Self-reported Hypoglycaemia in Patients treated with Insulin: A Large Slovenian Retrospectively-prospective Study

PubMed Central

Pongrac Barlovič, Draženka; Zavratnik, Andrej; Skvarča, Aleš; Janša, Karmen; Vukelič, Bojana; Tomažič, Marjeta; Ravnik Oblak, Maja

2017-01-01

Abstract Introduction Hypoglycaemia is the major barrier for glycaemic target achievement in patients treated with insulin. The aim of the present study was to investigate real-world incidence and predictors of hypoglycaemia in insulin-treated patients. Methods More than 300 consecutive patients with type 1 or type 2 diabetes treated with insulin were enrolled during regular out-patient visits from 36 diabetes practices throughout the whole country. They completed a comprehensive questionnaire on hypoglycaemia knowledge, awareness, and incidence in the last month and last six months. In addition, in the prospective part, patients recorded incidence of hypoglycaemic events using a special diary prospectively on a daily basis, through 4 weeks. Results At least one hypoglycaemic event was self-reported in 84.1%, and 56.4% of patients with type 1 and type 2 diabetes, respectively, during the prospective period of 4 weeks. 43.4% and 26.2% of patients with type 1 and type 2 diabetes, respectively, experienced a nocturnal hypoglycaemic event. In the same time-period, severe hypoglycaemia was experienced by 15.9% and 7.1% of patients with type 1 and type 2 diabetes, respectively. Lower glycated haemoglobin was not a significant predictor of hypoglycaemia. Conclusions Rates of self-reported hypoglycaemia in patients treated with insulin in the largest and most comprehensive study in Slovenia so far are higher than reported from randomised control trials, but comparable to data from observational studies. Hypoglycaemia incidence was high even with high glycated haemoglobin values. PMID:29062399

Impact of gastrointestinal events on patient-reported outcomes in Asia-Pacific women with osteoporosis: baseline results of the MUSIC OS-AP study.

PubMed

Modi, A; Ebeling, P R; Lee, M S; Min, Y K; Mithal, A; Yang, X; Baidya, S; Sen, S; Sajjan, S

2017-12-01

The purpose of this study was to describe the impact of gastrointestinal events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The results of this study show that gastrointestinal events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis. This study aimed to describe the impact of gastrointestinal (GI) events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The MUSIC OS-AP study included an observational cohort study of postmenopausal women with osteoporosis. Women were classified as untreated or treated, with treated patients further classified as new or experienced users. Adherence was measured by the Adherence Evaluation of Osteoporosis treatment (ADEOS) questionnaire, treatment satisfaction by the Osteoporosis Patient Satisfaction Questionnaire (OPSAT) while general health-related and osteoporosis-specific quality of life were measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire and the Osteoporosis Assessment Questionnaire (OPAQ), respectively. The association of GI events with these outcomes was determined by covariate-adjusted regression analysis of least squares mean differences in the scores of treated patients with and without GI events. Resource utilization was measured as the number of physician visits over the past 3 months, and multivariate regression analysis was used to assess the association of GI events with the likelihood of a visit. The GI event profile, quality of life scores, and resource use were numerically similar in untreated and treated women. The rate of adherence among treated women was higher in experienced than in new users. As indicated by mean scores, experienced users had better quality of life and slightly higher treatment satisfaction and fewer physician visits than new users. Except for adherence in new users, all measures were similarly adversely affected by GI events in both new and experienced users. GI events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis.

Weight loss and decubitus duodenal ulcer in Parkinson's disease treated with levodopa-carbidopa intestinal gel infusion.

PubMed

Martino, Tommaso; Melchionda, Donato; Tonti, Paolo; De Francesco, Vincenzo; Lalla, Alessandra; Specchio, Luigi Maria; Avolio, Carlo

2016-12-01

Apparently, unexplained weight loss is a common symptom experienced by patients affected by Parkinson's disease, especially in those treated by levodopa-carbidopa infusion gel (LCIG) with a poor control of dyskinesias. Weight loss is considered part of gastrointestinal dysfunction seen in patients affected by Parkinson's disease, along with gastroparesis and reduced bowel peristalsis. In patients treated with LCIG, weight loss needs to be accurately evaluated, because of possible underlying life-threatening adverse events, like duodenum decubitus ulcer.

Ejaculatory Function After Permanent {sup 125}I Prostate Brachytherapy for Localized Prostate Cancer

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

Huyghe, Eric; Department of Urology and Andrology, Paul Sabatier University, CHU Paule de Viguier, Toulouse; Delannes, Martine

Purpose: Ejaculatory function is an underreported aspect of male sexuality in men treated for prostate cancer. We conducted the first detailed analysis of ejaculatory function in patients treated with permanent {sup 125}I prostate brachytherapy for localized prostate cancer. Patients and Methods: Of 270 sexually active men with localized prostate cancer treated with permanent {sup 125}I prostate brachytherapy, 241 (89%), with a mean age of 65 years (range, 43-80), responded to a mailed questionnaire derived from the Male Sexual Health Questionnaire regarding ejaculatory function. Five aspects of ejaculatory function were examined: frequency, volume, dry ejaculation, pleasure, and pain. Results: Of themore » 241 sexually active men, 81.3% had conserved ejaculatory function after prostate brachytherapy; however, the number of patients with rare/absent ejaculatory function was double the pretreatment number (p < .0001). The latter finding was correlated with age (p < .001) and the preimplant International Index of Erectile Function score (p < .001). However, 84.9% of patients with maintained ejaculatory function after implantation reported a reduced volume of ejaculate compared with 26.9% before (p < .001), with dry ejaculation accounting for 18.7% of these cases. After treatment, 30.3% of the patients experienced painful ejaculation compared with 12.9% before (p = .0001), and this was associated with a greater number of implanted needles (p = .021) and the existence of painful ejaculation before implantation (p < .0001). After implantation, 10% of patients who continued to be sexually active experienced no orgasm compared with only 1% before treatment. in addition, more patients experienced late/difficult or weak orgasms (p = .001). Conclusion: Most men treated with brachytherapy have conserved ejaculatory function after prostate brachytherapy. However, most of these men experience a reduction in volume and a deterioration in orgasm.« less

Progestin treatment of atypical hyperplasia and well-differentiated adenocarcinoma of the endometrium to preserve fertility.

PubMed

Koskas, Martin; Azria, Elie; Walker, Francine; Luton, Dominique; Madelenat, Patrick; Yazbeck, Chadi

2012-03-01

To evaluate the outcome of a cohort of young women treated with progestin for fertility-sparing management of endometrial atypical hyperplasia (AH) and endometrial carcinoma (EC). This retrospective multicentre cohort study included women under the age of 40 years treated conservatively for AH and EC to preserve fertility using progestin for at least 3 months. Four inclusion criteria were defined: (i) the presence of AH or grade 1 EC confirmed by two pathologists (including a reference pathologist); (ii) the use of conservative management for fertility sparing; (iii) adequate radiological examination before conservative management; and (iv) a minimal follow-up time of one year. Twenty-two patients fulfilled the inclusion criteria (8 had EC, and 14 had AH). After progestin treatment, 17 patients responded. Among the 17 patients who experienced remission, three also experienced disease relapse. One patient initially diagnosed with AH experienced progression of her disease to stage IIIA EC. Ten pregnancies were achieved in eight patients. Fertility-sparing management using progestin offers the opportunity to fulfil maternal desires in young patients diagnosed with AH and EC. However, progression of the disease is possible and close follow-up is needed.

Treatment of Chronic Cough.

PubMed

Soni, Resha S; Ebersole, Barbara; Jamal, Nausheen

2017-01-01

Objective Chronic cough remains a challenging condition, especially in cases where it persists despite comprehensive medical management. For these particular patients, there appears to be an emerging role for behavior modification therapy. We report a series of patients with refractory chronic cough to assess if there is any benefit of adding behavioral therapy to their treatment regimen. Study Design A case series with planned chart review of patients treated for chronic cough. Setting The review was performed with an outpatient electronic health record system at a tertiary care center. Subjects and Methods The charts of all patients treated for chronic cough by a single laryngologist over a 30-month period were analyzed. Patients' response to treatment and rate of cough improvement were assessed for those with refractory chronic cough who underwent behavior modification therapy. Results Thirty-eight patients with chronic cough were initially treated empirically for the most common causes of cough, of which 32% experienced improvement. Nineteen patients who did not significantly improve with medical management underwent behavior modification therapy with a speech-language pathologist. Of these patients, 84% experienced resolution or marked improvement of their symptoms. Conclusion Behavioral therapy may be underutilized in practice and could lead to improvement of otherwise recalcitrant cough.

Low skeletal muscle mass is a predictive factor for chemotherapy dose-limiting toxicity in patients with locally advanced head and neck cancer.

PubMed

Wendrich, Anne W; Swartz, Justin E; Bril, Sandra I; Wegner, Inge; de Graeff, Alexander; Smid, Ernst J; de Bree, Remco; Pothen, Ajit J

2017-08-01

Low skeletal muscle mass (SMM) or sarcopenia is emerging as an adverse prognostic factor for chemotherapy dose-limiting toxicity (CLDT) and survival in cancer patients. Our aim was to determine the impact of low SMM on CDLT in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) treated with primary radiochemotherapy (RCT). Consecutive patients diagnosed with LA-HNSCC and treated with primary RCT between 2007 and 2011 in our center were included. Clinical variables were retrospectively retrieved and SMM was measured at the level of the third cervical vertebra using pre-treatment head and neck CT-scans. After determining a cut-off value for low SMM, multivariate analysis was performed to identify prognostic factors for CDLT. Of 112 patients included, 30.4% experienced CDLT. The optimal cut-off value for low SMM as a predictor of CDLT was ≤43.2cm 2 /m 2 . Using this cut-off, 54.5% patients had low SMM. Patients with low SMM experienced CDLT more frequently than patients with normal SMM (44.3% vs. 13.7%, p<0.001) and received a higher dose of chemotherapy/kg lean body mass (estimated from SMM, p=0.044). At multivariate analysis, low SMM was independently inversely associated with CDLT (OR 0.93, 95%CI: 0.88-0.98). Patients experiencing CDLT had a lower overall survival than patients who did not (mean 36.6vs. 54.2months, p=0.038). Low SMM is an independent risk factor for CDLT in LA-HNSCC patients treated with primary RCT. Pre-therapeutic estimation of SMM using routine CT-scans of the head and neck region may identify patients at risk of CDLT. Copyright © 2017 Elsevier Ltd. All rights reserved.

Ejaculatory function after permanent 125I prostate brachytherapy for localized prostate cancer.

PubMed

Huyghe, Eric; Delannes, Martine; Wagner, Fabien; Delaunay, Boris; Nohra, Joe; Thoulouzan, Matthieu; Shut-Yee, J Yeung; Plante, Pierre; Soulie, Michel; Thonneau, Patrick; Bachaud, Jean Marc

2009-05-01

Ejaculatory function is an underreported aspect of male sexuality in men treated for prostate cancer. We conducted the first detailed analysis of ejaculatory function in patients treated with permanent (125)I prostate brachytherapy for localized prostate cancer. Of 270 sexually active men with localized prostate cancer treated with permanent (125)I prostate brachytherapy, 241 (89%), with a mean age of 65 years (range, 43-80), responded to a mailed questionnaire derived from the Male Sexual Health Questionnaire regarding ejaculatory function. Five aspects of ejaculatory function were examined: frequency, volume, dry ejaculation, pleasure, and pain. Of the 241 sexually active men, 81.3% had conserved ejaculatory function after prostate brachytherapy; however, the number of patients with rare/absent ejaculatory function was double the pretreatment number (p < .0001). The latter finding was correlated with age (p < .001) and the preimplant International Index of Erectile Function score (p < .001). However, 84.9% of patients with maintained ejaculatory function after implantation reported a reduced volume of ejaculate compared with 26.9% before (p < .001), with dry ejaculation accounting for 18.7% of these cases. After treatment, 30.3% of the patients experienced painful ejaculation compared with 12.9% before (p = .0001), and this was associated with a greater number of implanted needles (p = .021) and the existence of painful ejaculation before implantation (p < .0001). After implantation, 10% of patients who continued to be sexually active experienced no orgasm compared with only 1% before treatment. in addition, more patients experienced late/difficult or weak orgasms (p = .001). Most men treated with brachytherapy have conserved ejaculatory function after prostate brachytherapy. However, most of these men experience a reduction in volume and a deterioration in orgasm.

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.

Efficacy, safety and tolerability of recombinant factor VIII (REFACTO) in patients with haemophilia A: interim data from a postmarketing surveillance study in Germany and Austria.

PubMed

Pollmann, H; Externest, D; Ganser, A; Eifrig, B; Kreuz, W; Lenk, H; Pabinger, I; Schramm, W; Schwarz, T F; Zimmermann, R; Zavazava, N; Oldenburg, J; Klamroth, R

2007-03-01

An open-label, multicentre, postmarketing surveillance study conducted in Germany and Austria with recombinant factor VIII (REFACTO) has enrolled 217 patients (mean age 26.3 years) from 38 haemophilia centres during the first 4.8 years. Most patients (188/217; 86.6%) had severe to moderately severe haemophilia A, of whom 153 completed sufficient diary information for the main efficacy analysis. These 153 patients experienced a median of 6.6 (interquartile range 1.4-18.6) bleeding episodes per year. Patients treated with prophylaxis experienced a median of 4.4 (1.1-9.3) bleeds per year, while patients treated on-demand experienced a median of 22.8 (11.3-29.0) bleeds per year. Overall, most physicians (41/43 [95.3%]) were 'very satisfied' or 'satisfied' with the efficacy of REFACTO in the treatment of bleeding episodes. A total of 137 non-serious adverse events have been reported in 52/217 patients (24.0%) to date. In addition, 129 serious adverse events in 87 patients (40%) were reported, including 41 cases of 'less than expected therapeutic effect' (LETE). Of these, 39 LETE cases were reported in one centre; however, patients in this centre experienced considerably fewer bleeding episodes per year than patients outside this centre. Overall, six patients (2.8%) have developed de novo inhibitors, three of which were considered high titre. Four of these patients were at high risk (0-50 exposure days [ED]) of inhibitor formation, one was at intermediate risk (51-100 ED) and one was at low risk (>100 ED). These results emphasize the benefit of postmarketing surveillance and, overall, this study confirms the efficacy, safety and tolerability of REFACTO in the treatment of patients with haemophilia A.

Long-Term Outcomes of Fractionated Stereotactic Radiation Therapy for Pituitary Adenomas at the BC Cancer Agency

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

Kim, Julian O.; Ma, Roy; Division of Radiation Oncology and Developmental Radiotherapeutics, University of British Columbia, Vancouver

2013-11-01

Purpose: To assess the long-term disease control and toxicity outcomes of fractionated stereotactic radiation therapy (FSRT) in patients with pituitary adenomas treated at the BC Cancer Agency. Methods and Materials: To ensure a minimum of 5 years of clinical follow-up, this study identified a cohort of 76 patients treated consecutively with FSRT between 1998 and 2007 for pituitary adenomas: 71% (54/76) had nonfunctioning and 29% (22/76) had functioning adenomas (15 adrenocorticotrophic hormone-secreting, 5 growth hormone-secreting, and 2 prolactin-secreting). Surgery was used before FSRT in 96% (73/76) of patients. A median isocenter dose of 50.4 Gy was delivered in 28 fractions,more » with 100% of the planning target volume covered by the 90% isodose. Patients were followed up clinically by endocrinologists, ophthalmologists, and radiation oncologists. Serial magnetic resonance imaging was used to assess tumor response. Results: With a median follow-up time of 6.8 years (range, 0.6 - 13.1 years), the 7-year progression-free survival was 97.1% and disease-specific survival was 100%. Of the 2 patients with tumor progression, both had disease control after salvage surgery. Of the 22 patients with functioning adenomas, 50% (11/22) had complete and 9% (2/22) had partial responses after FSRT. Of the patients with normal pituitary function at baseline, 48% (14/29) experienced 1 or more hormone deficiencies after FSRT. Although 79% (60/76) of optic chiasms were at least partially within the planning target volumes, no patient experienced radiation-induced optic neuropathy. No patient experienced radionecrosis. No secondary malignancy occurred during follow-up. Conclusion: In this study of long-term follow-up of patients treated for pituitary adenomas, FSRT was safe and effective.« less

Do specialist self-referral insurance policies improve access to HIV-experienced physicians as a regular source of care?

PubMed

Heslin, Kevin C; Andersen, Ronald M; Ettner, Susan L; Kominski, Gerald F; Belin, Thomas R; Morgenstern, Hal; Cunningham, William E

2005-10-01

Health insurance policies that require prior authorization for specialty care may be detrimental to persons with HIV, according to evidence that having a regular physician with HIV expertise leads to improved patient outcomes. The objective of this study is to determine whether HIV patients who can self-refer to specialists are more likely to have physicians who mainly treat HIV. The authors analyze cross-sectional survey data from the HIV Costs and Services Utilization Study. At baseline, 67 percent of patients had insurance that permitted self-referral. In multivariate analyses, being able to self-refer was associated with an 8-12 percent increased likelihood of having a physician at a regular source of care that mainly treats patients with HIV. Patients who can self-refer are more likely to have HIV-experienced physicians than are patients who need prior authorization. Insurance policies allowing self-referral to specialists may result in HIV patients seeing physicians with clinical expertise relevant to HIV care.

Cost-Effectiveness of Treating Hepatitis C with Sofosbuvir/Ledipasvir in Germany.

PubMed

Stahmeyer, Jona T; Rossol, Siegbert; Liersch, Sebastian; Guerra, Ines; Krauth, Christian

2017-01-01

Infections with the hepatitis C virus (HCV) are a global public health problem. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. Newly introduced direct acting antivirals, especially interferon-free regimens, have improved rates of sustained viral response above 90% in most patient groups and allow treating patients who were ineligible for treatment in the past. These new regimens have replaced former treatment and are recommended by current guidelines. However, there is an ongoing discussion on high pharmaceutical prices. Our aim was to assess the long-term cost-effectiveness of treating hepatitis C genotype 1 patients with sofosbuvir/ledipasvir (SOF/LDV) treatment in Germany. We used a Markov cohort model to simulate disease progression and assess cost-effectiveness. The model calculates lifetime costs and outcomes (quality-adjusted life years, QALYs) of SOF/LDV and other strategies. Patients were stratified by treatment status (treatment-naive and treatment-experienced) and absence/presence of cirrhosis. Different treatment strategies were compared to prior standard of care. Sensitivity analyses were performed to evaluate model robustness. Base-case analyses results show that in treatment-naive non-cirrhotic patients treatment with SOF/LDV dominates the prior standard of care (is more effective and less costly). In cirrhotic patients an incremental cost-effectiveness ratio (ICER) of 3,383 €/QALY was estimated. In treatment-experienced patients ICERs were 26,426 €/QALY and 1,397 €/QALY for treatment-naive and treatment-experienced patients, respectively. Robustness of results was confirmed in sensitivity analyses. Our analysis shows that treatment with SOF/LDV is cost-effective compared to prior standard of care in all patient groups considering international costs per QALY thresholds.

Four-corner fusion of the wrist: clinical and radiographic outcome of 31 patients.

PubMed

Mavrogenis, Andreas F; Flevas, Dimitrios A; Raptis, Konstantinos; Megaloikonomos, Panayiotis D; Igoumenou, Vasilios G; Antoniadou, Thekla; Dimopoulos, Leonidas; Antonopoulos, Dimitrios; Spyridonos, Sarantis G

2016-12-01

Four-corner fusion is a rational surgical option for the management of degenerative conditions of the wrist. Most related studies have compared four-corner fusion with scaphoid excision or proximal row carpectomy, with a variety of reported results. To enhance the literature, we performed this study to evaluate a series of patients with degenerative conditions of the wrist treated with four-corner fusion using 3 surgical techniques and to discuss the clinical and radiographic outcome of the patients. We retrospectively studied 31 patients (24 men, 7 women; mean age, 43 years; 9 heavy manual laborers) who underwent four-corner fusion of their wrists for degenerative conditions from 2005 to 2015. Internal fixation was done using multiple Kirschner wires (14 patients), headless compressive screws (8 patients), or a circular plate (9 patients). Mean follow-up was 4 years (1-11 years). We evaluated the clinical outcome with the Patient-Rated Wrist Evaluation (PRWE) score and fusion with radiographs. All patients experienced improvement of their pain, function, range of motion and grip strength (p < 0.05). Twenty-three patients (74 %) reported no pain, and eight patients reported mild, occasional pain. Twenty-one patients (68 %) were able to do usual and specific activities. Mean wrist motion improved to 70 % and mean grip strength improved to 85 % of opposite wrist. Two heavy manual labor patients requested a job modification because of wrist impairment. Radiographs of the wrist showed fusion of all fused joints in 28 (90.3 %) patients and partial fusion in three patients (9.7 %). No patient with partial fusion required a reoperation for symptomatic nonunion until the period of this study. Three patients experienced complications (10 %). Two patients treated with a circular plate experienced complex regional pain syndrome and painful implant impingement; another patient treated with Kirschner wires and headless compression screws experienced radiolunate arthritis from impingement of the lunate screw to the radius. Four-corner fusion is a reliable limited wrist fusion technique that provides pain relief, grip strength and satisfactory range of motion in patients with degenerative conditions of the wrist. Partial union is more common with Kirschner wire fixation and complications are more common with circular plate fixation.

TAK-264 (MLN0264) in Previously Treated Asian Patients with Advanced Gastrointestinal Carcinoma Expressing Guanylyl Cyclase C: Results from an Open-Label, Non-randomized Phase 1 Study

PubMed Central

Bang, Yung-Jue; Takano, Toshimi; Lin, Chia-Chi; Fasanmade, Adedigbo; Yang, Huyuan; Danaee, Hadi; Asato, Takayuki; Kalebic, Thea; Wang, Hui; Doi, Toshihiko

2018-01-01

Purpose This phase 1 dose-escalation portion of the study evaluated the safety, pharmacokinetics (PK), and antitumor activity of TAK-264 in Asian patients with advanced gastrointestinal (GI) carcinoma or metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma expressing guanylyl cyclase C (GCC). Materials and Methods Adult patients with advanced GI malignancies expressing GCC (H-score ≥ 10) received TAK-264 on day 1 of 3-week cycles as 30-minute intravenous infusions for up to 1 year or until disease progression or unacceptable toxicity. The primary objectives were to evaluate the safety profile including dose-limiting toxicities (DLTs) during cycle 1, determine the maximum tolerated dose (MTD), and characterize the PK profile of TAK-264. Results Twelve patients were enrolled and treated with 1.2 mg/kg (n=3), 1.5 mg/kg (n=3), or 1.8 mg/kg TAK-264 (n=6). Median number of treatment cycles received was two (range, 1 to 10). None of the patients experienced a DLT and the MTD was not determined. Ten patients (83%) experienced adverse events (AEs). The most common were neutropenia, anorexia, and nausea (each reported by four patients). Five patients (42%) experienced grade ≥ 3 AEs consisting of tumor hemorrhage and hypertension, ascites, adrenal insufficiency, neutropenia and asthenia. Serum exposure to TAK-264 increased proportionally with the dose and the median half-life was approximately 5.5-6.6 days. No patients experienced an objective response. Conclusion TAK-264 demonstrated a manageable safety profile with limited antitumor activity consistent with studies conducted in Western patients with advanced GI malignancies. TAK-264 exposure increased proportionally with the dose. PMID:28494535

Should ribavirin be used to treat hepatitis C in dialysis patients?

PubMed

Carrion, Andres F; Fabrizi, Fabrizio; Martin, Paul

2011-01-01

Hepatitis C virus infection adversely affects outcomes in patients with chronic kidney disease undergoing maintenance dialysis. Pegylated interferon and ribavirin, the standard-of-care treatment in patients with intact renal function, is associated with severe side effects, toxicity, and high dropout rates in this population. Ribavirin has an important role in maintaining antiviral response following completion of therapy and increases sustained viral response (SVR) rates. However, the use of ribavirin in dialysis patients has been limited by the high frequency of severe hemolytic anemia and is currently reserved for study protocols and highly selected candidates treated at experienced centers. Encouraging data from small trials have shown a significant increase in SVR rates with the use of different dosing regimens of ribavirin in addition to interferon-based therapy and aggressive erythroid-stimulating agent support in dialysis patients. Use of ribavirin in selected dialysis patients, particularly renal transplant candidates, by experienced clinicians is appropriate. © 2011 Wiley Periodicals, Inc.

Dentist's distress in the management of chronic pain control

PubMed Central

Yokoyama, Yoko; Kakudate, Naoki; Sumida, Futoshi; Matsumoto, Yuki; Gordan, Valeria V.; Gilbert, Gregg H.

2018-01-01

Abstract We aimed to obtain greater understanding of dentists’ distress when they diagnose and treat patients with temporomandibular disorders (TMD), and to explore ways in which TMD can be better treated. We conducted a cross-sectional study based on a questionnaire survey of dentists (n = 148). Dentists were queried using an open-ended questionnaire about distress they experienced when treating patients with TMD. Survey responses were analyzed using mixed methods. Associations between specific dentist and patient characteristics and types of distress were analyzed by one way analysis of variance and residual analysis. One hundred thirteen clinicians responded to the questionnaire, giving a 76% response rate. Thematic analysis identified 6 major themes: difficulty in predicting therapeutic effect and prognosis; difficulty in diagnosis; difficulty in the decision about whether to do occlusal adjustment; difficulty in specifying a cause; difficulty in communicating with patients and mental factors; and health insurance system barriers. Clinicians who reported difficulty in deciding whether to do occlusal adjustment saw significantly more patients who experienced shoulder stiffness and headache (P = .008 and P = .022, respectively). Dentists’ knowledge of TMD guidelines was associated with a lower percentage of difficulty in predicting therapeutic effect and prognosis (residual analysis; P = .010). These findings provide important insights into clinician's perception of difficulties with patients experiencing TMD-related pain. Knowledge of the existence of TMD clinical practice guidelines may lower dentist distress, particularly with regard to prognosis. Further studies are needed to decrease dentist's distress and to overcome the evidence-practice gap in TMD treatment. PMID:29505535

Pulmonary edema after electroconvulsive therapy in a patient treated for long-standing asthma with a beta2 stimulant.

PubMed

Hatta, Kotaro; Kitajima, Akiyoshi; Ito, Masanobu; Usui, Chie; Arai, Heii

2007-03-01

A 68-year-old man was scheduled to receive 8 treatments of electroconvulsive therapy (ECT) for severe depression. He was being treated for long-standing asthma with a beta2 stimulant, clenbuterol hydrochloride, and had experienced no asthma attack for 9 years. Although he experienced no adverse consequence in his 7 treatments, pulmonary edema ensued from his eighth treatment despite no change in anesthesia and in the technical parameters of ECT. He was treated with oxygen and intravenous hydrocortisone, after which he quickly recovered. Transient eosinophilia was observed, but clinical symptoms of asthma did not appear. Although the association between pulmonary edema and well-controlled asthma was unclear, thiopental as induction of anesthesia or esmolol as poststimulus delivery might have played a role in the event. There may be a possibility of pulmonary edema even after several uneventful ECT treatments in a patient with asthma.

Proton Beam Craniospinal Irradiation Reduces Acute Toxicity for Adults With Medulloblastoma

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

Brown, Aaron P.; Barney, Christian L.; Grosshans, David R.

2013-06-01

Purpose: Efficacy and acute toxicity of proton craniospinal irradiation (p-CSI) were compared with conventional photon CSI (x-CSI) for adults with medulloblastoma. Methods and Materials: Forty adult medulloblastoma patients treated with x-CSI (n=21) or p-CSI (n=19) at the University of Texas MD Anderson Cancer Center from 2003 to 2011 were retrospectively reviewed. Median CSI and total doses were 30.6 and 54 Gy, respectively. The median follow-up was 57 months (range 4-103) for x-CSI patients and 26 months (range 11-63) for p-CSI. Results: p-CSI patients lost less weight than x-CSI patients (1.2% vs 5.8%; P=.004), and less p-CSI patients had >5% weightmore » loss compared with x-CSI (16% vs 64%; P=.004). p-CSI patients experienced less grade 2 nausea and vomiting compared with x-CSI (26% vs 71%; P=.004). Patients treated with x-CSI were more likely to have medical management of esophagitis than p-CSI patients (57% vs 5%, P<.001). p-CSI patients had a smaller reduction in peripheral white blood cells, hemoglobin, and platelets compared with x-CSI (white blood cells 46% vs 55%, P=.04; hemoglobin 88% vs 97%, P=.009; platelets 48% vs 65%, P=.05). Mean vertebral doses were significantly associated with reductions in blood counts. Conclusions: This report is the first analysis of clinical outcomes for adult medulloblastoma patients treated with p-CSI. Patients treated with p-CSI experienced less treatment-related morbidity including fewer acute gastrointestinal and hematologic toxicities.« less

Continuing Medical Education-Driven Skills Acquisition and Impact on Improved Patient Outcomes in Family Practice Setting.

ERIC Educational Resources Information Center

Bellamy, Nicholas; Goldstein, Laurence D.; Tekanoff, Rory A.

2000-01-01

Family practitioners (n=474) accompanied by their patients were trained in injection techniques to treat osteoarthritis. Pre- and postsession assessments showed that physicians felt comfortable with the new technique, skill acquisition occurred in a supportive setting for physicians and patients, and many patients experienced significant health…

Parental satisfaction, efficacy, and adverse events in 54 patients treated with cantharidin for molluscum contagiosum infection.

PubMed

Cathcart, Shelley; Coloe, Jacqueline; Morrell, Dean S

2009-03-01

To study the efficacy, tolerability, and parental satisfaction of cantharidin in a patient population at a pediatric dermatology referral center. Chart review was completed for 110 patients who presented with molluscum infection and were treated with cantharidin. A total of 54 were available for follow-up by telephone interview regarding adverse effects, parental satisfaction, and overall clearance of the infection. Of those who were reachable, 96% improved after treatment with cantharidin. Parental satisfaction was 78%. Patients received an average of 2.2 treatments irrespective of outcome. Overall, 46% of patients experienced adverse events, including pain, pruritus, secondary infection, brisk immune response, and temporary hypopigmentation and 9% experienced an adverse event that they classified as severe. The results contribute to the data supporting cantharidin as a safe and effective treatment of molluscum contagiosum. Compared with other treatments, it appears to be equally effective and well-tolerated and should be considered a potential front-line treatment.

Recurrence Patterns and Second Primary Lung Cancers After Stereotactic Body Radiation Therapy for Early-Stage Non-Small-Cell Lung Cancer: Implications for Surveillance.

PubMed

Spratt, Daniel E; Wu, Abraham J; Adeseye, Victoria; Din, Shaun U; Shaikh, Fauzia; Woo, Kaitlin M; Zhang, Zhigang; Foster, Amanda; Rosenzweig, Kenneth E; Gewanter, Richard; Huang, James; Rimner, Andreas

2016-05-01

Patients treated with stereotactic body radiation therapy (SBRT) for early-stage non-small-cell lung cancer (NSCLC) are subject to locoregional and distant recurrence, as well as the formation of second primary lung cancers (SPLCs). The optimal surveillance regimen for patients treated with SBRT for early-stage NSCLC remains unclear; we therefore investigated the posttreatment recurrence patterns and development of SPLCs. Three hundred sixty-six patients with pathologically proven inoperable early-stage NSCLC treated with SBRT between 2006 and 2013 were assessed. Patients underwent a computed tomographic (CT) scan of the chest every 3 months during years 1 and 2, every 6 months during years 3 and 4, and annually thereafter. Competing risk analysis was used for all time-to-event analyses. With a median follow-up of 23 months, the 2-year cumulative incidence of local, nodal, and distant treatment failures were 12.2%, 16.1%, and 15.5%, respectively. In patients with disease progression after SBRT (n = 108), 84% (n = 91) of cases occurred within the first 2 years. Five percent (n = 19) of patients experienced SPLCs. The median time to development of an SPLC was 16.5 months (range, 6.5-71.1 months), with 33% (n = 6) of these patients experiencing SPLCs after 2 years. None of the never smokers, but 4% of former tobacco smokers and 15% of current tobacco smokers, experienced an SPLC (P = .005). Close monitoring with routine CT scans within the first 2 years after SBRT is effective in detecting early disease progression. In contrast, the risk for the development of an SPLC remains elevated beyond 2 years, particularly in former and current smokers. Copyright © 2015 Elsevier Inc. All rights reserved.

Pain after root canal treatment with different instruments: A systematic review and meta-analysis.

PubMed

Sun, Chengjun; Sun, Jicheng; Tan, Minmin; Hu, Bo; Gao, Xiang; Song, Jinlin

2018-03-07

The aims of this systematic review were to compare the incidence and intensity of postoperative pain after single-visit root canal treatment using manual, rotary and reciprocating instruments. An extensive literature search in PubMed, EMBASE, Cochrane Library, and Web of Science was performed to identify investigations that evaluated the effects of different instruments on post-endodontic pain. Meta-analyses and additional analyses, including subgroup and sensitivity analyses, were conducted. We included seventeen trials in this study. Pooled results showed that patients treated with rotary instruments experienced a significantly lower incidence of postoperative pain (RR, 0.32, P = 0.0005) and reduced pain intensity than did patients treated with manual instruments. In addition, patients treated with multiple rotary-file systems experienced a significantly lower incidence of postoperative pain than did those treated with reciprocating systems (RR, 0.73; P < 0.0001). The use of rotary instruments contributed to a lower incidence and intensity of postoperative pain than did the use of hand files in patients who received single-visit root canal treatment. In addition, the use of multiple rotary-file systems contributed to a lower incidence of postoperative pain than did the use of reciprocating systems. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Preliminary outcome and toxicity report of extended-field, intensity-modulated radiation therapy for gynecologic malignancies

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

Salama, Joseph K.; Mundt, Arno J.; Department of Radiation Oncology, University of Illinois, Chicago, IL

2006-07-15

Purpose: The aim of this article is to report a preliminary analysis of our initial clinical experience with extended-field intensity-modulated radiotherapy for gynecologic malignancies. Methods and Materials: Between November 2002 and May 2005, 13 women with gynecologic malignancies were treated with extended-field radiation therapy. Of the women, 7 had endometrial cancer, 4 cervical cancer, 1 recurrent endometrial cancer, and 1 suspected cervical cancer. All women underwent computed tomography planning, with the upper vagina, parametria, and uterus (if present) contoured within the CTV. In addition, the clinical target volume contained the pelvic and presacral lymph nodes as well as the para-aorticmore » lymph nodes. All acute toxicity was scored according to the Common Terminology Criteria for Adverse Events (CTCAE v 3.0). All late toxicity was scored using the Radiation Therapy Oncology Group late toxicity score. Results: The median follow-up was 11 months. Extended-field intensity-modulated radiation therapy (IMRT) for gynecologic malignancies was well tolerated. Two patients experienced Grade 3 or higher toxicity. Both patients were treated with concurrent cisplatin based chemotherapy. Neither patient was planned with bone marrow sparing. Eleven patients had no evidence of late toxicity. One patient with multiple previous surgeries experienced a bowel obstruction. One patient with bilateral grossly involved and unresectable common iliac nodes experienced bilateral lymphedema. Extended-field-IMRT achieved good local control with only 1 patient, who was metastatic at presentation, and 1 patient not able to complete treatment, experiencing in-field failure. Conclusions: Extended-field IMRT is safe and effective with a low incidence of acute toxicity. Longer follow-up is needed to assess chronic toxicity, although early results are promising.« less

Experience and needs of family members of patients treated with extracorporeal membrane oxygenation.

PubMed

Tramm, Ralph; Ilic, Dragan; Murphy, Kerry; Sheldrake, Jayne; Pellegrino, Vincent; Hodgson, Carol

2017-06-01

To explore the experiences of family members of patients treated with extracorporeal membrane oxygenation. Sudden onset of an unexpected and severe illness is associated with an increased stress experience of family members. Only one study to date has explored the experience of family members of patients who are at high risk of dying and treated with extracorporeal membrane oxygenation. A qualitative descriptive research design was used. A total of 10 family members of patients treated with extracorporeal membrane oxygenation were recruited through a convenient sampling approach. Data were collected using open-ended semi-structured interviews. A six-step process was applied to analyse the data thematically. Four criteria were employed to evaluate methodological rigour. Family members of extracorporeal membrane oxygenation patients experienced psychological distress and strain during and after admission. Five main themes (Going Downhill, Intensive Care Unit Stress and Stressors, Carousel of Roles, Today and Advice) were identified. These themes were explored from the four roles of the Carousel of Roles theme (decision-maker, carer, manager and recorder) that participants experienced. Nurses and other staff involved in the care of extracorporeal membrane oxygenation patients must pay attention to individual needs of the family and activate all available support systems to help them cope with stress and strain. An information and recommendation guide for families and staff caring for extracorporeal membrane oxygenation patients was developed and needs to be applied cautiously to the individual clinical setting. © 2016 John Wiley & Sons Ltd.

Two-Year Assessment of Entecavir Resistance in Lamivudine-Refractory Hepatitis B Virus Patients Reveals Different Clinical Outcomes Depending on the Resistance Substitutions Present▿

PubMed Central

Tenney, Daniel J.; Rose, Ronald E.; Baldick, Carl J.; Levine, Steven M.; Pokornowski, Kevin A.; Walsh, Ann W.; Fang, Jie; Yu, Cheng-Fang; Zhang, Sharon; Mazzucco, Charles E.; Eggers, Betsy; Hsu, Mayla; Plym, Mary Jane; Poundstone, Patricia; Yang, Joanna; Colonno, Richard J.

2007-01-01

Entecavir (ETV) is a deoxyguanosine analog approved for use for the treatment of chronic infection with wild-type and lamivudine-resistant (LVDr) hepatitis B virus (HBV). In LVD-refractory patients, 1.0 mg ETV suppressed HBV DNA levels to below the level of detection by PCR (<300 copies/ml) in 21% and 34% of patients by Weeks 48 and 96, respectively. Prior studies showed that virologic rebound due to ETV resistance (ETVr) required preexisting LVDr HBV reverse transcriptase substitutions M204V and L180M plus additional changes at T184, S202, or M250. To monitor for resistance, available isolates from 192 ETV-treated patients were sequenced, with phenotyping performed for all isolates with all emerging substitutions, in addition to isolates from all patients experiencing virologic rebounds. The T184, S202, or M250 substitution was found in LVDr HBV at baseline in 6% of patients and emerged in isolates from another 11/187 (6%) and 12/151 (8%) ETV-treated patients by Weeks 48 and 96, respectively. However, use of a more sensitive PCR assay detected many of the emerging changes at baseline, suggesting that they originated during LVD therapy. Only a subset of the changes in ETVr isolates altered their susceptibilities, and virtually all isolates were significantly replication impaired in vitro. Consequently, only 2/187 (1%) patients experienced ETVr rebounds in year 1, with an additional 14/151 (9%) patients experiencing ETVr rebounds in year 2. Isolates from all 16 patients with rebounds were LVDr and harbored the T184 and/or S202 change. Seventeen other novel substitutions emerged during ETV therapy, but none reduced the susceptibility to ETV or resulted in a rebound. In summary, ETV was effective in LVD-refractory patients, with resistant sequences arising from a subset of patients harboring preexisting LVDr/ETVr variants and with approximately half of the patients experiencing a virologic rebound. PMID:17178796

Two-year assessment of entecavir resistance in Lamivudine-refractory hepatitis B virus patients reveals different clinical outcomes depending on the resistance substitutions present.

PubMed

Tenney, Daniel J; Rose, Ronald E; Baldick, Carl J; Levine, Steven M; Pokornowski, Kevin A; Walsh, Ann W; Fang, Jie; Yu, Cheng-Fang; Zhang, Sharon; Mazzucco, Charles E; Eggers, Betsy; Hsu, Mayla; Plym, Mary Jane; Poundstone, Patricia; Yang, Joanna; Colonno, Richard J

2007-03-01

Entecavir (ETV) is a deoxyguanosine analog approved for use for the treatment of chronic infection with wild-type and lamivudine-resistant (LVDr) hepatitis B virus (HBV). In LVD-refractory patients, 1.0 mg ETV suppressed HBV DNA levels to below the level of detection by PCR (<300 copies/ml) in 21% and 34% of patients by Weeks 48 and 96, respectively. Prior studies showed that virologic rebound due to ETV resistance (ETVr) required preexisting LVDr HBV reverse transcriptase substitutions M204V and L180M plus additional changes at T184, S202, or M250. To monitor for resistance, available isolates from 192 ETV-treated patients were sequenced, with phenotyping performed for all isolates with all emerging substitutions, in addition to isolates from all patients experiencing virologic rebounds. The T184, S202, or M250 substitution was found in LVDr HBV at baseline in 6% of patients and emerged in isolates from another 11/187 (6%) and 12/151 (8%) ETV-treated patients by Weeks 48 and 96, respectively. However, use of a more sensitive PCR assay detected many of the emerging changes at baseline, suggesting that they originated during LVD therapy. Only a subset of the changes in ETVr isolates altered their susceptibilities, and virtually all isolates were significantly replication impaired in vitro. Consequently, only 2/187 (1%) patients experienced ETVr rebounds in year 1, with an additional 14/151 (9%) patients experiencing ETVr rebounds in year 2. Isolates from all 16 patients with rebounds were LVDr and harbored the T184 and/or S202 change. Seventeen other novel substitutions emerged during ETV therapy, but none reduced the susceptibility to ETV or resulted in a rebound. In summary, ETV was effective in LVD-refractory patients, with resistant sequences arising from a subset of patients harboring preexisting LVDr/ETVr variants and with approximately half of the patients experiencing a virologic rebound.

Primary genotypic resistance of HIV-1 to the maturation inhibitor PA-457 in protease inhibitor-experienced patients.

PubMed

Malet, Isabelle; Wirden, Marc; Derache, Anne; Simon, Anne; Katlama, Christine; Calvez, Vincent; Marcelin, Anne-Geneviève

2007-04-23

Sequences from 82 protease inhibitors (PI)-experienced patients were analysed for the presence of previously described in-vitro resistance mutations to PA-457 located in the C-terminal capside (H226Y, L231F, L231M) and in the N-terminal SP1 (A1V, A3T, A3V) within the CA-SP1 boundary domain. Overall, the CA-SP1 cleavage site was highly conserved in PI pre-treated patients and only one patient showed an L231M mutation. The impact of this mutation should be further addressed in vivo.

Fulvestrant Injection

MedlinePlus

... experienced menopause (change of life; end of monthly menstrual periods) and have not previously been treated with ... buttock).Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.

Association between experience of child abuse and severity of drug addiction measured by the Addiction Severity Index among Japanese drug-dependent patients.

PubMed

Ogai, Yasukazu; Senoo, Eiichi; Gardner, Fumiyuki Chin; Haraguchi, Ayako; Saito, Tamaki; Morita, Nobuaki; Ikeda, Kazutaka

2015-03-03

The aim of the present study was to clarify the association between child abuse experiences and drug addiction severity among Japanese drug-dependent patients using the Addiction Severity Index-Japanese version (ASI-J). One hundred and eleven inpatients and outpatients with drug dependence participated in the study. Some of the questions on the ASI-J asked about lifetime experiences of abuse. A higher percentage of female participants experienced child abuse compared with male participants. Male participants who experienced child abuse (MEA) had a significantly higher severity of drug use than men who did not experience it (MNEA). Female participants who experienced child abuse (FEA) had significantly more serious problems in family/social relationships than female participants who did not experience it (FNEA). Patients in the MEA group were arrested less frequently for drug charges, experienced more serious problems with their fathers, and experienced more severe anxiety in their lifetime compared with the MNEA group. The FEA group experienced more serious troubles with their sexual partners, close friends, and families and experienced more severe psychiatric problems in their lifetime compared with the FNEA group. These results suggest gender differences in the problems experienced by drug-dependent patients with child abuse experiences, and gender-specific interventions may be more effective in treating their drug dependence.

Association between Experience of Child Abuse and Severity of Drug Addiction Measured by the Addiction Severity Index among Japanese Drug-Dependent Patients

PubMed Central

Ogai, Yasukazu; Senoo, Eiichi; Gardner, Fumiyuki Chin; Haraguchi, Ayako; Saito, Tamaki; Morita, Nobuaki; Ikeda, Kazutaka

2015-01-01

The aim of the present study was to clarify the association between child abuse experiences and drug addiction severity among Japanese drug-dependent patients using the Addiction Severity Index-Japanese version (ASI-J). One hundred and eleven inpatients and outpatients with drug dependence participated in the study. Some of the questions on the ASI-J asked about lifetime experiences of abuse. A higher percentage of female participants experienced child abuse compared with male participants. Male participants who experienced child abuse (MEA) had a significantly higher severity of drug use than men who did not experience it (MNEA). Female participants who experienced child abuse (FEA) had significantly more serious problems in family/social relationships than female participants who did not experience it (FNEA). Patients in the MEA group were arrested less frequently for drug charges, experienced more serious problems with their fathers, and experienced more severe anxiety in their lifetime compared with the MNEA group. The FEA group experienced more serious troubles with their sexual partners, close friends, and families and experienced more severe psychiatric problems in their lifetime compared with the FNEA group. These results suggest gender differences in the problems experienced by drug-dependent patients with child abuse experiences, and gender-specific interventions may be more effective in treating their drug dependence. PMID:25741639

Dentist's distress in the management of chronic pain control: The example of TMD pain in a dental practice-based research network.

PubMed

Yokoyama, Yoko; Kakudate, Naoki; Sumida, Futoshi; Matsumoto, Yuki; Gordan, Valeria V; Gilbert, Gregg H

2018-01-01

We aimed to obtain greater understanding of dentists' distress when they diagnose and treat patients with temporomandibular disorders (TMD), and to explore ways in which TMD can be better treated.We conducted a cross-sectional study based on a questionnaire survey of dentists (n = 148). Dentists were queried using an open-ended questionnaire about distress they experienced when treating patients with TMD. Survey responses were analyzed using mixed methods. Associations between specific dentist and patient characteristics and types of distress were analyzed by one way analysis of variance and residual analysis.One hundred thirteen clinicians responded to the questionnaire, giving a 76% response rate. Thematic analysis identified 6 major themes: difficulty in predicting therapeutic effect and prognosis; difficulty in diagnosis; difficulty in the decision about whether to do occlusal adjustment; difficulty in specifying a cause; difficulty in communicating with patients and mental factors; and health insurance system barriers. Clinicians who reported difficulty in deciding whether to do occlusal adjustment saw significantly more patients who experienced shoulder stiffness and headache (P = .008 and P = .022, respectively). Dentists' knowledge of TMD guidelines was associated with a lower percentage of difficulty in predicting therapeutic effect and prognosis (residual analysis; P = .010).These findings provide important insights into clinician's perception of difficulties with patients experiencing TMD-related pain. Knowledge of the existence of TMD clinical practice guidelines may lower dentist distress, particularly with regard to prognosis. Further studies are needed to decrease dentist's distress and to overcome the evidence-practice gap in TMD treatment. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

Wound healing with honey--a randomised controlled trial.

PubMed

Ingle, Ronald; Levin, Jonathan; Polinder, Krijn

2006-09-01

To compare honey and IntraSite Gel as woundhealing agents, to record side-effects, gauge patient satisfaction and calculate the cost-effectiveness of the honey used. A prospective, randomised, double-blind controlled trial was carried out among goldmine workers. Outcome measures were healing times of shallow wounds and abrasions; side-effects; patient satisfaction with treatment; and amount of honey and IntraSite Gel used. The mean healing times of shallow wounds treated with honey or with IntraSite Gel did not differ significantly (p = 0.75, 95% confidence interval (CI): -5.41; 7.49 days). When adjusted for wound size, the 2.8-day difference in favour of honey was not significant (p = 0.21, 95% CI: -2.41; 8.09). In the case of abrasions there was also no significant difference (p = 0.83, 95% CI: -4.98; 6.19 days). When adjusted for wound size, the difference of 0.22 days in favour of IntraSite Gel was not significant (p = 0.94, 95% CI: -5.72; 6.15.4). Of patients treated with honey, 27% and 10% respectively experienced itching and pain, and 2 experienced burning for a short time after application. Of patients treated with IntraSite Gel, 31% experienced itching. All patients in both treatment groups were either satisfied or extremely satisfied with treatment. The average cost of treatment per patient was R0.49 with honey and R12.03 with with IntraSite Gel. A distinction should be made between shallow wounds and abrasions when wound healing is being measured. There was no evidence of a real difference between honey and IntraSite Gel as healing agents. Honey is a safe, satisfying and effective healing agent. Natural honey is extremely costeffective.

Tumor Stage-Related Role of Radiotherapy in Patients with an External Auditory Canal and Middle Ear Carcinoma.

PubMed

Choi, Jinhyun; Kim, Se-Heon; Koh, Yoon Woo; Choi, Eun Chang; Lee, Chang Geol; Keum, Ki Chang

2017-01-01

The purpose of this study was to evaluate the clinical outcomes of patients treated with radiotherapy (RT) for a carcinoma of the external auditory canal (EAC) and middle ear. The records of 32 patients who received RT from 1990 to 2013 were reviewed retrospectively. The Pittsburgh classification was used to stage all the cancers (early stage, T1/T2 [n=12]; advanced stage, T3/T4 or N positive [n=20]). Twenty-one patients (65.6%) were treated with postoperative RT and 11 patients (34.4%) were treated with definitive RT. The median radiation doses for postoperative and definitive RT were 60 Gy and 64.8 Gy, respectively. Chemotherapy was administered to seven patients (21.9%). The 5-year overall survival and disease-free survival rates for all patients were 57% and 52%, respectively. The disease control rates for the patients with early stage versus advanced stage carcinomawere 55.6% (5/9) and 50% (6/12) in the postoperative RT group and 66.7% (2/3) and 37.5% (3/8) in the definitive RT group, respectively. Overall, 15 cases (14 patients, 46.7%) experienced treatment failure; these failures were classified as local in four cases, regional in one case, and distant in 10 cases. The median follow-up period after RT was 51 months (range, 7 to 286 months). Patients with early stage carcinoma achieved better outcomes when definitive RT was used. Advanced stage carcinoma patients experienced better outcomes with postoperative RT. The high rate of distant failure after RT, with or without surgery, reflected the lack of a consensus regarding the best therapeutic approach for treating carcinoma of the EAC and middle ear.

Violence and Victimization in the Refugee Patient. I. Special Issues in Diagnostic and Therapeutic Interviewing.

ERIC Educational Resources Information Center

Westermeyer, Joseph; And Others

This paper is intended for teachers, faculty instructors, and clinical supervisors whose trainees are evaluating and treating refugee patients. It addresses special issues in the diagnostic and therapeutic interviewing of refugee patients who have experienced various types of physical violence and victimization. After a brief introduction, a…

Implanted Cardiac Defibrillator Care in Radiation Oncology Patient Population

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

Gelblum, Daphna Y.; Amols, Howard

2009-04-01

Purpose: To review the experience of a large cancer center with radiotherapy (RT) patients bearing implantable cardiac defibrillators (ICDs) to propose some preliminary care guidelines as we learn more about the devices and their interaction with the therapeutic radiation environment. Methods and Materials: We collected data on patients with implanted ICDs treated with RT during a 2.5-year period at any of the five Memorial Sloan-Kettering clinical campuses. Information regarding the model, location, and dose detected from the device, as well as the treatment fields, fraction size, and treatment energy was collected. During this time, a new management policy for thesemore » patients had been implemented requiring treatment with low-energy beams (6 MV) and close surveillance of the patients in partnership with their electrophysiologist, as they received RT. Results: During the study period, 33 patients were treated with an ICD in place. One patient experienced a default of the device to its initial factory setting that was detected by the patient hearing an auditory signal from the device. This patient had initially been treated with a 15-MV beam. After this episode, his treatment was replanned to be completed with 6-MV photons, and he experienced no further events. Conclusion: Patients with ICDs and other implanted computer-controlled devices will be encountered more frequently in the RT department, and proper management is important. We present a policy for the safe treatment of these patients in the radiation oncology environment.« less

The healthcare utilization and cost of treating patients experiencing inappropriate implantable cardioverter defibrillator shocks: a propensity score study.

PubMed

Bhavnani, Sanjeev P; Giedrimiene, Dalia; Coleman, Craig I; Guertin, Danette; Azeem, Meena; Kluger, Jeffrey

2014-10-01

Inappropriate shocks (IASs) from implantable cardioverter defibrillators (ICDs) are associated with decreased quality of life, but whether they increase healthcare utilization and treatment costs is unknown. We sought to determine the impact of IASs on subsequent healthcare utilization and treatment costs. We conducted a case-control analysis of ICD patients at a single institution from 1997 to 2010 and who had ≥12 months of post-ICD implant follow-up. Cases included all patients experiencing an IAS during the first 12 months after implantation. Eligible control patients did not receive a shock of any kind during the 12 months after implantation. Propensity scores based on 36 covariates (area under curve = 0.78) were used to match cases to controls. We compared the rate (occurrences/person year [PY]) of healthcare utilization immediately following IAS to the end of the 12-month follow-up period to the rate in the no-shock group over 12 months of follow-up. We also compared 12-month postimplant treatment (outpatient clinic, emergency room, and hospitalization) costs in both groups. A total of 76 patients experiencing ≥1 IAS during the first 12 months after implant (contributing 48 PYs) were matched to 76 no-shock patients (contributing 76 PYs). Cardiovascular (CV)-related clinic visit and hospitalization rates were increased following an IAS compared to those not receiving a shock (4.0 vs 3.3 and 0.7 vs 0.5, respectively, P = 0.02 for both). CV-related emergency room visitation (0.15 vs 0.08) rates were also numerically higher following an IAS, but did not reach statistical significance (P = 0.26). Patients experiencing an IAS accrued greater treatment costs during the 12 months postimplant compared to no-shock patients ($13,973 ± $46,345 vs $6,790 ± $19,091, P = 0.001). Recipients of IAS utilize the healthcare system more frequently following an IAS than patients not experiencing a shock. This increased utilization results in higher costs of treating IAS patients during the 12 months postimplant. ©2014 Wiley Periodicals, Inc.

Gamma knife surgery for epilepsy related to hypothalamic hamartomas.

PubMed

Régis, J; Bartolomei, F; de Toffol, B; Genton, P; Kobayashi, T; Mori, Y; Takakura, K; Hori, T; Inoue, H; Schröttner, O; Pendl, G; Wolf, A; Arita, K; Chauvel, P

2000-12-01

Drug-resistant epilepsy associated with hypothalamic hamartomas (HHs) can be cured by microsurgical resection of the lesions. Morbidity and mortality rates for microsurgery in this area are significant. Gamma knife surgery (GKS) is less invasive and seems to be well adapted for this indication. To evaluate the safety and efficacy of GKS to treat this uncommon pathological condition, we organized a multicenter retrospective study. Ten patients were treated in seven different centers. The follow-up periods were more than 12 months for eight patients, with a median follow-up period of 28 months (mean, 35 mo; range, 12-71 mo). All patients had severe drug-resistant epilepsy, including frequent gelastic and generalized tonic or tonicoclonic attacks. The median age was 13.5 years (range, 1-32 yr; mean, 14 yr) at the time of GKS. Three patients experienced precocious puberty. All patients had sessile HHs. The median marginal dose was 15.25 Gy (range, 12-20 Gy). Two patients were treated two times (at 19 and 49 mo) because of insufficient efficacy. All patients exhibited improvement. Four patients were seizure-free, one experienced rare nocturnal seizures, one experienced some rare partial seizures but no more generalized attacks, and two exhibited only improvement, with reductions in the frequency of seizures but persistence of some rare generalized seizures. Two patients, now seizure-free, were considered to exhibit insufficient improvement after the first GKS procedure and were treated a second time. A clear correlation between efficacy and dose was observed in this series. The marginal dose was more than 17 Gy for all patients in the successful group and less than 13 Gy for all patients in the "improved" group. No side effects were reported, except for poikilothermia in one patient. Behavior was clearly improved for two patients (with only slight improvements in their epilepsy). Complete coverage of the HHs did not seem to be mandatory, because the dosimetry spared a significant part of the lesions for two patients in the successful group. We report the first series demonstrating that GKS can be a safe and effective treatment for epilepsy related to HHs. We advocate marginal doses greater than or equal to 17 Gy and partial dose-planning when necessary, for avoidance of critical surrounding structures.

The effect of vildagliptin relative to sulphonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: the VIRTUE study

PubMed Central

Al-Arouj, M; Hassoun, A A K; Medlej, R; Pathan, M F; Shaltout, I; Chawla, M S; Hristoskova, S; DiTommaso, S; Kadwa, M Y

2013-01-01

SUMMARY Aims To assess, in a real-world setting, the effect of vildagliptin compared with sulphonylurea (SU) treatment on hypoglycaemia in Muslim patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan. Methods This multinational, non-interventional study, conducted in Asia and the Middle East, included Muslim adult patients with T2DM who received treatment with vildagliptin or SU as add-on to metformin or monotherapy. During a ∼16-week observation period, data were collected up to 6 weeks before and 6 weeks after Ramadan fasting. The primary study objective was to compare the proportion of patients with ≥ 1 hypoglycaemic event (HE) during fasting. Results Of > 1300 patients enrolled in the study, 684 were treated with vildagliptin and 631 with SUs. Significantly fewer patients experienced ≥ 1 HE with vildagliptin compared with those receiving SUs (5.4% vs. 19.8%, respectively; p < 0.001); no vildagliptin-treated patients reported a grade 2 HE, vs. 4 SU-treated patients (p = 0.053). Mean HbA1c changes from baseline were vildagliptin: –0.24%, SUs: +0.02% (p < 0.001). Mean body weight reductions from baseline were vildagliptin: –0.76 kg, SUs: –0.13 kg (p < 0.001). A higher proportion of SU-treated patients experienced adverse events (AEs) compared with vildagliptin (22.8% vs. 10.2%). This difference was driven by hypoglycaemia as the most common AE. Conclusions In this real-world study of fasting Muslim patients with T2DM, vildagliptin was associated with significantly fewer hypoglycaemic episodes compared with SU therapy. This outcome is particularly meaningful when viewed in the context of good glycaemic and weight control observed in vildagliptin-treated patients. Vildagliptin was well tolerated in this patient population. Linked Comment: Ahmed. Int J Clin Pract 2013; 67: 933–4. PMID:24001317

Doses of olanzapine, risperidone, and haloperidol used in clinical practice: results of a prospective pharmacoepidemiologic study. EFESO Study Group. Estudio Farmacoepidemiologico en la Esquizofrenia con Olanzapina.

PubMed

Sacristán, J A; Gómez, J C; Montejo, A L; Vieta, E; Gregor, K J

2000-05-01

The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score < or = 4. A total of 2657 patients were included in the analysis. The initial and overall mean daily doses for the 3 groups were as follows: OLZ, 12.2 and 13.0 mg, respectively; RIS, 5.2 and 5.4 mg; and HAL, 13.9 and 13.6 mg. Initial and overall median daily doses were the same in each group: OLZ, 10 mg; RIS, 6 mg; and HAL, 10 mg. A significantly lower proportion of OLZ-treated patients (36.9%) experienced EPS compared with RIS-treated (49.6%) and HAL-treated (76.0%) patients (P < or = 0.001). A significantly lower proportion of patients in the OLZ group (47.8%) experienced adverse events compared with patients in the RIS (57.2%) and HAL (79.8%) groups (P < or = 0.001). A significantly greater proportion of OLZ-treated patients (37.3%) were responders compared with RIS-treated patients (31.5%) (P < 0.05). In all 3 groups, patients who had an initial CGI score > or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

Determination of School-Related Problems in Children Treated for Cancer

ERIC Educational Resources Information Center

Yilmaz, Medine C.; Sari, Hatice Yildirim; Cetingul, Nazan; Kantar, Mehmet; Erermis, Serpil; Aksoylar, Serap

2014-01-01

This descriptive and case-control study was carried out in a pediatric oncology outpatient clinic to determine the school-related physical, social, and psychological problems and problems experienced in academic achievement of children treated for cancer. The sample of the study consisted of 56 Turkish patients with cancer, aged 7-18 years, who…

What happens when doctors are patients? Qualitative study of GPs.

PubMed

Fox, Fiona; Harris, Michael; Taylor, Gordon; Rodham, Karen; Sutton, Jane; Robinson, Brian; Scott, Jenny

2009-11-01

Current evidence about the experiences of doctors who are unwell is limited to poor quality data. To investigate GPs' experiences of significant illness, and how this affects their own subsequent practice. Qualitative study using interpretative phenomenological analysis to conduct and analyse semi-structured interviews with GPs who have experienced significant illness. Two primary care trusts in the West of England. A total of 17 GPs were recruited to take part in semi-structured interviews which were conducted and analysed using interpretative phenomenological analysis Results: Four main categories emerged from the data. The category, 'Who cares when doctors are ill?' embodies the tension between perceptions of medicine as a 'caring profession' and as a 'system'. 'Being a doctor-patient' covers the role ambiguity experienced by doctors who experience significant illness. The category 'Treating doctor-patients' reveals the fragility of negotiating shared medical care. 'Impact on practice' highlights ways in which personal illness can inform GPs' understanding of being a patient and their own consultation style. Challenging the culture of immunity to illness among GPs may require interventions at both individual and organisational levels. Training and development of doctors should include opportunities to consider personal health issues as well as how to cope with role ambiguity when being a patient and when treating doctor-patients. Guidelines about being and treating doctor-patients need to be developed, and GPs need easy access to an occupational health service.

Reevaluating response and failure of medical treatment of endometriosis: a systematic review.

PubMed

Becker, Christian M; Gattrell, William T; Gude, Kerstin; Singh, Sukhbir S

2017-07-01

To assess patient response rates to medical therapies used to treat endometriosis-associated pain. A systematic review with the use of Medline and Embase. Not applicable. Women receiving medical therapy to treat endometriosis. None. The proportions of patients who: experienced no reduction in endometriosis-associated pain symptoms; had pain symptoms remaining at the end of the treatment period; had pain recurrence after treatment cessation; experienced an increase or no change in disease score during the study; were satisfied with treatment; and discontinued therapy owing to adverse events or lack of efficacy. The change in pain symptom severity experienced during and after treatment, as measured on the visual analog scale, was also assessed. In total, 58 articles describing 125 treatment arms met the inclusion criteria. Data for the response of endometriosis-associated pain symptoms to treatment were presented in only 29 articles. The median proportions of women with no reduction in pain were 11%-19%; at the end of treatment, 5%-59% had pain remaining; and after follow-up, 17%-34% had experienced recurrence of pain symptoms after treatment cessation. After median study durations of 2-24 months, the median discontinuation rates due to adverse events or lack of efficacy were 5%-16%. Few studies of medical therapies for endometriosis report outcomes that are relevant to patients, and many women gain only limited or intermittent benefit from treatment. Copyright © 2017. Published by Elsevier Inc.

Making see and treat work for patients and staff.

PubMed

Parker, Louise

2004-02-01

Every department is at a different stage in the development of see and treat. Teams have been established in various ways and are experiencing different dilemmas in making see and treat work best. It is not enough to pick up an established see and treat model, place it in an emergency department and sit back and watch the results. There is no 'magic wand'; no single determining factor to make see and treat work well. Influencing factors need to be understood, applied locally and reviewed regularly to assess success. The NHS Modernisation Agency publishes its survey report, See and Treat: Making it work for patients and staff, on February 4. For Further details, access www.modern.nhs.uk/emergency

Analysis of incidence of bulla formation after tattoo treatment using the combination of the picosecond Alexandrite laser and fractionated CO2 ablation.

PubMed

Au, Sonoa; Liolios, Ana M; Goldman, Mitchel P

2015-02-01

The picosecond Alexandrite laser has shown increased efficacy in tattoo removal in comparison to Q-switched lasers. However, bulla formation is a well-known and expected side effect of this novel treatment and causes patient discomfort. To analyze the incidence of bulla formation after tattoo treatment using the combination of the picosecond Alexandrite laser and fractionated CO2 ablation. This is a retrospective chart review to determine the incidence of bulla formation after laser tattoo removal in 95 patients who were treated with either with the picosecond Alexandrite laser alone or in combination with fractional CO2 ablation. Twenty-six patients (32%) treated with the picosecond laser alone experienced blistering, whereas none of the patients treated with the combination of the picosecond laser and fractionated CO2 ablation experienced blistering. The difference in incidence of bulla formation between the 2 groups was found to be statistically significant (p < .05). This study shows a significant decrease in bulla formation associated with tattoo treatment when fractionated CO2 ablation is added to the picosecond Alexandrite laser, which is consistent with observations from a previous case series. This is important because decreasing extensive blistering likely results in increased patient satisfaction and willingness to return for future treatments.

Pentostatin and Rituximab Therapy for Previously Untreated B-CLL

PubMed Central

Kay, Neil E.; Wu, Wenting; Kabat, Brian; LaPlant, Betsy; Lin, Thomas S.; Byrd, John C.; Jelinek, Diane F.; Grever, Michael R.; Zent, Clive S.; Call, Timothy G.; Shanafelt, Tait D.

2010-01-01

We have shown that the combination of pentostatin (P), cyclophosphamide (C) and rituximab (R) achieves an overall response (OR) rate >90% with more than 40% complete responses (CR) in patients with untreated CLL. To evaluate if the tolerability of this regimen could be enhanced without sacrificing efficacy, we conducted a phase II trial of P and R without cyclophosphamide, using a higher P dose (4 mg/m2). Among the 33 patients enrolled, 82% were male, median age was 65 (9 patients ≥70 years) and 64% were Rai stage III-IV. The OR rate was 76% with 9 CR (27%), 5 nPR, and 11 PRs. At the time of this analysis, 29/33 patients are still alive and the median follow up for patients still alive is 14 months (range: 1-34.8 months). Four (12%) patients experienced grade 3 or higher hematologic toxicity and 5 (15%) experienced grade 3 or higher non-hematologic toxicity. Comparison of this trial to our previous PCR trial showed that patients treated with PCR had a higher OR rate (91% vs. 76%) and CR rate (41% vs. 27%) compared to patients treated with PR. Median treatment-free survival for all accrued patients was notably longer in PCR treated patients compared to PR (30 vs. 16 months). These findings suggest that increasing the dose of the purine nucleoside analogue does not eliminate the need for cyclophosphamide in chemoimmunotherapy for treatment of CLL. PMID:20187101

A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer.

PubMed

Alvarez, Edwin A; Wolfson, Aaron H; Pearson, J Matt; Crisp, Meredith P; Mendez, Luis E; Lambrou, Nicholas C; Lucci, Joseph A

2009-05-01

This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix. Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m(2), 30 mg/m(2) and 40 mg/m(2) given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD. Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m(2) dose level consisting of colonic and ureteral obstruction. At the 30 mg/m(2) dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m(2) dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67%) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67%) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months). The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m(2).

Assessment and pharmacotherapy of depression.

PubMed

Van Fleet, Sharon

2006-04-01

Depressive disorders are experienced by a significant number of patients with cancer, with reported rates of 0%-58% (Massie, 2004). Numerous studies have demonstrated that depression in patients with cancer is underdiagnosed and inadequately treated as a result of a number of factors (Schwartz, Lander, & Chochinov, 2002). Although more severe or complex situations involving depression or other mental illness necessitate specialist referral, sometimes professionals treating patients with cancer may find the need to initiate treatment. Thus, clinicians need to be aware of basic principles related to the assessment and treatment of depression.

Biologic Disease-modifying Antirheumatic Drug (bDMARD)-induced Neutropenia: A Registry from a Retrospective Cohort of Patients with Rheumatic Diseases Treated with 3 Classes of Intravenous bDMARD.

PubMed

Espinoza, Francisco; Le Blay, Pierre; Combe, Bernard

2017-06-01

To examine the rate, risks factors, and consequences of neutropenia induced by intravenous (IV) biologic disease-modifying antirheumatic drugs (bDMARD). We conducted a retrospective cohort study in 499 patients with rheumatic diseases treated by IV abatacept (ABA), infliximab (IFX), or tocilizumab (TCZ). Rheumatoid arthritis (RA) was the most frequent diagnosis (72%). Fifty-two patients (10.4%) experienced at least 1 episode of neutropenia. No episodes of grade 4 neutropenia were documented. TCZ was more frequently related to neutropenia than ABA or IFX (18.6% vs 3.8% and 2.8%, respectively, p < 0.001). The following factors were identified as predictors of experiencing neutropenia with IV bDMARD: history of neutropenia with methotrexate (MTX; synthetic DMARD; OR 1.56, 95% CI 1.17-7.14), concomitant treatment by MTX (OR 1.21, 95% CI 1.01-2.64), and TCZ treatment (OR 2.72, 95% CI 1.53-9.05). Patients experiencing a TCZ-induced neutropenia did not show a higher risk of severe infections; however, this group had a shorter drug survival (9 mos vs 20 mos, p < 0.02) compared with TCZ patients without neutropenia. Among 3 different classes of IV bDMARD, TCZ is associated with the higher risk of neutropenia. No increased frequency of infection episodes was documented in this group.

Following the canyon to reach and remove olfactory groove meningiomas.

PubMed

Stefini, Roberto; Zenga, Francesco; Giacomo, Esposito; Bolzoni, Andrea; Tartara, Fulvio; Spena, Giannantonio; Ambrosi, Claudia; Fontanella, Marco M

2017-04-01

Olfactory groove meningiomas (OGMs) represent approximately 10% of all intracranial meningiomas. They arise in the olfactory fossa, a variable depression delimited by the lateral lamella and perpendicular plate. The cribriform plate with the lateral lamella and ethmoidal and orbital roof could be viewed as a 'canyon' with the frontal sinus as the main entrance. Between January 2000 and December 2013, 32 consecutive patients underwent removal of OGMs through this 'canyon' at the Department of Neurosurgery of Brescia and Turin. Complete removal was achieved in all patients with this trans-frontal sinus subcranial approach (Simpson grade I; mean lesion volume, 46.6 cm3). Five patients (15.6%) experienced nasal CSF leakage, treated with external lumbar drain positioning for 4 days and resolved in all cases but one, which was re-operated. Two patients (6.2%) during the CSF leakage experienced meningitis at day 7 after surgery, both successfully treated by intravenous antibiotic therapy. After one month, one patient developed hydrocephalus, treated with a ventricular peritoneal shunt. In one patient, traction on the OGM caused bleeding of the callosomarginal artery, which was coagulated with superior frontal gyrus ischemia without neurological consequences. Glasgow Outcome Scale Score at 6 months was V in 29 patients, IV in one patient, and I in two patients. Advantages with this approach may include easy and early control of blood supply from its insertion in the skull base, minimal frontal lobe retraction, preservation of the frontal veins draining to the sagittal sinus, and a satisfactory aesthetic outcome.

Bedaquiline in the multidrug-resistant tuberculosis treatment: Belarus experience.

PubMed

Skrahina, Alena; Hurevich, Hennadz; Falzon, Dennis; Zhilevich, Liudmila; Rusovich, Valiantsin; Dara, Masoud; Setkina, Svetlana

2016-12-01

Outcomes of treatment for multidrug-resistant tuberculosis (MDR-TB) remain poor worldwide. Among patients with MDR-TB in Belarus who started treatment in 2012, only 54% completed it successfully, with treatment failure reported in 22% of the patients; additionally, 11% died and 13% were lost to follow-up or remained unevaluated. In Belarus, to improve outcomes, bedaquiline was introduced in MDR-TB treatment in June 2015. The national TB program developed measures to monitor safety and effectiveness of bedaquiline-containing regimens in line with the World Health Organization recommendations. After enrollment of patients, clinical, radiological, laboratory, and microbiological data were carefully collected at start, during treatment, and at follow-up. A total of 197 patients were enrolled: male, 140 (71%); female, 57 (29%); new TB cases, 83 (42%); previously treated, 114 (58%); extensively drug-resistant-TB (XDR-TB), 128 (65%), pre-XDR-TB (fluoroquinolone resistant), 34 (17%), pre-XDR-TB (injectables resistant), 25 (13%), and other MDR-TB cases, 10 (5%). According to the intermediate analysis, 186 patients currently are continuing with the treatment, two patients died, and nine patients were lost to follow-up. Sputum culture conversion were observed in 186 patients (94%) at 6months and one (0.5%) of these 197 patients started treatment; six patients (3%) remain sputum culture positive. The safety data were as follows: 135 patients (68%) experienced metabolism and nutrition disorders (hyperuricemia being the most common), 127 patients (64%) experienced hepatobiliary disorders (hepatic functions abnormality being the most common), 93 patients (47%) experienced electrolyte disorders (hypomagnesemia being the most common), 80 patients (41%) experienced cardiac disorders (abnormal electrocardiogram and arrhythmia being the most common), 68 patients (35%) experienced gastrointestinal system disorders (nausea, vomiting, and abdominal pain being the most common disorders), 54 patients (27%) experienced blood and the lymphatic system disorders (low platelet count being the most common), 42 patients (21%) experienced renal and urinary disorders (creatinine clearance decrease being the most common), 40 patients (20%) experienced nervous system disorders (headache, dizziness, and paresthesia being the most common ones), 36 patients (18%) experienced skin and subcutaneous tissue disorders (rush and pruritus being the most common), 35 patients (17%) experienced ear and labyrinth disorders (tinnitus and decreased hearing being the most common ones), 32 patients (15%) experienced psychiatric disorders (insomnia being the most common disorder), and 30 patients (14%) experienced infections and infestations (candidiasis being the most common). The most adverse events were mild or moderate in severity and reversible. One death was possibly related to MDR-TB therapy. Our interim results on safety and effectiveness of bedaquiline-containing regimens in multidrug and extensively drug-resistant tuberculosis (M/XDR-TB) patients are encouraging. They will add value to understanding role and place of this new anti-TB drug in M/XDR-TB treatment. Copyright © 2016.

High dose lansoprazole combined with metronomic chemotherapy: a phase I/II study in companion animals with spontaneously occurring tumors.

PubMed

Spugnini, Enrico P; Buglioni, Sabrina; Carocci, Francesca; Francesco, Menicagli; Vincenzi, Bruno; Fanciulli, Maurizio; Fais, Stefano

2014-08-21

The treatment of human cancer has been seriously hampered for decades by resistance to chemotherapeutic drugs. A very efficient mechanism of tumor resistance to drugs is the proton pumps-mediated acidification of tumor microenvironment. Metronomic chemotherapy has shown efficacy in adjuvant fashion as well as in the treatment of pets with advanced disease. Moreover, we have shown in veterinary clinical settings that pre-treatment with proton-pumps inhibitors (PPI) increases tumor responsiveness to chemotherapeutics. In this study pet with spontaneously occurring cancer have been recruited to be treated by a combination of metronomic chemotherapy and high dose PPIs and their responses have been matched to those of a historical control of ten patients treated with metronomic chemotherapy alone. Single arm, non randomized phase II open study, with historical control group, evaluating safety and efficacy of the combination of metronomic chemotherapy and alkalization. Twenty-four companion animals (22 dogs and 2 cats) were treated adding to their metronomic chemotherapy protocol the pump inhibitor lansoprazole at high dose, and a water alkalizer. Their responses have been evaluated by clinical and instrumental evaluation and matched to those of the control group. The protocol was overall well tolerated, with only two dogs experiencing side effects due to gastric hypochlorhydria consisting with vomiting and or diarrhea. In terms of overall response, in the alkalized cohort, 18 out of 24 had partial or complete responses (75%), two patients had a stable disease and the remaining patients experienced no response or progressive disease. On the other hand, only one patient in the control group experienced a complete response (10%) and three other experienced short lived responses. Median time to terminal event was 34 weeks for the experimental group versus 2 weeks in the controls (p= 0.042). Patient alkalization has shown to be well tolerated and to increase tumor response to metronomic chemotherapy as well the quality of life in pets with advanced cancer. Further studies are warranted to assess the efficacy of this strategy in patients with advanced cancers in companion animals as well as in humans.

