associated with post-traumatic stress disorder (PTSD). Successful treatment of PTSD symptoms with SGB has been reported previously. This is the largest published case series evaluating SGB with a minimum of 3 months follow-up. Following clinical interview including administration of the PTSD Checklist (PCL), 166 service members with symptoms of PTSD elected to receive a SGB. All patients received a SGB on the right side at the level of the sixth cervical vertebrae (C6). The PCL was administered the day before treatment to establish a baseline, repeated 1 week later, and then monthly out to 3 months. A positive response was considered to be an improvement in the PCL score by 10 or greater points. Follow-up PCL scores from 3 to 6 months were obtained and analyzed for 166 patients. In a military population with multiple combat deployments, over 70% of the patients treated had a clinically significant improvement in their PCL score which persisted beyond 3 to 6 months postprocedure. Selective blockade of the right cervical sympathetic chain at the C6 level is a safe and minimally invasive procedure that may provide durable relief from anxiety symptoms associated with PTSD. Reprint & Copyright © 2014 Association of Military Surgeons of the U.S.

Efficacy and toxicity of the combination chemotherapy of thalidomide, alkylating agent, and steroid for relapsed/refractory myeloma patients: a report from the Korean Multiple Myeloma Working Party (KMMWP) retrospective study.

PubMed

Kwon, Jihyun; Min, Chang-Ki; Kim, Kihyun; Han, Jae-Joon; Moon, Joon Ho; Kang, Hye Jin; Eom, Hyeon-Seok; Kim, Min Kyoung; Kim, Hyo Jung; Yoon, Dok Hyun; Lee, Jeong-Ok; Lee, Won Sik; Lee, Jae Hoon; Lee, Je-Jung; Choi, Yoon-Seok; Kim, Sung Hyun; Yoon, Sung-Soo

2017-01-01

We analyzed the treatment responses, toxicities, and survival outcomes of patients with relapsed or refractory multiple myeloma who received daily thalidomide, cyclophosphamide, and dexamethasone (CTD) or daily thalidomide, melphalan, and prednisolone (MTP) at 17 medical centers in Korea. Three-hundred and seventy-six patients were enrolled. The combined chemotherapy of thalidomide, corticosteroid, and an alkylating agent (TAS) was second-line chemotherapy in 142 (37.8%) patients, and third-line chemotherapy in 135 (35.9%) patients. The response rate overall was 69.4%. Patients who were not treated with bortezomib and lenalidomide before TAS showed a higher response rate compared to those who were exposed to these agents. The estimated median progression-free survival and overall survival times were 10.4 months and 28.0 months, respectively. The adverse events during TAS were generally tolerable, but 39 (10.4%) patients experienced severe infectious complications. There were no differences in terms of efficacy between CTD and MTP, but infectious complications were more common in CTD group. TAS is an effective treatment regimen which induces a high response rate in relapsed or refractory multiple myeloma patients. Due to the high incidence of grade 3 or 4 infection, proper management of infection is necessary during the TAS treatment, especially the CTD. © 2016 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Icing oral mucositis: Oral cryotherapy in multiple myeloma patients undergoing autologous hematopoietic stem cell transplant.

PubMed

Chen, Joey; Seabrook, Jamie; Fulford, Adrienne; Rajakumar, Irina

2017-03-01

Background Up to 70% of patients receiving hematopoietic stem cell transplant develop oral mucositis as a side effect of high-dose melphalan conditioning chemotherapy. Oral cryotherapy has been documented to be potentially effective in reducing oral mucositis. The aim of this study was to examine the effectiveness of the cryotherapy protocol implemented within the hematopoietic stem cell transplant program. Methods A retrospective chart review was conducted of adult multiple myeloma patients who received high-dose melphalan conditioning therapy for autologous hematopoietic stem cell transplant. Primary endpoints were incidence and severity of oral mucositis. Secondary endpoints included duration of oral mucositis, duration of hospital stay, parenteral narcotics use and total parenteral nutrition use. Results One hundred and forty patients were included in the study, 70 patients in both no cryotherapy and cryotherapy groups. Both oral mucositis incidence and severity were found to be significantly lower in the cryotherapy group. Fifty (71.4%) experienced mucositis post cryotherapy compared to 67 (95.7%) in the no cryotherapy group (p < 0.001). The median oral mucositis severity, assessed using the WHO oral toxicity scale from grade 0-4, experienced in the no group was 2.5 vs. 2 in the cryotherapy group (p = 0.03). Oral mucositis duration and use of parenteral narcotics were also significantly reduced. Duration of hospital stay and use of parenteral nutrition were similar between the two groups. Conclusion The cryotherapy protocol resulted in a significantly lower incidence and severity of oral mucositis. These results provide evidence for the continued use of oral cryotherapy, an inexpensive and generally well-tolerated practice.

Minocycline added to subcutaneous interferon β-1a in multiple sclerosis: randomized RECYCLINE study.

PubMed

Sørensen, P S; Sellebjerg, F; Lycke, J; Färkkilä, M; Créange, A; Lund, C G; Schluep, M; Frederiksen, J L; Stenager, E; Pfleger, C; Garde, E; Kinnunen, E; Marhardt, K

2016-05-01

Combining different therapies may improve disease control in patients with relapsing-remitting multiple sclerosis (RRMS). This study assessed the efficacy and safety of minocycline added to subcutaneous (sc) interferon (IFN) β-1a therapy. This was a double-blind, randomized, placebo-controlled multicentre study. Within 3 months (±1 month) of starting sc IFN β-1a 44 μg three times weekly, patients with RRMS were randomized to minocycline 100 mg twice daily or placebo, added to sc IFN β-1a, for 96 weeks. The primary efficacy endpoint was the time to first qualifying relapse. Secondary efficacy endpoints were the annualized relapse rate for qualifying relapses, the number of new/enlarging T2-weighted lesions and change in brain volume [magnetic resonance imaging (MRI) was performed only in a few selected centres]. In addition, a number of tertiary efficacy endpoints were assessed. One hundred and forty-nine patients received minocycline and 155 received placebo; MRI data were available for 23 and 27 patients, respectively. The time to first qualifying relapse did not differ significantly for minocycline versus placebo (hazard ratio 0.85; 95% confidence interval 0.53, 1.35; log-rank = 0.50; P = 0.48). There were no statistically significant differences between the two groups on other efficacy endpoints, although some numerical trends in favour of minocycline were observed. No unexpected adverse events were reported, but more patients discontinued because of adverse events with minocycline versus placebo. Minocycline showed no statistically significant beneficial effect when added to sc IFN β-1a therapy. © 2016 EAN.

Efficacy of multiple arterial coronary bypass grafting in patients with diabetes mellitus.

PubMed

Yamaguchi, Atsushi; Kimura, Naoyuki; Itoh, Satoshi; Adachi, Koichi; Yuri, Koichi; Okamura, Homare; Adachi, Hideo

2016-09-01

Use of the left internal mammary artery in patients with diabetes mellitus and multivessel coronary artery disease is known to improve survival after coronary artery bypass grafting (CABG); however, the survival benefit of multiple arterial grafts (MAGs) in diabetic patients is debated. We investigated the efficacy of CABG performed with MAGs in diabetic patients. The overall patient group comprised 2618 consecutive patients who underwent isolated CABG at our hospital between 1990 and 2014. Perioperative characteristics, in-hospital outcomes and long-term outcomes were compared between diabetic (n = 1110) and non-diabetic patients (n = 1508). The long-term outcomes of diabetic and non-diabetic patients were analysed between those who received a single arterial graft (SAG) and those who received MAGs. Both full unmatched patient population and propensity-matched patient population analyses (diabetic cohort = 431 pairs, non-diabetic cohort = 577 pairs) were performed. Preoperative comorbidities were much more common in the diabetic patients than in the non-diabetic patients; however, comorbidities were not associated with in-hospital outcomes (diabetes versus non-diabetes group, in-hospital mortality: 2.2 vs 1.5%; deep sternal wound infection: 2.2 vs 1.8%, P > 0.05). Although survival and freedom from major cardiac and cerebrovascular events (MACCEs) at 15 years were lower in the diabetes group than in the non-diabetes group (survival: 48.6 vs 55.0%, P = 0.019; MACCE-free survival: 40.8 vs 46.1%, P = 0.02), cardiac death-free survival at 15 years was similar (81.7 vs 83.9%, P = 0.24). Overall, 12-year survival was higher in both diabetic and non-diabetic patients treated with MAGs than in those treated with an SAG (64.9 vs 56.8%, P = 0.006, and 71.9 vs 60.5%, P < 0.001). Propensity-matched patient cohort analysis revealed improved 12-year survival with MAGs versus SAG in both the diabetes group (64.9 vs 58.8%, P = 0.041) and non-diabetes group (71.4 vs 63.8%, P = 0.014). Similarly, MACCE-free survival was improved in both groups. A long-term survival advantage, with no increase in perioperative morbidity, is conferred with the use of multiple arterial bypass grafts not only in non-diabetic patients but also in diabetic patients. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Parental satisfaction with paediatric care, triage and waiting times.

PubMed

Fitzpatrick, Nicholas; Breen, Daniel T; Taylor, James; Paul, Eldho; Grosvenor, Robert; Heggie, Katrina; Mahar, Patrick D

2014-04-01

The present study aims to determine parental and guardian's perceptions of paediatric emergency care and satisfaction with care, waiting times and triage category in a community ED. A structured questionnaire was provided to parents or guardians of paediatric patients presenting to emergency. The survey evaluated parent perceptions of waiting time, environment/facilities, professionalism and communication skills of staff and overall satisfaction of care. One hundred and thirty-three completed questionnaires were received from parents of paediatric patients. Responses were overall positive with respect to the multiple domains assessed. Parents generally considered waiting times to be appropriate and consistent with triage categories. Overall satisfaction was not significantly different for varying treatment or waiting times. Patients triaged as semi-urgent were of the opinion that waiting times were less appropriate than urgent, less-urgent or non-urgent patients. On the basis of the present study, patient perceptions and overall satisfaction of care does not appear to be primarily influenced by time spent waiting or receiving treatment. Attempts made at the triage process to ensure that semi-urgent patients have reasonable expectations of waiting times might provide an opportunity to improve these patients' expectations and perceptions. © 2014 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Cluster Bomb Ocular Injuries

PubMed Central

Mansour, Ahmad M.; Hamade, Haya; Ghaddar, Ayman; Mokadem, Ahmad Samih; El Hajj Ali, Mohamad; Awwad, Shady

2012-01-01

Purpose: To present the visual outcomes and ocular sequelae of victims of cluster bombs. Materials and Methods: This retrospective, multicenter case series of ocular injury due to cluster bombs was conducted for 3 years after the war in South Lebanon (July 2006). Data were gathered from the reports to the Information Management System for Mine Action. Results: There were 308 victims of clusters bombs; 36 individuals were killed, of which 2 received ocular lacerations and; 272 individuals were injured with 18 receiving ocular injury. These 18 surviving individuals were assessed by the authors. Ocular injury occurred in 6.5% (20/308) of cluster bomb victims. Trauma to multiple organs occurred in 12 of 18 cases (67%) with ocular injury. Ocular findings included corneal or scleral lacerations (16 eyes), corneal foreign bodies (9 eyes), corneal decompensation (2 eyes), ruptured cataract (6 eyes), and intravitreal foreign bodies (10 eyes). The corneas of one patient had extreme attenuation of the endothelium. Conclusions: Ocular injury occurred in 6.5% of cluster bomb victims and 67% of the patients with ocular injury sustained trauma to multiple organs. Visual morbidity in civilians is an additional reason for a global ban on the use of cluster bombs. PMID:22346132

Adaptive receiver structures for asynchronous CDMA systems

NASA Astrophysics Data System (ADS)

Rapajic, Predrag B.; Vucetic, Branka S.

1994-05-01

Adaptive linear and decision feedback receiver structures for coherent demodulation in asynchronous code division multiple access (CDMA) systems are considered. It is assumed that the adaptive receiver has no knowledge of the signature waveforms and timing of other users. The receiver is trained by a known training sequence prior to data transmission and continuously adjusted by an adaptive algorithm during data transmission. The proposed linear receiver is as simple as a standard single-user detector receiver consisting of a matched filter with constant coefficients, but achieves essential advantages with respect to timing recovery, multiple access interference elimination, near/far effect, narrowband and frequency-selective fading interference suppression, and user privacy. An adaptive centralized decision feedback receiver has the same advantages of the linear receiver but, in addition, achieves a further improvement in multiple access interference cancellation at the expense of higher complexity. The proposed receiver structures are tested by simulation over a channel with multipath propagation, multiple access interference, narrowband interference, and additive white Gaussian noise.

A phase 2 trial of lenalidomide, bortezomib, and dexamethasone in patients with relapsed and relapsed/refractory myeloma

PubMed Central

Xie, Wanling; Jagannath, Sundar; Jakubowiak, Andrzej; Lonial, Sagar; Raje, Noopur S.; Alsina, Melissa; Ghobrial, Irene M.; Schlossman, Robert L.; Munshi, Nikhil C.; Mazumder, Amitabha; Vesole, David H.; Kaufman, Jonathan L.; Colson, Kathleen; McKenney, Mary; Lunde, Laura E.; Feather, John; Maglio, Michelle E.; Warren, Diane; Francis, Dixil; Hideshima, Teru; Knight, Robert; Esseltine, Dixie-Lee; Mitsiades, Constantine S.; Weller, Edie; Anderson, Kenneth C.

2014-01-01

In this prospective, multicenter, phase 2 study, 64 patients with relapsed or relapsed and refractory multiple myeloma (MM) received up to 8 21-day cycles of bortezomib 1.0 mg/m2 (days 1, 4, 8, and 11), lenalidomide 15 mg/day (days 1-14), and dexamethasone 40/20 mg/day (cycles 1-4) and 20/10 mg/day (cycles 5-8) (days of/after bortezomib dosing). Responding patients could receive maintenance therapy. Median age was 65 years; 66% were male, 58% had relapsed and 42% had relapsed and refractory MM, and 53%, 75%, and 6% had received prior bortezomib, thalidomide, and lenalidomide, respectively. Forty-eight of 64 patients (75%; 90% confidence interval, 65-84) were alive without progressive disease at 6 months (primary end point). The rate of partial response or better was 64%; median duration of response was 8.7 months. Median progression-free and overall survivals were 9.5 and 30 months, respectively (median follow-up: 44 months). Common treatment-related toxicities included sensory neuropathy (53%), fatigue (50%), and neutropenia (42%); common grade 3/4 treatment-related toxicities included neutropenia (30%), thrombocytopenia (22%), and lymphopenia (11%). Grade 3 motor neuropathy was reported in 2 patients. Lenalidomide-bortezomib-dexamethasone appears effective and tolerable in patients with relapsed or relapsed and refractory MM, demonstrating substantial activity among patients with diverse prior therapies and adverse prognostic characteristics. This trial is registered with www.clinicaltrials.gov as #NCT00378209. PMID:24429336

FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

PubMed

Beaver, Julia A; Amiri-Kordestani, Laleh; Charlab, Rosane; Chen, Wei; Palmby, Todd; Tilley, Amy; Zirkelbach, Jeanne Fourie; Yu, Jingyu; Liu, Qi; Zhao, Liang; Crich, Joyce; Chen, Xiao Hong; Hughes, Minerva; Bloomquist, Erik; Tang, Shenghui; Sridhara, Rajeshwari; Kluetz, Paul G; Kim, Geoffrey; Ibrahim, Amna; Pazdur, Richard; Cortazar, Patricia

2015-11-01

On February 3, 2015, the FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The approval is based on a randomized, multicenter, open-label phase I/II trial (PALOMA-1) in 165 patients randomized to palbociclib (125 mg orally daily for 21 consecutive days, followed by 7 days off treatment) plus letrozole (2.5 mg orally daily) or letrozole alone. The phase II portion of the trial was divided into two cohorts: cohort 1 enrolled 66 biomarker-unselected patients and cohort 2 enrolled 99 biomarker-positive patients. The major efficacy outcome measure was investigator-assessed progression-free survival (PFS). A large magnitude of improvement in PFS was observed in patients receiving palbociclib plus letrozole compared with patients receiving letrozole alone (HR, 0.488; 95% confidence interval, 0.319-0.748). Multiple sensitivity analyses were supportive of clinical benefit. The most common adverse reaction in patients receiving palbociclib plus letrozole was neutropenia. This article summarizes the FDA thought process and data supporting accelerated approval based on PALOMA-1 that may be contingent upon verification and description of clinical benefit in the ongoing and fully accrued confirmatory trial PALOMA-2. ©2015 American Association for Cancer Research.

A web-based decision support tool for prognosis simulation in multiple sclerosis.

PubMed

Veloso, Mário

2014-09-01

A multiplicity of natural history studies of multiple sclerosis provides valuable knowledge of the disease progression but individualized prognosis remains elusive. A few decision support tools that assist the clinician in such task have emerged but have not received proper attention from clinicians and patients. The objective of the current work is to implement a web-based tool, conveying decision relevant prognostic scientific evidence, which will help clinicians discuss prognosis with individual patients. Data were extracted from a set of reference studies, especially those dealing with the natural history of multiple sclerosis. The web-based decision support tool for individualized prognosis simulation was implemented with NetLogo, a program environment suited for the development of complex adaptive systems. Its prototype has been launched online; it enables clinicians to predict both the likelihood of CIS to CDMS conversion, and the long-term prognosis of disability level and SPMS conversion, as well as assess and monitor the effects of treatment. More robust decision support tools, which convey scientific evidence and satisfy the needs of clinical practice by helping clinicians discuss prognosis expectations with individual patients, are required. The web-based simulation model herein introduced proposes to be a step forward toward this purpose. Copyright © 2014 Elsevier B.V. All rights reserved.

Saxagliptin versus glipizide as add-on therapy to metformin: assessment of hypoglycemia.

PubMed

Mintz, Matthew L; Minervini, Gianmaria

2014-05-01

To compare characteristics of hypoglycemic episodes in patients with type 2 diabetes receiving saxagliptin or glipizide add-on therapy to metformin. This was a post hoc analysis of an international, randomized, parallel-group, double-blind, active-controlled, phase 3 trial. The 52-week trial and 52-week extension were conducted from December 2007 to August 2010. Patients aged ≥18 years with glycated hemoglobin (HbA1c) >6.5% to 10.0% receiving stable metformin doses (≥1500 mg/d) were randomized 1:1 to add-on therapy with saxagliptin 5 mg/d or glipizide 5 to 20 mg/d (titrated to optimal effect or highest tolerable dose during the initial 18 weeks). Hypoglycemic episodes were recorded in patient diaries. Confirmed hypoglycemic events were defined as fingerstick glucose ≤50 mg/dL (≤2.8 mmol/L) with associated symptoms. Of 858 patients randomized, 428 received saxagliptin + metformin, and 430 received glipizide + metformin. Saxagliptin was noninferior to glipizide in lowering HbA1c. Hypoglycemia with saxagliptin + metformin and glipizide + metformin was reported by 15 (24 events) and 165 (896 events) patients, respectively, through week 104. The mean (SD) number of hypoglycemic events per patient reporting hypoglycemia was lower with saxagliptin + metformin versus glipizide + metformin through weeks 52 (1.5 [SD 0.88] vs 4.8 [SD 4.9], respectively) and 104 (1.6 [SD 0.99] vs 5.4 [SD 5.8]). Most patients receiving glipizide + metformin with hypoglycemia had multiple events (124/165 patients [75%]). Confirmed hypoglycemia, major events, and severe events occurred only with glipizide + metformin. Time to first hypoglycemic event was shorter with glipizide versus saxagliptin. Limitations of this analysis include its post hoc nature, a high rate of study discontinuation, and exclusion of patients with serious comorbidities and complications. Saxagliptin + metformin was associated with fewer patients reporting hypoglycemia and fewer and less severe hypoglycemic events in those experiencing hypoglycemia compared with glipizide + metformin. ClinicalTrials.gov registration number: NCT00575588.