Allogeneic Hematopoietic Cell Transplantation for Dyskeratosis Congenita: A Report of 3 Cases.

PubMed

Tamura, Shinichi; Imamura, Toshihiko; Urata, Takayo; Kobayashi, Miki; Gen, Mari; Tomii, Toshihiro; Do, Junko; Osone, Shinya; Ishida, Hiroyuki; Hosoi, Hajime; Kuroda, Hiroshi

2017-10-01

Although bone marrow failure in patients with dyskeratosis congenita (DKC) can be successfully treated with allogeneic hematopoietic cell transplantation (allo-HCT) using a reduced intensity conditioning (RIC) regimen, the outcome of nonhematological disorders in patients with DKC treated with allo-HCT using RIC has not been fully elucidated. Here, we describe the clinical course of nonhematological disorders after allo-HCT with RIC in 3 consecutive patients with DKC. Allo-HCT with RIC was feasible in all cases; however, patient 1 developed lethal pulmonary disease and patient 2 experienced progression of hepatic fibrosis. Careful follow-up of patient-specific complications is required after allo-HCT in patients with DKC.

Treating B-cell cancer with T cells expressing anti-CD19 chimeric antigen receptors.

PubMed

Kochenderfer, James N; Rosenberg, Steven A

2013-05-01

Most B-cell malignancies express CD19, and a majority of patients with B-cell malignancies are not cured by current standard therapies. Chimeric antigen receptors (CARs) are fusion proteins consisting of antigen recognition moieties and T-cell activation domains. T cells can be genetically modified to express CARs, and adoptive transfer of anti-CD19 CAR T cells is now being tested in clinical trials. Effective clinical treatment with anti-CD19 CAR T cells was first reported in 2010 after a patient with advanced-stage lymphoma treated at the NCI experienced a partial remission of lymphoma and long-term eradication of normal B cells. Additional patients have subsequently obtained long-term remissions of advanced-stage B-cell malignancies after infusions of anti-CD19 CAR T cells. Long-term eradication of normal CD19(+) B cells from patients receiving infusions of anti-CD19 CAR T cells demonstrates the potent antigen-specific activity of these T cells. Some patients treated with anti-CD19 CAR T cells have experienced acute adverse effects, which were associated with increased levels of serum inflammatory cytokines. Although anti-CD19 CAR T cells are at an early stage of development, the potent antigen-specific activity observed in patients suggests that infusions of anti-CD19 CAR T cells might become a standard therapy for some B-cell malignancies.

Oral metronidazole vs. Metrogel Vaginal for treating bacterial vaginosis. Cost-effectiveness evaluation.

PubMed

Ransom, S B; McComish, J F; Greenberg, R; Tolford, D A

1999-04-01

To compare the cost-effectiveness of metronidazole versus Metrogel Vaginal in the treatment of bacterial vaginosis. Sixty consecutive patients with a clinical diagnosis of bacterial vaginosis were randomly assigned prospectively into either the metronidazole, 500 mg (twice daily for seven days by mouth) or Metrogel Vaginal (one applicator twice daily for five days) treatment group. The study patients were aged 18-30 years, without other medical problems. The patients proceeded with outpatient therapy and returned 7-10 days after the completion of treatment for reevaluation. During the study, patients refrained from sexual relations, avoided alcohol and drugs, and avoided all medication. The physician evaluated the patients for bacterial vaginosis through standard wet preparation, whiff test and pH testing prior to and after treatment. The patients were randomized by a nurse and were blinded for study purposes to the evaluating physician. Successful treatment outcomes for bacterial vaginosis occurred in 27 and 28 patients for Metrogel Vaginal and metronidazole, respectively, out of the original 30 patients in each study group. All patients introduced into the study completed the study without difficulty. No significant complications were found in either treatment group. Three patients treated with metronidazole experienced nausea during the treatment interval. The entire cost of treatment was $19.71 and $1.51 for Metrogel Vaginal and metronidazole, respectively. The most cost-effective treatment for bacterial vaginosis was generic metronidazole. While the use of the more expensive Metrogel Vaginal may be reasonable for patients experiencing side effects of oral metronidazole, most patients should be treated with the less expensive generic metronidazole.

Minimally cultured or selected autologous tumor-infiltrating lymphocytes after a lympho-depleting chemotherapy regimen in metastatic melanoma patients.

PubMed

Besser, Michal J; Shapira-Frommer, Ronnie; Treves, Avraham J; Zippel, Dov; Itzhaki, Orit; Schallmach, Ester; Kubi, Adva; Shalmon, Bruria; Hardan, Izhar; Catane, Raphael; Segal, Eran; Markel, Gal; Apter, Sara; Nun, Alon Ben; Kuchuk, Iryna; Shimoni, Avichai; Nagler, Arnon; Schachter, Jacob

2009-05-01

Adoptive cell therapy with autologous tumor-infiltrating lymphocytes (TIL) and high-dose interleukin-2 (IL-2), after nonmyeloablative chemotherapy, has been shown to result in tumor regression in half of refractory metastatic melanoma patients. In the present study, we describe 2 separate clinical protocols. Twelve patients were treated with "Selected"-TIL, as previously reported and 8 patients with the modified version of "Young"-TIL. Selected-TIL protocol required the establishment of multiple T-cell cultures from 1 patient and in vitro selection of cultures secreting interferon-gamma upon antigenic stimulation. In contrast, Young-TIL are minimally cultured T cells with superior in vitro features that do not require further selection. Two of 12 Selected-TIL patients experienced objective clinical responses (1 complete response, 1 partial response). Out of 8 treated Young-TIL patients, 1 experienced complete response, 2 partial response, and 4 patients had disease stabilization. Twenty-one of 33 enrolled Selected-TIL patients were excluded from the protocol, mainly as cultures failed the interferon-gamma selection criteria or due to clinical deterioration, compared with only 3 Young-TIL patients. Expected bone marrow suppression and high-dose IL-2 toxicity were transient. There was no treatment-related mortality. This study vindicates the feasibility and effectiveness of TIL technology and calls for further efforts to implement and enhance this modality. The use of minimally cultured, unselected Young-TIL enables the treatment of most enrolled patients. Although the cohort of Young-TIL patients treated so far is rather small and the follow-up short, the response rate is encouraging.

Treating post-traumatic tremor with deep brain stimulation: report of five cases.

PubMed

Issar, Neil M; Hedera, Peter; Phibbs, Fenna T; Konrad, Peter E; Neimat, Joseph S

2013-12-01

Post-traumatic tremor is one of the most common movement disorders resulting from severe head trauma. However, literature regarding successful deep brain stimulation (DBS) treatment is scarce, resulting in ambiguity regarding the optimal lead location. Most cases support the ventral intermediate nucleus, but there is evidence to defend DBS of the zona incerta, ventral oralis anterior/posterior, and/or a combination of these targets. We report five patients with disabling post-traumatic tremor treated with DBS of the ventral intermediate nucleus and of the globus pallidus internus. Patients were referred to the Vanderbilt Movement Disorders Division, and surgical intervention was determined by a DBS Multidisciplinary Committee. Standard DBS procedure was followed. Patients 1-4 sustained severe diffuse axonal injuries. Patients 1-3 underwent unilateral ventral intermediate nucleus DBS for contralateral tremor, while Patient 4 underwent bilateral ventral intermediate nucleus DBS. Patients 1-3 experienced good tremor reduction, while Patient 4 experienced moderate tremor reduction with some dystonic posturing of the hands. Patient 5 had dystonic posturing of the right upper extremity with tremor of the left upper extremity. He was treated with bilateral DBS of the globus pallidus internus and showed good tremor reduction at follow-up. Unilateral or bilateral DBS of the ventral intermediate nucleus and bilateral DBS of the globus pallidus internus may be effective and safe treatment modalities for intractable post-traumatic tremor. Further studies are needed to clarify the optimal target for surgical treatment of post-traumatic tremor. Published by Elsevier Ltd.

Spontaneous dissection of the internal carotid artery manifesting as pain in an endodontically treated molar.

PubMed

Roz, Tamar M; Schiffman, Leonard E; Schlossberg, Sharon

2005-11-01

Dental pain is a common occurrence, whereas spontaneous dissection of an internal carotid artery is rare. The authors describe a patient who experienced a spontaneous dissection of an internal carotid artery that manifested initially as dental pain in an endodontically treated molar. It is important for dental practitioners to be familiar with unusual causes of dental pain. In this case in which the cause of dental pain was uncommon, the authors referred the patient appropriately, thus avoiding potentially serious complications.

Analysis of patients with atypical hemolytic uremic syndrome treated at the Mie University Hospital: concentration of C3 p.I1157T mutation.

PubMed

Matsumoto, Takeshi; Fan, Xinping; Ishikawa, Eiji; Ito, Masaaki; Amano, Keishirou; Toyoda, Hidemi; Komada, Yoshihiro; Ohishi, Kohshi; Katayama, Naoyuki; Yoshida, Yoko; Matsumoto, Masanori; Fujimura, Yoshihiro; Ikejiri, Makoto; Wada, Hideo; Miyata, Toshiyuki

2014-11-01

Atypical hemolytic uremic syndrome (aHUS) is caused by abnormalities of the complement system and has a significantly poor prognosis. The clinical phenotypes of 12 patients in nine families with aHUS with familial or recurrent onset and ADAMTS13 activity of ≥20 % treated at the Mie University Hospital were examined. In seven of the patients, the first episode of aHUS occurred during childhood and ten patients experienced a relapse. All patients had renal dysfunction and three had been treated with hemodialysis. Seven patients experienced probable triggering events including common cold, influenza, bacterial infection and/or vaccination for influenza. All patients had entered remission, and renal function was improved in 11 patients. DNA sequencing of six candidate genes, identified a C3 p.I1157T missense mutation in all eight patients in six families examined and this mutation was causative for aHUS. A causative mutation THBD p.D486Y was also identified in an aHUS patient. Four missense mutations, CFH p.V837I, p.Y1058H, p.V1060L and THBD p.R403K may predispose to aHUS manifestation; the remaining seven missense mutations were likely neutral. In conclusion, the clinical phenotypes of aHUS are various, and there are often trigger factors. The C3 p.I1157T mutation was identified as the causative mutation for aHUS in all patients examined, and may be geographically concentrated in or around the Mie prefecture in central Japan.

Phase III noninferiority trial comparing irinotecan with oxaliplatin, fluorouracil, and leucovorin in patients with advanced colorectal carcinoma previously treated with fluorouracil: N9841.

PubMed

Kim, George P; Sargent, Daniel J; Mahoney, Michelle R; Rowland, Kendrith M; Philip, Philip A; Mitchell, Edith; Mathews, Abraham P; Fitch, Tom R; Goldberg, Richard M; Alberts, Steven R; Pitot, Henry C

2009-06-10

The primary goal of this multicenter phase III trial was to determine whether overall survival (OS) of fluorouracil (FU) -refractory patients was noninferior when treated with second-line infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4; arm B) versus irinotecan (arm A). Cross-over to the other treatment on disease progression was mandated. Patients who experienced treatment failure with one prior FU-based therapy and had not received prior irinotecan or oxaliplatin, either for metastatic disease or within 6 months of adjuvant FU therapy, were randomly assigned to arm A (irinotecan 350 or 300 mg/m(2) every 3 weeks) or arm B (FOLFOX4). A total of 491 patients were randomly assigned (arm A, n = 245; arm B, n = 246); 288 (59%) had experienced treatment failure with FU for metastatic colorectal cancer. Two hundred twenty-seven patients (46%) received protocol-mandated third-line therapy (arm A, 43%; arm B, 57%). Median survival was 13.8 months (95% CI, 12.2 to 15.0 months) for initial treatment with FOLFOX4 and 14.3 months (95% CI, 12.0 to 15.9 months) for irinotecan (P = .38; hazard ratio = 0.92; 95% CI, 0.8 to 1.1). Response rates (RR; 28% v 15.5%; P = .0009) and time to progression (TTP; 6.2 v 4.4 months; P = .0009) were significantly superior with FOLFOX4. In the nonrandom subset of patients who crossed over, RR and TTP improvements with FOLFOX4 continued into third-line treatment. Irinotecan therapy was associated with more grade 3 nausea, vomiting, diarrhea, and febrile neutropenia; FOLFOX4 was associated with more neutropenia and paresthesias. In patients who experienced treatment failure with front-line FU therapy, OS does not significantly differ whether second-line therapy begins with irinotecan or FOLFOX4. FOLFOX4 produces higher RR and longer TTP. Both arms had notable OS in patients who experienced treatment failure with first-line FU therapy.

Clinical predictors of anticipatory emesis in patients treated with chemotherapy at a tertiary care cancer hospital.

PubMed

Qureshi, Fawad; Shafi, Azhar; Ali, Sheeraz; Siddiqui, Neelam

2016-01-01

To determine the clinical predictors of anticipatory emesis in patients treated with chemotherapy at a tertiary care cancer hospital. This was a cross-sectional study conducted on 200 patients undergoing first line chemotherapy with minimum of two cycles at inpatient department and chemotherapy bay of Shaukat Khanum Memorial Cancer Hospital and Research Centre Pakistan. Anticipatory nausea and vomiting develops before administration of chemotherapy. Clinical signs and symptoms in patients with or without anticipatory emesis were compared using chi square test statistics. The mean age of the study participants was 36.68 years (SD±12.23). The mean numbers of chemotherapy cycles administered were 3.23 (SD±1.2). Chemotherapy related nausea and vomiting was experienced by 188 (94%) patients and anticipatory nausea vomiting was reported in 90 (45%) of patients. Greater proportions of patients with anticipatory emesis were females. Fourteen (15.5%) p-value=0.031 patients with anticipatory emesis had history of anxiety and depression. Fifty nine (65.5%) p-value =< 0.0001 patients with anticipatory emesis had severe nausea after last chemotherapy cycle. Forty six (51.11%) p=<0.0001 patients had motion sickness. Female gender, history of motion sickness, anxiety and depression, severe nausea and vomiting experienced in pervious cycle of chemotherapy were clinical predictors of anticipatory nausea and vomiting.

Delayed Epithelial Closure After PRK Associated With Topical Besifloxacin Use.

PubMed

Talamo, Jonathan H; Hatch, Kathryn M; Woodcock, Emily C

2013-10-01

To report the observation of prolonged reepithelialization after photorefractive keratectomy (PRK) associated with the use of besifloxacin 0.6% (Besivance; Bausch & Lomb, Rochester, NY) underneath bandage contact lenses (BCLs) placed during surgery. An office-based private practice and retrospective chart review. The healing parameters examined included epithelial healing time, haze formation, discomfort, and visual recovery of 4 patients (7 eyes) treated with besifloxacin 0.6% under BCLs placed after the PRK was performed. All the eyes had delayed epithelial closure (mean, 8.8 days; range 5-13 days). All the patients experienced a delayed visual recovery and significant pain after the surgery, and 2 of 4 patients experienced recurrent corneal erosions for weeks to months after they underwent the PRK. All but 1 eye developed corneal haze persisting for 1 year or more after the surgery. Only 1 eye among the 7 eyes treated with besifloxacin 0.6% under the BCL had 20/20 or better uncorrected visual acuity 3 months postoperatively. All the patients treated with besifloxacin 0.6% on the stromal bed exhibited significant problems with corneal epithelial healing and delayed visual recovery. We caution the use of besifloxacin 0.6% underneath a BCL during a PRK or other ocular surface surgeries requiring corneal epithelial debridement.

How relatives of patients with head and neck cancer experience pain, disease progression and treatment: a qualitative interview study.

PubMed

Schaller, Anne; Liedberg, Gunilla M; Larsson, Britt

2014-08-01

This study of relatives to patients with head and neck cancer (HNC) treated with radiotherapy describes how the relatives experienced the patient's situation, especially with respect to pain, and how the relatives themselves experienced the situation. Semi-structured interviews of 21 relatives to HNC patients who suffered from pain were conducted, and a qualitative content analysis was performed. The relatives experienced that the patients suffered from physical, psychological, and social pain. A dark picture consisting of lack of participation and knowledge, psychological distress, and lack of support were reported. Thus, a main category: relatives struggle with loved one's pains related to head and neck cancer treatment and with their own demanding situation - was based on the following four categories: inability to relieve and comprehend the physical suffering of the patients; overwhelming emotions were experienced that affect the patients and the relatives themselves; in need of support from the health care service; and altered daily activities and family roles due to illness and treatment. In patients physical, psychological, and social pain were prominent and in relatives psychological distress, lack of knowledge and support were experienced. Thus, to reduce pain and anxiety in patients and relatives, the health care professionals should provide relevant knowledge about pain management. The health care professionals should also provide educational interventions that address the psychological and social factors that impact pain for HNC patients and their relatives. Well-thought supporting care and easily accessible information about practical concerns should be offered to HNC patients and their relatives. Copyright © 2014 Elsevier Ltd. All rights reserved.

A comparison of pain experienced by patients treated with labial and lingual orthodontic appliances.

PubMed

Wu, Abby K Y; McGrath, Colman; Wong, Ricky W K; Wiechmann, D; Rabie, A Bakr M

2010-08-01

The aim of this prospective longitudinal study was to compare pain experiences among Chinese adult patients treated with labial and lingual orthodontic appliances. Sixty patients, 30 with labial appliances (18 females and 12 males, mean age 20.33 years, SD +/- 4.205) and 30 with lingual appliances (22 females and 8 males, mean age 21.63 years, SD +/- 2.236), rated their overall pain experience on a 100 mm visual analogue scale (VAS) at three time points: 1 week (T(1)), 1 month (T(2)), and 3 months (T(3)) after bracket placement. In addition, on a separate 100 mm VAS, they rated their pain experience at the locations of the tongue, lips, cheeks, gums, face, and jaw at T(1), T(2), and T(3). Changes in pain VAS were conducted using Friedman analysis of variance, area under the curve (AUC) analysis and the data were compared using a t-test. There was no significant difference in global ratings of pain among those treated with labial or lingual appliances (P > 0.05). Among both groups, global ratings of pain decreased over the study period (P < 0.001). Patients treated with lingual appliances reported higher ratings of tongue pain (P < 0.001), while those treated with labial appliances reported higher ratings of lip (P < 0.001) and cheek (P < 0.001) pain. The findings indicate that patients treated with labial and lingual appliances rate similarly the level of overall pain they experience during treatment. Ratings of overall pain experienced decreased for both treatment groups with time. However, ratings of pain differed at various sites with respect to the type of orthodontic appliance. These findings have implications in informing patients' treatment decision-making processes regarding labial and lingual appliances and in the management of discomfort associated with different treatment modalities.

Influence of Fractionation Scheme and Tumor Location on Toxicities After Stereotactic Body Radiation Therapy for Large (≥5 cm) Non-Small Cell Lung Cancer: A Multi-institutional Analysis

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

Verma, Vivek; Shostrom, Valerie K.; Zhen, Weining

Purpose: To describe the impact of fractionation scheme and tumor location on toxicities in stereotactic body radiation therapy (SBRT) for ≥5-cm non-small cell lung cancer (NSCLC), as part of a multi-institutional analysis. Methods: Patients with primary ≥5-cm N0 M0 NSCLC who underwent ≤5-fraction SBRT were examined across multiple high-volume SBRT centers. Collected data included clinical/treatment parameters; toxicities were prospectively assessed at each institution according to the Common Terminology Criteria for Adverse Events. Patients treated daily were compared with those treated every other day (QOD)/other nondaily regimens. Stratification between central and peripheral tumors was also performed. Results: Ninety-two patients from 12 institutionsmore » were evaluated (2004-2016), with median follow-up of 12 months. In total there were 23 (25%) and 6 (7%) grade ≥2 and grade ≥3 toxicities, respectively. Grades 2 and 3 pulmonary toxicities occurred in 9% and 4%, respectively; 1 patient treated daily experienced grade 5 radiation pneumonitis. Of the entire cohort, 46 patients underwent daily SBRT, and 46 received QOD (n=40)/other nondaily (n=6) regimens. Clinical/treatment parameters were similar between groups; the QOD/other group was more likely to receive 3-/4-fraction schemas. Patients treated QOD/other experienced significantly fewer grade ≥2 toxicities as compared with daily treatment (7% vs 43%, P<.001). Patients treated daily also had higher rates of grade ≥2 pulmonary toxicities (P=.014). Patients with peripheral tumors (n=66) were more likely to receive 3-/4-fraction regimens than those with central tumors (n=26). No significant differences in grade ≥2 toxicities were identified according to tumor location (P>.05). Conclusions: From this multi-institutional study, toxicity of SBRT for ≥5-cm lesions is acceptable, and daily treatment was associated with a higher rate of toxicities.« less

Influence of Fractionation Scheme and Tumor Location on Toxicities After Stereotactic Body Radiation Therapy for Large (≥5 cm) Non-Small Cell Lung Cancer: A Multi-institutional Analysis.

PubMed

Verma, Vivek; Shostrom, Valerie K; Zhen, Weining; Zhang, Mutian; Braunstein, Steve E; Holland, John; Hallemeier, Christopher L; Harkenrider, Matthew M; Iskhanian, Adrian; Jabbour, Salma K; Attia, Albert; Lee, Percy; Wang, Kyle; Decker, Roy H; McGarry, Ronald C; Simone, Charles B

2017-03-15

To describe the impact of fractionation scheme and tumor location on toxicities in stereotactic body radiation therapy (SBRT) for ≥5-cm non-small cell lung cancer (NSCLC), as part of a multi-institutional analysis. Patients with primary ≥5-cm N0 M0 NSCLC who underwent ≤5-fraction SBRT were examined across multiple high-volume SBRT centers. Collected data included clinical/treatment parameters; toxicities were prospectively assessed at each institution according to the Common Terminology Criteria for Adverse Events. Patients treated daily were compared with those treated every other day (QOD)/other nondaily regimens. Stratification between central and peripheral tumors was also performed. Ninety-two patients from 12 institutions were evaluated (2004-2016), with median follow-up of 12 months. In total there were 23 (25%) and 6 (7%) grade ≥2 and grade ≥3 toxicities, respectively. Grades 2 and 3 pulmonary toxicities occurred in 9% and 4%, respectively; 1 patient treated daily experienced grade 5 radiation pneumonitis. Of the entire cohort, 46 patients underwent daily SBRT, and 46 received QOD (n=40)/other nondaily (n=6) regimens. Clinical/treatment parameters were similar between groups; the QOD/other group was more likely to receive 3-/4-fraction schemas. Patients treated QOD/other experienced significantly fewer grade ≥2 toxicities as compared with daily treatment (7% vs 43%, P<.001). Patients treated daily also had higher rates of grade ≥2 pulmonary toxicities (P=.014). Patients with peripheral tumors (n=66) were more likely to receive 3-/4-fraction regimens than those with central tumors (n=26). No significant differences in grade ≥2 toxicities were identified according to tumor location (P>.05). From this multi-institutional study, toxicity of SBRT for ≥5-cm lesions is acceptable, and daily treatment was associated with a higher rate of toxicities. Copyright © 2016 Elsevier Inc. All rights reserved.

Updated efficacy and toxicity analysis of irinotecan and oxaliplatin (IROX) : intergroup trial N9741 in first-line treatment of metastatic colorectal cancer.

PubMed

Ashley, Amanda C; Sargent, Daniel J; Alberts, Steven R; Grothey, Axel; Campbell, Megan E; Morton, Roscoe F; Fuchs, Charles S; Ramanathan, Ramesh K; Williamson, Stephen K; Findlay, Brian P; Pitot, Henry C; Goldberg, Richard M

2007-08-01

Efficacy and toxicity of oxaliplatin (Eloxatin; Sanofi-Aventis, Paris, France) combined with irinotecan (IROX) were examined in 383 patients enrolled on the IROX arm of Intergroup Study N9741. This IROX regimen was oxaliplatin 85 mg/m(2) and irinotecan 200 mg/m(2) administered every 3 weeks. The relation between adverse events on IROX to selected characteristics was analyzed. Time to progression (TTP), response rate, and overall survival for patients treated with IROX compared with patients treated with oxaliplatin with 5- fluorouracil (FOLFOX) were updated in this article. Grade >or=3 gastrointestinal and hematologic toxicities were common with 39% patients experiencing neutropenia, 28% diarrhea, and 21% vomiting. Patients ages >70 years experienced higher rates of grade >or=3 toxicity, with significantly higher rates of grade >or=3 hematologic toxicities (P = .02). Long-term toxicity was uncommon, and nearly all cases of grade >or=3 neurotoxicity resolved within 10 months. Fifty-two percent of patients required dose reductions for adverse events, and 26% experienced 119 hospitalizations related to complications of treatment or their disease, with 5 treatment-related deaths. This analysis confirmed prior findings that FOLFOX is superior to IROX in terms of response rate (43% vs 36%, p = 0.002), TTP (9.2 months vs 6.7 months, P < .0001), and overall survival (19.5 months vs 17.3 months, P = .0001). IROX was found to be less active than FOLFOX but with a similar toxicity profile except in patients ages >70 years. Although IROX may be considered in patients intolerant of 5-FU or in patients known to have a dihydropyrimidine dehydrogenase (DPD) deficiency, it should be used with caution in older patients. (c) 2007 American Cancer Society.

Impact of the Bim Deletion Polymorphism on Survival Among Patients With Completely Resected Non-Small-Cell Lung Carcinoma.

PubMed

Atsumi, Jun; Shimizu, Kimihiro; Ohtaki, Yoichi; Kaira, Kyoichi; Kakegawa, Seiichi; Nagashima, Toshiteru; Enokida, Yasuaki; Nakazawa, Seshiru; Obayashi, Kai; Takase, Yoshiaki; Kawashima, Osamu; Kamiyoshihara, Mitsuhiro; Sugano, Masayuki; Ibe, Takashi; Igai, Hitoshi; Takeyoshi, Izumi

2016-02-01

A deletion polymorphism of the Bim gene has been reported to be a prognostic factor for patients with non-small-cell lung cancer (NSCLC) treated with epidermal growth factor receptor-tyrosine kinase inhibitors in the Asian population. We investigated the impact of the Bim deletion polymorphism on survival among patients with completely resected NSCLC. The Bim polymorphism was detected by polymerase chain reaction analysis. We measured overall survival (OS) and recurrence-free survival rates in 411 patients and postrecurrence survival (PRS) in 94 patients who experienced recurrence and received additional anticancer therapy. The Bim deletion polymorphism was detected in 61 patients (14.8%). OS rates were significantly lower for patients with the Bim deletion polymorphism than for those with the wild-type sequence. On multivariable analysis, the Bim deletion polymorphism was identified as an independent prognostic factor for OS (hazard ratio, 1.98; 95% CI, 1.17 to 3.36; P = .011). Among the 94 patients who experienced recurrence and were treated with anticancer therapy, patients with the Bim deletion polymorphism showed significantly poorer PRS than those with the wild-type sequence (median, 9.8 months v 26.9 months, respectively; P < .001). Multivariable analysis revealed that the Bim deletion polymorphism was an independent predictor of PRS (hazard ratio, 3.36; 95% CI, 1.75 to 6.47; P < .001). This trend remained apparent in subgroup analyses stratified by EGFR status, histology, and therapeutic modality. The Bim deletion polymorphism is a novel indicator of shortened PRS among patients with recurrent NSCLC treated with anticancer therapy in the Asian population.

Embolization techniques for high-flow arteriovenous malformations with a dominant outflow vein.

PubMed

Conway, Allan M; Qato, Khalil; Drury, Jennifer; Rosen, Robert J

2015-04-01

The aim of this study was to assess the management and outcomes of arteriovenous malformations (AVMs) with a dominant outflow vein (DOV) treated with retrograde venous embolization. A retrospective review was performed from November 2010 to May 2014 on all patients with a high-flow AVM and associated DOV who underwent transvenous embolization of the DOV. Indications, techniques, complications, and outcomes were reviewed. Fourteen patients (five male; 36%) underwent transvenous embolization of high-flow AVMs with a DOV. Median age was 41.6 years (15.7-65.8 years). The AVM was located on an extremity in eight patients (57%) and in the pelvis in six patients (43%). The indication for the procedure was pain in 11 patients (79%), swelling in 3 patients (21%), a nonhealing wound in 1 patient (7%), and impotence in 1 patient (7%). The median number of prior procedures to treat the AVM was 2.5 (0-13). Transvenous embolization with coils was performed in 13 patients (93%). The Amplatzer vascular plug and Amplatzer septal occluder (St. Jude Medical, St. Paul, Minn) were used in four patients (29%). Concurrent percutaneous puncture embolization of the AVM nidus was used in seven patients (50%) and transcatheter arterial embolization in eight patients (57%). Technical angiographic success was seen in all patients. Five patients (36%) experienced a complete response to treatment, whereas eight (57%) experienced a partial response. Seven patients (50%) required further procedures for residual symptoms. AVMs with a DOV can be successfully treated by a transvenous approach. Percutaneous puncture embolization of the nidus or draining vein and transcatheter arterial embolization may assist in reducing flow. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Treatment of testicular hydrocele with tetracycline sclerotherapy.

PubMed

Ozkan, S; Bircan, K; Ozen, H

1990-01-01

Fifteen patients with primary hydrocele of the testis were treated by aspiration and injection of tetracycline. Only 5 patients (33.3%) were cured by a single injection of tetracycline. Furthermore, 46.6% of our patients experienced severe scrotal pain, three of whom required open surgery. We do not recommend single injection tetracycline therapy, and further injections were not performed due to severe side effects.

A retrospective analysis of the impact of treatments and blood counts on survival and the risk of vascular events during the course of polycythaemia vera.

PubMed

Enblom-Larsson, Anneli; Girodon, Francois; Bak, Marie; Hersby, Ditte; Jooste, Valérie; Hasselbalch, Hans; Johansson, Peter; Andreasson, Björn

2017-06-01

Vascular and non-vascular complications are common in patients with polycythaemia vera. This retrospective study of 217 patients with polycythaemia vera aimed to determine whether blood counts with respect to different treatments influenced the complication rate and survival. We found that 78 (36%) patients suffered from at least one complication during follow-up. Older age and elevated lactate dehydrogenase at diagnosis were found to be risk factors for vascular complications. When the vascular complication occurred, 41% of the patients with a complication had elevated white blood cells (WBC) compared with 20% of patients without a complication (P = 0·042). Patients treated with hydroxycarbamide (HC; also termed hydroxyurea) experienced significantly fewer vascular complications (11%) than patients treated with phlebotomy only (27%) (P = 0·013). We also found a survival advantage for patients treated with HC, when adjusted for age, gender and time period of diagnosis (Hazard ratio for phlebotomy-treated patients compared to HC-treated patients at 5 years was 2·42, 95% confidence interval 1·03-5·72, P = 0·043). Concerning survival and vascular complications, HC-treated patients who needed at least one phlebotomy per year were not significantly different from HC-treated patients with a low phlebotomy requirement. We conclude that complementary phlebotomy in HC-treated patients in order to maintain the haematocrit, is safe. © 2017 John Wiley & Sons Ltd.

Outcomes of malignant tumors of the lacrimal apparatus: the University of Texas MD Anderson Cancer Center experience.

PubMed

Skinner, Heath D; Garden, Adam S; Rosenthal, David I; Ang, K Kian; Morrison, William H; Esmaeli, Bita; Pinnix, Chelsea C; Frank, Steven J

2011-06-15

Malignant epithelial neoplasms of the lacrimal apparatus are rare and are typically treated with surgery and occasionally adjuvant radiation therapy (RT). The purpose of this study was to assess treatment outcomes by type of surgery (orbital exenteration vs eye-sparing surgery) and clarify the role of adjuvant RT for this rare disease. Forty-six patients with malignant epithelial neoplasms of the lacrimal apparatus were treated at a single institution from 1945 through 2008. Twenty-seven patients (59%) were treated with orbital exenteration and 19 (41%) with eye-sparing surgery; 64% of the orbital exenteration group and 83% of the eye-sparing surgery group also received adjuvant RT (median dose, 60 grays). Median follow-up time for all patients was 38 months (range, 3-460 months). For the orbital exenteration and eye-sparing surgery groups, the 5-year overall survival (OS) rates were 59% and 62%, and the 5-year disease-free survival (DFS) rates were 49% and 39%, respectively (P = .56, P = .35). Tumor status (T1-2 vs T3-4) was associated with OS (P = .02), and tumor size (<3.5 vs >3.5 cm) with DFS (P = .015). Median time to locoregional recurrence was 85 months for orbital exenteration, and 123 months for eye-sparing surgery. All patients who did not receive RT experienced local recurrence, and RT extended time to locoregional recurrence (median 460 vs 30 months, P = .009). Seven grade ≥3 complications were experienced after adjuvant RT. For appropriately selected patients, an eye-sparing surgery for lacrimal apparatus tumors can achieve similar survival outcomes to those in patients treated with an orbital exenteration. Adjuvant RT should be considered for all patients presenting with these rare tumors. Copyright © 2011 American Cancer Society.

Rituximab-Related Late-Onset Neutropenia in Kidney Transplant Recipients Treated for Antibody-Mediated Acute Rejection.

PubMed

Ahmadi, Fatemeh; Dashti-Khavidaki, Simin; Khatami, Mohammad-Reza; Lessan-Pezeshki, Mahboob; Khalili, Hossein; Khosravi, Malihe

2017-08-01

Kidney transplant is a new area for use of rituximab, which is being used to treat acute antibody-mediated rejection or as an induction agent in ABO- or HLA-incompatible grafts. We report on late-onset neutropenia in rituximab-treated kidney transplant recipients with antibody-mediated rejection. This observational prospective study was performed on kidney transplant recipients with clinically suspicious or biopsy-proven antibody-mediated rejection treated with plasmapheresis plus intravenous immunoglobulin with (cases) or without (controls) rituximab. Compared with none of the controls, 4 of 6 patients (66.7%) in the rituximab-treated group experienced late-onset neutropenia 35 to 93 days after the last dose of rituximab. The course of neutropenia was complicated by endocarditis in 1 patient, resulting in his death just because of a lack of valvular surgery. Increased use of rituximab to treat antibody-mediated rejection among kidney transplant recipients requires attention to its late-onset adverse event, neutropenia. Although asymptomatic in some patients, kidney transplant recipients treated concomitantly with plasmapheresis and mycophenolate mofetil are predisposed to hypogammaglobulinemia, and monitoring of patients for infections is required.

Improvement of psoriatic arthritis in a patient treated with bromocriptine for hyperprolactinemia.

PubMed

Buskila, D; Sukenik, S; Holcberg, G; Horowitz, J

1991-04-01

We describe a woman with psoriatic arthritis who experienced a remarkable improvement of her skin and joint disease while only taking bromocriptine therapy. She was treated with bromocriptine for primary infertility due to hyperprolactinemia. The improvement in joint symptoms appeared to parallel that of the skin. More studies are required to determine the reproducibility of this observation.

Apipuncture treatment for central post-stroke pain.

PubMed

Yun, Sang Pil; Sun, Bong Chul

2010-02-01

The objective of this study was to assess the effectiveness of apipuncture treatment for central post-stroke pain. Two (2) female subjects with central post-stroke pain were treated with apipuncture. Both patients experienced a reduction in the intensity of pain after receiving apipuncture treatment without adverse effects. Apipuncture is an effective and safe intervention to treat central post-stroke pain.

Low-dose rate prostate brachytherapy is well tolerated in patients with a history of inflammatory bowel disease

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

Peters, Christopher A.; Cesaretti, Jamie A.; Stone, Nelson N.

2006-10-01

Purpose: We report on the follow-up of 24 patients with a prior history of inflammatory bowel disease (IBD) treated with brachytherapy for early-stage prostate cancer. Methods and Materials: Twenty-four patients with a history of inflammatory bowel disease (17 with ulcerative colitis (UC), 7 with Crohn's disease [CD]) underwent prostate brachytherapy between 1992 and 2004. Fifteen patients were treated with I-125 implantation and 6 patients were treated with Pd-103 alone or in combination with 45 Gy external beam radiation. Charts were reviewed for all patients, and all living patients were contacted by phone. National Cancer Institute common toxicity scores for proctitismore » were assigned to all patients. Actuarial risk of late toxicity was calculated by the Kaplan-Meier method. Statistical analysis was performed using SPSS software. Follow-up ranged from 3 to 126 months (median, 48.5 months; mean, 56.8 months). Results: None of the patients experienced Grade 3 or 4 rectal toxicity. Four patients experienced Grade 2 late rectal toxicity. The 5-year actuarial freedom from developing late Grade 2 rectal toxicity was 81%. At a median follow-up of 48.5 months, 23 patients were alive and had no evidence of disease with a median prostate-specific antigen for the sample of 0.1 ng/mL (range, <0.05-0.88 ng/mL). One patient died of other causes unrelated to his prostate cancer. Conclusions: Prostate brachytherapy is well tolerated in patients with a history of controlled IBD. Therefore, brachytherapy should be considered a viable therapeutic option in this patient population.« less

Clinician burnout and satisfaction with resources in caring for complex patients.

PubMed

Whitebird, Robin R; Solberg, Leif I; Crain, A Lauren; Rossom, Rebecca C; Beck, Arne; Neely, Claire; Dreskin, Mark; Coleman, Karen J

To describe primary care clinicians' self-reported satisfaction, burnout and barriers for treating complex patients. We conducted a survey of 1554 primary care clinicians in 172 primary care clinics in 18 health care systems across 8 states prior to the implementation of a collaborative model of care for patients with depression and diabetes and/or cardiovascular disease. Of the clinicians who responded to the survey (n=709; 46%), we found that a substantial minority (31%) were experiencing burnout that was associated with lower career satisfaction (P<.0001) and lower satisfaction with resources to treat complex patients (P<.0001). Less than 50% of clinicians rated their ability to treat complex patients as very good to excellent with 21% rating their ability as fair to poor. The majority of clinicians (72%) thought that a collaborative model of care would be very helpful for treating complex patients. Burnout remains a problem for primary care clinicians and is associated with low job satisfaction and low satisfaction with resources to treat complex patients. A collaborative care model for patients with mental and physical health problems may provide the resources needed to improve the quality of care for these patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Ruptured intracranial aneurysms: the outcome of surgical treatment in experienced hands in the period prior to the advent of endovascular coiling

PubMed Central

Lafuente, J; Maurice-Williams, R

2003-01-01

Objectives: To evaluate the results of treatment of patients with a ruptured intracranial aneurysm treated by a single experienced vascular neurosurgeon in the period prior to the introduction of endovascular coiling. Methods: Over a mean (SD) period of 9 (2) years, between January 1990 and June 1999, 245 consecutive patients with ruptured intracranial aneurysms were treated. Patients' details were obtained from a database that had been constructed prospectively. The patients consisted of all those patients treated by the senior author (Mr Maurice-Williams) over this period—that is, every third day on call at his unit. During this period, all patients under the age of 75 years with a diagnosis of subarachnoid haemorrhage were admitted to the neurosurgical unit as soon as was practicable regardless of clinical grade. Results: Of 245 patients, 190 (77.6%) underwent treatment by open surgery using standard microsurgical techniques. At 1 year, the mortality of the operated patients was 2.6%, while 89.5% of the patients had a Glasgow Outcome Score (GOS) of 4 and 5. The overall management outcome (all patients treated, including operated and non-operated cases) at 1 year was: 17.1 % dead while 74.3% had GOS 4 and 5. Of the 190 patients who underwent surgery, 38 (20%) required additional operations, totalling 72 operations in all. Of these, 32 were for hydrocephalus and 17 for the evacuation of intracranial haematomas/collections. Complications of surgery occurred in 56 patients (29.5%). Conclusion: Open surgery, despite good eventual results, is associated with a significant rate of re-operations and complications that would probably be largely avoided with endovascular treatment. Nevertheless, although endovascular coiling has these immediate advantages over surgery it is still not certain that the long term results will be superior to surgery which leads to permanent obliteration of the aneurysm. There may still be a need for open surgery in the future. PMID:14638889

EURO-B.O.S.S.: A European study on chemotherapy in bone-sarcoma patients aged over 40: Outcome in primary high-grade osteosarcoma.

PubMed

Ferrari, Stefano; Bielack, Stefan S; Smeland, Sigbjørn; Longhi, Alessandra; Egerer, Gerlinde; Sundby Hall, Kirsten; Donati, Davide; Kevric, Matthias; Brosjö, Otte; Comandone, Alessandro; Werner, Mathias; Monge, Odd; Palmerini, Emanuela; Berdel, Wolfgang E; Bjerkehagen, Bodil; Paioli, Anna; Lorenzen, Sylvie; Eriksson, Mikael; Gambarotti, Marco; Tunn, Per-Ulf; Jebsen, Nina L; Cesari, Marilena; von Kalle, Thekla; Ferraresi, Virginia; Schwarz, Rudolf; Bertulli, Rossella; Kasparek, Anne-Katrin; Grignani, Giovanni; Krasniqi, Fatime; Sorg, Benjamin; Hecker-Nolting, Stefanie; Picci, Piero; Reichardt, Peter

2018-01-01

The EUROpean Bone Over 40 Sarcoma Study (EURO-B.O.S.S.) was the first prospective international study for patients 41-65 years old with high-grade bone sarcoma treated with an intensive chemotherapy regimen derived from protocols for younger patients with high-grade skeletal osteosarcoma. Chemotherapy based on doxorubicin, cisplatin, ifosfamide, and methotrexate was suggested, but patients treated with other regimens at the investigators' choice were also eligible for the study. The present report focuses on the subgroup of 218 patients with primary high-grade osteosarcoma. With a median follow-up of 47 months, the 5-year probability of overall survival (OS) was 66% in patients with localized disease and 22% in case of synchronous metastases. The 5-year OS in patients with localized disease was 29% in pelvic tumors, and 70% and 73% for extremity or craniofacial locations, respectively. In primary chemotherapy, tumor necrosis ≥90% was reported in 21% of the patients. There were no toxic deaths; however, hematological toxicity was considerable with 32% of patients experiencing 1 or more episodes of neutropenic fever. The incidence of nephrotoxicity and neurotoxicity (mainly peripheral) was 28% and 24%, respectively. After methotrexate, 23% of patients experienced delayed excretion, in 4 cases with nephrotoxicity. In patients over 40 years of age with primary high-grade osteosarcoma, an aggressive approach with chemotherapy and surgery can offer the probability of survival similar to that achieved in younger patients. Chemotherapy-related toxicity is significant and generally higher than that reported in younger cohorts of osteosarcoma patients treated with more intensive regimens.

Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection.

PubMed

Foster, Graham R; Pianko, Stephen; Brown, Ashley; Forton, Daniel; Nahass, Ronald G; George, Jacob; Barnes, Eleanor; Brainard, Diana M; Massetto, Benedetta; Lin, Ming; Han, Bin; McHutchison, John G; Subramanian, G Mani; Cooper, Curtis; Agarwal, Kosh

2015-11-01

We conducted an open-label, randomized, phase 3 trial to determine the efficacy and safety of sofosbuvir and ribavirin, with and without peginterferon-alfa, in treatment-experienced patients with cirrhosis and hepatitis C virus (HCV) genotype 2 infection and treatment-naïve or treatment-experienced patients with HCV genotype 3 infection. The study was conducted at 80 sites in Europe, North America, Australia, and New Zealand Patients were randomly assigned (1:1:1) to groups given sofosbuvir and ribavirin for 16 weeks (n = 196); sofosbuvir and ribavirin for 24 weeks (n = 199); or sofosbuvir, peginterferon-alfa, and ribavirin for 12 weeks (n = 197). The primary end point was the percentage of patients with HCV RNA <15 IU/mL 12 weeks after stopping therapy (sustained virologic response [SVR12]). From October 2013 until April 2014, we enrolled and treated 592 patients-48 with genotype 2 HCV and compensated cirrhosis who had not achieved SVR with previous treatments and 544 with genotype 3 HCV (279 treatment-naïve and 265 previously treated). Overall, 219 patients (37%) had compensated cirrhosis. The last post-treatment week 12 patient visit was in January 2015. Rates of SVR12 among patients with genotype 2 HCV were 87% and 100%, for those receiving 16 and 24 weeks of sofosbuvir and ribavirin, respectively, and 94% for those receiving sofosbuvir, peginterferon, and ribavirin for 12 weeks. Rates of SVR12 among patients with genotype 3 HCV were 71% and 84% in those receiving 16 and 24 weeks of sofosbuvir and ribavirin, respectively, and 93% in those receiving sofosbuvir, peginterferon, and ribavirin. On-treatment virologic failure occurred in 3 patients with HCV genotype 3a receiving sofosbuvir and ribavirin for 24 weeks. The most common adverse events were fatigue, headache, insomnia, and nausea. Overall, 1% of patients discontinued treatment due to adverse events. Among patients with genotype 3 HCV infection, including a large proportion of treatment-experienced patients with cirrhosis, the combination of sofosbuvir, peginterferon, and ribavirin for 12 weeks produces high rates of SVR. Treatment-experienced patients with cirrhosis and genotype 2 HCV infection had high rates of SVR in all groups. EudraCT ID 2013-002641-11. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Unintentional parathyroidectomy and postoperative hypocalcaemia. Conventional thyroidectomy versus miniinvasive thyroidectomy.

PubMed

Del Rio, Paolo; De Simone, Belinda; Viani, Lorenzo; Arcuri, Maria Francesca; Sianesi, Mario

2014-01-01

Hypocalcemia and unintentional parathyroidectomy would be associated as cause of post-thyroidectomy hypocalcemia. We analysed the cases treated with total thyroidectomy by two experienced endocrine surgeons from January 2010 to December 2011 at the Unit of General Surgery and Organ Transplantation of the University Hospital of Parma. These cases were divided in two groups: "Group A" included patients for whom a histological report was made that was negative for a parathyroid avulsion, and "Group B" included patients for whom an inadvertent avulsion of the intracapsular parathyroid glands had occurred. In total, 538 patients were treated with a total thyroidectomy from January 2010 to December 2011. In 26 cases, the histological report highlighted the presence of an intracapsular parathyroid gland. The values of pre-operative calcaemia in group A and group B were 9.204 ± 0.2703 mg/dl versus 9.283 ± 0.401 mg/dl, respectively (p=0.32). The values of post-operative calcaemia were 8.039 ± 0.596 mg/dl for group A versus 7.569 ± 0.618 mg/dl for group B (p=0.0002) In Group A, 91/512 patients were treated with the minimally invasive video-assisted thyroidectomy (MIVAT) technique (17,7%), while 1/26 patients in group B was treated with a MIVAT (3,8%). Unintentional parathyroidectomies can occur with experienced surgeons, but this complication is not related to a substantial difference in the incidence of hypocalcemia. MIVAT can helps the endocrine surgeon in the detection of the parathyroids glands, but when the parathyroid is intracapsular, is difficult to preserve it, during surgical dissection.

Treatment of mycosis fungoides with topical nitrosourea compounds: Further studies.

PubMed

Zackheim, H S; Epstein, E H

1975-12-01

Twenty-six patients with mycosis fungoides were treated topically with three nitrosourea compounds: carmustine (BCNU), lomustine (CCNU), and 1-methyl-1-nitrosourea. A high percentage experienced good to excellent results. Remissions following treatment of individual lesions varied from one month to at least three years. Remissions following total body surface treatment varied from two weeks to at least four months. Two of 13 patients treated over the entire body suffered temporary bone marrow depression, indluding one with severe pancytopenia. This toxic effect was attributed to lomustine and was not seen in patients treated with carmustine alone. Thirteen patients highly allergic to mechlorethamine hydrochloride showed no cross-sensitivity to nitrosourea compounds. A primary irritant dermatitis occurred in about one half of the patients and telangiectasia in two. Two patients developed hypersensitivity to nitrosourea compounds. Carmustine is the preferred nitrosourea compound for topical therapy of mycosis fungoides.

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.

Effect of a plaster containing DHEP and heparin in acute ankle sprains with oedema: a randomized, double-blind, placebo-controlled, clinical study.

PubMed

Coudreuse, J-M; de Vathaire, F

2010-09-01

Ankle sprains are the most frequent injuries in sport and daily life, and are usually treated with anti-inflammatory drugs or compounds that have an effect on microcirculation. The efficacy and tolerability of a novel plaster containing both diclofenac epolamine (DHEP) and heparin in the treatment of acute painful ankle sprains with oedema was investigated in a randomized, double-blind, placebo-controlled study. This study, carried out in 32 French medical centres, enrolled 233 patients (148 male and 86 female, aged 18-65 years) with an ankle sprain that had occurred within the previous 48 hours. Patients were treated once daily with DHEP heparin or placebo plaster for 7 days. Reduction in ankle joint swelling measured by submalleolar circumference was the primary efficacy endpoint; secondary endpoints were pain (at rest, in active mobilization, by passive stretch and by pressure), functional disability and global judgement of efficacy and tolerability. DHEP heparin-treated patients experienced a significantly greater reduction in joint swelling compared with placebo (p = 0.005). The reduction in pain was also in favour of DHEP heparin patients, with significantly lower pain in DHEP heparin-treated than placebo-treated patients within 3 hours of the first application (p < 0.05). Only two patients in the DHEP heparin plaster group and six in the placebo group experienced minor adverse events, all of which resolved spontaneously. By design, the study was limited to a placebo-controlled comparison, and there was no test for possible selection bias (subsequently ruled out by choice of efficacy parameters and measures) that may have resulted in a baseline imbalance between patient groups. Results confirm the efficacy of DHEP heparin plaster compared with placebo for the treatment of painful ankle sprain with oedema. Prompt control of pain and oedema may shorten the time to initiation of a rehabilitation programme, thus reducing the risk of ankle disability recurrence and the development of chronic injury.

Primary Ewing's sarcoma of the sinonasal tract in adults: A challenging disease.

PubMed

Lombardi, Davide; Mattavelli, Davide; Redaelli De Zinis, Luca O; Accorona, Remo; Morassi, Maria L; Facchetti, Fabio; Ferrari, Vittorio; Farina, Davide; Bertulli, Rossella; Nicolai, Piero

2017-03-01

Sinonasal localization of Ewing's sarcoma in adults is an exceedingly rare event. The clinical records of 5 patients with primary sinonasal Ewing's sarcoma treated from 1992 to 2012 were retrospectively analyzed. All pathologic slides were reviewed by 2 experienced pathologists. All patients underwent multimodality treatments. Median age was 36 years (range, 25-52 years). At referral, 2 patients had the original diagnosis changed by review of the histologic slides. Tumors were classified as T4aN0M0 (4 patients) and T2N0M0 (1 patient). Median follow-up was 110 months (range, 70-139 months). Only 1 patient, who started treatment elsewhere based on an incorrect histologic diagnosis, experienced multiple recurrences and eventually died of widespread metastasis. Correct pathologic diagnosis can have a crucial impact on treatment planning and outcome. Multimodality therapy is the key for long-term successful results. Because of the rarity of the tumor, referral to highly experienced care centers is strongly recommended. © 2016 Wiley Periodicals, Inc. Head Neck 39: E45-E50, 2017. © 2016 Wiley Periodicals, Inc.

Alectinib salvages CNS relapses in ALK-positive lung cancer patients previously treated with crizotinib and ceritinib.

PubMed

Gainor, Justin F; Sherman, Carol A; Willoughby, Kathryn; Logan, Jennifer; Kennedy, Elizabeth; Brastianos, Priscilla K; Chi, Andrew S; Shaw, Alice T

2015-02-01

Leptomeningeal metastases (LM) are an increasingly frequent and devastating complication of anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC). Currently, the optimal management of LM in ALK-positive patients remains poorly understood as these patients have been routinely excluded from clinical trials. We describe four ALK-positive patients with LM who were treated with the next-generation ALK inhibitor alectinib through single-patient, compassionate use protocols at two institutions. All patients had previously been treated with both FDA-approved ALK inhibitors--crizotinib and ceritinib. Patients received alectinib at a starting dose of 600 mg twice daily. Four ALK-positive NSCLC patients with symptomatic leptomeningeal disease were identified. Three of four patients experienced significant clinical and radiographic improvements in LM upon treatment with alectinib. A fourth patient had stable intracranial disease for 4 months before eventual systemic disease progression. Overall, alectinib was well tolerated. One patient required dose reduction due to grade 2 hyperbilirubinemia. Alectinib is active in ALK-rearranged NSCLC patients with LM, including in patients previously treated with crizotinib and ceritinib. Additional prospective studies of alectinib in ALK-positive patients with LM are warranted.

Alectinib Salvages CNS Relapses in ALK-Positive Lung Cancer Patients Previously Treated with Crizotinib and Ceritinib

PubMed Central

Gainor, Justin F.; Sherman, Carol A.; Willoughby, Kathryn; Logan, Jennifer; Kennedy, Elizabeth; Brastianos, Priscilla K.; Chi, Andrew S.; Shaw, Alice T.

2014-01-01

Background Leptomeningeal metastases (LM) are an increasingly frequent and devastating complication of anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC). Currently, the optimal management of LM in ALK-positive patients remains poorly understood as these patients have been routinely excluded from clinical trials. Methods We describe four ALK-positive patients with LM who were treated with the next-generation ALK inhibitor alectinib through single-patient, compassionate use protocols at two institutions. All patients had previously been treated with both FDA-approved ALK inhibitors—crizotinib and ceritinib. Patients received alectinib at a starting dose of 600 mg twice daily. Results Four ALK-positive NSCLC patients with symptomatic leptomeningeal disease were identified. Three of four patients experienced significant clinical and radiographic improvements in LM upon treatment with alectinib. A fourth patient had stable intracranial disease for four months before eventual systemic disease progression. Overall, alectinib was well tolerated. One patient required dose reduction due to grade 2 hyperbilirubinemia. Conclusions Alectinib is active in ALK-rearranged NSCLC patients with LM, including in patients previously treated with crizotinib and ceritinib. Additional prospective studies of alectinib in ALK-positive patients with LM are warranted. PMID:25526238

Predictors for Mild and Severe Hypoglycemia in Insulin-Treated Japanese Diabetic Patients.

PubMed

Sonoda, Nao; Morimoto, Akiko; Ugi, Satoshi; Morino, Katsutaro; Sekine, Osamu; Nemoto, Ken-Ichi; Godai, Kayo; Maegawa, Hiroshi; Miyamatsu, Naomi

2015-01-01

The objective of this study was to explore predictors, including social factors, lifestyle factors, and factors relevant to glycemic control and treatment, for mild and severe hypoglycemia in insulin-treated Japanese diabetic patients. This study included 123 insulin-treated diabetic patients who were referred to the diabetes clinic between January and July 2013 at Shiga University of Medical Science Hospital. After a survey examining the various factors, patients were followed for 6 months. During the follow-up period, blood glucose was self-monitored. Mild hypoglycemia was defined as blood glucose level 50-69 mg/dl, and severe hypoglycemia was defined as blood glucose level ≤49 mg/dl. Multinomial logistic regression was used to estimate the adjusted odds ratio (OR) and 95% confidence interval (CI) of each factor for mild and severe hypoglycemia. During the 6-month follow-up period, 41 (33.3%) patients experienced mild hypoglycemia, and 20 (16.3%) experienced severe hypoglycemia. In multivariable-adjusted analyses, assistance from family members at the time of the insulin injection [presence/absence, OR (95% CI): 0.39 (0.16-0.97)] and drinking [current drinker/non- and ex-drinker, OR (95% CI): 4.89 (1.68-14.25)] affected mild hypoglycemia. Assistance from family members at the time of insulin injection [presence/absence, OR (95% CI): 0.19 (0.05-0.75)] and intensive insulin therapy [yes/no, OR (95% CI): 3.61 (1.06-12.26)] affected severe hypoglycemia. In conclusion, our findings suggest that not only a factor relevant to glycemic control and treatment (intensive insulin therapy) but also a social factor (assistance from family members) and a lifestyle factor (current drinking) were predictors for mild or severe hypoglycemia in Japanese insulin-treated diabetic patients.

Effectiveness of clinical pathways for total knee and total hip arthroplasty: literature review.

PubMed

Kim, Stephen; Losina, Elena; Solomon, Daniel H; Wright, John; Katz, Jeffrey N

2003-01-01

Although many hospitals have implemented clinical pathways to standardize the process of care, the effectiveness of clinical pathways for total hip and knee arthroplasties has not been reviewed critically. We searched for articles comparing outcomes of total hip or knee arthroplasty for patients who were treated using clinical pathways as opposed to patients treated without these pathways. Eleven studies met criteria for inclusion. Ten used historical controls, and 1 was a randomized trial. The studies had important methodological limitations. In general, the articles showed that patients treated using pathways experienced shorter hospital stays and lower costs, with comparable clinical outcomes as compared with patients treated without clinical pathways. We concluded that clinical pathways appear successful in reducing costs and length of stay in the acute care hospital, with no compromise in patient outcomes. However, interpretation of these studies is complicated by substantial methodological limitations, particularly the use of historical controls and failure to account for length of stay in rehabilitation facilities. Copyright 2003, Elsevier Science (USA). All rights reserved.

Stereotactic body radiotherapy for second primary lung cancer and intra-parenchymal lung metastasis in patients previously treated with surgery: evaluation of indications and predictors of decreased respiratory function.

PubMed

Ishihara, Takeaki; Yamada, Kazunari; Harada, Aya; Yukiue, Haruhiro; Tanahashi, Masayuki; Niwa, Hiroshi; Matsui, Takashi; Yokomura, Koshi; Ejima, Yasuo; Sasaki, Ryohei

2018-05-03

The adaptation criteria for administration of stereotactic body radiotherapy (SBRT) to patients with lung cancer who previously underwent surgery and subsequently developed a second primary lung cancer (SPLC) or intra-parenchymal lung metastasis (IPLM) are controversial, unlike the criteria for repeat surgery. We aimed to evaluate the feasibility of SBRT for these patients. Factors associated with decreased respiratory function were also evaluated. Sixty-nine patients with 89 lesions who underwent SBRT between 2008 and 2017 were analyzed. Of these, 29 were diagnosed with SPLC while the remaining 40 had IPLM. The distribution of histological types was as follows: squamous cell carcinoma (n = 13 lesions); adenocarcinoma (n = 25); non-small cell carcinoma (n = 1); unknown histological type (n = 49). The prescribed doses to the planning target volume (PTV) were 50 Gy in five fractions for 85 lesions and 60 Gy in 10 fractions for four lesions at PTV mean. Over a median follow-up period of 55 months, the 4-year overall survival and local control rates were 50.3% and 87.6%, respectively. Six patients experienced grade 2 radiation pneumonitis and one experienced grade 3. Two patients experienced grade 5 pulmonary fibrosis. Decreased respiratory function was observed in 10 patients (15.1%). On multivariate analysis, the presence of pulmonary disease before SBRT was the only statistically significant factor associated with decreased respiratory function. SBRT is safe and feasible in patients with SPLC or IPLM previously treated surgically. Pre-existing pulmonary disease was a predictive factor for decreased respiratory function.

Topical brinzolamide for foveal schisis in juvenile retinoschisis.

PubMed

Yang, Francine P; Willyasti, Katharina; Leo, Seo Wei

2013-04-01

We describe a case series of 4 consecutive patients diagnosed with X-linked retinoschisis seen at a pediatric ophthalmology clinic during a 3-year period. All patients were treated with topical brinzolamide; 3 patients experienced significantly decreased severity of macular cysts on OCT in at least one eye. Copyright © 2013 American Association for Pediatric Ophthalmology and Strabismus. Published by Mosby, Inc. All rights reserved.

The clinical application of laparoscope-assisted peritoneal vaginoplasty for the treatment of congenital absence of vagina.

PubMed

Qin, Chenglu; Luo, Guangnan; Du, Min; Liao, Shi; Wang, Chunping; Xu, Keke; Tang, Jie; Li, Baoyan; Zhang, Juanjuan; Pan, Hongxin; Ball, Tyler W; Fang, Yujiang

2016-06-01

To evaluate the outcomes of laparoscope-assisted peritoneal vaginoplasty for the treatment of congenital vaginal atresia. A retrospective study enrolled patients diagnosed with congenital vaginal atresia who were treated with one of two different laparoscope-assisted peritoneal vaginoplasty techniques (named Luohu-one and Luohu-two) between October 31, 2001 and December 31, 2014. Operative time, intraoperative bleeding volume, surgical difficulty, complications, and post-procedure sexual satisfaction were reported. Data were collected for 620 patients. The Luohu-one procedure was used in the treatment of 145 patients, while 475 patients were treated with the Luohu-two procedure. In 5 (0.8%) patients, it was necessary to perform a sigmoid colon vaginoplasty. During surgery, 16 patients experienced a rectal injury, among whom, 9 patients experienced a rectal-vaginal fistula. Follow-up data extending to 7years were available for 285 patients. Of these 285 patients, 231 agreed to report details of their sexual experiences. In total, 222 (96.1%) patients reported being very satisfied with their vaginal conditions and sex life. The Luohu-two procedure demonstrated shorter operative and recovery time, and reduced intraoperative bleeding. However, both procedures demonstrated satisfactory results. Laparoscope-assisted peritoneal vaginoplasty demonstrated good safety and effectiveness in the treatment of patients with congenital vaginal atresia. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Olanzapine versus Placebo in Adolescents with Schizophrenia; a 6-Week, Randomized Double-Blind, Placebo-Controlled Trial

ERIC Educational Resources Information Center

Kryzhanovskaya, Ludmila; Schulz, Charles; McDougle, Christopher; Frazier, Jean; Dittman, Ralf; Robertson-Plouch, Carol; Bauer, Theresa; Xu, Wen; Wang, Wei; Carlson, Janice; Tohen, Mauricio

2009-01-01

The efficacy of olanzapine in treating schizophrenia was tested through a placebo-controlled trial involving one hundred seven inpatient and outpatients adolescents. Patients who took olanzapine experienced significant symptom improvement.

Accidental Overdose Intoxication: A Hazard of Drug Smuggling

PubMed Central

Arora, Sudhir; Tafreshi, Michael; Sobo, Steven; Krochmal, Paul; Alexander, Leslie L.

1982-01-01

Three patients involved in illicit drug smuggling via the swallowing of high dose, high purity drugs packed in multiple condoms are reported. Two of these patients experienced drug overdose symptoms due to leakage or rupture of the condoms in the GI tract. They were treated successfully. ImagesFigure 1Figure 2Figure 3Figure 4 PMID:7120497

Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis.

PubMed

Muir, Andrew J; Poordad, Fred; Lalezari, Jacob; Everson, Gregory; Dore, Gregory J; Herring, Robert; Sheikh, Aasim; Kwo, Paul; Hézode, Christophe; Pockros, Paul J; Tran, Albert; Yozviak, Joseph; Reau, Nancy; Ramji, Alnoor; Stuart, Katherine; Thompson, Alexander J; Vierling, John; Freilich, Bradley; Cooper, James; Ghesquiere, Wayne; Yang, Rong; McPhee, Fiona; Hughes, Eric A; Swenson, E Scott; Yin, Philip D

2015-05-05

Effective and well-tolerated, interferon-free regimens are needed for treatment of patients with chronic hepatitis C virus (HCV) infection and cirrhosis. All-oral therapy with daclatasvir (nonstructural protein 5A [NS5A] inhibitor), asunaprevir (NS3 protease inhibitor), and beclabuvir (nonnucleoside NS5B inhibitor), with or without ribavirin, was evaluated in patients with HCV genotype 1 infection and compensated cirrhosis. The UNITY-2 study was conducted between December 2013 and October 2014 at 49 outpatient sites in the United States, Canada, France, and Australia. Patients were treated for 12 weeks, with 24 weeks of follow-up after completion of treatment. Adult patients with cirrhosis were enrolled in 2 cohorts: HCV treatment-naive or HCV treatment-experienced. Statistical analyses were based on historical controls; there were no internal controls. All patients received twice-daily treatment with the fixed-dose combination of daclatasvir (30 mg), asunaprevir (200 mg), and beclabuvir (75 mg). In addition, patients within each cohort were stratified according to HCV genotype 1 subtype (1a or 1b) and randomly assigned (1:1) to receive double-blinded weight-based ribavirin (1000-1200 mg/d) or matching placebo. Sustained virologic response at posttreatment week 12 (SVR12). One hundred twelve patients in the treatment-naive group and 90 patients in the treatment-experienced group were treated and included in the analysis. Enrolled patients were 88% white with a median age of 58 years (treatment-naive group) or 60 years (treatment-experienced group); 74% had genotype 1a infection. SVR12 rates were 98% (97.5% CI, 88.9%-100%) for patients in the treatment-naive group and 93% (97.5% CI, 85.0%-100.0%) for those in the treatment-experienced group when ribavirin was included in the regimen. With the fixed-dose combination alone, response rates were 93% (97.5% CI, 85.4%-100.0%) for patients in the treatment-naive group and 87% (97.5% CI, 75.3%-98.0%) for those in the treatment-experienced group. Three serious adverse events were considered to be treatment related and there were 4 adverse event-related discontinuations. Treatment-emergent grade 3 or 4 alanine aminotransferase elevations were observed in 4 patients, of which 1 had concomitant total bilirubin elevation. In this open-label uncontrolled study, patients with chronic HCV genotype 1 infection and cirrhosis who received a 12-week oral fixed-dose regimen of daclatasvir, asunaprevir, and beclabuvir, with or without ribavirin, achieved high rates of SVR12.

Assessment of income growth in patients with rheumatoid arthritis treated with anti-tumor necrosis factor therapy.

PubMed

Bergman, Martin; De, Gourab; Ganguli, Arijit; Signorovitch, James; Bao, Yanjun

2015-01-01

To compare income growth over time between employees with RA treated with anti-TNFs and those treated with methotrexate (MTX). Privately insured employees (aged ≥18) with ≥1 RA diagnosis (ICD-9: 714.0) were identified from a large-scale US employer claims database (1998-2011). Patients were stratified into treatment groups (anti-TNF-treated patients and MTX-monotherapy patients) based on their treatment history. The anti-TNF-treated patients comprised patients who filled ≥1 prescription for anti-TNFs, with or without MTX (index date defined as the date of the first anti-TNF prescription). The MTX-treated patients comprised patients who filled ≥1 prescription for MTX-monotherapy (index date randomly selected). The primary study outcome was the annual income growth rate (US dollars). Patients were followed from their index date to health plan disenrollment or the end of data availability (maximum follow-up of 5 years). The effect of treatment type on income growth was assessed using a multivariable generalized estimating equation model, adjusting for key baseline characteristics. Income growth was compared to that of the general employed population using Social Security data (1998-2011). The regression-adjusted annual growth rate in income for anti-TNF-treated patients (n = 1848) was 2.8% (CI = 1.9-3.6%), significantly greater (p < 0.05) than the 0.6% (CI = -0.2-1.4%) for MTX-monotherapy patients (n = 1866). Compared to the general employed population, income growth was lower (p < 0.05) for MTX-monotherapy patients and comparable for anti-TNF-treated patients. Compared to MTX-monotherapy, anti-TNF treatment is associated with a higher income growth rate among employees with RA. Anti-TNF-treated patients experienced comparable income growth to the general employed population norm.

Phase III Noninferiority Trial Comparing Irinotecan With Oxaliplatin, Fluorouracil, and Leucovorin in Patients With Advanced Colorectal Carcinoma Previously Treated With Fluorouracil: N9841

PubMed Central

Kim, George P.; Sargent, Daniel J.; Mahoney, Michelle R.; Rowland, Kendrith M.; Philip, Philip A.; Mitchell, Edith; Mathews, Abraham P.; Fitch, Tom R.; Goldberg, Richard M.; Alberts, Steven R.; Pitot, Henry C.

2009-01-01

Purpose The primary goal of this multicenter phase III trial was to determine whether overall survival (OS) of fluorouracil (FU) -refractory patients was noninferior when treated with second-line infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4; arm B) versus irinotecan (arm A). Cross-over to the other treatment on disease progression was mandated. Patients and Methods Patients who experienced treatment failure with one prior FU-based therapy and had not received prior irinotecan or oxaliplatin, either for metastatic disease or within 6 months of adjuvant FU therapy, were randomly assigned to arm A (irinotecan 350 or 300 mg/m2 every 3 weeks) or arm B (FOLFOX4). Results A total of 491 patients were randomly assigned (arm A, n = 245; arm B, n = 246); 288 (59%) had experienced treatment failure with FU for metastatic colorectal cancer. Two hundred twenty-seven patients (46%) received protocol-mandated third-line therapy (arm A, 43%; arm B, 57%). Median survival was 13.8 months (95% CI, 12.2 to 15.0 months) for initial treatment with FOLFOX4 and 14.3 months (95% CI, 12.0 to 15.9 months) for irinotecan (P = .38; hazard ratio = 0.92; 95% CI, 0.8 to 1.1). Response rates (RR; 28% v 15.5%; P = .0009) and time to progression (TTP; 6.2 v 4.4 months; P = .0009) were significantly superior with FOLFOX4. In the nonrandom subset of patients who crossed over, RR and TTP improvements with FOLFOX4 continued into third-line treatment. Irinotecan therapy was associated with more grade 3 nausea, vomiting, diarrhea, and febrile neutropenia; FOLFOX4 was associated with more neutropenia and paresthesias. Conclusion In patients who experienced treatment failure with front-line FU therapy, OS does not significantly differ whether second-line therapy begins with irinotecan or FOLFOX4. FOLFOX4 produces higher RR and longer TTP. Both arms had notable OS in patients who experienced treatment failure with first-line FU therapy. PMID:19380443

Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis.

PubMed

Okamoto, Kohji; Suzuki, Kenji; Takada, Tadahiro; Strasberg, Steven M; Asbun, Horacio J; Endo, Itaru; Iwashita, Yukio; Hibi, Taizo; Pitt, Henry A; Umezawa, Akiko; Asai, Koji; Han, Ho-Seong; Hwang, Tsann-Long; Mori, Yasuhisa; Yoon, Yoo-Seok; Huang, Wayne Shih-Wei; Belli, Giulio; Dervenis, Christos; Yokoe, Masamichi; Kiriyama, Seiki; Itoi, Takao; Jagannath, Palepu; Garden, O James; Miura, Fumihiko; Nakamura, Masafumi; Horiguchi, Akihiko; Wakabayashi, Go; Cherqui, Daniel; de Santibañes, Eduardo; Shikata, Satoru; Noguchi, Yoshinori; Ukai, Tomohiko; Higuchi, Ryota; Wada, Keita; Honda, Goro; Supe, Avinash Nivritti; Yoshida, Masahiro; Mayumi, Toshihiko; Gouma, Dirk J; Deziel, Daniel J; Liau, Kui-Hin; Chen, Miin-Fu; Shibao, Kazunori; Liu, Keng-Hao; Su, Cheng-Hsi; Chan, Angus C W; Yoon, Dong-Sup; Choi, In-Seok; Jonas, Eduard; Chen, Xiao-Ping; Fan, Sheung Tat; Ker, Chen-Guo; Giménez, Mariano Eduardo; Kitano, Seigo; Inomata, Masafumi; Hirata, Koichi; Inui, Kazuo; Sumiyama, Yoshinobu; Yamamoto, Masakazu

2018-01-01

We propose a new flowchart for the treatment of acute cholecystitis (AC) in the Tokyo Guidelines 2018 (TG18). Grade III AC was not indicated for straightforward laparoscopic cholecystectomy (Lap-C). Following analysis of subsequent clinical investigations and drawing on Big Data in particular, TG18 proposes that some Grade III AC can be treated by Lap-C when performed at advanced centers with specialized surgeons experienced in this procedure and for patients that satisfy certain strict criteria. For Grade I, TG18 recommends early Lap-C if the patients meet the criteria of Charlson comorbidity index (CCI) ≤5 and American Society of Anesthesiologists physical status classification (ASA-PS) ≤2. For Grade II AC, if patients meet the criteria of CCI ≤5 and ASA-PS ≤2, TG18 recommends early Lap-C performed by experienced surgeons; and if not, after medical treatment and/or gallbladder drainage, Lap-C would be indicated. TG18 proposes that Lap-C is indicated in Grade III patients with strict criteria. These are that the patients have favorable organ system failure, and negative predictive factors, who meet the criteria of CCI ≤3 and ASA-PS ≤2 and who are being treated at an advanced center (where experienced surgeons practice). If the patient is not considered suitable for early surgery, TG18 recommends early/urgent biliary drainage followed by delayed Lap-C once the patient's overall condition has improved. Free full articles and mobile app of TG18 are available at: http://www.jshbps.jp/modules/en/index.php?content_id=47. Related clinical questions and references are also included. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Refractory major depression successfully treated with electroconvulsive therapy in a patient with Addison disease.

PubMed

Heijnen, Willemijn T C J; Pluijms, Esther M; Birkenhager, Tom K

2013-06-01

This report describes a 55-year-old woman who had 1 previous episode of major depression that responded favorably to treatment with tricyclic antidepressants. After the development of Addison disease, she experienced a new episode of major depression that failed to respond to adequate treatment with imipramine and was subsequently successfully treated with electroconvulsive therapy (ECT) with steroid cover. The patient did not experience adrenal crisis or adverse effects. After 9 ECT sessions, she attained full remission. These findings support the suggestion that ECT treatment is safe in patients with Addison disease when using 100 mg intravenous hydrocortisone as prophylaxis.

Complex partial status epilepticus: a recurrent problem.

PubMed Central

Cockerell, O C; Walker, M C; Sander, J W; Shorvon, S D

1994-01-01

Twenty patients with complex partial status epilepticus were identified retrospectively from a specialist neurology hospital. Seventeen patients experienced recurrent episodes of complex partial status epilepticus, often occurring at regular intervals, usually over many years, and while being treated with effective anti-epileptic drugs. No unifying cause for the recurrences, and no common epilepsy aetiologies, were identified. In spite of the frequency of recurrence and length of history, none of the patients showed any marked evidence of cognitive or neurological deterioration. Complex partial status epilepticus is more common than is generally recognised, should be differentiated from other forms of non-convulsive status, and is often difficult to treat. PMID:8021671

The Utility of Low-Dose Aripiprazole for the Treatment of Bipolar II and Bipolar NOS Depression.

PubMed

Kelly, Tammas; Lieberman, Daniel Z

2017-02-01

Despite initial reports of efficacy in bipolar depression, multicenter trials did not show aripiprazole to be better than placebo, possibly because the doses used were too high, leading to lower efficacy and high dropout rates. This study evaluated the effects of low-dose aripiprazole. Extensive clinical experience has suggested that doses beyond 5 mg are rarely efficacious. Data were gathered from patients with bipolar II or bipolar not otherwise specified depression using a retrospective chart review. Efficacy was assessed with the Clinical Global Impression-Improvement score. Patients who had at least 2 trials of aripiprazole were included in a retrospective off-on-off-on experimental design. All patients were on other medications when aripiprazole was started. Patients were treated with doses of 1 to 5 mg. On average, patients were rated improved or very much improved compared with baseline. Sixteen of 211 patients worsened or experienced no change. Forty-four patients (21%) discontinued due to adverse effects. The group of patients who underwent off-on-off-on trials experienced statistically significant improvement when they started and restarted aripiprazole, and statistically significant worsening when they discontinued it. When treating bipolar II or bipolar not otherwise specified depression, low doses of aripiprazole, 5 mg or less, may be more effective and better tolerated than higher ones. Clinicians should start treatment with a very low dose and give patients time to respond.

Integrated results from the COPERNICUS and GALILEO studies

PubMed Central

Pielen, Amelie; Clark, W Lloyd; Boyer, David S; Ogura, Yuichiro; Holz, Frank G; Korobelnik, Jean-Francois; Stemper, Brigitte; Asmus, Friedrich; Rittenhouse, Kay D; Ahlers, Christiane; Vitti, Robert; Saroj, Namrata; Zeitz, Oliver; Haller, Julia A

2017-01-01

Objectives To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO. Patients and methods Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52. Results At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients. Conclusion This analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO. PMID:28883712

Effect of single doses of pindolol and d-fenfluramine on flumazenil-induced anxiety in panic disorder patients.

PubMed

Bernik, M; Ramos, R T; Hetem, L A B; Graeff, F

2017-11-04

The effects of the 5-HT 1A receptor blocker pindolol and the 5-HT releasing and uptake blocking agent d-fenfluramine, both used as indirect serotonin agonists, on flumazenil-induced acute anxiety reactions were studied in panic disorder patients to test the hypothesis that serotonin (5-HT) inhibits neural systems mediating panic attacks. Thirty never treated or drug free PD patients (16 females) aged 22-49 y (mean±SD, 32.9±8) received single doses of d-fenfluramine (n=10; 30mg, p.o.), pindolol (n=10; 5mg, p.o.), or placebo (n=10) 90 and 45min before a challenge test with flumazenil (1.5mg, i.v., in 10min), under double-blind conditions. Panic attacks occurred in 5 control subjects (placebo-flumazenil group), 5 subjects in the pindolol group and in 7 in the d-fenluramine pre-treated patients. Patients experiencing anxiety attacks following flumazenil reported higher increases in anxiety scores. Respiratory rate increases were not different between patients experiencing or not a panic attack. Despite sample size limitation, this study suggests that flumazenil induced anxiety reaction is not a good pharmacological model of panic attacks, considering the absence of serotonergic modulation of its effects. Copyright © 2017. Published by Elsevier B.V.

Changes in body weight and body mass index among psychiatric patients receiving lithium, valproate, or topiramate: an open-label, nonrandomized chart review.

PubMed

Chengappa, K N Roy; Chalasani, L; Brar, Jaspreet S; Parepally, H; Houck, Patricia; Levine, Joseph

2002-10-01

Subsets of psychiatric patients gain excess body weight while receiving mood-stabilizing agents such as lithium carbonate or valproate sodium. Patients who gain excess weight may discontinue therapy, with severe consequences. Among the newer anticonvulsant agents, topiramate is a candidate agent for bipolar disorder and is associated with weight loss when used as adjunctive treatment. This open-label, nonrandomized, chart-review study assessed changes in body weight and body mass index (BMI) in patients receiving topiramate, lithium, or valproate. Data were extracted from the medical charts of patients admitted in 1999 and 2000 to a state psychiatric hospital with either schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric diagnoses who were prescribed valproate, lithium, or topiramate and were reviewed for changes in body weight and BMI. The use of concomitant psychotropic medicines was recorded (eg, antipsychotic agents, antidepressant agents, other mood stabilizers such as gabapentin or carbamazepine). Continuous variables were analyzed using a factorial analysis of variance and the Student t test. Contingency statistics were used to analyze categorical variables. A total of 214 patients were included in the chart review (123 men, 91 women; mean age, 39.4 years). Significantly more women than men received topiramate (P = 0.004). Patients receiving either lithium or valproate gained a mean (SD) of 6.3 (9.0) kg and 6.4 (9.0) kg, respectively, whereas patients receiving topiramate lost a mean 1.2 (6.3) kg (F = 11.54, df = 2,198; P < 0.001). Lithium- or valproate-treated patients experienced an increase in BMI (mean, 2.1 [3.0] for both groups), whereas topiramate-treated patients experienced a reduction in BMI (mean, -0.5 [2.4]); this result was statistically significant (F = 11.40, df = 2,198; P < 0.001). Finally, lithium- or valproate-treated patients gained >8% of their baseline body weight (8.2% [11.5%] for lithium-treated patients and 8.5% [11.9%] for valproate-treated patients), whereas topiramate-treated patients lost 0.7% (7.2%) of their body weight (F = 9.93, df= 2,198; P < 0.001). Controlled studies for the efficacy of topiramate therapy in various psychiatric conditions are awaited. These data indicate that patients receiving topiramate experience body weight loss and a reduction in BMI. This advantage of topiramate may promote long-term adherence to treatment among psychiatric patients and possibly decrease the medical risks associated with obesity.

Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

PubMed Central

2010-01-01

Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches) than just medications alone (50% experience a 50% reduction) and that the effect size of our study involving three different types of biofeedback for migraine (1.09) was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5). These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine. PMID:20205867

Epidural Hematoma and Abscess Related to Thoracic Epidural Analgesia: A Single-Center Study of 2,907 Patients Who Underwent Lung Surgery.

PubMed

Kupersztych-Hagege, Elisa; Dubuisson, Etienne; Szekely, Barbara; Michel-Cherqui, Mireille; François Dreyfus, Jean; Fischler, Marc; Le Guen, Morgan

2017-04-01

To report the major complications (epidural hematoma and abscess) of postoperative thoracic epidural analgesia in patients who underwent lung surgery. Prospective, monocentric study. A university hospital. All lung surgical patients who received postoperative thoracic epidural analgesia between November 2007 and November 2015. Thoracic epidural analgesia for patients who underwent lung surgery. During the study period, data for 2,907 patients were recorded. The following 3 major complications were encountered: 1 case of epidural hematoma (0.34 case/1,000; 95% confidence interval 0.061-1.946), for which surgery was performed, and 2 cases of epidural abscesses (0.68 case/1,000; 95% confidence interval 0.189-2.505), which were treated medically. The risk range of serious complications was moderate; only the patient who experienced an epidural hematoma also experienced permanent sequelae. Copyright © 2017 Elsevier Inc. All rights reserved.

The effect of race on the CYP3A-mediated metabolism of vincristine in pediatric patients with acute lymphoblastic leukemia.

PubMed

Sims, Rosalyn P

2016-02-01

The purpose of this preliminary study was to compare racial background and CYP3A distribution in pediatric acute lymphoblastic leukemia patients as it relates to vincristine-related neurotoxicity. Patients with B-precursor acute lymphoblastic leukemia treated at Children's Hospital of Michigan were eligible to participate in this study. Determination of the CYP3A variant for each patient was done using Qiagen DNA Blood Mini Kit and polymerase chain reaction amplification. Patients were monitored during their leukemia treatment course for vincristine-related neurotoxicity. Fifty-four patients were enrolled. Twenty-nine Caucasian patients (81%) and 13 African-American patients (77%) experienced neurotoxicity. CYP3A genotyping was done for 52 patients. Two African-American and two Caucasian patients were homozygous A/A for the CYP3A5*3 polymorphism. Three of these patients (75%) experienced grade 2 neuropathy. Two Caucasian patients and one African-American patient were heterozygous A/G. Two of these patients (66.7%) experienced grade 2 or 3 neuropathy. Thirty-five patients (67.3%) were homozygous for the mutant inactive G/G allele for CYP3A5*3, eight African-American and 27 Caucasian patients. Of these, six of the African-American patients (75%) and 22 of the Caucasian patients (81.5%) experienced neuropathy. The CYP3A5*3 genotype causes very low expression of the CYP3A5 protein and hence decreased vincristine metabolism. In this study, patients who expressed CYP3A5*3 had an increased incidence of vincristine-related neurotoxicity. Overall, a greater percentage of Caucasian patients had documented incidences of neurotoxicity. A larger sample size and more detailed gene analysis are needed for future studies. © The Author(s) 2014.

Higher than expected estradiol levels in aromatase inhibitor-treated, postmenopausal breast cancer patients.

PubMed

Kunovac Kallak, T; Baumgart, J; Stavreus Evers, A; Sundström Poromaa, I; Moby, L; Kask, K; Norjavaara, E; Kushnir, M M; Bergquist, J; Nilsson, K

2012-10-01

Vaginal estradiol is considered contraindicated in aromatase inhibitor (AI)-treated patients because of the risk of elevated estrogen levels. This leaves limited treatment options for patients experiencing gynecological symptoms. However, in clinical practice, no precise estimation has been performed of circulating estrogens and aromatase index in postmenopausal breast cancer patients on long-lasting AI or tamoxifen treatment. Steroid hormones were measured using liquid chromatography tandem mass spectrometry (LC-MS/MS) and extraction radioimmunoassay (RIA). Postmenopausal AI-treated patients (n =33) were compared with tamoxifen-treated patients (n =34) and controls without vaginal treatment (n =56), with vaginal estradiol (n =25), or with estriol (n =11) treatment. By use of LC-MS/MS, median (range) estradiol plasma concentrations were 16.7 (2.4-162.6), 31.0 (13.4-77.1), 27.2 (7.8-115.8) and 33.3 (20.3-340.1) pmol/l in AI-treated breast cancer patients, tamoxifen-treated breast cancer patients, postmenopausal controls and postmenopausal controls on vaginal estradiol, respectively. The AI-treated group and subgroups had significantly lower estradiol and estrone concentrations than all other groups (p <0.05). There was extensive interindividual variation in estradiol concentration within the AI-treated group, measured using both LC-MS/MS (2.3-182.0 pmol/l) and extraction RIA (2.4-162.6 pmol/l). The AI-treated group had lower aromatase index compared to all other groups (p <0.05-0.001). Circulating estrogen levels may have been underestimated in previous longitudinal studies of AI-treated breast cancer patients. Additional studies are required to further evaluate the role of circulating estrogens in breast cancer patients suffering from gynecological symptoms.

Vocal fold hemorrhage: factors predicting recurrence.

PubMed

Lennon, Christen J; Murry, Thomas; Sulica, Lucian

2014-01-01

Vocal fold hemorrhage is an acute phonotraumatic injury treated with voice rest; recurrence is a generally accepted indication for surgical intervention. This study aims to identify factors predictive of recurrence based on outcomes of a large clinical series. Retrospective cohort. Retrospective review of cases of vocal fold hemorrhage presenting to a university laryngology service. Demographic information was compiled. Videostroboscopic exams were evaluated for hemorrhage extent, presence of varix, mucosal lesion, and/or vocal fold paresis. Vocal fold hemorrhage recurrence was the main outcome measure. Follow-up telephone survey was used to complement clinical data. Forty-seven instances of vocal fold hemorrhage were evaluated (25M:22F; 32 professional voice users). Twelve of the 47 (26%) patients experienced recurrence. Only the presence of varix demonstrated significant association with recurrence (P = 0.0089) on multivariate logistic regression. Vocal fold hemorrhage recurred in approximately 26% of patients. Varix was a predictor of recurrence, with 48% of those with varix experiencing recurrence. Monitoring, behavioral management and/or surgical intervention may be indicated to treat patients with such characteristics. © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Long-term treatment with tenofovir in Asian-American chronic hepatitis B patients is associated with abnormal renal phosphate handling.

PubMed

Tien, Connie; Xu, Jason J; Chan, Linda S; Chang, Mimi; Lim, Carolina; Lee, Sue; Huh, Brian; Shinada, Shuntaro; Bae, Ho S; Fong, Tse-Ling

2015-02-01

Increased risk of defective urinary phosphate reabsorption and osteoporosis has been reported in HIV and chronic hepatitis B (CHB) patients treated with tenofovir disoproxil fumarate (TDF). Goals of this study were to evaluate the prevalence of renal phosphate wasting and abnormal bone mineral density in CHB patients taking TDF compared to CHB patients treated with entecavir (ETV) and untreated CHB patients. This is a cross-sectional study of 146 consecutive Asian-American CHB patients who were treatment naïve (n = 60) or treated with either TDF (n = 42) or ETV (n = 44). Proximal tubular handling of phosphate was assessed by the maximal rate of tubular reabsorption of phosphate (TmPO4) divided by glomerular filtration rate (GFR) (TmPO4/GFR). Bone mineral density (BMD) was measured using dual X-ray absorptiometry. TmPO4/GFR was similar among CHB patients treated with TDF compared to untreated patients and patients taking ETV. However, among patients treated with ≥18 months of TDF or ETV, prevalence of abnormal TmPO4/GFR was higher among patients treated with TDF compared to ETV (48.5 % (16/33) vs. 12.5 % (3/24), p = 0.005). Overall prevalence of osteoporosis in this cohort of CHB patients was 14 %, with no significant difference between the three groups. Renal phosphate handling did not correlate with osteoporosis. Chronic hepatitis B patients treated with ≥18 months of TDF experienced an increased risk of proximal tubular dysfunction. TDF did not increase the risk of osteoporosis. Longitudinal studies are needed to confirm these findings.

Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method.

PubMed

Weiss, Richard A; Lavin, Phillip T

2009-01-01

To evaluate the safety and efficacy of vapocoolants (topical skin refrigerants) to induce skin anesthesia and relieve patient anxiety and pain prior to cosmetic botulinum injections. A paired (split-face) design was used in 52 patients where patient side (left vs. right) was randomized to receive either vapocoolant spray or no treatment control to test the study hypothesis of better anesthetic efficacy of vapocoolant spray versus no treatment control. A pain and anxiety questionnaire was administered before, during, and after the injections. A considerable percentage of patients either expected pain (35% of naïve patients expected moderate pain) or had experienced pain from their prior treatment (35% had experienced moderate pain). Among naïve patients, 15% had moderate or severe anxiety and among experienced patients, 31% had moderate anxiety. Pain was a factor in delaying the scheduling of cosmetic botulinum toxin treatments in 19% of naïve patients and 31% of experienced patients. Pain reported from actual injections was higher than what was anticipated prior to treatment. There was a significant reduction in pain at injection sites treated with vapocoolant (p < 0.001, paired t test). Overall, 67% of all patients reported that the vapocoolant method had less pain than no anesthesia and 54% preferred vapocoolant for their next treatment. Overall, 6% of all patients would schedule their next botulinum toxin treatment sooner if vapocoolant were available. Vapocoolants represent a safe and effective means to reduce patient discomfort and anxiety before and during botulinum toxin type A treatments for glabellar area indications.

Buspirone in the treatment of posttraumatic stress disorder.

PubMed

Wells, B G; Chu, C C; Johnson, R; Nasdahl, C; Ayubi, M A; Sewell, E; Statham, P

1991-01-01

Three patients with a DSM-III-R diagnosis of posttraumatic stress disorder were successfully treated with buspirone in final maximum dosages ranging from 35-60 mg daily. The onset of clinical efficacy ranged from 5-29 days. Symptoms that improved included anxiety, insomnia, flashbacks, and depressed mood. Patients experienced no side effects. Serotonin partial agonist effects are a possible mechanism underlying buspirone's efficacy.

Using guided self-help to treat common mental health problems: The Westminster Primary Care Psychology Service

PubMed Central

Falbe-Hansen, Louise; Le Huray, Corin; Phull, Brendar; Shakespeare, Clare

2009-01-01

We describe a new service offering cognitive behavioural therapy in the form of guided self-help to patients experiencing mild mental health problems. The referral pathway is outlined and the various treatment options are illustrated with case descriptions of depression and panic disorder. Patients' responses to this new service are reported and discussed. PMID:26042170

Dental care in patients with epilepsy: a survey of 82 patients and their attending dentists and neurologists in southern Germany.

PubMed

Schöpper, Malin; Ludolph, Albert C; Fauser, Susanne

2016-12-01

The current study assessed the knowledge and attitudes of dentists and neurologists, and of their patients with epilepsy, in the catchment area of an outpatient clinic for epilepsy in southern Germany. One-hundred patients with epilepsy were asked to complete questionnaires about their dental treatment. Attitudes of their attending dentists and neurologists were also assessed. Patients with epilepsy: The questionnaires were returned by 82% of patients. Of these, 84% regularly (once or twice a year) sought out a dentist, 79% reported their epilepsy to the dentist, 6% were refused treatment by a dentist because of their epilepsy, 10% had already experienced a seizure while at a dental office and 52% wished for more detailed information pretreatment. Dentists: Although 97% treated patients with epilepsy, 21% believed that their equipment was inappropriate for treating a patient experiencing seizures. The majority were not familiar with interactions between antibiotics/analgetics and anti-epileptic drugs. Short-term general anaesthesia was preferred for critical patients by 70% of dentists, 70% recommended dental ceramic for prosthetic reconstruction of anterior teeth and 64% would not recommend use of a removable denture. Neurologists: Sixty-two per cent were asked for advice by their patients, 71% knew about particular risks and interactions between antibiotics/analgetics and anti-epileptic drugs, 8% would stop valproic acid before extensive dental intervention and 92% recommended general anaesthesia in critical patients (uncooperative patients, patients with learning difficulties, and patients with frequent generalised tonic-clonic or complex partial seizures). In general, patients were satisfied with their dental treatment. Regarding the clinician's role, however, dentists need to know more with respect to treating patients with seizures. Beyond that, it would be desirable for neurologists to take more time to answer their patients' questions regarding dental care. © 2016 FDI World Dental Federation.

Initial study of transdermal oxybutynin for treating hyperhidrosis.

PubMed

Millán-Cayetano, José Francisco; Del Boz, Javier; Toledo-Pastrana, Tomas; Nieto-Guindo, Miriam; García-Montero, Pablo; de Troya-Martín, Magdalena

2017-06-01

Oral oxybutynin for treating hyperhidrosis is effective and safe. Its side-effects are mild but frequent so we consider whether transdermal oxybutynin (considered to have a better side-effect profile) could be an alternative for treating hyperhidrosis. During 2015, a prospective study was conducted. Epidemiological variables, effectiveness (using the Hyperhidrosis Disease Severity Scale) and tolerance to transdermal oxybutynin were compiled concerning two different groups (patients previously treated or untreated with oral oxybutynin), at baseline, and at 3 and 12 months. Seven previously treated and six previously untreated patients were included. Five patients in the first group discontinued the treatment within 3 months. Of the two remaining patients, one reported ineffectiveness and the other obtained an excellent response but discontinued due to local irritation. Among the untreated patients, two showed no response and four experienced improvement (three with "partial response" and one with "excellent response"). All patients discontinued treatment within 12 months. No major adverse effects were observed. The absence of active metabolites after transdermal oxybutynin could result in less effectiveness than oral oxybutynin, although it is usually well tolerated. In conclusion, transdermal oxybutynin could have low effectiveness for the treatment of hyperhidrosis in patients following intolerance to oral oxybutynin but could provide good results in patients who have never tried systemic drugs. © 2017 Japanese Dermatological Association.

Integrated results from the COPERNICUS and GALILEO studies.

PubMed

Pielen, Amelie; Clark, W Lloyd; Boyer, David S; Ogura, Yuichiro; Holz, Frank G; Korobelnik, Jean-Francois; Stemper, Brigitte; Asmus, Friedrich; Rittenhouse, Kay D; Ahlers, Christiane; Vitti, Robert; Saroj, Namrata; Zeitz, Oliver; Haller, Julia A

2017-01-01

To report on the efficacy and safety of intravitreal aflibercept in patients with macular edema secondary to central retinal vein occlusion (CRVO) in an integrated analysis of COPERNICUS and GALILEO. Patients were randomized to receive intravitreal aflibercept 2 mg every 4 weeks or sham injections until week 24. From week 24 to week 52, all intravitreal aflibercept-treated patients in both studies and sham-treated patients in COPERNICUS were eligible to receive intravitreal aflibercept based on prespecified criteria. In GALILEO, sham-treated patients continued to receive sham treatment through week 52. At week 24, mean gain in best-corrected visual acuity and mean reduction in central retinal thickness were greater for intravitreal aflibercept-treated patients compared with sham, consistent with individual trial results. At week 52, after 6 months of intravitreal aflibercept as-needed treatment in COPERNICUS, patients originally randomized to sham group experienced visual and anatomic improvements but did not improve to the extent of those initially treated with intravitreal aflibercept, while the sham group in GALILEO did not improve over week 24 mean best-corrected visual acuity scores. Ocular serious adverse events occurred in <10% of patients. This analysis of integrated data from COPERNICUS and GALILEO confirmed that intravitreal aflibercept is an effective treatment for macular edema following CRVO.

An Audit of the Use of Gonadorelin Analogues to Prevent Recurrent Acute Symptoms in Patients with Acute Porphyria in the United Kingdom.

PubMed

Schulenburg-Brand, Danja; Gardiner, Tricia; Guppy, Simon; Rees, David C; Stein, Penelope; Barth, Julian; Felicity Stewart, M; Badminton, Michael

2017-01-01

Severe recurrent acute attacks of porphyria have traditionally been treated with either prophylactic human haemin or gonadorelin analogues (GnA) in females. Evidence on the most effective treatment for this patient subgroup is lacking. This audit surveyed the use of prophylactic GnA in the UK.Twenty female patients (who experienced between 2 and 45 acute attacks of porphyria requiring hospitalisation and treatment with human haemin prior to GnA prophylaxis) were included in the audit. Data was retrospectively collected based on patient history and case review.Twenty three treatment courses were given lasting a median period of 12 months. Monthly subcutaneous Goserelin was most commonly used. In three patients in whom timing with the menstrual cycle was not considered, an acute attack occurred after initiation of the first dose. The majority of patients experienced oestrogen deficiency symptoms during treatment. Fifty percent of the prescribed courses of GnA resulted in a degree of clinical benefit. This successfully treated group experienced between 3 and 20 acute attacks prior to and between 0 and 6 acute attacks during GnA treatment.The audit revealed large variation in practice in the United Kingdom regarding indication, duration of treatment, specific drug used and management of side effects. In view of the limited treatment options available for this cohort and the mixed outcome successes reported, we believe it is reasonable for porphyria specialists to continue offering GnA treatment to women with severe recurrent debilitating acute attacks of porphyria associated with the menstrual cycle, and we propose best practice guidelines to standardise management.

Alopecia areata treated with hydroxychloroquine: A retrospective study of nine pediatric cases.

PubMed

Yun, Duri; Silverberg, Nanette B; Stein, Sarah L

2018-05-01

Alopecia areata is a common hair loss condition that is often emotionally devastating for patients. There is a paucity of effective treatments available. Hydroxychloroquine has been reported as variably effective in inducing significant hair regrowth in adults with alopecia areata. The objective of this retrospective study was to assess the benefit and tolerability of hydroxychloroquine in pediatric alopecia areata. We conducted a retrospective review of nine children with a history of alopecia areata treated with hydroxychloroquine. Clinical data were obtained from patients treated at two tertiary care centers in the United States between July 1, 2013, and July 1, 2015. Alopecia scores of five patients improved by 6 months of treatment. Four patients experienced no improvement from baseline evaluation. The most common side effect associated with treatment was gastrointestinal intolerance and headache. This retrospective series suggests that hydroxychloroquine can be considered as a treatment option for alopecia areata in children. © 2018 Wiley Periodicals, Inc.

Novel strategy of endoscopic submucosal dissection using an insulation-tipped knife for early gastric cancer: near-side approach method

PubMed Central

Mori, Genki; Nonaka, Satoru; Oda, Ichiro; Abe, Seiichiro; Suzuki, Haruhisa; Yoshinaga, Shigetaka; Nakajima, Takeshi; Saito, Yutaka

2015-01-01

Background and study aims: Endoscopic submucosal dissection (ESD) using insulation-tipped knives (IT knives) to treat gastric lesions located on the greater curvature of the gastric body remains technically challenging because of the associated bleeding, control of which can be difficult and time consuming. To eliminate these difficulties, we developed a novel strategy which we have called the “near-side approach method” and assessed its utility. Patients and methods: We reviewed patients who underwent ESD for solitary early gastric cancer located on the greater curvature of the gastric body from January 2003 to September 2014. The technical results of ESD were compared between the group treated with the novel near-side approach method and the group treated with the conventional method. Results: This study included 238 patients with 238 lesions, 118 of which were removed using the near-side approach method and 120 of which were removed using the conventional method. The median procedure time was 92 minutes for the near-side approach method and 120 minutes for the conventional method. The procedure time was significantly shorter in the near-side approach method arm. Although, the procedure time required by an experienced endoscopist was not significantly different between the two groups (100 vs. 110 minutes), the near-side approach group showed significantly shorter procedure time for a less-experienced endoscopist (90 vs. 120 minutes). Conclusions: The near-side approach method appears to require less time to complete gastric ESD than the conventional method using IT knives for technically challenging lesions located on the greater curvature of the gastric body, especially if the procedure is performed by less-experienced endoscopists. PMID:26528496

Drug susceptibility to etravirine and darunavir among Human Immunodeficiency Virus Type 1-derived pseudoviruses in treatment-experienced patients with HIV/AIDS in South Korea.

PubMed

Kwon, Oh-Kyung; Kim, Sung Soon; Rhee, Jee Eun; Kee, Mee-Kyung; Park, Mina; Oh, Hye-Ri; Choi, Ju-Yeon

2015-04-09

In South Korea, about 20 types of antiretroviral drugs are used in the treatment of patients with human immunodeficiency virus/acquired immune deficiency syndrome. Since 2010, raltegravir, etravirine, and darunavir have been spotlighted as new drugs for highly active antiretroviral therapy (HAART)-experienced adults with resistant HIV-1 in South Korea. In this study, we investigated potential susceptibility of pseudoviruses derived from treatment-experienced Korean patients to etravirine vs efavirenz and to darunavir vs amprenavir and indinavir using a modified single-round assay. Pseudoviruses derived from nine treatment-experienced patients infected with HIV-1 were investigated by comparison with the wild-type strain pNL4-3. The 50% inhibitory concentration (IC50) values were calculated and drug susceptibility was compared. The intensity of genotypic drug resistance was classified based on the 'SIR' interpretation of the Stanford data base. Drug susceptibility was generally higher for etravirine and darunavir compared with efavirenz, amprenavir, and indinavir in pseudoviruses derived from treatment-experienced patients. Pseudoviruses derived from patients KRB4025 and KRB8014, who exhibited long-term use of protease inhibitors, showed an outside of tested drug concentration, especially for amprenavir and indinavir. However, they exhibited a lower fold-change in resistance to darunavir. Etravirine and darunavir have been used in HAART since 2010 in South Korea. Therefore, these antiretroviral drugs together with other newly introduced antiretroviral drugs are interesting for the optimal treatment of patients with treatment failure. This study may help to find a more effective HAART in the case of HIV-1 infected patients that have difficulty being treated.

Non-variceal upper gastrointestinal bleeding: Rescue treatment with a modified cyanoacrylate.

PubMed

Grassia, Roberto; Capone, Pietro; Iiritano, Elena; Vjero, Katerina; Cereatti, Fabrizio; Martinotti, Mario; Rozzi, Gabriele; Buffoli, Federico

2016-12-28

To evaluate the safety and efficacy of a modified cyanoacrylate [N-butyl-2-cyanoacrylate associated with methacryloxysulfolane (NBCA + MS)] to treat non-variceal upper gastrointestinal bleeding (NV-UGIB). In our retrospective study we took into account 579 out of 1177 patients receiving endoscopic treatment for NV-UGIB admitted to our institution from 2008 to 2015; the remaining 598 patients were treated with other treatments. Initial hemostasis was not achieved in 45 of 579 patients; early rebleeding occurred in 12 of 579 patients. Thirty-three patients were treated with modified cyanoacrylate: 27 patients had duodenal, gastric or anastomotic ulcers, 3 had post-mucosectomy bleeding, 2 had Dieulafoy's lesions, and 1 had duodenal diverticular bleeding. Of the 45 patients treated endoscopically without initial hemostasis or with early rebleeding, 33 (76.7%) were treated with modified cyanoacrylate glue, 16 (37.2%) underwent surgery, and 3 (7.0%) were treated with selective transarterial embolization. The mean age of patients treated with NBCA + MS (23 males and 10 females) was 74.5 years. Modified cyanoacrylate was used in 24 patients during the first endoscopy and in 9 patients experiencing rebleeding. Overall, hemostasis was achieved in 26 of 33 patients (78.8%): 19 out of 24 (79.2%) during the first endoscopy and in 7 out of 9 (77.8%) among early rebleeders. Two patients (22.2%) not responding to cyanoacrylate treatment were treated with surgery or transarterial embolization. One patient had early rebleeding after treatment with cyanoacrylate. No late rebleeding during the follow-up or complications related to the glue injection were recorded. Modified cyanoacrylate solved definitively NV-UGIB after failure of conventional treatment. Some reported life-threatening adverse events with other formulations, advise to use it as last option.

The development of agoraphobia is associated with the symptoms and location of a patient's first panic attack.

PubMed

Hara, Naomi; Nishimura, Yukika; Yokoyama, Chika; Inoue, Ken; Nishida, Atsushi; Tanii, Hisashi; Okada, Motohiro; Kaiya, Hisanobu; Okazaki, Yuji

2012-04-11

The place where a patient experiences his/her first panic attack (FPA) may be related to their agoraphobia later in life. However, no investigations have been done into the clinical features according to the place where the FPA was experienced. In particular, there is an absence of detailed research examining patients who experienced their FPA at home. In this study, patients were classified by the location of their FPA and the differences in their clinical features were explored (e.g., symptoms of FPA, frequency of agoraphobia, and severity of FPA). The subjects comprised 830 panic disorder patients who were classified into 5 groups based on the place of their FPA (home, school/office, driving a car, in a public transportation vehicle, outside of home), The clinical features of these patients were investigated. Additionally, for panic disorder patients with agoraphobia at their initial clinic visit, the clinical features of patients who experienced their FPA at home were compared to those who experienced their attack elsewhere. In comparison of the FPAs of the 5 groups, significant differences were seen among the 7 descriptors (sex ratio, drinking status, smoking status, severity of the panic attack, depression score, ratio of agoraphobia, and degree of avoidance behavior) and 4 symptoms (sweating, chest pain, feeling dizzy, and fear of dying). The driving and public transportation group patients showed a higher incidence of co-morbid agoraphobia than did the other groups. Additionally, for panic disorder patients with co-morbid agoraphobia, the at-home group had a higher frequency of fear of dying compared to the patients in the outside-of-home group and felt more severe distress elicited by their FPA. The results of this study suggest that the clinical features of panic disorder patients vary according to the place of their FPA. The at-home group patients experienced "fear of dying" more frequently and felt more distress during their FPA than did the subjects in the other groups. These results indicate that patients experiencing their FPA at home should be treated with a focus on the fear and distress elicited by the attack.

The development of agoraphobia is associated with the symptoms and location of a patient's first panic attack

PubMed Central

2012-01-01

Background The place where a patient experiences his/her first panic attack (FPA) may be related to their agoraphobia later in life. However, no investigations have been done into the clinical features according to the place where the FPA was experienced. In particular, there is an absence of detailed research examining patients who experienced their FPA at home. In this study, patients were classified by the location of their FPA and the differences in their clinical features were explored (e.g., symptoms of FPA, frequency of agoraphobia, and severity of FPA). Methods The subjects comprised 830 panic disorder patients who were classified into 5 groups based on the place of their FPA (home, school/office, driving a car, in a public transportation vehicle, outside of home), The clinical features of these patients were investigated. Additionally, for panic disorder patients with agoraphobia at their initial clinic visit, the clinical features of patients who experienced their FPA at home were compared to those who experienced their attack elsewhere. Results In comparison of the FPAs of the 5 groups, significant differences were seen among the 7 descriptors (sex ratio, drinking status, smoking status, severity of the panic attack, depression score, ratio of agoraphobia, and degree of avoidance behavior) and 4 symptoms (sweating, chest pain, feeling dizzy, and fear of dying). The driving and public transportation group patients showed a higher incidence of co-morbid agoraphobia than did the other groups. Additionally, for panic disorder patients with co-morbid agoraphobia, the at-home group had a higher frequency of fear of dying compared to the patients in the outside-of-home group and felt more severe distress elicited by their FPA. Conclusion The results of this study suggest that the clinical features of panic disorder patients vary according to the place of their FPA. The at-home group patients experienced "fear of dying" more frequently and felt more distress during their FPA than did the subjects in the other groups. These results indicate that patients experiencing their FPA at home should be treated with a focus on the fear and distress elicited by the attack. PMID:22494552

Intercultural communication through the eyes of patients: experiences and preferences.

PubMed

Paternotte, Emma; van Dulmen, Sandra; Bank, Lindsay; Seeleman, Conny; Scherpbier, Albert; Scheele, Fedde

2017-05-16

To explore patients' preferences and experiences regarding intercultural communication which could influence the development of intercultural patient-centred communication training. This qualitative study is based on interviews with non-native patients. Thirty non-native patients were interviewed between September and December 2015 about their preferences and experiences regarding communication with a native Dutch doctor. Fourteen interviews were established with an interpreter. The semi-structured interviews took place in Amsterdam. They were focused on generic and intercultural communication skills of doctors. Relevant fragments were coded by two researchers and analysed by the research team by means of thematic network analysis. Informed consent and ethical approval was obtained beforehand. All patients preferred a doctor with a professional patient-centred attitude regardless of the doctor's background. Patients mentioned mainly generic communication aspects, such as listening, as important skills and seemed to be aware of their own responsibility in participating in a consultation. Being treated as a unique person and not as a disease was also frequently mentioned. Unfamiliarity with the Dutch healthcare system influenced the experienced communication negatively. However, a language barrier was considered the most important problem, which would become less pressing once a doctor-patient relation was established. Remarkably, patients in this study had no preference regarding the ethnic background of the doctor. Generic communication was experienced as important as specific intercultural communication, which underlines the marginal distinction between these two. A close link between intercultural communication and patient-centred communication was reflected in the expressed preference 'to be treated as a person'.

Real-World Experiences with the Combination Treatment of Ledipasvir plus Sofosbuvir for 12 Weeks in HCV Genotype 1-Infected Japanese Patients: Achievement of a Sustained Virological Response in Previous Users of Peginterferon plus Ribavirin with HCV NS3/4A Inhibitors.

PubMed

Kanda, Tatsuo; Yasui, Shin; Nakamura, Masato; Suzuki, Eiichiro; Arai, Makoto; Ooka, Yoshihiko; Ogasawara, Sadahisa; Chiba, Tetsuhiro; Saito, Tomoko; Haga, Yuki; Takahashi, Koji; Sasaki, Reina; Wu, Shuang; Nakamoto, Shingo; Tawada, Akinobu; Maruyama, Hitoshi; Imazeki, Fumio; Kato, Naoya; Yokosuka, Osamu

2017-04-25

The aim of this study was to characterize the treatment response and serious adverse events of ledipasvir plus sofosbuvir therapies in Japanese patients infected with hepatitis C virus (HCV) genotype 1 (GT1). This retrospective study analyzed 240 Japanese HCV GT1 patients treated for 12 weeks with 90 mg of ledipasvir plus 400 mg of sofosbuvir daily. Sustained virological response at 12 weeks post-treatment (SVR12) was achieved in 236 of 240 (98.3%) patients. Among treatment-naïve patients, SVR12 was achieved in 136 of 138 (98.6%) patients, and among treatment-experienced patients, SVR12 was achieved in 100 of 102 (98.0%) patients. In patients previously treated with peginterferon plus ribavirin with various HCV NS3/4A inhibitors, 100% SVR rates (25/25) were achieved. Two relapsers had HCV NS5A resistance-associated variants (RAVs), but no HCV NS5B-S282 was observed after they relapsed. We experienced two patients with cardiac events during treatment. In conclusion, combination of ledipasvir plus sofosbuvir for 12 weeks is a potential therapy for HCV GT1 patients. Caution is needed for HCV NS5A RAVs, which were selected by HCV NS5A inhibitors and cardiac adverse events.

A psychological perspective of eye floaters.

PubMed

Cipolletta, Sabrina; Beccarello, Alessandra; Galan, Alessandro

2012-11-01

Patients experiencing flashes and spots in their perceptive fields often resort to consulting an ophthalmologist without finding an answer, mainly because these symptoms are not necessarily associated with pathology of the eye. The purpose of our research study was to understand the experience of these patients, differentiate among them, and propose different ways of treating them. We carried out an eye examination and echography, individual semistructured interviews, and dependency grids with 11 patients at the ophthalmology department of a public hospital in northern Italy. We found that individuals' ways of experiencing and reacting to eye floaters might be different and might depend on the perception of the disease, the personal explanation, the solutions tried, the trust placed in medicine, self-construction, and the dispersion of dependency. Understanding the experiences of patients suffering from eye floaters might help health care professionals to personalize their approaches to these patients.

[Retrospective Analysis of the Afatinib Clinical Pathway during the 28-Day Introductory Period-The Japanese Style of Collaborative Drug Therapy Management(J-CDTM)].

PubMed

Iwata, Kaori; Ryota, Noriko; Hikita, Ami; Sando, Masumi; Suzuki, Hidekazu; Tamiya, Motohiro; Azuma, Yuichiro; Tani, Eriko; Hamaguchi, Masanari; Tanaka, Ayako; Shiroyama, Takayuki; Morishita, Naoko; Okamoto, Norio; Futagami, Sumiko; Hirashima, Tomonori

2015-08-01

Afatinib is a newly approved second-generation epidermal growth factor receptor-tyrosine kinase inhibito r(EGFR-TKI). Afatinib has been shown to prolongthe overall survival of patients with non-small cell lungcancer (NSCLC) with EGFR mutations compared with the standard chemotherapy. However, Grade 3 or 4 toxicities, includingdiarrhea, rash, paronychia, and stomatitis, have been observed more frequently in patients treated with afatinib than in those treated with first-generation EGFR-TKIs. Accordingly, our institution developed an afatinib clinical pathway (the afatinib pathway), which was designed by certified nurses, medical physicians, and certified pharmacists, with the goal of reducing the severity of diarrhea and rash that occur most frequently duringthe 28-day introductory period of afatinib treatment. Between May and October 2014, afatinib was administered accordingto the afatinib pathway to 14 patients with NSCLC and EGFR mutations. Of these patients, only one (7.1%) experienced Grade 3 diarrhea. No other patient experienced Grade 3 or 4 toxicity. The afatinib pathway was effective in reducingthe severities of the diarrhea and rash duringthe 28-day introductory period of the afatinib treatment. Our implementation of the afatinib pathway could be considered the Japanese style of collaborative drugtherapy management (J-CDTM).

PubMed Central

N., Chuchueva; C., Gerosa; S., Sionis; R.A., Caria; R., Puxeddu

2017-01-01

SUMMARY Temporary and permanent facial nerve dysfunctions can be observed after parotidectomy for benign and malignant lesions. Intraoperative nerve monitoring is a recognised tool for the preservation of the nerve, while the efficacy of the operative microscope has been rarely stated. The authors report their experience on 198 consecutive parotidectomies performed on 196 patients with the aid of the operative microscope and intraoperative nerve monitoring. 145 parotidectomies were performed for benign lesions and 53 for malignancies. Thirteen patients treated for benign tumours experienced temporary (11 cases) or permanent facial palsy (2 cases, both of House-Brackmann grade II). Ten patients with malignant tumour presented with preoperative facial nerve weakness that did not improve after treatment. Five and 6 patients with malignant lesion without preoperative facial nerve deficit experienced postoperative temporary and permanent weakness respectively (the sacrifice of a branch of the nerve was decided intraoperatively in 2 cases). Long-term facial nerve weakness after parotidectomy for lesions not directly involving or originating from the facial nerve (n = 185) was 2.7%. Patients treated for benign tumours of the extra facial portion of the gland without inflammatory behaviour (n = 91) had 4.4% facial nerve temporary weakness rate and no permanent palsy. The combined use of the operative microscope and intraoperative nerve monitoring seems to guarantee facial nerve preservation during parotidectomy. PMID:29165432

Determination of school-related problems in children treated for cancer.

PubMed

Yilmaz, Medine C; Sari, Hatice Yildirim; Cetingul, Nazan; Kantar, Mehmet; Erermis, Serpil; Aksoylar, Serap

2014-10-01

This descriptive and case-control study was carried out in a pediatric oncology outpatient clinic to determine the school-related physical, social, and psychological problems and problems experienced in academic achievement of children treated for cancer. The sample of the study consisted of 56 Turkish patients with cancer, aged 7-18 years, who were in remission and attending school as well as their parents, a control group of patients who did not have cancer, and their teachers. A Child Information Form, a Child Health Questionnaire Parent's Form of 50 questions, a Behavior Evaluation Scale for Children, and Young People and a Teacher's Report Form were used as data collection tools in the study. Of the children, 30.3% experienced various physical difficulties stemming from cancer therapy that affected their school life. The number of late enrollments, the number of children repeating a grade, and the rates of school absenteeism were also found to be higher in the survivors than in the controls. © The Author(s) 2013.

Comparative efficacy and safety of antibiotics used to treat acute bacterial skin and skin structure infections: Results of a network meta-analysis.

PubMed

Guest, Julian F; Esteban, Jaime; Manganelli, Anton G; Novelli, Andrea; Rizzardini, Giuliano; Serra, Miquel

2017-01-01

This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI. Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1) clinical treatment success and (2) microbiological success at TOC visit. Safety-related endpoints were (1) number of discontinuations due to AEs/SAEs, (2) patients experiencing AEs, (3) patients experiencing SAEs and (4) all-cause mortality. Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline. Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different organisational settings. Notwithstanding, any introduction of an effective treatment with a differential mode of administration into healthcare systems must be followed by a change in clinical practice and patient management in order to fully achieve desirable economic outcomes.

Comparative efficacy and safety of antibiotics used to treat acute bacterial skin and skin structure infections: Results of a network meta-analysis

PubMed Central

Esteban, Jaime; Manganelli, Anton G.; Novelli, Andrea; Rizzardini, Giuliano; Serra, Miquel

2017-01-01

Objective This NMA compared the efficacy and safety between IV antibiotics that are used in the current standard of care for managing adult patients (≥18 years of age) with ABSSSI. Methods Comparators were chosen on the basis that both direct and indirect comparisons between the interventions of interest could be performed. Outcomes of the analysis were selected on the basis that they are frequently measured and reported in trials involving ABSSSI patients, and only published randomised control trials of any size and duration and with any blinding status were eligible for inclusion in the analysis. The NMA was performed using both a fixed-effect and random-effect model. Efficacy-related endpoints were (1) clinical treatment success and (2) microbiological success at TOC visit. Safety-related endpoints were (1) number of discontinuations due to AEs/SAEs, (2) patients experiencing AEs, (3) patients experiencing SAEs and (4) all-cause mortality. Results Study interventions included daptomycin, dalbavancin, linezolid and tigecycline. Vancomycin was the comparator in all studies, except in two where it was linezolid and teicoplanin. The NMA showed that irrespective of patient subgroup, the likelihood of clinical and microbiological success with dalbavancin was statistically similar to the comparators studied. No statistically significant differences were observed between dalbavancin and any of the comparators in the discontinuation rate due to AEs/SAEs. In contrast, dalbavancin was associated with a significantly lower likelihood of experiencing an AE than linezolid, a significantly lower likelihood of experiencing a SAE than vancomycin and daptomycin, and a significantly lower risk of all-cause mortality than vancomycin, linezolid and tigecycline. Conclusion Dalbavancin affords a promising, new alternative IV antimicrobial agent which is as effective as traditional therapies, but with the added benefit of enabling clinicians to treat patients with ABSSSI in different organisational settings. Notwithstanding, any introduction of an effective treatment with a differential mode of administration into healthcare systems must be followed by a change in clinical practice and patient management in order to fully achieve desirable economic outcomes. PMID:29136035

Thirty-Day Readmissions in Hospitalized Patients Who Received Bezlotoxumab With Antibacterial Drug Treatment for Clostridium difficile Infection

PubMed Central

Prabhu, Vimalanand S; Cornely, Oliver A; Golan, Yoav; Dubberke, Erik R; Heimann, Sebastian M; Hanson, Mary E; Liao, Jane; Pedley, Alison; Dorr, Mary Beth; Marcella, Stephen

2017-01-01

Abstract We estimated 30-day all-cause and Clostridium difficile infection (CDI)–associated hospital readmissions in participants at high risk of recurrent CDI enrolled in MODIFY I/II. Bezlotoxumab-treated inpatients experienced fewer CDI-associated readmissions compared with placebo-treated inpatients, notably in participants aged ≥65 years and with severe CDI. Clinical Trials Registration. NCT01241552 (MODIFY I) and NCT01513239 (MODIFY II).

Percutaneous endoscopic gastrostomy in patients with amyotrophic lateral sclerosis: Mortality and complications.

PubMed

Carbó Perseguer, J; Madejón Seiz, A; Romero Portales, M; Martínez Hernández, J; Mora Pardina, J S; García-Samaniego, J

2018-03-26

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that causes severe dysphagia and weight loss. Percutaneous endoscopic gastrostomy (PEG) is currently the technique of choice for the enteral nutrition of these patients. To analyse mortality and complications in a series of patients diagnosed with ALS who underwent PEG, and to evaluate factors related to patient survival after the procedure. We performed a prospective, observational study including all patients diagnosed with ALS and treated by our hospital's Gastroenterology Department in the period 1997-2013. We studied mortality, complications, and clinical and biochemical parameters, and correlated these with the survival rate. The study included a total of 57 patients, of whom 49 were ultimately treated with PEG. ALS onset was bulbar in 30 patients and spinal in 19. Mortality during the procedure and at 30 days was 2% (n = 1). Six patients (12.2%) experienced major complications; 17 (34.7%) experienced less serious complications which were easily resolved with conservative treatment. No significant differences were observed in forced vital capacity, albumin level, or age between patients with (n = 6) and without (n = 43) major complications. PEG is an effective, relatively safe procedure for the enteral nutrition of patients with ALS, although not without morbidity and mortality. Neither forced vital capacity nor the form of presentation of ALS were associated with morbidity in PEG. Copyright © 2018 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial.

PubMed

Hézode, Christophe; Asselah, Tarik; Reddy, K Rajender; Hassanein, Tarek; Berenguer, Marina; Fleischer-Stepniewska, Katarzyna; Marcellin, Patrick; Hall, Coleen; Schnell, Gretja; Pilot-Matias, Tami; Mobashery, Niloufar; Redman, Rebecca; Vilchez, Regis A; Pol, Stanislas

2015-06-20

Hepatitis C virus (HCV) genotype 4 accounts for about 13% of global HCV infections. Because interferon-containing treatments for genotype 4 infection have low efficacy and poor tolerability, an unmet need exists for effective all-oral regimens. We examined the efficacy and safety of an all-oral interferon-free regimen of ombitasvir, an NS5A inhibitor, and paritaprevir (ABT-450), an NS3/4A protease inhibitor dosed with ritonavir (ombitasvir plus paritaprevir plus ritonavir), given with or without ribavirin. In this multicentre ongoing phase 2b, randomised, open-label combination trial (PEARL-I), patients were recruited from academic, public, and private hospitals and clinics in France, Hungary, Italy, Poland, Romania, Spain, Turkey, and the USA. Eligible participants were aged 18-70 years with non-cirrhotic, chronic HCV genotype 4 infection (documented ≥6 months before screening) and plasma HCV RNA levels higher than 10,000 IU/mL. Previously untreated (treatment-naive) patients were randomly assigned (1:1) by computer-generated randomisation lists to receive once-daily ombitasvir (25 mg) plus paritaprevir (150 mg) plus ritonavir (100 mg) with or without weight-based ribavirin for 12 weeks. Previously treated (treatment-experienced) patients who had received pegylated interferon plus ribavirin all received the ribavirin-containing regimen. The primary endpoint was a sustained virological response (HCV RNA <25 IU/mL) 12 weeks after the end of treatment (SVR12). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01685203. Between Aug 14, 2012, and Nov 19, 2013, 467 patients with HCV infection were screened, of whom 174 were infected with genotype 4. 135 patients were randomly assigned to treatment and received at least one dose of study medication; 86 patients were treatment-naive, of whom 44 received ombitasvir plus paritaprevir plus ritonavir and 42 received ombitasvir plus paritaprevir plus ritonavir with ribavirin, and 49 treatment-experienced patients received the ribavirin-containing regimen. In previously untreated patients, SVR12 rates were 100% (42/42 [95% CI 91·6-100]) in the ribavirin-containing regimen and 90·9% (40/44 [95% CI 78·3-97·5]) in the ribavirin-free regimen. No statistically significant differences in SVR12 rates were noted between the treatment-naive groups (mean difference -9·16% [95% CI -19·61 to 1·29]; p=0·086). All treatment-experienced patients achieved SVR12 (49/49; 100% [95% CI 92·7-100]). In the ribavirin-free group, two (5%) of 42 treatment-naive patients had virological relapse, and one (2%) of 44 had virological breakthrough; no virological failures were recorded in the ribavirin-containing regimen. The most common adverse event was headache (14 [29%] of 49 treatment-experienced patients and 14 [33%] of 42 treatment-naive patients). No adverse event-related discontinuations or dose interruptions of study medications, including ribavirin, were noted, and only four patients (4%) of 91 receiving ribavirin required dose modification for haemoglobin less than 100 g/L or anaemia. An interferon-free regimen of ombitasvir plus paritaprevir plus ritonavir with or without ribavirin achieved high sustained virological response rates at 12 weeks after the end of treatment and was generally well tolerated, with low rates of anaemia and treatment discontinuation in non-cirrhotic previously untreated and previously treated patients with HCV genotype 4 infection. AbbVie. Copyright © 2015 Elsevier Ltd. All rights reserved.

Unilateral Radiotherapy for the Treatment of Tonsil Cancer

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

Chronowski, Gregory M., E-mail: gchronowski@mdanderson.org; Garden, Adam S.; Morrison, William H.

2012-05-01

Purpose: To assess, through a retrospective review, clinical outcomes of patients with squamous cell carcinoma of the tonsil treated at the M. D. Anderson Cancer Center with unilateral radiotherapy techniques that irradiate the involved tonsil region and ipsilateral neck only. Methods and Materials: Of 901 patients with newly diagnosed squamous cell carcinoma of the tonsil treated with radiotherapy at our institution, we identified 102 that were treated using unilateral radiotherapy techniques. All patients had their primary site of disease restricted to the tonsillar fossa or anterior pillar, with <1 cm involvement of the soft palate. Patients had TX (n =more » 17 patients), T1 (n = 52), or T2 (n = 33) disease, with Nx (n = 3), N0 (n = 33), N1 (n = 23), N2a (n = 21), or N2b (n = 22) neck disease. Results: Sixty-one patients (60%) underwent diagnostic tonsillectomy before radiotherapy. Twenty-seven patients (26%) underwent excision of a cervical lymph node or neck dissection before radiotherapy. Median follow-up for surviving patients was 38 months. Locoregional control at the primary site and ipsilateral neck was 100%. Two patients experienced contralateral nodal recurrence (2%). The 5-year overall survival and disease-free survival rates were 95% and 96%, respectively. The 5-year freedom from contralateral nodal recurrence rate was 96%. Nine patients required feeding tubes during therapy. Of the 2 patients with contralateral recurrence, 1 experienced an isolated neck recurrence and was salvaged with contralateral neck dissection only and remains alive and free of disease. The other patient presented with a contralateral base of tongue tumor and involved cervical lymph node, which may have represented a second primary tumor, and died of disease. Conclusions: Unilateral radiotherapy for patients with TX-T2, N0-N2b primary tonsil carcinoma results in high rates of disease control, with low rates of contralateral nodal failure and a low incidence of acute toxicity requiring gastrostomy.« less

Precision radiotherapy for cancer of the pancreas: technique and results. [Photons and electrons

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

Dobelbower, R.R. Jr.; Borgelt, B.B.; Strubler, K.A.

1980-09-01

Forty patients with locally extensive, unresectable adenocarcinoma of the pancreas received precision high dose (PHD) radiation therapy with a 45 MeV betatron. PHD radiotherapy was generally well tolerated. During treatment, only 7 patients experienced significant nausea, vomiting, diarrhea or anorexia. Late gastrointestinal radiation reactions were observed in 7 patients. Twelve patients received adjuvant chemotherapy. The projected survival of patients with unresectable pancreatic cancer treated with PHD radiotherapy is comparable to that of patients with resectable disease operated on for cure. The projected one year survival rate is 49%.

Dose to organs at risk in the upper abdomen in patients treated with extended fields by helical tomotherapy: a dosimetric and clinical preliminary study

PubMed Central

2013-01-01

Background The aim of this work was to determine the technical feasibility and safety of extended-field radiotherapy (EF), performed by Helical TomoTherapy, in patients with positive pelvic and/or para-aortic nodes. Dosimetric data were collected and acute and sub-acute toxicities of the upper abdominal organs at risk (OAR) were evaluated. Methods Twenty-nine patients suitable for EF irradiation for local disease and/or nodal disease in the pelvic or para-aortic area were treated. The prescription dose was 50.4/54 Gy (1.7-1.8 Gy/fraction) for prophylactic lymph nodes (N-) and 60–70.5 Gy (2–2.35 Gy/fraction) for clinically evident gross disease (N+). Modulation factor (MF), pitch and field width (FW) were chosen to optimize dose distribution and treatment duration. Dose values of PTVs and OAR were analysed. The length of the treatment field, the N + and N- volumes, and treatment duration were reported. To evaluate the safety of treatment, haematological, hepatic, renal and pancreatic functions were assessed before, during and after treatment. The median follow-up time was 17.6 months (range: 6–22 months). Results The treatment was well tolerated and all patients but one completed treatment without interruption. Four of the 29 patients experienced G3 haematological acute toxicity (13.8%), but no patient experienced sub-acute grade G3 toxicity. Ten patients experienced G1 and three G2 acute gastrointestinal toxicity (nausea). No sub-acute gastrointestinal or renal toxicity was observed. Only one (3.7%) patient had a persistent slight increase of pancreatic enzymes and two (7.4%) patients a slight increase of hepatic enzymes six months after radiotherapy (G1 toxicity). Conclusions With our treatment design and dose regimen, we found that EF treatment by TomoTherapy could be safely and effectively delivered with minimal acute and sub-acute toxicities in the upper abdomen area. PMID:24160769

Dose to organs at risk in the upper abdomen in patients treated with extended fields by helical tomotherapy: a dosimetric and clinical preliminary study.

PubMed

Bresciani, Sara; Garibaldi, Elisabetta; Cattari, Gabriella; Maggio, Angelo; Di Dia, Amalia; Delmastro, Elena; Gabriele, Domenico; Stasi, Michele; Gabriele, Pietro

2013-10-25

The aim of this work was to determine the technical feasibility and safety of extended-field radiotherapy (EF), performed by Helical TomoTherapy, in patients with positive pelvic and/or para-aortic nodes. Dosimetric data were collected and acute and sub-acute toxicities of the upper abdominal organs at risk (OAR) were evaluated. Twenty-nine patients suitable for EF irradiation for local disease and/or nodal disease in the pelvic or para-aortic area were treated. The prescription dose was 50.4/54 Gy (1.7-1.8 Gy/fraction) for prophylactic lymph nodes (N-) and 60-70.5 Gy (2-2.35 Gy/fraction) for clinically evident gross disease (N+). Modulation factor (MF), pitch and field width (FW) were chosen to optimize dose distribution and treatment duration. Dose values of PTVs and OAR were analysed. The length of the treatment field, the N + and N- volumes, and treatment duration were reported. To evaluate the safety of treatment, haematological, hepatic, renal and pancreatic functions were assessed before, during and after treatment. The median follow-up time was 17.6 months (range: 6-22 months). The treatment was well tolerated and all patients but one completed treatment without interruption. Four of the 29 patients experienced G3 haematological acute toxicity (13.8%), but no patient experienced sub-acute grade G3 toxicity. Ten patients experienced G1 and three G2 acute gastrointestinal toxicity (nausea). No sub-acute gastrointestinal or renal toxicity was observed. Only one (3.7%) patient had a persistent slight increase of pancreatic enzymes and two (7.4%) patients a slight increase of hepatic enzymes six months after radiotherapy (G1 toxicity). With our treatment design and dose regimen, we found that EF treatment by TomoTherapy could be safely and effectively delivered with minimal acute and sub-acute toxicities in the upper abdomen area.

Favorable Preliminary Outcomes for Men With Low- and Intermediate-risk Prostate Cancer Treated With 19-Gy Single-fraction High-dose-rate Brachytherapy

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

Krauss, Daniel J., E-mail: dkrauss@beaumont.edu; Ye, Hong; Martinez, Alvaro A.

Purpose: To report the toxicity and preliminary clinical outcomes of a prospective trial evaluating 19-Gy, single-fraction high-dose-rate (HDR) brachytherapy for men with low- and intermediate-risk prostate cancer. Methods and Materials: A total of 63 patients were treated according to an institutional review board-approved prospective study of single-fraction HDR brachytherapy. Eligible patients had tumor stage ≤T2a, prostate-specific antigen level ≤15 ng/mL, and Gleason score ≤7. Patients with a prostate gland volume >50 cm{sup 3} and baseline American Urologic Association symptom score >12 were ineligible. Patients underwent transrectal ultrasound-guided transperineal implantation of the prostate, followed by single-fraction HDR brachytherapy. Treatment was delivered using {sup 192}Irmore » to a dose of 19 Gy prescribed to the prostate, with no additional margin applied. Results: Of the 63 patients, 58 had data available for analysis. Five patients had withdrawn consent during the follow-up period. The median follow-up period was 2.9 years (range 0.3-5.2). The median age was 61.4 years. The median gland volume at treatment was 34.8 cm{sup 3}. Of the 58 patients, 91% had T1 disease, 71% had Gleason score ≤6 (29% with Gleason score 7), and the median pretreatment prostate-specific antigen level was 5.1 ng/mL. The acute and chronic grade 2 genitourinary toxicity incidence was 12.1% and 10.3%, respectively. No grade 3 urinary toxicity occurred. No patients experienced acute rectal toxicity grade ≥2, and 2 experienced grade ≥2 chronic gastrointestinal toxicity. Three patients experienced biochemical failure, yielding a 3-year cumulative incidence estimate of 6.8%. Conclusions: Single-fraction HDR brachytherapy is well-tolerated, with favorable preliminary biochemical and clinical disease control rates.« less

Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care.

PubMed

Kolotkin, Ronette L; Corey-Lisle, Patricia K; Crosby, Ross D; Kan, Hong J; McQuade, Robert D

2008-12-01

This is a secondary analysis of clinical trial data collected in 12 European countries. We examined changes in weight and weight-related quality of life among community patients with schizophrenia treated with aripiprazole (ARI) versus standard of care (SOC), consisting of other marketed atypical antipsychotics (olanzapine, quetiapine, and risperidone). Five-hundred and fifty-five patients whose clinical symptoms were not optimally controlled and/or experienced tolerability problems with current medication were randomized to ARI (10-30 mg/day) or SOC. Weight and weight-related quality of life (using the IWQOL-Lite) were assessed at baseline, and weeks 8, 18 and 26. Random regression analysis across all time points using all available data was used to compare groups on changes in weight and IWQOL-Lite. Meaningful change from baseline was also assessed. Participants were 59.7% male, with a mean age of 38.5 years (SD 10.9) and mean baseline body mass index of 27.2 (SD 5.1). ARI participants lost an average of 1.7% of baseline weight in comparison to a gain of 2.1% by SOC participants (p<0.0001) at 26 weeks. ARI participants experienced significantly greater increases in physical function, self-esteem, sexual life, and IWQOL-Lite total score. At 26 weeks, 20.7% of ARI participants experienced meaningful improvements in IWQOL-Lite score, versus 13.5% of SOC participants. A clinically meaningful change in weight was also associated with a meaningful change in quality of life (p<0.001). A potential limitation of this study was its funding by a pharmaceutical company. Compared to standard of care, patients with schizophrenia treated with aripiprazole experienced decreased weight and improved weight-related quality of life over 26 weeks. These changes were both statistically and clinically significant.

The Weekend Effect in AAA Repair.

PubMed

O'Donnell, Thomas F X; Li, Chun; Swerdlow, Nicholas J; Liang, Patric; Pothof, Alexander B; Patel, Virendra I; Giles, Kristina A; Malas, Mahmoud B; Schermerhorn, Marc L

2018-04-18

Conflicting reports exist regarding whether patients undergoing surgery on the weekend or later in the week experience worse outcomes. We identified patients undergoing abdominal aortic aneurysm (AAA) repair in the Vascular Quality Initiative between 2009 and 2017 [n = 38,498; 30,537 endovascular aneurysm repair (EVAR) and 7961 open repair]. We utilized mixed effects logistic regression to compare adjusted rates of perioperative mortality based on the day of repair. Tuesday was the most common day for elective repair (22%), Friday for symptomatic repairs (20%), and ruptured aneurysms were evenly distributed. Patients with ruptured aneurysms experienced similar adjusted mortality whether they underwent repair during the week or on weekends. Transfers of ruptured AAA were more common over the weekend. However, patients transferred on the weekend experienced higher adjusted mortality than those transferred during the week (28% vs 21%, P = 0.02), despite the fact that during the week, transferred patients actually experienced lower adjusted mortality than patients treated at the index hospital (21% vs 31%, P < 0.01). Among symptomatic patients, adjusted mortality was higher for those undergoing repair over the weekend than those whose surgeries were delayed until a weekday (7.9% vs 3.1%, P = 0.02). Adjusted mortality in elective cases did not vary across the days of the week. Results were consistent between open and EVAR patients. We found no evidence of a weekend effect for ruptured or symptomatic AAA repair. However, patients with ruptured AAA transferred on the weekend experienced higher mortality than those transferred during the week, suggesting a need for improvement in weekend transfer processes.

Outcomes of Peripheral Vascular Interventions in Select Patients With Lower Extremity Acute Limb Ischemia.

PubMed

Inagaki, Elica; Farber, Alik; Kalish, Jeffrey A; Eslami, Mohammad H; Siracuse, Jeffrey J; Eberhardt, Robert T; Rybin, Denis V; Doros, Gheorghe; Hamburg, Naomi M

2018-04-12

Contemporary data on patients presenting with acute limb ischemia (ALI), who are selected for treatment with endovascular peripheral vascular interventions (PVI), are limited. Our study examined outcomes following endovascular PVI in patients with ALI by comparing with patients treated for chronic critical limb ischemia using a regional quality improvement registry. Of the 11 035 patients in the Vascular Study Group of New England PVI database (2010-2014), we identified 365 patients treated for lower extremity ALI who were 5:1 frequency matched (by procedure year and arterial segments treated) to 1808 patients treated for critical limb ischemia. ALI patients treated with PVI had high burden of atherosclerotic risk factors and were more likely to have had prior ipsilateral revascularizations. ALI patients were less likely to be treated with self-expanding stents and more likely to undergo thrombolysis than patients with critical limb ischemia. In multivariable analysis, ALI was associated with higher technical failure (odds ratio 1.7, 95% confidence interval, 1.1%-2.5%), increased rate of distal embolization (odds ratio 2.7, 95% confidence interval, 1.5%-4.9%), longer length of stay (means ratio 1.6, 95% confidence interval, 1.4%-1.8%), and higher in-hospital mortality (odds ratio 2.8, 95% confidence interval, 1.3%-5.9%). ALI was not associated with risk of major amputation or mortality at 1 year. In a multicenter cohort of patients treated with PVI, we found that ALI patients selected for treatment with endovascular techniques experienced greater short-term adverse events but similar long-term outcomes as their critical limb ischemia counterparts. Further studies are needed to refine the selection of ALI patients who are best served by PVI. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Safety of Resuming Tumor Necrosis Factor Inhibitors in Ankylosing Spondylitis Patients Concomitant with the Treatment of Active Tuberculosis: A Retrospective Nationwide Registry of the Korean Society of Spondyloarthritis Research

PubMed Central

Kim, Hye Won; Kwon, Seong Ryul; Jung, Kyong-Hee; Kim, Seong-Kyu; Baek, Han Joo; Seo, Mi Ryung; Bang, So-Young; Lee, Hye-Soon; Suh, Chang-Hee; Jung, Ju Yang; Son, Chang-Nam; Shim, Seung Cheol; Lee, Sang-Hoon; Lee, Seung-Geun; Lee, Yeon-Ah; Lee, Eun Young; Kim, Tae-Hwan

2016-01-01

Backgrounds Patients who develop an active tuberculosis infection during tumor necrosis factor (TNF) inhibitor treatment typically discontinue TNF inhibitor and receive standard anti-tuberculosis treatment. However, there is currently insufficient information on patient outcomes following resumption of TNF inhibitor treatment during ongoing anti- tuberculosis treatment. Our study was designed to investigate the safety of resuming TNF inhibitors in ankylosing spondylitis (AS) patients who developed tuberculosis as a complication of the use of TNF inhibitors. Methods Through the nationwide registry of the Korean Society of Spondyloarthritis Research, 3929 AS patients who were prescribed TNF inhibitors were recruited between June 2003 and June 2014 at fourteen referral hospitals. Clinical information was analyzed about the patients who experienced tuberculosis after exposure to TNF inhibitors. The clinical features of resumers and non-resumers of TNF inhibitors were compared and the outcomes of tuberculosis were surveyed individually. Findings Fifty-six AS patients were treated for tuberculosis associated with TNF inhibitors. Among them, 23 patients resumed TNF inhibitors, and these patients were found to be exposed to TNF inhibitors for a longer period of time and experienced more frequent disease flare-up after discontinuation of TNF inhibitors compared with those who did not resume. Fifteen patients resumed TNF inhibitors during anti-tuberculosis treatment (early resumers) and 8 after completion of anti-tuberculosis treatment (late resumers). Median time to resuming TNF inhibitor from tuberculosis was 3.3 and 9.0 months in the early and late resumers, respectively. Tuberculosis was treated successfully in all resumers and did not relapse in any of them during follow-up (median 33.8 [IQR; 20.8–66.7] months). Conclusions Instances of tuberculosis were treated successfully in our AS patients, even when given concomitantly with TNF inhibitors. We suggest that early resumption of TNF inhibitors in AS patients could be safe under effective coverage of tuberculosis. PMID:27101309

Pretransplant thymic function predicts acute rejection in antithymocyte globulin-treated renal transplant recipients.

PubMed

Bamoulid, Jamal; Courivaud, Cécile; Crepin, Thomas; Carron, Clémence; Gaiffe, Emilie; Roubiou, Caroline; Laheurte, Caroline; Moulin, Bruno; Frimat, Luc; Rieu, Philippe; Mousson, Christiane; Durrbach, Antoine; Heng, Anne-Elisabeth; Rebibou, Jean-Michel; Saas, Philippe; Ducloux, Didier

2016-05-01

Lack of clear identification of patients at high risk of acute rejection hampers the ability to individualize immunosuppressive therapy. Here we studied whether thymic function may predict acute rejection in antithymocyte globulin (ATG)-treated renal transplant recipients in 482 patients prospectively studied during the first year post-transplant of which 86 patients experienced acute rejection. Only CD45RA(+)CD31(+)CD4(+) T cell (recent thymic emigrant [RTE]) frequency (RTE%) was marginally associated with acute rejection in the whole population. This T-cell subset accounts for 26% of CD4(+) T cells. Pretransplant RTE% was significantly associated with acute rejection in ATG-treated patients (hazard ratio, 1.04; 95% confidence interval, 1.01-1.08) for each increased percent in RTE/CD4(+) T cells), but not in anti-CD25 monoclonal (αCD25 mAb)-treated patients. Acute rejection was significantly more frequent in ATG-treated patients with high pretransplant RTE% (31.2% vs. 16.4%) or absolute number of RTE/mm(3) (31.7 vs. 16.1). This difference was not found in αCD25 monclonal antibody-treated patients. Highest values of both RTE% (>31%, hazard ratio, 2.50; 95% confidence interval, 1.09-5.74) and RTE/mm(3) (>200/mm(3), hazard ratio, 3.71; 95% confidence interval, 1.59-8.70) were predictive of acute rejection in ATG-treated patients but not in patients having received αCD25 monoclonal antibody). Results were confirmed in a retrospective cohort using T-cell receptor excision circle levels as a marker of thymic function. Thus, pretransplant thymic function predicts acute rejection in ATG-treated patients. Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

A Modeling and Simulation Framework for Adverse Events in Erlotinib-Treated Non-Small-Cell Lung Cancer Patients.

PubMed

Suleiman, Ahmed Abbas; Frechen, Sebastian; Scheffler, Matthias; Zander, Thomas; Nogova, Lucia; Kocher, Martin; Jaehde, Ulrich; Wolf, Jürgen; Fuhr, Uwe

2015-11-01

Treatment with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor used for treating non-small-cell lung cancer (NSCLC) and other cancers, is frequently associated with adverse events (AE). We present a modeling and simulation framework for the most common erlotinib-induced AE, rash, and diarrhea, providing insights into erlotinib toxicity. We used the framework to investigate the safety of high-dose erlotinib pulses proposed to limit acquired resistance while treating NSCLC. Continuous-time Markov models were developed using rash and diarrhea AE data from 39 NSCLC patients treated with erlotinib (150 mg/day). Exposure and different covariates were investigated as predictors of variability. Rash was also tested as a survival predictor. Models developed were used in a simulation analysis to compare the toxicities of different regimens, including the previously mentioned pulsed strategy. Probabilities of experiencing rash or diarrhea were found to be highest early during treatment. Rash, but not diarrhea, was positively correlated with erlotinib exposure. In contrast with some common understandings, radiotherapy decreased transitioning to higher rash grades by 81% (p < 0.01), and experiencing rash was not correlated with positive survival outcomes. Model simulations predicted that the proposed pulsed regimen (1600 mg/week + 50 mg/day remaining week days) results in a maximum of 20% of the patients suffering from severe rash throughout the treatment course in comparison to 12% when treated with standard dosing (150 mg/day). In conclusion, the framework demonstrated that radiotherapy attenuates erlotinib-induced rash, providing an opportunity to use radiotherapy and erlotinib together, and demonstrated the tolerability of high-dose pulses intended to address acquired resistance to erlotinib.

Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials.

PubMed

Camporeale, Angelo; Porsdal, Vibeke; De Bruyckere, Katrien; Tanaka, Yoko; Upadhyaya, Himanshu; Deix, Claudia; Deberdt, Walter

2015-01-01

The safety profile of atomoxetine in the treatment of attention deficit hyperactivity disorder has been studied in many clinical trials. We performed an integrated safety analysis of 15 clinical trials in adults with attention deficit hyperactivity disorder. The analysis pooled patient data into three groups: acute placebo-controlled trials; long-term placebo-controlled trials; all trials. In total, 4829 adults (18-77 years, median: 36 years) were exposed to atomoxetine. Statistically significantly more atomoxetine-treated than placebo-treated patients experienced treatment-emergent adverse events (81.3% vs. 68.3% acute; 90.6% vs. 76.8% long term) and discontinued due to adverse events (8.9% vs. 4.0% acute; 17.9% vs. 6.3% long term). No statistically significant differences were observed in the proportion of patients experiencing serious adverse events. No previously unknown adverse events were identified. The most common adverse events included nausea, dry mouth, decreased appetite, insomnia and erectile dysfunction. Mean increases in heart rate (+5.2 beats per min) and blood pressure (systolic +2 mmHg, diastolic +1.9 mmHg) were modest. The proportion of patients experiencing clinically significant increases in blood pressure and heart rate at any time was statistically significantly higher with atomoxetine (systolic blood pressure 13-17%, diastolic blood pressure 37-40%, heart rate 42-43%) compared to placebo (systolic blood pressure 8-13%, diastolic blood pressure 29-34%, heart rate 21-26%). There was no increased risk of suicidal ideation or behaviour. Our findings confirm atomoxetine's known safety profile. From a safety perspective, atomoxetine is a useful treatment option for adults with attention deficit hyperactivity disorder. © The Author(s) 2014.

Clobazam-Treated Patients with Lennox Gastaut Syndrome Experienced Fewer Seizure-Related Injuries than Placebo Patients During Trail OV-1012

DTIC Science & Technology

2016-08-19

injuries based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms from all adverse event (AE) listings. Patients receiving...injuries For this post hoc analysis, medical review of all adverse event (AE) listings, based on Medical Dictionary for Regu- latory Activities (MedDRA...study results of clobazam in Lennox-Gastaut syndrome. Neurology 2011;77:1473–1481. 5. Medical Dictionary for Regulatory Activities. Available at: http

Management of Radiation-induced Severe Anophthalmic Socket Contracture in Patients with Uveal Melanoma

PubMed Central

Nasser, Qasiem J.; Gombos, Dan S.; Williams, Michelle D.; Guadagnolo, B. Ashleigh; Morrison, William H.; Garden, Adam S.; Beadle, Beth M.; Canseco, Elvia; Esmaeli, Bita

2012-01-01

Purpose High-dose radiotherapy can cause contracture of the anophthalmic socket, but the incidence of this complication in patients with enucleation for uveal melanoma has not previously been reported. We reviewed the surgical management and outcomes in terms of successful prosthesis wear in patients with severe contracture of the anophthalmic socket treated with high-dose radiotherapy for high-risk uveal melanoma and estimated the relative risk of this complication. Methods The medical records of all consecutive patients enrolled in a prospective uveal-melanoma tissue-banking protocol at our institution who underwent enucleation between January 2003 and December 2010 were reviewed. Patients who underwent adjuvant radiotherapy of the enucleated socket were further studied. Results Of the 68 patients enrolled in the prospective tissue banking protocol, 12 had high-risk histologic features (e.g., extrascleral spread or vortex vein invasion) and were treated with 60 Gy of external-beam radiotherapy after enucleation. Five of these patients (41.7%) experienced severe socket contracture precluding prosthesis wear. The median time to onset of contracture following completion of radiotherapy was 20 months. Three patients underwent surgery, which entailed scar tissue release, oral mucous membrane grafting, and socket reconstruction; 2 patients declined surgery. All 3 patients who had surgery experienced significant improvement of socket contracture that enabled patients to wear a prosthesis again. Conclusion High-dose radiotherapy after enucleation in patients with uveal melanoma caused severe socket contracture and inability to wear a prosthesis in approximately 40% of patients. Surgical repair of the contracted socket using oral mucous membrane grafting can allow resumption of prosthesis wear. PMID:22581085

Simultaneous Delorme's procedure and inter-sphinteric prosthetic implant for the treatment of rectal prolapse and faecal incontinence: preliminary experience and literature review.