Multiple bio-monitoring system using visible light for electromagnetic-wave free indoor healthcare

NASA Astrophysics Data System (ADS)

An, Jinyoung; Pham, Ngoc Quan; Chung, Wan-Young

2017-12-01

In this paper, a multiple biomedical data transmission system with visible light communication (VLC) is proposed for an electromagnetic-wave-free indoor healthcare. VLC technology has emerged as an alternative solution to radio-frequency (RF) wireless systems, due to its various merits, e.g., ubiquity, power efficiency, no RF radiation, and security. With VLC, critical bio-medical signals, including electrocardiography (ECG), can be transmitted in places where RF radiation is restricted. This potential advantage of VLC could save more lives in emergency situations. A time hopping (TH) scheme is employed to transfer multiple medical-data streams in real time with a simple system design. Multiple data streams are transmitted using identical color LEDs and go into an optical detector. The received multiple data streams are demodulated and rearranged using a TH-based demodulator. The medical data is then monitored and managed to provide the necessary medical care for each patient.

The US Network of Pediatric Multiple Sclerosis Centers: Development, Progress, and Next Steps.

PubMed

Casper, T Charles; Rose, John W; Roalstad, Shelly; Waubant, Emmanuelle; Aaen, Gregory; Belman, Anita; Chitnis, Tanuja; Gorman, Mark; Krupp, Lauren; Lotze, Timothy E; Ness, Jayne; Patterson, Marc; Rodriguez, Moses; Weinstock-Guttman, Bianca; Browning, Brittan; Graves, Jennifer; Tillema, Jan-Mendelt; Benson, Leslie; Harris, Yolanda

2015-09-01

Multiple sclerosis and other demyelinating diseases in the pediatric population have received an increasing level of attention by clinicians and researchers. The low incidence of these diseases in children creates a need for the involvement of multiple clinical centers in research efforts. The Network of Pediatric Multiple Sclerosis Centers was created initially in 2006 to improve the diagnosis and care of children with demyelinating diseases. In 2010, the Network shifted its focus to multicenter research while continuing to advance the care of patients. The Network has obtained support from the National Multiple Sclerosis Society, the Guthy-Jackson Charitable Foundation, and the National Institutes of Health. The Network will continue to serve as a platform for conducting impactful research in pediatric demyelinating diseases of the central nervous system. This article provides a description of the history and development, organization, mission, research priorities, current studies, and future plans of the Network. © The Author(s) 2014.

The US Network of Pediatric Multiple Sclerosis Centers: Development, Progress, and Next Steps

PubMed Central

Casper, T. Charles; Rose, John W.; Roalstad, Shelly; Waubant, Emmanuelle; Aaen, Gregory; Belman, Anita; Chitnis, Tanuja; Gorman, Mark; Krupp, Lauren; Lotze, Timothy E.; Ness, Jayne; Patterson, Marc; Rodriguez, Moses; Weinstock-Guttman, Bianca; Browning, Brittan; Graves, Jennifer; Tillema, Jan-Mendelt; Benson, Leslie; Harris, Yolanda

2014-01-01

Multiple sclerosis and other demyelinating diseases in the pediatric population have received an increasing level of attention by clinicians and researchers. The low incidence of these diseases in children creates a need for the involvement of multiple clinical centers in research efforts. The Network of Pediatric Multiple Sclerosis Centers was created initially in 2006 to improve the diagnosis and care of children with demyelinating diseases. In 2010, the Network shifted its focus to multicenter research while continuing to advance the care of patients. The Network has obtained support from the National Multiple Sclerosis Society, the Guthy-Jackson Charitable Foundation, and the National Institutes of Health. The Network will continue to serve as a platform for conducting impactful research in pediatric demyelinating diseases of the central nervous system. This article provides a description of the history and development, organization, mission, research priorities, current studies, and future plans of the Network. PMID:25270659

Combined Diffusion Tensor Imaging and Apparent Transverse Relaxation Rate Differentiate Parkinson Disease and Atypical Parkinsonism.

PubMed

Du, G; Lewis, M M; Kanekar, S; Sterling, N W; He, L; Kong, L; Li, R; Huang, X

2017-05-01

Both diffusion tensor imaging and the apparent transverse relaxation rate have shown promise in differentiating Parkinson disease from atypical parkinsonism (particularly multiple system atrophy and progressive supranuclear palsy). The objective of the study was to assess the ability of DTI, the apparent transverse relaxation rate, and their combination for differentiating Parkinson disease, multiple system atrophy, progressive supranuclear palsy, and controls. A total of 106 subjects (36 controls, 35 patients with Parkinson disease, 16 with multiple system atrophy, and 19 with progressive supranuclear palsy) were included. DTI and the apparent transverse relaxation rate measures from the striatal, midbrain, limbic, and cerebellar regions were obtained and compared among groups. The discrimination performance of DTI and the apparent transverse relaxation rate among groups was assessed by using Elastic-Net machine learning and receiver operating characteristic curve analysis. Compared with controls, patients with Parkinson disease showed significant apparent transverse relaxation rate differences in the red nucleus. Compared to those with Parkinson disease, patients with both multiple system atrophy and progressive supranuclear palsy showed more widespread changes, extending from the midbrain to striatal and cerebellar structures. The pattern of changes, however, was different between the 2 groups. For instance, patients with multiple system atrophy showed decreased fractional anisotropy and an increased apparent transverse relaxation rate in the subthalamic nucleus, whereas patients with progressive supranuclear palsy showed an increased mean diffusivity in the hippocampus. Combined, DTI and the apparent transverse relaxation rate were significantly better than DTI or the apparent transverse relaxation rate alone in separating controls from those with Parkinson disease/multiple system atrophy/progressive supranuclear palsy; controls from those with Parkinson disease; those with Parkinson disease from those with multiple system atrophy/progressive supranuclear palsy; and those with Parkinson disease from those with multiple system atrophy; but not those with Parkinson disease from those with progressive supranuclear palsy, or those with multiple system atrophy from those with progressive supranuclear palsy. DTI and the apparent transverse relaxation rate provide different but complementary information for different parkinsonisms. Combined DTI and apparent transverse relaxation rate may be a superior marker for the differential diagnosis of parkinsonisms. © 2017 by American Journal of Neuroradiology.

Cardiac dose reduction with deep inspiration breath hold for left-sided breast cancer radiotherapy patients with and without regional nodal irradiation.

PubMed

Yeung, Rosanna; Conroy, Leigh; Long, Karen; Walrath, Daphne; Li, Haocheng; Smith, Wendy; Hudson, Alana; Phan, Tien

2015-09-22

Deep inspiration breath hold (DIBH) reduces heart and left anterior descending artery (LAD) dose during left-sided breast radiation therapy (RT); however there is limited information about which patients derive the most benefit from DIBH. The primary objective of this study was to determine which patients benefit the most from DIBH by comparing percent reduction in mean cardiac dose conferred by DIBH for patients treated with whole breast RT ± boost (WBRT) versus those receiving breast/chest wall plus regional nodal irradiation, including internal mammary chain (IMC) nodes (B/CWRT + RNI) using a modified wide tangent technique. A secondary objective was to determine if DIBH was required to meet a proposed heart dose constraint of Dmean < 4 Gy in these two cohorts. Twenty consecutive patients underwent CT simulation both free breathing (FB) and DIBH. Patients were grouped into two cohorts: WBRT (n = 11) and B/CWRT + RNI (n = 9). 3D-conformal plans were developed and FB was compared to DIBH for each cohort using Wilcoxon signed-rank tests for continuous variables and McNemar's test for discrete variables. The percent relative reduction conferred by DIBH in mean heart and LAD dose, as well as lung V20 were compared between the two cohorts using Wilcox rank-sum testing. The significance level was set at 0.05 with Bonferroni correction for multiple testing. All patients had comparable target coverage on DIBH and FB. DIBH statistically significantly reduced mean heart and LAD dose for both cohorts. Percent reduction in mean heart and LAD dose with DIBH was significantly larger in the B/CWRT + RNI cohort compared to WBRT group (relative reduction in mean heart and LAD dose: 55.9 % and 72.1 % versus 29.2 % and 43.5 %, p < 0.02). All patients in the WBRT group and five patients (56 %) in the B/CWBRT + RNI group met heart Dmean <4 Gy with FB. All patients met this constraint with DIBH. All patients receiving WBRT met Dmean Heart < 4 Gy on FB, while only slightly over half of patients receiving B/CWRT + RNI were able to meet this constraint in FB. DIBH allowed a greater reduction in mean heart and LAD dose in patients receiving B/CWRT + RNI, including IMC nodes than patients receiving WBRT. These findings suggest greatest benefit from DIBH treatment for patients receiving regional nodal irradiation.

Comparison of primary and reoperative surgery in patients with Crohns disease.

PubMed Central

Heimann, T M; Greenstein, A J; Lewis, B; Kaufman, D; Heimann, D M; Aufses, A H

1998-01-01

OBJECTIVE: This study was performed to determine the clinical results of patients with Crohns disease who require surgical resection. The outcome of patients undergoing initial surgery was compared with those having reoperation. METHODS: One hundred sixty-four patients undergoing intestinal resection for Crohns disease at The Mount Sinai Hospital from 1976 to 1989 were studied prospectively. The mean duration of follow-up was 72 months. RESULTS: Ninety patients (55%) underwent initial intestinal resection whereas 74 patients (45%) underwent reoperation for recurrent disease. Patients undergoing reoperation were older (33.4 vs. 38.7 years), had longer durations of disease (8.7 vs. 15.2 years), had shorter resections (60 vs. 46 cm), and were more likely to require ileostomy. Forty-seven percent of the patients with multiple previous resections required an ileostomy. This group also received a mean of 2.3 U blood in the perioperative period and showed a trend to increased symptomatic recurrence (49% vs. 71% at 5 years). CONCLUSIONS: Patients with Crohns disease undergoing first and second reoperation have outcomes similar to those in patients undergoing primary resection. Patients requiring multiple reoperations are more likely to require blood transfusions and permanent ileostomy and to show a greater trend to early symptomatic recurrence. PMID:9563535

Hepatitis B reactivation and rituximab: a new boxed warning and considerations for solid organ transplantation.

PubMed

Martin, S T; Cardwell, S M; Nailor, M D; Gabardi, S

2014-04-01

Use of rituximab, a chimeric monoclonal antibody directed at the CD20 antigen, continues to increase in solid organ transplantation (SOT) for several off-label uses. In September 2013, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication to oncology, rheumatology and pharmacy communities outlining a new Boxed Warning for rituximab. Citing 109 cases of fatal hepatitis B virus (HBV) reactivation in persons receiving rituximab therapy with previous or chronic HBV infection documented in their Adverse Event Reporting System (AERS), the FDA recommends screening for HBV serologies in all patients planned to receive rituximab and antiviral prophylaxis in any patient with a positive history of HBV infection. There is a lack of data pertaining to this topic in the SOT population despite an increase in off-label indications. Previous reports suggest patients receiving rituximab, on average, were administered six doses prior to HBV reactivation. Recommendations on prophylaxis, treatment and re-challenging patients with therapy after resolution of reactivation remain unclear. Based on data from the FDA AERS and multiple analyses in oncology, SOT providers utilizing rituximab should adhere to the FDA warnings and recommendations regarding HBV reactivation until further data are available in the SOT population. © Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.

Addition of doxycycline to ciprofloxacin for infection prophylaxis during autologous stem cell transplants for multiple myeloma.

PubMed

Sivik, J M; Davidson, J; Hale, C M; Drabick, J J; Talamo, G

2018-03-21

The most commonly used antibacterial prophylaxis during autologous stem cell transplants (ASCT) for multiple myeloma (MM) involves a fluoroquinolone, such as ciprofloxacin or levofloxacin. We assessed the impact of adding doxycycline to ciprofloxacin as routine antibacterial prophylaxis in these patients. We retrospectively reviewed electronic medical records and our ASCT database to analyze rates and types of bacterial infections in MM patients who underwent ASCT in our institution. Among 419 patients, 118 received ciprofloxacin alone (cipro group), and 301 ciprofloxacin and doxycycline (cipro-doxy group). Neutropenic fever (NF) developed in 63 (53%) and 108 (36%) patients of the cipro and cipro-doxy groups, respectively (p = 0.010). The number of documented bacteremic episodes was 13 (11%) and 14 (4.7%) in the two groups, respectively (p = 0.017). Antimicrobial resistance and Clostridium difficile infections were uncommon. Transplant-related mortality was 1% in both groups. The addition of doxycycline to standard prophylaxis with ciprofloxacin seems to reduce the number of NF episodes and documented bacterial infections in patients with MM undergoing ASCT, without increasing rate of serious complications.

Cyclophosphamide's addition in relapsed/refractory multiple myeloma patients with biochemical progression during lenalidomide-dexamethasone treatment.

PubMed

Cesini, Laura; Siniscalchi, Agostina; Grammatico, Sara; Andriani, Alessandro; Fiorini, Alessia; De Rosa, Luca; Za, Tommaso; Rago, Angela; Caravita, Tommaso; Petrucci, Maria Teresa

2018-05-02

The aim of this study was to evaluate the addition of cyclophosphamide in relapsed-refractory multiple myeloma patients (RRMM) who experienced biochemical relapse or progression without CRAB, during treatment with lenalidomide and dexamethasone (Rd), to slow down the progression in active relapse. This analysis included 31 patients with RRMM treated with Rd who received cyclophosphamide (CRd) at biochemical relapse. The CRd regimen was continued until disease progression. The median number of CRd cycles administered was 8 (range: 1-35). A response was observed in 9 (29%) patients. After a median observation time of 11 months, the median overall survival (OS) from the beginning of CRd was 17.7 months. The median progression-free survival (PFS) from the beginning of CRd was 13.1 months. The addition of cyclophosphamide delays the progression in patients who present a biochemical relapse during Rd treatment. The response rate and the duration of PFS obtained with minimal toxicities and low costs induced us to setting up a randomized clinical trial. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

[Fingolimod compassionate use program: case study on the concept of a therapy option for multiple sclerosis prior to marketing approval].

PubMed

Haas, J; Linker, R A; Hartung, H P; Meergans, M; Ortler, S; Tracik, F

2012-12-01

In order to meet the needs of therapy of multiple sclerosis (MS) new immune therapies with a user-friendly application and better effectiveness together with good tolerability are necessary. With respect to its potential to improve MS therapy, patients with a high medical need were given access to Fingolimod even before marketing approval. Therefore, a compassionate use program unique in the field of MS was initiated. In total 137 centers participated (75 % outpatient neurologists and 25 % hospitals). Within 19 weeks 135 patients were enrolled to receive Fingolimod. The patients in the compassionate use program can be representatively described as showing hardly controllable disease activity and progression with currently available, often poorly tolerated therapy. The compassionate use program for these patients offered better control of the disease with Fingolimod. The adverse events were as expected. The Fingolimod compassionate use program demonstrated the need for this new therapeutic option. Patients who were not yet sufficiently treated were provided with an effective therapy with a good safety profile and a user-friendly administration form.

Pleural effusion in 11:14 translocation q1 multiple myeloma in the setting of proteasome inhibitor presents therapeutic complexity.

PubMed

Ghannam, Malik; Bryan, Maria; Kuross, Erik; Berry, Brent

2018-01-01

Primary malignant pleural effusion has been reported in about 134 cases of multiple myeloma (MM). Associated pleural effusions in cases of MM portend a poor prognosis and identifying them is highly relevant. Reported is the case of a man diagnosed with MM who developed primary myelomatous pleural effusion in the setting of multiple relapses and subsequent mortality within 2 months of the pleural effusion diagnosis. A 61-year-old African American man was diagnosed with MM in 2011. He received induction therapy of lenalidomide and dexamethasone and an autologous stem cell transplant in 2012. Over the next 5 years, the patient went through alternating periods of remission and relapse that were treated with two rounds of thoracic spine radiation therapy and chemotherapeutic agents. In September 2017, the patient presented with worsening dyspnea and was found to have pleural effusion. Fluid analysis showed plasma cell dyscrasia. Fluid drainage was performed, then the patient was discharged after 1 week which was followed by rapid re-accumulation of fluid and rehospitalization about 10 days after discharge. The patient passed away a few weeks after the second admission. Pleural effusion carries a differential diagnosis which may include malignancy but is commonly thought to be less specific to multiple myeloma but should still remain in the differential diagnosis. To our knowledge, this is the first case of myelomatous pleural effusion (MPE) that was reported after multiple relapses of MM. MPE is a very rare complication of MM, and its presence is a strong indicator of imminent mortality and need for comfort care in case of multiple relapses. End-stage pleural effusion in MM in the setting of proteasome inhibitor adds more therapeutic and diagnostic challenges.

Perioperative antimicrobial prophylaxis in neurosurgery: clinical trial of systemic flomoxef administration and saline containing gentamicin for irrigation.

PubMed

Yamamoto, M; Jimbo, M; Ide, M; Tanaka, N; Umebara, Y; Hagiwara, S

1996-06-01

The efficacy of a new protocol consisting of a prophylactic antibiotic regimen of peri- and postoperative intravenous administration of flomoxef and irrigation of the operative field with saline containing gentamicin was assessed by comparing infection rates in two consecutive series of patients who underwent neurosurgical procedures. Group A received postoperative flomoxef administration, with saline containing no antibiotics for irrigation, from July 1988 to December 1989. Group B received the new protocol from January 1990 to December 1991. For further evaluation, this protocol was continued in most patients who underwent surgery from January 1992 through December 1993 (Group C). Only adult or adolescent patients who underwent clean neurosurgical procedures were included. The number of patients and procedures in each group were: 76 patients (97 procedures) in Group A, 103 (133) in Group B, and 107 (137) in Group C. There were no significant differences between Groups A and B in age, sex, clinical category, coexistent disease, clinical outcome, surgical procedures, general anesthesia, emergency operation, steroid administration, and the timing (season), duration, and frequency of surgery. Meningitis developed in three patients and subcutaneous infection in one in Group A. None of the patients in Group B experienced postoperative infection. This difference in infection rates (4.1% vs. 0%) was statistically significant (p = 0.0305). Furthermore, no postoperative infections developed in the Group C patients. The most appropriate interval for multiple dose administration was determined by analyzing intraoperative time-related changes in the serum flomoxef concentration during surgery in 21 recent patients. Serum flomoxef concentrations fell below therapeutic levels (3.0 micrograms/ml) by the 6th post-administration hour in 70% of patients. We conclude that this antibiotic regimen significantly reduces the postoperative infection rate following neurosurgical procedures. Multiple dose administration of flomoxef is recommended when the duration of surgery is 6 hours or more.

Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study.

PubMed

Giovannoni, Gavin; Soelberg Sorensen, Per; Cook, Stuart; Rammohan, Kottil; Rieckmann, Peter; Comi, Giancarlo; Dangond, Fernando; Adeniji, Abidemi K; Vermersch, Patrick

2017-08-01

In the 2-year CLARITY study, cladribine tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis (MS). To assess the safety and efficacy of cladribine treatment in a 2-year Extension study. In this 2-year Extension study, placebo recipients from CLARITY received cladribine 3.5 mg/kg; cladribine recipients were re-randomized 2:1 to cladribine 3.5 mg/kg or placebo, with blind maintained. A total of 806 patients were assigned to treatment. Adverse event rates were generally similar between groups, but lymphopenia Grade ⩾ 3 rates were higher with cladribine than placebo (Grade 4 lymphopenia occurred infrequently). In patients receiving cladribine 3.5 mg/kg in CLARITY and experiencing lymphopenia Grade ⩾ 3 in the Extension, >90% of those treated with cladribine 3.5 mg/kg and all treated with placebo in the Extension, recovered to Grade 0-1 by study end. Cladribine treatment in CLARITY produced efficacy improvements that were maintained in patients treated with placebo in the Extension; in patients treated with cladribine 3.5 mg/kg in CLARITY, approximately 75% remained relapse-free when given placebo during the Extension. Cladribine tablets treatment for 2 years followed by 2 years' placebo treatment produced durable clinical benefits similar to 4 years of cladribine treatment with a low risk of severe lymphopenia or clinical worsening. No clinical improvement in efficacy was apparent following further treatment with cladribine tablets after the initial 2-year treatment period in this trial setting.

Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma.

PubMed

Facon, Thierry; Dimopoulos, Meletios A; Dispenzieri, Angela; Catalano, John V; Belch, Andrew; Cavo, Michele; Pinto, Antonello; Weisel, Katja; Ludwig, Heinz; Bahlis, Nizar J; Banos, Anne; Tiab, Mourad; Delforge, Michel; Cavenagh, Jamie D; Geraldes, Catarina; Lee, Je-Jung; Chen, Christine; Oriol, Albert; De La Rubia, Javier; White, Darrell; Binder, Daniel; Lu, Jin; Anderson, Kenneth C; Moreau, Philippe; Attal, Michel; Perrot, Aurore; Arnulf, Bertrand; Qiu, Lugui; Roussel, Murielle; Boyle, Eileen; Manier, Salomon; Mohty, Mohamad; Avet-Loiseau, Herve; Leleu, Xavier; Ervin-Haynes, Annette; Chen, Guang; Houck, Vanessa; Benboubker, Lotfi; Hulin, Cyrille

2018-01-18

This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥60 months' follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.67-0.92; P = .0023), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had an ≈30-month longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. This trial was registered at www.clinicaltrials.gov as #NCT00689936 and EudraCT as 2007-004823-39. © 2018 by The American Society of Hematology.

Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma

PubMed Central

Dimopoulos, Meletios A.; Dispenzieri, Angela; Catalano, John V.; Belch, Andrew; Cavo, Michele; Pinto, Antonello; Weisel, Katja; Ludwig, Heinz; Bahlis, Nizar J.; Banos, Anne; Tiab, Mourad; Delforge, Michel; Cavenagh, Jamie D.; Geraldes, Catarina; Lee, Je-Jung; Chen, Christine; Oriol, Albert; De La Rubia, Javier; White, Darrell; Binder, Daniel; Lu, Jin; Anderson, Kenneth C.; Moreau, Philippe; Attal, Michel; Perrot, Aurore; Arnulf, Bertrand; Qiu, Lugui; Roussel, Murielle; Boyle, Eileen; Manier, Salomon; Mohty, Mohamad; Avet-Loiseau, Herve; Leleu, Xavier; Ervin-Haynes, Annette; Chen, Guang; Houck, Vanessa; Benboubker, Lotfi; Hulin, Cyrille

2018-01-01

This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥60 months’ follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.67-0.92; P = .0023), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had an ≈30-month longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. This trial was registered at www.clinicaltrials.gov as #NCT00689936 and EudraCT as 2007-004823-39. PMID:29150421

Quality of life of patients who undergo breast reconstruction after mastectomy: effects of personality characteristics.

PubMed

Bellino, Silvio; Fenocchio, Marina; Zizza, Monica; Rocca, Giuseppe; Bogetti, Paolo; Bogetto, Filippo

2011-01-01

Reconstruction after mastectomy has become an integral part of breast cancer treatment. The effects of psychological factors on quality of life after reconstruction have been poorly investigated. The authors examined clinical and personality characteristics related to quality of life in patients receiving reconstructive surgery. All patients received immediate reconstruction and were evaluated in the week before tissue expander implantation (T0) with a semistructured interview for demographic and clinical characteristics, the Temperament and Character Inventory, the Inventory of Interpersonal Problems, the Short Form Health Survey, the Severity Item of the Clinical Global Impression, the Hamilton Depression Rating Scale, and the Hamilton Anxiety Rating Scale. Assessment with the Short Form was repeated 3 months after expander placement (T1). Statistics were calculated with univariate regression and analysis of variance. Significant variables were included in a multiple regression analysis to identify factors related to the change T1-T0 of the mean of the Short Form-transformed scores. Results were significant when p was less than or equal to 0.05. Fifty-seven women were enrolled. Results of multiple regression analysis showed that the Temperament and Character Inventory personality dimension harm avoidance and the Inventory of Interpersonal Problems domain vindictive/self-centered were significantly and independently related to the change in Short Form mean score. Personality dimensions and patterns of interpersonal functioning produce significant effects on patients' quality of life during breast reconstruction. Patients with high harm avoidance are apprehensive and doubtful. Restoration of body image could help them to reduce social anxiety and insecurity. Vindictive/self-centered patients are resentful and aggressive. Breast reconstruction could symbolize the conclusion of a reparative process and fulfill the desire of revenge on cancer.

Alemtuzumab CARE-MS II 5-year follow-up

PubMed Central

Cohen, Jeffrey A.; Fox, Edward J.; Giovannoni, Gavin; Hartung, Hans-Peter; Havrdova, Eva; Schippling, Sven; Selmaj, Krzysztof W.; Traboulsee, Anthony; Compston, D. Alastair S.; Margolin, David H.; Thangavelu, Karthinathan; Chirieac, Madalina C.; Jody, Darlene; Xenopoulos, Panos; Hogan, Richard J.; Panzara, Michael A.; Arnold, Douglas L.

2017-01-01

Objective: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. Methods: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. Annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs) were assessed. Results: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3–5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1–5: −0.48%, −0.22%, −0.10%, −0.19%, −0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter. Conclusions: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment. Classification of evidence: This study provides Class III evidence that alemtuzumab provides efficacy and slowing of brain atrophy through 5 years. PMID:28835403

Older Age and Leg Pain Are Good Predictors of Pain and Disability Outcomes in 2710 Patients Who Receive Lumbar Fusion.

PubMed

Cook, Chad E; Frempong-Boadu, Anthony K; Radcliff, Kristen; Karikari, Isaac; Isaacs, Robert

2015-10-01

Identifying appropriate candidates for lumbar spine fusion is a challenging and controversial topic. The purpose of this study was to identify baseline characteristics related to poor/favorable outcomes at 1 year for a patient who received lumbar spine fusion. The aims of this study were to describe baseline characteristics of those who received lumbar surgery and to identify baseline characteristics from a spine repository that were related to poor and favorable pain and disability outcomes for patient who received lumbar fusion (with or without decompression), who were followed up for 1 full year and discriminate predictor variables that were either or in contrast to prognostic variables reported in the literature. This study analyzed data from 2710 patients who underwent lumbar spine fusion. All patient data was part of a multicenter, multi-national spine repository. Ten relatively commonly captured data variables were used as predictors for the study. Univariate/multivariate logistic regression analyses were run against outcome variables of pain/disability. Multiple univariate findings were associated with pain/disability outcomes at 1 year including age, previous surgical history, baseline disability, baseline pain, baseline quality of life scores, and leg pain greater than back pain. Notably significant multivariate findings for both pain and disability include older age, previous surgical history, and baseline mental summary scores, disability, and pain. Leg pain greater than back pain and older age may yield promising value when predicting positive outcomes. Other significant findings may yield less value since these findings are similar to those that are considered to be prognostic regardless of intervention type.

[GP medication prioritisation in older patients with multiple comorbidities recently discharged from hospital: a case-based bottom-up approach].

PubMed

Herrmann, M L H; von Waldegg, G H; Kip, M; Lehmann, B; Andrusch, S; Straub, H; Robra, B-P

2015-01-01

After the hospital discharge of older patients with multiple morbidities, GPs are often faced with the task of prioritising the patients' drug regimens so as to reduce the risk of overmedication. How do GPs prioritise such medications in multimorbid elderly patients at the transition between inpatient and home care? The experience by the GPs is documented in typical case vignettes. 44 GPs in Sachsen-Anhalt were recruited--they were engaged in focus group discussions and interviewed using semi-standardised questionnaires. Typical case vignettes were developed, relevant to the everyday care that elderly patients would typically receive from their GPs with respect to their drug optimisation. According to the results of the focus groups, the following issues affect GPs' decisions: drug and patient safety, their own competence in the health system, patient health literacy, evidence base, communication between secondary and primary care (and their respective influences on each other). When considering individual cases, patient safety, patient wishes, and quality of life were central. This is demonstrated by the drug dispositions of one exemplary case vignette. GPs do prioritise drug regimens with rational criteria. Initial problem delineation, process documentation and the design of a transferable product are interlinking steps in the development of case vignettes. Care issues of drug therapy in elderly patients with multiple morbidities should be investigated further with larger representative samples in order to clarify whether the criteria used here are applied contextually or consistently. Embedding case vignettes into further education concepts is also likely to be useful. © Georg Thieme Verlag KG Stuttgart · New York.

What Do Patients Prefer? Understanding Patient Perspectives on Receiving a New Breast Cancer Diagnosis.

PubMed

Attai, Deanna J; Hampton, Regina; Staley, Alicia C; Borgert, Andrew; Landercasper, Jeffrey

2016-10-01

There is variability in physician practice regarding delivery method and timeliness of test results to cancer patients. Our aim was to survey patients to determine if there was a difference between actual and preferred care for disclosure of test results. A de-identified survey was distributed to online cancer support groups to query patients about their experience regarding communication of cancer testing and timeliness. Analyses of the differences between actual and preferred communication and wait times were performed. Overall, 1000 patients completed the survey. The analysis herein was restricted to 784 breast cancer survivors. Survey responders were predominately White (non-Hispanic; 89 %), college educated (78 %), and media 'savvy' (online medical media usage; 97 %). Differences between actual and preferred care were identified for the domains of mode of communication and wait times for initial breast cancer diagnostic biopsies and other tests. A total of 309 (39 %) of 784 patients received face-to-face communication for a new cancer diagnosis, with 394 (50 %) patients preferring this option (p < 0.0001). In addition, 315 (40 %) of 784 patients received their cancer biopsy result within 2 days, with 646 (82 %) patients preferring this option (p < 0.0001). Differences were also identified between actual and preferred care for multiple other test types. Actual care for timeliness and modes of communication did not reflect patient-desired care. National and local initiatives to improve performance are needed. As a first step, we recommend that each patient be queried about their preference for mode of communication and timeliness, and efforts made to comply.

Gastrointestinal damage caused by swallowing multiple magnets.

PubMed

Liu, Shiqi; Li, Jianhui; Lv, Yi

2012-09-01

Swallowing multiple magnets is not uncommon worldwide and it frequently leads to serious consequences. However, most patients fail to receive timely and correct diagnosis and treatment. A literature search was performed to establish an algorithm for these accidents by the authors to identify relevant articles published from June 1987 to October 2010 in Google, Medline, ISI Web of Knowledge Ovid, CNKI, Korea Med and library document delivery, using search terms "magnet ingestion, " "fistula," and "perforation." A total of 149 patients with ingestion of magnetic foreign bodies from 20 countries and areas were identified. 22 of them were companioned with neurological and psychiatric disorders. Swallowing magnets occurred throughout childhood and adolescent, mostly ranging 2 to 4 years in age. Various gastrointestinal damages such as necrosis and intestinal perforation or fistula were encountered. Damage from swallowing multiple magnets carries a significant risk of morbidity and even mortality throughout childhood to adolescent worldwide. Older children and adults with neurological and psychiatric problems may be at high risk for such accidents. Early intervention is crucial.

Histopathologic characteristics of therapy-associated cutaneous neoplasms with vemurafenib, a selective BRAF kinase inhibitor, used in the treatment of melanoma.

PubMed

Sufficool, Kari E; Hepper, Donna M; Linette, Gerald P; Hurst, Eva A; Lu, Dongsi; Lind, Anne C; Cornelius, Lynn A

2014-07-01

Activating mutations in BRAF have been observed in up to 60% of melanomas, indicating a pivotal role for kinase deregulation in tumor progression. Vemurafenib is a specific inhibitor of BRAF for treatment of melanomas with activating BRAF V600E mutations and has been a major advancement in melanoma treatment. Treatment with vemurafenib, and to a lesser extent, sorafenib, a relatively non-specific inhibitor of BRAF, has been associated with cutaneous squamous cell carcinoma (SCC). Clinical and microscopic characteristics of cutaneous neoplasms were evaluated following vemurafenib administration. Twenty-four of 47 (51%) patients receiving vemurafenib at our institution developed 146 total cutaneous neoplasms, with 75% developing multiple lesions. The median number of lesions in affected patients was three. Body distribution included head/neck (29%), chest/back (21%), upper (23%) and lower extremities (27%). Lesions were biopsied and pathologically showed multiple types of epidermal tumors including, but not limited to, verrucous keratoses with/without partial thickness dysplasia, actinic keratoses and well-differentiated and invasive SCCs with/without keratoacanthomatous features. We describe the histopathologic findings of skin lesions potentially associated with vemurafenib. Additional investigation is necessary to further elucidate cutaneous neoplasms associated with vemurafenib; however, frequent dermatologic evaluation is warranted in all patients receiving BRAF inhibitors. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Extensive traumatic anterior skull base fractures with cerebrospinal fluid leak: classification and repair techniques using combined vascularized tissue flaps.

PubMed

Archer, Jacob B; Sun, Hai; Bonney, Phillip A; Zhao, Yan Daniel; Hiebert, Jared C; Sanclement, Jose A; Little, Andrew S; Sughrue, Michael E; Theodore, Nicholas; James, Jeffrey; Safavi-Abbasi, Sam

2016-03-01

This article introduces a classification scheme for extensive traumatic anterior skull base fracture to help stratify surgical treatment options. The authors describe their multilayer repair technique for cerebrospinal fluid (CSF) leak resulting from extensive anterior skull base fracture using a combination of laterally pediculated temporalis fascial-pericranial, nasoseptal-pericranial, and anterior pericranial flaps. Retrospective chart review identified patients treated surgically between January 2004 and May 2014 for anterior skull base fractures with CSF fistulas. All patients were treated with bifrontal craniotomy and received pedicled tissue flaps. Cases were classified according to the extent of fracture: Class I (frontal bone/sinus involvement only); Class II (extent of involvement to ethmoid cribriform plate); and Class III (extent of involvement to sphenoid bone/sinus). Surgical repair techniques were tailored to the types of fractures. Patients were assessed for CSF leak at follow-up. The Fisher exact test was applied to investigate whether the repair techniques were associated with persistent postoperative CSF leak. Forty-three patients were identified in this series. Thirty-seven (86%) were male. The patients' mean age was 33 years (range 11-79 years). The mean overall length of follow-up was 14 months (range 5-45 months). Six fractures were classified as Class I, 8 as Class II, and 29 as Class III. The anterior pericranial flap alone was used in 33 patients (77%). Multiple flaps were used in 10 patients (3 salvage) (28%)--1 with Class II and 9 with Class III fractures. Five (17%) of the 30 patients with Class II or III fractures who received only a single anterior pericranial flap had persistent CSF leak (p < 0.31). No CSF leak was found in patients who received multiple flaps. Although postoperative CSF leak occurred only in high-grade fractures with single anterior flap repair, this finding was not significant. Extensive anterior skull base fractures often require aggressive treatment to provide the greatest long-term functional and cosmetic benefits. Several vascularized tissue flaps can be used, either alone or in combination. Vascularized flaps are an ideal substrate for cranial base repair. Dual and triple flap techniques that combine the use of various anterior, lateral, and nasoseptal flaps allow for a comprehensive arsenal in multilayered skull base repair and salvage therapy for extensive and severe fractures.

Dental esthetic satisfaction, received and desired dental treatments for improvement of esthetics.

PubMed

Akarslan, Zühre Zafersoy; Sadik, Burak; Erten, Hüya; Karabulut, Erdem

2009-01-01

The purposes of this research were to investigate factors influencing patients' satisfaction with their present dental esthetic, received previous dental treatments on anterior teeth and basic treatments that they wanted to undergo to improve their dental appearance. A total of 1014 patients who attended a dental school in a major city in Turkey participated in the study. The participants were surveyed with a questionnaire containing questions about gender, age, education level, self-reported tooth appearance, received previous dental treatments on anterior teeth and desired basic esthetic dental treatments. Statistical analysis of the verifying data was made with descriptive statistics, chi2 test and multiple logistic regression analyses. According to the analyses of the verifying data, 55.1% of the patients were dissatisfied with the color of their teeth, 42.7% with dental appearance, 29.9% with crowding of anterior teeth, 23.3% were hiding teeth while smiling, 16.1% had non-esthetic restorations and 11.9% thought that their anterior teeth were protruding. Esthetic restoration was found to be the most-performed treatment recently (29.0%) and whitening of teeth was the most-desired dental treatment (49.0%). Gender, age and education level had an effect on satisfaction and received previous and desired dental treatments for improvement of esthetics. Many of the Turkish patients surveyed in the study were dissatisfied and desired the improvement of dental esthetics. Therefore, dentists should consider this as an important dimension in their practice.

Analysis of dose-volume parameters predicting radiation pneumonitis in patients with esophageal cancer treated with 3D-conformal radiation therapy or IMRT.