PubMed

Cavazzoni, Emanuel; Rosati, Emanuele; Zavagno, Valentina; Graziosi, Luigina; Donini, Annibale

2015-02-01

Rectal prolapse is a distressing condition affecting mostly elderly patients and females. Delorme's procedure is frequently performed since it offers good results and is burdened by a particularly low morbidity. Faecal Incontinence is associated with prolapse in a large percentage of patients, due to the sphincter damage caused by the prolapsed rectum through the anal canal. Prolapse resection is often ineffective in treating incontinence, and further specific procedures are frequently required. At present, no data are available on combined Delorme's procedure with the implant of Bulking Agents for the simultaneous treatment of rectal prolapse and faecal incontinence. Three patients affected by complete external rectal prolapse underwent simultaneous Delorme's procedure with application of six polyacrylonitrile prosthetic cylinders in the inter-sphinteric space (Gate Keeper™, THD, Correggio Italy). Follow up was at 3,6 and 12 months. Gate Keeper procedure required a short operative time; no morbidity or complications were experienced. Prolapse was successfully treated in all patients and the mean Vaizey's incontinence score value dropped from pre-operative 19.3 to 9.3 after 3 months. All patients experienced a reduction of incontinence episodes and an improvement in daily activities and lifestyle. Gate Keeper implant is feasible and safe when associated to surgical procedures like Delorme's prolapse resection. Preliminary results are positive even if a study with a larger numbers of patients is needed to confirm the efficacy. A simultaneous treatment of faecal incontinence should be always considered when performing surgery for rectal prolapse. The present manuscript describes a simultaneous combination of two surgical techniques to treat rectal prolapse and faecal incontinence. To date, there are no published data on a similar approach. The paper underlies the importance of treating faecal incontinence when performing surgery for rectal prolapse. Copyright © 2015 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

The incidence of wound complications related to negative pressure wound therapy power outage and interruption of treatment in orthopaedic trauma patients.

PubMed

Collinge, Cory; Reddix, Robert

2011-02-01

Negative pressure wound therapy (NPWT) using the Vacuum Assisted Closure system is an invaluable tool for use on patients with complex limb and soft tissue problems. Recently, the manufacturer (Kinetic Concepts, Inc, San Antonio, TX) made significant modifications to the NPWT platform, including computer software, battery, alarming systems, electric cord and plug apparatus, and others. Since these modifications, we have seen several cases in which the NPWT device has powered off resulting in an unrecognized interruption of therapy. We sought to evaluate the conditions and clinical effects, if any, to orthopaedic trauma patients who experienced an interruption of NPWT therapy when the device powers off. Retrospective study of consecutive patients. Two neighboring regional trauma centers. One hundred twenty-three consecutive orthopaedic trauma patients treated with NPWT by two orthopaedic trauma surgeons between May and November 2008. Patient/injury, treatment, and perioperative clinical outcomes data (with emphasis on wound complications such as infection, graft loss, and unscheduled surgery) were collected from medical records and wound care databases. Twelve patients (10%) had problems with the NPWT device powering off causing an unrecognized interruption of therapy. Eleven patients underwent early (less than 6 hours) wound débridement and reapplication of NPWT after detection, of which nine required unplanned surgery. Seven of the 12 patients recognized as having failed NPWT of this type ultimately experienced wound complications, including five deep infections and both patients being treated with an Integra graft (loss of graft). We have seen substantial problems in orthopaedic trauma patients treated with the NPWT, in which the device has powered off resulting in an unrecognized interruption of therapy. This has resulted in atypically unhealthy-appearing wounds, unplanned surgeries for débridement, and most importantly, an increased incidence of wound complications, including infection and graft loss (P < 0.05).

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

Lee, C.K.K.; Bloomfield, C.D.; Goldman, A.I.

Since Hodgkin's disease patients with large mediastinal masses frequently relapse in the intrathoracic area after regular mantle field irradiation, the feasibility and utility of low dose lung irradiation as an initial part of the supradiaphragmatic field was examined. Fifteen newly diagnosed patients with Hodgkin's disease and large mediastinal masses were treated with 1000 to 2000 rad to the lung as a part of extended field radiotherapy. All patients received radiotherapy alone. Results of treatment were compared with those in 20 similar patients who were treated only with extended field irradiation. With a minimum follow-up of 24 months, only 2 patientsmore » (13%) who received lung irradiation have recurred and only one of these recurred in the lung. In contrast 15 (79%) of the 19 complete responders who were treated without lung irradiation had relapsed by 24 months, 9 in the intrathoracic region. Recurrence-free survival was significantly longer in patients who received lung irradiation. No increased frequency in serious complications has been experienced to date with low dose whole lung irradiation, compared with regular mantle field treatment. This study suggests that lung irradiation may be a feasible alternative to adjuvant combination chemotherapy when treating patients with Hodgkin's desease and large mediastinal masses.« less

Peginterferon Alfa-2a plus Ribavirin in Japanese Patients Infected with Hepatitis C Virus Genotype 2 Who Failed Previous Interferon Therapy

PubMed Central

Kanda, Tatsuo; Nakamoto, Shingo; Nishino, Takayoshi; Takada, Nobuo; Tsubota, Akihito; Kato, Keizo; Miyamura, Tatsuo; Maruoka, Daisuke; Wu, Shuang; Tanaka, Takeshi; Arai, Makoto; Mikami, Shigeru; Fujiwara, Keiichi; Imazeki, Fumio; Yokosuka, Osamu

2013-01-01

Some patients infected with hepatitis C virus (HCV) genotype 2 could be cured with treatment shorter than 24 weeks using peginterferon plus ribavirin, but there are still treatment-refractory patients. Direct-acting antivirals (DAAs) are not currently available for HCV genotype 2 patients, different from genotype 1 patients, in clinical practice. We investigated 29 HCV genotype 2-infected Japanese patients who had been previously treated and failed to clear HCV. We retreated them with peginterferon alfa-2a plus ribavirin and measured HCV RNA level to assess the efficacy and safety of this treatment in patients who had failed previous therapy. We found that retreatment of HCV genotype 2-infected Japanese patients with peginterferon alfa-2a plus ribavirin for 24-48 weeks led to 60 to 66.6% sustained virological response (SVR) in patients previously treated with (peg-)interferon monotherapy and to 69.9% SVR in relapsers previously treated with peginterferon plus ribavirin. Attention should be paid to certain patients with unique features. Selection of patients according to their previous treatment could lead to optimal therapy in HCV genotype 2 treatment-experienced patients. PMID:23289004

Retrospective study evaluating dose standards for infliximab in patients with rheumatoid arthritis at Hospital Israelita Albert Einstein, São Paulo, Brazil.

PubMed

Scheinberg, Morton; Goldenberg, José; Feldman, Daniel P; Nóbrega, João Luiz

2008-08-01

We determined, in our surrounding environment, the proportion of patients being treated with infliximab who required a therapeutic scheme escalation (an infliximab dose increase surpassing the level of 3 mg/kg every 8 weeks and/or a decrease on the current between infusions' interval). This was a study of the retrospective analysis of data from the 41 rheumatoid arthritis (RA) patients receiving an infliximab therapy at the Albert Einstein Israelita Hospital, from January 2001 up to December 2005. A questionnaire was applied to these patients, assessing their clinical and laboratory data, adverse events, and individual information regarding the infliximab administration. Therapeutic dose information was available in 68% (28/41) of the RA patients, with 46% of these (13/28) receiving a dose increase, and 30% (8/27) experiencing a shortening of the between infusions' interval. The average final infliximab dose (4.21 mg/kg) was significantly greater than their average initial dose (3.29 mg/kg). The average time intervals between the initial and final infusions, though shortened, were not significantly different. A proportion of 73% (30/41) of these patients demonstrated improvement in at least one of the assessed clinical parameters, and 50% of these patients (15/30) experienced a dose increase, while 20% (6/30) experienced shortening of the between treatments' interval. A total of 20% (8/41) of the original patients experienced adverse events. Although infliximab is effective in the control of RA, dose adjustment and/or shortening of the between treatments' interval is frequently required.

Proton pump inhibitor use and risk of adverse cardiovascular events in aspirin treated patients with first time myocardial infarction: nationwide propensity score matched study

PubMed Central

Grove, Erik L; Hansen, Peter Riis; Olesen, Jonas B; Ahlehoff, Ole; Selmer, Christian; Lindhardsen, Jesper; Madsen, Jan Kyst; Køber, Lars; Torp-Pedersen, Christian; Gislason, Gunnar H

2011-01-01

Objective To examine the effect of proton pump inhibitors on adverse cardiovascular events in aspirin treated patients with first time myocardial infarction. Design Retrospective nationwide propensity score matched study based on administrative data. Setting All hospitals in Denmark. Participants All aspirin treated patients surviving 30 days after a first myocardial infarction from 1997 to 2006, with follow-up for one year. Patients treated with clopidogrel were excluded. Main outcome measures The risk of the combined end point of cardiovascular death, myocardial infarction, or stroke associated with use of proton pump inhibitors was analysed using Kaplan-Meier analysis, Cox proportional hazard models, and propensity score matched Cox proportional hazard models. Results 3366 of 19 925 (16.9%) aspirin treated patients experienced recurrent myocardial infarction, stroke, or cardiovascular death. The hazard ratio for the combined end point in patients receiving proton pump inhibitors based on the time dependent Cox proportional hazard model was 1.46 (1.33 to 1.61; P<0.001) and for the propensity score matched model based on 8318 patients it was 1.61 (1.45 to 1.79; P<0.001). A sensitivity analysis showed no increase in risk related to use of H2 receptor blockers (1.04, 0.79 to 1.38; P=0.78). Conclusion In aspirin treated patients with first time myocardial infarction, treatment with proton pump inhibitors was associated with an increased risk of adverse cardiovascular events. PMID:21562004

Efficacy and Safety of Methylnaltrexone for Opioid-Induced Constipation in Patients With Chronic Noncancer Pain

PubMed Central

Viscusi, Eugene R.; Barrett, Andrew C.; Paterson, Craig; Forbes, William P.

2016-01-01

Background and Objectives In patients with chronic noncancer pain, subcutaneous methylnaltrexone for opioid-induced constipation (OIC) was examined in a randomized controlled trial (RCT) followed by an open-label extension (OLE). This study examined the reproducibility of RCT findings by analyzing data from placebo-treated patients who crossed over to methylnaltrexone. Methods Adults with less than 3 weekly rescue-free bowel movements (RFBMs), taking 50 mg or more of an oral morphine equivalent per day, were randomized to receive methylnaltrexone 12 mg or placebo for 4 weeks, followed by open-label methylnaltrexone 12 mg as needed for 8 weeks. Results A total of 134 placebo-treated patients (median morphine equivalent dose, 150 mg/d; mean of 1.1 RFBM per week) crossed over to methylnaltrexone in OLE. During the RCT, 9.7% of placebo-treated patients experienced an RFBM within 4 hours of first dose and 9.0% of all placebo injections resulted in an RFBM within 4 hours compared with 45.9% and 34.5%, respectively, with methylnaltrexone treatment in the OLE. When expressed as percentage of patients experiencing 3 or more RFBMs per week and a 1-RFBM increase over baseline, weekly values ranged from 35% to 40% during placebo treatment; at week 5 of OLE methylnaltrexone, this percentage increased to more than 70% and remained relatively stable throughout the OLE. The most common adverse events during methylnaltrexone treatment were abdominal pain (9.7% vs 1.5% for placebo) and nausea (5.2% vs 6.7%). Conclusions Findings during placebo treatment further establish the profile of OIC and support that little or no gastrointestinal tolerance develops across time. Findings under open-label conditions established the reproducibility and durability of methylnaltrexone for OIC. PMID:26650429

A pilot study using the Chinese herbal paste Liu-He-Dan to manage radiodermatitis associated with breast cancer radiotherapy.

PubMed

Zhou, J; Fang, L; Xie, H; Yao, W X; Zhou, X; Xiong, Z J

2015-12-01

During radiotherapy for breast cancer, patients are greatly affected by pain, infection, and delayed healing of wounds caused by radiodermatitis. In the present study, we aimed to determine the efficacy of Liu-He-Dan in treating radiodermatitis. In 26 breast cancer patients who experienced moist decrustation while receiving radiotherapy, 5 g Liu-He-Dan was applied externally once daily after the wound surface had been cleaned and dried. The healing time was recorded, and a Kaplan-Meier survival curve was applied to analyze the treatment course. Meanwhile, a pain assessment using the Numeric Rating Scale (nrs) recorded the pain level experienced by patients after application of the Liu-He-Dan. After application of Liu-He-Dan, the average healing time for the surface of the moist decrustation wounds was 14.17 ± 2.03 days (range: 5-22 days). Inflammatory seepage decreased significantly and exudation almost disappeared in 3 days. The pain trend line indicated that the average nrs score declined with treatment in all patients. The average nrs scores at days 1, 4, and 7 were 6.13, 3.62, and 2.58 respectively. After 3 days of treatment, pain was remarkably alleviated in 80.76% of patients. After treatment for 1 week, the pain remission rate was 96.15%, without any obvious adverse reactions. Liu-He-Dan was efficacious in treating radiation skin injury with little toxicity and few side effects; the economic efficiency of the treatment was also favourable. The Liu-He-Dan was generally well tolerated by patients. In future, randomized control trials will be established for further observation of the value of Liu-He-Dan in treating radiodermatitis in breast cancer.

Laparoscopic Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids

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

Milic, Andrea; Asch, Murray R.; Hawrylyshyn, Peter A.

Four patients with symptomatic uterine fibroids measuring less than 6 cm underwent laparoscopic ultrasound-guided radiofrequency ablation (RFA) using multiprobe-array electrodes. Follow-up of the treated fibroids was performed with gadolinium-enhanced magnetic resonance imaging (MRI) and patients' symptoms were assessed by telephone interviews. The procedure was initially technically successful in 3 of the 4 patients and MRI studies at 1 month demonstrated complete fibroid ablation. Symptom improvement, including a decrease in menstrual bleeding and pain, was achieved in 2 patients at 3 months. At 7 months, 1 of these 2 patients experienced symptom worsening which correlated with recurrent fibroid on MRI. Themore » third, initially technically successfully treated patient did not experience any symptom relief after the procedure and was ultimately diagnosed with adenomyosis. Our preliminary results suggest that RFA is a technically feasible treatment for symptomatic uterine fibroids in appropriately selected patients.« less

Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms.

PubMed

Tesarz, Jonas; Gerhardt, Andreas; Leisner, Sabine; Janke, Susanne; Hartmann, Mechthild; Seidler, Günther H; Eich, Wolfgang

2013-08-30

Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient.Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma.Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone. The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later.The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0-10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment.In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed.The statistical analysis of the primary outcome will be performed on an intention-to-treat basis. The secondary outcomes will be analyzed in an explorative, descriptive manner. This study adapts the standard EMDR treatment for traumatized patients to patients with CBP who have experienced psychological trauma. This specific, mechanism-based approach might benefit patients. This trial has been registered with ClinicalTrials.gov (NCT01850875).

Effects of eye movement desensitization and reprocessing (EMDR) on non-specific chronic back pain: a randomized controlled trial with additional exploration of the underlying mechanisms

PubMed Central

2013-01-01

Background Non-specific chronic back pain (CBP) is often accompanied by psychological trauma, but treatment for this associated condition is often insufficient. Nevertheless, despite the common co-occurrence of pain and psychological trauma, a specific trauma-focused approach for treating CBP has been neglected to date. Accordingly, eye movement desensitization and reprocessing (EMDR), originally developed as a treatment approach for posttraumatic stress disorders, is a promising approach for treating CBP in patients who have experienced psychological trauma. Thus, the aim of this study is to determine whether a standardized, short-term EMDR intervention added to treatment as usual (TAU) reduces pain intensity in CBP patients with psychological trauma vs. TAU alone. Methods/design The study will recruit 40 non-specific CBP patients who have experienced psychological trauma. After a baseline assessment, the patients will be randomized to either an intervention group (n = 20) or a control group (n = 20). Individuals in the EMDR group will receive ten 90-minute sessions of EMDR fortnightly in addition to TAU. The control group will receive TAU alone. The post-treatment assessments will take place two weeks after the last EMDR session and six months later. The primary outcome will be the change in the intensity of CBP within the last four weeks (numeric rating scale 0–10) from the pre-treatment assessment to the post-treatment assessment two weeks after the completion of treatment. In addition, the patients will undergo a thorough assessment of the change in the experience of pain, disability, trauma-associated distress, mental co-morbidities, resilience, and quality of life to explore distinct treatment effects. To explore the mechanisms of action that are involved, changes in pain perception and pain processing (quantitative sensory testing, conditioned pain modulation) will also be assessed. The statistical analysis of the primary outcome will be performed on an intention-to-treat basis. The secondary outcomes will be analyzed in an explorative, descriptive manner. Discussion This study adapts the standard EMDR treatment for traumatized patients to patients with CBP who have experienced psychological trauma. This specific, mechanism-based approach might benefit patients. Trial registration This trial has been registered with ClinicalTrials.gov (NCT01850875). PMID:23987561

Etravirine in treatment-experienced, HIV-1-infected children and adolescents: 48-week safety, efficacy and resistance analysis of the phase II PIANO study.

PubMed

Tudor-Williams, G; Cahn, P; Chokephaibulkit, K; Fourie, J; Karatzios, C; Dincq, S; Opsomer, M; Kakuda, T N; Nijs, S; Tambuyzer, L; Tomaka, F L

2014-10-01

PIANO (Paediatric study of Intelence As an NNRTI Option; TMC125-C213; NCT00665847) assessed the safety/tolerability, antiviral activity and pharmacokinetics of etravirine plus an optimized background regimen (OBR) in treatment-experienced, HIV-1-infected children (≥ 6 to < 12 years) and adolescents (≥ 12 to < 18 years) over 48 weeks. In a phase II, open-label, single-arm study, 101 treatment-experienced patients (41 children; 60 adolescents) with screening viral load (VL) ≥ 500 HIV-1 RNA copies/mL received etravirine 5.2 mg/kg (maximum dose 200 mg) twice a day (bid) plus OBR. Sixty-seven per cent of patients had previously used efavirenz or nevirapine. At week 48, the most common treatment-related grade ≥ 2 adverse event (AE) was rash (13%); 12% experienced grade 3 AEs. Only two grade 4 AEs occurred (both thrombocytopaenia, not etravirine related). At week 48, 56% of patients (68% children; 48% adolescents) achieved a virological response (VL<50 copies/mL; intent-to-treat, noncompleter=failure). Factors predictive of response were adherence > 95%, male sex, low baseline etravirine weighted genotypic score and high etravirine trough concentration (C0h ). Seventy-six patients (75%) completed the trial; most discontinuations occurred because of protocol noncompliance or AEs (8% each). Sixty-five per cent of patients were > 95% adherent by questionnaire and 39% by pill count. Forty-one patients experienced virological failure (VF; time-to-loss-of-virological-response non-VF-censored algorithm) (29 nonresponders; 12 rebounders). Of 30 patients with VF with paired baseline/endpoint genotypes, 18 (60%) developed nonnucleoside reverse transcriptase inhibitor (NNRTI) mutations, most commonly Y181C. Mean etravirine area under the plasma concentration-time curve over 12 h (AUC0-12h ; 5216 ng h/mL) and C0h (346 ng/mL) were comparable to adult target values. Results with etravirine 5.2 mg/kg bid (with OBR) in this treatment-experienced paediatric population and etravirine 200 mg bid in treatment-experienced adults were comparable. Etravirine is an NNRTI option for treatment-experienced paediatric patients. © 2014 British HIV Association.

Ibrutinib for treatment of chronic lymphocytic leukemia.

PubMed

Vela, Cory M; McBride, Ali; Jaglowski, Samantha M; Andritsos, Leslie A

2016-03-15

The pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, and safety of ibrutinib are described. Ibrutinib is a first-in-class oral inhibitor of Bruton tyrosine kinase (BTK) approved for treatment of relapsed chronic lymphocytic leukemia (CLL). Ibrutinib blocks downstream signaling of the B-cell receptor, disrupting stromal microenvironment interactions and B-cell cytokine signaling. BTK inhibition has been shown to be effective in relapsed or refractory CLL. A recent Phase III study evaluated ibrutinib (420 mg daily) versus ofatumumab (consistent with labeling) in relapsed or refractory CLL with a primary endpoint of progression free survival (PFS, n = 391). After a median follow-up period of 9.4 months, a PFS was not attained in ibrutinib-treated individuals with and without deletion 17p. In contrast, ofatumumab-treated individuals experienced a PFS of 8.1 months and those with deletion 17p experienced a PFS of 5.8 months. Major hemorrhage was reported in 2 (1%) patients treated with ibrutinib, and a total of 8 (4%) patients discontinued treatment due to toxicity or adverse reactions. Partial response or partial response with lymphocytosis was achieved in 63% of ibrutinib-treated individuals as determined by independent assessments. Overall, ibrutinib reduced the rate of mortality by 57%. Ibrutinib is a first-in-class, orally active, irreversible BTK inhibitor with a novel mechanism of action. This unique mechanism of action and high overall response rates observed in clinical trials make ibrutinib an attractive second-line option in patients who have disease progression while receiving monoclonal antibody therapy or chemoimmunotherapy. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Caplacizumab reduces the frequency of major thromboembolic events, exacerbations and death in patients with acquired thrombotic thrombocytopenic purpura.

PubMed

Peyvandi, F; Scully, M; Kremer Hovinga, J A; Knöbl, P; Cataland, S; De Beuf, K; Callewaert, F; De Winter, H; Zeldin, R K

2017-07-01

Essentials Acquired thrombotic thrombocytopenic purpura (aTTP) is linked with significant morbidity/mortality. Caplacizumab's effect on major thromboembolic (TE) events, exacerbations and death was studied. Fewer caplacizumab-treated patients had a major TE event, an exacerbation, or died versus placebo. Caplacizumab has the potential to reduce the acute morbidity and mortality associated with aTTP. Background Acquired thrombotic thrombocytopenic purpura (aTTP) is a life-threatening autoimmune thrombotic microangiopathy. In spite of treatment with plasma exchange and immunosuppression, patients remain at risk for thrombotic complications, exacerbations, and death. In the phase II TITAN study, treatment with caplacizumab, an anti-von Willebrand factor Nanobody ® was shown to reduce the time to confirmed platelet count normalization and exacerbations during treatment. Objective The clinical benefit of caplacizumab was further investigated in a post hoc analysis of the incidence of major thromboembolic events and exacerbations during the study drug treatment period and thrombotic thrombocytopenic purpura-related death during the study. Methods The Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ) for 'embolic and thrombotic events' was run to investigate the occurrence of major thromboembolic events and exacerbations in the safety population of the TITAN study, which consisted of 72 patients, of whom 35 received caplacizumab and 37 received placebo. Results Four events (one pulmonary embolism and three aTTP exacerbations) were reported in four patients in the caplacizumab group, and 20 such events were reported in 14 patients in the placebo group (two acute myocardial infarctions, one ischemic stroke, one hemorrhagic stroke, one pulmonary embolism, one deep vein thrombosis, one venous thrombosis, and 13 aTTP exacerbations). Two of the placebo-treated patients died from aTTP during the study. Conclusion In total, 11.4% of caplacizumab-treated patients and 43.2% of placebo-treated patients experienced one or more major thromboembolic events, experienced an exacerbation, or died. This analysis shows the potential for caplacizumab to reduce the risk of major thromboembolic morbidities and mortality associated with aTTP. © 2017 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.

Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF).

PubMed

Sherwood, Matthew W; Douketis, James D; Patel, Manesh R; Piccini, Jonathan P; Hellkamp, Anne S; Lokhnygina, Yuliya; Spyropoulos, Alex C; Hankey, Graeme J; Singer, Daniel E; Nessel, Christopher C; Mahaffey, Kenneth W; Fox, Keith A A; Califf, Robert M; Becker, Richard C

2014-05-06

During long-term anticoagulation in atrial fibrillation, temporary interruptions (TIs) of therapy are common, but the relationship between patient outcomes and TIs has not been well studied. We sought to determine reasons for TI, the characteristics of patients undergoing TI, and the relationship between anticoagulant and outcomes among patients with TI. In the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), a randomized, double-blind, double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation, baseline characteristics, management, and outcomes, including stroke, non-central nervous system systemic embolism, death, myocardial infarction, and bleeding, were reported in participants who experienced TI (3-30 days) for any reason. The at-risk period for outcomes associated with TI was from TI start to 30 days after resumption of study drug. In 14 236 participants who received at least 1 dose of study drug, 4692 (33%) experienced TI. Participants with TI were similar to the overall ROCKET AF population in regard to baseline clinical characteristics. Only 6% (n=483) of TI incidences involved bridging therapy. Stroke/systemic embolism rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants (0.30% versus 0.41% per 30 days; hazard ratio [confidence interval]=0.74 [0.36-1.50]; P=0.40). Risk of major bleeding during the at-risk period was also similar in rivaroxaban-treated and warfarin-treated participants (0.99% versus 0.79% per 30 days; hazard ratio [confidence interval]=1.26 [0.80-2.00]; P=0.32). TI of oral anticoagulation is common and is associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin. Further investigation is needed to determine the optimal management strategy in patients with atrial fibrillation requiring TI of anticoagulation. http://www.clinicaltrials.gov. Unique identifier: NCT00403767.

Outcomes of Temporary Interruption of Rivaroxaban Compared With Warfarin in Patients With Nonvalvular Atrial Fibrillation

PubMed Central

Sherwood, Matthew W.; Douketis, James D.; Patel, Manesh R.; Piccini, Jonathan P.; Hellkamp, Anne S.; Lokhnygina, Yuliya; Spyropoulos, Alex C.; Hankey, Graeme J.; Singer, Daniel E.; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A. A.; Califf, Robert M.; Becker, Richard C.

2014-01-01

Background During long-term anticoagulation in atrial fibrillation, temporary interruptions (TIs) of therapy are common, but the relationship between patient outcomes and TIs has not been well studied. We sought to determine reasons for TI, the characteristics of patients undergoing TI, and the relationship between anticoagulant and outcomes among patients with TI. Methods and Results In the Rivaroxaban Once Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), a randomized, double-blind, double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation, baseline characteristics, management, and outcomes, including stroke, non–central nervous system systemic embolism, death, myocardial infarction, and bleeding, were reported in participants who experienced TI (3–30 days) for any reason. The at-risk period for outcomes associated with TI was from TI start to 30 days after resumption of study drug. In 14 236 participants who received at least 1 dose of study drug, 4692 (33%) experienced TI. Participants with TI were similar to the overall ROCKET AF population in regard to baseline clinical characteristics. Only 6% (n=483) of TI incidences involved bridging therapy. Stroke/systemic embolism rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants (0.30% versus 0.41% per 30 days; hazard ratio [confidence interval]=0.74 [0.36–1.50]; P=0.40). Risk of major bleeding during the at-risk period was also similar in rivaroxaban-treated and warfarin-treated participants (0.99% versus 0.79% per 30 days; hazard ratio [confidence interval]=1.26 [0.80–2.00]; P=0.32). Conclusions TI of oral anticoagulation is common and is associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin. Further investigation is needed to determine the optimal management strategy in patients with atrial fibrillation requiring TI of anticoagulation. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767. PMID:24552831

Treatment patterns and resource utilization and costs among patients with pulmonary arterial hypertension in the United States.

PubMed

Angalakuditi, Mallik; Edgell, Eric; Beardsworth, Anthony; Buysman, Erin; Bancroft, Tim

2010-01-01

To explore treatment patterns and resource utilization and cost for subjects with pulmonary arterial hypertension (PAH). Retrospective claims database analysis of 706 patients with PAH enrolled in a large, geographically diverse US managed-care organization. In the final sample of PAH patients treated with bosentan (n=251) or sildenafil (n=455), average age was 57 years, 86% of patients were commercially insured, and 52% of patients were male. Gender distribution varied significantly across subgroups, with a lower proportion of males in the bosentan (30%) subgroup compared with the sildenafil group (64%) (p<0.001). Average baseline Charlson comorbidity score was 2.4. Average numbers of fills per month were 0.8 and 0.4 for bosentan and sildenafil patients, respectively (p<0.001). Over 80% of patients received only one PAH treatment in the first 90 days following the index date, with 28% of bosentan and 13% of sildenafil patients receiving combination therapy (p<0.001). Over one-third of bosentan patients and one-quarter of sildenafil patients experienced a dose increase in the follow-up period (p=0.009). Sixteen percent of sildenafil patients experienced a dose decrease in the follow-up period, while a smaller proportion of patients receiving bosentan (4%) experienced a dose decrease (p<0.001). On average, number of PAH-related per subject per month (PSPM) inpatient stays and emergency department visits and PSPM length of inpatient stays were statistically similar between the subgroups. PAH-related PSPM healthcare costs were high for both subgroups, with average monthly costs of $5,332 and $3,632 among bosentan and sildenafil patients, respectively (p=0.003). Differences in total costs were driven mainly by differences in pharmacy expenditures. Of the oral agents approved for treating PAH at the time of this study, sildenafil was most commonly prescribed as index therapy and was also associated with the lowest costs, largely due to significantly lower pharmacy costs. This study is characterized by limitations inherent to claims database analyses, such as the potential for coding errors and lack of information on whether a drug was taken as prescribed. Furthermore, PAH severity (WHO functional class) was not assessed.

Ebola virus disease cluster in the United States--Dallas County, Texas, 2014.

PubMed

Chevalier, Michelle S; Chung, Wendy; Smith, Jessica; Weil, Lauren M; Hughes, Sonya M; Joyner, Sibeso N; Hall, Emily; Srinath, Divya; Ritch, Julia; Thathiah, Prea; Threadgill, Heidi; Cervantes, Diana; Lakey, David L

2014-11-21

Since March 10, 2014, Guinea, Liberia, and Sierra Leone have experienced the largest known Ebola virus disease (Ebola) epidemic with approximately 13,000 persons infected as of October 28, 2014. Before September 25, 2014, only four patients with Ebola had been treated in the United States; all of these patients had been diagnosed in West Africa and medically evacuated to the United States for care.

[Efficacy of dolutegravir in treatment-experienced patients: the SAILING and VIKING trials].

PubMed

Moreno, Santiago; Berenguer, Juan

2015-03-01

Dolutegravir is an HIV integrase inhibitor with a high genetic barrier to resistance and is active against raltegravir- and/or elvitegravir-resistant strains. The clinical development of dolutegravir for HIV infection rescue therapy is based on 3 clinical trials. In the SAILING trial, dolutegravir (5 mg once daily) in combination with 2 other antiretroviral agents was well tolerated and showed greater virological effect than raltegravir (400 mg twice daily) in the treatment of integrase inhibitor-naïve adults with virological failure infected with HIV strains with at least two-class drug resistance. The VIKING studies were designed to evaluate the efficacy of dolutegravir as rescue therapy in treatment-experienced patients infected with HIV strains with resistance mutations to raltegravir and/or elvitegravir. VIKING-1-2 was a dose-ranging phase IIb trial. VIKING-3 was a phase III trial in which dolutegravir (50 mg twice daily) formed part of an optimized regimen and proved safe and effective in this difficult-to-treat group of patients. Dolutegravir is the integrase inhibitor of choice for rescue therapy in multiresistant HIV infection, both in integrase inhibitor-naïve patients and in those previously treated with raltegravir or elvitegravir. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

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

Pinnix, Chelsea C.; Dabaja, Bouthaina, E-mail: bdabaja@mdanderson.org; Ahmed, Mohamed Amin

Purpose: Excellent outcomes obtained after infusional dose-adjusted etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, and rituximab (R-EPOCH) alone have led some to question the role of consolidative radiation therapy (RT) in the treatment of primary mediastinal B cell lymphoma (PMBL). We reviewed the outcomes in patients treated with 1 of 3 rituximab-containing regimens (cyclophosphamide, doxorubicin, vincristine, prednisone [R-CHOP]; hyperfractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone [R-HCVAD], or R-EPOCH) with or without RT. We also evaluated the ability of positron emission tomography–computed tomography (PET-CT) to identify patients at risk of relapse. Methods and Materials: We retrospectively identified 97 patients with diagnoses of stage I/IImore » PMBCL treated at our institution between 2001 and 2013. The clinical characteristics, treatment outcomes, and toxicity were assessed. We analyzed whether postchemotherapy PET-CT could identify patients at risk for progressive disease according to a 5 point scale (5PS) Deauville score assigned. Results: Among 97 patients (median follow-up time, 57 months), the 5-year overall survival rate was 99%. Of patients treated with R-CHOP, 99% received RT; R-HCVAD, 82%; and R-EPOCH, 36%. Of 68 patients with evaluable end-of-chemotherapy PET-CT scans, 62% had a positive scan (avidity above that of the mediastinal blood pool [Deauville 5PS = 3]), but only 9 patients experienced relapse (n=1) or progressive disease (n=8), all with a 5PS of 4 to 5. Of the 25 patients who received R-EPOCH, 4 experienced progression, all with 5PS of 4 to 5; salvage therapy (RT and autologous stem cell transplantation) was successful in all cases. Conclusion: Combined modality immunochemotherapy and RT is well tolerated and effective for treatment of PMBCL. A postchemotherapy 5PS of 4 to 5, rather than 3 to 5, can identify patients at high risk of progression who should be considered for therapy beyond chemotherapy alone after R-EPOCH.« less

A study comparing the safety and efficacy of febuxostat, allopurinol, and benzbromarone in Chinese gout patients: a retrospective cohort study
.

PubMed

Zhou, Qiao; Su, Jiang; Zhou, Ting; Tian, Juan; Chen, Xixi; Zhu, Jing

2017-02-01

To evaluate and compare the safety and efficacy of three urate lowering agents: febuxostat, allopurinol, and benzbromarone, when used to treat Chinese gout patients. A total of 120 patients treated in our department from November 2011 to December 2014 were randomly selected and divided into four groups: febuxostat (40 mg per day), febuxostat (80 mg per day), allopurinol (100 mg, 3 × per day) or benzbromarone (50 mg per day), (n = 30 patients/group). The serum uric acid (UA) concentrations of the patients in each group were recorded and compared from week 2 through week 24 after the treatments, and all adverse events were evaluated to determine the safety of the various treatment regimens. Treatment with febuxostat (40 mg) significantly reduced serum UA levels to those achieved with allopurinol or benzbromarone treatment. The treatment with febuxostat (80 mg) produced the best therapeutic effect and achieved the targeted UA level as early as week 2. However, the total number of patients experiencing adverse events was significantly higher in the febuxostat 80-mg group. The incidences of abnormal liver function, hyperlipidemia, and gout flare were higher in both febuxostat treatment groups. The allopurinol group had a higher incidence of hypersensitivity, and the benzbromarone group had a higher incidence of renal dysfunction. Chinese patients treated with the 40-mg dose of febuxostat experienced a treatment effect and total rate of adverse events similar to those produced by allopurinol or benzbromarone. To achieve a better therapeutic effect, the dose of febuxostat can be elevated to 80 mg per day; however, patients receiving the higher dose must be closely monitored for signs of liver dysfunction. Febuxostat is an alternative treatment for Chinese gout patients who are at a much higher risk for severe cutaneous adverse reactions as well as for patients with a history of kidney stones.
.

Combination of hemostatic therapies for treatment of patients with hemophilia A and inhibitors.

PubMed

Livnat, Tami; Budnik, Ivan; Levy-Mendelovich, Sarina; Avishai, Einat; Misgav, Mudi; Barg, Assaf Arie; Lubetsky, Aharon; Brutman-Barazani, Tami; Kenet, Gili

2017-07-01

Therapy application and monitoring of patients with hemophilia A (HA) and inhibitors are challenging. In the current study, combined FVIII - bypass therapy was implemented for a cohort of severe HA patients with inhibitors. Plasma of 15 HA patients with inhibitors was spiked ex vivo with FVIII, rFVIIa, FEIBA and their combinations and thrombin generation (TG) was studied. Some patients who experienced hemarthroses or required minor surgeries were treated by a combined concomitant administration of FVIII+FEIBA as IV bolus doses. TG spiking studies showed individual responses not correlated to inhibitor titer. Combinations of agents augmented TG as compared to any single agent, while combined FVIII+FEIBA yielded the highest TG, supporting it as a potential treatment. Following emergent successful surgery of child treated by concomitant FVIII+FEIBA, a total of 396 episodes in 7/15 patients were treated with concomitant FVIII+FEIBA. Five patients were treated for bleeding episodes only, whereas 2 were children undergoing immune tolerance induction (ITI) with FEIBA prophylaxis. Four minor surgeries were performed on FVIII+FEIBA repeated infusions. Neither thrombosis nor any other adverse events were documented. A combination of FVIII+FEIBA may be effective and safe as an alternative treatment option for some high-responding inhibitor patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Recurrent Primary Spontaneous Pneumothorax is Common Following Chest Tube and Conservative Treatment.

PubMed

Olesen, Winnie Hedevang; Lindahl-Jacobsen, Rune; Katballe, Niels; Sindby, Jesper Eske; Titlestad, Ingrid Louise; Andersen, Poul Erik; Licht, Peter Bjørn

2016-09-01

Previous studies on primary spontaneous pneumothorax reported variable recurrence rates, but they were based on heterogeneous patient populations including secondary pneumothorax. We investigated young patients with primary spontaneous pneumothorax exclusively and used a national registry to track readmissions and calculate independent predictors of recurrence. A prospective cohort study of consecutive young patients who were admitted over a 5-year period with their first episode of primary spontaneous pneumothorax and treated conservatively with a chest tube. Baseline characteristics were obtained from questionnaires presented on admittance. All patients were discharged with fully expanded lungs on chest radiography. Patient charts were identified in the national electronic patient registry for detailed information on readmissions due to recurrent spontaneous pneumothorax. We included 234 patients. Male/female = ratio 5/1. After a median observation period of 3.6 years (range 1-6 years), recurrent pneumothorax was observed in 54 %. Ipsilateral recurrence was the most common (79 %) but 30 % also experienced contralateral pneumothorax during the study period. Females had a significantly higher age at debut (p < 0.01) and experienced significantly more recurrences over time (p < 0.01). Low body weight (<60 kg) was an independent predictor of recurrence and patients with repeated recurrences were significantly younger at debut (p = 0.01). Primary spontaneous pneumothorax in younger patients with their first episode had a much higher recurrence rate than previously reported. Every doctor who treats patients with primary spontaneous pneumothorax should be aware and patients informed.

Syphilis and neurosyphilis in a human immunodeficiency virus type-1 seropositive population: evidence for frequent serologic relapse after therapy.

PubMed

Malone, J L; Wallace, M R; Hendrick, B B; LaRocco, A; Tonon, E; Brodine, S K; Bowler, W A; Lavin, B S; Hawkins, R E; Oldfield, E C

1995-07-01

To describe clinical and treatment aspects of syphilis infection among patients seropositive for the human immunodeficiency virus (HIV). Results of serologic tests for syphilis, CD4+ T-lymphocyte counts, and clinical response to therapy were retrospectively monitored in 100 HIV-infected adults with syphilis from a tertiary-care military HIV program. Of the 1,206 HIV-infected patients, 100 (8.3%) in the cohort had syphilis; 61 patients were treated for active syphilis. Serologic or clinical relapse eventually occurred in 10 of the 56 treated patients (17.9%) with follow-up available; 7 of the 10 who relapsed had previously received high-dose intravenous or procaine penicillin therapy. Relapse occurred more than 12 months after initial therapy in 6 of 10 patients (60%) who experienced relapse; 5 patients experienced multiple relapses. The mean CD4+ T-lymphocyte count was not predictive of relapse. Patients with reactive cerebrospinal fluid (CSF) Venereal Disease Research Laboratory (VDRL) test titers (4 of 7 patients [57%]) or the rash of secondary syphilis (4 of 14 patients [29%]) were at highest risk of subsequent relapse or treatment failure when monitored for an average of 2 years. Standard penicillin regimens, including high-dose intravenous penicillin, transiently lowered serum VDRL titers in nearly all cases, but were sometimes inadequate in preventing serologic and clinical relapse in patients infected with HIV type-1, especially among those with secondary syphilis and reactive CSF VDRL titers. Careful long-term follow-up is essential, and repeated courses of therapy may be needed for patients infected with HIV type-1 who have syphilis.

Magnetic Resonance Imaging to Evaluate Cervical Spinal Cord Injury from Gunshot Wounds from Handguns.

PubMed

Slavin, Justin; Beaty, Narlin; Raghavan, Prashant; Sansur, Charles; Aarabi, Bizhan

2015-12-01

Patients presenting with gunshot wounds (GSWs) to the neck are difficult to assess because of their injuries are often severe and they are incompletely evaluated by computed tomography (CT) alone. Our institution treats hundreds of patients with GSWs each year and we present our experience using magnetic resonance imaging (MRI) in the evaluation of cervical GSWs. From August 2000 to July 2012, all GSWs to the cervical spine treated at our institution were cataloged. Seventeen patients had 1 or more MRI studies of the cervical spine. Informed consent was obtained before MRI indicating the risks of retained metal fragments in the setting of high magnetic fields. CT scans were obtained before and after MRI to document any possible migration of metal fragments. We documented patients' neurologic examination results before and after MRI and at follow-up. Patients' age range was 18-56 years (mean 29.8 years). Eleven of 17 patients had retained metal fragments seen on CT scan, including 3 patients with fragments within the spinal canal. No patient experienced a decline in neurologic function after MRI. No migration of retained fragments was observed. Fifteen of 17 patients returned for follow-up examinations, with an average follow-up interval of 39.1 weeks (range, 1.3-202.3 weeks; median, 8 weeks). For carefully selected patients, MRI can be an effective tool in assessing GSWs to the neck and it can significantly improve the evaluation and management of this cohort. No patient in our series experienced a complication related to MRI. Copyright © 2015 Elsevier Inc. All rights reserved.

Analysis of factors in successful nasal endoscopic resection of nasopharyngeal angiofibroma.

PubMed

Ye, Dong; Shen, Zhisen; Wang, Guoli; Deng, Hongxia; Qiu, Shijie; Zhang, Yuna

2016-01-01

Endoscopic resection of nasopharyngeal angiofibroma is less traumatic, causes less bleeding, and provides a good curative effect. Using pre-operative embolization and controlled hypotension, reasonable surgical strategies and techniques lead to successful resection tumors of a maximum Andrews-Fisch classification stage of III. To investigate surgical indications, methods, surgical technique, and curative effects of transnasal endoscopic resection of nasopharyngeal angiofibroma, this study evaluated factors that improve diagnosis and treatment, prevent large intra-operative blood loss and residual tumor, and increase the cure rate. A retrospective analysis was performed of the clinical data and treatment programs of 23 patients with nasopharyngeal angiofibroma who underwent endoscopic resection with pre-operative embolization and controlled hypotension. The surgical method applied was based on the size of tumor and extent of invasion. Curative effects were observed. No intra-operative or perioperative complications were observed in 22 patients. Upon removal of nasal packing material 3-7 days post-operatively, one patient experienced heavy bleeding of the nasopharyngeal wound, which was treated compression hemostasis using post-nasal packing. Twenty-three patients were followed up for 6-60 months. Twenty-two patients experienced cure; one patient experienced recurrence 10 months post-operatively, and repeat nasal endoscopic surgery was performed and resulted in cure.

Leaving the street and reconstructing lives: impact of DOTS in empowering homeless people in Tokyo, Japan.

PubMed

Kawatsu, L; Sato, N; Ngamvithayapong-Yanai, J; Ishikawa, N

2013-07-01

Since 2000, the Public Health Centre (PHC) in Shinjuku, an area of Tokyo with one of the largest homeless populations in Japan, has been implementing PHC-based DOTS treatment for homeless tuberculosis (TB) patients, with much epidemiological success. Anecdotal evidence indicates that homeless patients treated under DOTS have experienced various positive changes. However, this experience has not yet been systematically analysed. To explore the changes experienced by homeless TB patients, and to discuss the possible role of PHC-based DOTS treatment in effecting these changes. A qualitative study via in-depth interviews with 18 ex-homeless patients who completed DOTS-based treatment at Shinjuku City PHC. The data were analysed using the interpretive content analysis method. The various changes experienced by the participants were categorised into five sub-categories of empowerment, including improved mental health and interpersonal relationships. Some of these changes were attributable to the participants undergoing PHC-based DOTS, which, by addressing their various emotional needs, helped to trigger patient empowerment. Based on our findings, a model of empowerment using PHC-based DOTS was constructed. PHC-based DOTS not only successfully controlled TB, it also empowered homeless patients by addressing their emotional needs. The interpersonal skills of the nurses played a critical role in this process.

Gene therapy for immune disorders: good news tempered by bad news.

PubMed

Puck, Jennifer M; Malech, Harry L

2006-04-01

After a dozen years of human gene therapy trials characterized by minimal gene correction and disappointing clinical impact, the field of gene therapy received some good news in 2000. Infants with X-linked severe combined immunodeficiency who received retroviral gene addition to cells from their bone marrow developed impressive immune reconstitution. During the following 2 years, additional patients were treated and the news was even better-babies receiving gene therapy had sustained T-cell production and in several cases developed better cell function than most patients treated with standard bone marrow transplants. Unfortunately, bad news followed. Three of the patients experienced leukemic T-cell expansions, found to be associated with retroviral insertions into genomic DNA. Where does the field stand today?

Rerupture rate after early weightbearing in operative versus conservative treatment of Achilles tendon ruptures: a meta-analysis.

PubMed

van der Eng, Dorien M; Schepers, Tim; Goslings, J Carel; Schep, Niels W L

2013-01-01

Whether Achilles tendon rupture benefits from surgery or conservative treatment remains controversial. Moreover, the outcome can be influenced by the rehabilitation protocol. The goal of the present meta-analysis was to compare the rerupture rate after surgical repair of the Achilles tendon followed by weightbearing within 4 weeks versus conservative treatment with weightbearing within 4 weeks. In addition, a secondary analysis was performed to compare the rerupture rates in patients who started weightbearing after 4 weeks. Seven randomized controlled trials published from 2001 to 2012, with 576 adult patients, were included. The primary outcome measure was the rerupture rate. The secondary outcomes were minor and major complications other than rerupture. In the early weightbearing group, 7 of 182 operatively treated patients (4%) experienced rerupture versus 21 of 176 of the conservatively treated patients (12%). A secondary analysis of the patients treated with late weightbearing showed a rerupture rate of 6% (7 of 108) for operatively treated patients versus 10% (11 of 110) for conservatively treated patients. The differences concerning the rerupture rate in both groups were not statistically significant. No differences were found in the occurrence of minor or major complications after early weightbearing in both patient groups. In conclusion, we found no difference in the rerupture rate between the surgically and nonsurgically treated patients followed by early weightbearing. Weightbearing after 4 weeks also resulted in no differences in the rupture rate in the surgical versus conservatively treated patients. However, surgical treatment was associated with a twofold greater complication rate than conservative treatment. Copyright © 2013 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

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

Mouw, Kent W.; Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts; Sethi, Roshan V.

Purpose: To investigate long-term disease and toxicity outcomes for pediatric retinoblastoma patients treated with proton radiation therapy (PRT). Methods and Materials: This is a retrospective analysis of 49 retinoblastoma patients (60 eyes) treated with PRT between 1986 and 2012. Results: The majority (84%) of patients had bilateral disease, and nearly half (45%) had received prior chemotherapy. At a median follow-up of 8 years (range, 1-24 years), no patients died of retinoblastoma or developed metastatic disease. The post-PRT enucleation rate was low (18%), especially in patients with early-stage disease (11% for patients with International Classification for Intraocular Retinoblastoma [ICIR] stage A-B disease vs 23%more » for patients with ICIR stage C-D disease). Post-PRT ophthalmologic follow-up was available for 61% of the preserved eyes (30 of 49): 14 of 30 eyes (47%) had 20/40 visual acuity or better, 7 of 30 (23%) had moderate visual acuity (20/40-20/600), and 9 of 30 (30%) had little or no useful vision (worse than 20/600). Twelve of 60 treated eyes (20%) experienced a post-PRT event requiring intervention, with cataracts the most common (4 eyes). No patients developed an in-field second malignancy. Conclusions: Long-term follow-up of retinoblastoma patients treated with PRT demonstrates that PRT can achieve high local control rates, even in advanced cases, and many patients retain useful vision in the treated eye. Treatment-related ocular side effects were uncommon, and no radiation-associated malignancies were observed.« less

Safety and tolerability of olanzapine compared with other antipsychotics in the treatment of elderly patients with schizophrenia: a naturalistic study.

PubMed

Ciudad, Antonio; Montes, José-Manuel; Olivares, José-Manuel; Gómez, Juan-Carlos

2004-09-01

To evaluate the safety and tolerability of olanzapine in the treatment of elderly patients with schizophrenia. A total of 135 outpatients with schizophrenia > or =60 years of age were treated with olanzapine (n = 105) or another antipsychotic (n = 30) and followed up for 6 months. Safety measures included the recording of spontaneous adverse events and extrapyramidal symptoms (EPS). Clinical status and effectiveness of the medications were measured using the Clinical Global Impressions-Severity of Illness and the Global Assessment of Function (GAF) scales. Quality of life was assessed by means of the Spanish version of the EuroQol. The Awad scale was applied to evaluate patients' subjective attitude towards medication. The incidence of overall adverse events and EPS was non-significantly lower in patients treated with olanzapine than in patients treated with other antipsychotics. The use of anticholinergic drugs was significantly lower (P = 0.04) in patients treated with olanzapine. Both groups of patients experienced similar improvements in Clinical Global Impressions-Severity and GAF scores. Non-significantly greater improvement in the acceptance of medication occurred at endpoint in olanzapine-treated patients than in control patients as measured by the Awad scale. The improvement in the EuroQol quality of life scale achieved at the end of study did not differ between both treatment groups. Results from this naturalistic study showed that olanzapine was as safe and effective as other antipsychotic drugs in the treatment of elderly patients with schizophrenia.

Recurrent craniopharyngioma after conformal radiation in children and the burden of treatment.

PubMed

Klimo, Paul; Venable, Garrett T; Boop, Frederick A; Merchant, Thomas E

2015-05-01

In this paper the authors present their experience treating children with recurrent craniopharyngioma who were initially managed with surgery followed by conformal radiation therapy (CRT). A departmental oncology information system was queried to identify all children (< 18 years old) who received CRT for a craniopharyngioma between 1998 and 2010 (inclusive) and specifically those who experienced tumor progression. For each patient, the authors recorded the type of recurrence (solid, cystic, or both), the time interval to first progression and each subsequent progression, the associated treatment complications, and disease status at last follow-up evaluation. Among the 97 patients that met criteria for entry into this study, 18 (18.6%) experienced tumor progression (9 cystic, 3 solid, 6 cystic and solid). The median time to first recurrence was 4.62 years (range 1.81-9.11 years). The subgroup included 6 female and 12 male patients with a median age of 7.54 years (range 3.61-13.83 years). Ten patients experienced first progression within 5 years of CRT. The 5- and 10-year treatment-free survival rates for the entire cohort were 89.0% (95% confidence interval [CI] 80.5%-93.9%) and 76.2% (95% CI 64%-85%), respectively. Seven patients had a single episode of progression and 11 had more than 1. The time interval between each subsequent progression was progressively shorter. The 18 patients underwent 38 procedures. The median follow-up duration for this group was 9.32 years (range 4.04-19.0 years). Three patients died, including 1 from perioperative complications. Craniopharyngioma progression after prior irradiation is exceedingly difficult to treat and local control is challenging despite repeated surgical procedures. Given our results, gross-total resection may need to be the surgical goal at the time of first recurrence, if possible. Decompressing new cyst formation alone has a low rate of long-term success.

Intercultural communication through the eyes of patients: experiences and preferences

PubMed Central

van Dulmen, Sandra; Bank, Lindsay; Seeleman, Conny; Scherpbier, Albert; Scheele, Fedde

2017-01-01

Objectives To explore patients’ preferences and experiences regarding intercultural communication which could influence the development of intercultural patient-centred communication training. Methods This qualitative study is based on interviews with non-native patients. Thirty non-native patients were interviewed between September and December 2015 about their preferences and experiences regarding communication with a native Dutch doctor. Fourteen interviews were established with an interpreter. The semi-structured interviews took place in Amsterdam. They were focused on generic and intercultural communication skills of doctors. Relevant fragments were coded by two researchers and analysed by the research team by means of thematic network analysis. Informed consent and ethical approval was obtained beforehand. Results All patients preferred a doctor with a professional patient-centred attitude regardless of the doctor’s background. Patients mentioned mainly generic communication aspects, such as listening, as important skills and seemed to be aware of their own responsibility in participating in a consultation. Being treated as a unique person and not as a disease was also frequently mentioned. Unfamiliarity with the Dutch healthcare system influenced the experienced communication negatively. However, a language barrier was considered the most important problem, which would become less pressing once a doctor-patient relation was established. Conclusions Remarkably, patients in this study had no preference regarding the ethnic background of the doctor. Generic communication was experienced as important as specific intercultural communication, which underlines the marginal distinction between these two. A close link between intercultural communication and patient-centred communication was reflected in the expressed preference ‘to be treated as a person’.   PMID:28535143

High-intensity focused ultrasound (HIFU) for pancreatic carcinoma: evaluation of feasibility, reduction of tumour volume and pain intensity.

PubMed

Marinova, Milka; Rauch, Maximilian; Mücke, Martin; Rolke, Roman; Gonzalez-Carmona, Maria A; Henseler, Jana; Cuhls, Henning; Radbruch, Lukas; Strassburg, Christian P; Zhang, Lian; Schild, Hans H; Strunk, Holger M

2016-11-01

Prognosis of patients with locally advanced pancreatic adenocarcinoma is extremely poor. They often suffer from cancer-related pain reducing their quality of life. This prospective observational study aimed to evaluate feasibility, local tumour response, and changes in quality of life and symptoms in Caucasian patients with locally advanced pancreatic cancer treated by ultrasound-guided high-intensity focused ultrasound (HIFU). Thirteen patients underwent HIFU, five with stage III, eight with stage IV UICC disease. Ten patients received simultaneous palliative chemotherapy. Postinterventional clinical assessment included evaluation of quality of life and symptom changes using standardized questionnaires. CT and MRI follow-up evaluated the local tumour response. HIFU was successfully performed in all patients. Average tumour reduction was 34.2 % at 6 weeks and 63.9 % at 3 months. Complete or partial relief of cancer-related pain was achieved in 10 patients (77 %), five of whom required less analgesics for pain control. Quality of life was improved revealing increased global health status and alleviated symptoms. HIFU treatment was well tolerated. Eight patients experienced transient abdominal pain directly after HIFU. HIFU ablation of pancreatic carcinoma is a feasible, safe and effective treatment with a crucial benefit in terms of reduction of tumour volume and pain intensity. • US-guided HIFU is feasible and safe for patients with unresectable pancreatic cancer. • HIFU can considerably reduce tumour volume and cancer-related pain. • Patients treated with HIFU experienced significant and lasting reduction of pain intensity. • HIFU has a crucial clinical benefit for patients with pancreatic cancer.

OK432 versus doxycycline for treatment of macrocystic lymphatic malformations.

PubMed

Motz, Kevin M; Nickley, Katherine B; Bedwell, Joshua R; Yadav, Bhupender; Guzzetta, Philip C; Oh, Albert K; Bauman, Nancy M

2014-02-01

A variety of sclerotherapy agents are used to treat macrocystic lymphatic malformations (LMs). This retrospective study at a single institution was performed to compare the outcomes of pediatric macrocystic LMs of the head and neck that were treated with doxycycline or with OK432. The outcomes measured included early response to therapy, number of treatments required, operating room time, and adverse events. The rates of clinical success for OK432 and doxycycline were similar (83% and 82%, respectively; p > 0.05), although OK432-treated patients required more treatments than did doxycycline-treated patients (1.9 versus 1.0 injections; p = 0.01; 95% confidence interval, 1.57 to 0.27). The average operating room time for a single OK432 injection was significantly shorter than that for doxycycline (53.2 versus 98.1 minutes; p < 0.001); however, when the total number of treatments administered was considered, the overall times in the operating room were similar. Adverse events in the early postoperative period were more common in OK432-treated patients, who experienced marked postoperative swelling compared to doxycycline-treated patients. OK432 and doxycycline are both effective sclerosants for the treatment of predominantly macrocystic LMs. The administration time for OK432 is shorter than that for doxycycline, but OK432 required more treatments overall to achieve clinical success. Early adverse events were more common in OK432-treated patients, but longer follow-up is necessary to determine whether rates of recurrence and adverse events are similar, particularly in light of the risk of tooth discoloration in doxycycline-treated patients.

Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study)

PubMed Central

Pedersen, Elena Didenko; Stenager, Egon; Vadgaard, JL; Jensen, MB; Schmid, R; Meland, N; Magnussen, G; Frederiksen, Jette L

2018-01-01

Background Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes. Objective To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart® and assess injection-site reactions and treatment satisfaction. Methods This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13–23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks. Results Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain. Conclusion RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated. PMID:29720872

Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study).

PubMed

Pedersen, Elena Didenko; Stenager, Egon; Vadgaard, J L; Jensen, M B; Schmid, R; Meland, N; Magnussen, G; Frederiksen, Jette L

2018-01-01

Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes. To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart ® and assess injection-site reactions and treatment satisfaction. This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13-23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks. Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain. RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated.

Parotid tumours: clinical and oncologic outcomes after microscope-assisted parotidectomy with intraoperative nerve monitoring.

PubMed

Carta, F; Chuchueva, N; Gerosa, C; Sionis, S; Caria, R A; Puxeddu, R

2017-10-01

Temporary and permanent facial nerve dysfunctions can be observed after parotidectomy for benign and malignant lesions. Intraoperative nerve monitoring is a recognised tool for the preservation of the nerve, while the efficacy of the operative microscope has been rarely stated. The authors report their experience on 198 consecutive parotidectomies performed on 196 patients with the aid of the operative microscope and intraoperative nerve monitoring. 145 parotidectomies were performed for benign lesions and 53 for malignancies. Thirteen patients treated for benign tumours experienced temporary (11 cases) or permanent facial palsy (2 cases, both of House-Brackmann grade II). Ten patients with malignant tumour presented with preoperative facial nerve weakness that did not improve after treatment. Five and 6 patients with malignant lesion without preoperative facial nerve deficit experienced postoperative temporary and permanent weakness respectively (the sacrifice of a branch of the nerve was decided intraoperatively in 2 cases). Long-term facial nerve weakness after parotidectomy for lesions not directly involving or originating from the facial nerve (n = 185) was 2.7%. Patients treated for benign tumours of the extra facial portion of the gland without inflammatory behaviour (n = 91) had 4.4% facial nerve temporary weakness rate and no permanent palsy. The combined use of the operative microscope and intraoperative nerve monitoring seems to guarantee facial nerve preservation during parotidectomy. © Copyright by Società Italiana di Otorinolaringologia e Chirurgia Cervico-Facciale, Rome, Italy.

Conservative treatment of a patient with previously unresponsive whiplash-associated disorders using clinical biomechanics of posture rehabilitation methods.

PubMed

Ferrantelli, Joseph R; Harrison, Deed E; Harrison, Donald D; Stewart, Denis

2005-01-01

To describe the treatment of a patient with chronic whiplash-associated disorders (WADs) previously unresponsive to multiple physical therapy and chiropractic treatments, which resolved following Clinical Biomechanics of Posture (CBP) rehabilitation methods. A 40-year-old man involved in a high-speed rear-impact collision developed chronic WADs including cervicothoracic, shoulder, and arm pain and headache. The patient was diagnosed with a confirmed chip fracture of the C5 vertebra and cervical and thoracic disk herniations. He was treated with traditional chiropractic and physical therapy modalities but experienced only temporary symptomatic reduction and was later given a whole body permanent impairment rating of 33% by an orthopedic surgeon. The patient was treated with CBP mirror-image cervical spine adjustments, exercise, and traction to reduce forward head posture and cervical kyphosis. A presentation of abnormal head protrusion resolved and cervical kyphosis returned to lordosis posttreatment. His initial neck disability index was 46% and 0% at the end of care. Verbal pain rating scales also improved for neck pain (from 5/10 to 0/10). A patient with chronic WADs and abnormal head protrusion, cervical kyphosis, and disk herniation experienced an improvement in symptoms and function after the use of CBP rehabilitation protocols when other traditional chiropractic and physical therapy procedures showed little or no lasting improvement.

Effect of Vildagliptin Versus Sulfonylurea in Muslim Patients with Type 2 Diabetes Fasting During Ramadan in Egypt: Results from VIRTUE Study.

PubMed

Khattab, Mohamed; Mahmoud, Khalifa; Shaltout, Inass

2016-09-01

Fasting in patients with type 2 diabetes mellitus (T2DM) is associated with high risk of hypoglycemia. The aim of this study was to compare the effectiveness and safety of vildagliptin in T2DM patients fasting during Ramadan in a real-life setting in Egypt. In this 16-week prospective and noninterventional study, data were collected up to 6 weeks before and after Ramadan fasting. Patients who had received vildagliptin or sulfonylurea (SU) either as dual therapy with metformin or as monotherapy were enrolled into the study. Two hundred fifty four patients were enrolled in the study, out of which 246 [121 (97.6%) treated with vildagliptin and 125 (99.2%) with SU] were included in the safety analysis set. A significantly lower proportion of patients experienced ≥1 hypoglycemic event (HE) with vildagliptin as compared to those receiving SUs (1.7% vs. 19.2%, respectively; p < 0.001). No patient in either group reported a grade 2 HE. At week 16, mean change in HbA1c from baseline for vildagliptin and SU were -0.1% and +0.3%, respectively, with a between-treatment difference of -0.4% (p < 0.001). Mean change in body weight from baseline for vildagliptin and SU were -0.8 and -0.1 kg, with a between-treatment difference of -0.7 kg (p = 0.011). A higher proportion of SU-treated patients experienced adverse events compared to those treated with vildagliptin (23.2% vs. 5.8%, respectively), the primary reason being the high incidence of hypoglycemia in the SU group (n = 24, 19.2%). Treatment with vildagliptin was associated with lower incidence of hypoglycemia compared with SU and showed good glycemic and weight control in patients with T2DM fasting during Ramadan in a real-life setting in Egypt. Novartis Pharma AG.

Salvage image guided radiation therapy to the prostate after cryotherapy failure.

PubMed

Hopper, Austin B; Sandhu, Ajay P S; Parsons, J Kellogg; Rose, Brent; Einck, John P

2018-01-01

Cryotherapy is an option for the primary treatment of localized prostate cancer, along with radical prostatectomy, external beam radiation therapy, and brachytherapy. Although it is known that local recurrence can occur in >20% of patients treated with primary cryotherapy, unfortunately there is a paucity of data on later salvage treatments. The use of external beam radiation therapy is an attractive option after cryotherapy failure, but there is little data on its efficacy and toxicity. We evaluated the biochemical control and complication rates of salvage dose-escalated image guided intensity modulated radiation therapy (IG-IMRT) after cryotherapy failure. Patients who were treated at our institution from 2005 to 2016 were reviewed for those who underwent cryotherapy as initial treatment followed by salvage IGRT. Patients were treated with dose-escalated IG-IMRT using standard treatment margins of 3 mm posterior and 7 mm in all other directions and daily cone beam computed tomography or kv imaging to implanted fiducial markers. Biochemical progression was defined in accordance with the Phoenix consensus conference definition. Eight patients were identified as having received post-cryotherapy salvage radiation within the study period. The median total dose was 77.7 Gy (range, 75.6-81.0 Gy). Median follow-up was 55 months (range, 6-88 months). Six patients remained biochemically controlled at the latest follow-up. One patient developed distant metastases after 22 months and one experienced biochemical failure at 30 months with no evidence of distant metastases. No patients experienced acute gastrointestinal toxicities of grade 2 or higher. There were no cases of late gastrointestinal or genitourinary toxicity. High-dose IG-IMRT results in high rates of salvage and extremely low rates of serious late toxicity for patients with locally recurrent prostate cancer after cryotherapy. Although the results are encouraging, given the small number of patients in this and other series, we remain cautious with regard to this treatment and believe the use of salvage radiation therapy after cryotherapy warrants further study.

Predictors of pulmonary toxicity in limited stage small cell lung cancer patients treated with induction chemotherapy followed by concurrent platinum-based chemotherapy and 70 Gy daily radiotherapy: CALGB 30904.

PubMed

Salama, Joseph K; Pang, Herbert; Bogart, Jeffrey A; Blackstock, A William; Urbanic, James J; Hogson, Lydia; Crawford, Jeffrey; Vokes, Everett E

2013-12-01

Standard therapy for limited stage small cell lung cancer (L-SCLC) is concurrent chemotherapy and radiotherapy followed by prophylactic cranial radiotherapy. Predictors of post chemoradiotherapy pulmonary toxicity in limited stage (LS) small cell lung cancer (SCLC) patients are not well defined. Current guidelines are derived from non-small cell lung cancer regimens, and do not account for the unique biology of this disease. Therefore, we analyzed patients on three consecutive CALGB LS-SCLC trials treated with concurrent chemotherapy and daily high dose radiotherapy (70 Gy) to determine patient and treatment related factors predicting for post-treatment pulmonary toxicity. Patients treated on CALGB protocols 39808, 30002, 30206 investigating two cycles of chemotherapy followed by concurrent chemotherapy and 70 Gy daily thoracic radiation therapy were pooled. Patient, tumor, and treatment related factors were evaluated to determine predictors of grade 3–5 pulmonary toxicities after concurrent chemoradiotherapy. 100 patients were included. No patient experienced grade 4–5 post-treatment pulmonary toxicity. Patients who experienced post-treatment pulmonary toxicity were more likely to be older (median age 69 vs 60, p = 0.09) and have smaller total lung volumes (2565 cc vs 3530 cc, p = 0.05).). Furthermore,exposure of larger volumes of lung to lower (median V5 = 70%, p = 0.09, median V10 = 63%, p = 0.07), inter-mediate (median V20 = 50, p = 0.04) and high (median V60 = 25%, p = 0.01) doses of radiation were all associated with post-treatment grade 3 pulmonary toxicity, as was a larger mean lung radiation dose(median 31 Gy) p = 0.019. Post-treatment pulmonary toxicity following the completion of 2 cycles of chemotherapy followed by concurrent chemotherapy and high dose daily radiation therapy was uncommon. Care should be taken to minimize mean lung radiation exposure, as well as volumes of low, intermediate and high doses of radiation.

Older women with a serious cardiac event experience support with a Vifladt & Hopen inspired patient group education programme.

PubMed

Hagberth, Vivika; Sjöberg, Trygve; Ivarsson, Bodil

2008-06-01

Older women are less likely to be invited to access cardiac rehabilitation programmes. The Vifladt & Hopen model for patient education is aimed to strengthen the ability of patients with long-term illnesses to cope in everyday life. To examine how this model was experienced by older women (>70 years) treated with percutaneous coronary intervention. A one-year follow-up of the education programme was conducted by means of focus group interviews (n=13). A qualitative descriptive design using content analysis was used. Two main categories emerged: views on topics and matter, and views on form. Experiences of heart event, stress and anxiety were important topics. The women experienced advantages and benefits by meeting others in a similar situation. A focus on knowledge exchange instead of knowledge transfer encourages talking about self-experienced needs. The women expressed the benefits of the education programme since the discussions emerged from themselves. For the health care professionals there are gains to be made from obtaining the women's point of view and learning more about their needs.

Safety and efficacy of stereotactic radiosurgery for tumors of the spine.

PubMed

Benzil, Deborah L; Saboori, Mehran; Mogilner, Alon Y; Rocchio, Ronald; Moorthy, Chitti R

2004-11-01

The extension of stereotactic radiosurgery treatment of tumors of the spine has the potential to benefit many patients. As in the early days of cranial stereotactic radiosurgery, however, dose-related efficacy and toxicity are not well understood. The authors report their initial experience with stereotactic radiosurgery of the spine with attention to dose, efficacy, and toxicity. All patients who underwent stereotactic radiosurgery of the spine were treated using the Novalis unit at Westchester Medical Center between December 2001 and January 2004 are included in a database consisting of demographics on disease, dose, outcome, and complications. A total of 31 patients (12 men, 19 women; mean age 61 years, median age 63 years) received treatment for 35 tumors. Tumor types included 26 metastases (12 lung, nine breast, five other) and nine primary tumors (four intradural, five extradural). Thoracic tumors were most common (17 metastases and four primary) followed by lumbar tumors (four metastases and four primary). Lesions were treated to the 85 to 90% isodose line with spinal cord doses being less than 50%. The dose per fraction and total dose were selected on the basis of previous treatment (particularly radiation exposure), size of lesion, and proximity to critical structures. Rapid and significant pain relief was achieved after stereotactic radiosurgery in 32 of 34 treated tumors. In patients treated for metastases, pain was relieved within 72 hours and remained reduced 3 months later. Pain relief was achieved with a single dose as low as 500 cGy. Spinal cord isodoses were less than 50% in all patients except those with intradural tumors (mean single dose to spinal cord 268 cGy and mean total dose to spinal cord 689 cGy). Two patients experienced transient radiculitis (both with a biological equivalent dose (BED) > 60 Gy). One patient who suffered multiple recurrences of a conus ependymoma had permanent neurological deterioration after initial improvement. Pathological evaluation of this lesion at surgery revealed radiation necrosis with some residual/recurrent tumor. No patient experienced other organ toxicity. Stereotactic radiosurgery of the spine is safe at the doses used and provides effective pain relief. In this study, BEDs greater than 60 Gy were associated with an increased risk of radiculitis.

A Phase I Dose Escalation Study of Hypofractionated IMRT Field-in-Field Boost for Newly Diagnosed Glioblastoma Multiforme

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

Monjazeb, Arta M., E-mail: arta.monjazeb@ucdmc.ucdavis.edu; Ayala, Deandra; Jensen, Courtney

2012-02-01

Objectives: To describe the results of a Phase I dose escalation trial for newly diagnosed glioblastoma multiforme (GBM) using a hypofractionated concurrent intensity-modulated radiotherapy (IMRT) boost. Methods: Twenty-one patients were enrolled between April 1999 and August 2003. Radiotherapy consisted of daily fractions of 1.8 Gy with a concurrent boost of 0.7 Gy (total 2.5 Gy daily) to a total dose of 70, 75, or 80 Gy. Concurrent chemotherapy was not permitted. Seven patients were enrolled at each dose and dose limiting toxicities were defined as irreversible Grade 3 or any Grade 4-5 acute neurotoxicity attributable to radiotherapy. Results: All patientsmore » experienced Grade 1 or 2 acute toxicities. Acutely, 8 patients experienced Grade 3 and 1 patient experienced Grade 3 and 4 toxicities. Of these, only two reversible cases of otitis media were attributable to radiotherapy. No dose-limiting toxicities were encountered. Only 2 patients experienced Grade 3 delayed toxicity and there was no delayed Grade 4 toxicity. Eleven patients requiring repeat resection or biopsy were found to have viable tumor and radiation changes with no cases of radionecrosis alone. Median overall and progression-free survival for this cohort were 13.6 and 6.5 months, respectively. One- and 2-year survival rates were 57% and 19%. At recurrence, 15 patients received chemotherapy, 9 underwent resection, and 5 received radiotherapy. Conclusions: Using a hypofractionated concurrent IMRT boost, we were able to safely treat patients to 80 Gy without any dose-limiting toxicity. Given that local failure still remains the predominant pattern for GBM patients, a trial of dose escalation with IMRT and temozolomide is warranted.« less

Dedicated linear accelerator radiosurgery for trigeminal neuralgia: a single-center experience in 179 patients with varied dose prescriptions and treatment plans.

PubMed

Smith, Zachary A; Gorgulho, Alessandra A; Bezrukiy, Nikita; McArthur, David; Agazaryan, Nzhde; Selch, Michael T; De Salles, Antonio A F

2011-09-01

Dedicated linear accelerator radiosurgery (D-LINAC) has become an important treatment for trigeminal neuralgia (TN). Although the use of gamma knife continues to be established, few large series exist using D-LINAC. The authors describe their results, comparing the effects of varied target and dose regimens. Between August 1995 and January 2008, 179 patients were treated with D-LINAC radiosurgery. Ten patients (5.58%) had no clinical follow-up. The median age was 74.0 years (range, 32-90 years). A total of 39 patients had secondary or atypical pain, and 130 had idiopathic TN. Initially, 28 patients received doses between 70 and 85 Gy, with the 30% isodose line (IDL) touching the brainstem. Then, using 90 Gy, 82 consecutive patients were treated with a 30% IDL and 59 patients with a 50% IDL tangential to the pons. Of 169 patients, 134 (79.3%) experienced significant relief at a mean of 28.8 months (range, 5-142 months). Average time to relief was 1.92 months (range, immediate to 6 months). A total of 31 patients (19.0%) had recurrent pain at 13.5 months. Of 87 patients with idiopathic TN without prior procedures, 79 (90.8%) had initial relief. Among 28 patients treated with 70 Gy and 30% IDL, 18 patients (64.3%) had significant relief, and 10 (35.7%) had numbness. Of the patients with 90 Gy and 30% IDL at the brainstem, 59 (79.0%) had significant relief and 48.9% had numbness. Among 59 consecutive patients with similar dose but the 50% isodoseline at the brainstem, 49 patients (88.0%) had excellent/good relief. Numbness, averaging 2.49 on a subjective scale of 1 to 5, was experienced by 49.7% of the patients, Increased radiation dose and volume of brainstem irradiation may improve clinical outcomes with the trade-off of trigeminal dysfunction. Further study of the implications of dose and target are needed to optimize outcomes and to minimize complications. Published by Elsevier Inc.

Dedicated Linear Accelerator Radiosurgery for Trigeminal Neuralgia: A Single-Center Experience in 179 Patients With Varied Dose Prescriptions and Treatment Plans

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

Smith, Zachary A.; Gorgulho, Alessandra A.; Bezrukiy, Nikita

2011-09-01

Purpose: Dedicated linear accelerator radiosurgery (D-LINAC) has become an important treatment for trigeminal neuralgia (TN). Although the use of gamma knife continues to be established, few large series exist using D-LINAC. The authors describe their results, comparing the effects of varied target and dose regimens. Methods and Materials: Between August 1995 and January 2008, 179 patients were treated with D-LINAC radiosurgery. Ten patients (5.58%) had no clinical follow-up. The median age was 74.0 years (range, 32-90 years). A total of 39 patients had secondary or atypical pain, and 130 had idiopathic TN. Initially, 28 patients received doses between 70 andmore » 85 Gy, with the 30% isodose line (IDL) touching the brainstem. Then, using 90 Gy, 82 consecutive patients were treated with a 30% IDL and 59 patients with a 50% IDL tangential to the pons. Results: Of 169 patients, 134 (79.3%) experienced significant relief at a mean of 28.8 months (range, 5-142 months). Average time to relief was 1.92 months (range, immediate to 6 months). A total of 31 patients (19.0%) had recurrent pain at 13.5 months. Of 87 patients with idiopathic TN without prior procedures, 79 (90.8%) had initial relief. Among 28 patients treated with 70 Gy and 30% IDL, 18 patients (64.3%) had significant relief, and 10 (35.7%) had numbness. Of the patients with 90 Gy and 30% IDL at the brainstem, 59 (79.0%) had significant relief and 48.9% had numbness. Among 59 consecutive patients with similar dose but the 50% isodoseline at the brainstem, 49 patients (88.0%) had excellent/good relief. Numbness, averaging 2.49 on a subjective scale of 1 to 5, was experienced by 49.7% of the patients, Conclusions: Increased radiation dose and volume of brainstem irradiation may improve clinical outcomes with the trade-off of trigeminal dysfunction. Further study of the implications of dose and target are needed to optimize outcomes and to minimize complications.« less

One-year prospective follow-up of pharmacological treatment in children with attention-deficit/hyperactivity disorder.