PubMed

Kumar, Gaurav; Rawat, Sheh; Puri, Abhishek; Sharma, Manoj Kumar; Chadha, Pranav; Babu, Anand Giri; Yadav, Girigesh

2012-01-01

Multimodality therapy for esophageal cancer can cause various kinds of treatment-related sequelae, especially pulmonary toxicities. This prospective study aims to investigate the clinical and dosimetric parameters predicting lung injury in patients undergoing radiation therapy for esophageal cancer. Forty-five esophageal cancer patients were prospectively analyzed. The pulmonary toxicities (or sequelae) were evaluated by comparing chest X-ray films, pulmonary function tests and symptoms caused by pulmonary damage before and after treatment. All patients were treated with either three-dimensional radiotherapy (3DCRT) or with intensity-modulated radiotherapy (IMRT). The planning dose volume histogram was used to compute the lung volumes receiving more than 5, 10, 20 and 30 Gy (V5, V10, V20, V30) and mean lung dose. V20 was larger in the IMRT group than in the 3DCRT group (p = 0.002). V20 (>15%) and V30 (>20%) resulted in a statistically significant increase in the occurrence of chronic pneumonitis (p = 0.03) and acute pneumonitis (p = 0.007), respectively. The study signifies that a larger volume of lung receives lower doses because of multiple beam arrangement and a smaller volume of lung receives higher doses because of better dose conformity in IMRT plans. Acute pneumonitis correlates more with V30 values, whereas chronic pneumonitis was predominantly seen in patients with higher V20 values.

Short-term Androgen-Deprivation Therapy Improves Prostate Cancer-Specific Mortality in Intermediate-Risk Prostate Cancer Patients Undergoing Dose-Escalated External Beam Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zumsteg, Zachary S.; Spratt, Daniel E.; Pei, Xin

2013-03-15

Purpose: We investigated the benefit of short-term androgen-deprivation therapy (ADT) in patients with intermediate-risk prostate cancer (PC) receiving dose-escalated external beam radiation therapy. Methods and Materials: The present retrospective study comprised 710 intermediate-risk PC patients receiving external beam radiation therapy with doses of ≥81 Gy at a single institution from 1992 to 2005, including 357 patients receiving neoadjuvant and concurrent ADT. Prostate-specific antigen recurrence-free survival (PSA-RFS) and distant metastasis (DM) were compared using the Kaplan-Meier method and Cox proportional hazards models. PC-specific mortality (PCSM) was assessed using competing-risks analysis. Results: The median follow-up was 7.9 years. Despite being more likelymore » to have higher PSA levels, Gleason score 4 + 3 = 7, multiple National Comprehensive Cancer Network intermediate-risk factors, and older age (P≤.001 for all comparisons), patients receiving ADT had improved PSA-RFS (hazard ratio [HR], 0.598; 95% confidence interval [CI], 0.435-0.841; P=.003), DM (HR, 0.424; 95% CI, 0.219-0.819; P=.011), and PCSM (HR, 0.380; 95% CI, 0.157-0.921; P=.032) on univariate analysis. Using multivariate analysis, ADT was an even stronger predictor of improved PSA-RFS (adjusted HR [AHR], 0.516; 95% CI, 0.360-0.739; P<.001), DM (AHR, 0.347; 95% CI, 0.176-0.685; P=.002), and PCSM (AHR, 0.297; 95% CI, 0.128-0.685; P=.004). Gleason score 4 + 3 = 7 and ≥50% positive biopsy cores were other independent predictors of PCSM. Conclusions: Short-term ADT improves PSA-RFS, DM, and PCSM in patients with intermediate-risk PC undergoing dose-escalated external beam radiation therapy.« less

Parecoxib relieves pain and has an opioid-sparing effect following major gastrointestinal surgery.

PubMed

Essex, Margaret Noyes; Xu, Hao; Parsons, Bruce; Xie, Li; Li, Chunming

2017-01-01

Parecoxib provides analgesia following a variety of surgeries, including minor gastrointestinal procedures. To our knowledge, there is no data on parecoxib following major gastrointestinal surgery. This study assessed the efficacy and opioid-sparing effects of parecoxib following major gastrointestinal surgeries. Patients in this analysis were a subset from a large, randomized, double-blind, placebo-controlled trial of parecoxib following noncardiac surgeries and consisted of those undergoing a variety of major gastrointestinal surgeries via laparotomy. Pain, pain interference with function, supplemental opioid utilization, opioid-related symptoms, and Patient/Physician Global Evaluation of Study Medication were compared between placebo and parecoxib groups in the 2-3 days following surgery. Significantly ( p <0.001) lower pain scores were observed in the parecoxib group (n=111), relative to placebo (n=126), on Day 2 (-33%) and Day 3 (-35%). Pain interference with function scores was also significantly ( p <0.001) lower among patients receiving parecoxib compared with placebo on Day 2 (-29%) and Day 3 (-36%). At 24, 48, and 72 hours, the cumulative amount of supplemental morphine consumed was 45%, 41%, and 40% less in patients receiving parecoxib compared with placebo (all p <0.001). The risk of experiencing ≥1 opioid-related symptoms was also significantly lower with parecoxib than with placebo on Day 2 (relative risk=0.75; p <0.001). Specifically, the risks of fatigue and drowsiness were significantly (both p <0.05) lower in patients receiving parecoxib compared to those receiving placebo. Patient and Physician Global Evaluation of Study Medication scores were significantly better in the parecoxib group than in the placebo group ( p <0.001). This study is the first to demonstrate that multiple-dose parecoxib, initiated upon recovery from anesthesia, provides analgesia and opioid-sparing effects following a variety of major gastrointestinal surgeries employing laparotomy.

Patient Navigation Improves Subsequent Breast Cancer Screening After a Noncancerous Result: Evidence from the Patient Navigation in Medically Underserved Areas Study.

PubMed

Molina, Yamile; Kim, Sage J; Berrios, Nerida; Glassgow, Anne Elizabeth; San Miguel, Yazmin; Darnell, Julie S; Pauls, Heather; Vijayasiri, Ganga; Warnecke, Richard B; Calhoun, Elizabeth A

2018-03-01

Past efforts to assess patient navigation on cancer screening utilization have focused on one-time uptake, which may not be sufficient in the long term. This is partially due to limited resources for in-person, longitudinal patient navigation. We examine the effectiveness of a low-intensity phone- and mail-based navigation on multiple screening episodes with a focus on screening uptake after receiving noncancerous results during a previous screening episode. The is a secondary analysis of patients who participated in a randomized controlled patient navigation trial in Chicago. Participants include women referred for a screening mammogram, aged 50-74 years, and with a history of benign/normal screening results. Navigation services focused on identification of barriers and intervention via shared decision-making processes. A multivariable logistic regression intent-to-treat model was used to examine differences in odds of obtaining a screening mammogram within 2 years of the initial mammogram (yes/no) between navigated and non-navigated women. Sensitivity analyses were conducted to explore patterns across subsets of participants (e.g., navigated women successfully contacted before the initial appointment; women receiving care at Hospital C). The final sample included 2,536 women (741 navigated, 1,795 non-navigated). Navigated women exhibited greater odds of obtaining subsequent screenings relative to women in the standard care group in adjusted models and analyses including women who received navigation before the initial appointment. Our findings suggest that low-intensity navigation services can improve follow-up screening among women who receive a noncancerous result. Further investigation is needed to confirm navigation's impacts on longitudinal screening.

Relationship between pain and post-traumatic stress symptoms in palliative care.

PubMed

Roth, Maya L; St Cyr, Kate; Harle, Ingrid; Katz, Joel D

2013-08-01

Previous research suggests that patients receiving palliative care may simultaneously experience poorly managed pain and post-traumatic stress disorder (PTSD)-related symptoms as a result of their deteriorating health. To: 1) examine predictors of PTSD-related symptoms in patients requiring palliative care; 2) assess whether anxiety, depression, pain catastrophizing, and pain anxiety mediate the relationship between pain interference and PTSD-related symptoms; and 3) evaluate the impact of these variables on pain interference and PTSD-related symptoms. One hundred patients receiving palliative care at one of two palliative care sites in London, ON, Canada, completed the PTSD Checklist-Civilian version (PCL-C), the Hospital Anxiety and Depression Scale (HADS), the Pain Catastrophizing Scale (PCS), the Brief Pain Inventory-Short Form (BPI-SF), and the Pain Anxiety Symptoms Scale-20 (PASS-20). Hierarchical multiple regressions were used to examine HADS-Anxiety, HADS-Depression, PCS and PASS-20 scores as predictors of PCL-C scores; and mediation analyses were used to test the effect of HADS-Anxiety, HADS-Depression, PCS, and PASS-20 on the relationship between BPI-SF interference and PCL-C. Mediators that significantly affected this relationship in the individual mediator models were entered into a multiple mediator model. Only pain anxiety and pain catastrophizing emerged as significant mediators of the relationship between pain interference and PTSD-related symptoms. After being entered in a multiple mediator model, pain anxiety emerged as the strongest mediator. The findings of the present study reveal that pain and PTSD-related symptoms are important concerns in palliative care, and that pain must be addressed to best meet the needs of this population. Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Changes in magnetic resonance imaging disease measures over 3 years in mildly disabled patients with relapsing-remitting multiple sclerosis receiving interferon β-1a in the COGnitive Impairment in MUltiple Sclerosis (COGIMUS) study

PubMed Central

2011-01-01

Background Conventional magnetic resonance imaging (MRI) has improved the diagnosis and monitoring of multiple sclerosis (MS). In clinical trials, MRI has been found to detect treatment effects with greater sensitivity than clinical measures; however, clinical and MRI outcomes tend to correlate poorly. Methods In this observational study, patients (n = 550; 18-50 years; relapsing-remitting MS [Expanded Disability Status Scale score ≤4.0]) receiving interferon (IFN) β-1a therapy (44 or 22 µg subcutaneously [sc] three times weekly [tiw]) underwent standardized MRI, neuropsychological and quality-of-life (QoL) assessments over 3 years. In this post hoc analysis, MRI outcomes and correlations between MRI parameters and clinical and functional outcomes were analysed. Results MRI data over 3 years were available for 164 patients. T2 lesion and T1 gadolinium-enhancing (Gd+) lesion volumes, but not black hole (BH) volumes, decreased significantly from baseline to Year 3 (P < 0.0001). Percentage decreases (baseline to Year 3) were greater with the 44 μg dose than with the 22 μg dose for T2 lesion volume (-10.2% vs -4.5%, P = 0.025) and T1 BH volumes (-7.8% vs +10.3%, P = 0.002). A decrease in T2 lesion volume over 3 years predicted stable QoL over the same time period. Treatment with IFN β-1a, 44 μg sc tiw, predicted an absence of cognitive impairment at Year 3. Conclusion Subcutaneous IFN β-1a significantly decreased MRI measures of disease, with a significant benefit shown for the 44 µg over the 22 µg dose; higher-dose treatment also predicted better cognitive outcomes over 3 years. PMID:21999142

Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma

PubMed Central

Dimopoulos, Meletios A.; Masszi, Tamás; Špička, Ivan; Oriol, Albert; Hájek, Roman; Rosiñol, Laura; Siegel, David S.; Niesvizky, Ruben; Jakubowiak, Andrzej J.; San-Miguel, Jesus F.; Ludwig, Heinz; Buchanan, Jacqui; Cocks, Kim; Yang, Xinqun; Xing, Biao; Zojwalla, Naseem; Tonda, Margaret; Moreau, Philippe; Palumbo, Antonio

2016-01-01

Purpose To determine the effects of carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) on health-related quality of life (HR-QoL) in the Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone for the Treatment of Patients With Relapsed Multiple Myeloma (ASPIRE) trial. Methods Patients with relapsed multiple myeloma were randomly assigned to receive KRd or Rd. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and myeloma-specific module were administered at baseline; day 1 of cycles 3, 6, 12, and 18; and after treatment. The Global Health Status/Quality of Life (GHS/QoL) scale and seven subscales (fatigue, nausea and vomiting, pain, physical functioning, role functioning, disease symptoms, and adverse effects of treatment) were compared between groups using a mixed model for repeated measures. The percentages of responders with ≥ 5- or 15-point GHS/QoL improvement at each cycle were compared between groups. Results Baseline questionnaire compliance was excellent (94.1% of randomly assigned patients). KRd patients had higher GHS/QoL scores versus Rd patients over 18 treatment cycles (two-sided P < .001). The minimal important difference was met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points). There was no difference between groups for the other prespecified subscales from ASPIRE. A higher proportion of KRd patients met the GHS/QoL responder definition (≥ 5-point improvement) with statistical differences at cycle 12 (KRd v Rd patients, 25.5% v 17.4%, respectively) and 18 (KRd v Rd patients, 24.2% v 12.9%, respectively). Conclusion KRd improves GHS/QoL without negatively affecting patient-reported symptoms when compared with Rd. These data further support the benefit of KRd in patients with relapsed multiple myeloma. PMID:27601539

Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma.

PubMed

Stewart, A Keith; Dimopoulos, Meletios A; Masszi, Tamás; Špička, Ivan; Oriol, Albert; Hájek, Roman; Rosiñol, Laura; Siegel, David S; Niesvizky, Ruben; Jakubowiak, Andrzej J; San-Miguel, Jesus F; Ludwig, Heinz; Buchanan, Jacqui; Cocks, Kim; Yang, Xinqun; Xing, Biao; Zojwalla, Naseem; Tonda, Margaret; Moreau, Philippe; Palumbo, Antonio

2016-11-10

Purpose To determine the effects of carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) on health-related quality of life (HR-QoL) in the Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone for the Treatment of Patients With Relapsed Multiple Myeloma (ASPIRE) trial. Methods Patients with relapsed multiple myeloma were randomly assigned to receive KRd or Rd. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and myeloma-specific module were administered at baseline; day 1 of cycles 3, 6, 12, and 18; and after treatment. The Global Health Status/Quality of Life (GHS/QoL) scale and seven subscales (fatigue, nausea and vomiting, pain, physical functioning, role functioning, disease symptoms, and adverse effects of treatment) were compared between groups using a mixed model for repeated measures. The percentages of responders with ≥ 5- or 15-point GHS/QoL improvement at each cycle were compared between groups. Results Baseline questionnaire compliance was excellent (94.1% of randomly assigned patients). KRd patients had higher GHS/QoL scores versus Rd patients over 18 treatment cycles (two-sided P < .001). The minimal important difference was met at cycle 12 (5.6 points) and approached at cycle 18 (4.8 points). There was no difference between groups for the other prespecified subscales from ASPIRE. A higher proportion of KRd patients met the GHS/QoL responder definition (≥ 5-point improvement) with statistical differences at cycle 12 (KRd v Rd patients, 25.5% v 17.4%, respectively) and 18 (KRd v Rd patients, 24.2% v 12.9%, respectively). Conclusion KRd improves GHS/QoL without negatively affecting patient-reported symptoms when compared with Rd. These data further support the benefit of KRd in patients with relapsed multiple myeloma.

[Therapeutic failure in scabies: An observational study].

PubMed

De Sainte Marie, B; Mallet, S; Gaudy-Marqueste, C; Baumstarck, K; Bentaleb, N; Loundou, A; Hesse, S; Monestier, S; Grob, J-J; Richard, M-A

2016-01-01

Several sources suggest an escalation of scabies in France. To describe a population of patients continuing to present with scabies despite multiple treatments in order to identify factors associated with persistence of infection. A descriptive cross-sectional study in adults and children consulting for persistent scabies despite at least one previous treatment. A standardized questionnaire explored potential sources of treatment failure. Thirty-one patients were analyzed. Initial symptoms were noted to have started between two and 52 weeks earlier (mean: 19 weeks). The mean number of prior consultations with a general practitioner was 3.1 (0-10) and 1.7 with a dermatologist (0-7). The mean number of patients per household was 3.5 (1-9). At least one dose of oral ivermectin (maximum of 6 doses per household) was prescribed for 84 % of patients (29 % of whom were not fasted at the time). Further, 74 % of patients received at least one local application of esdepallethrin and piperonyl butoxide (maximum: 5 courses), four received benzyl benzoate and two received permethrin; however, 58 % did not reapply the substance after hand washing. All households bought the prescribed treatments despite the costs. Close contacts of patients were treated in 58 % of households. Decontamination of bedding and clothing was carried out properly in 90 % of households. Persistence of infection appears to be linked to: (1) insufficient treatment of close contacts; (2) absence of a second treatment between days 7 and 14; (3) insufficient efficacy of the available treatments, doubtless due to multiple factors (intrinsic resistance of Sarcoptes, failure to repeat treatment, poor explanation of methods for dosing and application, and oral intake of treatments). Access to non-reimbursed treatments was not identified as a problem and decontamination of bedding and clothing was correctly performed in most cases. Though certain fundamental aspects of scabies treatment must be better known, longer consultations and provision of efficacious treatments are also a priority. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Prediction of hearing outcomes by multiple regression analysis in patients with idiopathic sudden sensorineural hearing loss.

PubMed

Suzuki, Hideaki; Tabata, Takahisa; Koizumi, Hiroki; Hohchi, Nobusuke; Takeuchi, Shoko; Kitamura, Takuro; Fujino, Yoshihisa; Ohbuchi, Toyoaki

2014-12-01

This study aimed to create a multiple regression model for predicting hearing outcomes of idiopathic sudden sensorineural hearing loss (ISSNHL). The participants were 205 consecutive patients (205 ears) with ISSNHL (hearing level ≥ 40 dB, interval between onset and treatment ≤ 30 days). They received systemic steroid administration combined with intratympanic steroid injection. Data were examined by simple and multiple regression analyses. Three hearing indices (percentage hearing improvement, hearing gain, and posttreatment hearing level [HLpost]) and 7 prognostic factors (age, days from onset to treatment, initial hearing level, initial hearing level at low frequencies, initial hearing level at high frequencies, presence of vertigo, and contralateral hearing level) were included in the multiple regression analysis as dependent and explanatory variables, respectively. In the simple regression analysis, the percentage hearing improvement, hearing gain, and HLpost showed significant correlation with 2, 5, and 6 of the 7 prognostic factors, respectively. The multiple correlation coefficients were 0.396, 0.503, and 0.714 for the percentage hearing improvement, hearing gain, and HLpost, respectively. Predicted values of HLpost calculated by the multiple regression equation were reliable with 70% probability with a 40-dB-width prediction interval. Prediction of HLpost by the multiple regression model may be useful to estimate the hearing prognosis of ISSNHL. © The Author(s) 2014.

Multifocal systemic tuberculosis: the many faces of an old nemesis.