PubMed

Didoni, Anna; Sequi, Marco; Panei, Pietro; Bonati, Maurizio

2011-10-01

To delineate the safety and tolerability profile of methylphenidate and atomoxetine in children and adolescents with attention deficit hyperactivity disorder (ADHD) monitored for more than 1 year. A cohort study analyzing data from the national ADHD register on patients from the Lombardy Region treated with MPH or atomoxetine. A total of 229 children (median age 11 years, range 6-17), enrolled in 15 regional centers between June 2007 and May 2010. The prevalence rate of pharmacological treatment for ADHD was 0.23%, whereas the estimated ADHD prevalence in the population was 0.95%. In total, 73.8% of patients had been treated with atomoxetine (10-90 mg daily) or MPH (10-75 mg daily); 22% of patients also received an additional psychotropic drug. Of the treated children, 26.9% discontinued the drug prior to 1 year of treatment, mostly because of adverse effects (28.6%). No new or unexpected adverse events (rate 39.2%) were encountered. Decreased appetite, headache, and unstable mood were the leading events. The most severe events occurred in two boys: one experienced absence seizures for the first time with MPH, the other experienced hallucinations with atomoxetine. Therapy was discontinued in ten male patients (7.7%) because of adverse events. All patients with adverse effects recovered well. A very low rate of ADHD prevalence was estimated in Italian children compared to that reported in other countries. Although the medications for ADHD are generally well tolerated, with only mild or minor adverse effects in most cases, their rational use can only be guaranteed by disseminating and monitoring evidence-based practices and by monitoring the safety and efficacy of treatments in both the short and long terms with appropriate tools and approaches.

Long-term prosthetic aftercare of direct vs. indirect attachment incorporation techniques to mandibular implant-supported overdenture.

PubMed

Nissan, Joseph; Oz-Ari, Beni; Gross, Ora; Ghelfan, Oded; Chaushu, Gavriel

2011-06-01

The aim of this long-term study was to compare the need for prosthetic aftercare of direct vs. indirect attachment incorporation techniques to mandibular implant-supported overdenture. Forty-five consecutive patients were included (130 implants were placed). Treatment was randomly allocated, resulting in 22 patients (group A) to be treated with direct ball attachment incorporation and 23 patients (group B) to be treated with indirect ball attachment incorporation. All patients were treated by experienced oral-maxillofacial surgeons/periodontists and experienced prosthodontists/residents. From the first day that the patients visited the clinic up to 20 years after the first treatment session, all surgical or prosthetic therapeutic interventions were recorded. The recorded data for the present study included the number of aftercare visits and dental treatment received (pressure sores relieve, liner changes due to loss of retention and attachment replacement due to wear). The mean follow-up was 93±57 months. No implants were lost. Statistical analysis revealed a statistically significantly (P<0.001) greater need for prosthetic interventions in group B vs. group A. The mean number of visits dedicated to - pressure sores relieve (7.04±1.4 vs. 3.63±0.84); liner exchange due to loss of retention (3.6±1.3 vs. 1.09±1.06) was significantly higher in group B. Attachment replacement due to wear occurred only in group B (11/23 - 47.8%). The direct technique for attachment incorporation in mandibular implant-supported overdentures using ball attachments is superior to the indirect technique from the aftercare perspective during a long-term evaluation period. © 2010 John Wiley & Sons A/S.

Usefulness of the Pipeline Embolic Device for Large and Giant Carotid Cavernous Aneurysms

PubMed Central

Hiramatsu, Ryo; Ohnishi, Hiroyuki; Yagi, Ryokichi; Kuroiwa, Toshihiko

2017-01-01

Purpose Conventional coil embolization for large carotid cavernous aneurysms (CCAs) has limited utility due to its inability to prevent recurrences and reduce mass effect. Trapping of the parent artery may have a risk of ischemic complications due to intracranial perfusion disorders. We successfully treated 24 patients with large CCAs using a flow diverter (Pipeline™ embolic device: PED), and this report discusses the safety and efficacy of this method. Materials and Methods Twenty four patients (23 females, mean age 71.5 years old) with large CCAs, including 6 giant CCAs, were treated with a PED over three years. Under sufficient dual anti-platelet management, the PED was deployed over the orifice of the aneurysm. Two patients required multiple telescoping stents. Clinical and radiological states were checked with MRI at 1, 3 and 6 months post-surgically. Angiographic follow-up was performed at 6 months. Results In all patients, PED was appropriately deployed. Stagnation of contrast with eclipse signs was observed post-angiogram in 21 cases. One patient requiring 5 telescoping stents experienced temporary ischemic symptoms. Fourteen patients experienced improvement of ocular motor impairment deficiency, including 6 patients who recovered. Angiograms at 6 months follow-up showed complete occlusion in 63% (12/19) of patients, and MRI showed reduction of aneurysm volume in 89% (17/19) of patients. Conclusion Flow diverters for large CCAs showed promising clinical and radiological efficacy. They can shrink the aneurysm and improve symptoms without sacrificing the parent artery. It will be necessary to summarize the cases and to verify the long-term results. PMID:28955510

Subjective Memory Immediately Following Electroconvulsive Therapy.

PubMed

Brus, Ole; Nordanskog, Pia; Båve, Ullvi; Cao, Yang; Hammar, Åsa; Landén, Mikael; Lundberg, Johan; Nordenskjöld, Axel

2017-06-01

The aims of the present study were to describe the short-term rate of subjective memory worsening (SMW) and identify factors of importance for SMW in a large clinical sample treated for depression with electroconvulsive therapy (ECT). This register-based study included 1212 patients from the Swedish National Quality Register for ECT. Subjective memory worsening was defined as a 2-point worsening on the memory item of the Comprehensive Psychopathological Rating Scale from before to within 1 week after treatment. Associations between patient characteristics and treatment factors were examined using logistic regression. Subjective memory worsening was experienced in 26%. It was more common in women than in men (31% vs 18%; P < 0.001) and more common in patients aged 18 to 39 years than in patients 65 years or older (32% vs 22%; P = 0.008). Patients with less subjective memory disturbances before ECT had a greater risk of SMW. Patients in remission after ECT had a lower risk of SMW. A brief pulse width stimulus gave higher risk of SMW compared with ultrabrief pulse (odds ratio, 1.61; 95% confidence interval, 1.05-2.47). Subjective memory worsening is reported by a minority of patients. However, young women are at risk of experiencing SMW. Ultrabrief pulse width stimulus could be considered for patients treated with unilateral electrode placement who experience SMW. Each patient should be monitored with regard to symptoms and adverse effects, and treatment should be adjusted on an individual basis to maximize the clinical effect and with efforts to minimize the cognitive adverse effects.

Vaginal reconstruction with sigmoid colon in patients with congenital absence of vagina and menses retention: a report of treatment experience in 22 young women.

PubMed

Yang, Bin; Wang, Ning; Zhang, Shulan; Wang, Mingqian

2013-01-01

We evaluated the surgical feasibility, sexual satisfaction and complications of vaginal reconstruction with sigmoid colon in patients with congenital absence of vagina and menses retention. Retrospective analysis of surgical techniques and long-term postoperative follow-up was performed for 22 patients who underwent vaginal reconstruction with sigmoid colon at a single hospital between 1977 and 2011 to treat congenital absence of vagina with menses retention. All patients achieved satisfactory sexual function after marriage. No patients experienced enterospastic abdominal pain during sexual intercourse. The neovaginas accommodated two or more fingers and had depths >10 cm. The mucous membranes were soft and flexible, and secretions of the sigmoid mucosa provided adequate and acceptable lubrication. No patient required vaginal stents, and none developed vaginal stenosis or reported pain with vaginal expansion. Fifteen of the 22 patients underwent hysterectomies due to cervical agenesis; seven retained their uterus and had onset of normal menses postoperatively. Two patients became pregnant 1 year after marriage; one achieved 38-week gestation, underwent cesarean section due to premature rupture of membranes, and delivered a healthy boy. The other experienced natural incomplete abortion and underwent curettage at her local hospital. This study confirms that sigmoid colon vaginal reconstruction is a good choice for treating congenital absence of vagina and menses retention and results in the closest approximation to the physical function of a normal female vagina. Reproductive ability can be retained in many cases for patients with a well-developed uterus and cervix.

Single session treatment for bleeding hemorrhoids

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

Weinstein, S.J.; Rypins, E.B.; Houck, J.

1987-12-01

Fifty consecutive outpatients with bleeding internal hemorrhoids were prospectively treated with a single application of rubber band ligation or infrared coagulation. Complete follow-up observation was obtained in 48 patients (23 underwent rubber band ligation and 25 underwent infrared coagulation). At one month after treatment, 22 patients who underwent rubber band ligation and 16 who underwent infrared coagulation, were symptomatically improved (p less than 0.05). At six months, 15 patients who had undergone rubber band ligation and ten who had infrared coagulation treatment, remained improved (p less than 0.05). There was no statistical difference in the discomfort experienced by either groupmore » during or after the procedure as determined by a self-assessment scale. Two patients who underwent rubber band ligation experienced complications--a thrombosed external hemorrhoid developed in one patient and another had delayed rectal bleeding. Although associated with occasional complications after treatment, rubber band ligation is more effective than in infrared coagulation for single session treatment of bleeding internal hemorrhoids.« less

EFFICACY OF PROPRANOLOL ON SCHIZOPHRENIC THOUGHT DISORDER

PubMed Central

Sethi, B. B.; Dube, Sanjay

1981-01-01

SUMMARY 15 schizophrenic patients were treated with dl-propranolol in a 4 week open study. Dosage was gradually increased over a period of 17 days to 1920 mg/day. Improvements were rated on Thought Disorder Scores (A & B) of the MBPRS and GPRS subscale for schizophrenia. Majority of the patients showed a 50% improvement in terms of their residual scores by the 4th week of treatment and the side effects experienced were minimal. PMID:22064778

Axillary hyperhidrosis - topical treatment with aluminium chloride hexahydrate

PubMed Central

Ellis, Harold; Scurr, John H.

1979-01-01

Forty-two patients with axillary hyperhidrosis on the waiting list for surgery were treated with topical saturated solution of aluminium chloride hexahydrate in absolute alcohol. There have been 7 failures. Three patients were unable to cope with the treatment and 4 more experienced severe local irritation or soreness; these 4 were submitted to local surgery. This is a simple and effective treatment for the majority of cases of severe axillary sweating. PMID:548949

Patients' perception of their experience of primary percutaneous intervention for ST segment elevation myocardial infarction.

PubMed

Young, Lynne E; Murray, Jackie

2011-01-01

Many patients experiencing ST segment elevation myocardial infarction (STEMI) are currently treated with primary percutaneous intervention (PCI). This relatively new procedure has reduced the time patients with the diagnosis of STEMI spend in hospital. In this literature review we explore patients' perceptions of their experience of receiving primary percutaneous intervention (PCI) as a treatment for STEMI. We critiqued and graded for relevance 10 papers that included original research and other sources. Key findings indicate that there is considerable variability in how patients treated for STEMI perceive the experience of PCI. Further, there is a misalignment between some patients' perceptions and health professionals' perceptions of this experience related to the event as well as the language used to speak of it. Thus, we recommend that nurses assess patients' perception of the experience and patients' health literacy level, then tailor the content and language of patient and family education to ensure an effective educative intervention.

Follow-up period of 13 years after endoscopic total extraperitoneal repair of inguinal hernias: a cohort study.

PubMed

Brandt-Kerkhof, Alexandra; van Mierlo, Marjolein; Schep, Niels; Renken, Nondo; Stassen, Laurents

2011-05-01

Endoscopic inguinal hernia repair was introduced in the Netherlands in the early 1990s. The authors' institution was among the first to adopt this technique. In this study, long-term hernia recurrence among patients treated by the total extraperitoneal (TEP) approach for an inguinal hernia is described. A cohort study was conducted. Between January 1993 and December 1997, 346 TEP hernia repairs were performed for 318 patients. After a mean follow-up period of 13-years, a senior resident examined each patient. An experienced surgeon subsequently examined the patients with a diagnosis of recurrent hernia. Data were collected on an intention-to-treat basis, meaning that conversions were included in the analysis. Univariant tests were used to analyze age older than 50 years, chronic obstructive pulmonary disease, body mass index, smoking habit, hernia type, history of open hernia repair, conversion, and surgeon as potential risk factors. The analysis included 191 patients (62%) with 213 hernias. Of the original 318 patients, 59 patients died, and 68 were lost to follow-up evaluation. Perioperatively, 105 lateral, 55 medial, and 53 pantalon hernias were observed. Of the 213 hernias, 176 were primary and 37 were recurrent. The overall recurrence rate was 8.9% (8.5% for primary and 10.8% for recurrent hernias). Of the total study group, 48% of the patients experienced a bilateral inguinal hernia during their lifetime. No predicting factor for recurrent hernia could be identified. The current long-term results for TEP repair of primary and secondary inguinal hernia show an overall recurrence rate of 8.9%, which is slightly higher than in previous studies. The thorough examination at follow-up assessment, the learning curve effect, and the intention-to-treat-analysis may have influenced the observed recurrence rate. Also, the percentage of bilateral hernias was higher than known to date. Therefore, examination of the contralateral side should be standard procedure.

Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study.

PubMed

DeAngelo, Daniel J; Stock, Wendy; Stein, Anthony S; Shustov, Andrei; Liedtke, Michaela; Schiffer, Charles A; Vandendries, Erik; Liau, Katherine; Ananthakrishnan, Revathi; Boni, Joseph; Laird, A Douglas; Fostvedt, Luke; Kantarjian, Hagop M; Advani, Anjali S

2017-06-27

This study evaluated the safety, antitumor activity, pharmacokinetics, and pharmacodynamics of inotuzumab ozogamicin (InO) for CD22-positive relapsed/refractory acute lymphoblastic leukemia. In phase 1, patients received InO 1.2 (n = 3), 1.6 (n = 12), or 1.8 (n = 9) mg/m 2 per cycle on days 1, 8, and 15 over a 28-day cycle (≤6 cycles). The recommended phase 2 dose (RP2D) was confirmed (expansion cohort; n = 13); safety and activity of InO were assessed in patients receiving the RP2D in phase 2 (n = 35) and in all treated patients (n = 72). The RP2D was 1.8 mg/m 2 per cycle (0.8 mg/m 2 on day 1; 0.5 mg/m 2 on days 8 and 15), with reduction to 1.6 mg/m 2 per cycle after complete remission (CR) or CR with incomplete marrow recovery (CRi). Treatment-related toxicities were primarily cytopenias. Four patients experienced treatment-related venoocclusive disease/sinusoidal obstruction syndrome (VOD/SOS; 1 fatal). Two VOD/SOS events occurred during treatment without intervening transplant; of 24 patients proceeding to poststudy transplant, 2 experienced VOD/SOS after transplant. Forty-nine (68%) patients had CR/CRi, with 41 (84%) achieving minimal residual disease (MRD) negativity. Median progression-free survival was 3.9 (95% confidence interval, 2.9-5.4) months; median overall survival was 7.4 (5.7-9.2) months for all treated patients, with median 23.7 (range, 6.8-29.8) months of follow-up for all treated patients alive at data cutoff. Achievement of MRD negativity was associated with higher InO exposure. InO was well tolerated and demonstrated high single-agent activity and MRD-negativity rates. This trial was registered at www.clinicaltrials.gov as #NCT01363297.

Nasal symptoms and clinical findings in adult patients treated for unilateral cleft lip and palate.

PubMed

Morén, Staffan; Mani, Maria; Lundberg, Kristina; Holmström, Mats

2013-10-01

The aim of the study was to investigate self-experienced nasal symptoms among adults treated for UCLP and the association to clinical findings, and to evaluate whether palate closure in one-stage or two-stages affected the symptoms or clinical findings. All people with UCLP born between 1960-1987, treated at Uppsala University Hospital, were considered for participation in this cross-sectional population study with long-term follow-up. Eighty-three patients (76% participation rate) participated, a mean of 37 years after the first operation. Fifty-two patients were treated with one-stage palate closure and 31 with two-stage palate closure. An age-matched group of 67 non-cleft controls completed the same study protocol, which included a questionnaire regarding nasal symptoms, nasal inspection, anterior rhinoscopy, and nasal endoscopy. Patients reported a higher frequency of nasal symptoms compared with the control group, e.g., nasal obstruction (81% compared with 60%) and mouth breathing (20% compared with 5%). Patients also rated their nasal symptoms as having a more negative impact on their daily life and physical activities than controls. Nasal examination revealed higher frequencies of nasal deformities among patients. No positive correlation was found between nasal symptoms and severity of findings at nasal examination. No differences were identified between patients treated with one-stage and two-stage palate closure regarding symptoms or nasal findings. Adult patients treated for UCLP suffer from more nasal symptoms than controls. However, symptoms are not associated with findings at clinical nasal examination or method of palate closure.

How to Avoid a Learning Curve in Stapedotomy: A Standardized Surgical Technique.

PubMed

Kwok, Pingling; Gleich, Otto; Dalles, Katharina; Mayr, Elisabeth; Jacob, Peter; Strutz, Jürgen

2017-08-01

To evaluate, whether a learning curve for beginners in stapedotomy can be avoided by using a prosthesis with thermal memory-shape attachment in combination with a standardized laser-assisted surgical technique. Retrospective case review. Tertiary referral center. Fifty-eight ears were operated by three experienced surgeons and compared with a group of 12 cases operated by a beginner in stapedotomy. Stapedotomy. Difference of pure-tone audiometry thresholds measured before and after surgery. The average postoperative gain for air conduction in the frequencies below 2 kHz was 20 to 25 dB and decreased for the higher frequencies. Using the Mann-Whitney-U test for comparing mean gain between experienced and inexperienced surgeons showed no significant difference (p = 0.281 at 4 kHz and p > 0.7 for the other frequencies). A Spearman rank correlation of the postoperative gain for air- and bone-conduction thresholds was obtained at each test frequency for the first 12 patients consecutively treated with a thermal memory-shape attachment prosthesis by two experienced and one inexperienced surgeon. This analysis does not support the hypothesis of a "learning effect" that should be associated with an improved outcome for successively treated patients. It is possible to avoid a learning curve in stapes surgery by applying a thermal memory-shape prosthesis in a standardized laser-assisted surgical procedure.

Can claudication be improved with medication?

PubMed

Conners, Michael S; Money, Samuel R

2002-12-01

Intermittent claudication is a common disabling condition that affects approximately 5% to 15% of patients with atherosclerotic disease. Recommended treatment involves lifestyle modification and physical conditioning through the adoption of a regular exercise program. These methods of treatment often have been unsuccessful in the past because of noncompliance, in large part related to the relatively minor degree of improvement experienced by the patient. However, some recent trials have resulted in greater relative improvements in both pain-free and maximal walking distances in some patients treated with medication. Surgical and endovascular options offer greater degrees of improvement but also greater morbidity and should be reserved as treatment for severe claudication. The efficacies, as well as common adverse reactions associated with current medications used to treat patients with intermittent claudication are reviewed. Copyright 2002, Elsevier Science (USA). All rights reserved.

Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years.

PubMed

Gonwa, Thomas; Johnson, Christopher; Ahsan, Nasimul; Alfrey, Edward J; Halloran, Philip; Stegall, Mark; Hardy, Mark; Metzger, Robert; Shield, Charles; Rocher, Leslie; Scandling, John; Sorensen, John; Mulloy, Laura; Light, Jimmy; Corwin, Claudia; Danovitch, Gabriel; Wachs, Michael; VanVeldhuisen, Paul; Leonhardt, Maryanne; Fitzsimmons, William E

2003-06-27

Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1% vs. 49.9%, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF. All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.

Efficacy and Toxicity of Intrathecal Liposomal Cytarabine in First-line Therapy of Childhood Acute Lymphoblastic Leukemia.

PubMed

Levinsen, Mette; Harila-Saari, Arja; Grell, Kathrine; Jonsson, Olafur Gisli; Taskinen, Mervi; Abrahamsson, Jonas; Vettenranta, Kim; Åsberg, Ann; Risteli, Juha; Heldrup, Jesper; Schmiegelow, Kjeld

2016-11-01

We investigated efficacy and toxicity of replacing conventional triple (cytarabine, methotrexate, and hydrocortisone) intrathecal therapy (TIT) with liposomal cytarabine during maintenance therapy among 40 acute lymphoblastic leukemia patients. Twenty-eight of 29 patients in the TIT arm received TIT and 9/11 in the liposomal cytarabine arm received liposomal cytarabine. Arachnoiditis occurred in all initial 5 patients given liposomal cytarabine and intrathecal prednisolone succinate. Subsequently liposomal cytarabine was given with systemic dexamethasone. Neurotoxicity occurred at 6/27 liposomal cytarabine administrations with concomitant dexamethasone (22%). More liposomal cytarabine-treated patients experienced neurotoxicity in relation to intrathecal therapy during at least 1 cycle compared with TIT-treated patients (6/9 [67%] vs. 3/28 [11%], P=0.002). Apart from intermittent lower extremity sensory pain in 1 liposomal cytarabine-treated patient, no permanent adverse neurological sequelae were observed. In intention-to-treat analysis, projected 5-year event-free survival (pEFS-5y) was borderline higher for patients in the liposomal cytarabine arm compared with the TIT arm (1.0 vs. 0.69, P=0.046). However, pEFS-5y and projected 5-year relapse-free survival did not differ signficantly between patients treated with liposomal cytarabine or TIT (1.0 vs. 0.73, P=0.10; 1.0 vs. 0.76, P=0.12). Larger prospective trials are needed to explore whether liposomal cytarabine should be used as first-line prevention of relapse.

Early Experience With a Partial Stapled Hemorrhoidopexy for Treating Patients With Grades III–IV Prolapsing Hemorrhoids

PubMed Central

Jeong, Hyeonseok; Ryu, Kil O; Lim, Jiyong; Kim, Hyun Tae; Yu, Hye Mi; Yoon, Jihoon; Lee, Ju-Young; Kim, Hyoung Rae; Choi, Young Gil

2017-01-01

Purpose Circular stapled hemorrhoidopexy (CSH) is widely used to treat patients with grades III–IV hemorrhoids because of less pain and short hospital stay. However, this procedure is associated with some complications, such as urge to defecate, anal stenosis, staple line dehiscence, abscess and sepsis. To avoid these complications, surgeons perform a partial stapled hemorrhoidopexy (PSH). The aim of this study is to present our early experience with the PSH. Methods We retrospectively reviewed the medical records of 58 patients with hemorrhoids who were treated with a PSH at Busan Hang-Un Hospital from January 2016 to June 2016. A specially designed tri-window anoscope was used, and a purse string suture was made at the mucosae of the protruding hemorrhoids through the window of the anoscope. The hemorrhoidopexy was done by using a circular stapler. Results Of the 58 patients included in this study, 34 were male and 24 were female patients (mean age, 50.4 years). The mean operation time was 12.4 minutes, and the mean postoperative hospital stay was 3.8 days. Three patients experienced bleeding (5.1%) 5 urinary retention (8.6%) and 5 skin tags (8.6%). Urge to defecate, tenesmus, abscess, rectovaginal fistula, anal stricture, incontinence, and recurrence did not occur. Conclusion PSH is a minimally invasive, feasible, and safe technique for treating patients with grades III–IV hemorrhoids. A PSH, instead of a CSH, can be used to treat certain patients with hemorrhoids. PMID:28289661

Analgesic Effect of Botulinum Toxin A in Myofascial Pain Syndrome Patients Previously Treated with Local Infiltration of Anesthetic and Steroids.

PubMed

Cartagena-Sevilla, Joaquín; García-Fernández, María R; Vicente-Villena, Juan P

2016-12-01

The purpose of this study was to evaluate the analgesic effect of botulinum toxin A (BoNTA) injections in patients with myofascial pain syndrome (MPS) who were previously treated with the local infiltration of anesthetic and steroids (LIAS). The study included a retrospective phase and a longitudinal open-label prospective phase, which were conducted on consecutive patients with MPS previously treated with the local infiltration of anesthetic (levobupivacaíne 0.25%) and steroids (triamcinolone 40 mg). Eligible patients were treated with a single intramuscular injection of BoNTA (Botox; Allergan, Inc., Irvine, CA). The treatment efficacy was determined according to the degree of pain relief obtained. Eighty-two patients met the inclusion/exclusion criteria and were included in the study. Successful results were obtained for 32 (39.0%) and 30 (36.6%) patients, during treatment with BoNTA and LIAS, respectively. The mean (standard deviation) length of the analgesic effect was significantly longer with BoNTA (29.6 [SD = 17.7] weeks) than with LIAS (8.5 [SD = 6.4] weeks), P <.0001. As regards the side effects, 19 (23.2%) patients reported transient soreness at the injection site for 2 to 3 days with BoNTA. The MPS patients previously treated with a local infiltration of anesthetic and steroids who then received a single injection of BoNTA experienced significantly reduced pain for a relatively long time.

[Fine mesh metal endoprostheses for treatment of extensive cervical and intrathoracic tracheomalacia].

PubMed

Wilmes, E; Berger, H; Dienemann, H; Jolk, A

1994-01-01

The treatment of tracheal stenoses caused by tracheomalacia is mainly carried out by means of sleeve resection, tracheopexy with ring support or other tracheoplastic operative procedures. If patients cannot be treated by surgical operative strategies, conventional stents are usually used to dilate the trachea. The use of a self-expanding elastic metal prosthesis in 5 patients with tracheal airway obstruction caused by tracheomalacia proved to be a true alternative in the therapy of tracheobronchial stenoses. We report on the long term use of 5 patients with tracheal stenoses treated by implantation of elastic metal wallstents. The implantation of the stents resulted in immediate improvement in respiratory function in all 5 patients. None of the patients experienced complications secondary to the stent placement. The stents were well tolerated (long-time follow-up 26 months). The implantation of self-expanding metal stents type "wallstent" seems to offer alternative possibilities for the treatment of tracheomalacia.

Multimodality treatment with intensity modulated radiation therapy for esophageal cancer.

PubMed

La, T H; Minn, A Y; Su, Z; Fisher, G A; Ford, J M; Kunz, P; Goodman, K A; Koong, A C; Chang, D T

2010-05-01

The objective of this study is to determine the feasibility and report the outcome of patients with locally advanced esophageal cancer treated with preoperative or definitive chemoradiotherapy (CRT) using intensity-modulated radiation therapy (IMRT). Between 2003 and 2007, 30 patients with non-cervical esophageal cancer received concurrent chemotherapy and IMRT at Stanford University. Eighteen patients were planned for definitive CRT and 12 were planned for preoperative CRT. All patients had computed tomography-based treatment planning and received IMRT. The median dose delivered was 50.4 Gy. Patients planned for preoperative CRT underwent surgery 4-13 weeks (median 8.3 weeks) following completion of CRT. Median follow-up of surviving patients from start of RT was 24.2 months (range 8.2-38.3 months). The majority of tumors were adenocarcinomas (67%) and poorly differentiated (57%). Tumor location was 7% upper, 20% mid, 47% lower, and 27% gastroesophageal junction. Actuarial 2-year local-regional control (LRC) was 64%. High tumor grade was an adverse prognostic factor for LRC and overall survival (OS) (P= 0.015 and 0.012, respectively). The 2-year LRC was 83% vs. 51% for patients treated preoperatively vs. definitively (P= 0.32). The 2-year disease-free and OS were 38% and 56%, respectively. Twelve patients (40%) required feeding tube placement, and the average weight loss from baseline was 4.8%. Twelve (40%) patients experienced grade 3+ acute complications and one patient died of complications following feeding tube placement. Three patients (10%) required a treatment break. Eight patients (27%) experienced grade 3 late complications. No grade 4 complications were seen. IMRT was effective and well tolerated. Disease recurrence remains a challenge and further investigation with dose escalation to improve LRC and OS is warranted.

Surgical management of dural arteriovenous fistulas with transosseous arterial feeders involving the jugular bulb.

PubMed

Tirakotai, W; Benes, L; Kappus, C; Sure, U; Farhoud, A; Bien, S; Bertalanffy, H

2007-01-01

Dural arteriovenous fistulas located in the vicinity of the jugular foramen are complex vascular malformations and belong to the most challenging skull base lesions to treat. The authors comprehensively analyze multiple features in a series of dural arteriovenous fistulas with transosseous arterial feeders involving the jugular bulb. Four patients who underwent surgery via the transcondylar approach to treat dural arteriovenous fistulas around the jugular foramen were retrospectively reviewed. Previously, endovascular treatment was attempted in all patients. The success of the surgical treatment was examined with postoperative angiography. Complete obliteration of the dural arteriovenous fistulas (DAVFs) was achieved in three patients, and significant flow reduction in one individual. All patients had a good postoperative outcome, and only one experienced mild hypoglossal nerve palsy. Despite extensive bone drilling, an occipitocervical fusion was necessary in only one patient with bilateral lesions. The use of an individually tailored transcondylar approach to treat dural arteriovenous fistulas at the region of the jugular foramen is most effective. This approach allows for complete obliteration of the connecting arterial feeders, and removal of bony structures containing pathological vessels.

Hypofractionated Intensity Modulated Radiation Therapy in Combined Modality Treatment for Bladder Preservation in Elderly Patients With Invasive Bladder Cancer

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

Turgeon, Guy-Anne; Souhami, Luis, E-mail: luis.souhami@muhc.mcgill.ca; Cury, Fabio L.

2014-02-01

Purpose/Objective(s): To review our experience with bladder-preserving trimodality treatment (TMT) using hypofractionated intensity modulated radiation therapy (IMRT) for the treatment of elderly patients with muscle-invasive bladder cancer. Methods and Materials: Retrospective study of elderly patients treated with TMT using hypofractionated IMRT (50 Gy in 20 fractions) with concomitant weekly radiosensitizing chemotherapy. Eligibility criteria were as follows: age ≥70 years, a proven diagnosis of muscle-invasive transitional cell bladder carcinoma, stage T2-T3N0M0 disease, and receipt of TMT with curative intent. Response rate was assessed by cystoscopic evaluation and bladder biopsy. Results: 24 patients with a median age of 79 years were eligible.more » A complete response was confirmed in 83% of the patients. Of the remaining patients, 1 of them underwent salvage cystectomy, and no disease was found in the bladder on histopathologic assessment. After a median follow-up time of 28 months, of the patients with a complete response, 2 patients had muscle-invasive recurrence, 1 experienced locoregional failure, and 3 experienced distant metastasis. The overall and cancer-specific survival rates at 3 years were 61% and 71%, respectively. Of the surviving patients, 75% have a disease-free and functioning bladder. All patients completed hypofractionated IMRT, and 19 patients tolerated all 4 cycles of chemotherapy. Acute grade 3 gastrointestinal or genitourinary toxicities occurred in only 4% of the patients, and acute grade 3 or 4 hematologic toxicities, liver toxicities, or both were experienced by 17% of the cohort. No patient experienced grade 4 gastrointestinal or genitourinary toxicity. Conclusions: Hypofractionated IMRT with concurrent radiosensitizing chemotherapy appears to be an effective and well-tolerated curative treatment strategy in the elderly population and should be considered for patients who are not candidates for cystectomy or who wish to avoid cystectomy.« less

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.

Surgical stabilisation of the lower limb in osteogenesis imperfecta using the Sheffield Telescopic Intramedullary Rod System.

PubMed

Wilkinson, J M; Scott, B W; Clarke, A M; Bell, M J

1998-11-01

The Sheffield Expanding Intramedullary Rod System was developed after experiencing problems with existing rod systems in the management of osteogenesis imperfecta. Between 1986 and 1996 we treated 74 bones in the lower limb in 28 children at a median follow-up of 5.25 years. We have reviewed 24 children with a total of 60 rods. Before surgery, all children had had multiple fractures of the lower limb. At review eight patients had experienced no further fractures, but three had suffered five or more subsequently. Before initial stabilisation, 15 children had never walked, and only three (13%) used walking as their main means of mobility. After surgery, half of those who showed motor arrest were able to walk (p = 0.016). The number of patients able to walk, with or without aids, increased to 17 (p = 0.0001). We have experienced no evidence of epiphyseal damage after the procedure, and complication rates requiring rod exchange have been low (7%).

Intracoronary bivalirudin for no reflow reversal: a second chance to treat this disorder?

PubMed

Cortese, Bernardo; Picchi, Andrea; Micheli, Andrea; Limbruno, Ugo

2009-07-01

No reflow, defined as failure to restore normal myocardial blood flow despite removal of coronary obstruction, is a not rare complication of ST-elevation acute myocardial infarction. We here describe the case of an old patient experiencing inferior and right ventricle myocardial infarction complicated by cardiogenic shock, anaemia and thrombocytopenia. We managed it with urgent PCI using thrombus aspirator, that determined onset of no reflow, that we successfully managed with intracoronary bivalirudin. We showed how bivalirudin, a drug whose use is increasing in the catheterization laboratories, could be safely used via the intracoronary route to treat no reflow phenomenon due to distal microembolization in a complex patient.

Burnout and Doctors: Prevalence, Prevention and Intervention

PubMed Central

Kumar, Shailesh

2016-01-01

Doctors are exposed to high levels of stress in the course of their profession and are particularly susceptible to experiencing burnout. Burnout has far-reaching implications on doctors; patients and the healthcare system. Doctors experiencing burnout are reported to be at a higher risk of making poor decisions; display hostile attitude toward patients; make more medical errors; and have difficult relationships with co-workers. Burnout among doctors also increases risk of depression; anxiety; sleep disturbances; fatigue; alcohol and drug misuse; marital dysfunction; premature retirement and perhaps most seriously suicide. Sources of stress in medical practice may range from the emotions arising in the context of patient care to the environment in which doctors practice. The extent of burnout may vary depending on the practice setting; speciality and changing work environment. Understanding dynamic risk factors associated with burnout may help us develop strategies for preventing and treating burnout. Some of these strategies will be reviewed in this paper. PMID:27417625

A longitudinal, retrospective cohort study on the impact of roflumilast on exacerbations and economic burden among chronic obstructive pulmonary disease patients in the real world.

PubMed

Wan, Yin; Sun, Shawn X; Corman, Shelby; Huang, Xingyue; Gao, Xin; Shorr, Andrew F

2015-01-01

Roflumilast is approved in the United States to reduce the risk of COPD exacerbations in patients with severe COPD. Exacerbation rates, health care resource utilization (HCRU), and costs were compared between roflumilast patients and those receiving other COPD maintenance drugs. LifeLink™ Health Plan Claims Database was used to identify patients diagnosed with COPD who initiated roflumilast (roflumilast group) or ≥3 other COPD maintenance drugs (non-roflumilast group) from May 1, 2011 to December 31, 2012. Patients must have been enrolled for 12 months before (baseline) and 3 months after (postindex) the initiation date, ≥40 years old, not systemic corticosteroid dependent, and without asthma diagnosis at baseline. Difference-in-difference models compared change from baseline in exacerbations, HCRU (office, emergency visits, and hospitalizations), and total costs between groups, adjusting for baseline differences. A total of 14,211 patients (roflumilast, n=710; non-roflumilast, n=13,501) were included. During follow-up, the rate of overall exacerbations per patient per month decreased by 11.1% in the roflumilast group and increased by 15.9% in the non-roflumilast group (P<0.001). After controlling for baseline differences, roflumilast-treated patients experienced a greater reduction in exacerbations (0.0160 fewer exacerbations per month, P=0.01), numerically greater reductions in hospital admissions (0.003 fewer per month, P=0.57), office visits (0.46 fewer per month, P=0.26), and total costs from baseline compared with non-roflumilast patients ($116 less per month, P=0.62). In a real-world setting, patients initiating roflumilast experienced reductions in exacerbations versus patients treated with other COPD medications.

A Retrospective Study of Cleft lip and palate Patients' Satisfaction after Maxillary Distraction or Traditional Advancement of the Maxilla.

PubMed

Andersen, Kristian; Nørholt, Sven Erik; Küseler, Annelise; Jensen, John; Pedersen, Thomas Klit

2012-01-01

To compare cleft lip and palate patients' satisfaction with aesthetics and functional parameters after conventional advancement of the maxilla or by the use of distraction osteogenesis. Case series observational study. Group of distraction osteogenesis (DO) consisted of 15 patients treated with distraction osteogenesis while group conventional (CONV) included 10 patients treated with traditional advancement of the maxilla. Patients were asked to fill out a questionnaire about their subjective evaluation of satisfaction with facial aesthetics and functional parameters on a continuous visual analog-scale (VAS) when the treatment was finished. The total response rate was 76%. Preoperatively the two groups did not differ significantly according to group characteristics. At follow-up both groups were satisfied with aesthetics and functional parameters. The DO group was less satisfied with the duration of the treatment than the CONV group. There were no statistically significant differences among the groups regarding functional parameters or facial aesthetics. Cleft lip and palate patients experienced a high level of satisfaction with functional parameters and aesthetics as a result of surgical maxillary advancement. The patients treated with distraction osteogenesis were less satisfied with the duration of the treatment. Further studies are needed.

Anagrelide reduces thrombotic risk in essential thrombocythaemia vs. hydroxyurea plus aspirin.

PubMed

Dombi, Péter; Illés, Árpád; Demeter, Judit; Homor, Lajos; Simon, Zsofia; Karadi, Eva; Udvardy, Miklos; Egyed, Miklos

2017-02-01

To evaluate the reduction in thrombotic events (TE) in patients with essential thrombocythaemia (ET) treated with anagrelide versus hydroxyurea + aspirin (HU + ASA). A questionnaire was developed using 2008 WHO diagnostic criteria, and thrombotic risk factors were stratified according to Landolfi criteria. Through questionnaire completion, clinicians at Hungarian haematological centres entered data into the Hungarian MPN Registry on patients with myeloproliferative neoplasms. Based on ET registry data, TEs in anagrelide-treated patients (n = 139) were compared with HU + ASA-treated patients (n = 141). Patients were followed up for (median) 6 yr. TEs were reported in significantly fewer anagrelide-treated patients versus HU + ASA (15.1% versus 49.6%; P < 0.001). Numbers of major arterial and major venous events were similar between the groups, although there were over fivefold more minor arterial and minor venous events in the HU + ASA group (P < 0.001). While median age at diagnosis was older and length of follow-up shorter in the HU + ASA group (P < 0.05), this did not influence TE incidence; medication and TE before diagnosis only influenced TE incidence. Anagrelide significantly decreased the number of patients experiencing minor arterial and minor venous TEs versus HU + ASA over 6 yr. Risk of TE after diagnosis was significantly increased if the patient had TE before diagnosis. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Stereotactic body radiation therapy for palliative management of pancreatic adenocarcinoma in elderly and medically inoperable patients.

PubMed

Ryan, John F; Rosati, Lauren M; Groot, Vincent P; Le, Dung T; Zheng, Lei; Laheru, Daniel A; Shin, Eun J; Jackson, Juan; Moore, Joseph; Narang, Amol K; Herman, Joseph M

2018-03-27

Stereotactic body radiation therapy (SBRT) represents a promising treatment option for patients with localized pancreatic ductal adenocarcinoma (PDAC) who cannot tolerate surgical therapy. We retrospectively reviewed the records of patients with localized PDAC treated with SBRT at our institution between 2010 and 2016 to identify patients deemed medically inoperable due to poor performance status, advanced age, and/or comorbid conditions. Overall survival (OS), progression-free survival (PFS), and local progression-free survival (LPFS) were estimated using Kaplan-Meier curves. Twenty-nine patients were included. Median age was 74 (IQR 68-79). Thirteen patients (45%) had an Eastern Cooperative Oncology Group performance status of 2. Six patients (19%) had chronic obstructive pulmonary disease, 9 (31%) had cardiovascular disease, and 17 (58%) had diabetes mellitus. SBRT was delivered over 5 fractions to a median dose of 28 Gy (IQR, 25-33). Twenty-two patients (76%) received induction chemotherapy prior to SBRT, and 9 (31%) received maintenance chemotherapy after SBRT. Median OS was 13 months from diagnosis. Median OS and PFS were 8 and 6 months from SBRT, respectively. Six and 12-month LPFS rates were 91% and 78%, respectively. Patients receiving induction chemotherapy had superior survival from diagnosis than those who did not (14 vs. 7 months, p = 0.01). Three patients (10%) experienced acute grade ≥3 toxicity, and 1 patient (4%) experienced grade ≥3 late toxicity. Symptom relief was achieved at three-month follow-up in 8 of 11 patients (73%) experiencing abdominal pain. These results suggest SBRT may be safe and effective for patients who cannot tolerate surgery.

Predictors of Peritonitis and the Impact of Peritonitis on Clinical Outcomes of Continuous Ambulatory Peritoneal Dialysis Patients in Taiwan—10 Years’ Experience in a Single Center

PubMed Central

Hsieh, Yao-Peng; Chang, Chia-Chu; Wen, Yao-Ko; Chiu, Ping-Fang; Yang, Yu

2014-01-01

♦ Objective: Peritoneal dialysis (PD) has become more prevalent as a treatment modality for end-stage renal disease, and peritonitis remains one of its most devastating complications. The aim of the present investigation was to examine the frequency and predictors of peritonitis and the impact of peritonitis on clinical outcomes. ♦ Methods: Our retrospective observational cohort study enrolled 391 patients who had been treated with continuous ambulatory PD (CAPD) for at least 90 days. Relevant demographic, biochemical, and clinical data were collected for an analysis of CAPD-associated peritonitis, technique failure, drop-out from PD, and patient mortality. ♦ Results: The peritonitis rate was 0.196 episodes per patient-year. Older age (>65 years) was the only identified risk factor associated with peritonitis. A multivariate Cox regression model demonstrated that technique failure occurred more often in patients experiencing peritonitis than in those free of peritonitis (p < 0.001). Kaplan-Meier analysis revealed that the group experiencing peritonitis tended to survive longer than the group that was peritonitis-free (p = 0.11). After multivariate adjustment, the survival advantage reached significance (hazard ratio: 0.64; 95% confidence interval: 0.46 to 0.89; p = 0.006). Compared with the peritonitis-free group, the group experiencing peritonitis also had more drop-out from PD (p = 0.03). ♦ Conclusions: The peritonitis rate was relatively low in the present investigation. Elderly patients were at higher risk of peritonitis episodes. Peritonitis independently predicted technique failure, in agreement with other reports. However, contrary to previous studies, all-cause mortality was better in patients experiencing peritonitis than in those free of peritonitis. The underlying mechanisms of this presumptive “peritonitis paradox” remain to be clarified. PMID:24084840

Phase 1 Trial of Sorafenib and Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

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

Brade, Anthony M., E-mail: anthony.brade@rmp.uhn.on.ca; Department of Radiation Oncology, Faculty of Medicine, University of Toronto, Toronto, Ontario; Ng, Sylvia

Purpose: To determine the maximally tolerated dose of sorafenib delivered before, during, and after stereotactic body radiation therapy (SBRT) in hepatocellular carinoma (HCC). Methods and Materials: Eligible patients had locally advanced Child-Pugh class A HCC, showed Eastern Cooperative Oncology Group performance status 0-1, and were ineligible for standard local-regional therapies. Sorafenib was dose escalated in 2 strata: (1) low effective irradiated liver volume (veff) < 30% and (2) high veff 30%to 60%. Sorafenib (400 mg daily = dose level 1) was administered for 12 weeks, with 6 fractions SBRT delivered weeks 2 and 3, and escalation to full dose (400 mg twice daily) after 12 weeks as tolerated.more » Standard 3 + 3 cohorts with dose escalation of sorafenib were planned. Results: Sixteen patients (4 low veff, median dose 51 Gy; 12 high veff, median dose 33 Gy) were treated at 2 sorafenib dose levels. Of those patients 75% were had Barcelona Clinic Liver Cancer stage C, and 63% had main branch portal vein invasion. In the low veff stratum, no dose-limiting toxicities (DLTs) were observed in 4 patients treated with SBRT and sorafenib 400 mg. Inb the high veff stratum: 2 of 3 evaluable patients treated with sorafenib 400 mg experienced DLT (grade 3 large bowel bleed and grade 4 bowel obstruction 51 and 27 days, respectively, after SBRT). One of 6 evaluable patients at dose level −1 (200 mg once daily) experienced a grade 3 tumor rupture at week 5. Median overall survival and in-field local progression have not been reached. Worsening of Child-Pugh liver function class was seen in 6 of 12 patients in the high veff stratum. Conclusions: Significant toxicity was observed in the high veff stratum, and concurrent SBRT with sorafenib is not recommended outside a clinical trial.« less

Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial.

PubMed

Piccini, Jonathan P; Garg, Jyotsna; Patel, Manesh R; Lokhnygina, Yuliya; Goodman, Shaun G; Becker, Richard C; Berkowitz, Scott D; Breithardt, Günter; Hacke, Werner; Halperin, Jonathan L; Hankey, Graeme J; Nessel, Christopher C; Mahaffey, Kenneth W; Singer, Daniel E; Califf, Robert M; Fox, Keith A A

2014-07-21

There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors. Using data from ROCKET AF, we analysed the management and outcomes of major bleeding overall and according to the randomized treatment. During a median follow-up of 1.9 years, 779 (5.5%) patients experienced major bleeding at a rate of 3.52 events/100 patient-years with a similar event rate in each arm (n = 395 rivaroxaban vs. n = 384 warfarin). The median number of transfused packed red blood cells (PRBC) per episode was similar in both arms [2 (25th, 75th: 2, 4) units]. Overall, few transfusions of whole blood (n = 14), platelets (n = 10), or cryoprecipitate (n = 2) were used. Transfusion of fresh frozen plasma (FFP) was significantly less in the rivaroxaban arm (n = 45 vs. n = 81 units) after adjustment for covariates [odds ratio (OR) 0.43 (95% CI 0.29-0.66); P < 0.0001]. Prothrombin complex concentrates (PCC) were administered less in the rivaroxaban arm (n = 4 vs. n = 9). Outcomes after major bleeding, including stroke or non-central nervous system embolism (4.7% rivaroxaban vs. 5.4% warfarin; HR 0.89; 95% CI 0.42-1.88) and all-cause death (20.4% rivaroxaban vs. 26.1% warfarin; HR 0.69, 95% CI 0.46-1.04) were similar in patients treated with rivaroxaban and warfarin (interaction P = 0.51 and 0.11). Among high-risk patients with atrial fibrillation who experienced major bleeding in ROCKET AF, the use of FFP and PCC was less among those allocated rivaroxaban compared with warfarin. However, use of PRBCs and outcomes after bleeding were similar among patients randomized to rivaroxaban or to warfarin. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Vacuum sealing drainage therapy in the presence of an external fixation device

PubMed Central

Sun, Dahui; Ju, Weina; Wang, Tiejun; Yu, Tiecheng; Qi, Baochang

2016-01-01

Abstract Rationale: Vacuum sealing drainage (VSD) is widely utilized for treating traumatic wounds. Patient concerns: It is particularly difficult and time consuming to use in combination with an external fixator. Diagnoses: This is because the hardware or pins used for fixation interfere with maintaining a seal, resulting in poor adhesion and subsequent air leakage. Interventions: To resolve this problem, we have devised a new method for sealing the wound dressing, while maintaining the required vacuum.When using this technique, a rubber strip is wrapped around each pin in 3 circles outside the plastic drape, and then tightly tied. Outcomes: After completing this procedure, a vacuum is obtained, and any air leakage stops. We employed this technique to treat a cohort of patients in our department over a period of two years, and obtained good healing of soft tissue without air leakage, as well as good clinical outcomes. Lessons: We have observed that patients treated with this method experienced good clinical outcomes without air leakage, and we recommend its use in treating cases where an external fixation device is present. PMID:27861393

Neurosurgical injuries resulting from the 2011 tornados in Alabama: the experience at the University of Alabama at Birmingham Medical Center.

PubMed

Miller, Joseph H; Zywicke, Holly A; Fleming, James B; Griessenauer, Christoph J; Whisenhunt, Thomas R; Okor, Mamerhi O; Harrigan, Mark R; Pritchard, Patrick R; Hadley, Mark N

2013-06-01

The April 27, 2011, tornados that affected the southeastern US resulted in 248 deaths in the state of Alabama. The University of Alabama at Birmingham (UAB) Medical Center, the largest Level I trauma center in the state, triaged and treated a large number of individuals who suffered traumatic injuries during these events, including those requiring neurosurgical assessment and treatment. A retrospective review of all adult patients triaged at UAB Medical Center during the April 27, 2011, tornados was conducted. Those patients who were diagnosed with and treated for neurosurgical injuries were included in this cohort. The Division of Neurosurgery at UAB Medical Center received 37 consultations in the 36 hours following the tornado disaster. An additional patient presented 6 days later, having suffered a lumbar spine fracture that ultimately required operative intervention. Twenty-seven patients (73%) suffered injuries as a direct result of the tornados. Twenty-three (85%) of these 27 patients experienced spine and spinal cord injuries. Four patients (15%) suffered intracranial injuries and 2 patients (7%) suffered combined intracranial and spinal injuries. The spinal fractures that were evaluated and treated were predominantly thoracic (43.5%) and lumbar (43.5%). The neurosurgery service performed 14 spinal fusions, 1 ventriculostomy, 2 halo placements, 1 diagnostic angiogram, 1 endovascular embolectomy, and 1 wound debridement and lavage. Twenty-two patients (81.5%) were neurologically intact at discharge and all but 4 had 1 year of follow-up. Three patients had persistent deficits from spinal cord injuries and there was 1 death in a patient with multisystem injuries in whom no procedures were performed. Two patients experienced postoperative complications in the form of 1 wound infection and 1 stroke. The April 27, 2011, tornados in Alabama produced significant neurosurgical injuries that primarily involved the spine. There were a disproportionate number of patients with thoracolumbar fractures, a finding possibly due to the county medical examiner's postmortem findings that demonstrated a high prevalence of fatal cervical spine and traumatic brain injuries. The UAB experience can be used to aid other institutions in preparing for the appropriate allotment of resources in the event of a similar natural disaster.

Long-Term Efficacy of Oxybutynin for Palmar and Plantar Hyperhidrosis in Children Younger than 14 Years.

PubMed

Wolosker, Nelson; Teivelis, Marcelo P; Krutman, Mariana; de Paula, Rafael P; Schvartsman, Claudio; Kauffman, Paulo; de Campos, José R M; Puech-Leão, Pedro

2015-01-01

Oxybutynin for treating hyperhidrosis in children has been evaluated only in short-term studies. We aimed to investigate the long-term effects of oxybutynin in treating children with palmar and plantar hyperhidrosis who had not undergone surgery and who were monitored for at least 6 months (median 19.6 mos). A cohort of 97 patients was evaluated retrospectively, with particular attention to 59 children (ages 4-14 yrs) who were treated for longer than 6 months. Their quality of life (QOL) was evaluated using a validated clinical questionnaire before and after 6 weeks of pharmacologic therapy. A self-assessment of hyperhidrosis was performed after 6 weeks and after the last consultation. By their final office visit, more than 91% of the children with hyperhidrosis treated with oxybutynin experienced moderate or great improvement in their level of sweating and 94.9% experienced improvement in QOL. More than 90% of children reported improvement of hyperhidrosis at other sites. Dry mouth was the most common side effect. Oxybutynin appears to be an effective treatment option for children with hyperhidrosis, and positive results are maintained over the long term (median 19.6 mos). © 2014 Wiley Periodicals, Inc.

Three Hundred Patients Treated with Ultrapulsed 980 nm Diode Laser for Skin Disorders

PubMed Central

Wollina, Uwe

2016-01-01

The use of lasers in skin diseases is quite common. In contrast to other laser types, medical literature about 980 nm ultrapulsed diode laser is sparse in dermatology. Herein, we report the use of ultrapulsed diode 980 nm laser in 300 patients with vascular lesions, cysts and pseudocysts, infectious disease, and malignant tumors. This laser is a versatile tool with excellent safety and efficacy in the hands of the experienced user. PMID:27688445

Treatment of ischemic ulcers of the lower limbs with alprostadil (prostaglandin E1).

PubMed

Tondi, Paolo; Gerardino, Laura; Santoliquido, Angelo; Pola, Roberto; Gabrielli, Maurizio; Papaleo, Pierangelo; Gasbarrini, Antonio; Pola, Paolo; Flore, Roberto

2004-08-01

Hemodynamic, hemorheologic, and metabolic changes are main determinants in the genesis of ischemic leg ulcers. Because prostaglandin E1 (alprostadil) could successfully counteract these changes, it has been intravenously used in the treatment of this disease. The aim of this study was to evaluate the efficacy of alprostadil in the treatment of ischemic ulcers and to compare subcutaneous with intravenous administration. Eighty patients were enrolled. Twenty-five were treated by injecting low doses of alprostadil around ischemic ulcers of the leg and saline solution intravenously and 25 were treated with intravenous alprostadil and local injections of saline solution; the control group was composed of 30 patients who received saline solution around the ulcers and intravenously. All patients showed a statistically significant improvement in ulcer diameter, pain, and transcutaneous oxygen pressure compared to the control group. No relevant differences in the clinical outcome in the two treated groups were found, but patients treated with subcutaneous alprostadil experienced no side effects and showed higher values of transcutaneous oxygen pressure. Both intravenous and local subcutaneous alprostadil are useful in the treatment of ischemic leg ulcers, but subcutaneous administration is less expensive and easier to perform.

Subgaleal Retention Sutures: Internal Pressure Dressing Technique for Dolenc Approach.

PubMed

Burrows, Anthony M; Rayan, Tarek; Van Gompel, Jamie J

2017-08-01

Extradural approach to the cavernous sinus, the "Dolenc" approach recognizing its developing Dr. Vinko Dolenc, is a critically important skull base approach. However, resection of the lateral wall of the cavernous sinus, most commonly for cavernous sinus meningiomas, results commonly in a defect that often cannot be reconstructed in a water-tight fashion. This may result in troublesome pseudomeningocele postoperatively. To describe a technique designed to mitigate the development of pseudomeningocele. We found the Dolenc approach critical for resection of cavernous lesions. However, a number of pseudomeningoceles were managed with prolonged external pressure wrapping in the early cohort. Therefore, we incorporated subgaleal to muscular sutures, which were designed to close this potential space and retrospectively analyzed our results. Twenty-one patients treated with a Dolenc approach and resection of the lateral wall of the cavernous sinus over a 2-year period were included. Prior to incorporation of this technique, 12 patients were treated and 3 (25%) experienced postoperative pseudomeningoceles requiring multiple clinic visits and frequent dressing. After incorporation of subgaleal retention sutures, no patient (0%) experienced this complication. Although basic, subgaleal to temporalis muscle retention sutures likely aid in eliminating this potential dead space, thereby preventing patient distress postoperatively. This technique is simple and further emphasizes the importance of dead space elimination in complex closures. Copyright © 2017 by the Congress of Neurological Surgeons

Comparison of Re-irradiation Outcomes for Charged Particle Radiotherapy and Robotic Stereotactic Radiotherapy Using CyberKnife for Recurrent Head and Neck Cancers: A Multi-institutional Matched-cohort Analysis.

PubMed

Yamazaki, Hideya; Demizu, Yusuke; Okimoto, Tomoaki; Ogita, Mikio; Himei, Kengo; Nakamura, Satoaki; Suzuki, Gen; Yoshida, Ken; Kotsuma, Tadayuki; Yoshioka, Yasuo

2016-10-01

To compare survival outcomes for charged particle radiotherapy (CP) and stereotactic body radiotherapy using CyberKnife (CK) in patients who had undergone re-irradiation for head and neck cancers. We conducted a retrospective multi-institutional matched-cohort analysis on 25 patients treated with CP and 25 matched patients treated with CK according to three prognostic factors (nasopharyngeal cancer or not, interval between initial radiotherapy and re-irradiation, and planning target volume). CP was used more often to treat non-squamous cell cancer ((non-SCC): 52% vs. 0%) with a higher prescribed dose (median=57.6 Gy(RBE)/16 fractions) than CK (32 Gy/5 fractions). The local control rate (LC) for patients treated with CP was 71.2% at 1 year and that for patients treated with CK was 63.8% (p=0.24). The 1-year overall survival (OS) rates were 67.1% for CP and 36.3% for CK (p=0.0002), respectively. Non-SCC patients showed better OS rates at 1 year than SCC patients. In the SCC sub-group analysis, the 1-year LC, OS rates were 65%, 58.3% in the CP group and 64%, 36.3% in the CK group (p=0.81, p=0.02), respectively. A total of 16 patients (32%) experienced grade 3 or worse toxicities (24% in CK and 40% in CP, p=0.36), including six grade 5 toxicities. CP produced higher survival rates than CK, treated more non-SCC patients and used a higher prescribed dose. On the other hand, severe toxicities occurred in both groups, which, however, require further investigation. Copyright© 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Visual acuity and astigmatism in periocular infantile hemangiomas treated with oral beta-blocker versus intralesional corticosteroid injection.

PubMed

Herlihy, Erin P; Kelly, John P; Sidbury, Robert; Perkins, Jonathan A; Weiss, Avery H

2016-02-01

Periocular infantile hemangiomas (PIH) can induce anisometropic astigmatism, a risk factor for amblyopia. Oral beta-blocker therapy has largely supplanted systemic or intralesional corticosteroids. The purpose of this study was to evaluate the effect and time course of these treatment modalities on visual acuity and induced astigmatism. The medical records of patients with PIH treated with oral propanolol between November 2008 and July 2013 were retrospectively reviewed for data on visual acuity and astigmatism. Patients with incomplete pre- and post-treatment ophthalmic examinations were excluded. Results were compared to those of a similar cohort treated with intralesional corticosteroid injection. Mean astigmatism in affected eyes was 1.90 D before propranolol and 1.00 D after; patients showed a monophasic reduction in astigmatism over 12 months. By comparison, patients treated with corticosteroid injection showed a biphasic response, with an immediate steep decrease followed by a slow monophasic decline, paralleling propranolol-treated patients. Oral propranolol treatment caused a 47% reduction in mean induced astigmatism, less than the 63% reduction reported for the cohort treated with corticosteroid. No patient had visual acuity in the affected eye more than 1 standard devation below the age-matched norm, and none experienced significant side effects when treated with oral propranolol. In this patient cohort oral beta-blocker was well-tolerated. Treatment was therefore often initiated prior to the induction of significant astigmatism, with treatment effects comparable to steroid treatment. Visual outcomes were good. Early treatment may minimize the potential effect of astigmatism on postnatal visual development. Copyright © 2016 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

Total hip arthroplasty and perioperative oral carbohydrate treatment: a randomised, double-blind, controlled trial.

PubMed

Harsten, Andreas; Hjartarson, Hjörtur; Toksvig-Larsen, Sören

2012-06-01

Perioperative oral carbohydrate intake is beneficial to general surgery patients. Total hip arthroplasty is a common surgical procedure, and even a moderate improvement in patient outcome could have a significant effect on the resources needed for these patients. However, few studies have focused on the effects of carbohydrate intake on orthopaedic patients. The purpose of this study was to investigate if perioperative oral carbohydrate intake alters the postoperative course for patients undergoing total hip arthroplasty. The primary hypothesis was that pain scores would be lower in patients treated with carbohydrate. A randomised, double-blind, controlled trial. This study was carried out between September 2009 and April 2011 at a district Swedish hospital that specialises in orthopaedic surgery. Sixty ASA physical status I-III patients scheduled for elective total hip arthroplasty were included. Exclusion criteria were obesity, diabetes, prior hip surgery to the same hip, ongoing infection, immunological deficiency or age less than 50 or more than 80 years. Patients were given 400 ml of either an oral 12.5% carbohydrate solution or a placebo beverage (flavoured water) 1.5 h before and 2 h after surgery. Visual analogue scales were used to score six discomfort parameters. Immediately prior to surgery, the carbohydrate-treated patients were less hungry (median score 9.5 vs. 22 mm) and experienced less nausea (0 vs. 1.5 mm) (P< 0.05). Postoperatively, patients in the carbohydrate group experienced less pain at 12, 16 and 20 h (median scores 20, 30 and 34 vs. 7, 5 and 0 mm; P<0.05). This study shows that there is limited benefit from administering oral carbohydrate prior to total hip arthroplasty.

Management of amiodarone extravasation with intradermal hyaluronidase.

PubMed

Fox, Ashley N; Villanueva, Ruben; Miller, Jamie L

2017-10-01

The case of a patient who experienced extravasation while receiving amiodarone via a peripheral infusion and was treated with intradermal hyaluronidase is reported. A 60-year-old Caucasian man arrived at the emergency department after a motor vehicle collision. The patient was noted to have a subdural hematoma, multiple rib fractures, sternal body fracture, abdominal wall injury, left clavicle fracture, right humerus fracture, and vertebral fractures. His medical history included hypertension, atrial fibrillation, and stroke with residual right-sided weakness. On postoperative day 1, the patient developed atrial fibrillation and was started on i.v. amiodarone. Treatment resulted in conversion to sinus rhythm, but the patient again developed atrial fibrillation on postoperative day 5. During the morning hours of postoperative day 6, the patient experienced a peripheral i.v. line extravasation of amiodarone in his left arm. The amiodarone drip was discontinued, and amiodarone 400 mg orally twice daily was started. The nursing staff was instructed to treat the patient for the amiodarone extravasation with traditional nonpharmacologic measures, including warm compresses and elevation of the extremity. After extravasation, the patient reported severe pain at the site. Due to the patient's continued complaints of pain and the expanding area of induration, the interdisciplinary team elected to proceed with intradermal hyaluronidase. The patient reported significantly decreased pain and was discharged to inpatient rehabilitation on postoperative day 10 without any significant adverse effects. Administration of intradermal hyaluronidase after amiodarone extravasation was associated with decreased expansion of erythema and warmth as well as an improvement in patient-reported pain scores without any noted adverse effects. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Long-term outcomes of fertility-sparing treatment of atypical polypoid adenomyoma with medroxyprogesterone acetate.

PubMed

Nomura, Hidetaka; Sugiyama, Yuko; Tanigawa, Terumi; Matoda, Maki; Kanao, Hiroyuki; Kondo, Eiji; Takeshima, Nobuhiro

2016-01-01

Our objective was to analyze the long-term oncologic outcomes of fertility-preserving hormonal treatment with medroxyprogesterone acetate (MPA) in patients with APA. In a retrospective chart review, we identified patients with APA who were treated with MPA for fertility preservation at our hospital between 2001 and 2011. Eighteen patients with histologically diagnosed APA were identified. Clinical data including treatment, obstetrical, and oncologic outcomes were recorded. The mean observation period was 77.6 months (median 73.5, range 22-142), and the mean age was 33.6 years. Four patients also developed well-differentiated endometrial carcinoma. After the treatment, 14 patients (77.8 %) achieved either a complete response or partial response. Eight patients experienced recurrence, while four experienced persistent disease. Ten patients (55.6 %) eventually underwent hysterectomy. The median time to hysterectomy was 40.3 months (range 24-68). Nine patients progressed to endometrial cancer, and one experienced persistent APA. Among younger patients (<35 years of age), four out of five patients who were married could have children. Seven patients (38.9 %) showed no evidence of the disease during the observation period (median 60 months, range 22-117 months). No one died because of the disease during the observation period. MPA yields a high response rate in APA, and if only younger patients are considered, a favorable pregnancy rate can be obtained. However, because recurrence rate is high, long-term follow-up under supervision of a trained gynecologic oncologist is required. To confirm MPA's utility, multi-center collaboration would be warranted.

Utilisation of psychotropic drugs in patients of the long stay ward.

PubMed

El Hefny, F; Al Haddad, M K; Mathur, V

1992-03-01

A survey of the prescribing of psychotropic drugs was carried out at the Psychiatric Hospital of Bahrain. This retrospective study on 60 inpatients of the Long Stay Ward revealed a man:woman ratio of 2.7. 91% of the men and 88% of the women were over 40 years old. 44 of the 60 patients had a diagnosis of schizophrenia, the rest had dementia, depression, schizoaffective disorders, drug-induced psychosis, general paralysis or Huntington's chorea. 95% of patients received antipsychotic drugs. Thioridazine was the most common drug followed by chlorpromazine. The mean number of drugs/patient was 1.7, with 41.7% of patients receiving only 1 drug. Tardive dyskinesia was observed in 11 patients and 9 experienced varying degrees of tremor. The findings confirm that psychiatric illness treated by psychiatrists need not lead to polypharmacy. As a consequence, its treatment may be less likely to result in adverse reactions than when patients are treated by general practitioners.

Actinomyces canaliculitis and its surgical treatment.

PubMed

Yuksel, Dilek; Hazirolan, Dicle; Sungur, Gulten; Duman, Sunay

2012-04-01

The objective of this article is to describe four rare cases of Actinomyces israelii canaliculitis and their surgical treatment in a case series consisting of four cases of Actinomyces israelii canaliculitis. Patient charts were reviewed retrospectively. All four patients presented with epiphora, recurrent conjunctivitis, swelling around the superior canaliculus, and mucopurulent punctal discharge persisting despite medical treatments. Two patients with large canalicular dilation were treated with canaliculoplasty and the other two patients with minimal canalicular dilation were treated with one-snip punctoplasty. The specimens that were evacuated were sent for microbiological and histopathological examinations. The results showed that Actinomyces israelii was isolated in all patients. After medical and surgical treatment, the patients experienced resolution of signs and symptoms. The disease did not recur during the 2-4-year follow-up period. In conclusion Canaliculoplasty with canalicular intubation and one-snip punctoplasty may be safe and efficacious techniques in largely dilated canaliculum and mildly dilated canaliculum, respectively, with no demonstrable risk of post-treatment epiphora in patients with Actinomyces canaliculitis.

Eleven years of experience with bisphosphonate plus alfacalcidol treatment in a man with osteogenesis imperfecta type I

PubMed Central

Iwamoto, Jun; Sato, Yoshihiro; Uzawa, Mitsuyoshi; Matsumoto, Hideo

2013-01-01

We report the 11-year follow-up of a man with osteogenesis imperfecta type I who was treated with bisphosphonates and alfacalcidol. A 36-year-old Japanese man with osteogenesis imperfecta type I who had frequently experienced painful fragility fractures consulted our clinic because of chronic back pain. The patient had multiple morphometric vertebral fractures and a low bone mineral density (BMD) at the lumbar spine. The patient was treated with cyclical etidronate 200 mg, for 2 weeks every 3 months, plus alfacalcidol 1 μg daily, for 2 years; and alendronate 5 mg daily or 35 mg weekly, plus alfacalcidol 1 μg daily for 9 years. After 11 years of treatment, BMD at the lumbar spine increased by 6.4%, following a 20.3% reduction in serum alkaline phosphatase. Serum calcium, phosphorus, and intact parathyroid hormone levels remained within the normal ranges. Three clinical fractures occurred at two ribs and the metacarpus, and two morphometric vertebral fractures occurred at the thoracic spine during the 11-year treatment period, but the patient experienced no adverse effects. Thus, the present case report shows the long-term outcome and safety of bisphosphonate plus alfacalcidol treatment in a man with osteogenesis imperfecta type I. PMID:23293527

Mechanical Recanalization of Subacute Vessel Occlusion in Peripheral Arterial Disease with a Directional Atherectomy Catheter

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

Massmann, Alexander, E-mail: Alexander.Massmann@uks.eu; Katoh, Marcus; Shayesteh-Kheslat, Roushanak

2012-10-15

Purpose: To retrospectively examine the technical feasibility and safety of directional atherectomy for treatment of subacute infrainguinal arterial vessel occlusions. Methods: Five patients (one woman, four men, age range 51-81 years) with peripheral arterial disease who experienced sudden worsening of their peripheral arterial disease-related symptoms during the last 2-6 weeks underwent digital subtraction angiography, which revealed vessel occlusion in native popliteal artery (n = 4) and in-stent occlusion of the superficial femoral artery (n = 1). Subsequently, all patients were treated by atherectomy with the SilverHawk (ev3 Endovascular, USA) device. Results: The mean diameter of treated vessels was 5.1 {+-}more » 1.0 mm. The length of the occlusion ranged 2-14 cm. The primary technical success rate was 100%. One patient experienced a reocclusion during hospitalization due to heparin-induced thrombocytopenia. There were no further periprocedural complications, in particular no peripheral embolizations, until hospital discharge or during the follow-up period of 1 year. Conclusion: The recanalization of infrainguinal arterial vessel occlusions by atherectomy with the SilverHawk device is technically feasible and safe. In our limited retrospective study, it was associated with a high technical success rate and a low procedure-related complication rate.« less

Female sexual stimulation during antidepressant treatment.

PubMed

Elmore, J L; Quattlebaum, J T

1997-01-01

Three women with several diagnoses, including depression and psychosis, personality disorder, attention deficit hyperactivity disorder, alcohol abuse, and physical disease, were treated with selective serotonin reuptake inhibitors (fluoxetine, paroxetine, fluvoxamine). One patient was prescribed paroxetine in addition to methylphenidate. While receiving these agents, two women experienced undesirable sexual arousal and the third had increased sexual desire, arousal, and hypersexuality.

Acute kidney injury KDIGO stage 2 to 3 in HIV-positive patients treated with cART--a case series over 11 years in a cohort of 1,153 patients.

PubMed

Kurz, Mario; Burkhalter, Felix; Dickenmann, Michael; Hopfer, Helmut; Mayr, Michael; Elzi, Luigia; Battegay, Manuel

2015-01-01

We aimed to explore acute kidney injury (AKI) Kidney Disease Improving Global Guidelines (KDIGO) stage 2 to 3 in a cohort of antiretroviral treated HIV-infected individuals. HIV-infected individuals of the Swiss HIV Cohort Study (Basel site), treated with combination antiretroviral therapy (cART) 2002-2013, were included. AKI was defined and classified according to the KDIGO Clinical Practice Guidelines for AKI. Data were prospectively collected and reports of kidney biopsies obtained from records. Among 1,153 cART-treated patients, 13 experienced AKI KDIGO stage 2 to 3 (1 patient stage 2, 12 patients stage 3; median age 46 years; 9 male; median CD4 count 366 cells/μl), corresponding to an incidence rate of AKI of 0.77 (95% confidence interval 0.45-1.33) per 1000 patient-years. Baseline estimated glomerular filtration rate (eGFR) was 87 ml/min (interquartile range 66-100). Ten patients were treated with tenofovir (TDF). Nine patients (69%) had ≥1 cardiovascular risk factor, only two patients had known pre-existing kidney disease. Three patients needed chronic and two temporary dialysis. AKI was associated with TDF therapy in 6 of 13 (46%) patients (mean TDF exposure time before AKI 41 months). Impaired renal function was partially reversible in all patients. In three patients with biopsy-proven pre-existing kidney disease (AA amyloidosis, calcineurin inhibitor-induced nephropathy and minimal change glomerulopathy), TDF potentially added to AKI. AKI KDIGO stage 2 to 3 demonstrates complex associations at the individual level and can occur without early signs. Although treatment with TDF and presence of cardiovascular risk factors were found frequently, predicting AKI seems very difficult.

Sleep disturbances in individuals at clinical high risk for psychosis

PubMed Central

Poe, Sarah-Lucy; Brucato, Gary; Bruno, Nicolina; Arndt, Leigh Y.; Ben-David, Shelly; Gill, Kelly E.; Colibazzi, Tiziano; Kantrowitz, Joshua T.; Corcoran, Cheryl M.; Girgis, Ragy R.

2018-01-01

There has been recent interest in understanding the role that sleep disturbance plays in patients at Clinical High Risk for psychosis (CHR). We assessed sleep disturbance in 194 CHR patients and 66 healthy control subjects and their relationship to symptoms (positive, negative and general functioning). Patients experienced significantly more sleep disturbance than healthy control subjects and their sleep disturbance was related to greater positive and negative symptoms and worse overall functioning. Targeting sleep disturbance in CHR individuals may provide alternative means of treating the CHR syndrome. PMID:28126579

Ocular changes with oxaliplatin.

PubMed

O'Dea, Denise; Handy, Catherine M; Wexler, Ann

2006-04-01

Ocular toxicity, although uncommon, can occur with many chemotherapeutic agents. Platinum compounds have been documented to produce a variety of ocular side effects, and reports have been made of ocular toxicity with oxaliplatin. This article reports on four patients who experienced ocular symptoms while receiving oxaliplatin. The symptoms included tunnel vision and visual loss with postural changes. One patient had objective findings that included papilledema. All of the changes were reversible. Oxaliplatin will continue to be used widely, so clinicians treating patients with it must be alert for unusual toxicities such as those described in this article.

Earfold Implantable Clip System for Correction of Prominent Ears: Analysis of Safety in 403 Patients

PubMed Central

Sojitra, Nilesh; Glumicic, Sinisa; Vlok, Jacobus A.; O’Toole, Greg; Hannan, S. Alam; Sabbagh, Walid

2018-01-01

Background: The Earfold system, a new treatment for the correction of prominent ears, consists of 3 components: the Earfold implant, the Earfold introducer, and the Prefold positioner. Methods: This is an interim report based on an ongoing analysis of safety in a series of patients treated for prominent ears with the Earfold implant between February 2013 and September 2014. Safety was assessed based on adverse event reports and the need for implant revision; follow-up is ongoing. Results: Seven surgeons used 1,200 Earfold implants to treat 403 patients (ages, 7–70 years; 63% male); the time since the initial implant procedure now ranges from 30 to 48 months. To date, 145 patients (36%) have returned for a follow-up visit (mean, 7.7 months [range, 1–34 months]). Adverse events requiring intervention have affected 39 of 403 (9.7%) patients; these include implant revisions (n = 17 [4.2%], most often due to implant visibility), skin erosion over the implant (n = 15 [3.7%]), and infection (n = 7 [1.7%]). Bleeding, recurrence of prominence, hematoma, deformity, or adverse scarring did not occur. Conclusions: This interim analysis has shown that Earfold prominent ear correction system is associated with relatively few adverse events that require intervention; a small number of patients experienced infection, implant extrusion, or implant visibility that required revision. Most adverse events were related to either patient selection or technical errors at implantation. It is expected that with continued use of Earfold by surgeons experienced in otoplasty, the adverse event incidence will decrease. PMID:29464160

Life-threatening Duodenal Ulcer Bleeding from a Ruptured Gastroduodenal Artery Aneurysm in a Patient with Neurofibromatosis Type 1.

PubMed

Im, Kyu Sung; Kim, Sunyong; Lim, Jun Uk; Jeon, Jung Won; Shin, Hyun Phil; Cha, Jae Myung; Joo, Kwang Ro; Lee, Joung Il; Park, Jae Jun

2015-09-01

Vasculopathy is rarely reported in neurofibromatosis type 1, but when it occurs it primarily involves the aorta and its main branches. Among vasculopathies, aneurysmal dilatation is the most common form. Although several case reports concerning aneurysms or pseudoaneurysms of visceral arteries in neurofibromatosis type 1 patients have been reported, there are no reports describing gastroduodenal artery aneurysms associated with neurofibromatosis type 1. We experienced a case of life-threatening duodenal ulcer bleeding from a ruptured gastroduodenal artery aneurysm associated with neurofibromatosis type 1. We treated our patient by transarterial embolization after initial endoscopic hemostasis. To our knowledge, this is the first reported case of its type. High levels of suspicion and prompt diagnosis are required to select appropriate treatment options for patients with neurofibromatosis type 1 experiencing upper gastrointestinal bleeding. Embolization of the involved arteries should be considered an essential treatment over endoscopic hemostasis alone to achieve complete hemostasis and to prevent rebleeding.

Carcinoma of the cervix and sexual function.

PubMed

Seibel, M M; Freeman, M G; Graves, W L

1980-04-01

Forty-six patients were interviewed more than a year after treatment for carcinoma of the cervix to establish the effects of radiation therapy and of surgical therapy on sexual feelings and performance. Group 1 consisted of 22 patients who had undergone radiation therapy for stage I, II, or III cancer of the cervix. Group 2 consisted of 20 patients who had undergone hysterectomy with or without partial vaginectomy for carcinoma in situ. The irradiated patients experienced statistically significant decreases in sexual enjoyment, ability to attain orgasm, libido, frequency of intercourse, opportunity, and sexual dreams. The surgically treated group had no significant change in sexual function after treatment. Both groups experienced a change in self-image but did not feel that their partners or family viewed them differently. Myths about cancer and the actual effects of pelvic irradiation were found to have disrupted the sexual-marital relationships of many women. Therapeutic programs are discussed through which women can be helped through this difficult time in their lives.

Laparoscopic adrenalectomy for phaeochromocytoma: a case series.

PubMed

Hotu, Cheri; Harman, Richard; Cutfield, Richard; Hodges, Nicola; Taylor, Eletha; Young, Simon

2015-10-16

To describe our 13-year experience in laparoscopic adrenalectomy for phaeochromocytoma. We performed a retrospective analysis of case notes of 29 patients who underwent laparoscopic adrenalectomy for phaeochromocytoma between 2000 and 2013. Twenty-nine patients (16 female), aged 16 to 67 years, underwent laparoscopic adrenalectomy for phaeochromocytoma. All patients were treated preoperatively with alpha-blocking agents. 80% were prescribed additional preoperative antihypertensive agents. 90% received antihypertensive agents intraoperatively. All patients received intraoperative magnesium sulphate for haemodynamic stabilisation. The mean operative time was 160 minutes. Nearly all of the patients experienced haemodynamic stability during surgery. Two patients required conversion to open adrenalectomy, due to severe intraoperative hypertension during tumour handling, and due to extensive intra-abdominal adhesions. Postoperative complications were minimal, and included blood loss, superior epigastric artery damage, and cellulitis at the laparoscopic port site. There was no perioperative mortality. The median length of stay postoperatively was 4 days. 24% were prescribed antihypertensive medication on discharge. In our experience, favourable perioperative outcomes were achieved, demonstrating that laparoscopic adrenalectomy for phaeochromocytoma is a safe and effective procedure in the setting of experienced and skilled surgical, anaesthetic and medical teams delivering the perioperative care.

Chemotherapy-Induced Peripheral Neuropathy: A Current Review

PubMed Central

Staff, Nathan P.; Grisold, Anna; Grisold, Wolfgang; Windebank, Anthony J.

2017-01-01

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect experienced by patients receiving treatment for cancer. Approximately 30–40% of patients treated with neurotoxic chemotherapy will develop CIPN and there is considerable variability in its severity between patients. It is often sensory-predominant with pain and can lead to long-term morbidity in survivors. The prevalence and burden of CIPN late effects will likely increase as cancer survival rates continue to improve. In this review, we discuss the approach to peripheral neuropathy in patients with cancer and address the clinical phenotypes and pathomechanisms of specific neurotoxic chemotherapeutic agents. PMID:28486769

Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis.

PubMed

Singh, Jasvinder A; Cameron, Chris; Noorbaloochi, Shahrzad; Cullis, Tyler; Tucker, Matthew; Christensen, Robin; Ghogomu, Elizabeth Tanjong; Coyle, Doug; Clifford, Tammy; Tugwell, Peter; Wells, George A

2015-07-18

Serious infections are a major concern for patients considering treatments for rheumatoid arthritis. Evidence is inconsistent as to whether biological drugs are associated with an increased risk of serious infection compared with traditional disease-modifying antirheumatic drugs (DMARDs). We did a systematic review and meta-analysis of serious infections in patients treated with biological drugs compared with those treated with traditional DMARDs. We did a systematic literature search with Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from their inception to Feb 11, 2014. Search terms included "biologics", "rheumatoid arthritis" and their synonyms. Trials were eligible for inclusion if they included any of the approved biological drugs and reported serious infections. We assessed the risk of bias with the Cochrane Risk of Bias Tool. We did a Bayesian network meta-analysis of published trials using a binomial likelihood model to assess the risk of serious infections in patients with rheumatoid arthritis who were treated with biological drugs, compared with those treated with traditional DMARDs. The odds ratio (OR) of serious infection was the primary measure of treatment effect and calculated 95% credible intervals using Markov Chain Monte Carlo methods. The systematic review identified 106 trials that reported serious infections and included patients with rheumatoid arthritis who received biological drugs. Compared with traditional DMARDs, standard-dose biological drugs (OR 1.31, 95% credible interval [CrI] 1.09-1.58) and high-dose biological drugs (1.90, 1.50-2.39) were associated with an increased risk of serious infections, although low-dose biological drugs (0.93, 0.65-1.33) were not. The risk was lower in patients who were methotrexate naive compared with traditional DMARD-experienced or anti-tumour necrosis factor biological drug-experienced patients. The absolute increase in the number of serious infections per 1000 patients treated each year ranged from six for standard-dose biological drugs to 55 for combination biological therapy, compared with traditional DMARDs. Standard-dose and high-dose biological drugs (with or without traditional DMARDs) are associated with an increase in serious infections in rheumatoid arthritis compared with traditional DMARDs, although low-dose biological drugs are not. Clinicians should discuss the balance between benefit and harm with the individual patient before starting biological treatment for rheumatoid arthritis. Rheumatology Division at the University of Alabama at Birmingham. Copyright © 2015 Elsevier Ltd. All rights reserved.

Proton or photon irradiation for hemangiomas of the choroid? A retrospective comparison

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

Hoecht, Stefan; Wachtlin, Joachim; Bechrakis, Nikolaos E.

2006-10-01

Purpose: The aim of this study was to compare, on a retrospective basis, the results of therapy in patients with uveal hemangioma treated with photon or proton irradiation at a single center. Methods and Materials: From 1993 to 2002 a total of 44 patients were treated. Until 1998 radiotherapy was given with 6 MV photons in standard fractionation of 2.0 Gy 5 times per week. In 1998 proton therapy became available and was used since then. A dose of 20 to 22.5 Cobalt Gray Equivalent (CGE) 68 MeV protons was given on 4 consecutive days. Progressive symptoms or deterioration ofmore » vision were the indications for therapy. Results: Of the 44 patients treated, 36 had circumscribed choroidal hemangiomas and 8 had diffuse choroidal hemangiomas (DCH) and Sturge-Weber syndrome. Of the patients, 19 were treated with photons with a total dose in the range of 16 to 30 Gy. A total of 25 patients were irradiated with protons. All patients with DCH but 1 were treated with photons. Stabilization of visual acuity was achieved in 93.2% of all patients. Tumor thickness decreased in 95.4% and retinal detachment resolved in 92.9%. Late effects, although generally mild or moderate, were frequently detected. In all, 40.9% showed radiation-induced optic neuropathy, maximum Grade I. Retinopathy was found in 29.5% of cases, but only 1 patient experienced more than Grade II severity. Retinopathy and radiation-induced optic neuropathy were reversible in some of the patients and in some resolved completely. No differences could be detected between patients with circumscribed choroidal hemangiomas treated with protons and photons. Treatment was less effective in DCH patients (75%). Conclusions: Radiotherapy is effective in treating choroidal hemangiomas with respect to visual acuity and tumor thickness but a benefit of proton therapy could not be detected. Side effects are moderate but careful monitoring for side effects should be part of the follow-up procedures.« less

The pharmacological and hormonal therapy of hot flushes in breast cancer survivors.

PubMed

Wiśniewska, Iwona; Jochymek, Bożena; Lenart-Lipińska, Monika; Chabowski, Mariusz

2016-03-01

The side effects of oncological treatment, which appear during or after therapy, are sometimes very annoying for patients and are not adequately treated by physicians. Among the symptoms experienced by breast cancer patients are hot flushes, which result from a natural or cancer therapy-induced menopause. The intensity of hot flushes in breast cancer patients may be more severe than those experienced by women undergoing a natural menopause. Taking into account the incidence of breast cancer and long-lasting hormone-suppression therapies, the problem of hot flushes will affect many women. Hormonal replacement therapy, the most effective therapeutic means for alleviating hot flushes, is usually contraindicated for breast cancer patients. For intense and severe hot flushes, pharmacological treatment using agents from a group of selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors such as venlafaxine or citalopram may be introduced. Other agents from different pharmacological groups, such as clonidine, gabapentin, or pregabalin, have also proved to be effective in treating hot flushes. The efficacy of phytoestrogens has not been proven in randomized clinical trials. The importance of the placebo effect in decreasing vasomotor symptoms has also been reported in many research papers. Educating breast cancer patients in lifestyle changes which decrease the frequency and intensity of vasomotor symptoms can offer significant help too. This paper reviews the current state of research in order to assess the options for the treatment of hot flushes in breast cancer survivors.

Thyroid lobe ablation with iodine- ¹³¹I in patients with differentiated thyroid carcinoma: a randomized comparison between 1.1 and 3.7 GBq activities.

PubMed

Giovanella, Luca; Piccardo, Arnoldo; Paone, Gaetano; Foppiani, Luca; Treglia, Giorgio; Ceriani, Luca

2013-08-01

The present study was undertaken to evaluate the ablation rate after administration of 1.1 or 3.7 GBq of iodine- (¹³¹I) to patients with low-risk differentiated thyroid carcinoma (DTC) primarily treated by lobectomy. Enrolled were 136 consecutive patients affected by histologically proven low-risk DTC previously treated by lobectomy. Patients were randomized to receive a single dose of 1.1 or 3.7 GBq of ¹³¹I in an equivalence trial. Successful thyroid ablation was defined as a negative diagnostic whole-body scan and stimulated thyroglobulin levels lower than 2 ng/ml in the absence of thyroglobulin antibodies. The patient demographic and clinical data were well balanced at baseline. The ablation rate was significantly (P<0.01) higher in patients treated with 3.7 GBq (75%) than in those treated with 1.1 GBq (54%) of radioiodine. No relevant side effects occurred in either group. Radioiodine lobe ablation with a single administration of 3.7 GBq is a simple and safe mode of treatment, achieving an ablation rate higher than that of 1.1 GBq. This procedure may be offered as an alternative to completion thyroidectomy in highly selected DTC patients who had experienced complications during initial surgery or for whom completion thyroidectomy is contraindicated.

Effects of mannose-binding lectin polymorphisms on irinotecan-induced febrile neutropenia.

PubMed

van der Bol, Jessica M; de Jong, Floris A; van Schaik, Ron H; Sparreboom, Alex; van Fessem, Marianne A; van de Geijn, Fleur E; van Daele, Paul L; Verweij, Jaap; Sleijfer, Stefan; Mathijssen, Ron H

2010-01-01

Mannose-binding lectin (MBL) is important in the innate immune response. MBL2 gene polymorphisms affect MBL expression, and genotypes yielding low MBL levels have been associated with an elevated risk for infections in hematological cancer patients undergoing chemotherapy. However, these reported associations are inconsistent, and data on patients with solid tumors are lacking. Here, we investigated the effects of MBL2 genotypes on irinotecan-induced febrile neutropenia in patients with solid tumors. Irinotecan-treated patients were genotyped for the MBL2 gene. Two promoter (-550 H/L and -221 X/Y) and three exon polymorphisms (52 A/D, 54 A/B, and 57 A/C) were determined, together with known risk factors for irinotecan-induced toxicity. Neutropenia and febrile neutropenia were recorded during the first course. Of the 133 patients, 28% experienced severe neutropenia and 10% experienced febrile neutropenia. No associations were found between exon polymorphisms and febrile neutropenia. However, patients with the H/H promoter genotype, associated with high MBL levels, experienced significantly more febrile neutropenia than patients with the H/L and L/L genotypes (20% versus 13% versus 5%). Moreover, patients with the HYA haplotype encountered significantly more febrile neutropenia than patients without this high MBL-producing haplotype (16% versus 4%). In the subgroup with wild-type exon polymorphisms (A/A), patients with the high MBL promoter phenotype had the highest incidence of febrile neutropenia, regardless of known risk factors. Patients with high MBL2 promoter genotypes and haplotypes seem more at risk for developing febrile neutropenia. If confirmed, these preliminary findings may contribute to more individualized approaches of irinotecan treatment.

Venous Lake of the Lips Treated Using Photocoagulation with High-Intensity Diode Laser

PubMed Central

Galletta, Vivian C.; de Paula Eduardo, Carlos; Migliari, Dante A.

2010-01-01

Abstract Objective: To evaluate the effectiveness of photocoagulation with high-intensity diode laser in the treatment of venous lake (VL) lesions. Background Data: VL is a common vascular lesion characterized by elevated, usually dome-shaped papules, ranging in color from dark blue to dark purple, seen more frequently in elderly patients. They often occur as single lesions on the ears, face, lips, or neck. Once formed, lesions persist throughout life. Although these lesions are usually asymptomatic, they can bleed if injured. Methods: Seventeen patients (7 men and 10 women) with VL on the lip were treated using a noncontact diode laser (wavelength 808 nm, power output 2–3 W in continuous wave). Results: After only one irradiation exposure, all lesions were successfully treated. Healing was completed in approximately 2 to 3 weeks, and none of the patients experienced complications. Postoperative discomfort and scarring were not present or were minimal. Conclusion: Photocoagulation with high-intensity diode laser is an effective, bloodless procedure for the treatment of VL. PMID:19811083

Mycophenolate mofetil as maintenance therapy for childhood-onset systemic lupus erythematosus patients with severe lupus nephritis.

PubMed

Kizawa, Toshitaka; Nozawa, Tomo; Kikuchi, Masako; Nagahama, Kiyotaka; Okudela, Koji; Miyamae, Takako; Imagawa, Tomoyuki; Nakamura, Tomoko; Mori, Masaaki; Yokota, Shumpei; Tsutsumi, Hiroyuki

2015-03-01

We evaluated histological changes occurring in renal biopsy specimens, between the time before initial induction therapy and after 12 months' maintenance therapy, as well as changes in laboratory parameters, SLE disease activity (SLEDAI), and dosage of corticosteroid (CS) in childhood-onset systemic lupus erythematosus (SLE) patients treated with mycophenolate mofetil (MMF). A retrospective analysis was performed on nine patients diagnosed with childhood-onset SLE and lupus nephritis. They were treated with pulsed mPSL and intravenous cyclophosphamide as induction therapy and MMF (500-1500 mg/day) plus CS as maintenance therapy. Renal biopsy was performed before the initial induction therapy and after 12 months' maintenance therapy. Pathological findings at second biopsy were improved in eight of nine patients (89%). The findings of SLEDAI, urinalysis, and blood tests also showed improvement. CS doses could be tapered satisfactorily. Adverse events were observed in two patients. No patients treated with MMF experienced any disease flares during maintenance therapy. MMF as maintenance therapy might be useful in that not only the histological findings of lupus nephritis were improved, but also CS doses could be beneficially tapered. Nonetheless, this is a retrospective report of only nine cases and further prospective multicenter studies are necessary.

Vitamin E and essential polyunsaturated fatty acids supplementation in schizophrenia patients treated with haloperidol.

PubMed

Bošković, Marija; Vovk, Tomaž; Koprivšek, Jure; Plesničar, Blanka Kores; Grabnar, Iztok

2016-05-01

Previously, oxidative damage has been associated with severity of clinical symptoms and supplementation with antioxidants and essential polyunsaturated fatty acids (EPUFAs) was proposed to have beneficial effects in schizophrenia. We evaluated the effects of supplementation with EPUFAs and vitamin E in patients treated with haloperidol depot injection. This was a double-blind randomized placebo-controlled study with four arms (Placebo, vitamin E, EPUFAs, and vitamin E + EPUFAs). Biomarkers of oxidative stress, neurochemistry, psychopathology, and extrapyramidal symptoms were assessed at baseline and after 4 months. In EPUFAs group of patients, reduced glutathione concentration was increased compared to placebo. Concentration of oxidized glutathione was decreased in patients receiving vitamin E. In addition, compared to placebo a non-significant trend of increased activity of catalase and superoxide dismutase was observed in all three treatment groups. Patients receiving vitamin E experienced less motor retardation. No difference in extrapyramidal symptoms was found. Our study indicates that supplementation with vitamin E and EPUFAs may improve the antioxidative defense, especially glutathione system, while there is no major effect on symptoms severity. Supplemental treatment with EPUFAs and vitamin E in schizophrenia patients treated with haloperidol is potentially beneficial and a larger independent study appears warranted.

Factors in Maintaining a Stable Patient-Physician Relationship among Individuals with Schizophrenia.

PubMed

Huang, Hsin-Hui; Chen, Chuan-Yu; Tsay, Jen-Huoy; Chou, Yiing-Jenq; Huang, Nicole

2017-07-01

This study aimed to determine whether adequate continuity of care (COC) existed among individuals with schizophrenia, and what the associated determinants were. The National Health Insurance Research Database of Taiwan was used to identify individuals with newly diagnosed schizophrenia from 2000 to 2009. Two outcome indicators were first derived to conduct the continuity assessment based on the usual provider continuity (UPC) index and the continuity of care index (COCI). The average scores of the UPC and COCI were 0.78 and 0.67, respectively. Patients who have been hospitalized, with lower income, and unemployed had significantly poorer continuity of care. In addition, patients were cared for by higher caseload physicians, treated at mental health specialty institutions, and at hospital outpatient settings also experienced significantly poorer continuity. Patients cared for by middle-aged physicians, psychiatrists, and treated at private institutions had significantly better continuity of mental health care.

Functional outcome in amputation versus limb sparing of patients with lower extremity sarcoma: a matched case-control study.

PubMed

Davis, A M; Devlin, M; Griffin, A M; Wunder, J S; Bell, R S

1999-06-01

To quantify the differences in physical disability and handicap experienced by patients with lower extremity sarcoma who required amputation for their primary tumor as compared with those treated by limb-sparing surgery. Matched case-control study. Twelve patients with amputation were matched with 24 patients treated by limb-sparing surgery on the following variables: age, gender, length of follow-up, bone versus soft-tissue tumor, anatomic site, and treatment with adjuvant chemotherapy. Patients who underwent above-knee amputation (AKA) or below-knee amputation (BKA) for primary soft-tissue or bone sarcoma, who had not developed local or systemic recurrence, and who had been followed up for at least 1 year since surgery. The Toronto Extremity Salvage Score (TESS), a measure of physical disability; the Shortform-36 (SF-36), a generic health status measure; and the Reintegration to Normal Living (RNL), a measure of handicap. Mean TESS score for the patients with amputations was 74.5 versus 85.1 for the limb-sparing patients. (p = .15). Only the physical function subscale of the SF-36 showed statistically significant differences, with means of 45 and 71.1 for the amputation versus limb-sparing groups, respectively (p = .03). The RNL for the amputation group was 84.4 versus 97 for the limb-sparing group (p = .05). Seven of the 12 patients with amputations experienced ongoing difficulty with the soft tissues overlying their stumps. There was a trend toward increased disability for those in the amputation group versus those in the limb-sparing group, with the amputation group showing significantly higher levels of handicap. These data suggest that the differences in disability between amputation and limb-sparing patients are smaller than anticipated. The differences may be more notable in measuring handicap.

O6-Methylguanine DNA Methyltransferase Status Does Not Predict Response or Resistance to Alkylating Agents in Well-Differentiated Pancreatic Neuroendocrine Tumors.

PubMed

Raj, Nitya; Klimstra, David S; Horvat, Natally; Zhang, Liying; Chou, Joanne F; Capanu, Marinela; Basturk, Olca; Do, Richard Kinh Gian; Allen, Peter J; Reidy-Lagunes, Diane

2017-07-01

Alkylating agents have activity in well-differentiated pancreatic neuroendocrine tumors (WD panNETs). In glioblastoma multiforme, decreased activity of O-methylguanine DNA methyltransferase (MGMT) predicts response; in panNETs, MGMT relevance is unknown. We identified patients with WD panNETs treated with alkylating agents, determined best overall response by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, and performed MGMT activity testing. Fifty-six patients were identified; 26 (46%) of the 56 patients experienced partial response, 24 (43%) of 56 experienced stable disease, and 6 (11%) of 56 experienced progression of disease. O-methylguanine DNA methyltransferase status was available for 36 tumors. For tumors with partial response, 10 (67%) of 15 were MGMT deficient, and 5 (33%) of 15 were MGMT intact. For tumors with stable disease, 7 (47%) of 15 were MGMT deficient, and 8 (53%) of 15 were MGMT intact. For tumors with progression of disease, 3 (50%) of 6 were MGMT deficient, and 3 (50%) of 6 were MGMT intact. We observed response and resistance to alkylating agents in MGMT-deficient and MGMT-intact tumors. O-methylguanine DNA methyltransferase status should not guide alkylating agent therapy in WD panNETs.

Apical root resorption in patients treated with comprehensive orthodontics.

PubMed

Harris, E F; Boggan, B W; Wheeler, D A

2001-01-01

External apical root resorption (EARR) is a common--but seldom extreme--consequence of orthodontic treatment. Incisors are most at risk, perhaps because of their single roots and because they typically are moved farther than other teeth. We followed a cohort of patients (n = 153) treated with comprehensive orthodontics. EARR was scored on the upper incisors with a qualitative five-grade ordinal scale. There was no EARR at the start of treatment, but most (> 80%) exhibited slight-to-moderate EARR by the end of treatment (i.e., a loss of 1-2 mm). Cases treated with premolar extractions experienced more EARR because their incisors were retracted farther; however, the sum of the effects of patients' sex and age, and severity of the malocclusion, and the kind of mechanics used accounts for little of the overall variation in EARR. Instead, it appears that genetically-based inter-individual variation in susceptibility to EARR is the most influential factor. Research should be directed at understanding the biochemical nature of susceptibility so prospective patients can be screened to identify those at particular risk.

Behaviors of providers of traditional korean medicine therapy and complementary and alternative medicine therapy for the treatment of cancer patients.

PubMed

Yu, Jun-Sang; Kim, Chun-Bae; Kim, Ki-Kyong; Lee, Ji-Eun; Kim, Min-Young

2015-03-01

In Korea, cancer is one of the most important causes of death. Cancer patients have sought alternative methods, like complementary and alternative medicine (CAM) together with Western medicine, to treat cancer. Also, there are many kinds of providers of CAM therapy, including providers of Korean oriental medicine therapy. The purpose of this study is to identify the behaviors of Korean oriental medicine therapy and CAM therapy providers who treat cancer patients and to provide background knowledge for establishing a new policy with the management and quality control of CAM. Structured and well organized questionnaires were made, and 350 persons were surveyed concerning the providers of CAM or Korean oriental medicine. The questionnaires were collected and analyzed. The questionnaires (182) were collected. The questionnaires identified a total of 73 known providers, such as medicinal professionals or other providers of CAM suppliers, 35.6% of whom had had experience with treating cancer patients (52.6% vs. 29.6%). The treatment methods were a little different: alternative therapy and nutritional therapy being preferred by medicinal professionals and mind body modulation therapy and alternative therapy being preferred by other CAM providers. Four patients (7.4%) experienced side effects, and 6 patients (12.5%) experienced legal problems. As the method for managing the therapy, CAM providers, medicinal professionals, and other CAM providers had different viewpoints. For example, some CAM providers stated that both legislation and an official education on CAM or a national examination were needed as a first step to establish the provider's qualifications and that as a second step, a license test was needed for quality control. To the contrary, medicinal professionals stated that a license test was needed before legislation. Adequate management and quality control of CAM providers is thought to involve both education and legislation.

Just a drop of cement: a case of cervical spine bone aneurysmal cyst successfully treated by percutaneous injection of a small amount of polymethyl-methacrylate cement

PubMed Central

Fahed, Robert; Clarençon, Frédéric; Riouallon, Guillaume; Cormier, Evelyne; Bonaccorsi, Raphael; Pascal-Mousselard, Hugues; Chiras, Jacques

2014-01-01

Aneurysmal bone cyst (ABC) is a benign hemorrhagic tumor, commonly revealed by local pain. The best treatment for this lesion is still controversial. We report the case of a patient with chronic neck pain revealing an ABC of the third cervical vertebra. After percutaneous injection of a small amount of polymethyl-methacrylate bone cement, the patient experienced significant clinical and radiological improvement. PMID:25498806

Just a drop of cement: a case of cervical spine bone aneurysmal cyst successfully treated by percutaneous injection of a small amount of polymethyl-methacrylate cement.

PubMed

Fahed, Robert; Clarençon, Frédéric; Riouallon, Guillaume; Cormier, Evelyne; Bonaccorsi, Raphael; Pascal-Mousselard, Hugues; Chiras, Jacques

2014-12-12

Aneurysmal bone cyst (ABC) is a benign hemorrhagic tumor, commonly revealed by local pain. The best treatment for this lesion is still controversial. We report the case of a patient with chronic neck pain revealing an ABC of the third cervical vertebra. After percutaneous injection of a small amount of polymethyl-methacrylate bone cement, the patient experienced significant clinical and radiological improvement. 2014 BMJ Publishing Group Ltd.

Misoprostol for tinnitus.

PubMed

Crinnion, C L; McCart, G M

1995-01-01

Practitioners should realize that further study of misoprostol in larger patient populations must be undertaken to determine its efficacy and safety in the treatment of tinnitus. Previous approaches to treating tinnitus have included carbamazepine, phenytoin, lidocaine, tocainide, flecainide acetate, alprazolam, and nortriptyline. Studies using lidocaine, nortriptyline, or alprazolam have shown encouraging results. The relative contribution of misoprostol remains to be seen; however, it may offer a new treatment option to patients who have experienced adverse effects or have contraindications to the pharmacologic agents currently available.

Renal Infarction Caused by Spontaneous Renal Artery Dissection: Treatment with Catheter-Directed Thrombolysis and Stenting

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

Jeon, Yong Sun, E-mail: radjeon@korea.com; Cho, Soon Gu; Hong, Ki Cheon

2009-03-15

Spontaneous renal artery dissection (SRAD) is rare and presents a diagnostic and therapeutic challenge. We report a case of a 36-year-old man who had an SRAD-complicated renal infarction. The patient experienced severe unilateral flank pain. Enhanced abdominal computed axial tomography scan showed renal infarction, and urinalysis showed no hematuria. Selective renal angiography was essential to evaluate the extent of dissection and suitability for repair. The patient was treated with catheter-directed thrombolysis and frenal artery stenting.

[The efficacy of lacosamide in relation to antiepileptic drug history. Clinical experiences in adult partial epilepsy].

PubMed

Barcs Gábor; Szűcs, Anna; Horváth, András; Kamondi, Anita

2015-01-30

A retrospective study in adult partial epilepsy on the efficacy of lacosamide in relation to previous antiepileptic drug experiences. We analysed 3-65 months' data on epilepsy-care of 43 pharmacoresistant partial epilepsy patients treated with lacosamide. Further analysis of antiepileptic drug history was carried out in strictly selected subgroups of patients with good and poor therapeutic response to lacosamide (10 and 9 patients, respectively) for 2-10 years long retrospective follow up. Adult patients with partial-onset seizures had been treated previously with three or more lifetime antiepileptic drugs without permanent success. Six patients (14%) were seizure free, eleven patients (25%) have experienced important improvement (their seizure-frequency decreased by at least 50%) for more than 12 months. Fourteen patients (32%) improved for less than 6 months and then have relapsed; and add-on lacosamide proved ineffective in 12 patients (28%). Those selected 10 patients successfully treated with lacosamide (seizure free for at least six months) favourably responded to carbamazepine or oxcarbazepine earlier and levetiracetam was ineffective or even caused worsening. The selected lacosamide-unresponsive nine patients responded unfavourably to carbamazepine or oxcarbazepine earlier. Fifteen patients (35%) suffered side effects as dizziness or sleepiness, in 11 of them lacosamide was combined with a "traditional" sodium-channal blocker antiepileptic drug. Lacosamide is an effective add-on antiepileptic drug in difficult-to treat adult partial epilepsy patients. Our data suggest that good lacosamide response may be expected in those patients who reacted favourably to "traditional" sodium-channel blocker carbamazepine or oxcarbazepine earlier.

Is Diversion with Ileostomy Non-inferior to Hartmann Resection for Left-sided Colorectal Anastomotic Leak?

PubMed

Stafford, Caitlin; Francone, Todd D; Marcello, Peter W; Roberts, Patricia L; Ricciardi, Rocco

2018-03-01

Treatment of left-sided colorectal anastomotic leaks often requires fecal stream diversion for prevention of further septic complications. To manage anastomotic leak, it is unclear if diverting ileostomy provides similar outcomes to Hartmann resection with colostomy. We identified all patients who developed anastomotic leak following left-sided colorectal resections from 1/2012 through 12/2014 using the American College of Surgeons National Surgical Quality Improvement Program. Then, we examined the risk of mortality and abdominal reoperation in patients treated with diverting ileostomy as compared to Hartmann resection. There were 1745 patients who experienced an anastomotic leak in a cohort of 63,748 patients (3.7%). Two hundred thirty-five patients had a reoperation for anastomotic leak involving the formation of a diverting ileostomy (n = 77) or Hartmann resection (n = 158). There was no difference in mortality or abdominal reoperation in patients treated with diverting ileostomy (3.9, 7.8%) versus Hartmann resection (3.8, 6.3%) (p = 0.8). There was no difference in the outcomes of mortality or need for second abdominal reoperation in patients treated with diverting ileostomy as compared to Hartmann resection for left-sided colorectal anastomotic leak. Thus, select patients with left-sided colorectal anastomotic leaks may be safely managed with diverting ileostomy.

Paget's disease of the vulva--a review of our experience.

PubMed

Petković, S; Jeremić, K; Vidakovic, S; Jeremić, J; Lazović, G

2006-01-01

The aim of our study was to review our experience with Paget's disease of the vulvar relative to initial examination, treatment and oncological outcome. Ten women with extramammary Paget's diseases of the vulva were treated during the 10-year period. The charts of these patients were reviewed and data were collected regarding patient demographics, symptoms, previous Paget's disease, surgical treatments and time to recurrence. Eight women (80%) were treated with wide local excision or partial vulvectomy, and two patients (20%) required radical resection for invasive adenocarcinoma. The group of women who had invasive diseases also underwent inquinofemoral lymphadenectomy and no lymphatic metastases were noted. Three women (30%) experienced recurrence. The mean time to relapse was 30 months (range 3-88 months). Recurrence is very common and long-term monitoring is recommended with careful examination of any abnormal vulvar lesion.

Risk of Hippocampal Metastases in Small Cell Lung Cancer Patients at Presentation and After Cranial Irradiation: A Safety Profile Study for Hippocampal Sparing During Prophylactic or Therapeutic Cranial Irradiation

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

Kundapur, Vijayananda, E-mail: Vijayananda.kundapur@saskcancer.ca; Ellchuk, Tasha; Ahmed, Shahid

2015-03-15

Purpose: Neurocognitive impairment (NI) in patients with small cell lung cancer (SCLC) after whole brain radiation treatment (WBRT) is a significant cause of morbidity. Hippocampal avoidance (HA) during WBRT may mitigate or prevent NI in such patients. However, this has not been tested in SCLC patients. The estimated risk of metastases in the HA region (HM) in patients with SCLC at diagnosis or after WBRT is unknown. Our study aimed to determine the risk of HM in patients with SCLC and to assess correlated clinical factors. Methods and Materials: Patients with SCLC who experienced brain metastases (BM) at presentation (demore » novo) or after WBRT treated at the Saskatoon Cancer Centre between 2005 and 2012 were studied. Relevant neuroimaging was independently reviewed by a neuroradiologist. HM was defined as metastases within 5 mm of the hippocampus. Logistic regression analysis was performed to assess correlation between various clinical variables and HM. Results: Seventy eligible patients were identified. Of 59 patients presenting with de novo BM, 3 patients (5%, 95% confidence interval [CI]: 0%-10.7%) had HM. Collectively there were 359 (range, 1-33) de novo BM with 3 (0.8%, 95% CI: 0%-1.7%) HM deposits. Twenty patients experienced progression of metastatic disease in the brain after WBRT. Of the 20 patients, only 1 patient (5%, 95% CI: 0%-14.5%) experienced HM. On logistic regression, no factors significantly correlated with HM. Conclusion: The overall incidence of HM before or after WBRT in SCLC patients is low, providing preliminary support for the safety of HA during planned clinical trials of HA-WBRT for SCLC.« less

Ethinylestradiol/Chlormadinone acetate for use in dermatological disorders.

PubMed

Gómez Vázquez, Mercedes; Navarra Amayuelas, Ramón; Lamarca, Marta; Baquedano, Laura; Romero Ruiz, Sebastián; Vilar-Checa, Eduardo; Iniesta, Maria D

2011-09-06

The diagnosis and management of four cases of dermatological disorders, most of which are related to the endocrine disorder of androgen excess, are presented. Combined oral contraceptives (COCs) may be useful when well-tolerated hormonal therapy and/or when contraception is required. A female patient with androgenetic alopecia or female pattern balding, without underlying hyperandrogenism, was treated with ethinylestradiol/chlormadinone acetate (EE/CMA) 0.03 mg/2 mg for 6 months and experienced stabilization of hair loss (case report 1). A patient who had previously received a COC for an irregular menstrual pattern but again experienced irregular menses and also acne after stopping treatment was diagnosed with acne associated with polycystic ovary syndrome (PCOS) [case report 2]. After 6 month's treatment with EE/CMA 0.03 mg/2 mg, this patient had fewer acne lesions and became eumenorrheic. A third patient who had excess hair since childhood was diagnosed with idiopathic hirsutism (no underlying gynecological or endocrinological disorder was found) and was treated with EE/CMA 0.03 mg/2 mg (case report 3). Less hair growth was reported after 6 months' treatment. Case report 4 describes a patient who presented with oligomenorrhea and acne. She was diagnosed with PCOS with acne, seborrhea and mild hirsutism. Treatment with EE/CMA 0.03 mg/2 mg for 6 months resulted in improvements in her facial acne, seborrhea and hirsutism; she also became eumenorrheic. These four cases illustrate that EE/CMA may be a useful and well tolerated treatment option in the management of patients with dermatological disorders with or without hyperandrogenization.

A prospective study of health-related quality-of-life outcomes for patients with low-risk prostate cancer managed by active surveillance or radiation therapy.

PubMed

Banerji, John S; Hurwitz, Lauren M; Cullen, Jennifer; Wolff, Erika M; Levie, Katherine E; Rosner, Inger L; Brand, Timothy C; LʼEsperance, James O; Sterbis, Joseph R; Porter, Christopher R

2017-05-01

Patients with low-risk prostate cancer (PCa) often have excellent oncologic outcomes. However, treatment with curative intent can lead to decrements in health-related quality of life (HRQoL). Patients treated with radical prostatectomy have been shown to suffer declines in urinary and sexual HRQoL as compared to those managed with active surveillance (AS). Similarly, patients treated with external-beam radiation therapy (EBRT) are hypothesized to experience greater declines in bowel HRQoL. As health-related quality-of-life (HRQoL) concerns are paramount when selecting among treatment options for low-risk PCa, this study examined HRQoL outcomes in men undergoing EBRT as compared to AS in a prospective, racially diverse cohort. A prospective study of HRQoL in patients with PCa enrolled in the Center for Prostate Disease Research (CPDR) Multicenter National Database was initiated in 2007. The current study included patients diagnosed through April 2014. HRQoL was assessed with the Expanded Prostate Cancer Index Composite (EPIC) and the Medical Outcomes Study Short Form (SF-36). Temporal changes in HRQoL were compared for patients with low-risk PCa managed on AS vs. EBRT at baseline, 1-, 2-, and 3 years post-PCa diagnosis. Longitudinal patterns were modeled using linear regression models fitted with generalized estimating equations (GEE), adjusting for baseline HRQoL, demographic, and clinical patient characteristics. Of the 499 eligible patients with low-risk PCa, 103 (21%) selected AS and 60 (12%) were treated with EBRT. Demographic characteristics of the treatment groups were similar, though a greater proportion of patients in the EBRT group were African American (P = 0.0003). At baseline, both treatment groups reported comparable HRQoL. EBRT patients experienced significantly worse bowel function and bother at 1 year (adjusted mean score: 87 vs. 95, P = 0.001 and 89 vs. 95, P = 0.008, respectively) and 2 years (87 vs. 93, P = 0.007 and 87 vs. 96, P = 0.002, respectively) compared to patients managed on AS. In contrast to those on AS, more than half the number of patients who received EBRT experienced a decline in bowel function (52% vs. 17%, p=0.003) and bother (52% vs. 15%, P = 0.002) from baseline to 1 year. Patients who received EBRT were significantly more likely to experience a decrease in more than one functional domain (urinary, sexual, bowel, or hormonal) at 1 year when compared with those on AS (60% vs. 28%, P = 0.004). Patients receiving EBRT for low-risk prostate cancer suffer declines in bowel HRQoL. These declines are not experienced by patients on AS, suggesting that management of low-risk prostate cancer with AS may offer a means for preserving HRQoL following prostate cancer diagnosis. Copyright © 2017 Elsevier Inc. All rights reserved.

Postoperative ileus-related morbidity profile in patients treated with alvimopan after bowel resection.

PubMed

Wolff, Bruce G; Weese, James L; Ludwig, Kirk A; Delaney, Conor P; Stamos, Michael J; Michelassi, Fabrizio; Du, Wei; Techner, Lee

2007-04-01

Postoperative ileus (POI), an interruption of coordinated bowel motility after operation, is exacerbated by opioids used to manage pain. Alvimopan, a peripherally acting mu-opioid receptor antagonist, accelerated gastrointestinal (GI) recovery after bowel resection in randomized, double-blind, placebo-controlled, multicenter phase III POI trials. The effect of alvimopan on POI-related morbidity for patients who underwent bowel resection was evaluated in a post-hoc analysis. Incidence of POI-related postoperative morbidity (postoperative nasogastric tube insertion or POI-related prolonged hospital stay or readmission) was analyzed in four North American trials for placebo or alvimopan 12 mg administered 30 minutes or more preoperatively and twice daily postoperatively until hospital discharge (7 or fewer postoperative days). GI-related adverse events and opioid consumption were summarized for each treatment. Estimations of odds ratios of alvimopan to placebo and number needed to treat (NNT) to prevent one patient from experiencing an event of POI-related morbidity were derived from the analysis. Patients receiving alvimopan 12 mg were less likely to experience POI-related morbidity than patients receiving placebo (odds ratio = 0.44, p < 0.001). Fewer patients receiving alvimopan (alvimopan, 7.6%; placebo, 15.8%; NNT = 12) experienced POI-related morbidity. There was a lower incidence of postoperative nasogastric tube insertion, and other GI-related adverse events on postoperative days 3 to 6 in the alvimopan group than the placebo group. Opioid consumption was comparable between groups. Alvimopan 12 mg was associated with reduced POI-related morbidity compared with placebo, without compromising opioid-based analgesia in patients undergoing bowel resection. Relatively low NNTs are clinically meaningful and reinforce the potential benefits of alvimopan for the patient and health care system.

What Makes a Good Palliative Care Physician? A Qualitative Study about the Patient’s Expectations and Needs when Being Admitted to a Palliative Care Unit

PubMed Central

Masel, Eva K; Kitta, Anna; Huber, Patrick; Rumpold, Tamara; Unseld, Matthias; Schur, Sophie; Porpaczy, Edit; Watzke, Herbert H

2016-01-01

Objective The aims of the study were to examine a) patients’ knowledge of palliative care, b) patients’ expectations and needs when being admitted to a palliative care unit, and c) patient’s concept of a good palliative care physician. Methods The study was based on a qualitative methodology, comprising 32 semistructured interviews with advanced cancer patients admitted to the palliative care unit of the Medical University of Vienna. Interviews were conducted with 20 patients during the first three days after admission to the unit and after one week, recorded digitally, and transcribed verbatim. Data were analyzed using NVivo 10 software, based on thematic analysis enhanced with grounded theory techniques. Results The results revealed four themes: (1) information about palliative care, (2) supportive care needs, (3) being treated in a palliative care unit, and (4) qualities required of palliative care physicians. The data showed that patients lack information about palliative care, that help in social concerns plays a central role in palliative care, and attentiveness as well as symptom management are important to patients. Patients desire a personal patient-physician relationship. The qualities of a good palliative care physician were honesty, the ability to listen, taking time, being experienced in their field, speaking the patient’s language, being human, and being gentle. Patients experienced relief when being treated in a palliative care unit, perceived their care as an interdisciplinary activity, and felt that their burdensome symptoms were being attended to with emotional care. Negative perceptions included the overtly intense treatment. Conclusions The results of the present study offer an insight into what patients expect from palliative care teams. Being aware of patient’s needs will enable medical teams to improve professional and individualized care. PMID:27389693

Mutated PPP1R3B is recognized by T cells used to treat a melanoma patient who experienced a durable complete tumor regression

PubMed Central

Lu, Yong-Chen; Yao, Xin; Li, Yong F.; El-Gamil, Mona; Dudley, Mark E.; Yang, James C.; Almeida, Jorge R.; Douek, Daniel C.; Samuels, Yardena; Rosenberg, Steven A.; Robbins, Paul F.

2013-01-01

Adoptive cell therapy with tumor infiltrating lymphocytes (TILs) represents an effective treatment for patients with metastatic melanoma. However, most of the antigen targets recognized by effective melanoma reactive TILs remain elusive. In this study, patient 2369 experienced a complete response, including regressions of bulky liver tumor masses ongoing beyond seven years following adoptive TILs transfer. The screening of a cDNA library generated from the autologous melanoma cell line resulted in the isolation of a mutated PPP1R3B (protein phosphatase 1, regulatory (inhibitor) subunit 3B) gene product. The mutated PPP1R3B peptide represents the immunodominant epitope recognized by tumor reactive T cells in TIL 2369. Five years following adoptive transfer, peripheral blood T lymphocytes obtained from patient 2369 recognized the mutated PPP1R3B epitope. These results demonstrate that adoptive T cell therapy targeting a tumor-specific antigen can mediate long-term survival for a patient with metastatic melanoma. This study also provides an impetus to develop personalized immunotherapy targeting tumor-specific, mutated antigens. PMID:23690473

Nd:YAG laser treatment of herpes and aphthous ulcers: a preliminary study

NASA Astrophysics Data System (ADS)

Parkins, Frederick M.; O'Toole, Thomas J.; Yancey, John M.

2000-06-01

Previously herpes labialis and recurrent aphthous ulcers have not been successfully treated. A preliminary study with a pulsed Nd:YAG laser evaluated the results with a protocol of four minute non-contact exposures for both types of lesions. Most patients experienced relief of symptoms. The progress of herpes lesion was halted and aphthous lesions became desensitized.

Acute electroconvulsive therapy followed by maintenance electroconvulsive therapy decreases hospital re-admission rates of older patients with severe mental illness.

PubMed

Shelef, Assaf; Mazeh, Doron; Berger, Uri; Baruch, Yehuda; Barak, Yoram

2015-06-01

Electroconvulsive therapy (ECT) is a highly effective treatment for patients with severe mental illness (SMI). Maintenance ECT (M-ECT) is required for many elderly patients experiencing severe recurrent forms of mood disorders, whereas M-ECT for schizophrenia patients is a poorly studied treatment. We report on the outcomes in aged patients with SMI: schizophrenia and severe affective disorders treated by M-ECT of varying duration to prevent relapse after a successful course of acute ECT. The study measured the effectiveness of M-ECT in preventing hospital readmissions and reducing admission days. A retrospective chart review of 42 consecutive patients comparing the number and length of psychiatric admissions before and after the start of M-ECT was used. We analyzed diagnoses, previous ECT treatments, number of ECT treatments, and number and length of psychiatric admissions before and after M-ECT. Mean age in our sample was 71.5 (6.9) years. Twenty-two (52%) patients experienced severe affective disorders and 20 (48%) experienced schizophrenia. Patients were administered 92.8 (85.9) M-ECT treatments. Average duration of the M-ECT course was 34 (29.8) months. There were on average 1.88 admissions before M-ECT and only 0.38 admissions in the M-ECT period (P < 0.001). Duration of mean hospitalization stay decreased from 215.9 to 12.4 days during the M-ECT (P < 0.01). Our findings suggest that acute ECT followed by M-ECT is highly effective in selected elderly patients with SMIs.

Laparoscopic extended liver resection: are postoperative outcomes different?

PubMed

Pietrasz, Daniel; Fuks, David; Subar, Daren; Donatelli, Gianfranco; Ferretti, Carlotta; Lamer, Christian; Portigliotti, Luca; Ward, Marc; Cowan, Jane; Nomi, Takeo; Beaussier, Marc; Gayet, Brice

2018-05-16

Although laparoscopic major hepatectomy (LMH) is becoming increasingly common in specialized centers, data regarding laparoscopic extended major hepatectomies (LEMH) and their outcomes are limited. The aim of this study was to compare the perioperative characteristics and postoperative outcomes of LEMH to standard LMH. All patients who underwent purely laparoscopic anatomical right or left hepatectomy and right or left trisectionectomy between February 1998 and January 2016 are enrolled. Demographic, clinicopathological, and perioperative factors were collected prospectively and analyzed retrospectively. Perioperative characteristics and postoperative outcomes in LEMH were compared to those of standard LMH. Among 195 patients with LMH, 47 (24.1%) underwent LEMH, colorectal liver metastases representing 66.7% of all indications. Preoperative portal vein embolization was undertaken in 31 (15.9%) patients. Despite more frequent vascular clamping, blood loss was higher in LEMH group (400 vs. 214 ml; p = 0.006). However, there was no difference in intraoperative transfusion requirements. Thirty-one patients experienced liver failure with no differences between LMH and LEMH groups. Postoperative mortality was comparable in the two groups [3 (2.5%) LMH patients vs. 2 (5%) LEMH patients (p = 0.388)]. Overall morbidity was higher in the LEMH group [49 LMH patients (41.5%) vs. 24 LEMH patients (60%) (p = 0.052)]. Patients treated with left LEMH experienced more biliary leakage (p = 0.011) and more major pulmonary complications (p = 0.015) than left LMH. LEMH is feasible at the price of important morbidity, with manageable and acceptable outcomes. These exigent procedures require high-volume centers with experienced surgeons.

Real-World Adverse Effects of Capecitabine Toxicity in an Elderly Population.

PubMed

van Beek, Michiel W H; Roukens, Monique; Jacobs, Wilco C H; Timmer-Bonte, Johanna N H; Kramers, Cees

2018-06-22

Few studies have assessed the safety and effectiveness of the numerous available chemotherapeutic therapies for geriatric oncology patients. Most safety studies are conducted in large trials, and there is some uncertainty surrounding whether the results would be the same in typical daily use. This retrospective study aims to assess the adverse effects of real-world capecitabine use in elderly patients. We reviewed the records of patients treated with capecitabine in an oncology department of a University Clinic in Nijmegen, The Netherlands. We scored adverse effects such as hand-foot syndrome and diarrhea, and dosage adjustments and the reasons for them. In total, 132 patients were included, 69 of whom were aged 70 years or below (mean age: 57 years), while 63 were aged older than 70 years (mean age: 74 years). Patients aged over 70 years experienced more serious adverse effects than younger patients. Grade 2 or 3 hand-foot syndrome toxicity was experienced by 20.2% of patients aged younger than 70 years and by 34.9% of patients older than 70 years (p = 0.059). Grade 2, 3, or 4 diarrhea was experienced by 17.4% of the patients aged younger than 70 years but by 31.7% of the patients aged older than 70 years (p = 0.044). Dosage was adjusted for 27/69 patients in the younger group and 52/63 patients in the older group (p = 0.001). The difference in observed adverse effects cannot be the sole explanation for the high incidence of observed dose adjustments. A prospective follow-up study of elderly patients using capecitabine outside clinical trials is needed to evaluate the optimum balance between adverse effects and efficacy.

Presence of acute and chronic renal failure in patients with paroxysmal nocturnal hemoglobinuria: results of a retrospective analysis from the Spanish PNH Registry.

PubMed

Villegas, Ana; Núñez, Ramiro; Gaya, Anna; Cuevas-Ruiz, María Victoria; Bosch, José Miguel; Carral, Anna; Arrizabalaga, Beatriz; Gómez-Roncero, María Isabel; Mora, Asunción; Bravo, Pilar; Lavilla, Esperanza; Monteserín, Carmen; Hernández, Belén; Martínez-Barranco, Pilar; Jarque, Isidro; Urquía, María Anunciación; García-Donas, Gloria; Brunet, Salut; González, Fernando Ataulfo; Urbano, Álvaro

2017-10-01

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening blood disease. With the advent of eculizumab treatment, renal function has substantially improved, although no data from real-world clinical practice are available. An observational, retrospective, multicenter study was conducted in Spain on clinical data obtained from outpatient visits of patients with PNH (Spanish PNH Registry) who had experienced acute (ARF) or chronic (CRF) renal failure. Of the 128 patients registered (April 2014), 60 were diagnosed with classic PNH. Twenty-seven (45.0%) patients with a mean age of 48.5 (±16.2) years had renal failure, ARF or CRF, and were included in this study. Near half of the patients (n = 13; 48.1%) presented with ARF alone, 33.3% (n = 9) had CRF with episodes of ARF, while 18.5% (n = 5) were diagnosed with CRF alone. For patients with diagnosis of PNH and renal failure (n = 27), the median time to the first ARF episode was 6.5 (CI 95%; 2.2, 14.9) years, whereas the median to the diagnosis of CRF was 14.5 (CI 95%; 3.8, 19.2) years after the diagnosis of PNH. Patients with ARF (n = 22) were treated with eculizumab and did not experience new episodes of ARF, except for one patient with sepsis. Of the patients with CRF, two received treatment without experiencing further episodes of ARF. Sixteen patients who completed treatment (11 with ARF and 5 with ARF + CRF) recovered from the episode of ARF or from CRF. Of the remaining patients treated with eculizumab, one patient improved from stages III to II, three patients stabilized without showing disease progression, and one patient progressed from stages III to IV. Treatment with eculizumab in PNH patients has beneficial effects on renal function, preventing ARF and progression to CRF.

Analysis of therapeutic methods for treating vocal process granulomas.

PubMed

Ma, Lijing; Xiao, Yang; Ye, Jingying; Yang, Qingwen; Wang, Jun

2015-03-01

The combination of laryngeal microsurgery and local injections of botulinum toxin type A (BTA) can increase the cure rate of patients with vocal process granulomas (VPGs). To analyze the therapeutic effects of conservative treatments, microsurgical resection with suturing and microsurgery in combination with local injections of BTA for the treatment of VPGs. A retrospective analysis of 168 cases of VPG was performed. All of the patients initially received a conservative treatment. Some of the patients who did not respond to the conservative treatments were treated using microsurgical resection and microsuturing using an 8-0 absorbable filament. Other patients additionally received a four-point injection of BTA into the thyroarytenoid muscle and the arytenoid muscle on the operated side. The lesions of 41.3% (71/168) of the patients who were given the conservative treatments (including acid suppression, vocal rest, and voice therapy) disappeared, and the lesions of 10.7% (18/168) of the patients were reduced. The conservative treatments were unsuccessful for 47% (79/168) of the patients. The cure rate was 78.4% (29/37) for the patients who were treated by microscope resection using a CO2 laser and microsuturing of the surrounding mucosa. Of the eight patients who experienced a recurrence, five of them had lesions that disappeared after 3 months of conservative treatment, whereas the other three patients recovered after a second operation. The cure rate of the 42 patients who were treated using microsurgery combined with local injections of BTA was 95.2% (40/42), with only 2 cases of recurrence at 2 months post-treatment.

Participating in an International Stereotactic Radiotherapy Patient Registry: The Establishment of Data Collection Pathways.

PubMed

Yahya, Aylin; Arneric, Eva; Kernutt, Elizabeth; Baldacchino, Fiona; Haworth, Claire; Kedda, Mary-Anne; Tang, Colin; Bydder, Sean; Corica, Tammy

2017-06-29

Aim To describe data collection pathways and practical challenges experienced by an academic comprehensive cancer centre aiming to record clinical data for patients being treated with a novel radiotherapy treatment modality. Methods Various options to capture data from all patients treated with the CyberKnife Robotic Radiosurgery System at Sir Charles Gairdner Hospital (SCGH) in Western Australia were explored. An international multicenter web-based secure database established and maintained by the Radiosurgery Society the RSSearch® Patient Registry was selected. Data were collected and entered over four contiguous phases, with either opt-in or opt-out consent and the completion of Patient Reported Outcome questionnaires for specific sub-groups. Results Between April 2014 and June 2016, 461 patients at Sir Charles Gairdner Hospital were enrolled in the RSSearch® Patient Registry with the collection of over 17,500 data items. From 461 patients enrolled, 447 patients were treated with the CyberKnife Robotic Radiosurgery System. The majority of patients were treated for either a malignant primary (43.2%) or metastatic disease (39.4%). The establishment of matrix organisational processes for data collection led to the development of improved workflow patterns and data collection pathways. Conclusions This article describes the processes developed by a single centre to establish an efficient system for data collection and participation in an international registry. The opt-out approach was more efficient in terms of patient recruitment compared to the informed-consent method used in earlier phases. The experience of this single centre may help inform other institutions considering data collection options for assessments of new or novel treatments.

Effects of Mannose-Binding Lectin Polymorphisms on Irinotecan-Induced Febrile Neutropenia

PubMed Central

de Jong, Floris A.; van Schaik, Ron H.; Sparreboom, Alex; van Fessem, Marianne A.; van de Geijn, Fleur E.; van Daele, Paul L.; Verweij, Jaap; Sleijfer, Stefan; Mathijssen, Ron H.

2010-01-01

Objective. Mannose-binding lectin (MBL) is important in the innate immune response. MBL2 gene polymorphisms affect MBL expression, and genotypes yielding low MBL levels have been associated with an elevated risk for infections in hematological cancer patients undergoing chemotherapy. However, these reported associations are inconsistent, and data on patients with solid tumors are lacking. Here, we investigated the effects of MBL2 genotypes on irinotecan-induced febrile neutropenia in patients with solid tumors. Patients and Methods. Irinotecan-treated patients were genotyped for the MBL2 gene. Two promoter (−550 H/L and −221 X/Y) and three exon polymorphisms (52 A/D, 54 A/B, and 57 A/C) were determined, together with known risk factors for irinotecan-induced toxicity. Neutropenia and febrile neutropenia were recorded during the first course. Results. Of the 133 patients, 28% experienced severe neutropenia and 10% experienced febrile neutropenia. No associations were found between exon polymorphisms and febrile neutropenia. However, patients with the H/H promoter genotype, associated with high MBL levels, experienced significantly more febrile neutropenia than patients with the H/L and L/L genotypes (20% versus 13% versus 5%). Moreover, patients with the HYA haplotype encountered significantly more febrile neutropenia than patients without this high MBL-producing haplotype (16% versus 4%). In the subgroup with wild-type exon polymorphisms (A/A), patients with the high MBL promoter phenotype had the highest incidence of febrile neutropenia, regardless of known risk factors. Conclusion. Patients with high MBL2 promoter genotypes and haplotypes seem more at risk for developing febrile neutropenia. If confirmed, these preliminary findings may contribute to more individualized approaches of irinotecan treatment. PMID:20930093

A Retrospective Study of Cleft lip and palate Patients' Satisfaction after Maxillary Distraction or Traditional Advancement of the Maxilla

PubMed Central

Nørholt, Sven Erik; Küseler, Annelise; Jensen, John; Pedersen, Thomas Klit

2012-01-01

ABSTRACT Objectives To compare cleft lip and palate patients' satisfaction with aesthetics and functional parameters after conventional advancement of the maxilla or by the use of distraction osteogenesis. Material and methods Case series observational study. Group of distraction osteogenesis (DO) consisted of 15 patients treated with distraction osteogenesis while group conventional (CONV) included 10 patients treated with traditional advancement of the maxilla. Patients were asked to fill out a questionnaire about their subjective evaluation of satisfaction with facial aesthetics and functional parameters on a continuous visual analog-scale (VAS) when the treatment was finished. Results The total response rate was 76%. Preoperatively the two groups did not differ significantly according to group characteristics. At follow-up both groups were satisfied with aesthetics and functional parameters. The DO group was less satisfied with the duration of the treatment than the CONV group. There were no statistically significant differences among the groups regarding functional parameters or facial aesthetics. Conclusions Cleft lip and palate patients experienced a high level of satisfaction with functional parameters and aesthetics as a result of surgical maxillary advancement. The patients treated with distraction osteogenesis were less satisfied with the duration of the treatment. Further studies are needed. PMID:24422010

Topical resiquimod can induce disease regression and enhance T-cell effector functions in cutaneous T-cell lymphoma.

PubMed

Rook, Alain H; Gelfand, Joel M; Gelfand, Joel C; Wysocka, Maria; Troxel, Andrea B; Benoit, Bernice; Surber, Christian; Elenitsas, Rosalie; Buchanan, Marie A; Leahy, Deborah S; Watanabe, Rei; Kirsch, Ilan R; Kim, Ellen J; Clark, Rachael A

2015-09-17

Early-stage cutaneous T-cell lymphoma (CTCL) is a skin-limited lymphoma with no cure aside from stem cell transplantation. Twelve patients with stage IA-IIA CTCL were treated in a phase 1 trial of 0.03% and 0.06% topical resiquimod gel, a Toll-like receptor 7/8 agonist. Treated lesions significantly improved in 75% of patients and 30% had clearing of all treated lesions. Resiquimod also induced regression of untreated lesions. Ninety-two percent of patients had more than a 50% improvement in body surface area involvement by the modified Severity-Weighted Assessment Tool analysis and 2 patients experienced complete clearing of disease. Four of 5 patients with folliculotropic disease also improved significantly. Adverse effects were minor and largely skin limited. T-cell receptor sequencing and flow cytometry studies of T cells from treated lesions demonstrated decreased clonal malignant T cells in 90% of patients and complete eradication of malignant T cells in 30%. High responses were associated with recruitment and expansion of benign T-cell clones in treated skin, increased skin T-cell effector functions, and a trend toward increased natural killer cell functions. In patients with complete or near eradication of malignant T cells, residual clinical inflammation was associated with cytokine production by benign T cells. Fifty percent of patients had increased activation of circulating dendritic cells, consistent with a systemic response to therapy. In summary, topical resiquimod is safe and effective in early-stage CTCL and the first topical therapy to our knowledge that can induce clearance of untreated lesions and complete remissions in some patients. This trial was registered at www.clinicaltrials.gov as #NCT813320. © 2015 by The American Society of Hematology.

Radiation therapy in patients with inflammatory bowel disease and colorectal cancer: risks and benefits.

PubMed

Chang, Bianca W; Kumar, Aryavarta M S; Koyfman, Shlomo A; Kalady, Matthew; Lavery, Ian; Abdel-Wahab, May

2015-03-01

The effects of radiotherapy are debated in inflammatory bowel disease (IBD). We examined IBD patients with colorectal cancer (CRC) and compared those who underwent external beam radiation therapy (EBRT) to those who did not. We then compared those same patients treated with EBRT to similarly treated non-IBD patients to ascertain differences in toxicity and perioperative outcomes. Fifty-seven IBD patients with CRC received EBRT, of which 23 had perioperative follow-up and 15 had complete records. The 23 patients were compared to 229 IBD patients with CRC who did not receive EBRT. The 15 patients were matched, 1:2, to similarly treated non-IBD patients with CRC based on age (±5 years), treatment year (±1 year), BMI (±10 kg/m2), and clinical stage. There was significantly more postoperative bleeding (5.3 % vs. 0 %, p < 0.01), wound dehiscence (3.5 % vs. 0 %, p < 0.01), and perineal infection (8.8 % vs. 1.3 %, p < 0.01) in IBD patients with EBRT compared to those without EBRT. IBD patients were significantly more likely to have grade 3 or higher lower GI toxicity (40 % vs. 7 %, p = 0.02) and wound dehiscence (36 % vs. 7 %, p = 0.02) than non-IBD patients, however without significant difference in bleeding, infection, ileus, or survival. IBD patients with CRC who received EBRT were more likely than similar patients without EBRT to experience perioperative complications. These patients also experienced more lower GI toxicity than similarly treated non-IBD patients with CRC. The expected decrease in survival in IBD-associated CRC was not observed. Thus, EBRT may contribute to a survival benefit in this group.

Establishing a general medical outpatient clinic for cancer survivors in a public city hospital setting.

PubMed

Goytia, Elliott J; Lounsbury, David W; McCabe, Mary S; Weiss, Elisa; Newcomer, Meghan; Nelson, Deena J; Brennessel, Debra; Rapkin, Bruce D; Kemeny, M Margaret

2009-11-01

Many cancer centers and community hospitals are developing novel models of survivorship care. However, few are specifically focused on services for socio-economically disadvantaged cancer survivors. To describe a new model of survivorship care serving culturally diverse, urban adult cancer patients and to present findings from a feasibility evaluation. Adult cancer patients treated at a public city hospital cancer center. The clinic provides comprehensive medical and psychosocial services for patients within a public hospital cancer center where they receive their oncology care. Longitudinal data collected over a 3-year period were used to describe patient demographics, patient needs, and services delivered. Since inception, 410 cancer patients have been served. Demand for services has grown steadily. Hypertension was the most frequent comorbid condition treated. Pain, depression, cardiovascular disease, hyperlipidemia, and bowel dysfunction were the most common post-treatment problems experienced by the patients. Financial counseling was an important patient resource. This new clinical service has been well-integrated into its public urban hospital setting and constitutes an innovative model of health-care delivery for socio-economically challenged, culturally diverse adult cancer survivors.

Comparison of patient centeredness of visits to emergency departments, physicians, and dentists for dental problems and injuries.

PubMed

Cohen, Leonard A; Bonito, Arthur J; Eicheldinger, Celia; Manski, Richard J; Macek, Mark D; Edwards, Robert R; Khanna, Niharika

2010-01-01

Patient-centered care has a positive impact on patient health status. This report compares patient assessments of patient centeredness during treatment in hospital emergency departments (EDs) and physician and dentist offices for dental problems and injuries. Participants included low-income White, Black, and Hispanic adults who had experienced a dental problem or injury during the previous 12 months and who visited an emergency department, physician, or dentist for treatment. A stratified random sample of Maryland households participated in a cross-sectional telephone survey. Interviews were completed with 94.8% (401/423) of eligible individuals. Multivariable logistic regression analyses were performed. The measure of predictive power, the pseudo-R2s, calculated for the logistic regression models ranged from 12% to 18% for the analyses of responses to the measures of patient centeredness (satisfaction with treatment, careful listening, thorough explaining, spending enough time, and treated with courtesy and respect). EDs were less likely than dentists to treat patients with great courtesy and respect. Further research is needed to identify factors that support patient-centered care.

Combined vitamin C sonophoresis and neodymium-doped yttrium aluminum garnet (NdYAG) laser for facial hyperpigmentation: An outcome observation study in Asian patients.

PubMed

Chen, Yu-Tsung; Chang, Chang-Cheng; Hsu, Cherng-Ru; Shen, Jen-Hsiang; Shih, Chao-Jen; Lin, Bor-Shyh

2016-01-01

The neodymium-doped yttrium aluminum garnet (NdYAG) laser therapy has been a popular technique for facial rejuvenation but certain adverse effects like post-inflammatory hyperpigmentation are issues of concern to Asian patients. To assess the outcome following combined treatment with vitamin C sonophoresis and NdYAG laser, in selected cases of facial hyperpigmentation. Twenty three women with dyschromia or melasma who had undergone five sessions of Q-switched NdYAG laser therapy followed by transdermal delivery of vitamin C via sonophoresis were selected after a retrospective review of case records. The objective and subjective clinical outcomes and the side effects, including erythema, scaling, pruritus, dryness and post-inflammatory hyperpigmentation were evaluated. In both objective or subjective outcomes, 91.3% (21/23) of the patients showed an excellent or better outcome, while 8.7% (2/23) showed no change. A majority of the patients (73.9%, 17/23) experienced no post-inflammatory hyperpigmentation or had slight post-inflammatory hyperpigmentation which quickly resolved within 1 week. Only one (4.3%) patient had extreme post-inflammatory hyperpigmentation which lasted for over a month. This was a retrospective study without a control group; a comparative study with a control group (patients treated with the laser alone, without vitamin C sonopheresis) is needed to determine the difference in the outcome. The use of vitamin C sonophoresis along with NdYAG laser may reduce the incidence of adverse effects in Asian patients. Patients experienced obvious improvement in hyperpigmentation and had lower chances of experiencing extreme or severe post-inflammatory hyperpigmentation.

[Percutaneous radiofrequency ablation of hepatic metastases. Preliminary experience].

PubMed

De Baere, T; Elias, D; Ducreux, M; Dromain, C; Kuach, V; Gamal El Din, M; Sobotka, A; Lasser, P; Roche, A

1999-11-01

To evaluate the efficiency of percutaneous radiofrequency ablation in the treatment of liver metastases. Eighteen patients with 31 liver metastases, mainly from colorectal cancer, 10 - 35 mm in diameter (m = 23), underwent 26 courses of percutaneous radiofrequency ablation. Fifteen patients had previously undergone hepatectomy, and 3 patients had contra-indications to surgery. Imaging guidance was ultrasound in 21 patients, CT in 4 (tumors not seen with ultrasound), and both in 1. A generator working at 450 KHz with a maximum output power of 150 W was used to treat each lesion for 18 - 20 min. Treatment was monitored with real time ultrasound. Among the 12 patients followed more than 3 months, only one of the 24 treated lesions recurred after a mean follow up of 259 ¿ 109 days. Liver disease was controlled in 8 of the 12 patients after 90 - 509 days (m = 306). Among these 8 patients, 3 were tumor free after 559, 378 and 90 days, respectively; 2 died tumor free of non-tumoral disease (pulmonary embolism, digestive bleeding); 3 developed lung metastases treated with chemotherapy (n = 2) or surgery (n = 1). Three of the 12 patients had widespread hepatic tumor occurrence, and one patient died of these metastases. Six patients experienced mild skin burns, but no major complication was observed. Radiofrequency ablation of hepatic metastases appears safe and promising in this preliminary experience. Further investigation is needed.

A Comprehensive Approach to the Patient at End of Life: Assessment of Multidimensional Suffering

PubMed Central

Wachholtz, Amy B.; Fitch, Christina E.; Makowski, Suzana; Tjia, Jennifer

2016-01-01

Pain is a multidimensional, complex experience. There are many challenges in identifying and meeting the needs of patients experiencing pain. Evaluation of pain from a bio-psycho-social-spiritual framework is particularly germane for patients approaching the end of life. This review explores the relation between the psychospiritual dimensions of suffering and the experience of physical pain, and how to assess and treat pain in a multidimensional framework. A review of empirical data on the relation between pain and suffering as well as interdisciplinary evidence-based approaches to alleviate suffering are provided. PMID:27043799

Sacral neuromodulation in the treatment of the unstable bladder.

PubMed

Bosch, J L

1998-07-01

Sacral neuromodulation as a treatment for urge incontinence in patients with an unstable bladder is the subject of ongoing clinical studies. Although approximately 75% of the patients treated with a permanent sacral foramen electrode implant have experienced significant improvements, it is now also clear that there is an initial failure rate of about 25%. Recent studies have pointed out the importance of improved patient selection on the basis of sex differences, urodynamic parameters and psychological factors. Also, newer forms of test stimulation and permanent electrode implantation are being explored in an effort to improve on the present results.

Sleep disturbances in individuals at clinical high risk for psychosis.

PubMed

Poe, Sarah-Lucy; Brucato, Gary; Bruno, Nicolina; Arndt, Leigh Y; Ben-David, Shelly; Gill, Kelly E; Colibazzi, Tiziano; Kantrowitz, Joshua T; Corcoran, Cheryl M; Girgis, Ragy R

2017-03-01

There has been recent interest in understanding the role that sleep disturbance plays in patients at Clinical High Risk for psychosis (CHR). We assessed sleep disturbance in 194 CHR patients and 66 healthy control subjects and their relationship to symptoms (positive, negative and general functioning). Patients experienced significantly more sleep disturbance than healthy control subjects and their sleep disturbance was related to greater positive and negative symptoms and worse overall functioning. Targeting sleep disturbance in CHR individuals may provide alternative means of treating the CHR syndrome. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Syncope cluster in a patient with vasovagal history.

PubMed

Zyśko, Dorota; Sokalski, Leszek; Gajek, Jacek; Loboz-Grudzień, Krystyna

2010-10-01

We report a case of a 55 year-old man with a history of vasovagal syncope who experienced six unexpected syncopal events over the course of two hours. Two of these occurred in the supine position during ECG monitoring, which showed a long-lasting sinus pause. Before the last syncopal episode, the ECG recording was started at the moment when the patient had the recurrence of presyncopal symptoms. Recordings showed sinus rhythm slowing for 12 s and then sinus arrest lasting for 29 s. A thorough clinical examination revealed no relevant abnormalities. The patient was treated with a permanent pacemaker implantation.

Effectiveness of bortezomib in cardiac Al amyloidosis: a report of two cases.

PubMed

Nigrelli, Santi; Curciarello, Giuseppe; Ballo, Piercarlo; Michelassi, Stefano; Pizzarelli, Francesco

2014-01-01

Cardiac involvement is a major prognostic determinant in patients with primary AL amyloidosis. The clinical results of standard therapeutic approaches are suboptimal. It has been recently shown that bortezomib, an inhibitor of the proteasome, can induce rapid favourable responses in AL amyloidosis improving cardiac function and survival. Herein we report on two patients with cardiac amyloidosis treated by bortezomib who experienced partial or total remission of hematologic disease and of cardiac involvement. However, death of one patient, suffering from chronic kidney disease stage 5, due to fulminant respiratory syndrome suggests the need for caution in bortezomib use if patients have this comorbid condition.

Effectiveness of Bortezomib in Cardiac AL Amyloidosis: A Report of Two Cases

PubMed Central

Nigrelli, Santi; Curciarello, Giuseppe; Ballo, Piercarlo; Michelassi, Stefano; Pizzarelli, Francesco

2014-01-01

Cardiac involvement is a major prognostic determinant in patients with primary AL amyloidosis. The clinical results of standard therapeutic approaches are suboptimal. It has been recently shown that bortezomib, an inhibitor of the proteasome, can induce rapid favourable responses in AL amyloidosis improving cardiac function and survival. Herein we report on two patients with cardiac amyloidosis treated by bortezomib who experienced partial or total remission of hematologic disease and of cardiac involvement. However, death of one patient, suffering from chronic kidney disease stage 5, due to fulminant respiratory syndrome suggests the need for caution in bortezomib use if patients have this comorbid condition. PMID:24715916

Trihexyphenidyl for acute life-threatening episodes due to a dystonic movement disorder in Rett syndrome.

PubMed

Gika, Artemis D; Hughes, Elaine; Goyal, Sushma; Sparkes, Matthew; Lin, Jean-Pierre

2010-02-15

In Rett syndrome (RS), acute life-threatening episodes (ALTEs) are usually attributed to epilepsy or autonomic dysfunction but they can represent a movement disorder (MD). We describe three girls with RS who experienced ALTEs from an early age. These were long considered epileptic until video-EEG in Patients 1 and 3 revealed their non-epileptic nature. A primary dystonic mechanism was suspected and Patients 1 and 2 were treated with Trihexyphenidyl with significantly reduced frequency of the ALTEs. Patient 3 died before Trihexyphenidyl was tried. Trihexyphenidyl in RS patients with similar presentations can modify the dystonia and prevent ALTEs. (c) 2009 Movement Disorder Society.

A phase I/pharmacokinetic study of sunitinib in combination with highly active antiretroviral therapy (HAART) in HIV-positive patients with cancer: AIDS Malignancy Consortium Trial AMC 061

PubMed Central

Rudek, Michelle A; Moore, Page C.; Mitsuyasu, Ronald T.; Dezube, Bruce J.; Aboulafia, David; Gerecitano, John; Sullivan, Ryan; Cianfrocca, Mary E.; Henry, David H.; Ratner, Lee; Haigentz, Missak; Dowlati, Afshin; Little, Richard F.; Ivy, S. Percy; Deeken, John F.

2014-01-01

Background Treatment of non-AIDS defining cancers (NADCs) may be complicated by drug interactions between highly active antiretroviral therapy (HAART) and chemotherapy. This trial is the first by the AIDS Malignancy Consortium assessing targeted therapies and HAART in HIV+ cancer patients (ClinicalTrials.gov NCT00890747). Methods Patients were stratified into two arms based on whether they were taking ritonavir, a potent CYP3A4 inhibitor, in a modified phase I study of sunitinib. Patients in arm 1 (non-ritonavir HAART) received standard sunitinib dosing (50mg/day). Arm 2 (ritonavir-based HAART) used a phase I, 3+3 dose escalation design (from 25 to 50mg/day). Cycles were with four weeks on treatment followed by a two week break (6 weeks total). Pharmacokinetics of sunitinib and its active metabolite (N-desethyl sunitinib) were assessed. Results Nineteen patients were enrolled and evaluable. Patients on Arm 1 tolerated treatment with one observed dose limiting toxicity (DLT). In Arm 2, a DLT was experienced at 37.5mg, and an additional 3 of 5 patients experienced grade 3 neutropenia, an uncommon toxicity of sunitinib. No patient had a response, but 10 had stable disease, including 8 with prolonged disease stability. Efavirenz, a potent inducer of CYP3A4, resulted in increased exposure of N-desethyl sunitinib, whereas ritonavir caused decreased exposure of the metabolite. Hand-foot syndrome was associated with higher steady-state trough concentrations of sunitinib. Conclusions Patients on non-ritonavir based HAART regimens tolerated standard dosing of sunitinib. Patients on ritonavir-based therapy treated with 37.5mg/day experienced higher toxicities. Dose reduction of sunitinib to 37.5mg may be warranted in patients on ritonavir. PMID:24474568

Management of Major Bleeding in Patients With Atrial Fibrillation Treated With Non-Vitamin K Antagonist Oral Anticoagulants Compared With Warfarin in Clinical Practice (from Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF II]).