PubMed

Al-Tawfiq, Jaffar A

2007-04-01

Tuberculosis continues to be a major health problem, where an estimated 7-8 million new cases are diagnosed each year. Multifocal tuberculosis is characterized by the presence of large multifocal tuberculous areas in the same or different organs. Difficulty in diagnosis of multifocal tuberculosis and consideration of other diseases may lead to a delay in diagnosing this entity. Here the clinical features and characteristics of three patients with multifocal systemic tuberculosis are described. During the period of 1999-2005, a total of 128 confirmed cases of tuberculosis were identified. Three (2.3%) patients had multifocal systemic tuberculosis. The first case had involvement of the lung, psoas muscle, and the vertebral bodies. The second patient had multiple brain lesions with mediastinal and retroperitoneal lymphadenopathy. The third patient had multiple brain lesions, lymphadenopathy, and colonic lesions initially mimicking a metastatic disease. Mycobacterium tuberculosis was grown from pleural fluid in one patient and from lymph node biopsies in another patient. The third patient had histopathologic evidence of tuberculosis. All patients received standard anti-tuberculous treatment, resulting in a full recovery in two patients, while the third patient had residual weakness. Multifocal systemic tuberculosis may pose a diagnostic challenge and may occur in immunocompetent hosts, in whom this entity generally has a good outcome.

Predictors of dietary and fluid non-adherence in Jordanian patients with end-stage renal disease receiving haemodialysis: a cross-sectional study.

PubMed

Khalil, Amani A; Darawad, Muhammad; Al Gamal, Eklas; Hamdan-Mansour, Ayman M; Abed, Mona A

2013-01-01

The purpose of this study is to provide insight into the relationship between dietary and fluid non-adherence, depressive symptoms, quality of life, perceived barriers and benefits of exercise, and perceived social support among Jordanian patients with end-stage renal disease receiving haemodialysis using Pender's health promotion model. Non-adherence to dietary and fluid restrictions is a leading cause of treatment failure and poor outcomes in end-stage renal disease. Yet, factors that interfere with the patients' ability to follow their dietary restrictions are unknown. A descriptive, correlational, cross-sectional design was used. Jordanian patients (n = 190) with end-stage renal disease receiving haemodialysis from three main Jordanian cities were included. The dialysis diet and fluid nonadherence questionnaire, Beck Depression Inventory-II, Quality Of Life Index, Dialysis Patient-Perceived Exercise Benefits and Barriers Scale, and the Multidimensional Perceived Social Support were employed to measure the key variables. Patients were more likely men with mean age of 48·2 ± 14·9. Only 27% of the patients showed full commitment to diet guidelines and 23% to fluid guidelines during the last 14 days. Depression (M = 18·8 ± 11·4) had significant negative association with quality of life (importance and satisfaction) (r = -0·60, r = -0·32, p = 0·001, respectively). Multiple hierarchal regressions revealed a predictive model of only two variables: age (B = -0·22, p = 0·05) and residual renal function (B = -0·23, p = 0·012) for dietary non-adherence. Non-adherence to diet and fluid guidelines association with individual characteristics, health perception and psychosocial variables should be investigated in a longitudinal design. Relationship of non-adherence with culture-related factors should deeply be assessed among Jordanian patients with end-stage renal disease receiving haemodialysis. Identification of the factors that may worsen dietary and fluid non-adherence may lead to improved therapeutic interventions within the mainstream of medical practice for Jordanian patients with end-stage renal disease receiving haemodialysis. © 2012 Blackwell Publishing Ltd.

Clinical features and outcomes of blunt splenic injury in children

PubMed Central

Yang, Kaiying; Li, Yanan; Wang, Chuan; Xiang, Bo; Chen, Siyuan; Ji, Yi

2017-01-01

Abstract Although the spleen is the most commonly injured intra-abdominal organ after blunt trauma, there are limited data available in China. The objectives of this study were to investigate the clinical features and determine the risk factors for operative management (OM) in children with blunt splenic injury (BSI). A review of the medical records of children diagnosed with BSI between January 2010 and September 2016 at West China Hospital of Sichuan University was performed. A total of 101 patients diagnosed with BSI were recruited, including 76 patients transferred from other hospitals. The male-to-female ratio was 2.06:1, with a mean age of 7.8 years old. The most common injury season was summer and the most common injury mechanism was road traffic accidents. Sixty-eight patients suffered multiple injuries. Thirty-four patients received blood transfusions. Two patients died from multiple organ failure or hemorrhagic shock. Significant differences were observed in the injury season, injury mechanism, injury date, and hemoglobin levels between the isolated injury group and the multiple injuries group. The overall operative rate was 29.7%. Multivariate regression analysis revealed that age, blood transfusion, and grade of injury were independent risk factors for OM. Our study provided evidence that the management of pediatric BSI was variable. The operative rate in pediatric BSI may be higher in certain patient groups. Although nonoperative management is one of the standard treatment options, our data suggest that OM is an appropriate way to treat patients who are hemodynamically unstable. PMID:29390566

Design and Weighting Methods for a Nationally Representative Sample of HIV-infected Adults Receiving Medical Care in the United States-Medical Monitoring Project

PubMed Central

Iachan, Ronaldo; H. Johnson, Christopher; L. Harding, Richard; Kyle, Tonja; Saavedra, Pedro; L. Frazier, Emma; Beer, Linda; L. Mattson, Christine; Skarbinski, Jacek

2016-01-01

Background: Health surveys of the general US population are inadequate for monitoring human immunodeficiency virus (HIV) infection because the relatively low prevalence of the disease (<0.5%) leads to small subpopulation sample sizes. Objective: To collect a nationally and locally representative probability sample of HIV-infected adults receiving medical care to monitor clinical and behavioral outcomes, supplementing the data in the National HIV Surveillance System. This paper describes the sample design and weighting methods for the Medical Monitoring Project (MMP) and provides estimates of the size and characteristics of this population. Methods: To develop a method for obtaining valid, representative estimates of the in-care population, we implemented a cross-sectional, three-stage design that sampled 23 jurisdictions, then 691 facilities, then 9,344 HIV patients receiving medical care, using probability-proportional-to-size methods. The data weighting process followed standard methods, accounting for the probabilities of selection at each stage and adjusting for nonresponse and multiplicity. Nonresponse adjustments accounted for differing response at both facility and patient levels. Multiplicity adjustments accounted for visits to more than one HIV care facility. Results: MMP used a multistage stratified probability sampling design that was approximately self-weighting in each of the 23 project areas and nationally. The probability sample represents the estimated 421,186 HIV-infected adults receiving medical care during January through April 2009. Methods were efficient (i.e., induced small, unequal weighting effects and small standard errors for a range of weighted estimates). Conclusion: The information collected through MMP allows monitoring trends in clinical and behavioral outcomes and informs resource allocation for treatment and prevention activities. PMID:27651851

Clinical Application and Pharmacodynamic Monitoring of Apixaban in a Patient with End-Stage Renal Disease Requiring Chronic Hemodialysis.

PubMed

Kufel, Wesley D; Zayac, Adam S; Lehmann, David F; Miller, Christopher D

2016-11-01

Despite prescribing guidance, limited data exist to describe the use of apixaban in patients with end-stage renal disease (ESRD) requiring hemodialysis (HD). Current apixaban dosing recommendations for this patient population are based largely on a single-dose pharmacokinetic study of eight patients. We describe the clinical application and pharmacodynamic monitoring of apixaban in a 62-year-old 156-kg African-American woman with nonvalvular atrial fibrillation and ESRD requiring hemodialysis who developed calciphylaxis while receiving warfarin therapy. Based on a multidisciplinary clinical judgment decision due to concern for drug accumulation after multiple doses in patients with ESRD receiving HD, she was anticoagulated with apixaban 2.5 mg twice/day, as opposed to 5 mg twice/day as recommended by the package insert. Antifactor Xa monitoring was used, and resultant peak and trough apixaban concentrations were above the upper limit of detection for our clinical laboratory (more than 2.00 IU/ml). On day 7 of her hospitalization, the patient developed gastrointestinal bleeding, and apixaban was discontinued; no further clinical signs of bleeding occurred during her subsequent hospitalization course. Use of the Naranjo Adverse Drug Reaction Probability Scale indicated a probable relationship (score of 6) between apixaban exposure and the manifestation of gastrointestinal bleeding. The patient ultimately died 44 days after the acute bleeding event; however, coagulation concerns were not implicated in the patient's death. To our knowledge, this is the first case report that describes apixaban use and associated antifactor Xa monitoring in a patient with ESRD receiving HD, and it provides concern for current apixaban dosing recommendations in this patient population. Further pharmacokinetic and clinical data are likely necessary to better characterize apixaban use in these patients to optimize safety and efficacy. © 2016 Pharmacotherapy Publications, Inc.

Ambulatory Medication Reconciliation in Dialysis Patients: Benefits and Community Practitioners’ Perspectives

PubMed Central

Wilson, Jo-Anne S; Ladda, Matthew A; Tran, Jaclyn; Wood, Marsha; Poyah, Penelope; Soroka, Steven; Rodrigues, Glenn; Tennankore, Karthik

2017-01-01

Background Ambulatory medication reconciliation can reduce the frequency of medication discrepancies and may also reduce adverse drug events. Patients receiving dialysis are at high risk for medication discrepancies because they typically have multiple comorbid conditions, are taking many medications, and are receiving care from many practitioners. Little is known about the potential benefits of ambulatory medication reconciliation for these patients. Objectives To determine the number, type, and potential level of harm associated with medication discrepancies identified through ambulatory medication reconciliation and to ascertain the views of community pharmacists and family physicians about this service. Methods This retrospective cohort study involved patients initiating hemodialysis who received ambulatory medication reconciliation in a hospital renal program over the period July 2014 to July 2016. Discrepancies identified on the medication reconciliation forms for study patients were extracted and categorized by discrepancy type and potential level of harm. The level of harm was determined independently by a pharmacist and a nurse practitioner using a defined scoring system. In the event of disagreement, a nephrologist determined the final score. Surveys were sent to 52 community pharmacists and 44 family physicians involved in the care of study patients to collect their opinions and perspectives on ambulatory medication reconciliation. Results Ambulatory medication reconciliation was conducted 296 times for a total of 147 hemodialysis patients. The mean number of discrepancies identified per patient was 1.31 (standard deviation 2.00). Overall, 30% of these discrepancies were deemed to have the potential to cause moderate to severe patient discomfort or clinical deterioration. Survey results indicated that community practitioners found ambulatory medication reconciliation valuable for providing quality care to dialysis patients. Conclusions This study has provided evidence that ambulatory medication reconciliation can increase patient safety and potentially prevent adverse events associated with medication discrepancies. PMID:29299004

Sustained Erythroid Response in a Patient with Myelofibrosis Receiving Concomitant Treatment with Ruxolitinib and Deferasirox.

PubMed

Piro, Eugenio; Lentini, Maria; Levato, Luciano; Russo, Antonio; Molica, Stefano

2018-04-25

Iron overload (IOL) due to transfusion-dependent anemia is a serious adverse effect in patients with myelofibrosis (MF). Recent studies have shown that the oral iron chelator deferasirox may prevent multiple organ damage due to IOL in MF. However, it is not clear whether deferasirox may contribute to revert transfusion-dependent anemia. Here, we present a patient with transfusion-dependent intermediate-2 MF according to the International Prognostic Scoring System treated with ruxolitinib in combination with deferasirox. In addition to a reduced serum ferritin level, the patient required less blood transfusions, ultimately resulting in long-lasting transfusion-free survival. © 2018 S. Karger AG, Basel.

[Interest of crizotinib in a lung cancer patient with de novo amplification of MET].

PubMed

Rabeau, A; Rouquette, I; Vantelon, J-M; Taranchon-Clermont, E; Mazières, J

2017-01-01

Targeted therapy in lung cancer changes the prognostic and treatment of patients. MET is an oncogene including exon 14 mutations and gene amplification associated with worse prognosis. We here report the case of a 47-year-old former smoker, woman, with a stage IV lung adenocarcinoma with multiple chemotherapy failure. A MET amplification was identified and the patient consequently received crizotinib. A major response was observed after eight weeks of treatment. MET amplification screening appears to be interesting with some oncogenic-addicted tumor response rate. Those patients should be enrolled in clinical trials dedicated to tumor with MET alteration. Copyright © 2016 SPLF. Published by Elsevier Masson SAS. All rights reserved.

Assessing Patient Activation among High-Need, High-Cost Patients in Urban Safety Net Care Settings.

PubMed

Napoles, Tessa M; Burke, Nancy J; Shim, Janet K; Davis, Elizabeth; Moskowitz, David; Yen, Irene H

2017-12-01

We sought to examine the literature using the Patient Activation Measure (PAM) or the Patient Enablement Instrument (PEI) with high-need, high-cost (HNHC) patients receiving care in urban safety net settings. Urban safety net care management programs serve low-income, racially/ethnically diverse patients living with multiple chronic conditions. Although many care management programs track patient progress with the PAM or the PEI, it is not clear whether the PAM or the PEI is an effective and appropriate tool for HNHC patients receiving care in urban safety net settings in the United States. We searched PubMed, EMBASE, Web of Science, and PsycINFO for articles published between 2004 and 2015 that used the PAM and between 1998 and 2015 that used the PEI. The search was limited to English-language articles conducted in the United States and published in peer-reviewed journals. To assess the utility of the PAM and the PEI in urban safety net care settings, we defined a HNHC patient sample as racially/ethnically diverse, low socioeconomic status (SES), and multimorbid. One hundred fourteen articles used the PAM. All articles using the PEI were conducted outside the U.S. and therefore were excluded. Nine PAM studies (8%) included participants similar to those receiving care in urban safety net settings, three of which were longitudinal. Two of the three longitudinal studies reported positive changes following interventions. Our results indicate that research on patient activation is not commonly conducted on racially and ethnically diverse, low SES, and multimorbid patients; therefore, there are few opportunities to assess the appropriateness of the PAM in such populations. Investigators expressed concerns with the potential unreliability and inappropriate nature of the PAM on multimorbid, older, and low-literacy patients. Thus, the PAM may not be able to accurately assess patient progress among HNHC patients receiving care in urban safety net settings. Assessing progress in the urban safety net care setting requires measures that account for the social and structural challenges and competing demands of HNHC patients.

Delayed-release oral mesalamine 4.8 g/day (800-mg tablet) is effective for patients with moderately active ulcerative colitis.

PubMed

Sandborn, William J; Regula, Jaroslaw; Feagan, Brian G; Belousova, Elena; Jojic, Njegica; Lukas, Milan; Yacyshyn, Bruce; Krzeski, Piotr; Yeh, Chyon-Hwa; Messer, Christi A; Hanauer, Stephen B

2009-12-01

It is not clear what induction dose of mesalamine is optimal for treating patients with mildly and moderately active ulcerative colitis (UC). This study was conducted to determine the efficacy and safety of mesalamine 4.8 g/day compared with 2.4 g/day for the treatment of moderately active UC. A multicenter, randomized, double-blind, 6-week, active-control study (ASCEND III) was conducted to assess the noninferiority of delayed-release mesalamine 4.8 g/day (Asacol HD, 800-mg tablet; Procter & Gamble, Pharmaceuticals, Inc, Mason, Ohio) with 2.4 g/day (Asacol, 400-mg tablet; Procter & Gamble Pharmaceuticals, Inc) in 772 patients with moderately active UC. The primary endpoint was treatment success (overall improvement) at week 6, defined as improvement in the Physician's Global Assessment (based on clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy), with no worsening in any individual clinical assessment. The primary objective of noninferiority was met. Seventy percent (273 of 389) of patients who received 4.8 g/day of mesalamine achieved treatment success at week 6, compared with 66% (251 of 383) of patients receiving 2.4 g/day (95% confidence interval for 2.4 g/day minus 4.8 g/day, -11.2 to 1.9). In addition, 43% of patients who received 4.8 g/day mesalamine achieved clinical remission at week 6 compared with 35% of patients who received 2.4 g/day (P = .04). A therapeutic advantage for the 4.8 g/day dose was observed among patients previously treated with corticosteroids, oral mesalamines, rectal therapies, or multiple UC medications. Both regimens were well-tolerated with similar adverse events. Delayed-release mesalamine 4.8 g/day (800-mg tablet) is efficacious and well-tolerated in patients with moderately active UC.

Accuracy of the paracetamol-aminotransferase multiplication product to predict hepatotoxicity in modified-release paracetamol overdose.

PubMed

Wong, Anselm; Sivilotti, Marco L A; Graudins, Andis

2017-06-01

The paracetamol-aminotransferase multiplication product (APAP × ALT) is a risk predictor of hepatotoxicity that is somewhat independent of time and type of ingestion. However, its accuracy following ingestion of modified-release formulations is not known, as the product has been derived and validated after immediate-release paracetamol overdoses. The aim of this retrospective cohort study was to evaluate the accuracy of the multiplication product to predict hepatotoxicity in a cohort of patients with modified-release paracetamol overdose. We assessed all patients with modified-release paracetamol overdose presenting to our hospital network from October 2009 to July 2016. Ingestion of a modified-release formulation was identified by patient self-report or retrieval of the original container. Hepatotoxicity was defined as peak alanine aminotransferase ≥1000 IU/L, and acute liver injury (ALI) as a doubling of baseline ALT to more than 50 IU/L. Of 1989 paracetamol overdose presentations, we identified 73 modified-release paracetamol exposures treated with acetylcysteine. Five patients developed hepatotoxicity, including one who received acetylcysteine within eight hours of an acute ingestion. No patient with an initial multiplication product <10,000 mg/L × IU/L developed hepatotoxicity (sensitivity 100% [95%CI 48%, 100%], specificity 97% [90%, 100%]). Specificity fell to 54% (95%CI: 34, 59%) at a product cut-off point <1500 mg/L × IU/L. When calculated within eight hours of ingestion, mild elevations of the multiplication product fell quickly on repeat testing in patients without ALI or hepatotoxicity. In modified-release paracetamol overdose treated with acetylcysteine, the paracetamol-aminotransferase multiplication product demonstrated similar accuracy and temporal profile to previous reports involving mostly immediate-release formulations. Above a cut-point of 10,000 mg/L × IU/L, it was very strongly associated with the development of acute liver injury and hepatotoxicity, especially when calculated more than eight hours post-ingestion. When below 1500 mg/L × IU/L the likelihood of developing hepatotoxicity was very low. Persistently high serial multiplication product calculations were associated with the greatest risk of hepatotoxicity.

Definitive radiotherapy for extramedullary plasmacytomas of the head and neck.

PubMed

Michalaki, V J; Hall, J; Henk, J M; Nutting, C M; Harrington, K J

2003-10-01

Extramedullary plasmacytoma of the head and neck region (EMPHN) is an uncommon malignant plasma cell neoplasm. In this study we conducted a retrospective analysis of our experience of EMPHN with particular emphasis on the role of definitive radiotherapy. From 1982 to 2001, 10 patients (6 males, 4 females) with EMPHN were treated in our institution. Of nine patients treated at initial diagnosis, all received definitive radiotherapy. One patient treated at relapse underwent surgical resection followed by post-operative radiotherapy. The median age at diagnosis was 55 years (range 35-84 years). The disease was most frequently localized in the paranasal sinuses (50%). All nine patients who received definitive radiotherapy at a dose of 40-50 Gy achieved a complete response. The median follow up period was 29 months (range 7-67 months). Four patients (40%) relapsed, three have died of their disease. Two patients (20%) with paranasal sinus disease subsequently relapsed with multiple myeloma at 10 months and 24 months, respectively. Our results indicate that treatment of EMPHN with radiotherapy achieves excellent rates of local control. The relapse rate in neck nodes of 10% does not justify elective irradiation of the uninvolved neck.

Predictors for half-year outcome of impairment in daily life for back pain patients referred for physiotherapy: a prospective observational study.

PubMed

Karstens, Sven; Hermann, Katja; Froböse, Ingo; Weiler, Stephan W

2013-01-01

From observational studies, there is only sparse information available on the predictors of development of impairment in daily life for patients receiving physiotherapy. Therefore, our aim was to identify factors which predict impairment in daily life for patients with back pain 6 months after receiving physiotherapy. We conducted a prospective cohort study with 6-month follow-up. Patients were enrolled for treatment in private physiotherapy practices. Patients with a first physiotherapy referral because of thoracic or low back pain, aged 18 to 65 years were included. Primary outcome impairment was measured utilising the 16-item version of the Musculoskeletal Function Assessment Questionnaire. Therapy was documented on a standardized form. Baseline scores for impairment in daily life, symptom characteristics, sociodemographic and psychosocial factors, physical activity, nicotine consumption, intake of analgesics, comorbidity and delivered primary therapy approach were investigated as possible predictors. Univariate and multiple linear regression analyses were performed. A total of 792 patients participated in the study (59% female, mean age 44.4 (SD 11.4), with 6-month follow-up results available from 391 patients. In univariate analysis 17 variables reached significance. In multiple linear regression identified predictors were: impairment in daily life before therapy, mental disorders, duration of the complaints, self-prognosis on work ability, rheumatoid arthritis, age, form of stress at work and physical activity. The variables explain 34% of variance (adjusted R(2), p<0.001). With minimal information available from observational studies on the predictors of development of back problems for physiotherapy patients, this study adds new knowledge for forming appropriate referral guidelines. Impairment in daily life before therapy, mental disorder as comorbidity and the duration of the complaints can be named as outstanding factors. The results of this study can be used to facilitate comparison of patient therapy goals with the prognosis in everyday practice.

Baseline factors that influence ASAS 20 response in patients with ankylosing spondylitis treated with etanercept.

PubMed

Davis, John C; Van der Heijde, Désirée M F M; Dougados, Maxime; Braun, Jurgen; Cush, John J; Clegg, Daniel O; Inman, Robert D; de Vries, Todd; Tsuji, Wayne H

2005-09-01

To examine the baseline demographic and disease characteristics that might influence improvement as measured by the Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) in patients with ankylosing spondylitis (AS). A multicenter Phase 3 study was performed to compare the safety and efficacy of 24 weeks of etanercept 25 mg subcutaneous injection twice weekly (n = 138) and placebo (n = 139) in patients with AS. The ASAS 20 was measured at multiple time points. Using a significance level of 0.05, a repeated measures logistic regression model was used to determine which baseline factors influenced response in the etanercept-treated patients during the 24-week double blind portion of the trial. The following baseline factors were used in the model: demographic and disease severity variables, concomitant medications, extra-articular manifestations, and HLA-B27 status. The predictive capability of the model was then tested on the patients receiving placebo after they had received open-label etanercept treatment. Baseline factors that were significant predictors of an ASAS 20 response in etanercept-treated patients were C-reactive protein (CRP), back pain score, and Bath Ankylosing Spondylitis Functional Index (BASFI) score. Although clinical response to etanercept was seen at all levels of baseline disease activity, responses were consistently more likely with higher CRP levels or back pain scores and less likely with increased BASFI scores at baseline. Higher CRP values and back pain scores and lower BASFI scores at baseline were significant predictors of a higher ASAS 20 response in patients with AS receiving etanercept but predictive value was of insufficient magnitude to determine treatment in individual patients.

Impact of the Adalimumab Patient Support Program's Care Coach Calls on Persistence and Adherence in Canada: An Observational Retrospective Cohort Study.

PubMed

Marshall, John K; Bessette, Louis; Thorne, Carter; Shear, Neil H; Lebovic, Gerald; Gerega, Sebastien K; Millson, Brad; Oraichi, Driss; Gaetano, Tania; Gazel, Sandra; Latour, Martin G; Laliberté, Marie-Claude

2018-03-01

Adalimumab (ADA) is a tumor necrosis factor-α inhibitor indicated for use in various immune-mediated inflammatory diseases. Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care's Patient Support Program (PSP), which provides personalized services, including tailored interventions in the form of nurse-provided care coach calls (CCCs), with the goal of improving patients' experiences and outcomes. The primary objective of this study was to evaluate the impact of PSP services, including CCCs and patient characteristics, on persistence with and adherence to ADA for those patients enrolled in the PSP. A secondary objective was to estimate the effect of initial CCCs on treatment-initiation abandonment (ie, failure to initiate therapy after enrollment in the PSP). An observational retrospective cohort study was conducted. A patient linkage algorithm based on probabilistic matching was developed to link the AbbVie Care PSP database to the QuintilesIMS longitudinal pharmacy transaction database. Patients who started ADA therapy between July 2010 and August 2014 were selected, and their prescriptions were evaluated for 12 months after the date of ADA start to calculate days until drug discontinuation, that is, the end of persistence, defined as >90 days without therapy. Cox proportional hazards modeling was used for estimating hazard ratios for the association between persistence and patient characteristics and each PSP service. Adherence, measured by medication possession ratio, was calculated, and multivariate logistic regression provided adjusted odds ratios for the relationship between being adherent (medication possession ratio ≥80%) and patient characteristics and each PSP service. Treatment-initiation abandonment among patients who received an initial CCC compared with those who did not was analyzed using the χ 2 test. Analysis of 10,857 linked patients yielded statistically significant differences in the hazard ratio of discontinuation and the likelihood of being adherent across multiple variables between patients who received CCCs in comparison to patients who did not. Patients receiving CCCs were found to have a 72% decreased risk for therapy discontinuation (hazard ratio = 0.282; P < 0.0001), and a greater likelihood of being adherent (odds ratio = 1.483; P < 0.0001), when compared with those patients who did not receive CCCs. The rate of treatment-initiation abandonment was significantly higher in patients who did not receive initial CCCs (P < 0.0001). Ongoing CCCs, provided by AbbVie Care PSP, were associated with greater patient persistence and adherence over the first 12 months of treatment, while initial CCCs were associated with a lower rate of treatment-initiation abandonment. Results may inform the planning of interventions aimed at improving treatment adherence and patient outcomes. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

[Systematic review of safeness and therapeutic efficacy of cannabis in patients with multiple sclerosis, neuropathic pain, and in oncological patients treated with chemotherapy].

PubMed

Amato, Laura; Minozzi, Silvia; Mitrova, Zuzana; Parmelli, Elena; Saulle, Rosella; Cruciani, Fabio; Vecchi, Simona; Davoli, Marina

2017-01-01

medical cannabis refers to the use of cannabis or cannabinoids as medical therapy to treat disease or alleviate symptoms. In the United States, 23 states and Washington DC (May 2015) have introduced laws to permit the medical use of cannabis. Within the European Union, medicinal cannabis laws and praxis vary wildly between Countries. to provide evidence for benefits and harms of cannabis (including extracts and tinctures) treatment for adults in the following indications: control of spasticity and pain in patients with multiple sclerosis; control of pain in patients with chronic neuropathic pain; control of nausea and vomiting in adults with cancer receiving chemotherapy. we searched the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE from inception to September 2016. We also searched for on-going studies via ClinicalTrials.gov and the World Health Organization and International Clinical Trials Registry Platform (ICTRP) search portal. All searches included also non-English language literature. All relevant randomized controlled trials (RCTs) evaluating the safety and efficacy of cannabis (including extracts and tinctures) compared with placebo or other pharmacological agents were included. Three authors independently evaluated the titles and abstracts of studies identified in the literature searches for their eligibility. For studies considered eligible, we retrieved full texts. Three investigators independently extracted data. For the assessment of the quality of evidence, we used the standard methodological procedures recommended by Cochrane and GRADE working Group. 41 trials (4,550 participants) were included; 15 studies considered efficacy and safety of cannabis for patients with multiple sclerosis, 12 for patients with chronic pain, and 14 for patients with cancer receiving chemotherapy. The included studies were published between 1975 and 2015, and the majority of them were conducted in Europe. We judged almost 50% of these studies to be at low risk of bias. The large majority (80%) of the comparisons were with placebo; only 8 studies included patients with cancer receiving chemotherapy comparing cannabis with other antiemetic drugs. Concerning the efficacy of cannabis (compared with placebo) in patients with multiple sclerosis, confidence in the estimate was high in favour of cannabis for spasticity (numerical rating scale and visual analogue scale, but not the Ashworth scale) and pain. For chronic and neuropathic pain (compared with placebo), there was evidence of a small effect; however, confidence in the estimate is low and these results could not be considered conclusive. There is uncertainty whether cannabis, including extracts and tinctures, compared with placebo or other antiemetic drugs reduces nausea and vomiting in patients with cancer requiring chemotherapy, although the confidence in the estimate of the effect was low or very low. In the included studies, many adverse events were reported and none of the studies assessed the development of abuse or dependence. there is incomplete evidence of the efficacy and safety of medical use of cannabis in the clinical contexts considered in this review. Furthermore, for many of the outcomes considered, the confidence in the estimate of the effect was again low or very low. To give conclusive answers to the efficacy and safety of cannabis used for medical purposes in the clinical contexts considered, further studies are needed, with higher quality, larger sample sizes, and possibly using the same diagnostic tools for evaluating outcomes of interest.

Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial.

PubMed

Poewe, Werner; Seppi, Klaus; Fitzer-Attas, Cheryl J; Wenning, Gregor K; Gilman, Sid; Low, Phillip A; Giladi, Nir; Barone, Paolo; Sampaio, Cristina; Eyal, Eli; Rascol, Olivier

2015-02-01

Multiple system atrophy is a complex neurodegenerative disorder for which no effective treatment exists. We aimed to assess the effect of rasagiline on symptoms and progression of the parkinsonian variant of multiple system atrophy. We did this randomised, double-blind, placebo-controlled trial between Dec 15, 2009, and Oct 20, 2011, at 40 academic sites specialised in the care of patients with multiple systemic atrophy across 12 countries. Eligible participants aged 30 years or older with possible or probable parkinsonian variant multiple system atrophy were randomly assigned (1:1), via computer-generated block randomisation (block size of four), to receive either rasagiline 1 mg per day or placebo. Randomisation was stratified by study centre. The investigators, study funder, and personnel involved in patient assessment, monitoring, analysis and data management were masked to group assignment. The primary endpoint was change from baseline to study end in total Unified Multiple System Atrophy Rating Scale (UMSARS) score (parts I and II). Analysis was by modified intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00977665. We randomly assigned 174 participants to the rasagiline group (n=84) or the placebo group (n=90); 21 (25%) patients in the rasagiline group and 15 (17%) in the placebo group withdrew from the study early. At week 48, patients in the rasagiline group had progressed by an adjusted mean of 7·2 (SE 1·2) total UMSARS units versus 7·8 (1·1) units in those in the placebo group. This treatment difference of -0·60 (95% CI -3·68 to 2·47; p=0·70) was not significant. 68 (81%) patients in the rasagiline group and 67 (74%) patients in the placebo group reported adverse events, and we recorded serious adverse events in 29 (35%) versus 23 (26%) patients. The most common adverse events in the rasagiline group were dizziness (n=10 [12%]), peripheral oedema (n=9 [11%]), urinary tract infections (n=9 [11%]), and orthostatic hypotension (n=8 [10%]). In this population of patients with the parkinsonian variant of multiple system atrophy, treatment with rasagiline 1 mg per day did not show a significant benefit as assessed by UMSARS. The study confirms the sensitivity of clinical outcomes for multiple system atrophy to detect clinically significant decline, even in individuals with early disease. Teva Pharmaceutical Industries and H Lundbeck A/S. Copyright © 2015 Elsevier Ltd. All rights reserved.

Diagnosis and conservative management of intrathoracic leakage after oesophagectomy.

PubMed

Sauvanet, A; Baltar, J; Le Mee, J; Belghiti, J

1998-10-01

Although intrathoracic leakage is a major complication of oesophagectomy, precise data concerning diagnostic features and results of conservative treatment are lacking. From 1986 to 1994, 409 oesophagectomies with stapled oesophagogastrostomy were performed, including 358 Lewis-Tanner and 51 Sweet procedures. A water-soluble contrast swallow was routinely performed on day 7 or later, before oral intake was begun. All patients except one received conservative non-surgical treatment, including nutritional support and perianastomotic drainage. Leaks were diagnosed in 38 patients (9.3 per cent). The leakage rate was 7.8 per cent after the Lewis-Tanner procedure and 20 per cent after the Sweet procedure (P < 0.01). Eleven patients had no symptoms. Seven of the 27 patients with symptoms had a contrast swallow that was normal, and subsequently developed a confirmed fistula after the onset of oral intake. Five patients had to undergo reoperation. All asymptomatic patients and 18 symptomatic patients recovered. Nine patients died, mainly from multiple organ failure, including three who had reoperation for resection of the gastroplasty. The potential presence of clinically silent fistula and the deleterious role of oral intake still justify routine detection of leakage after oesophageal resection. Conservative treatment results in survival with preservation of the gastroplasty in most patients, unless multiple organ failure occurs.

Tandem autologous non-myeloablative allogeneic transplantation in patients with multiple myeloma relapsing after a first high dose therapy.

PubMed

Karlin, L; Arnulf, B; Chevret, S; Ades, L; Robin, M; De Latour, R P; Malphettes, M; Kabbara, N; Asli, B; Rocha, V; Fermand, J P; Socie, G

2011-02-01

We retrospectively studied a series of 23 patients (median age 50 years, range 29-59 years) with multiple myeloma (MM), treated in first relapse by a sequential autologous-allogeneic tandem approach. Tandem transplantation (TT) consisted in high dose melphalan (HDT) and auto-SCT followed by an (allo-SCT) preceded by two gray TBI non-myeloablative conditioning. All patients received a first HDT as frontline treatment. At day 100 post allo-SCT, complete donor chimerism was detected in 22 patients (95%). Acute GVHD was observed in 19 patients (15 grade I-II (65%) and 4 grade III-IV (17%)). Ten patients (43%) developed an extensive chronic GVHD. The non-relapse mortality at 1 year was 17%. After TT, the overall response rate was 91% (17% partial response, 35% very good partial remission and 39% complete remission). At 2 years, OS was 61%. Median event-free survival and OS were 36.8 and 60 months, respectively. Based on the propensity score matching method, a significant survival advantage could be seen in patients treated with TT as compared with non-allografted patients. Thus, allo-SCT, in TT approach, provides a high response rate with low toxicity and may improve survival of patients with relapsing MM.

Cutaneous manifestations of phosphate solution extravasation.

PubMed

Verykiou, S; Aljefri, K; Gopee, H; Taheri, L; Charlton, F; Langtry, J A; Blasdale, C

2018-01-01

Extravasation injuries are common in patients receiving multiple intravenous infusions. Although such injuries are closely associated with the infusion of cytotoxic chemotherapy, they have also been been associated with extravasation of noncytotoxic drugs. Extravasation injuries can lead to skin ulceration and nerve and tendon damage, and therefore to permanent disability. We report three cases of phosphate solution extravasation leading to unusual cutaneous manifestations. © 2017 British Association of Dermatologists.

Cerebellar hemorrhage provoked by combined use of nattokinase and aspirin in a patient with cerebral microbleeds.

PubMed

Chang, Yung-Yee; Liu, Jia-Shou; Lai, Shung-Lon; Wu, Hsiu-Shan; Lan, Min-Yu

2008-01-01

Nattokinase is used as a health-promoting medicine for preventing thrombosis due to its fibrinolytic activity. Cerebral microbleed is remnant of blood extravasations from the damaged vessels related to cerebral microangiopathies. We report a patient, having used aspirin for secondary stroke prevention, who had an acute cerebellar hemorrhage after taking nattokinase 400 mg daily for 7 consecutive days. In addition to the hemorrhagic lesion, multiple microbleeds were demonstrated on brain MR images. We suggest that nattokinase may increase risk of intracerebral hemorrhage in patients who have bleeding-prone cerebral microangiopathy and are receiving other antithrombotic agent at the same time.

Clinical assessment of patients with orofacial pain and temporomandibular disorders.

PubMed

Stern, Ilanit; Greenberg, Martin S

2013-07-01

Accurate diagnosis of chronic pain disorders of the mouth, jaws, and face is frequently complex. It is common for patients with chronic orofacial pain to consult multiple clinicians and receive ineffective treatment before a correct diagnosis is reached. This problem is a significant public health concern. Clinicians can minimize error by starting the diagnostic procedure with a careful, accurate history and thorough head and neck examination followed by a thoughtfully constructed differential diagnosis. The possibility that the patient has symptoms of a life-threatening underlying disease rather than a more common dental, sinus, or temporomandibular disorder must always be considered. Published by Elsevier Inc.

[A comparative evaluation of the efficacy of magneto- and laser therapy in patients with osteoarthrosis deformans].

PubMed

Selivonenko, V G; Syvolap, V D; Porada, L V; Medvedeva, V N; Boev, S S; Morozov, A I; Slin'ko, V G; Berest, S M; Garbuz, L N; Sholokh, S G

1997-01-01

A comparative evaluation of efficacy of magneto- and laser therapy was carried out in 82 patients with osteoarthrosis deformans. The magnetic field and laser irradiation dispelled the pain syndrome and synovitis manifestations. It is recommendable that the multiple-modality therapy of patients with osteoarthrosis deformans should involve magneto- and laser therapy (15 to 20 procedures per one course) that improve results of the treatment being received and allow the time of hospitalization to be reduced at an average by 5 bed-days. Laser appeared to be a very effective mode of treatment. No unfavourable side effects were recordable.

A TAD better for myeloma therapy?

PubMed

Giralt, Sergio

2010-02-11

In this issue of Blood, Lokhorst and colleagues report on the results of HOVON-50, a phase 3 randomized trial designed to evaluate the effects of thalidomide during induction treatment and as maintenance in patients with multiple myeloma. There were 556 patients randomly assigned either to 3 cycles of VAD or to TAD. All patients were to receive high-dose melphalan with autologous stem cell support followed by maintenance with interferon for the VAD arm or thalidomide for the TAD arm.(1) This study together with other randomized and nonrandomized trials establish a definitive role for thalidomide as induction therapy in conjunction with dexamethasone, anthracyclines, and alkylating agents.

Variation in type and frequency of diagnostic imaging during trauma care across multiple time points by patient insurance type.