PubMed

Steinberg, Benjamin A; Simon, DaJuanicia N; Thomas, Laine; Ansell, Jack; Fonarow, Gregg C; Gersh, Bernard J; Kowey, Peter R; Mahaffey, Kenneth W; Peterson, Eric D; Piccini, Jonathan P

2017-05-15

Non-vitamin K antagonist oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the management of bleeding in contemporary, clinical use of NOACs. We aimed to assess the frequency, management, and outcomes of major bleeding in the setting of community use of NOACs. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II registry, we analyzed rates of International Society on Thrombosis and Haemostasis major bleeding and subsequent outcomes in patients treated with NOACs versus warfarin. Outcomes of interest included acute and chronic bleeding management, recurrent bleeding, thromboembolic events, and death. In total, 344 patients with atrial fibrillation experienced major bleeding events over a median follow-up of 360 days follow-up: n = 273 on NOAC (3.3 per 100 patient-years) and n = 71 on warfarin (3.5 per 100 patient-years). Intracranial bleeding was uncommon but similar (0.34 per 100 patient-years for NOAC vs 0.44 for warfarin, p = 0.5), as was gastrointestinal bleeding (1.8 for NOAC vs 1.3 for warfarin, p = 0.1). Blood products and correction agents were less commonly used in NOAC patients with major bleeds compared with warfarin-treated patients (53% vs 76%, p = 0.0004 for blood products; 0% vs 1.5% for recombinant factor; p = 0.0499); no patients received pharmacologic hemostatic agents (aminocaproic acid, tranexamic acid, desmopressin, aprotinin). Within 30 days, 23 NOAC-treated patients (8.4%) died versus 5 (7.0%) on warfarin (p = 0.7). At follow-up, 126 NOAC-treated (46%) and 29 warfarin-treated patients (41%) were not receiving any anticoagulation. In conclusion, rates of major bleeding are similar in warfarin and NOAC-treated patients in clinical practice. However, NOAC-related bleeds require less blood product administration and rarely require factor replacement. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Quality of life in patients on chronic dialysis in South Africa: a comparative mixed methods study.

PubMed

Tannor, Elliot K; Archer, Elize; Kapembwa, Kenneth; van Schalkwyk, Susan C; Davids, M Razeen

2017-01-05

The increasing prevalence of treated end-stage renal disease and low transplant rates in Africa leads to longer durations on dialysis. Dialysis should not only be aimed at prolonging lives but also improve quality of life (QOL). Using mixed methods, we investigated the QOL of patients on chronic haemodialysis (HD) and peritoneal dialysis (PD). We conducted a cross-sectional study at Tygerberg Hospital in Cape Town, South Africa. All the PD patients were being treated with continuous ambulatory peritoneal dialysis. The KDQOL-SF 1.3 questionnaire was used for the quantitative phase of the study. Thereafter, focus-group interviews were conducted by an experienced facilitator in groups of HD and PD patients. Electronic recordings were transcribed verbatim and analysed manually to identify emerging themes. A total of 106 patients completed questionnaires and 36 of them participated in the focus group interviews. There was no difference between PD and HD patients in the overall KDQOL-SF scores. PD patients scored lower with regard to symptoms (P = 0.005), energy/fatigue (P = 0.025) and sleep (P = 0.023) but scored higher for work status (P = 0.005) and dialysis staff encouragement (P = 0.019) than those on HD. Symptoms and complications were verbalised more in the PD patients, with fear of peritonitis keeping some housebound. PD patients were more limited by their treatment modality which impacted on body image, sexual function and social interaction but there were less dietary and occupational limitations. Patients on each modality acknowledged the support received from family and dialysis staff but highlighted the lack of support from government. PD patients had little opportunity for interaction with one another and therefore enjoyed less support from fellow patients. PD patients experienced a heavier symptom burden and greater limitations related to their dialysis modality, especially with regards to social functioning. The mixed-methods approach helped to identify several issues affecting quality of life which are amenable to intervention.

Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label study.

PubMed

Nash, Peter; Nayiager, Sauithree; Genovese, Mark C; Kivitz, Alan J; Oelke, Kurt; Ludivico, Charles; Palmer, William; Rodriguez, Cristian; Delaet, Ingrid; Elegbe, Ayanbola; Corbo, Michael

2013-05-01

To evaluate the impact of concomitant methotrexate (MTX) on subcutaneous (SC) abatacept immunogenicity, and to assess safety and efficacy. This phase III, open-label study had a 4-month short-term (ST) period and an ongoing long-term extension (LTE) period. Rheumatoid arthritis patients were stratified to receive SC abatacept (125 mg/week) with (combination) or without MTX (monotherapy), with no intravenous loading dose; patients receiving monotherapy could add MTX in the LTE period. Immunogenicity (percentage of anti-abatacept antibody-positive patients) was assessed. ST and LTE period data are reported, including efficacy through LTE month 14 and safety through LTE month 20. Ninety-six of 100 enrolled patients completed the ST period; 3.9% (combination) and 4.1% of patients (monotherapy) developed transient immunogenicity, and no patients were antibody positive at month 4. Serious adverse events (SAEs) were reported in 3.9% (combination) and 6.1% of patients (monotherapy); 5.9% (combination) and 8.2% of patients (monotherapy) experienced SC injection reactions, and all were mild in intensity. Mean 28-joint Disease Activity Score (DAS28) changes were -1.67 (95% confidence interval [95% CI] -2.06, -1.28; combination) and -1.94 (95% CI -2.46, -1.42; monotherapy) at month 4. Ninety patients entered and were treated in the LTE period; 83.3% (75 of 90) remained ongoing at month 24. One LTE-treated patient (1.1%) developed immunogenicity, 14.4% of patients experienced SAEs, and no SC injection reactions were reported. For patients entering the LTE period, mean DAS28 changes from baseline were -1.84 (95% CI -2.23, -1.34; combination) and -2.86 (95% CI -3.46, -2.27; monotherapy) at month 18. SC abatacept did not elicit immunogenicity associated with loss of safety or efficacy, either with or without MTX. Copyright © 2013 by the American College of Rheumatology.

Long-term outcomes of gastrografin in small bowel obstruction

PubMed Central

Baghdadi, Yaser M.K.; Choudhry, Asad J.; Goussous, Naeem; Khasawneh, Mohammad A.; Polites, Stephanie F.; Zielinski, Martin D.

2016-01-01

Background The gastrografin (GG) challenge is a diagnostic and therapeutic tool used to treat patients with small bowel obstruction (SBO); however, long-term data on SBO recurrence after the GG challenge remain limited. We hypothesized that patients treated with GG would have the same long-term recurrence as those treated before the implementation of the GG challenge protocol. Methods Patients ≥18 years who were treated for SBO between July 2009 and December 2012 were identified. We excluded patients with contraindications to the GG challenge (i.e., signs of strangulation), patients having SBO within 6-wk of previous abdominal or pelvic surgery and patients with malignant SBO. All patients had been followed a minimum of 1 y or until death. Kaplan–Meier method and Cox regression models were used to describe the time-dependent outcomes. Results A total of 202 patients were identified of whom 114 (56%) received the challenge. Mean patients age was 66 y (range, 19–99 y) with 110 being female (54%). A total of 184 patients (91%) were followed minimum of 1 year or death (18 patients lost to follow-up). Median follow-up of living patients was 3 y (range, 1–5 y). During follow-up, 50 patients (25%) experienced SBO recurrences, and 24 (12%) had exploration for SBO recurrence. The 3-year cumulative rate of SBO recurrence in patients who received the GG was 30% (95% confidence interval [CI], 21%–42%) compared to 27% (95% CI, 18%–38%) for those who did not (P = 0.4). The 3-year cumulative rate of exploration for SBO recurrence in patients who received the GG was 15% (95% CI, 8%–26%) compared to 12 % (95% CI, 6%–22%) for those who did not (P = 0.6). Conclusions The GG challenge is a clinically useful tool in treating SBO patients with comparable long-term recurrence rates compared to traditional management of SBO. PMID:27083946

Long-term outcomes of gastrografin in small bowel obstruction.

PubMed

Baghdadi, Yaser M K; Choudhry, Asad J; Goussous, Naeem; Khasawneh, Mohammad A; Polites, Stephanie F; Zielinski, Martin D

2016-05-01

The gastrografin (GG) challenge is a diagnostic and therapeutic tool used to treat patients with small bowel obstruction (SBO); however, long-term data on SBO recurrence after the GG challenge remain limited. We hypothesized that patients treated with GG would have the same long-term recurrence as those treated before the implementation of the GG challenge protocol. Patients ≥18 years who were treated for SBO between July 2009 and December 2012 were identified. We excluded patients with contraindications to the GG challenge (i.e., signs of strangulation), patients having SBO within 6-wk of previous abdominal or pelvic surgery and patients with malignant SBO. All patients had been followed a minimum of 1 y or until death. Kaplan-Meier method and Cox regression models were used to describe the time-dependent outcomes. A total of 202 patients were identified of whom 114 (56%) received the challenge. Mean patients age was 66 y (range, 19-99 y) with 110 being female (54%). A total of 184 patients (91%) were followed minimum of 1 year or death (18 patients lost to follow-up). Median follow-up of living patients was 3 y (range, 1-5 y). During follow-up, 50 patients (25%) experienced SBO recurrences, and 24 (12%) had exploration for SBO recurrence. The 3-year cumulative rate of SBO recurrence in patients who received the GG was 30% (95% confidence interval [CI], 21%-42%) compared to 27% (95% CI, 18%-38%) for those who did not (P = 0.4). The 3-year cumulative rate of exploration for SBO recurrence in patients who received the GG was 15% (95% CI, 8%-26%) compared to 12 % (95% CI, 6%-22%) for those who did not (P = 0.6). The GG challenge is a clinically useful tool in treating SBO patients with comparable long-term recurrence rates compared to traditional management of SBO. Copyright © 2016 Elsevier Inc. All rights reserved.

Use of Vitex agnus-castus in migrainous women with premenstrual syndrome: an open-label clinical observation.

PubMed

Ambrosini, Anna; Di Lorenzo, Cherubino; Coppola, Gianluca; Pierelli, Francesco

2013-03-01

Premenstrual syndrome (PMS) affects most women during their reproductive life. Headache is regarded as a typical symptom of PMS and, close to menses, migrainous women could experience their worst migraine attacks. Vitex agnus-castus (VAC) is a phytopharmaceutical compound, considered worldwide to be a valid tool to treat PMS. Aim of this study is to explore if headache is ameliorate in migrainous women treated with VAC for PMS by an open-label clinical observation. Migrainous women with PMS were enrolled in the study and advised to assume a treatment with VAC (40 mg/day) for PMS for a 3-month period. Effects both on PMS and headache were assessed. Out of 107 women, 100 completed the 3-month treatment for PMS. Out of them, 66 women reported a dramatic reduction of PMS symptoms, 26 a mild reduction, and 8 no effect. Concerning migraine, 42 % of patients experienced a reduction higher than 50 % in frequency of monthly attacks, and 57 % of patients experienced a reduction higher than 50 % in monthly days with headache. No patients reported remarkable side effects. Pending a placebo-controlled trial to confirm our results, we observed that the use of VAC in migrainous women affected by PMS resulted to be safe and well tolerated, and may positively influence the frequency and duration of migraine attacks.

Peripheral nerve stimulation for occipital neuralgia: surgical leads.

PubMed

Kapural, Leonardo; Sable, James

2011-01-01

Peripheral nerve stimulation (PNS) has been used for the treatment of various neuropathic pain disorders, including occipital neuralgia, for the patients who failed less-invasive therapeutic approaches. Several different mechanisms of pain relief were proposed when PNS is used to treat occipital neuralgia and clinical studies using various types of electrical leads suggested largely positive clinical responses in patients with mostly refractory, severe neuropathic pain. With advancements in cylindrical lead design for PNS and placement/implantation techniques, there are very few clear indications where 'paddle' (surgical) leads could be advantageous. Those include patients who experienced repeated migration of cylindrical lead as paddle lead may provide greater stability, who are experiencing unpleasant recruitment of surrounding muscle and/or motor nerve stimulation and for cases where skin erosions were caused by a cylindrical lead. However, disregarding the type of lead used, multiple clinical advantages of this minimally invasive, easily reversible approach include relatively low morbidity and a high treatment efficacy. Copyright © 2011 S. Karger AG, Basel.

Perioperative incidents associated with internal maxillary distraction osteogenesis: a retrospective study of 20 patients.

PubMed

Kristian, Andersen; Erik, Nørholt Sven; Annelise, Küseler; John, Jensen; Klit, Pedersen Thomas

2012-12-01

This retrospective study aimed to assess the frequency and distribution of incidents encountered during the perioperative period of maxillary distraction with internal devices. The perioperative period was defined as the period between device placement and removal. Records of 20 patients treated during 2004-2011 with internal maxillary distraction osteogenesis were examined. Incidents were registered in terms of severity and need of intervention. Eighty percent of the patients experienced minor incidents, of which the most frequent were pain during activation and infections; 80% of these experienced ≥1 hard and soft tissue-related incidents, and 20% ≥1 device-related incidents. All incidents were solved with minimal or no intervention. Maxillary distraction using internal devices is a safe treatment with only minor incidents in the perioperative period. Preoperative planning and good cooperation are essential for preventing postoperative incidents. Prophylactic antibiotic treatment during the distraction period may be indicated. Copyright © 2012 Elsevier Inc. All rights reserved.

Sofosbuvir plus ledispasvir for recurrent hepatitis C in liver transplant recipients.

PubMed

Kwok, Ryan M; Ahn, Joseph; Schiano, Thomas D; Te, Helen S; Potosky, Darryn R; Tierney, Amber; Satoskar, Rohit; Robertazzi, Suzanne; Rodigas, Colleen; Lee Sang, Michelle; Wiegel, Joshua; Patel, Neal; Gripshover, Janet; Hassan, Mohamed A; Branch, Andrea; Smith, Coleman I

2016-11-01

Hepatitis C virus (HCV) recurrence after liver transplantation (LT) is associated with worse outcomes. The combination of ledipasvir (LDV) and sofosbuvir (SOF) has been approved for HCV treatment after LT, but there are limited data on the effectiveness and safety of LDV/SOF in the "real-world" setting. This multicenter study is the largest report to date on the effectiveness and safety of LDV/SOF in the post-LT setting. A total of 204 patients (72% male, 68% Caucasian, 66% genotype [GT] 1a, 21% METAVIR F3-F4, 49% treatment-experienced) were treated with LDV/SOF. The mean duration from LT to treatment initiation was 4.8 years. The overall sustained virological response rate 12 weeks after completion of therapy (SVR12) was 96%. Patients treated with 8 or 12 weeks of LDV/SOF without RBV experienced an SVR12 rate of 100% and 96%, respectively. Calcineurin inhibitors were used in 89% of patients, and 32% of patients underwent adjustment in immunosuppression during treatment. One episode of mild rejection, responsive to an increase in immunosuppression dosage, was observed. There was no graft loss attributed to HCV treatment. Four deaths occurred unrelated to HCV treatment, and no significant serious adverse events were documented. In conclusion, SOF and LDV with or without RBV for 8, 12, or 24 weeks in post-LT patients was effective and safe with a high SVR12 rate across a spectrum of GTs and stages of fibrosis. Liver Transplantation 22 1536-1543 2016 AASLD. © 2016 by the American Association for the Study of Liver Diseases.

Initial experience of single-port laparoscopic surgery for sigmoid colon cancer.

PubMed

Park, Sun Jin; Lee, Kil Yeon; Kang, Byung Mo; Choi, Sung Il; Lee, Suk Hwan

2013-03-01

Single-port laparoscopic surgery has attracted attention in the field of minimally invasive colorectal surgery. We hypothesized that an experienced laparoscopic surgeon could perform single-port surgery for colon cancer eligible for conventional laparoscopic anterior resection. Our aim was to analyze our initial experience and immediate surgical outcomes of single-port anterior resection. A total of 37 consecutive patients with presumed sigmoid colonic cancer underwent single-port anterior resection with standard laparoscopic instruments between May 2009 and June 2010. Each operation was performed by one of two experienced colorectal surgeons. A cohort of patients who had undergone conventional laparoscopic surgery (CLS) for the same duration a year earlier (August 2007 to September 2008) was used as a historical control. Patient demographics and perioperative outcomes were analyzed and compared with those of CLS. There were no significant differences in mean estimated blood loss, mean length of the resection margin, or morbidity between the two groups, but operative time for the single-port group was significantly shorter (118 ± 41 vs. 140 ± 42 min; p = 0.017). Single-port laparoscopic surgery was successfully performed in 78.4% (29/37) of the patients treated in 2010, and CLS was successfully completed in all of the patients treated the previous year (p = 0.000). The main causes of single-port surgery failure were adhesion and tumor location. Single-port anterior resection is a feasible and safe procedure with immediate outcomes comparable to those of conventional laparoscopy. Further studies are required to determine the feasibility of single-port surgery for colonic tumors outside the sigmoid colon and the long-term outcome.

Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study.

PubMed

Murrell, Dedee F; Gebauer, Kurt; Spelman, Lynda; Zane, Lee T

2015-10-01

A novel approach for treating atopic dermatitis (AD) is the inhibition of phosphodiesterase 4 (PDE4), an enzyme involved in the proinflammatory cascade. Crisaborole topical ointment, 2% is a novel, boron-based small-molecule PDE4 inhibitor with anti-inflammatory properties. The objective of this proof-of-concept study was to assess the efficacy and safety of crisaborole topical ointment, 2% in adults with mild to moderate AD. This phase 2a, randomized, double-blind, bilateral, 6-week study of crisaborole topical ointment, 2% was conducted in adult patients with mild to moderate AD with 2 comparable target AD lesions. Patients were randomly assigned to twice-daily application of crisaborole topical ointment, 2% or vehicle, each to 1 of the 2 target lesions. The primary efficacy endpoint was change from baseline in Atopic Dermatitis Severity Index (ADSI) score at day 28. Safety assessments included local tolerability and incidence of adverse events (AEs). A total of 25 enrolled patients received study medication. At day 28, 17 patients (68%) experienced a greater decrease in ADSI score in the active-treated lesion than in the vehicle-treated lesion; 5 patients (20%) had a greater decrease in ADSI score in the vehicle-treated lesion than in the active-treated lesion. Local application-site reactions were reported in 3 patients (12%). A total of 29 AEs were reported in 11 patients; most (90%) were mild in intensity and unrelated to study medication. No serious or severe AEs were reported, and no patient discontinued due to an AE. These findings provide preliminary evidence of the efficacy and safety of treatment with crisaborole topical ointment, 2% in adults with mild to moderate AD. The study is registered on ClinicalTrials.gov (identifier NCT01301508).

Diagnostic Accuracy of Tests for Polyuria in Lithium-Treated Patients.

PubMed

Kinahan, James Conor; NiChorcorain, Aoife; Cunningham, Sean; Freyne, Aideen; Cooney, Colm; Barry, Siobhan; Kelly, Brendan D

2015-08-01

In lithium-treated patients, polyuria increases the risk of dehydration and lithium toxicity. If detected early, it is reversible. Despite its prevalence and associated morbidity in clinical practice, it remains underrecognized and therefore undertreated. The 24-hour urine collection is limited by its convenience and practicality. This study explores the diagnostic accuracy of alternative tests such as questionnaires on subjective polyuria, polydipsia, nocturia (dichotomous and ordinal responses), early morning urine sample osmolality (EMUO), and fluid intake record (FIR). This is a cross-sectional study of 179 lithium-treated patients attending a general adult and an old age psychiatry service. Participants completed the tests after completing an accurate 24-hour urine collection. The diagnostic accuracy of the individual tests was explored using the appropriate statistical techniques. Seventy-nine participants completed all of the tests. Polydipsia severity, EMUO, and FIR significantly differentiated the participants with polyuria (area under the receiver operating characteristic curve of 0.646, 0.760, and 0.846, respectively). Of the tests investigated, the FIR made the largest significant change in the probability that a patient experiences polyuria (<2000 mL/24 hours; interval likelihood ratio, 0.18 and >3500 mL/24 hours; interval likelihood ratio, 14). Symptomatic questioning, EMUO, and an FIR could be used in clinical practice to inform the prescriber of the probability that a lithium-treated patient is experiencing polyuria.

Icodextrin does not impact infectious and culture-negative peritonitis rates in peritoneal dialysis patients: a 2-year multicentre, comparative, prospective cohort study

PubMed Central

Vychytil, Andreas; Remón, César; Michel, Catherine; Williams, Paul; Rodríguez-Carmona, Ana; Marrón, Belén; Vonesh, Ed; van der Heyden, Synke; Filho, Jose C. Divino

2008-01-01

Background. Icodextrin is a glucose polymer derived by hydrolysis of cornstarch. The different biocompatibility profile of icodextrin-containing peritoneal dialysis (PD) solutions may have a positive influence on peritoneal host defence. Furthermore, cases of sterile peritonitis potentially associated with icodextrin have been reported. Methods. The primary objective of this multicentre, longitudinal, observational, non-interventional, prospective cohort study, which included 722 PD patients, was to evaluate the incidence of overall peritonitis in patients treated with icodextrin-containing PD solutions (Extraneal™) used during one long-dwell exchange/day compared with those treated with non-icodextrin-containing PD solutions. The secondary objective was to determine if culture-negative peritonitis rates differed between patients treated with icodextrin from two independent manufacturers. All peritonitis episodes were assessed by a Steering Committee in a blind manner. Results. There was no significant difference between icodextrin-treated and control patients in the adjusted overall, culture-positive or culture-negative peritonitis rates. When stratified by the icodextrin supplier, there was no significant difference in the adjusted rate of culture-negative peritonitis episodes between groups. Conclusion. Subjects receiving icodextrin as part of their PD regimen experienced neither a higher rate of culture-negative peritonitis nor a lower rate of infectious peritonitis compared with non-icodextrin users. There was no significant influence of the icodextrin raw material supplier on peritonitis rates. PMID:18556747

Post-tonsillectomy hemorrhagic outcomes in children with bleeding disorders at a single institution.

PubMed

Patel, Priyesh N; Arambula, Alexandra M; Wheeler, Allison P; Penn, Edward B

2017-09-01

To report on the post-tonsillectomy bleeding outcomes and factors associated with hemorrhage among children with pre- or post-operatively diagnosed bleeding disorders treated with an institutional protocol. Retrospective cohort study of patients with hematologic disorders who underwent tonsillectomy between 2003 and 2016 and were treated with perioperative desmopressin or factor replacement and/or aminocaproic acid. Postoperative outcomes were compared to controls matched for age, sex, and indication for surgery. Analysis of factors associated with hemorrhage was performed in patients with bleeding disorders using Mann-Whitney U or chi-squared tests. 45 patients with hematologic disorders met inclusion criteria. Platelet dysfunction, including von Willebrand Disease (vWD), was the most common diagnosis (77.8%). Most patients had a preoperative diagnosis of a bleeding disorder and received perioperative hematologic medications (86.7%). Compared to matched controls, patients with hematologic disorders experienced more postoperative bleeding (15.5%; 12 bleeds, 7 patients vs. 1.7%; 1 bleed, 1 patient, p = 0.05) and had longer postoperative stays (1.3 days vs. 0.4 days, p < 0.001). Among the patients with hematologic disorders, patients who experienced a postoperative bleed were significantly more likely to have a factor deficiency (e.g. Hemophilia over vWD) and have a postoperative diagnosis (compared to preoperative diagnosis) for which they did not receive perioperative hematologic medication. Of patients with a postoperative bleed, all those diagnosed postoperatively required at least one surgical intervention to control bleeding compared to 33% of patients with a preoperative diagnosis. A history of post-surgical bleeding, male sex, age at surgery, and pharyngitis as surgical indication were not associated with higher hemorrhage rates in this group. This study suggests a clinically important magnitude of increased bleeding risk in patients with hematologic disease. This risk appears to decrease with the use of an institutional protocol consisting of desmopressin or factor replacement and an antifibrinolytic agent extending through postoperative day 10. Copyright © 2017 Elsevier B.V. All rights reserved.

Postoperative Outcomes in Vedolizumab-Treated Patients Undergoing Abdominal Operations for Inflammatory Bowel Disease.

PubMed

Lightner, Amy L; Raffals, Laura E; Mathis, Kellie L; Cima, Robert R; Tse, Chung Sang; Pemberton, John H; Dozois, Eric J; Loftus, Edward V

2017-02-01

Vedolizumab was recently approved by the Food and Drug Administration for the treatment of moderate to severe ulcerative colitis [UC] and Crohn's disease [CD]. No study to date has examined the rate of postoperative infectious complications among patients who received vedolizumab in the perioperative period. We sought to determine the 30-day postoperative infectious complication rate among inflammatory bowel disease [IBD] patients who received vedolizumab within 12 weeks of an abdominal operation as compared to patients who received tumour necrosis factor α [TNFα] inhibitors or no biological therapy. A retrospective chart review between May 1, 2014 and December 31, 2015 of adult IBD patients who underwent an abdominal operation was performed. The study cohort comprised patients who received vedolizumab within 12 weeks of their abdominal operation and the control cohorts were patients who received TNFα inhibitors or no biological therapy. In total, 94 patients received vedolizumab within 12 weeks of an abdominal operation. Fifty experienced postoperative complications [53%], 35 of which were surgical site infections [SSIs] [36%]. The vedolizumab group experienced significantly higher rates of any postoperative infection [53% vs 33% anti-TNF and 28% non-biologics; p<0.001] and SSI [37% vs 10% and 13%; p<0.001]. On univariate and multivariate analysis, exposure to vedolizumab remained a significant predictor of postoperative SSI [p<0.001]. Thirty-seven per cent of IBD patients who received vedolizumab within 30 days of a major abdominal operation experienced a 30-day postoperative SSI, significantly higher than patients receiving TNFα inhibitors or no biological therapy. Vedolizumab within 12 weeks of surgery remained the only predictor of 30-day postoperative SSI on multivariate analysis. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Rehabilitation Nutrition for Possible Sarcopenic Dysphagia After Lung Cancer Surgery: A Case Report.

PubMed

Wakabayashi, Hidetaka; Uwano, Rimiko

2016-06-01

Sarcopenic dysphagia is characterized by the loss of swallowing muscle mass and function associated with generalized loss of skeletal muscle mass and function. In this report, the authors describe a patient with possible sarcopenic dysphagia after lung cancer surgery and was treated subsequently by rehabilitation nutrition. A 71-year-old man with lung cancer experienced complications of an acute myocardial infarction and pneumonia after surgery. He was ventilated artificially, and a tracheotomy was performed. The patient received diagnoses of malnutrition, severe sarcopenia, and possible sarcopenic dysphagia. His dysphagia was improved by a combination of dysphagia rehabilitation including physical and speech therapy and an improvement in nutrition initiated by a nutrition support team. Finally, he no longer had dysphagia and malnutrition. Sarcopenic dysphagia should be considered in patients with sarcopenia and dysphagia. Rehabilitation nutrition using a combination of both rehabilitation and nutritional care management is presumptively useful for treating sarcopenic dysphagia.

Flashes of light-radiation therapy to the brain.

PubMed

Blumenthal, Deborah T; Corn, Benjamin W; Shtraus, Natan

2015-08-01

We present a series of three patients who received therapeutic external beam radiation to the brain and experienced a phenomenon of the sensation of flashes of bright or blue light, simultaneous with radiation delivery. We relate this benign phenomenon to low-dose exposure to the eye fields and postulate that the occurrence is underreported in this treated population. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Outcomes of breast cancer patients with triple negative receptor status treated with accelerated partial breast irradiation.

PubMed

Wilkinson, J Ben; Reid, Robert E; Shaitelman, Simona F; Chen, Peter Y; Mitchell, Christine K; Wallace, Michelle F; Marvin, Kimberly S; Grills, Inga S; Margolis, Jeffrey M; Vicini, Frank A

2011-11-01

Triple negative receptor status (TNRS) of patients undergoing breast-conserving therapy treated with whole-breast irradiation has been associated with increased distant metastasis and decreased disease-free and overall survival. This paper reports the outcomes of TNRS patients treated with accelerated partial breast irradiation (APBI). We studied 455 patients who received APBI at our institution, using interstitial, intracavitary, and three-dimensional conformal radiation therapy. TNRS was assigned if a patient tested negative for all three (ER [estrogen receptor], PR [progesterone receptor], and HER2/neu) receptors. Of 202 patients with all receptor results available, 20 patients were designated TNRS, and 182 patients had at least one receptor positive (RP). We analyzed ipsilateral breast tumor recurrence (IBTR), regional nodal failure (RNF), distant metastasis (DM), and overall survival (OS). Mean follow-up was 4.1 years for the TNRS group and 5.1 years for the RP cohort (p = 0.11). TNRS patients had a higher histologic grade (59% TNRS vs. 13% RP; p < 0.001). Mean tumor size, stage N1 disease, and margin status were similar. Based on a 5-year actuarial analysis, the TNRS cohort experienced no IBTR, RNF, or DM, with an OS of 100% versus rates of 1.4% IBTR, 1.5% RNF, and 2.8% DM in the RP cohort (p > 0.52). OS for the RP cohort was 93% at 5 years (p > 0.28). In our patient population, TNRS conferred a clinical outcome similar to that of patients with RP disease treated with APBI. Further investigation with larger patient populations and longer follow-up periods is warranted to confirm that APBI is a safe and effective treatment for patients with localized TNRS breast cancer. Copyright © 2011 Elsevier Inc. All rights reserved.

Longterm Safety and Efficacy of Adalimumab and Infliximab for Uveitis Associated with Juvenile Idiopathic Arthritis.

PubMed

Cecchin, Vanessa; Zannin, Maria Elisabetta; Ferrari, Daniele; Pontikaki, Irene; Miserocchi, Elisabetta; Paroli, Maria P; Bracaglia, Claudia; Marafon, Denise Pires; Pastore, Serena; Parentin, Fulvio; Simonini, Gabriele; De Libero, Cinzia; Falcini, Fernanda; Petaccia, Antonella; Filocamo, Giovanni; De Marco, Riccardo; La Torre, Francesco; Guerriero, Silvana; Martino, Silvana; Comacchio, Francesco; Muratore, Valentina; Martini, Giorgia; Vittadello, Fabio; Zulian, Francesco

2018-04-15

Anti-TNF-α agents have significantly changed the management of juvenile idiopathic arthritis (JIA). We evaluated the safety and efficacy of adalimumab (ADA) and infliximab (IFX) for the treatment of JIA-associated uveitis in patients treated for ≥ 2 years. Patients with JIA-associated uveitis treated with IFX and ADA were managed by a standardized protocol and data were entered in the ORCHIDEA registry. At baseline, all patients were refractory to standard immunosuppressive treatment or were corticosteroid-dependent. Data recorded every 3 months were uveitis course, number/type of ocular flares and complications, drug-related adverse events (AE), and treatment switch or withdrawal. Data of patients treated for ≥ 2 years were analyzed by descriptive statistics. Up to December 2014, 154 patients with ≥ 24 months followup were included in the study. Fifty-nine patients were treated with IFX and 95 with ADA. Clinical remission, defined as the absence of flares for > 6 months on treatment, was achieved in 69 patients (44.8%), with a better remission rate for ADA (60.0%) as compared to IFX (20.3%; p < 0.001). A significant reduction of flares was observed in all patients without difference between the 2 treatment modalities. The number of new ocular complications decreased in both groups but was lower for ADA (p = 0.015). No serious AE were recorded; 16.4% of patients experienced 35 minor AE and the incidence rate was lower with ADA than with IFX. At the 2-year followup, ADA showed a better efficacy and safety profile than IFX for the treatment of refractory JIA-associated uveitis.

Are clinical decisions in endodontics influenced by the patient's fee-paying status?

PubMed

Walker, I; Gilbert, D; Asimakopoulou, K

2015-12-01

We explored whether the fee status of a UK patient influences clinical decision-making in endodontics. In a randomised-controlled vignette study describing either an 'NHS-funded', 'Privately-funded' or undisclosed fee-status patient, we examined the importance vocational trainer dentists placed on a series of factors normally considered when deciding whether to offer patients endodontic treatment as opposed to extracting the tooth. N = 119 experienced (M years post qualification = 20.01) dentists participated. Having read a vignette describing a hypothetical patient who could potentially be treated either endodontically or through an extraction, dentists rated a series of factors they would normally consider (for example, poor oral hygiene, the rest of their mouth is unfilled and caries-free), before recommending either endodontic treatment or an extraction. The patient's funding status had no influence on these dentists' clinical decision-making when considering endodontic treatment as an option (p >0.05) with the exception of a single item relating to infrequent attendance where the NHS patient was more likely than the 'undisclosed-fee' patient, to be offered extractions (F (2, 116) 3.43, p <0.04). We have found no strong evidence to suggest that the fee-status of a patient influences clinical decision-making in endodontic treatment by experienced dentists.

Aspiration sclerotherapy for hydroceles in the tropics.

PubMed

Musa, M T; Fahal, A H; el Arabi, Y E

1995-10-01

To assess the usefulness of aspiration sclerotherapy in the treatment of hydroceles in the tropics. This prospective study included 82 patients with 94 primary vaginal hydroceles of which 62 hydroceles were treated by aspiration and tetracycline hydrochloride sclerotherapy as an outpatient procedure (mean age of patients 56.5 years, range 40-82) and 28 were treated surgically and included as controls (mean age 52.4 years, range 40-70). All patients were followed for a year. In the sclerotherapy group, the overall cure rate after a year was 95%. Few complications were encountered in this group: six patients (10%) experienced pain during the procedure, seven patients (12%) had local infection and three patients (5%) developed haematoma. No recurrence was encountered in the surgical group, seven patients (25%) had infection and two patients (7%) developed haematoma. The mean hospital stay for the surgical group was 3.4 +/- 1.3 days (range 1-7). Four patients with thick-walled hydroceles had persistent swelling after sclerotherapy, the recurrence of which dissatisfied the patients. Aspiration sclerotherapy for thin-walled hydroceles proved to be a curative, simple, safe and cost-effective out-patient procedure. It can be an alternative to surgery in developing countries where resources are limited.

Recurrent Candida albicans Ventriculitis Treated with Intraventricular Liposomal Amphotericin B

PubMed Central

Toprak, Demet; Öcal Demir, Sevliya; Kadayifci, Eda Kepenekli; Türel, Özden; Soysal, Ahmet; Bakir, Mustafa

2015-01-01

Central nervous system (CNS) infection with Candida is rare but significant because of its high morbidity and mortality. When present, it is commonly seen among immunocompromised and hospitalized patients. Herein, we describe a case of a four-year-old boy with acute lymphoblastic leukemia (ALL) who experienced recurrent Candida albicans meningitis. The patient was treated successfully with intravenous liposomal amphotericin B at first attack, but 25 days after discharge he was readmitted to hospital with symptoms of meningitis. Candida albicans was grown in CFS culture again and cranial magnetic resonance imaging (MRI) showed ventriculitis. We administered liposomal amphotericin B both intravenously and intraventricularly and favorable result was achieved without any adverse effects. Intraventricular amphotericin B may be considered for the treatment of recurrent CNS Candida infections in addition to intravenous administration. PMID:26558119

Clinical outcome of extended-field irradiation vs. pelvic irradiation using intensity-modulated radiotherapy for cervical cancer.

PubMed

Ouyang, Yi; Wang, Yanhong; Chen, Kai; Cao, Xinping; Zeng, Yiming

2017-12-01

The aim of the present study was to evaluate the distinctions in survival and toxicity between patients with cervical cancer with common iliac node or para-aortic node involvement, who were treated with extended-field intensity-modulated radiotherapy (EF-IMRT) and patients with or without lower involved pelvic nodes, who were treated with pelvic IMRT. A total of 55 patients treated with EF-IMRT and 52 patients treated with pelvic IMRT at the Sun Yat-Sen University Cancer Center (Guangzhou, China) were retrospectively analyzed. Patients treated with EF-IMRT had the highest level of lymph node involvement to the para-aortic or common iliac nodes, while patients treated with pelvic IMRT had no para-aortic or common iliac nodes involved (P<0.001). The median follow-up time was 29.5 months. The 3-year overall survival (OS) rates of EF-IMRT and pelvic IMRT were 79.4 and 82.3% (P=0.45), respectively, and the 3-year disease-free survival (DFS) rates of EF-IMRT and pelvic IMRT were 61.0 and 73.7% (P=0.55), respectively. Cox's regression analysis revealed that EF irradiation was a protective prognostic factor for OS and DFS. A total of 16 patients in the EF-IMRT group and 13 patients in the pelvic IMRT group experienced treatment failure (P=0.67), with the patterns of failure being the same for the two groups (P=0.88). The cumulative incidence of grade 3 and 4 acute toxicities in the EF-IMRT group was 34.5%, in comparison with 19.2% in the pelvic group (P=0.048). The results of the present study suggest that patients with cervical cancer with grossly involved common iliac or para-aortic nodes should be electively subjected to EF irradiation to improve the survival and alter patterns of recurrence. Notably, EF irradiation delivered via IMRT exhibits an increased toxicity incidence, however, this remains within an acceptable range.

Clinical outcome of extended-field irradiation vs. pelvic irradiation using intensity-modulated radiotherapy for cervical cancer

PubMed Central

Ouyang, Yi; Wang, Yanhong; Chen, Kai; Cao, Xinping; Zeng, Yiming

2017-01-01

The aim of the present study was to evaluate the distinctions in survival and toxicity between patients with cervical cancer with common iliac node or para-aortic node involvement, who were treated with extended-field intensity-modulated radiotherapy (EF-IMRT) and patients with or without lower involved pelvic nodes, who were treated with pelvic IMRT. A total of 55 patients treated with EF-IMRT and 52 patients treated with pelvic IMRT at the Sun Yat-Sen University Cancer Center (Guangzhou, China) were retrospectively analyzed. Patients treated with EF-IMRT had the highest level of lymph node involvement to the para-aortic or common iliac nodes, while patients treated with pelvic IMRT had no para-aortic or common iliac nodes involved (P<0.001). The median follow-up time was 29.5 months. The 3-year overall survival (OS) rates of EF-IMRT and pelvic IMRT were 79.4 and 82.3% (P=0.45), respectively, and the 3-year disease-free survival (DFS) rates of EF-IMRT and pelvic IMRT were 61.0 and 73.7% (P=0.55), respectively. Cox's regression analysis revealed that EF irradiation was a protective prognostic factor for OS and DFS. A total of 16 patients in the EF-IMRT group and 13 patients in the pelvic IMRT group experienced treatment failure (P=0.67), with the patterns of failure being the same for the two groups (P=0.88). The cumulative incidence of grade 3 and 4 acute toxicities in the EF-IMRT group was 34.5%, in comparison with 19.2% in the pelvic group (P=0.048). The results of the present study suggest that patients with cervical cancer with grossly involved common iliac or para-aortic nodes should be electively subjected to EF irradiation to improve the survival and alter patterns of recurrence. Notably, EF irradiation delivered via IMRT exhibits an increased toxicity incidence, however, this remains within an acceptable range. PMID:29344136

Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis.

PubMed

Bassiouni, Hassan; Spargo, Catherine Elizabeth; Vlahos, Bonnie; Jones, Heather E; Pedersen, Ron; Shirazy, Khalid

2018-06-01

To compare etanercept (ETN) and placebo (PBO) for maintaining low disease activity (LDA) achieved with ETN in patients with rheumatoid arthritis (RA) from Africa and the Middle East. In this subset analysis of the Treat-to-Target trial (ClinicalTrials.gov identifier NCT01981473), 53 adult patients with moderate-to-severe RA nonresponsive to methotrexate were treated with 50 mg ETN/week for 24 weeks (Period 1). Patients achieving LDA were randomized to continue ETN treatment or switched to PBO for an additional 28 weeks (Period 2). The proportion of patients maintaining LDA or remission in each arm at the end of Period 2 was determined. Additional efficacy and patient-reported outcomes (PROs) were also evaluated. During Period 1, 51 patients achieved LDA according to the disease activity score-28 joints-erythrocyte sedimentation rate (DAS28-ESR LDA) and 30 achieved remission. At week 52, nine of 22 and eight of 29 in the ETN and PBO groups, respectively, remained in DAS28-ESR LDA without experiencing a flare. Additionally, six of 14 and five of 16 in the ETN and PBO groups, respectively, remained in remission. Among patients experiencing a flare during Period 2, 13 of 22 and 21 of 29 received ETN or PBO, respectively. The median time to flare was 193 and 87 days in the ETN and PBO groups, respectively. At week 52, consistently more patients in the ETN group than in the PBO group achieved predetermined efficacy and PRO endpoints. These data suggest continuing ETN maintenance therapy is beneficial to patients after they have achieved their treatment target. However, this subset analysis is limited by the small patient population and must be interpreted with caution. Pfizer. ClinicalTrials.gov identifier, NCT0198147.

Optimal efficacy of interferon-free HCV retreatment after protease inhibitor failure in real life.

PubMed

Cento, V; Barbaliscia, S; Lenci, I; Ruggiero, T; Magni, C F; Paolucci, S; Babudieri, S; Siciliano, M; Pasquazzi, C; Ciancio, A; Perno, C F; Ceccherini-Silberstein, F

2017-10-01

First-generation protease-inhibitors (PIs) have suboptimal efficacy in GT-1 patients with advanced liver disease, and patients experiencing treatment failure may require urgent retreatment. Our objective was to analyse the real-life efficacy of interferon (IFN)-free retreatment after PI-failure, and the role of genotypic-resistance-testing (GRT) in guiding retreatment choice. In this multi-centre observational study, patients retreated with IFN-free regimens after first-generation PI-failure (telaprevir-boceprevir-simeprevir) were included. Sustained-virological-response (SVR) was evaluated at week 12 of follow-up. GRT was performed by population-sequencing. After PI-failure, 121 patients (cirrhotic=86.8%) were retreated following three different strategies: A) with 'GRT-guided' regimens (N=18); B) with 'AASLD/EASL recommended, not GRT-guided' regimens (N=72); C) with 'not recommended, not GRT-guided' regimens (N=31). Overall SVR rate was 91%, but all 18 patients treated with 'GRT-guided' regimens reached SVR (100%), despite heterogeneity in treatment duration, use of PI and ribavirin, versus 68/72 patients (94.4%) receiving 'AASLD/EASL recommended, not GRT-guided' regimens. SVR was strongly reduced (77.4%) among the 31 patients who received a 'not recommended, not GRT-guided regimen' (p <0.01). Among 37 patients retreated with a PI, SVR rate was 89.2% (33/37). Four GT-1a cirrhotic patients failed an option (C) simeprevir-containing treatment; three out of four had a baseline R155K NS3-RAS. All seven patients treated with paritaprevir-containing regimens reached SVR, regardless of treatment duration and performance of a baseline-GRT. Retreatment of PI-experienced patients can induce maximal SVR rates in real life. Baseline-GRT could help to optimize retreatment strategy, allowing PIs to be reconsidered when chosen after a RASs evaluation. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Clinical and genetic characteristics in a group of 45 patients with Turner syndrome (monocentric study).

PubMed

Bucerzan, Simona; Miclea, Diana; Popp, Radu; Alkhzouz, Camelia; Lazea, Cecilia; Pop, Ioan Victor; Grigorescu-Sido, Paula

2017-01-01

Recent years have seen a shift in perspective on Turner syndrome, as it is no longer considered a significant disability due to therapeutic advances. The delay of diagnosis and the underdiagnosis are common in Turner syndrome, especially because of the great phenotypic variability and lack of firm diagnostic criteria. Our first aim was to assess the clinical and the cytogenetic characteristics and growth rate in growth hormone (GH)-treated patients as compared to those with spontaneous growth. The second aim was to analyze the Y chromosomal sequences. We analyzed 45 patients diagnosed with Turner syndrome in Genetic Pathology Centre of Cluj Emergency Children's Hospital. We carried out a study of the clinical features, the correlations between the karyotype and the phenotype, and we also made a research of Y chromosome sequences. The average age at diagnosis was 8.9±5.4 years. A significant association was observed between the number of external phenotypical abnormalities and internal malformations ( r =0.45), particularly the cardiovascular ones ( r =0.44). Patients treated with GH showed improvement in growth rate, with final stature significantly better than in untreated patients; benefits following treatment were greater if diagnosis was made before the age of 5 years. Thirteen percent of patients experienced spontaneous and complete puberty, whereas 30% experienced incomplete puberty. Patients with the 45,X genotype had a greater stature deficit and a higher incidence of cardiac malformations, compared with patients with 45,X/46,XX mosaic karyotype. Y chromosome sequences were found in only one patient, who subsequently underwent gonadectomy. The importance of this study resides, to the best of our knowledge, in the fact that the largest group of patients in Romania was analyzed and assessed. To draw firm conclusions on the most valuable clinical indicators for Turner syndrome diagnosis in clinical practice, studies on large groups of patients should be conducted.

Clinical and genetic characteristics in a group of 45 patients with Turner syndrome (monocentric study)

PubMed Central

Bucerzan, Simona; Miclea, Diana; Popp, Radu; Alkhzouz, Camelia; Lazea, Cecilia; Pop, Ioan Victor; Grigorescu-Sido, Paula

2017-01-01

Introduction Recent years have seen a shift in perspective on Turner syndrome, as it is no longer considered a significant disability due to therapeutic advances. The delay of diagnosis and the underdiagnosis are common in Turner syndrome, especially because of the great phenotypic variability and lack of firm diagnostic criteria. Aim Our first aim was to assess the clinical and the cytogenetic characteristics and growth rate in growth hormone (GH)-treated patients as compared to those with spontaneous growth. The second aim was to analyze the Y chromosomal sequences. Materials and methods We analyzed 45 patients diagnosed with Turner syndrome in Genetic Pathology Centre of Cluj Emergency Children’s Hospital. We carried out a study of the clinical features, the correlations between the karyotype and the phenotype, and we also made a research of Y chromosome sequences. Results The average age at diagnosis was 8.9±5.4 years. A significant association was observed between the number of external phenotypical abnormalities and internal malformations (r=0.45), particularly the cardiovascular ones (r=0.44). Patients treated with GH showed improvement in growth rate, with final stature significantly better than in untreated patients; benefits following treatment were greater if diagnosis was made before the age of 5 years. Thirteen percent of patients experienced spontaneous and complete puberty, whereas 30% experienced incomplete puberty. Patients with the 45,X genotype had a greater stature deficit and a higher incidence of cardiac malformations, compared with patients with 45,X/46,XX mosaic karyotype. Y chromosome sequences were found in only one patient, who subsequently underwent gonadectomy. Conclusion The importance of this study resides, to the best of our knowledge, in the fact that the largest group of patients in Romania was analyzed and assessed. To draw firm conclusions on the most valuable clinical indicators for Turner syndrome diagnosis in clinical practice, studies on large groups of patients should be conducted. PMID:28496331

Surgical Resection of Brain Metastases and the Risk of Leptomeningeal Recurrence in Patients Treated With Stereotactic Radiosurgery

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

Johnson, Matthew D., E-mail: Matthewjohnson@beaumont.edu; Avkshtol, Vladimir; Baschnagel, Andrew M.

Purpose: Recent prospective data have shown that patients with solitary or oligometastatic disease to the brain may be treated with upfront stereotactic radiosurgery (SRS) with deferral of whole-brain radiation therapy (WBRT). This has been extrapolated to the treatment of patients with resected lesions. The aim of this study was to assess the risk of leptomeningeal disease (LMD) in patients treated with SRS to the postsurgical resection cavity for brain metastases compared with patients treated with SRS to intact metastases. Methods and Materials: Four hundred sixty-five patients treated with SRS without upfront WBRT at a single institution were identified; 330 ofmore » these with at least 3 months' follow-up were included in this analysis. One hundred twelve patients had undergone surgical resection of at least 1 lesion before SRS compared with 218 treated for intact metastases. Time to LMD and overall survival (OS) time were estimated from date of radiosurgery, and LMD was analyzed by the use of cumulative incidence method with death as a competing risk. Univariate and multivariate analyses were performed with competing risk regression to determine whether various clinical factors predicted for LMD. Results: With a median follow-up time of 9.0 months, 39 patients (12%) experienced LMD at a median of 6.0 months after SRS. At 1 year, the cumulative incidence of LMD, with death as a competing risk, was 5.2% for the patients without surgical resection versus 16.9% for those treated with surgery (Gray test, P<.01). On multivariate analysis, prior surgical resection (P<.01) and breast cancer primary (P=.03) were significant predictors of LMD development. The median OS times for patients undergoing surgery compared with SRS alone were 12.9 and 10.6 months, respectively (log-rank P=.06). Conclusions: In patients undergoing SRS with deferral of upfront WBRT for intracranial metastatic disease, prior surgical resection and breast cancer primary are associated with an increased risk for the development of LMD.« less

Successful management of chronic disseminated candidiasis in hematologic patients treated with high-dose liposomal amphotericin B: a retrospective study of the SEIFEM registry.

PubMed

Della Pepa, Roberta; Picardi, M; Sorà, F; Stamouli, M; Busca, A; Candoni, A; Delia, M; Fanci, R; Perriello, V; Zancanella, M; Nosari, A; Salutari, P; Marchesi, F; Pane, F; Pagano, L

2016-09-01

Chronic disseminated candidiasis (CDC) is a complication of Candida infection in immunocompromised patients, involving the liver and spleen, and rarely other organs. The aim of the study is to identify the best antifungal drug for hematologic immunocompromised patients with CDC. In this multicentric retrospective study, the charts of 20 patients with CDC following cytotoxic agent protocols for hematological malignancies, diagnosed from 2003 to 2013, were analyzed. The response to systemic antifungal therapy within 90 days from CDC diagnosis and the possible delay in chemotherapy plan, due to the infection, were evaluated. Six patients were treated with high-dose (HD; 5 mg/kg/daily) liposomal amphotericin B (L-AmB), whereas three received standard-dose (SD) L-AmB (3 mg/kg/daily). Azoles were given to six patients; the remaining five were treated with echinocandins. All patients treated with HD L-AmB (6/6-100 %) achieved complete resolution of CDC; one of them had to interrupt the chemotherapy program for the infection. In the SD L-AmB group, treatment failed in the 100 % of cases and one patient had to delay chemotherapy for the infection. Of the six patients who received azoles, two achieved complete resolution of the infection, four experienced treatment failure, and only three performed chemotherapy as planned. Echinocandins treatment resulted in complete resolution of the infection in 2/5 cases, partial response in 2/5 cases, and failure in one case. In this group, 3/5 patients completed chemotherapy as planned. This study shows that HD L-AmB was particularly effective against CDC in hematologic patients, allowing most patients to continue cytotoxic agent program.

Immunoadsorption (IAS) as a rescue therapy in SLE: considerations on safety and efficacy.

PubMed

Stummvoll, Georg H; Aringer, Martin; Jansen, Martin; Smolen, Josef S; Derfler, Kurt; Graninger, Winfried B

2004-11-30

In SLE, extracorporeal procedures aiming at reduction of immunoglobulin (Ig) and immune complexes (IC) are used as a rescue therapy. Plasma exchange (PE) has not been proven overall effective in SLE, and long-term treatment in particular has been associated with severe bacterial and viral infections. Immunoadsorption (IAS), in contrast, selectively removes Ig and IC and may thus be safer. We therefore investigated the rate of infections in SLE patients who were undergoing long-term IAS. 16 SLE patients were treated with > or = 10 courses of IAS, and nine patients with highly active disease received pulse cyclophosphamide (IVCP) therapy in parallel. We retrospectively analysed the records of all these patients for the occurrence of infections. Patients receiving IAS therapy plus IVCP were compared with 25 patients with similarly active disease treated with standard IVCP therapy within the same observation period. Patients receiving IAS without additional IVCP were compared with patients with similarly moderate disease activity receiving neither IAS nor IVCP. No potentially life-threatening viral infection occurred in IAS-treated patients and episodes of herpes zoster were equally distributed. No severe infection was observed during IAS without concomittant cyclophosphamide. As expected, more patients with highly active disease receiving IVCP experienced infections than those with less active disease (16 of 34 [47%] vs. 2 of 22 [9%], p < 0.04). On comparing the two groups with highly active disease, infections were similar (IAS+IVCP: 3 of 9 patients [33%], IVCP only: 5 of 25 [20%]), but one patient receiving IAS+IVCP died of septicaemia. Disease activity significantly decreased in both groups treated with IAS. IAS has an acceptable safety profile with regard to severe infections and appears safe with regard to severe viral disease. Highly active disease and IVCP therapy increase the risk of severe infections in SLE.

Sofosbuvir/Ledipasvir Without Ribavirin Achieved High Sustained Virologic Response for Hepatitis C Recurrence After Liver Transplantation: Two-Center Experience.

PubMed

Elfeki, Mohamed A; Abou Mrad, Rachel; Modaresi Esfeh, Jamak; Zein, Nizar N; Eghtesad, Bijan; Zervos, Xaralambos; Hanouneh, Ibrahim A; O'Shea, Robert; Carey, William D; Alkhouri, Naim

2017-05-01

Current recommended regimens to treat patients with hepatitis C virus (HCV) infection after liver transplantation include the use of ribavirin (RBV). Limited data are available on the efficacy of RBV-free regimens posttransplant, particularly the use of sofosbuvir (SOF)/ledipasvir (LDV) without RBV in this patient population. We aimed to assess the efficacy and safety of SOF/LDV fixed-dose combination without RBV in patients with HCV recurrence posttransplant. This is a retrospective study of 46 patients with HCV recurrence posttransplant. SOF/LDV without RBV was used for 12 weeks in patients with early-stage fibrosis (F0-F2) or for 24 weeks in those with advanced fibrosis (F3-F4) and/or cholestatic hepatitis. The primary endpoint was sustained virologic response at 12 weeks after the end of treatment. Secondary outcomes included relapse after treatment and adverse events. Forty-six patients, with a mean age of 62 ± 8 years, a median duration since time of transplant of 904 days (range, 78-3525 days), an HCV genotype 1, and a mean baseline viral load of 7.79 million IU/mL, were treated. Of these, 32 patients were treated for 12 weeks, and 14 patients were treated for 24 weeks. Twenty-five patients (54%) were treatment experienced (21 with interferon and 4 with SOF). All 46 patients (100%) achieved sustained virological response (SVR) 12. Neither virologic relapses nor serious adverse events were noted. The combination of SOF/LDV without RBV for 12 or 24 weeks produced 100% SVR 12 in patients with HCV recurrence after liver transplantation. The use of RBV may not be necessary to achieve SVR in this patient population.

Outcomes of Breast Cancer Patients With Triple Negative Receptor Status Treated With Accelerated Partial Breast Irradiation

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

Wilkinson, J. Ben; Reid, Robert E.; Shaitelman, Simona F.

2011-11-01

Purpose: Triple negative receptor status (TNRS) of patients undergoing breast-conserving therapy treated with whole-breast irradiation has been associated with increased distant metastasis and decreased disease-free and overall survival. This paper reports the outcomes of TNRS patients treated with accelerated partial breast irradiation (APBI). Methods and Materials: We studied 455 patients who received APBI at our institution, using interstitial, intracavitary, and three-dimensional conformal radiation therapy. TNRS was assigned if a patient tested negative for all three (ER [estrogen receptor], PR [progesterone receptor], and HER2/neu) receptors. Of 202 patients with all receptor results available, 20 patients were designated TNRS, and 182 patientsmore » had at least one receptor positive (RP). We analyzed ipsilateral breast tumor recurrence (IBTR), regional nodal failure (RNF), distant metastasis (DM), and overall survival (OS). Results: Mean follow-up was 4.1 years for the TNRS group and 5.1 years for the RP cohort (p = 0.11). TNRS patients had a higher histologic grade (59% TNRS vs. 13% RP; p < 0.001). Mean tumor size, stage N1 disease, and margin status were similar. Based on a 5-year actuarial analysis, the TNRS cohort experienced no IBTR, RNF, or DM, with an OS of 100% versus rates of 1.4% IBTR, 1.5% RNF, and 2.8% DM in the RP cohort (p > 0.52). OS for the RP cohort was 93% at 5 years (p > 0.28). Conclusions: In our patient population, TNRS conferred a clinical outcome similar to that of patients with RP disease treated with APBI. Further investigation with larger patient populations and longer follow-up periods is warranted to confirm that APBI is a safe and effective treatment for patients with localized TNRS breast cancer.« less

Survey on Tuberculosis Patients in Rural Areas in China: Tracing the Role of Stigma in Psychological Distress.

PubMed

Xu, Minlan; Markström, Urban; Lyu, Juncheng; Xu, Lingzhong

2017-10-04

Depressed patients had risks of non-adherence to medication, which brought a big challenge for the control of tuberculosis (TB). The stigma associated with TB may be the reason for distress. This study aimed to assess the psychological distress among TB patients living in rural areas in China and to further explore the relation of experienced stigma to distress. This study was a cross-sectional study with multi-stage randomized sampling for recruiting TB patients. Data was collected by the use of interviewer-led questionnaires. A total of 342 eligible and accessible TB patients being treated at home were included in the survey. Psychological distress was measured using the Kessler Psychological Distress Scale (K10). Experienced stigma was measured using a developed nine-item stigma questionnaire. Univariate analysis and multiple logistic regression were used to analyze the variables related to distress, respectively. Odds ratios (ORs) and 95% confidence intervals (CIs) were used to present the strength of the associations. Finally, the prediction of logistic model was assessed in form of the Receiver Operating Characteristic (ROC) curve and the area under the ROC curve (AUC). According to the referred cut-off point from K10, this study revealed that 65.2% (223/342) of the participants were categorized as having psychological distress. Both the stigma questionnaire and the K10 were proven to be reliable and valid in measurement. Further analysis found that experienced stigma and illness severity were significant variables to psychological distress in the model of logistic regression. The model was assessed well in predicting distress by use of experienced stigma and illness severity in form of ROC and AUC. Rural TB patients had a high prevalence of psychological distress. Experience of stigma played a significant role in psychological distress. To move the barrier of stigma from the surroundings could be a good strategy in reducing distress for the patients and TB controlling for public health management.

RT-06GAMMA KNIFE SURGERY AFTER NAVIGATION-GUIDED ASPIRATION FOR CYSTIC METASTATIC BRAIN TUMORS

PubMed Central

Chiba, Yasuyoshi; Mori, Kanji; Toyota, Shingo; Kumagai, Tetsuya; Yamamoto, Shota; Sugano, Hirofumi; Taki, Takuyu

2014-01-01

Metastatic brain tumors over 3 cm in diameter (volume of 14.1ml) are generally considered poor candidates for Gamma Knife surgery (GKS). We retrospectively assessed the method and efficacy of GKS for large cystic metastatic brain tumors after navigation-guided aspiration under local anesthesia. From September 2007 to April 2014, 38 cystic metastatic brain tumors in 32 patients (12 males, 20 females; mean age, 63.2 years) were treated at Kansai Rosai Hospital. The patients were performed navigation-guided cyst aspiration under local anesthesia, then at the day or the next day, were performed GKS and usually discharged on the day. The methods for preventing of leptomeningeal dissemination are following: 1) puncture from the place whose cerebral thickness is 1 cm or more; 2) avoidance of Ommaya reservoir implantation; and 3) placement of absorbable gelatin sponge to the tap tract. Tumor volume, including the cystic component, decreased from 25.4 ml (range 8.7-84.7 ml) to 11.4 ml (range 2.9-36.7 ml) following aspiration; the volume reduction was approximately 51.6%. Follow-up periods in the study population ranged from 0 to 24 months (median 3.5 months). The overall median survival was 6.7 months. There was no leptomeningeal dissemination related to the aspiration. One patient experienced radiation necrosis after GKS, one patient experienced re-aspiration by failure of aspiration, and two patients experienced surgical resections and one patient experienced re-aspiration by cyst regrowth after GKS. Long-term hospitalization is not desirable for the patients with brain metastases. In japan, Long-term hospitalization is required for surgical resection or whole brain radiation therapy, but only two days hospitalization is required for GKS after navigation-guided aspiration at our hospital. This GKS after navigation-guided aspiration is more effective and less invasive than surgical resection or whole brain radiation therapy.

Neuroscience education in addition to trigger point dry needling for the management of patients with mechanical chronic low back pain: A preliminary clinical trial.

PubMed

Téllez-García, Mario; de-la-Llave-Rincón, Ana I; Salom-Moreno, Jaime; Palacios-Ceña, Maria; Ortega-Santiago, Ricardo; Fernández-de-Las-Peñas, César

2015-07-01

The objective of the current study was to determine the short-term effects of trigger point dry needling (TrP-DN) alone or combined with neuroscience education on pain, disability, kinesiophobia and widespread pressure sensitivity in patients with mechanical low back pain (LBP). Twelve patients with LBP were randomly assigned to receive either TrP-DN (TrP-DN) or TrP-DN plus neuroscience education (TrP-DN + EDU). Pain intensity (Numerical Pain Rating Scale, 0-10), disability (Roland-Morris Disability Questionnaire-RMQ-, Oswestry Low Back Pain Disability Index-ODI), kinesiophobia (Tampa Scale of Kinesiophobia-TSK), and pressure pain thresholds (PPT) over the C5-C6 zygapophyseal joint, transverse process of L3 vertebra, second metacarpal, and tibialis anterior muscle were collected at baseline and 1-week after the intervention. Patients treated with TrP-DN + EDU experienced a significantly greater reduction of kinesiophobia (P = 0.008) and greater increases in PPT over the transverse process of L3 (P = 0.049) than those patients treated only with TrP-DN. Both groups experienced similar decreases in pain, ODI and RMQ, and similar increases in PPT over the C5/C6 joint, second metacarpal, and tibialis anterior after the intervention (all, P > 0.05). The results suggest that TrP-DN was effective for improving pain, disability, kinesiophobia and widespread pressure sensitivity in patients with mechanical LBP at short-term. The inclusion of a neuroscience educational program resulted in a greater improvement in kinesiophobia. Copyright © 2014 Elsevier Ltd. All rights reserved.

MORTALITY AFTER ACUTE MYOCARDIAL INFARCTION IN HOSPITALS THAT DISPROPORTIONATELY TREAT AFRICAN-AMERICANS

PubMed Central

Skinner, Jonathan; Chandra, Amitabh; Staiger, Douglas; Lee, Julie; McClellan, Mark

2006-01-01

Background African-Americans are more likely be seen by physicians with less clinical training or treated at hospitals with deficient times to acute reperfusion therapies. Less is known about differences in health outcomes. This paper compares risk-adjusted mortality following Acute Myocardial Infarction (AMI) between U.S. hospitals with high and low fractions of elderly black AMI patients. Methods and Results A prospective cohort study was performed for fee-for-service Medicare patients hospitalized for AMI during 1997–2001 (N = 1,136,736). Hospitals (N =4289) were classified into approximate deciles depending on the extent to which the hospital served the African-American population. The lowest category (12.5 percent of AMI patients) included hospitals without any African-American AMI admissions during 1997–2001. Decile 10 (10 percent of AMI patients) included hospitals with the highest fraction of black AMI patients (33.6 percent). The main outcome measures were 90-day and 30-day mortality following AMI. Patients admitted to hospitals disproportionately serving African-Americans experienced no greater level of morbidities or severity of the infarction. Yet hospitals in Decile 10 experienced risk-adjusted 90-day mortality rate of 23.7 percent (95% CI: 23.2–24.2) compared to 20.1 percent (95% CI: 19.7–20.4) in Decile 1 hospitals. Differences in outcomes between hospitals were not explained by income, hospital ownership status, hospital volume, Census region, urban status, or hospital surgical treatment intensity. Conclusions Risk-adjusted mortality following AMI is significantly higher in U.S. hospitals that disproportionately serve African-Americans. A reduction in overall mortality at these hospitals could reduce dramatically black-white disparities in health care outcomes. PMID:16246963

Extreme hepatic resections for the treatment of advanced hepatoblastoma: Are planned close margins an acceptable approach?

PubMed

Fonseca, Adriana; Gupta, Abha; Shaikh, Furqan; Ramphal, Raveena; Ng, Vicky; McGilvray, Ian; Gerstle, J Ted

2018-02-01

Orthotopic liver transplantation (OLT) is considered the standard for children with hepatoblastoma (HB) in whom complete surgical resection is not possible. However, OLT is not always available or feasible. To describe the outcome of children with HB who were initially deemed unresectable and underwent complex hepatectomy with planned close margins, and ultimately avoided OLT. Demographic data, surgical and pathologic details, and survival information were collected from children treated for HB between January 2010 to December 2015. Among six children (median age 12 months (3-41 months)), PRETEXT classification was III (n = 2), III/IV (n = 1), and IV (n = 3). Patients received a median of six cycles (range 4-7) of platinum-based induction chemotherapy; five received doxorubicin. Experienced pediatric surgeons performed extended right and left hepatectomy in five and one patients, respectively, with assistance of an experienced liver transplant surgeon (n = 4). Microscopic margins were positive (n = 2) and negative but close (n = 4; 2-5 mm). Two patients required vascular reconstruction of the vena cava. At median follow-up of 3.3 years (1.7-4.6 years), there was no evidence of local recurrence. One patient had recurrence of pulmonary disease 3 months after surgery. Patients with advanced HB treated with complex surgical resections with positive or close negative margins had good outcomes without OLT. We suggest that planned positive or close microscopic margins in highly selected HB patients may spare the morbidity of OLT and offer an alternative for those ineligible for OLT. Our experience illustrates the importance of a multidisciplinary team specialized in the management of liver tumors. © 2017 Wiley Periodicals, Inc.

An open comparative study of dispersible piroxicam versus soluble acetylsalicylic acid for the treatment of osteoarticular painful attack during sickle cell crisis.

PubMed

Eke, F U; Obamyonyi, A; Eke, N N; Oyewo, E A

2000-02-01

We compared the efficacy and tolerability of oral piroxicam 1 mg/kg/day with soluble aspirin given at 100 mg/kg/day taken four-hourly in 58 patients with sickle cell anaemia and severe ostcoarticular painful attacks requiring hospitalization in a randomized, paralleled study. Main investigational criteria were pain relief, limitation of movement, fever, and insomnia or agitation. Both groups were well-matched at the commencement of therapy but most patients on piroxicam showed remarkable and significant pain relief and improvement in other parameters within 24 h. Unwanted effects were absent in the piroxicam-treated group whereas those treated with aspirin experienced nausea and vomiting. There were no significant changes in liver function tests with both forms of treatment. Oral piroxicam is an effective and safe treatment in the management of the osteoarticular painful crisis in sickle cell anaemia. It might prevent the use of parenteral analgesics and hospitalization and reduce the loss of school hours in patients who are being treated for bone pain crises that characterize sickle cell anaemia.

Clinical characteristics of patients with treated epilepsy in Korea: a nationwide epidemiologic study.

PubMed

Kim, Dong Wook; Lee, Seo-Young; Chung, Soo-Eun; Cheong, Hae-Kwan; Jung, Ki-Young

2014-01-01

Although a number of epidemiologic studies have been conducted on the prevalence and incidence of epilepsy around the world, only a few studies have investigated the clinical characteristics of patients with epilepsy in a population-based sample. The purpose of the present study was to describe the clinical characteristics of treated patients with epilepsy in Korea via a nationwide medical records survey. The study population was obtained through a nationwide database registered to the Health Insurance Review and Assessment service. Patients were recruited from clinics and hospitals in each cluster according to region and referral level by random selection from a preallocated sample of patients. All patients were being treated with antiepileptic drug medication with or without a diagnosis code for epilepsy or seizure between January 2009 and December 2009. Among the 6,436 selected patients, 2,150 met the diagnostic criteria for epilepsy and were included in our survey on the clinical characteristics of patients who were with treated epilepsy. The proportion of male patients with epilepsy in this study was higher (1,226; 57.0%) than that of female patients. In addition, 10.6% of patients were first diagnosed with epilepsy in 2009, and 53.6% of patients experienced at least one seizure over the course of 2009; 78.1% were classified as having localization-related epilepsy, whereas 7.3% were considered to have generalized epilepsy. Thirty-five percent of patients were thus classified as idiopathic or cryptogenic cases. The most common cause of symptomatic epilepsy was trauma (10.0%), followed by stroke (9.6%), central nervous system (CNS) infection (5.7%), and hippocampal sclerosis (4.9%). This is the first nationwide study of the clinical characteristics of treated epilepsy in Korea using a national database validated by medical records survey. The etiologies of epilepsy and epilepsy syndrome classifications were comparable to those previously reported in other developed countries. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Guillain-Barré syndrome following chickenpox: a case series.

PubMed

Tatarelli, P; Garnero, M; Del Bono, V; Camera, M; Schenone, A; Grandis, M; Benedetti, L; Viscoli, C

2016-01-01

Guillain-Barré syndrome (GBS) is an acute, immune-mediated polyradiculoneuropathy, usually triggered by an infectious episode, mostly of viral origin. Varicella zoster virus (VZV) is a rare cause of GBS, mainly in the case of latent infection reactivation. We report on three adult patients who developed GBS following chickenpox, after a short period of latency. They were promptly treated with intravenous immunoglobulin, and the first one with plasma exchange additionally. All the patients experienced almost complete clinical recovery. Our experience suggests that primary VZV infection constitutes a GBS triggering event.

Genitourinary small-cell carcinoma: 11-year treatment experience.

PubMed

Chang, Kun; Dai, Bo; Kong, Yun-Yi; Qu, Yuan-Yuan; Gan, Hua-Lei; Gu, Wei-Jie; Ye, Ding-Wei; Zhang, Hai-Liang; Zhu, Yao; Shi, Guo-Hai

2014-01-01

The predictive factors of prognosis and treatment strategies for small-cell carcinoma (SCC) of the urinary tract are controversial. This study was aimed to investigate the clinical experience and management of patients with SCC of the urinary tract. We collected data of patients who were diagnosed with genitourinary SCC (GSCC) between 2002 and 2013 and were treated in the Fudan University Shanghai Cancer Center. A total of 18 patients were diagnosed with GSCC of which 10 originated from the prostate, seven from the bladder and one from the adrenal gland. The mean follow-up time was 15.5 months and progression-free survival (PFS) was 9.3 months. Primary tumor resection was attempted in 13 of 18 patients (72.2%) in whom radical surgery was performed in six of 14 (42.9%) limited disease patients. Most of the patients (13, 72.2%) received cisplatin-based chemotherapy. Patients who had normal lactic dehydrogenase (LDH) levels showed a significantly higher median PFS and overall survival (OS) compared with patients with high LDH levels (P = 0.030, P= 0.010). Patients with limited disease treated with a radical operation experienced a non-significant (P = 0.211) longer PFS compared with patients who were not treated, but this reached statistical significance after analyzing OS (P = 0.211, P= 0.039). Our patients showed a poor prognosis as reported previously. Serum LDH levels beyond the normal range indicate a poor prognosis. For GSCC patients who are diagnosed with limited disease, radical surgery is strongly recommended along with cisplatin-based chemotherapy.

Atezolizumab in platinum-treated locally advanced or metastatic urothelial carcinoma: post-progression outcomes from the phase II IMvigor210 study.

PubMed

Necchi, A; Joseph, R W; Loriot, Y; Hoffman-Censits, J; Perez-Gracia, J L; Petrylak, D P; Derleth, C L; Tayama, D; Zhu, Q; Ding, B; Kaiser, C; Rosenberg, J E

2017-12-01

Conventional criteria for tumor progression may not fully reflect the clinical benefit of immunotherapy or appropriately guide treatment decisions. The phase II IMvigor210 study demonstrated the efficacy and safety of atezolizumab, a programmed death-ligand 1-directed antibody, in patients with platinum-treated locally advanced or metastatic urothelial carcinoma. Patients could continue atezolizumab beyond Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 progression at the investigator's discretion: this analysis assessed post-progression outcomes in these patients. Patients were treated with atezolizumab 1200 mg i.v. every 3 weeks until loss of clinical benefit. Efficacy and safety outcomes in patients who experienced RECIST v1.1 progression and did, or did not, continue atezolizumab were analyzed descriptively. In total, 220 patients who experienced progression from the overall cohort (n = 310) were analyzed: 137 continued atezolizumab for ≥ 1 dose after progression, 19 received other systemic therapy, and 64 received no further systemic therapy. Compared with those who discontinued, patients continuing atezolizumab beyond progression were more likely to have had a baseline Eastern Cooperative Oncology Group performance status of 0 (43.1% versus 31.3%), less likely to have had baseline liver metastases (27.0% versus 41.0%), and more likely to have had an initial response to atezolizumab (responses in 11.7% versus 1.2%). Five patients (3.6%) continuing atezolizumab after progression had subsequent responses compared with baseline measurements. Median post-progression overall survival was 8.6 months in patients continuing atezolizumab, 6.8 months in those receiving another treatment, and 1.2 months in those receiving no further treatment. Atezolizumab exposure-adjusted adverse event frequencies were generally similar before and following progression. In this single-arm study, patients who continued atezolizumab beyond RECIST v1.1 progression derived prolonged clinical benefit without additional safety signals. Identification of patients most likely to benefit from atezolizumab beyond progression remains an important challenge in the management of metastatic urothelial carcinoma. NCT02108652. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Duodenal Atresia: Open versus MIS Repair-Analysis of Our Experience over the Last 12 Years.

PubMed

Chiarenza, Salvatore Fabio; Bucci, Valeria; Conighi, Maria Luisa; Zolpi, Elisa; Costa, Lorenzo; Fasoli, Lorella; Bleve, Cosimo

2017-01-01

Objective . Duodenal atresia (DA) routinely has been corrected by laparotomy and duodenoduodenostomy with excellent long-term results. We revisited the patients with DA treated in the last 12 years (2004-2016) comparing the open and the minimally invasive surgical (MIS) approach. Methods . We divided our cohort of patients into two groups. Group 1 included 10 patients with CDO (2004-09) treated with open procedure: 5, DA; 3, duodenal web; 2, extrinsic obstruction. Three presented with Down's syndrome while 3 presented with concomitant malformations. Group 2 included 8 patients (2009-16): 1, web; 5, DA; 2, extrinsic obstruction. Seven were treated by MIS; 1 was treated by Endoscopy. Three presented with Down's syndrome; 3 presented with concomitant malformations. Results . Average operating time was 120 minutes in Group 1 and 190 minutes in Group 2. In MIS Group the visualization was excellent. We recorded no intraoperative complications, conversions, or anastomotic leakage. Feedings started on 3-7 postoperative days. Follow-up showed no evidence of stricture or obstruction. In Group 1 feedings started within 10-22 days and we have 1 postoperative obstruction. Conclusions . Laparoscopic repair of DA is one of the most challenging procedures among pediatric laparoscopic procedures. These patients had a shorter length of hospitalization and more rapid advancement to full feeding compared to patients undergoing the open approach. Laparoscopic repair of DA could be the preferred technique, safe, and efficacious, in the hands of experienced surgeons.

Efficacy of postoperative prophylactic antibiotics in reducing permanent pacemaker infections.

PubMed

Lee, Wen-Huang; Huang, Ting-Chun; Lin, Li-Jen; Lee, Po-Tseng; Lin, Chih-Chan; Lee, Cheng-Han; Chao, Ting-Hsing; Li, Yi-Heng; Chen, Ju-Yi

2017-08-01

Despite limited evidence, postoperative prophylactic antibiotics are often used in the setting of permanent pacemaker implantation or replacement. The aim of this study is to investigate the efficacy of postoperative antibiotics. Postoperative prophylactic antibiotics may be not clinically useful. We recruited 367 consecutive patients undergoing permanent pacemaker implantation or generator replacement at a tertiary referral center. Baseline demographics, clinical characteristics, and procedure information were collected, and all patients received preoperative prophylactic antibiotics. Postoperative prophylactic antibiotics were administered at the discretion of the treating physician, and all patients were seen in follow-up every 3 to 6 months for an average follow-up period of 16 months. The primary endpoint was device-related infection. A total of 110 patients were treated with preoperative antibiotics only (group 1), whereas 257 patients received both preoperative and postoperative antibiotics (group 2). After a mean follow-up period of 16 months, 1 patient in group 1 (0.9%) and 4 patients in group 2 (1.5%) experienced a device-related infection. There was no significant difference in the rate of infection between the 2 groups (P = 0.624). In the univariate analysis, only the age (60 ± 11 vs 75 ± 12 years, P < 0.001) was significantly different between the infected and noninfected groups. In the multivariate analysis, younger age was an independent risk factor for infective complications (odds ratio = 1.08, P = 0.016). Patients treated with preoperative and postoperative antibiotics had a similar rate of infection as those treated with preoperative antibiotics alone. Further studies are needed to confirm these preliminary findings. © 2017 Wiley Periodicals, Inc.