PubMed

Bell, Nathaniel; Repáraz, Laura; Fry, William R; Smith, R Stephen; Luis, Alejandro

2016-11-03

Research has shown that uninsured patients receive fewer radiographic studies during trauma care, but less is known as to whether differences in care are present among other insurance groups or across different time points during hospitalization. Our objective was to examine the number of radiographic studies administered to a cohort of trauma patients over the entire hospital stay as well as during the first 24-hours of care. Patient data were obtained from an American College of Surgeons (ACS) verified Level I Trauma Center between January 1, 2011 and December 31, 2012. We used negative binomial regression to construct relative risk (RR) ratios for type and frequency of radiographic imaging received among persons with Medicare, Medicaid, no insurance, or government insurance plans in reference to those with commercial indemnity plans. The analysis was adjusted for patient age, sex, race/ethnicity, injury severity score, injury mechanism, comorbidities, complications, hospital length of stay, and Intensive Care Unit (ICU) admission. A total of 3621 records from surviving patients age > =18 years were assessed. After adjustment for potential confounders, the expected number of radiographic studies decreased by 15 % among Medicare recipients (RR 0.85, 95 % CI 0.78-0.93), 11 % among Medicaid recipients (0.89, 0.81-0.99), 10 % among the uninsured (0.90, 0.85-0.96) and 19 % among government insurance groups (0.81, 0.72-0.90), compared with the reference group. This disparity was observed during the first 24-hours of care among patients with Medicare (0.78, 0.71-0.86) and government insurance plans (0.83, 0.74-0.94). Overall, there were no differences in the number of radiographic studies among the uninsured or among Medicaid patients during the first 24-hours of care compared with the reference group, but differences were observed among the uninsured in a sub-analysis of severely injured patients (ISS > 15). Both uninsured and insured patients treated at a not-for-profit verified Level I Trauma Center receive fewer radiographic studies than patients with commercial indemnity plans, even after adjusting for clinical and demographic confounders. There is less disparity in care during the first 24-hours, which suggests that patient pathology is the determining factor for radiographic evaluation during the acute care phase. Results from this study offer initial evidence of disparity in diagnostic imaging across multiple insurance groups over different periods of trauma care.

A Semi-flexible 64-channel Receive-only Phased Array for Pediatric Body MRI at 3T

PubMed Central

Zhang, Tao; Grafendorfer, Thomas; Cheng, Joseph Y.; Ning, Peigang; Rainey, Bob; Giancola, Mark; Ortman, Sarah; Robb, Fraser J.; Calderon, Paul D.; Hargreaves, Brian A.; Lustig, Michael; Scott, Greig C.; Pauly, John M.; Vasanawala, Shreyas S.

2015-01-01

Purpose To design, construct, and validate a semi-flexible 64-channel receive-only phased array for pediatric body MRI at 3T. Methods A 64-channel receive-only phased array was developed and constructed. The designed flexible coil can easily conform to different patient sizes with non-overlapping coil elements in the transverse plane. It can cover a field of view of up to 44 × 28 cm2 and removes the need for coil repositioning for body MRI patients with multiple clinical concerns. The 64-channel coil was compared with a 32-channel standard coil for signal-to-noise ratio (SNR) and parallel imaging performances on different phantoms. With IRB approval and informed consent/assent, the designed coil was validated on 21 consecutive pediatric patients. Results The pediatric coil provided higher SNR than the standard coil on different phantoms, with the averaged SNR gain at least 23% over a depth of 7 cm along the cross-section of phantoms. It also achieved better parallel imaging performance under moderate acceleration factors. Good image quality (average score 4.6 out of 5) was achieved using the developed pediatric coil in the clinical studies. Conclusion A 64-channel semi-flexible receive-only phased array has been developed and validated to facilitate high quality pediatric body MRI at 3T. PMID:26418283

Invited manuscript poster on renal-related education American Society of Nephrology, Nov. 16-21, 2010. Do medical trainees receive adequate training in the management of acute kidney injury?

PubMed

Ali, Mansoor N; Lewington, Andrew J P

2011-01-01

There has been increased interest in acute kidney injury (AKI) over the past decade following the recognition of the association of relatively small rises in serum creatinine with worse patient outcomes. This association has resulted in newly proposed definitions in AKI based on changes in serum creatinine. In 2009, the National Confidential Enquiry into Patient Outcomes and Death Adding Insult to Injury AKI study reported that only 50% of patients who died with a diagnosis of AKI received good care. The study identified multiple deficiencies and made a number of recommendations which included improving the training of undergraduate and postgraduate trainees in the management of AKI. The aim of the evaluation was to try and identify the perception of medical trainees in Leeds Teaching Hospitals of the training they had received on AKI. A simple questionnaire was used and captured the views of 73 trainees (including 13 final-year medical students). The evaluation indicated that the majority of trainees were unaware of newly proposed definitions of AKI, and many trainees felt that the training they had received in AKI was inadequate for their needs. Following this evaluation, we have made a number of changes to the training that is delivered to both undergraduate and postgraduate trainees in Leeds on the management of AKI.

Impact of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod: Subgroup analyses of the Fingolimod Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study.

PubMed

Kremenchutzky, Marcelo; O'Connor, Paul; Hohlfeld, Reinhard; Zhang-Auberson, Lixin; von Rosenstiel, Philipp; Meng, Xiangyi; Grinspan, Augusto; Hashmonay, Ron; Kappos, Ludwig

2014-05-01

Fingolimod is a once-daily, oral sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing multiple sclerosis. This post-hoc analysis of phase 3 FREEDOMS data assessed whether the effects of fingolimod are consistent among subgroups of patients defined by prior treatment history. Annualized relapse rate and safety profile of treatment with fingolimod 0.5mg, 1.25mg, or placebo once-daily for 24 months were analyzed in 1272 relapsing multiple sclerosis patients, by subgroups based on disease-modifying therapy history (treatment-naive; prior interferon-β or glatiramer acetate), reason for discontinuation of prior disease-modifying therapy (unsatisfactory therapeutic response or adverse events), and prior disease-modifying therapy duration. Both fingolimod doses significantly reduced annualized relapse rate in patients that received prior interferon-β or glatiramer acetate, discontinued prior disease-modifying therapy owing to unsatisfactory therapeutic effect, were treatment-naive, or had prior disease-modifying therapy duration of >1-3 years (P≤0.0301 for all comparisons vs placebo). Fingolimod 1.25mg resulted in greater reductions in annualized relapse rate in patients that discontinued prior disease-modifying therapy for adverse events or had prior disease-modifying therapy duration of ≤1 year or >3 years (P≤0.0194 vs placebo). Fingolimod demonstrated similar efficacy in relapsing multiple sclerosis patients regardless of prior treatment history. Clinicaltrials.gov identifier: NCT00289978. © 2013 The Authors. Published by Elsevier B.V. All rights reserved.

Differences in clinical Pneumocystis pneumonia in rheumatoid arthritis and other connective tissue diseases suggesting a rheumatoid-specific interstitial lung injury spectrum.

PubMed

Shimada, Kota; Yokosuka, Kyoko; Nunokawa, Takahiro; Sugii, Shoji

2018-06-06

To compare Pneumocystis pneumonia (PCP) in patients with rheumatoid arthritis (RA) with PCP in patients with non-RA connective tissue diseases (CTDs) in order to clarify the characteristics of the former. We extracted consecutive patients satisfying the following criteria for "clinical PCP": (1) positive plasma β-D-glucan, (2) PCP-compatible computed tomography findings of the lung, and (3) successful treatment with antipneumocystic antibiotics. Patients who underwent methylprednisolone "pulse" therapy or sufficient antibiotics to cure bacterial pneumonia were excluded. We used the t test, U test, or Fischer's exact probability test to compare the two groups and Jonckheere-Terpstra's test and Ryan's procedure for the trend test. Thirty-five cases were extracted. The underlying rheumatic diseases were RA in 25 and non-RA CTDs in ten. At the onset of clinical PCP, the lymphocyte counts were 884 vs 357/mm 3 (p < 0.001), PC-PCR positivity 64% vs 100% (p = 0.029), glucocorticoid dose 4.0 vs 17.5 mg PSL/day (p < 0.001), and methotrexate dose 8 vs 0 mg/week (p = 0.003). The PC-PCR-negative patients, observed only in the RA group, were all receiving methotrexate (MTX) therapy except one patient who was receiving high-dose prednisolone alone. All PC-PCR-positive patients were receiving glucocorticoid, TNF inhibitor, or a non-MTX immunosuppressant. No patient with MTX alone had positive PC-PCR results. Clinical PCP in RA patients differed from that in non-RA CTD patients and may be understood as only a part of the rheumatoid-specific interstitial lung injury spectrum influenced by multiple, synergistic factors including MTX, Pneumocystis, and RA itself.

Impact of Florida's prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis.

PubMed

Chang, Hsien-Yen; Murimi, Irene; Faul, Mark; Rutkow, Lainie; Alexander, G Caleb

2018-04-01

We quantified the effects of Florida's prescription drug monitoring program and pill mill law on high-risk patients. We used QuintilesIMS LRx Lifelink data to identify patients receiving prescription opioids in Florida (intervention state, N: 1.13 million) and Georgia (control state, N: 0.54 million). The preintervention, intervention, and postintervention periods were July 2010 to June 2011, July 2011 to September 2011, and October 2011 to September 2012. We identified 3 types of high-risk patients: (1) concomitant users: patients with concomitant use of benzodiazepines and opioids; (2) chronic users: long-term, high-dose, opioid users; and (3) opioid shoppers: patients receiving opioids from multiple sources. We compared changes in opioid prescriptions between Florida and Georgia before and after policy implementation among high-risk/low-risk patients. Our monthly measures included (1) average morphine milligram equivalent per transaction, (2) total opioid volume across all prescriptions, (3) average days supplied per transaction, and (4) total number of opioid prescriptions dispensed. Among opioid-receiving individuals in Florida, 6.62% were concomitant users, 1.96% were chronic users, and 0.46% were opioid shoppers. Following policy implementation, Florida's high-risk patients experienced relative reductions in morphine milligram equivalent (opioid shoppers: -1.08 mg/month, 95% confidence interval [CI] -1.62 to -0.54), total opioid volume (chronic users: -4.58 kg/month, CI -5.41 to -3.76), and number of dispensed opioid prescriptions (concomitant users: -640 prescriptions/month, CI -950 to -340). Low-risk patients generally did not experience statistically significantly relative reductions. Compared with Georgia, Florida's prescription drug monitoring program and pill mill law were associated with large relative reductions in prescription opioid utilization among high-risk patients. Copyright © 2018 John Wiley & Sons, Ltd.

The Effects of Massage Therapy on Multiple Sclerosis Patients' Quality of Life and Leg Function

PubMed Central

2014-01-01

Background. Massage therapy is a noninvasive treatment that many individuals with multiple sclerosis (MS) use to supplement their conventional treatment. Objective. We hypothesize that massage therapy will improve the leg function and overall quality of life (QoL) of MS patients. Design. A two-period (rest, massage) crossover design was used. Twenty-four individuals with MS ranging from 3.0 to 7.0 on the Expanded Disability Status Scale (EDSS) received Swedish massage treatments for four weeks. Exercise capacity and leg function as well as QoL were assessed using the Six-Minute Walk Test (6MWT) and the Hamburg Quality of Life in Multiple Sclerosis (HAQUAMS) instrument, respectively. Assessments were measured before and after a massage period and a rest period where no massages were employed. Results. The results displayed no significant changes in 6MWT distances or HAQUAMS scores. However, the participants perceived improvement in overall health as expressed in written comments. Conclusions. Massage is a safe, noninvasive treatment that may assist MS patients in managing the stress of their symptoms. Future studies with larger sample size and cortisol measures are warranted. PMID:24949078

Prophylactic low-dose aspirin is effective antithrombotic therapy for combination treatments of thalidomide or lenalidomide in myeloma.

PubMed

Niesvizky, Ruben; Martínez-Baños, Déborah; Jalbrzikowski, Jessica; Christos, Paul; Furst, Jessica; De Sancho, Maria; Mark, Tomer; Pearse, Roger; Mazumdar, Madhu; Zafar, Faiza; Pekle, Karen; Leonard, John; Jayabalan, David; Coleman, Morton

2007-12-01

Multiple myeloma (MM) patients have a propensity for thromboembolic events (TE), and treatment with thalidomide/dexamethasone or lenalidomide/dexamethasone increases this risk. This report describes the use of low-dose aspirin (81 mg) as primary thromboprophylaxis in three series of MM patients receiving thalidomide or lenalidomide with other drugs. In the first regimen (clarithromycin, thalidomide, dexamethasone), initiation of low-dose aspirin negated the occurrence of any further TE. In a second study, prophylactic aspirin given with thalidomide/dexamethasone resulted in a rate of TE similar to that seen with dexamethasone alone (without aspirin). A third study (n = 72) evaluated thrombosis rates with aspirin and a lenalidomide-containing regimen (clarithromycin, lenalidomide, dexamethasone). Of nine occurrences of thromboembolism, five were associated with aspirin interruption or poor compliance. Low-dose aspirin appears to reduce the incidence of thrombosis with these regimens. Routine use of aspirin as antithrombotic prophylaxis in MM patients receiving immunomodulatory drugs with corticosteroids is warranted.

Moderators and determinants of satisfaction with diet counseling for patients consuming a therapeutic diet.

PubMed

Trudeau, E; Dubé, L

1995-01-01

To identify moderators and key determinants of patient satisfaction with diet counseling. Survey questionnaire. A French-Canadian acute-care urban hospital. Population of eligible patients hospitalized for a minimum stay of 5 days. Patients excluded from the study were those with notable physical, cognitive, or emotional limitations; those receiving enteral and parenteral nutrition; and those from long-term-care units. Analyses were performed on 49 patients who consumed a therapeutic diet and who received diet counseling during their current hospital stay. Overall satisfaction with diet counseling, compliance intentions, and satisfaction with four components of diet counseling. Measures were taken on seven-point graphic scales and five-point semantic scales. Reliability estimates with Cronbach's alpha correlation coefficient, stepwise multiple regression analyses, t tests, and one-way analyses of variance. Facilitation skills and knowledge components of diet counseling were the key determinants of patient satisfaction. Among the moderators of patient satisfaction with diet counseling, women and patients with a good appetite were more satisfied with the knowledge components and had stronger compliance intentions. Patients who spent more than 50% of the time at rest were less satisfied than more active patients. Enhancing patient satisfaction implies having a good understanding of a patient's social and cultural context, developing problem-solving skills, and demonstrating greater flexibility and creativity about the means of providing diet counseling.

Factors associated with discontinuation of aripiprazole treatment after switching from other antipsychotics in patients with chronic schizophrenia: A prospective observational study.

PubMed

Takaesu, Yoshikazu; Kishimoto, Taishiro; Murakoshi, Akiko; Takahashi, Nobutada; Inoue, Yuichi

2016-02-28

The purpose of the study was to identify factors associated with discontinuation of aripiprazole after switching from other antipsychotics in patients with schizophrenia in real world clinical settings. From January 2011 to December 2012, a prospective, 48-week open-label study was undertaken. Thirty-eight subjects on antipsychotic monotherapy were switched to aripiprazole. Patients who discontinued aripiprazole were compared to those who continued with regards to demographic characteristics as well as treatment factors. Multiple regression analysis was conducted to identify predictors for aripiprazole discontinuation. Thirteen out of 38 patients (34.2%) discontinued aripiprazole during the follow up period. Nine patients (23.7%) discontinued aripiprazole due to worsening of psychotic symptoms. Multiple logistic regression analysis revealed that only the duration of previous antipsychotic treatment was associated with aripiprazole discontinuation after switching to aripiprazole. The receiver operating curve (ROC) analysis identified that the cut-off length for duration of illness to predict aripiprazole discontinuation was 10.5 years. Longer duration of illness was associated with aripiprazole discontinuation. Greater caution may be required when treating such patients with aripiprazole. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Icotinib versus whole-brain irradiation in patients with EGFR-mutant non-small-cell lung cancer and multiple brain metastases (BRAIN): a multicentre, phase 3, open-label, parallel, randomised controlled trial.

PubMed

Yang, Jin-Ji; Zhou, Caicun; Huang, Yisheng; Feng, Jifeng; Lu, Sun; Song, Yong; Huang, Cheng; Wu, Gang; Zhang, Li; Cheng, Ying; Hu, Chengping; Chen, Gongyan; Zhang, Li; Liu, Xiaoqing; Yan, Hong Hong; Tan, Fen Lai; Zhong, Wenzhao; Wu, Yi-Long

2017-09-01

For patients with non-small-cell lung cancer (NSCLC) and multiple brain metastases, whole-brain irradiation (WBI) is a standard-of-care treatment, but its effects on neurocognition are complex and concerning. We compared the efficacy of an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), icotinib, versus WBI with or without chemotherapy in a phase 3 trial of patients with EGFR-mutant NSCLC and multiple brain metastases. We did a multicentre, open-label, parallel randomised controlled trial (BRAIN) at 17 hospitals in China. Eligible participants were patients with NSCLC with EGFR mutations, who were naive to treatment with EGFR-TKIs or radiotherapy, and had at least three metastatic brain lesions. We randomly assigned participants (1:1) to either icotinib 125 mg orally (three times per day) or WBI (30 Gy in ten fractions of 3 Gy) plus concurrent or sequential chemotherapy for 4-6 cycles, until unacceptable adverse events or intracranial disease progression occurred. The randomisation was done by the Chinese Thoracic Oncology Group with a web-based allocation system applying the Pocock and Simon minimisation method; groups were stratified by EGFR gene mutation status, treatment line (first line or second line), brain metastases only versus both intracranial and extracranial metastases, and presence or absence of symptoms of intracranial hypertension. Clinicians and patients were not masked to treatment assignment, but individuals involved in the data analysis did not participate in the treatments and were thus masked to allocation. Patients receiving icotinib who had intracranial progression only were switched to WBI plus either icotinib or chemotherapy until further progression; those receiving icotinib who had extracranial progression only were switched to icotinib plus chemotherapy. Patients receiving WBI who progressed were switched to icotinib until further progression. Icotinib could be continued beyond progression if a clinical benefit was observed by the investigators (eg, an improvement in cognition or intracranial pressure). The primary endpoint was intracranial progression-free survival (PFS), defined as the time from randomisation to either intracranial disease progression or death from any cause. We assessed efficacy and safety in the intention-to-treat population (all participants who received at least one dose of study treatment), hypothesising that intracranial PFS would be 40% longer (hazard ratio [HR] 0·60) with icotinib compared with WBI. This trial is registered with ClinicalTrials.gov, number NCT01724801. Between Dec 10, 2012, and June 30, 2015, we assigned 176 participants to treatment: 85 to icotinib and 91 to WBI. 18 withdrew from the WBI group before treatment, leaving 73 for assessment. Median follow-up was 16·5 months (IQR 11·5-21·5). Median intracranial PFS was 10·0 months (95% CI 5·6-14·4) with icotinib versus 4·8 months (2·4-7·2) with WBI (equating to a 44% risk reduction with icotinib for an event of intracranial disease progression or death; HR 0·56, 95% CI 0·36-0·90; p=0·014). Adverse events of grade 3 or worse were reported in seven (8%) of 85 patients in the icotinib group and 28 (38%) of 73 patients in the WBI group. Raised concentrations of alanine aminotransferase and rash were the most common adverse events of any grade in both groups, occurring in around 20-30% of each group. At the time of final analysis, 42 (49%) patients in the icotinib group and 37 (51%) in the WBI group had died. 78 of these patients died from disease progression, and one patient in the WBI group died from thrombogenesis related to chemotherapy. In patients with EGFR-mutant NSCLC and multiple brain metastases, icotinib was associated with significantly longer intracranial PFS than WBI plus chemotherapy, indicating that icotinib might be a better first-line therapeutic option for this patient population. Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine, National Health and Family Planning Commission of China, Guangzhou Science and Technology Bureau, Betta Pharmaceuticals, and the Chinese Thoracic Oncology Group. Copyright © 2017 Elsevier Ltd. All rights reserved.

Is platelet transfusion associated with hospital-acquired infections in critically ill patients?

PubMed

Aubron, Cécile; Flint, Andrew W; Bailey, Michael; Pilcher, David; Cheng, Allen C; Hegarty, Colin; Martinelli, Antony; Reade, Michael C; Bellomo, Rinaldo; McQuilten, Zoe

2017-01-06

Platelets are commonly transfused to critically ill patients. Reports suggest an association between platelet transfusion and infection. However, there is no large study to have determined whether platelet transfusion in critically ill patients is associated with hospital-acquired infection. We conducted a multi-centre study using prospectively maintained databases of two large academic intensive care units (ICUs) in Australia. Characteristics of patients who received platelets in ICUs between 2008 and 2014 were compared to those of patients who did not receive platelets. Association between platelet administration and infection (bacteraemia and/or bacteriuria) was modelled using multiple logistic regression and Cox regression, with blood components as time-varying covariates. A propensity covariate adjustment was also performed to verify results. Of the 18,965 patients included, 2250 (11.9%) received platelets in ICU with a median number of 1 platelet unit (IQR 1-3) administered. Patients who received platelets were more severely ill at ICU admission (mean Acute Physiology and Chronic Health Evaluation III score 65 (SD 29) vs 52 (SD 25), p < 0.01) and had more comorbidities (31% vs 19%, p < 0.01) than patients without platelet transfusion. Invasive mechanical ventilation (87% vs 57%, p < 0.01) and renal replacement therapy (20% vs 4%, p < 0.01) were more frequently administered in patients receiving platelets than in patients without platelets. On univariate analysis, platelet transfusion was associated with hospital-acquired infection in the ICU (7.7% vs 1.4%, p < 0.01). After adjusting for confounders, including other blood components administered, patient severity, centre, year, and diagnosis category, platelet transfusions were independently associated with infection (adjusted OR 2.56 95% CI 1.98-3.31, p < 0.001). This association was also found in survival analysis with blood components as time-varying covariates (adjusted HR 1.85, 95% CI 1.41-2.41, p < 0.001) and when only bacteraemia was considered (adjusted OR 3.30, 95% CI 2.30-4.74, p <0.001). Platelet transfusions remained associated with infection after propensity covariate adjustment. After adjustment for confounders, including patient severity and other blood components, platelet transfusion was independently associated with ICU-acquired infection. Further research aiming to better understand this association and to prevent this complication is warranted.

Exploration of the recurrence in radiation brain necrosis after bevacizumab discontinuation

PubMed Central

Zhuang, Hongqing; Yuan, Xiangkun; Chang, Joe Y.; Song, Yongchun; Wang, Junjie; Yuan, Zhiyong; Wang, Xiaoguang; Wang, Ping

2016-01-01

Objective: The aim of the paper was to investigate the recurrence and its causes of radiation brain necrosis following bevacizumab discontinuation. Methods: This study included 14 patients with radiation brain necrosis (confirmed through imaging) after stereotactic radiotherapy for a primary or metastatic brain tumor and who received bevacizumab treatment from June 2011 through December 2014. The patients received bevacizumab at 5 mg/kg, q3-4w, for at least 3 cycles. The T1 signal intensity from enhanced MRI images was used as the evaluation criteria for the brain necrosis treatment efficacy. Results: brain necrosis improved in 13 of the 14 cases (92.9%). However, during follow-up, 10 of the 13 responsive patients (76.9%) exhibited a recurrence in brain necrosis, and a multiple linear regression analysis shows that brain necrosis recurrence was related to the follow-up time after the initial bevacizumab treatment discontinuation. Conclusion: bevacizumab produced good short-term effects for radiation brain necrosis; however, most of the patients would recurrence after bevacizumab is discontinued. Thus, brain necrosis was irreversible. PMID:26934327

Assessment of quality of life in patients with advanced non-small cell lung carcinoma treated with a combination of carboplatin and paclitaxel*

PubMed Central

Avelino, Camila Uanne Resende; Cardoso, Rafael Marques; de Aguiar, Suzana Sales; da Silva, Mário Jorge Sobreira

2015-01-01

OBJECTIVE: Non-small cell lung carcinoma (NSCLC) is the most common type of lung cancer. Most patients are diagnosed at an advanced stage, palliative chemotherapy therefore being the only treatment option. This study was aimed at evaluating the health-related quality of life (HRQoL) of advanced-stage NSCLC patients receiving palliative chemotherapy with carboplatin and paclitaxel. METHODS: This was a multiple case study of advanced-stage NSCLC outpatients receiving chemotherapy at a public hospital in Rio de Janeiro, Brazil. The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire was used in conjunction with its supplemental lung cancer-specific module in order to assess HRQoL. RESULTS: Physical and cognitive functioning scale scores differed significantly among chemotherapy cycles, indicating improved and worsened HRQoL, respectively. The differences regarding the scores for pain, loss of appetite, chest pain, and arm/shoulder pain indicated improved HRQoL. CONCLUSIONS: Chemotherapy was found to improve certain aspects of HRQoL in patients with advanced-stage NSCLC. PMID:25972967

Epilepsy.

PubMed

Devinsky, Orrin; Vezzani, Annamaria; O'Brien, Terence J; Jette, Nathalie; Scheffer, Ingrid E; de Curtis, Marco; Perucca, Piero

2018-05-03

Epilepsy affects all age groups and is one of the most common and most disabling neurological disorders. The accurate diagnosis of seizures is essential as some patients will be misdiagnosed with epilepsy, whereas others will receive an incorrect diagnosis. Indeed, errors in diagnosis are common, and many patients fail to receive the correct treatment, which often has severe consequences. Although many patients have seizure control using a single medication, others require multiple medications, resective surgery, neuromodulation devices or dietary therapies. In addition, one-third of patients will continue to have uncontrolled seizures. Epilepsy can substantially impair quality of life owing to seizures, comorbid mood and psychiatric disorders, cognitive deficits and adverse effects of medications. In addition, seizures can be fatal owing to direct effects on autonomic and arousal functions or owing to indirect effects such as drowning and other accidents. Deciphering the pathophysiology of epilepsy has advanced the understanding of the cellular and molecular events initiated by pathogenetic insults that transform normal circuits into epileptic circuits (epileptogenesis) and the mechanisms that generate seizures (ictogenesis). The discovery of >500 genes associated with epilepsy has led to new animal models, more precise diagnoses and, in some cases, targeted therapies.

Phase I/II study of the novel proteasome inhibitor delanzomib (CEP-18770) for relapsed and refractory multiple myeloma.

PubMed

Vogl, Dan T; Martin, Thomas G; Vij, Ravi; Hari, Parameswaran; Mikhael, Joseph R; Siegel, David; Wu, Ka Lung; Delforge, Michel; Gasparetto, Cristina

2017-08-01

Delanzomib (CEP-18770), a reversible P2 threonine boronic acid proteasome (β5/β1 subunits) inhibitor that showed promising anti-myeloma effects in preclinical studies, was investigated in a single-agent multicenter phase I/II study in patients with relapsed/refractory myeloma. Sixty-one patients (17 during dose escalation; 44 in the expansion cohort) received delanzomib on days 1, 8, and 15 in 28-d cycles; 47 received the maximum tolerated dose (MTD), 2.1 mg/m 2 . Dose-limiting toxicities (DLTs) at 2.4 mg/m 2 were rash and thrombocytopenia. At the MTD, the most prominent adverse events were nausea, vomiting, anorexia, fatigue, and pyrexia; grade 3/4 thrombocytopenia and neutropenia occurred in 53 and 23% of patients, respectively. Peripheral neuropathy (21%) was limited to grades 1/2. At the MTD, 26 patients (55%) had stable disease and four (9%) had a partial response (PR). Median time to progression (TTP) was 2.5 months across the cohort. Based upon the efficacy results, development of delanzomib for myeloma was discontinued.

Transient febrile reaction after electroconvulsive therapy (ECT) in a young adult with intellectual disability and bipolar disorder.

PubMed

Majeske, Matthew F; Garakani, Amir; Maloutas, Eleni; Bryson, Ethan O; Kellner, Charles H

2013-12-01

We report the case of a 27-year-old man with mild-moderate intellectual disability (ID) and bipolar disorder treated with electroconvulsive therapy (ECT). He was psychiatrically hospitalized for agitation, aggression, and manic symptoms including insomnia, rapid and pressured speech, and hyperactivity. After multiple medication trials, ECT was recommended. The treatment was delayed owing to the need to obtain evaluation for incapacity and then substituted consent from the patient's mother. He received 2 ECT treatments with marked improvement but complicated by transient fevers, which resolved without treatment. Fever workup was unremarkable. The patient became calm and cooperative and was discharged home. He was readmitted 3 weeks later, again in an agitated manic state. He received 5 additional ECT treatments, but this time with no post-ECT fevers. Once again, his manic symptoms resolved, and he was safely discharged. Whereas patients with ID pose special challenges, our case is in keeping with the previous literature, which supports the use of ECT in patients with ID and comorbid psychiatric disorders.

The effect of ketorolac on pregnancy rates when used immediately after oocyte retrieval.

PubMed

Mesen, Tolga B; Kacemi-Bourhim, Lamya; Marshburn, Paul B; Usadi, Rebecca S; Matthews, Michelle; Norton, H James; Hurst, Bradley S

2013-09-01

To study the effect of ketorolac, a potent anti-inflammatory medication, on in vitro fertilization (IVF) pregnancy outcomes when used at the time of oocyte retrieval. Retrospective review of 454 patients from 2003-2009. Tertiary hospital-affiliated fertility center. Consecutive subfertile women undergoing their first IVF cycle. Ketorolac administration immediately after oocyte retrieval. Pregnancy, implantation, live-birth, and miscarriage rates, and postsurgical visual analog pain score. Of the 454 patients undergoing their first IVF cycle for all indications, 103 received intravenous ketorolac immediately after oocyte retrieval, based on anesthesiologist preference. Patient and procedural characteristics were similar between both groups. The use of ketorolac had no effect on the rates of implantation, miscarriage, pregnancy, live birth, or multiple pregnancy. The patients receiving ketorolac experienced statistically significantly less pain. This study suggests ketorolac has no apparent detrimental effect on IVF pregnancy outcomes when administered immediately after oocyte retrieval. Ketorolac appears to be a safe and effective analgesic to use at the time of oocyte retrieval. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

A study of the biological receptor activator of nuclear factor-kappaB ligand inhibitor, denosumab, in patients with multiple myeloma or bone metastases from breast cancer.

PubMed

Body, Jean-Jacques; Facon, Thierry; Coleman, Robert E; Lipton, Allan; Geurs, Filip; Fan, Michelle; Holloway, Donna; Peterson, Mark C; Bekker, Pirow J

2006-02-15

Receptor activator of nuclear factor-kappaB ligand (RANKL) is essential for the differentiation, function, and survival of osteoclasts, which play a key role in establishment and propagation of skeletal disease in patients with multiple myeloma or bone metastases as well as many other skeletal diseases. Denosumab (AMG 162), a fully human monoclonal antibody to RANKL, was developed to treat patients with skeletal diseases. This was a randomized, double-blind, double-dummy, active-controlled, multicenter study to determine the safety and efficacy of denosumab in patients with breast cancer (n = 29) or multiple myeloma (n = 25) with radiologically confirmed bone lesions. Patients received a single dose of either denosumab (0.1, 0.3, 1.0, or 3.0 mg/kg s.c.) or pamidronate (90 mg i.v.). Bone antiresorptive effect was assessed by changes in urinary and serum N-telopeptide levels. Pharmacokinetics of denosumab also were assessed. Following a single s.c. dose of denosumab, levels of urinary and serum N-telopeptide decreased within 1 day, and this decrease lasted through 84 days at the higher denosumab doses. Pamidronate also decreased bone turnover, but the effect diminished progressively through follow-up. Denosumab injections were well tolerated. Mean half-lives of denosumab were 33.3 and 46.3 days for the two highest dosages. A single s.c. dose of denosumab given to patients with multiple myeloma or bone metastases from breast cancer was well tolerated and reduced bone resorption for at least 84 days. The decrease in bone turnover markers was similar in magnitude but more sustained than with i.v. pamidronate.

2-micrometer continuous wave laser treatment for multiple non-muscle-invasive bladder cancer with intravesical instillation of epirubicin.

PubMed

Liu, Haitao; Xue, Song; Ruan, Yuan; Sun, Xiaowen; Han, Bangmin; Xia, Shujie

2011-01-01

We have reported the efficacy and safety of 2-micrometer continuous wave laser resection of non-muscle-invasive bladder tumor (NMIVBC) (World J Urology 2010;28:157-161). In this study, we evaluated the use of 2-micrometer continuous wave laser resection in combination with intravesical instillation of epirubicin for the treatment of multiple NMIVBC. From September 2007 to April 2008, sixty patients with multiple NMIVBC were included in this study (44 cases of low grade papillary urothelial carcinoma, 10 cases of high grade papillary urothelial carcinoma, and six cases of papillary urothelial neoplasm with low malignant potential). Imaging examinations including pelvic computer tomography (CT) and intravenous urography showed no extravesical extension, lymphatic metastasis or any lesions of upper urinary tract. All patients received 2-micrometer continuous wave laser therapy under continuous epidural anesthesia, and intravesical chemotherapy with epirubicin 1 week later (intravesical instillation weekly for 8 weeks, followed by monthly maintenance to 12 months). Totally 211 tumors in 60 patients were successfully removed with 2-micrometer continuous wave laser. The mean operation time was 48 minutes per patient (ranged 20-90 minutes) and 13.6 minutes per tumor (range 5-25 minutes). No obturator nerve reflection or bladder perforation occurred during the procedure. All patients finished 12 months of intravesical chemotherapy without severe complications. The mean followed-up time was 23 months. Tumor recurrences were found in 13 patients (22%). The combination of 2-micrometer continuous wave laser and intravesical chemotherapy is feasible, safe, and efficacious for the treatment of multiple NMIVBC. Copyright © 2011 Wiley-Liss, Inc.

Delineating the role of multiple intraarticular corticosteroid injections in the management of juvenile idiopathic arthritis in the biologic era.

PubMed

Papadopoulou, Charalampia; Kostik, Mikhail; Gonzalez-Fernandez, Maria Isabel; Bohm, Marek; Nieto-Gonzalez, Juan Carlos; Pistorio, Angela; Lanni, Stefano; Consolaro, Alessandro; Martini, Alberto; Ravelli, Angelo

2013-07-01

To investigate the outcome and predicting factors of multiple intraarticular corticosteroid (IAC) injections in children with juvenile idiopathic arthritis (JIA). The clinical charts of patients who received their first IAC injection in ≥3 joints between January 2002 and December 2011 were reviewed. The corticosteroid used was triamcinolone hexacetonide for large joints and methylprednisolone acetate for small or difficult to access joints. In each patient, the followup period after IAC injection was censored in case of synovitis flare or at the last visit with continued remission. Predictors included sex, age at disease onset, JIA category, antinuclear antibody (ANA) status, age and disease duration, disease course, general anesthesia, number and type of injected joints, acute-phase reactants, and concomitant systemic medications. A total of 220 patients who had 1,096 joints injected were included. Following IAC therapy, 66.4% of patients had synovitis flare after a median of 0.5 years, whereas 33.6% of patients had sustained remission after a median of 0.9 years. The cumulative probability of survival without synovitis flare was 50.0%, 31.5%, and 19.5% at 1, 2, and 3 years, respectively. On Cox regression analysis, positive C-reactive protein value, negative ANA, lack of concomitant methotrexate administration, and a polyarticular (versus an oligoarticular) disease course were the strongest predictors for synovitis flare. Multiple IAC injection therapy induced sustained remission of joint synovitis in a substantial proportion of patients. A controlled trial comparing multiple IAC injection therapy and methotrexate versus methotrexate and a tumor necrosis factor antagonist is worthy of consideration. Copyright © 2013 by the American College of Rheumatology.

Risk of Febrile Neutropenia Associated With Select Myelosuppressive Chemotherapy Regimens in a Large Community-Based Oncology Practice.

PubMed

Li, Yanli; Family, Leila; Yang, Su-Jau; Klippel, Zandra; Page, John H; Chao, Chun

2017-09-01

Background: NCCN has classified commonly used chemotherapy regimens into high (>20%), intermediate (10%-20%), or low (<10%) febrile neutropenia (FN) risk categories based primarily on clinical trial evidence. Many chemotherapy regimens, however, remain unclassified by NCCN or lack FN incidence data in real-world clinical practice. Patients and Methods: We evaluated incidence proportions of FN and grade 4 and 3/4 neutropenia during the first chemotherapy course among patients from Kaiser Permanente Southern California who received selected chemotherapy regimens without well-established FN risk. Patients given granulocyte colony-stimulating factor (G-CSF) prophylaxis were excluded. Sensitivity analyses were performed to account for FN misclassification and censoring. Results: From 2008 to 2013, 1,312 patients with breast cancer who received docetaxel and cyclophosphamide (TC; n=853) or docetaxel, carboplatin, and trastuzumab (TCH; n=459); 1,321 patients with colorectal cancer who received capecitabine and oxaliplatin (XELOX; n=401) or leucovorin, 5-fluorouracil, and oxaliplatin (FOLFOX6; n=920); 307 patients with non-Hodgkin's lymphoma who received bendamustine with or without rituximab; and 181 patients with multiple myeloma who received lenalidomide with or without dexamethasone were included. Crude FN risk was >20% for both breast cancer regimens (TC and TCH). Crude FN risks for XELOX, FOLFOX6, bendamustine, and lenalidomide were <10%; however, when potential FN misclassification and censoring were considered, FN risks were >10%. Conclusions: Our results support published literature highlighting the real-world, "high" FN risk of the TC and TCH regimens for breast cancer. There is strong suggestive evidence that FN risks for XELOX, FOLFOX6, bendamustine, and lenalidomide are >10%. Calculation of chemotherapy course-level FN incidence without controlling for differential censoring for patients who discontinued regimens early, or possible FN misclassification, might have resulted in bias toward an underestimation of the true FN risk. These findings help define FN risk of the selected regimens in the real-world setting and inform prophylactic G-CSF use. Copyright © 2017 by the National Comprehensive Cancer Network.