Outcomes of uterine cervical cancer patients with pelvic lymph node metastases after radiotherapy without boost irradiation of metastases.

PubMed

Yoshizawa, Eriko; Koiwai, Keiichiro; Ina, Hironobu; Fukazawa, Ayumu; Sakai, Katsuya; Ozawa, Takesumi; Matsushita, Hirohide; Kadoya, Masumi

2017-04-01

The aim of this study was to evaluate the outcomes of uterine cervical cancer patients with pelvic lymph node (PLN) metastases after radiotherapy without boost irradiation of the metastases and to clarify the necessity of the boost irradiation of metastatic lesions. Thirty-two patients with uterine cervical cancer metastasizing only to the PLN were treated with definitive radiotherapy without boost irradiation of the metastases between 2008 and 2012 at our institution and were selected for this study. The pattern of progression, overall survival, and progression-free survival were analyzed. Ninety percent of the PLN metastases were controlled by radiotherapy. Twenty-two of 32 patients (69%) experienced progression. Distant metastases as initial progression were observed in 21 of these 22 patients (95%). Only two patients experienced failures in pre-treatment metastatic PLN as initial progression, along with other failures. Severe late lower gastrointestinal toxicities were not observed in any patients. Two-year cumulative overall survival and progression-free survival were 74% and 31%, respectively. Boost irradiation of PLN metastases is not necessarily indispensable. Further studies to examine the necessity of boost irradiation of PLN metastases in radiotherapy for uterine cervical cancer patients with metastases are required. © 2017 Japan Society of Obstetrics and Gynecology.

The Audible Pop from Thoracic Spine Thrust Manipulation and Its Relation to Short-Term Outcomes in Patients with Neck Pain

PubMed Central

Cleland, Joshua A.; Flynn, Timothy W.; Childs, John D.; Eberhart, Sarah

2007-01-01

Clinicians routinely consider the success of a thrust manipulation technique based on the presence or absence of an audible pop despite the lack of evidence suggesting that this pop is associated with improved outcomes. The purpose of this study was to determine the relationship between the number of audible pops with thoracic spinal manipulation and improvement in pain and function in patients with mechanical neck pain. In this prospective cohort study, 78 patients referred to physical therapy with mechanical neck pain underwent a standardized examination and thoracic spine manipulation treatment protocol. All patients were treated with a total of 6 thrust manipulation techniques directed to the thoracic spine followed by a basic cervical range of motion exercise. The treating clinician recorded the presence or absence of a pop during each manipulation. Outcomes were assessed at a 2–4 day follow-up with an 11-point numeric pain rating (NPRS), the Neck Disability Index, the patient Global Rating of Change (GROC), and measurements of cervical range of motion (CROM). The relationship between the number of pops and change scores for pain, disability, and CROM was first examined using Pearson correlation coefficients. Individuals were then categorized as having received ≤3 or >3 pops. Repeated measures analyses of variance were used to examine whether achievement of >3 pops resulted in improved outcome. Seventy-eight patients with a mean age of 42 (SD 11.3) years participated in the study. Pearson correlation coefficients revealed no significant correlation existed between the number of pops and outcomes with the exception of 3 of the 6 CROM measurements, which were inversely related. There was no significant interaction for group X time for any of the dependent measures (P>0.05). The odds ratio for patients experiencing dramatic improvement was in favor of the group experiencing ≤3 pops but this was not clinically meaningful (1.3: 95% CI 0.46, 3.7). The results of this analysis provide preliminary evidence for the hypothesis that there is no relationship between the number of audible pops during thoracic spine thrust manipulation and clinically meaningful improvements in pain, disability, or CROM in patients with mechanical neck pain. Additionally, a greater number of audible pops experienced was not associated with a dramatic improvement with manipulation treatment. PMID:19066662

Efficacy of Antibiotic Suppressive Therapy in Patients with a Prosthetic Joint Infection.

PubMed

Wouthuyzen-Bakker, Marjan; Nijman, Jasperina M; Kampinga, Greetje A; van Assen, Sander; Jutte, Paul C

2017-01-01

Introduction: For chronic prosthetic joint infections (PJI), complete removal of the infected prosthesis is necessary in order to cure the infection. Unfortunately, a subgroup of patients is not able to undergo a revision surgery due to high surgical risk. Alternatively, these patients can be treated with antibiotic suppressive therapy (AST) to suppress the infection. Aim: To evaluate the efficacy and tolerability of AST. Methods: We retrospectively collected data (period 2009-2015) from patients with a PJI (of hip, knee or shoulder) who were treated with AST at the University Medical Center Groningen, the Netherlands. AST was defined as antibiotic treatment for PJI that was started after the usual 3 months of antibiotic treatment. The time of follow-up was defined from the time point AST was started. Treatment was considered as failed, when the patient still experienced joint pain, when surgical intervention (debridement, removal, arthrodesis or amputation) was needed to control the infection and/or when death occurred due to the infection. Results: We included 21 patients with a median age of 67 years (range 21 - 88) and with a median follow-up of 21 months (range 3 - 81). Coagulase negative staphylococci (CNS) (n=6), S. aureus (n=6) and polymicrobial flora (n=4) were the most frequently found causative pathogens. Most patients with CNS and S. aureus were treated with minocycline (67%) and clindamycin (83%) as AST, respectively. Overall, treatment was successful in 67% of patients. Failure was due to persistent joint pain (n=1), surgical intervention because of an uncontrolled infection (n=3), and death due the infection (n=3). We observed a treatment success of 90% in patients with a 'standard' prosthesis (n=11), compared to only 50% in patients with a tumor-prosthesis (n=10). Also, treatment was successful in 83% of patients with a CNS as causative microorganism for the infection, compared to 50% in patients with a S. aureus . Patients who failed on AST had a higher ESR in comparison to patients with a successful treatment (mean 73 ± 25SD versus 32 ± 19SD mm/hour (p = 0.007), respectively. 43% of patients experienced side effects and led to a switch of antibiotic treatment or a dose adjustment in almost all of these patients. Conclusions: Removal of the implant remains first choice in patients with chronic PJI. However, AST is a reasonable alternative treatment option in a subgroup of patients with a PJI who are no candidate for revision surgery, in particular in patients with a 'standard' prosthesis and/or CNS as the causative micro-organism.

A lower starting dose of eltrombopag is efficacious in Japanese patients with previously treated chronic immune thrombocytopenia.

PubMed

Tomiyama, Y; Miyakawa, Y; Okamoto, S; Katsutani, S; Kimura, A; Okoshi, Y; Ninomiya, H; Kosugi, H; Nomura, S; Ozaki, K; Ikeda, Y; Hattori, T; Katsura, K; Kanakura, Y

2012-05-01

Eltrombopag is an oral, non-peptide thrombopoietin receptor agonist that has shown efficacy and safety in chronic immune thrombocytopenia (ITP). However, ethnic differences in eltrombopag exposure have been reported: area under the curve exposure to eltrombopag was 87% greater among ITP patients of East Asian descent than among ITP patients of non-East Asian ITP descent. To evaluate the efficacy and safety of eltrombopag by using, in Japanese ITP patients, lower starting (12.5 mg) and maximum (50 mg) doses of eltrombopag than the standard starting (50 mg) and maximum (75 mg) doses approved in the USA and Europe. We examined 23 Japanese patients with previously treated chronic ITP with a platelet count of < 30,000 μL(-1) in a multicenter study comprising a randomized, double-blind, placebo-controlled phase for 6-week evaluation (15 eltrombopag, and eight placebo) and an open-label phase for 6-month evaluation (23 eltrombopag). The response rate (platelet count of ≥ 50,000 μL(-1) ) at week 6 of the 6-week double-blind phase was 60% in eltrombopag-treated patients and 0% in placebo-treated patients. Ten of 23 patients (43.5%) responded for ≥ 75% of predefined assessment visits during the 6-month open-label phase. Notably, 22% (5/23) of patients responded to 12.5 mg of eltrombopag, which was administered within the first 3 weeks of eltrombopag treatment. Bleeding decreased with eltrombopag treatment as compared with baseline. Eltrombopag was generally well tolerated; one patient experienced a transient ischemic attack on day 9. Eltrombopag (12.5-50 mg) is effective for the management of Japanese patients with chronic ITP (NCT00540423). © 2012 International Society on Thrombosis and Haemostasis.

Analysis of Patients With Oligometastases Undergoing Two or More Curative-Intent Stereotactic Radiotherapy Courses

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

Milano, Michael T.; Philip, Abraham; Okunieff, Paul

2009-03-01

Purpose: A subset of patients treated with curative-intent stereotactic radiotherapy (RT) for limited metastases (defined as five lesions or fewer) develop local failure and/or a small number of new lesions. We hypothesized that these patients would remain amenable to curative-intent treatment with additional RT courses. Methods and Materials: Of 121 prospective patients with five lesions or fewer treated with stereotactic RT, 32 underwent additional RT courses for local failure (n = 9) and/or new lesions (n = 29). Ten patients underwent three or more courses of RT. Results: The treated local failures developed a median of 20 months after RTmore » completion. For the new oligometastases, the interval between the first and second RT course was 1-71 months (median, 8). Of the 32 patients undergoing multiple courses of curative-intent RT, the 2-year overall survival and progression-free survival rate was 65% and 54%, respectively. The corresponding 4-year rates were 33% and 28%. Compared with the 89 patients who underwent one RT course, these patients experienced a trend toward improved overall survival (median, 32 vs. 21 months, p = 0.13) and significantly greater progression-free survival (median, 28 vs. 9 months, p = 0.008). Conclusion: The results of our study have shown that patients fare well with respect to survival and disease control with aggressive RT for limited metastases, even after local failure and/or the development of new metastases. Although patients amenable to multiple courses of curative-intent RT are arguably selected for more indolent disease, our hypothesis-generating analysis supports the notion of aggressively treating limited metastases, which, in some patients, might be curable and/or represent a chronic disease state.« less

Postmarketing comparison of labetalol and propranolol in hypertensive patients.

PubMed

Due, D L; Giguere, G C; Plachetka, J R

1986-01-01

A survey was conducted to compare the safety and effectiveness of labetalol and propranolol under routine conditions of clinical use. Patients received either labetalol (n = 805) or propranolol (n = 135) twice daily, according to package insert instructions, for six weeks. Every two weeks the patients were evaluated and weight, heart rate, blood pressure, dose, and adverse symptoms were recorded. Both treatment groups experienced a significant decline in blood pressure at six weeks; blood pressure decreased by 24/15 mmHg in the labetalol patients and by 20/14 mmHg in the propranolol patients. Heart rate decreased significantly in both groups, but the drop in the propranolol group was greater than in the labetalol group. Significantly more propranolol-treated patients reported fatigue (15.2% versus 6.3%), impotence (9.0% versus 3.2%), bad dreams (2.3% versus 0.3%), and cold extremities (2.3% versus 0%). Dizziness was reported more frequently by the labetalol group (9.1% versus 3.8%). Overall, both drugs were safe and effective in treating hypertension, but complaints of beta-blocker-associated side effects were more frequent with propranolol.

Pharmacogenetics and induction/consolidation therapy toxicities in acute lymphoblastic leukemia patients treated with AIEOP-BFM ALL 2000 protocol.

PubMed

Franca, R; Rebora, P; Bertorello, N; Fagioli, F; Conter, V; Biondi, A; Colombini, A; Micalizzi, C; Zecca, M; Parasole, R; Petruzziello, F; Basso, G; Putti, M C; Locatelli, F; d'Adamo, P; Valsecchi, M G; Decorti, G; Rabusin, M

2017-01-01

Drug-related toxicities represent an important clinical concern in chemotherapy, genetic variants could help tailoring treatment to patient. A pharmacogenetic multicentric study was performed on 508 pediatric acute lymphoblastic leukemia patients treated with AIEOP-BFM 2000 protocol: 28 variants were genotyped by VeraCode and Taqman technologies, deletions of GST-M1 and GST-T1 by multiplex PCR. Toxicities were derived from a central database: 251 patients (49.4%) experienced at least one gastrointestinal (GI) or hepatic (HEP) or neurological (NEU) grade III/IV episode during the remission induction phase: GI occurred in 63 patients (12.4%); HEP in 204 (40.2%) and NEU in 44 (8.7%). Logistic regression model adjusted for sex, risk and treatment phase revealed that ITPA rs1127354 homozygous mutated patients showed an increased risk of severe GI and NEU. ABCC1 rs246240 and ADORA2A rs2236624 homozygous mutated genotypes were associated to NEU and HEP, respectively. These three variants could be putative predictive markers for chemotherapy-related toxicities in AIEOP-BFM protocols.

Vestibular rehabilitation in a patient with whiplash-associated disorders.

PubMed

Tuo, Kwo-Shieng; Cheng, Yuan-Yang; Kao, Chung-Lan

2006-12-01

Whiplash-associated disorders are characterized by multiple physical complaints after a flexion-extension trauma to the neck. They are difficult to treat, and they often result in great impact on the patient's quality of life. In this paper, the comprehensive treatment of a patient with whiplash-associated disorders is presented. The purpose is to highlight the importance of accurate diagnosis and appropriate treatment plans to improve patients' quality of life. This 23-year-old woman experienced a traffic accident which caused severely painful neck disability, numbness over bilateral upper limbs, dizziness, double vision and loss of balance. Among these symptoms, dizziness was the problem that bothered the patient most. She received a comprehensive rehabilitation program including physical modalities, trigger point injections for relief of pain, as well as a vestibular rehabilitation program, which included exercises challenging and improving her balance function, head-eye coordination exercise, visual-ocular control exercise and sensory substitution-promoting exercises. She resumed her previous full-time work after 3 weeks of treatment. This successfully treated case illustrates the importance of correct diagnosis and appropriate treatment for patients who suffer from whiplash-associated disorders.

Treatment of Oral Cavity Squamous Cell Carcinoma With Adjuvant or Definitive Intensity-Modulated Radiation Therapy

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

Sher, David J., E-mail: dsher@lroc.harvard.edu; Thotakura, Vijaya; Balboni, Tracy A.

2011-11-15

Purpose: The optimal management of oral cavity squamous cell carcinoma (OCSCC) typically involves surgical resection followed by adjuvant radiotherapy or chemoradiotherapy (CRT) in the setting of adverse pathologic features. Intensity-modulated radiation therapy (IMRT) is frequently used to treat oral cavity cancers, but published IMRT outcomes specific to this disease site are sparse. We report the Dana-Farber Cancer Institute experience with IMRT-based treatment for OCSCC. Methods and Materials: Retrospective study of all patients treated at Dana-Farber Cancer Institute for OCSCC with adjuvant or definitive IMRT between August 2004 and December 2009. The American Joint Committee on Cancer disease stage criteria distributionmore » of this cohort included 5 patients (12%) with stage I; 10 patients (24%) with stage II (n = 10, 24%),; 14 patients (33%) with stage III (n = 14, 33%),; and 13 patients (31%) with stage IV. The primary endpoint was overall survival (OS); secondary endpoints were locoregional control (LRC) and acute and chronic toxicity. Results: Forty-two patients with OCSCC were included, 30 of whom were initially treated with surgical resection. Twenty-three (77%) of 30 surgical patients treated with adjuvant IMRT also received concurrent chemotherapy, and 9 of 12 (75%) patients treated definitively without surgery were treated with CRT or induction chemotherapy and CRT. With a median follow-up of 2.1 years (interquartile range, 1.1-3.1 years) for all patients, the 2-year actuarial rates of OS and LRC following adjuvant IMRT were 85% and 91%, respectively, and the comparable results for definitive IMRT were 63% and 64% for OS and LRC, respectively. Only 1 patient developed symptomatic osteoradionecrosis, and among patients without evidence of disease, 35% experienced grade 2 to 3 late dysphagia, with only 1 patient who was continuously gastrostomy-dependent. Conclusions: In this single-institution series, postoperative IMRT was associated with promising LRC, OS, and lower late toxicity rates, and chemoradiotherapy was a successful treatment for patients with high-risk disease. In contrast, outcomes of radiation-based treatment for patients with inoperable locally advanced disease were markedly less successful.« less

The significance of HIV 'blips' in resource-limited settings: is it the same? analysis of the treat Asia HIV Observational Database (TAHOD) and the Australian HIV Observational Database (AHOD).

PubMed

Kanapathipillai, Rupa; McManus, Hamish; Kamarulzaman, Adeeba; Lim, Poh Lian; Templeton, David J; Law, Matthew; Woolley, Ian

2014-01-01

Magnitude and frequency of HIV viral load blips in resource-limited settings, has not previously been assessed. This study was undertaken in a cohort from a high income country (Australia) known as AHOD (Australian HIV Observational Database) and another cohort from a mixture of Asian countries of varying national income per capita, TAHOD (TREAT Asia HIV Observational Database). Blips were defined as detectable VL (≥ 50 copies/mL) preceded and followed by undetectable VL (<50 copies/mL). Virological failure (VF) was defined as two consecutive VL ≥50 copies/ml. Cox proportional hazard models of time to first VF after entry, were developed. 5040 patients (AHOD n = 2597 and TAHOD n = 2521) were included; 910 (18%) of patients experienced blips. 744 (21%) and 166 (11%) of high- and middle/low-income participants, respectively, experienced blips ever. 711 (14%) experienced blips prior to virological failure. 559 (16%) and 152 (10%) of high- and middle/low-income participants, respectively, experienced blips prior to virological failure. VL testing occurred at a median frequency of 175 and 91 days in middle/low- and high-income sites, respectively. Longer time to VF occurred in middle/low income sites, compared with high-income sites (adjusted hazards ratio (AHR) 0.41; p<0.001), adjusted for year of first cART, Hepatitis C co-infection, cART regimen, and prior blips. Prior blips were not a significant predictor of VF in univariate analysis (AHR 0.97, p = 0.82). Differing magnitudes of blips were not significant in univariate analyses as predictors of virological failure (p = 0.360 for blip 50-≤1000, p = 0.309 for blip 50-≤400 and p = 0.300 for blip 50-≤200). 209 of 866 (24%) patients were switched to an alternate regimen in the setting of a blip. Despite a lower proportion of blips occurring in low/middle-income settings, no significant difference was found between settings. Nonetheless, a substantial number of participants were switched to alternative regimens in the setting of blips.

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

Eriguchi, Takahisa; Takeda, Atsuya; Sanuki, Naoko

Purpose: To evaluate biliary toxicity after stereotactic body radiation therapy (SBRT) for liver tumors. Methods and Materials: Among 297 consecutive patients with liver tumors treated with SBRT of 35 to 50 Gy in 5 fractions, patients who were irradiated with >20 Gy to the central biliary system (CBS), including the gallbladder, and had follow-up times >6 months were retrospectively analyzed. Toxicity profiles, such as clinical symptoms and laboratory and radiologic data especially for obstructive jaundice and biliary infection, were investigated in relation to the dose volume and length relationship for each biliary organ. Results: Fifty patients with 55 tumors weremore » irradiated with >20 Gy to the CBS. The median follow-up period was 18.2 months (range, 6.0-80.5 months). In the dose length analysis, 39, 34, 14, and 2 patients were irradiated with >20 Gy, >30 Gy, >40 Gy, and >50 Gy, respectively, to >1 cm of the biliary tract. Seven patients were irradiated with >20 Gy to >20% of the gallbladder. Only 2 patients experienced asymptomatic bile duct stenosis. One patient, metachronously treated twice with SBRT for tumors adjacent to each other, had a transient increase in hepatic and biliary enzymes 12 months after the second treatment. The high-dose area >80 Gy corresponded to the biliary stenosis region. The other patient experienced biliary stenosis 5 months after SBRT and had no laboratory changes. The biliary tract irradiated with >20 Gy was 7 mm and did not correspond to the bile duct stenosis region. No obstructive jaundice or biliary infection was found in any patient. Conclusions: SBRT for liver tumors adjacent to the CBS was feasible with minimal biliary toxicity. Only 1 patient had exceptional radiation-induced bile duct stenosis. For liver tumors adjacent to the CBS without other effective treatment options, SBRT at a dose of 40 Gy in 5 fractions is a safe treatment with regard to biliary toxicity.« less

Whole Lung Irradiation for Adults With Pulmonary Metastases From Ewing Sarcoma

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

Casey, Dana L.; Alektiar, Kaled M.; Gerber, Naamit K.

Purpose: To evaluate feasibility and patterns of failure in adult patients with Ewing sarcoma (ES) treated with whole lung irradiation (WLI) for pulmonary metastases. Methods and Materials: Retrospective review of all ES patients treated at age 18 or older with 12-15 Gy WLI for pulmonary metastases at a single institution between 1990 and 2014. Twenty-six patients met the study criteria. Results: The median age at WLI was 23 years (range, 18-40). The median follow-up time of the surviving patients was 3.8 years (range, 1.0-9.6). The 3-year cumulative incidence of pulmonary relapse (PR) was 55%, with a 3-year cumulative incidence of PR as themore » site of first relapse of 42%. The 3-year event-free survival (EFS) and overall survival (OS) were 38 and 45%, respectively. Patients with exclusively pulmonary metastases had better outcomes than did those with extrapulmonary metastases: the 3-year PR was 45% in those with exclusively lung metastases versus 76% in those with extrapulmonary metastases (P=.01); the 3-year EFS was 49% versus 14% (P=.003); and the 3-year OS was 61% versus 13% (P=.009). Smoking status was a significant prognostic factor for EFS: the 3-year EFS was 61% in nonsmokers versus 11% in smokers (P=.04). Two patients experienced herpes zoster in the radiation field 6 and 12 weeks after radiation. No patients experienced pneumonitis or cardiac toxicity, and no significant acute or late sequelae were observed among the survivors. Conclusion: WLI in adult patients with ES and lung metastases is well tolerated and is associated with freedom from PR of 45% at 3 years. Given its acceptable toxicity and potential therapeutic effect, WLI for pulmonary metastases in ES should be considered for adults, as it is in pediatric patients. All patients should be advised to quit smoking before receiving WLI.« less

[Accelerated desensitization for hymenoptera venom allergy in 30 hours: efficacy and safety in 150 cases].

PubMed

van der Brempt, X; Ledent, C; Mairesse, M

1997-06-01

In this study, we performed 150 desensitizations in 139 Hymenoptera venom allergic patients (109 Yellow jacket allergic patients, 19 Honey bee allergic patients and 11 patients sensitized to both insects, who received a dual desensitization). We used a rush protocol, allowing injection of a total cumulated dose of 125,1 (Honey bee) to 175,1 (Yellow jacket) microgram of venom in 30 hours. Patients were hospitalized, with all emergency precautions for treating systemic reactions. The protocol was well tolerated in 147/150 cases; 3 patients had a benign systemic reaction. Patients received monthly maintenance doses of 100 micrograms venom. 39 patients experienced a field sting during immunotherapy; 2 of them (5%) had a benign systemic reaction. Thus, our rush desensitization protocol seems to be safe and effective.

Optic neuritis occurring with anti‐tumour necrosis factor α therapy

PubMed Central

Simsek, Ismail; Erdem, Hakan; Pay, Salih; Sobaci, Gungor; Dinc, Ayhan

2007-01-01

Objective Various demyelinating disorders have been reported in association with anti‐tumour necrosis factor α (TNFα) agents. The objective of this study was to review the occurrence, clinical features and outcome of optic neuritis (ON) during treatment with anti‐TNFα agents. Methods A PubMed search was conducted to identify literature addressing the potential association between anti‐TNFα agents and ON, following our experience with a patient having rheumatoid arthritis in whom ON developed while being treated with infliximab. Results 15 patients including the case presented here with ON in whom the symptoms developed following TNFα antagonist therapy were evaluated. Eight of these patients had received infliximab, five had received etanercept and two patients had received adalimumab. Among them, nine patients experienced complete resolution, and two patients had partial resolution, while four patients continued to have symptoms. Discussion Patients being treated with a TNFα antagonist should be closely monitored for the development of ophthalmological or neurological signs and symptoms. Furthermore, consideration should be given to avoiding such therapies in patients with a history of demyelinating disease. If clinical evaluation leads to the diagnosis of ON, discontinuation of the medication and institution of steroid treatment should be a priority. PMID:17456525

Aesthetic Refinements in Patients with Prominent Eyes.

PubMed

Richter, Dirk F; Schwaiger, Nina; Wiedner, Maria

2015-12-01

The treatment of prominent eyes is still a challenging task. As well as the surgery, proper preoperative diagnosis differentiating between patients with and without Graves ophthalmopathy plays an important role. In functionally asymptomatic patients with Graves disease suffering from the aesthetic impairment of prominent eyes, the transpalpebral decompression by intraorbital fat removal technique has been proved to be reliable, effective, safe, and easily performed by a trained and experienced oculoplastic surgeon. This technique provides long-lasting results, leading to improvement not only in visual function but also in personal well-being and in the patient's social life, with a high benefit-to-risk ratio. The most powerful tool to treat the lower lid deformity and malar bags in patients without Graves disease is the subperiosteal midface lift. It shortens the lid-cheek junction and blends the retaining periorbital ligaments. Furthermore, it adds volume to the lower lid and gives a stable support. By the nature of the procedure, it also turns a negative into a positive vector. In experienced hands, Olivari's orbital decompression and Hester's midface lift are ideal options for the treatment of prominent eyes. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated systemic vasculitis with high-dose intravenous immunoglobulin.

PubMed

Richter, C; Schnabel, A; Csernok, E; De Groot, K; Reinhold-Keller, E; Gross, W L

1995-07-01

In this uncontrolled study 15 patients with ANCA-associated systemic vasculitis, who were poor responders to conventional therapy, were treated with single or multiple courses of intravenous immunoglobulin (IVIG), 30 g/day over 5 days. Clinical and serological evaluation was performed before and 4 weeks after IVIG. Six of the 15 patients experienced clinically significant benefit from IVIG. Improvement was confined to single organ manifestations (skin, ENT findings), no improvement was seen with conjunctivitis and scleritis, pericarditis or nephritis. No patient experienced complete remission after IVIG. Repeated courses of IVIG at 4-week intervals were no more effective than single courses. In six anti-proteinase 3 (PR3)-positive patients pretreatment sera were incubated with F(ab')2 fragments of the IVIG preparation in vitro to measure the inhibitory effect of IVIG on anti-PR3 activity. An inhibition of anti-PR3 activity by 25-70% was observed; this did not correlate with clinical effects. Approximately 40% of patients benefited from IVIG treatment, though complete remission of disease activity did not occur. Neither clinical characteristics nor the inhibitory effect of the IVIG preparation on serum anti-PR3 activity in vitro predicted clinical response to this treatment modality.

Clinical outcomes of patients treated with a second course of stereotactic radiosurgery for locally or regionally recurrent brain metastases after prior stereotactic radiosurgery.

PubMed

Kim, Daniel H; Schultheiss, Timothy E; Radany, Eric H; Badie, Behnam; Pezner, Richard D

2013-10-01

Patients with metastatic disease are living longer and may be confronted with locally or regionally recurrent brain metastases (BM) after prior stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT). This study analyzes outcomes in patients without prior whole brain radiotherapy (WBRT) who were treated with a second course of SRS/FSRT for locally or regionally recurrent BM. We identified 32 patients at our institution who were treated with a second course of SRS/FSRT after initial SRS/FSRT for newly diagnosed BM. We report clinical outcomes including local control, survival, and toxicities. Control rates and survival were calculated using Kaplan-Meier analysis and the multivariate proportional hazards model. The Kaplan-Meier estimate of local control at 6 months was 77 % for targets treated by a second course of SRS/FSRT with 11/71 (15 %) targets experiencing local failure. Multivariate analysis shows that upon re-treatment, local recurrences were more likely to fail than regional recurrences (OR 8.8, p = 0.02). Median survival for all patients from first SRS/FSRT was 14.6 months (5.3-72.2 months) and 7.9 months (0.7-61.1 months) from second SRS/FSRT. Thirty-eight percent of patients ultimately received WBRT as salvage therapy after the second SRS/FSRT. Seventy-one percent of patients died without active neurologic symptoms. The present study demonstrates that the majority of patients who progress after SRS/FSRT for newly diagnosed BM are candidates for salvage SRS/FSRT. By reserving WBRT for later salvage, we believe that a significant proportion of patients can avoid WBRT all together, thus putting fewer patients at risk for neurocognitive toxicity.

The impact of body mass index on inpatient- versus outpatient-treated chronic obstructive pulmonary disease exacerbations.

PubMed

Jacob, Ariane; Laurin, Catherine; Lavoie, Kim L; Moullec, Gregory; Boudreau, Maxine; Lemière, Catherine; Bacon, Simon

2013-01-01

Increased body weight has been associated with worse prognoses for many chronic diseases; however, this relationship is less clear in patients with chronic obstructive pulmonary disease (COPD), with underweight patients experiencing higher morbidity than normal or overweight patients. To assess the impact of body mass index (BMI) on the risk for COPD exacerbations. The present study included 115 patients with stable COPD (53% women; mean [± SD] age 67±8 years). Height and weight were measured to calculate BMI. Patients were followed for a mean of 1.8±0.8 years to assess the prospective risk of inpatient-treated exacerbations and outpatient-treated exacerbations, all of which were verified by chart review. Cox regression models revealed that underweight patients were at greater risk for inhospital-treated exacerbations (RR 2.93 [95% CI 1.27 to 6.76) relative to normal weight patients. However, overweight (RR 0.59 [95% CI 0.33 to 1.57) and obese (RR 0.99 [95% CI 0.53 to 1.86]) patients did not differ from normal weight patients. All analyses were adjusted for age, sex, length of diagnosis, smoking pack-years, forced expiratory volume in 1 s, and time between recruitment and last exacerbation. BMI did not influence the risk of out-of-hospital exacerbations. The present study showed that underweight patients were at greater risk for inhospital exacerbations. However, BMI did not appear to be a risk factor for out-of-hospital exacerbations. This suggests that the BMI-exacerbation link may differ according to the nature of the exacerbation, the mechanisms for which are not yet known.

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

Smith, Benjamin D., E-mail: bsmith3@mdanderson.org; Bentzen, Soren M.; Correa, Candace R.

Purpose: In patients with early-stage breast cancer treated with breast-conserving surgery, randomized trials have found little difference in local control and survival outcomes between patients treated with conventionally fractionated (CF-) whole breast irradiation (WBI) and those receiving hypofractionated (HF)-WBI. However, it remains controversial whether these results apply to all subgroups of patients. We therefore developed an evidence-based guideline to provide direction for clinical practice. Methods and Materials: A task force authorized by the American Society for Radiation Oncology weighed evidence from a systematic literature review and produced the recommendations contained herein. Results: The majority of patients in randomized trials weremore » aged 50 years or older, had disease Stage pT1-2 pN0, did not receive chemotherapy, and were treated with a radiation dose homogeneity within {+-}7% in the central axis plane. Such patients experienced equivalent outcomes with either HF-WBI or CF-WBI. Patients not meeting these criteria were relatively underrepresented, and few of the trials reported subgroup analyses. For patients not receiving a radiation boost, the task force favored a dose schedule of 42.5 Gy in 16 fractions when HF-WBI is planned. The task force also recommended that the heart should be excluded from the primary treatment fields (when HF-WBI is used) due to lingering uncertainty regarding late effects of HF-WBI on cardiac function. The task force could not agree on the appropriateness of a tumor bed boost in patients treated with HF-WBI. Conclusion: Data were sufficient to support the use of HF-WBI for patients with early-stage breast cancer who met all the aforementioned criteria. For other patients, the task force could not reach agreement either for or against the use of HF-WBI, which nevertheless should not be interpreted as a contraindication to its use.« less

The Bruton tyrosine kinase inhibitor ibrutinib with chemoimmunotherapy in patients with chronic lymphocytic leukemia

PubMed Central

Barrientos, Jacqueline C.; Barr, Paul M.; Flinn, Ian W.; Burger, Jan A.; Tran, Anh; Clow, Fong; James, Danelle F.; Graef, Thorsten; Friedberg, Jonathan W.; Rai, Kanti; O’Brien, Susan

2015-01-01

The safety and efficacy of ibrutinib, an oral inhibitor of Bruton tyrosine kinase, were evaluated with chemoimmunotherapy (CIT) in a multicenter phase 1b study. Patients with relapsed/refractory chronic lymphocytic leukemia received bendamustine and rituximab (BR) or fludarabine, cyclophosphamide, and rituximab (FCR) for up to 6 cycles with daily ibrutinib (420 mg) until progressive disease or unacceptable toxicity. Enrollment to FCR-ibrutinib closed early due to a lack of fludarabine-naïve previously treated patients. No patients treated with BR-ibrutinib (n = 30) or FCR-ibrutinib (n = 3) experienced prolonged hematologic toxicity in cycle 1 (primary end point). Tolerability was as expected with either CIT or single-agent ibrutinib. The overall response rate (ORR) with BR-ibrutinib was 93.3%, including 16.7% complete responses (CRs) initially, which increased to 40% with the extension period. Including 1 patient with partial response with lymphocytosis, the best ORR was 96.7%. Sixteen of 21 patients with baseline cytopenias had sustained hematologic improvement. At 12 and 36 months, 86.3% and 70.3% remained progression-free, respectively. All 3 patients treated with ibrutinib-FCR achieved CR. Ibrutinib may enhance CIT efficacy without additive toxicities, providing the rationale for studying this combination in an ongoing phase 3 trial. The study is registered to www.clinicaltrials.gov as #NCT01292135. PMID:25755291

Medium-term follow-up after deployment of ultraflex expandable metallic stents to manage endobronchial pathology.

PubMed

Madden, Brendan P; Park, John E S; Sheth, Abhijat

2004-12-01

Between March 1997 and March 2004 we deployed 80 Ultraflex metallic expandable stents (Boston Scientific, Waterson, MA) in 69 patients under direct vision using rigid bronchoscopy. We report our medium- to long-term experience in patients for whom these stents were deployed. To date 15 patients have been followed for more than 1 year (median 41 months, range 12 to 83 months) after stent deployment. Indications for stenting in these patients were neoplasia (5), stricture (5), airway malacia (1), iatrogenic tracheal tear (1), and compression from an aortic aneurysm (1), a right interrupted aortic arch (1), and a right brachiocephalic artery aneurysm with tracheomalacia (1). Ten tracheal stents (9 covered, 1 uncovered) and 10 bronchial stents (8 uncovered, 2 covered) were inserted, and 5 patients received two stents. Five of these patients experienced no long-term problems. Complications included troublesome halitosis (5), which was difficult to treat despite various antibiotic regimes; granulation tissue formation above and below the stent that was successfully treated with low-power Nd:YAG laser therapy (7); and metal fatigue (1). We did not encounter stent migration. We conclude that Ultraflex expandable metallic stents have an important role in the management of selected patients with diverse endobronchial pathologies and are well tolerated in the long-term. Although associated granulation tissue can be successfully treated with Nd:YAG laser, halitosis can be a difficult problem to address.

The Bruton tyrosine kinase inhibitor ibrutinib with chemoimmunotherapy in patients with chronic lymphocytic leukemia.

PubMed

Brown, Jennifer R; Barrientos, Jacqueline C; Barr, Paul M; Flinn, Ian W; Burger, Jan A; Tran, Anh; Clow, Fong; James, Danelle F; Graef, Thorsten; Friedberg, Jonathan W; Rai, Kanti; O'Brien, Susan

2015-05-07

The safety and efficacy of ibrutinib, an oral inhibitor of Bruton tyrosine kinase, were evaluated with chemoimmunotherapy (CIT) in a multicenter phase 1b study. Patients with relapsed/refractory chronic lymphocytic leukemia received bendamustine and rituximab (BR) or fludarabine, cyclophosphamide, and rituximab (FCR) for up to 6 cycles with daily ibrutinib (420 mg) until progressive disease or unacceptable toxicity. Enrollment to FCR-ibrutinib closed early due to a lack of fludarabine-naïve previously treated patients. No patients treated with BR-ibrutinib (n = 30) or FCR-ibrutinib (n = 3) experienced prolonged hematologic toxicity in cycle 1 (primary end point). Tolerability was as expected with either CIT or single-agent ibrutinib. The overall response rate (ORR) with BR-ibrutinib was 93.3%, including 16.7% complete responses (CRs) initially, which increased to 40% with the extension period. Including 1 patient with partial response with lymphocytosis, the best ORR was 96.7%. Sixteen of 21 patients with baseline cytopenias had sustained hematologic improvement. At 12 and 36 months, 86.3% and 70.3% remained progression-free, respectively. All 3 patients treated with ibrutinib-FCR achieved CR. Ibrutinib may enhance CIT efficacy without additive toxicities, providing the rationale for studying this combination in an ongoing phase 3 trial. The study is registered to www.clinicaltrials.gov as #NCT01292135. © 2015 by The American Society of Hematology.

[Premenstrual Dysphoric Disorder (PMDD)].

PubMed

Yamada, Kazuo

2015-01-01

Premenstrual dysphoric disorder (PMDD) is categorized as a subclass in depressive disorders of DSM-5. Speaking without fear of misunderstanding, my opinion is that patients with PMDD should be treated with medication, if there is no misdiagnosis as premenstrual syndrome (PMS). For the appropriate treatment of PMDD, it must be diagnosed accurately according to the DSM-5 criteria. The differential diagnosis and treatment of PMDD should be carried out by experienced psychiatrists.

Molecular Solutions to Low Vision Resulting from Battlefield Injuries

DTIC Science & Technology

2011-02-01

optic nerve regeneration; (5) dry eye by determining how to minimize dry eye after LASIK refractive surgery by developing new tests to predict pre...experienced acute, non-granulomatous anterior uveitis OS 2 weeks following uncomplicated LASIK . The subject was treated with Prednisolone Acetate 1.0...studied. • Enrolled 146 subjects for LASIK or PRK completing our patient enrollment. • Performed analysis of tear film before and after surgery using

Recurrent Fever Syndromes in Patients After Recovery From Kawasaki Syndrome

PubMed Central

Tremoulet, Adriana H.; Burns, Jane C.; Bastian, John F.; Hoffman, Hal M.

2011-01-01

The recurrence of fever in a child with a history of Kawasaki syndrome (KS) poses a dilemma for clinicians who must consider the possibility of recurrent KS. In this report we present the cases of 4 patients who presented with classical symptoms of KS, were successfully treated with intravenous immunoglobulin, and later experienced a reappearance of inflammatory symptoms in a pattern consistent with a recurrent fever syndrome. The association of these syndromes within the same patient suggests that some patients may have a genetic propensity toward altered immune responses and autoinflammatory syndromes. We propose that these 2 syndromes exist within a family of febrile disorders related to innate immune dysregulation. PMID:21220401

ACTH Antibodies in Patients Receiving Depot Porcine ACTH to Hasten Recovery from Pituitary-Adrenal Suppression*

PubMed Central

Fleischer, Norman; Abe, Kaoru; Liddle, Grant W.; Orth, David N.; Nicholson, Wendell E.

1967-01-01

Six patients who had experienced prolonged steroid-induced pituitary-adrenal suppression were treated with 100 U of depot procine ACTH every 2 to 4 days for several months. Such treatment did not hasten the recovery of normal pituitary-adrenal function compared with the rate of recovery of a group of similarly suppressed patients who received no depot ACTH. Eight of nine patients who received prolonged courses of depot porcine ACTH developed antibodies to ACTH that cross-reacted with endogenous ACTH, binding it in the circulation in inactive form and retarding its removal from the circulation. The presence of such antibodies did not in itself grossly alter pituitary-adrenal interrelationships. Images PMID:4289551

Epinephrine-induced pulmonary edema during hip arthroscopy: a report of two cases and a review of the literature.

PubMed

Belkin, Nicole S; Degen, Ryan M; Liguori, Gregory A; Kelly, Bryan T

2017-09-01

Hip arthroscopy utilization has significantly increased in recent years. While it is a relatively safe procedure, it is not without risk. Life-threatening complications, albeit rare, can potentially occur and must be appropriately recognized and treated. We describe 2 cases in which patients' undergoing hip arthroscopy developed pulmonary edema and their respective courses of treatment. Both patients were being treated for symptomatic femoroacetabular impingement (FAI), with labral tears, requiring operative management after a failed trial of conservative management. The complication occurred during a primary hip arthroscopy procedure and a retrospective review of their clinical records and intra-operative notes was performed. Hip arthroscopy was performed under spinal anesthetic in the supine position in both patients. In both procedures, patients developed severe hypertension and tachycardia, with subsequent oxygen desaturations with noted pulmonary edema. The postulated etiology was systemic effects from intra-articular epinephrine, causing acute pulmonary edema with corresponding cardiovascular changes. With supportive ventilation, selective alpha-adrenergic blocker and furosemide administration, and cessation of epinephrine exposure, vital signs normalized and both patients experienced symptom resolution. During arthroscopy, if acute hypertension, tachycardia and hypoxia develop, epinephrine-induced pulmonary edema should be considered as a cause by the treating orthopedic surgeon and anesthesiologist in order to initiate an appropriate treatment plan.

Benign orbital apex tumors treated with multisession gamma knife radiosurgery.

PubMed

Goh, Alice Siew Ching; Kim, Yoon-Duck; Woo, Kyung In; Lee, Jung-Il

2013-03-01

The orbital apex is an important anatomic landmark that hosts numerous critical neurovascular structures. Tumor resection performed at this complex region poses a therapeutic challenge to orbital surgeons and often is associated with significant visual morbidity. This article reports the efficacy and safety of multisession gamma knife radiosurgery (GKRS) in benign, well-circumscribed tumors located at the orbital apex. Retrospective interventional case series. Five patients with visual disturbances resulting from a benign, well-circumscribed orbital apex tumor (3 cases of cavernous hemangioma and 2 cases of schwannoma). Each patient treated with GKRS with a total radiation dose of 20 Gy in 4 sessions (5 Gy in each session with an isodose line of 50%) delivered to the tumor margin. Best-corrected visual acuity, visual field changes, orbital imaging, tumor growth control, and side effects of radiation. All patients demonstrated improvement in visual acuity, pupillary responses, color vision, and visual field. Tumor shrinkage was observed in all patients and remained stable until the last follow-up. No adverse events were noted during or after the radiosurgery. None of the patients experienced any radiation-related ocular morbidity. From this experience, multisession GKRS seems to be an effective management strategy to treat solitary, benign, well-circumscribed orbital apex tumors. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Two-Stage Thoracoscopic Repair of Long-Gap Esophageal Atresia Using Internal Traction Is Safe and Feasible.

PubMed

Tainaka, Takahisa; Uchida, Hiroo; Tanano, Akihide; Shirota, Chiyoe; Hinoki, Akinari; Murase, Naruhiko; Yokota, Kazuki; Oshima, Kazuo; Shirotsuki, Ryo; Chiba, Kosuke; Amano, Hizuru; Kawashima, Hiroshi; Tanaka, Yujiro

2017-01-01

The treatment of long-gap esophageal atresia remains an issue for pediatric surgeons. Many techniques for treating long-gap esophageal atresia have been proposed, but the optimal method has not been established. The thoracoscopic esophageal elongation technique has recently been developed. We previously reported a case in which two-stage thoracoscopic repair was performed using internal esophageal traction without esophageal tearing, and we retrospectively reviewed the outcomes of this procedure in this study. Five patients underwent thoracoscopic treatment involving internal esophageal traction for esophageal atresia involving a long gap or vascular ring over a 5-year period. Between November 2010 and November 2015, 5 patients were treated with thoracoscopic traction. All of these patients successfully underwent thoracoscopic-delayed primary anastomosis. Conversion to open thoracotomy was not required in any case. The postoperative complications experienced by the patients included minor anastomotic leakage in 2 cases, anastomotic stenosis in 1 case, gastroesophageal reflux (GER) in 4 cases, and a hiatal hernia in 1 case. None of the patients died. Two-stage thoracoscopic repair for esophageal atresia involving a long gap or vascular ring is a safe and feasible procedure; however, we must develop methods for treating minor anastomotic complications and GER due to esophageal traction in future.

A Case Report: Subanesthetic Ketamine Infusion for Treatment of Cancer-Related Pain Produces Urinary Urge Incontinence.

PubMed

Vickers, Barbara A; Lee, Wayne; Hunsberger, Joann

2017-05-01

Oncology patients undergoing treatment can experience substantial pain related to their disease or prescribed therapy. Ketamine infusions at subanesthetic doses have been used at our institution to supplement the pain management regimens of 262 patients. We present 2 cases in which young adult patients being treated with subanesthetic ketamine for cancer-related pain experienced urinary urgency and incontinence after initiation or increase of the ketamine infusion. This adverse effect has not been reported previously at this dosing range. These case reports suggest that subanesthetic ketamine infusions may cause side effects that previously have been reported only at anesthetic or abuse doses.

Phase I Results of Vinorelbine With Concurrent Radiotherapy in Elderly Patients With Unresectable, Locally Advanced Non-Small-Cell Lung Cancer: West Japan Thoracic Oncology Group (WJTOG3005-DI)

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

Harada, Hideyuki, E-mail: h.harada@scchr.jp; Seto, Takashi; Igawa, Satoshi

Purpose: To investigate the safety and efficacy of concurrent vinorelbine and thoracic radiotherapy in elderly patients with locally advanced non-small-cell lung cancer (NSCLC). Methods and Materials: Eligible patients were 71 years of age or older with unresectable Stage III NSCLC. Patients were treated with thoracic radiotherapy (60 Gy) and concurrent vinorelbine (20 mg/m{sup 2} in Level 1 and 25 mg/m{sup 2} in Level 2) on Days 1 and 8 every 3 weeks for two cycles, followed by adjuvant vinorelbine (25 mg/m{sup 2}) on Days 1 and 8 every 3 weeks for two cycles. Results: Four patients were enrolled at Levelmore » 1. One patient experienced Grade 3 febrile neutropenia at Level 1 and the dose was escalated to Level 2. At Level 2, 2 of 6 patients experienced dose-limiting toxicities (Grade 4 neutropenia in 1 patient and Grade 3 infection in another). Three of 6 patients developed late Grade 2 or 3 pneumonitis. Therefore, the dose was de-escalated to Level 1. An additional 6 patients were enrolled at Level 1, 4 of whom experienced dose-limiting toxicities (incomplete radiotherapy because of Grade 2 pneumonitis in 1 patient and Grade 3 infection in 1, Grade 3 febrile neutropenia in 1, and Grade 3 esophagitis in 1). Moreover, late Grade 3 pneumothorax and Grade 5 pneumonitis occurred in 1 and 1 patient, respectively. Overall, Grade 2, 3 and 5 pneumonitis occurred in 3, 3, and 1 among 16 patients, respectively. Conclusions: Concurrent vinorelbine and thoracic radiotherapy resulted in a high incidence of severe pneumonitis when the standard dose of this agent was used for elderly patients. We therefore recommend caution in the use of this regimen and schedule for elderly patients.« less

The Icatibant Outcome Survey: treatment of laryngeal angioedema attacks

PubMed Central

Aberer, Werner; Bouillet, Laurence; Caballero, Teresa; Maurer, Marcus; Fabien, Vincent; Zanichelli, Andrea

2016-01-01

Objective To characterize the management and outcomes of life-threatening laryngeal attacks of hereditary angioedema (HAE) treated with icatibant in the observational Icatibant Outcome Survey (NCT01034969) registry. Methods This retrospective analysis was based on data from patients with HAE type I/II who received healthcare professional-administered or self-administered icatibant to treat laryngeal attacks between September 2008 and May 2013. Results Twenty centers in seven countries contributed data. Overall, 42 patients with HAE experienced 67 icatibant-treated laryngeal attacks. Icatibant was self-administered for 62.3% of attacks (healthcare professional-administered, 37.7%). One icatibant injection was used for 87.9% of attacks, with rescue or concomitant medication used for 9.0%. The median time to treatment was 2.0 h (n=31 attacks) and the median time to resolution was 6.0 h (n=35 attacks). Conclusions This analysis describes successful use of icatibant for the treatment of laryngeal HAE attacks in a real-world setting. PMID:27116379

Transurethral Resection of the Prostate (TURP) Versus Original and PErFecTED Prostate Artery Embolization (PAE) Due to Benign Prostatic Hyperplasia (BPH): Preliminary Results of a Single Center, Prospective, Urodynamic-Controlled Analysis

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

Carnevale, Francisco C., E-mail: fcarnevale@uol.com.br; Iscaife, Alexandre, E-mail: iscaifeboni@yahoo.com.br; Yoshinaga, Eduardo M., E-mail: dumuracca@ig.com.br

PurposeTo compare clinical and urodynamic results of transurethral resection of the prostate (TURP) to original and PErFecTED prostate artery embolization (PAE) methods for benign prostatic hyperplasia.MethodsWe prospectively randomized 30 patients to receive TURP or original PAE (oPAE) and compared them to a cohort of patients treated by PErFecTED PAE, with a minimum of 1-year follow-up. Patients were assessed for urodynamic parameters, prostate volume, international prostate symptom score (IPSS), and quality of life (QoL).ResultsAll groups were comparable for all pre-treatment parameters except bladder contractility and peak urine flow rate (Q{sub max}), both of which were significantly better in the TURP group,more » and IIEF score, which was significantly higher among PErFecTED PAE patients than TURP patients. All groups experienced significant improvement in IPSS, QoL, prostate volume, and Q{sub max}. TURP and PErFecTED PAE both resulted in significantly lower IPSS than oPAE but were not significantly different from one another. TURP resulted in significantly higher Q{sub max} and significantly smaller prostate volume than either original or PErFecTED PAE but required spinal anesthesia and hospitalization. Two patients in the oPAE group with hypocontractile bladders experienced recurrence of symptoms and were treated with TURP. In the TURP group, urinary incontinence occurred in 4/15 patients (26.7 %), rupture of the prostatic capsule in 1/15 (6.7 %), retrograde ejaculation in all patients (100 %), and one patient was readmitted for temporary bladder irrigation due to hematuria.ConclusionsTURP and PAE are both safe and effective treatments. TURP and PErFecTED PAE yield similar symptom improvement, but TURP is associated with both better urodynamic results and more adverse events.« less

Acne keloidalis nuchae in Asian: A single institutional experience

PubMed Central

Na, Kiyong; Oh, Sang Ho

2017-01-01

Acne keloidalis nuchae, a type of folliculitis involving the back of the neck, is common in black men, although rare cases have been reported in patients of other ethnicities. We analyzed the clinicopathological features of acne keloidalis nuchae in 17 Asians. Patients’ age at the time of presentation ranged from 20 to 69 years. Most patients experienced the disease over 2 years (range, 3 months–20 years); follow-up data were available for 11 (65%) patients (range, 2–95 months). Nine (53%) patients had comorbidities, but none had a history of other skin disease or a family history of acne keloidalis nuchae. Macroscopically, seven (41%) patients had multiple erythematous pustulopapular lesions, and 10 (59%) had a single large plaque. Histopathologically, deep scarring folliculitis containing naked hair shafts was identified. In all cases, inflammation was most severe in the upper two-thirds of the dermis, and the differences in pustulopapular and plaque lesions were more prominent in the peri-inflammation area. Of the seven patients with plaque lesions treated with steroids alone or steroids and cryotherapy, three experienced plaque reduction. Acne keloidalis nuchae occurring in Asian patients frequently present with typical clinicopathological features, and therefore in spite of very low incidence the diagnosis of this disease entity should be considered in idiopathic scarring folliculitis of the posterior neck. PMID:29240822

Pediatric symptomatic Rathke cleft cyst compared with cystic craniopharyngioma.

PubMed

Hayashi, Yasuhiko; Kita, Daisuke; Fukui, Issei; Sasagawa, Yasuo; Oishi, Masahiro; Okajima, Michiko; Tachibana, Osamu; Nakada, Mitsutoshi

2016-09-01

Symptomatic Rathke cleft cysts (RCCs) are rarely detected in neuroradiological screening and are less commonly found in children than in adults. However, when RCCs are observed in children, it is important to carefully distinguish a RCC from a cystic craniopharyngioma (CP) even if surgically treated or conservatively followed up. We conducted a retrospective review of clinical data from 11 patients with symptomatic RCCs whose ages were under 18 years and compared the data with data from 15 age- and sex-matched patients with cystic CP who were treated at our institute. The mean age of the patients with RCCs was 12.2 years (range, 6-18). There were six males and five females. As initial symptoms, nine patients presented with headache, while two each had impaired visual function, diabetes insipidus, and activity loss. The 14 patients with CP suffered from impaired visual function. Magnetic resonance imaging (MRI) mainly showed hyperintensity on T1-weighted images (WIs) and hypointensity on T2-WI in patients with RCC. However, patients with CP had characteristic hyperintensity on T2-WI. The average maximum diameter of the RCCs was 19.0 mm on average (range, 8-33 mm). The RCCs were thus significantly smaller than CPs (34.9 mm; range, 21-54 mm). The RCCs were usually oval or dumbbell-shaped and regular in appearance, while the larger CPs were lobular and irregular. A preoperative endocrinological evaluation revealed insufficiencies in four axes in five patients with RCC. Postoperative endocrinological status improved in three patients, remained unchanged in three, and worsened in one. The gonadotropin axis was damaged in a majority (nine) of the patients with CP preoperatively. Postoperative evaluation revealed deficits in five axes in 14 patients with CP, which is a significantly different trend than observed in patients with RCC. Eight patients underwent surgical procedures (transsphenoidal surgery (TSS) in four, craniotomy in four). Two of these patients experienced a recurrence of the cysts. One of these patients subsequently underwent two craniotomies followed by radiation and other underwent TSS. Among the three conservatively treated patients, two experienced a transient worsening of their symptoms along with cyst enlargement. However, none of the three conservatively treated patients required an operation. When RCCs become symptomatic in children, the most common symptom they lead to is headache. The cysts are commonly small, regular, and oval in shape. Hypointensity of cyst contents on MRI is a characteristic of RCCs, which distinguishes them from CPs. Surgical intervention can be effective and lead to the relief of symptoms without a high rate of complications. However, there seems to be a relatively high recurrence rate following surgery. Thus, if the patient's symptoms remain minor, the surgical treatment option should be used only when prudent, as the patient's symptoms may improve over time.

Association of hypoglycaemia severity with clinical, patient‐reported and economic outcomes in US patients with type 2 diabetes using basal insulin

PubMed Central

Lee, Lulu K.; Gupta, Shaloo; Preblick, Ron

2018-01-01

Aims To evaluate the clinical and patient‐reported outcomes and healthcare utilization and costs associated with patient‐reported hypoglycaemia in US adults with type 2 diabetes (T2D) treated with basal insulin. Materials and methods This was an observational, cross‐sectional, survey‐based study of adults with T2D on basal insulin ± oral antidiabetes drugs (OADs) or rapid‐acting/premixed insulin, who had in the past ever experienced hypoglycaemia, using US data from the National Health and Wellness Survey. Eligible patients were categorized as having no hypoglycaemia (38.7%), non‐severe hypoglycaemia (55.1%), or severe hypoglycaemia (6.2%) in the preceding 3 months. Outcomes included health‐related quality of life (HRQoL), work productivity and activity impairment, healthcare resource utilization, and estimated direct and indirect costs. Multivariable regression models were performed to control for patient characteristics. Results Patients who experienced severe hypoglycaemia had significantly (P < .05) lower HRQoL scores, greater overall impairment of work productivity and activity, greater healthcare resource utilization, and higher costs compared with those who experienced non‐severe or no hypoglycaemia. Patients with non‐severe hypoglycaemia also reported an impact on the number of provider visits, indirect costs, and HRQoL. Conclusions Patients with T2D using basal insulin ± OADs or rapid‐acting/premixed insulin in the United States who experienced severe hypoglycaemia had greater impairment of activity and work productivity, utilized more healthcare resources, and incurred higher associated costs than those with non‐severe or no hypoglycaemia. The study also demonstrated the impact that non‐severe hypoglycaemic events have on economic and HRQoL outcomes. Reducing the incidence and severity of hypoglycaemia could lead to clinically meaningful improvements in HRQoL and may result in lower healthcare utilization and associated costs. PMID:29316141

Collagen nerve guides for surgical repair of brachial plexus birth injury.

PubMed

Ashley, William W; Weatherly, Trisha; Park, Tae Sung

2006-12-01

Standard brachial plexus repair techniques often involve autologous nerve graft placement and neurotization. However, when performed to treat severe injuries, this procedure can sometimes yield poor results. Moreover, harvesting the autologous graft is time-consuming and exposes the patient to additional surgical risks. To improve surgical outcomes and reduce surgical risks associated with autologous nerve graft retrieval and placement, the authors use collagen matrix tubes (Neurogen) instead of autologous nerve graft material. Between 1991 and 2005, the authors surgically treated 65 infants who had suffered brachial plexus injury at birth. During this time, seven patients were treated using collagen matrix tubes (Neurogen). This study is a retrospective analysis of the initial five patients who were treated using the tubes. Two patients underwent tube placement recently and were excluded from the analysis because of the inadequate follow-up period. Four of the five patients experienced a good recovery (motor scale composite [MSC] > 0.6), and three exhibited an excellent recovery (MSC > 0.75) at 2 years postoperatively. The MSC improved by an average of 69 and 78% at 1 and 2 years, respectively. The movement scores improved to greater than or equal to 50% range of motion in most patients, and the contractures were usually mild or moderate. Follow-up physical and occupational therapy evaluations confirm these patients' functional status. When last seen, four of five of these children could feed and dress themselves. Technically, the use of the collagen matrix tubes was straightforward and efficient, and there were no complications. The outcomes in this small series are encouraging.

XRCC3 polymorphisms are associated with the risk of developing radiation-induced late xerostomia in nasopharyngeal carcinoma patients treated with intensity modulation radiated therapy.

PubMed

Zou, Yan; Song, Tao; Yu, Wei; Zhao, Ruping; Wang, Yong; Xie, Ruifei; Chen, Tian; Wu, Bo; Wu, Shixiu

2014-03-01

The incidence of radiation-induced late xerostomia varies greatly in nasopharyngeal carcinoma patients treated with radiotherapy. The single-nucleotide polymorphisms in genes involved in DNA repair and fibroblast proliferation may be correlated with such variability. The purpose of this paper was to evaluate the association between the risk of developing radiation-induced late xerostomia and four genetic polymorphisms: TGFβ1 C-509T, TGFβ1 T869C, XRCC3 722C>T and ATM 5557G>A in nasopharyngeal carcinoma patients treated with Intensity Modulation Radiated Therapy. The severity of late xerostomia was assessed using a patient self-reported validated xerostomia questionnaire. Polymerase chain reaction-ligation detection reaction methods were performed to determine individual genetic polymorphism. The development of radiation-induced xerostomia associated with genetic polymorphisms was modeled using Cox proportional hazards, accounting for equivalent uniform dose. A total of 43 (41.7%) patients experienced radiation-induced late xerostomia. Univariate Cox proportional hazard analyses showed a higher risk of late xerostomia for patients with XRCC3 722 TT/CT alleles. In multivariate analysis adjusted for clinical and dosimetric factors, XRCC3 722C>T polymorphisms remained a significant factor for higher risk of late xerostomia. To our knowledge, this is the first study that demonstrated an association between genetic polymorphisms and the risk of radiation-induced late xerostomia in nasopharyngeal carcinoma patients treated with Intensity Modulation Radiated Therapy. Our findings suggest that the polymorphisms in XRCC3 are significantly associated with the risk of developing radiation-induced late xerostomia.

Olanzapine versus risperidone. A prospective comparison of clinical and economic outcomes in schizophrenia.

PubMed

Edgell, E T; Andersen, S W; Johnstone, B M; Dulisse, B; Revicki, D; Breier, A

2000-12-01

To compare the clinical and economic outcomes associated with olanzapine and risperidone treatment for schizophrenia. An international, multicentre, double-blind, prospective study. To facilitate economic comparisons, our sample was restricted to patients enrolled in US sites. 150 patients with a Diagnostic and Statistical Manual of mental disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder were randomised to therapy with either olanzapine 10 to 20 mg/day (n = 75) or risperidone 4 to 12 mg/day (n = 75) for a maximum of 28 weeks. In addition to tolerability and efficacy assessments, use of health services was assessed at baseline and prospectively, at 8-week intervals and at study completion. Clinically important response, defined as a 40% improvement in the Positive and Negative Syndrome Scale total score, maintenance of response and rates of treatment-emergent extrapyramidal symptoms were compared between groups. Direct medical costs were estimated by assigning standardised prices to resource units. Median total, inpatient/outpatient service and medication acquisition costs were compared between treatment groups. The mean modal dosages for the olanzapine and risperidone treatment groups were 17.7 +/- 3.4 mg/day and 7.9 +/- 3.2 mg/day, respectively. Olanzapine-treated patients were more likely to maintain response compared with risperidone-treated patients (p = 0.048). In addition, a smaller proportion of olanzapine-treated patients required anticholinergic therapy compared with risperidone-treated patients (25.3 vs 45.3%; p = 0.016). Total per patient medical costs over the study interval were $US2843 (1997 values) [36%] lower in the olanzapine treatment group than in the risperidone treatment group (p = 0.342). Medication costs were significantly higher for olanzapine-treated patients ($US2513 vs $US1581; p < 0.001), but this difference was offset by a reduction of $US3774 (52%) in inpatient/outpatient service costs for olanzapine-treated patients in comparison with risperidone-treated patients ($US3516 vs $US7291, p = 0.083). Median cost findings were consistent with results observed using other robust measures of central tendency and provide conservative estimates of potential savings that may be obtained from olanzapine therapy. In this study, olanzapine-treated patients experienced clinical improvements that translated into savings in costs of care for both inpatient and outpatient services. These savings offset the difference in medication acquisition cost between olanzapine and risperidone.

PHOTODYNAMIC THERAPY (PDT) USING HPPH FOR THE TREATMENT OF PRECANCEROUS LESIONS ASSOCIATED WITH BARRETT’S ESOPHAGUS

PubMed Central

Nava, Hector R; Allamaneni, Shyam S; Dougherty, Thomas J; Cooper, Michele T; Tan, Wei; Wilding, Gregory; Henderson, Barbara W

2011-01-01

Background and Objectives Photodynamic therapy (PDT) with porfimer sodium, FDA approved to treat premalignant lesions in Barrett’s esophagus, causes photosensitivity for 6-8 weeks. HPPH (2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a) shows minimal photosensitization of short duration and promising efficacy in preclinical studies. Here we explore toxicity and optimal drug and light dose with endoscopic HPPH-PDT. We also want to know the efficacy of one time treatment with HPPH-PDT. Study Design/Materials and Methods Two nonrandomized dose escalation studies were performed (18 patients each) with biopsy-proven high grade dysplasia or early intramucosal adenocarcinoma of esophagus. HPPH doses ranged from 3 to 6 mg/m2. At 24 or 48 hours after HPPH administration the lesions received one endoscopic exposure to 150, 175 or 200 J/cm of 665 nm light. Results Most patients experienced mild to moderate chest pain requiring symptomatic treatment only. Six patients experienced Grade 3 & 4 adverse events (16.6%). Three esophageal strictures were treated with dilatation. No clear pattern of dose dependence of toxicities emerged. In the drug dose ranging study (light dose of 150 J/cm at 48 h), 3 and 4 mg/m2 of HPPH emerged as most effective. In the light dose ranging study (3 or 4 mg/m2 HPPH, light at 24 h), complete response rates (disappearance of high grade dysplasia and early carcinoma) of 72% were achieved at 1 year, with all patients treated with 3 mg/m2 HPPH plus 175 J/cm and 4 mg/m2 HPPH plus 150 J/cm showing complete responses at 1 year. Conclusions HPPH-PDT for precancerous lesions in Barrett’s esophagus appears to be safe and showing promising efficacy. Further clinical studies are required to establish the use of HPPH-PDT. PMID:22057498

A retrospective review of safety using a nursing driven protocol for autonomic dysreflexia in patients with spinal cord injuries.

PubMed

Solinsky, Ryan; Svircev, Jelena N; James, Jennifer J; Burns, Stephen P; Bunnell, Aaron E

2016-11-01

Autonomic dysreflexia is a potentially life-threatening condition which afflicts a significant proportion of individuals with spinal cord injuries (SCI). To date, the safety and efficacy of several commonly used interventions for this condition have not been studied. A retrospective chart review of the safety of a previously implemented nursing driven inpatient autonomic dysreflexia protocol. Seventy-eight male patients with SCI who experienced autonomic dysreflexia while inpatient at our Veterans Affairs SCI unit over a 3-1/2-year period were included. The safety of a nursing driven protocol utilizing conservative measures, nitroglycerin paste, and oral hydralazine was evaluated. Occurrence of adverse events and relative hypotensive events during all episodes treated with the protocol, and efficacy of attaining target blood pressure for all episodes with protocol adherence and for initial episode experienced by each patient. Four hundred forty-five episodes of autonomic dysreflexia were recorded in the study period, with 92% adherence to the protocol. When the protocol was followed, target blood pressure was achieved for 97.6% of all episodes. Twenty-three total adverse events occurred (5.2% of all episodes). All adverse events were due to hypotension and only 0.9% required interventions beyond clinical monitoring. Of each patient's initial autonomic dysreflexia episode, 97.3% resolved using the protocol without need for further escalation of care. This inpatient nursing driven-protocol for treating autonomic dysreflexia utilizing conservative measures, nitroglycerin paste and oral hydralazine achieved target blood pressure with a high success rate and a low incidence of adverse events.

Meningioma Causing Visual Impairment: Outcomes and Toxicity After Intensity Modulated Radiation Therapy

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

Maclean, Jillian, E-mail: jillian.maclean@uclh.nhs.uk; Fersht, Naomi; Bremner, Fion

2013-03-15

Purpose: To evaluate ophthalmologic outcomes and toxicity of intensity modulated radiation therapy (IMRT) in patients with meningiomas causing visual deficits. Methods and Materials: A prospective observational study with formal ophthalmologic and clinical assessment of 30 consecutive cases of meningioma affecting vision treated with IMRT from 2007 to 2011. Prescriptions were 50.4 Gy to mean target dose in 28 daily fractions. The median follow-up time was 28 months. Twenty-six meningiomas affected the anterior visual pathway (including 3 optic nerve sheath meningiomas); 4 were posterior to the chiasm. Results: Vision improved objectively in 12 patients (40%). Improvements were in visual field (5/16more » patients), color vision (4/9 patients), acuity (1/15 patients), extraocular movements (3/11 patients), ptosis (1/5 patients), and proptosis (2/6 patients). No predictors of clinical response were found. Two patients had minor reductions in tumor dimensions on magnetic resonance imaging, 1 patient had radiological progression, and the other patients were stable. One patient experienced grade 2 keratitis, 1 patient had a minor visual field loss, and 5 patients had grade 1 dry eye. Conclusion: IMRT is an effective method for treating meningiomas causing ophthalmologic deficits, and toxicity is minimal. Thorough ophthalmologic assessment is important because clinical responses often occur in the absence of radiological change.« less

Comparison of Treatment Tolerance and Outcomes in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy in a Prospective Randomized Trial or With Standard Treatment

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

Torres, Mylin A.; Jhingran, Anuja; Thames, Howard D.

Purpose: To compare the treatment and outcomes of cervical cancer patients treated with concurrent chemoradiotherapy (CT-RT) in a multi-institutional trial or as standard care. Patients and Methods: We reviewed the records of 302 patients treated with CT-RT for locoregionally confined, intact cervical cancer between 1990 and 2005. Of the 302 patients, 76 were treated using cisplatin and 5-fluorouracil (C/F) on Radiation Therapy Oncology Group protocol 90-01 (CT-RT{sub 90-01}); 226 underwent CT-RT as standard care with either C/F [CT-RT{sub SC(C/F)}; n = 115] or weekly cisplatin [CT-RT{sub SC(WC)}; n = 111). Results: The CT-RT{sub 90-01} patients more often had tumors {>=}6more » cm and were less often diabetic than were the CT-RT{sub SC} patients. The CT-RT{sub SC(WC)} patients were more likely than the CT-RT{sub SC(C/F)} patients to be {>=}60 years old or to have Stage III-IV disease. During treatment, CT-RT{sub SC(C/F)} patients experienced more Grade 2-3 neutropenia and were, therefore, less likely to receive 200 mg/m{sup 2} cisplatin than were either CT-RT{sub SC(WC)} or CT-RT{sub 90-01} patients (52% vs. 77% vs. 85%, respectively; p <0.001). At 5 years, the disease-specific survival rates were greater for patients treated with C/F [CT-RT{sub SC(C/F)}, 75%; CT-RT{sub 90-01}, 79%] than for those treated with CT-RT{sub SC(WC)} (58%; p = 0.02). On multivariate analysis, C/F chemotherapy, cisplatin dose {>=}200 mg/m{sup 2}, Stage I-II disease, and negative pelvic lymph nodes were independent predictors of improved disease-specific survival. Conclusions: Even within a large comprehensive cancer center, the high rates of chemotherapy completion achieved on a multi-institutional trial can be difficult to reproduce in standard practice. Although C/F toxicity was greater in the standard care patients, their outcomes were similar to those of patients treated with C/F on Radiation Therapy Oncology Group protocol 90-01.« less

Refractory gastroesophageal reflux disease

PubMed Central

Subramanian, Charumathi Raghu; Triadafilopoulos, George

2015-01-01

Gastroesophageal reflux disease (GERD) is a condition that develops when the reflux of stomach contents into the esophagus causes troublesome symptoms, esophageal injury, and/or complications. Use of proton pump inhibitors (PPI) remains the standard therapy for GERD and is effective in most patients. Those whose symptoms are refractory to PPIs should be evaluated further and other treatment options should be considered, according to individual patient characteristics. Response to PPIs could be total (no symptoms), partial (residual breakthrough symptoms), or absent (no change in symptoms). Patients experiencing complete response do not usually need further management. Patients with partial response can be treated surgically or by using emerging endoscopic therapies. Patients who exhibit no response to PPI need further evaluation to rule out other causes. PMID:25274499

Efficacy and Safety of Second-Line 5-Day Dactinomycin in Case of Methotrexate Failure for Gestational Trophoblastic Neoplasia.

PubMed

Prouvot, Catherine; Golfier, François; Massardier, Jérôme; You, Benoit; Lotz, Jean-Pierre; Patrier, Sophie; Devouassoux, Mojgan; Schott, Anne-Marie; Hajri, Touria; Bolze, Pierre-Adrien

2018-06-01

The objective of this study was to evaluate the characteristics and outcomes of patients treated for gestational trophoblastic neoplasia (GTN) with second-line 5-day dactinomycin after failed first-line 8-day methotrexate. From 1999 to 2017, patients with methotrexate resistant GTN treated with second line dactinomycin were identified at the French Trophoblastic Disease Reference Center. Using univariate and multivariate analysis, we identified significant predictive factors of second line dactinomycin failure. A total of 877 GTN patients were treated with first-line 8-day methotrexate, of which 103 required second-line 5-day dactinomycin for methotrexate failure. Complete response was observed in 78 patients (75.7% [95% confidence interval, 66.3-83.6]; P < 0.0001), whereas 25 needed third-line treatment, 13 for dactinomycin resistance and 12 for post-dactinomycin relapse. Overall survival of patients treated with dactinomycin was 100%. An interval of greater than or equal to 7 months between antecedent pregnancy termination and methotrexate initiation was a predictive factor significantly associated with second-line dactinomycin failure in multivariate analysis (exact odds ratio, 9.17 [95% confidence interval, 1.98-50.70]; P = 0.0029). No grades 4 and 5 adverse effects were experienced and the most common toxicity being grade 1 nausea (14.6%). Given a 75.7% complete response rate in methotrexate failed low-risk GTN patients treated with second-line dactinomycin and an overall survival rate of 100% after third-line treatment, the use of dactinomycin should be favored as second-line, regardless of human chorionic gonadotropin level at the time of dactinomycin initiation. However, an interval between the termination of the antecedent pregnancy and methotrexate initiation longer than 6 months should encourage considering alternative therapeutic strategies.

Treatment of juvenile idiopathic arthritis with intra-articular triamcinolone hexacetonide: evaluation of clinical effectiveness correlated with circulating ANA and T gamma/delta + and B CD5+ lymphocyte populations of synovial fluid.

PubMed

Lepore, L; Del Santo, M; Malorgio, C; Presani, G; Perticarari, S; Prodan, M; Di Leo, G; Leone, V; Tommasini, A

2002-01-01

The aims of the study were to assess the effect of intra-articular treatment with triamcinolone hexacetonide (TH) in juvenile idiopathic arthritis (JIA) and to investigate whether treatment response correlates with the presence of antinuclear antibodies (ANA) in the serum and/or B CD5+ and T gamma/delta + lymphocytes in the synovial fluid. A total of 37 patients (81% females, 56% ANA+) with oligoarticular JIA involving knees were treated with intra-articular injections of TH after failing to respond to NSAIDs for two months. Eighteen patients were treated within 6 months of onset, 19 were treated more than 6 months after onset. Mean duration of remission was 13.9 months. Twelve patients (7 ANA+) had stable remission after a single injection; 13 patients (3 ANA+) experienced more than 6 months' remission but subsequently had a relapse; 12 patients (11 ANA+) had a relapse within six months of injection. Of 20 patients treated within 6 months of onset, 17 had stable remission whereas only 8 out of 17 who were treated during relapse attained stable remission (p = 0.03). The mean percentage of T gamma/delta + and of B CD5+ lymphocytes in synovial fluid was the same as in peripheral blood of normal subjects. Our data indicate that local treatment with slow-release steroids is very effective in oligoarticular JIA. Prolonged remission was less likely in the presence of ANA positivity, probably because the disease is immunologically more active. Finally, our data suggest that the earlier the treatment, the easier it is to obtain a protracted, and possibly permanent, response.

The effect of perceived adherence to the Bobath concept on physiotherapists' choice of intervention used to treat postural control after stroke.

PubMed

Tyson, S F; Selley, A B

2007-03-15

The Bobath concept is the predominant stroke physiotherapy approach in the UK but there is little literature about its operationalization. The aim of this study was to assess the effect of perceived adherence to the Bobath concept on interventions used by physiotherapists to treat postural control problems after stroke. The physiotherapists' experience, clinical grade and the type of patients treated were also compared. The design was a cross sectional survey involving 11 NHS Trusts. The participants were 35 stroke physiotherapists who recorded the treatment of 132 patients in 644 sessions using the Stroke Physiotherapy Intervention Recording Tool. Descriptive statistics, independent t-tests and Chi-squares were used in the analysis to describe the physiotherapists and patients, and compare the effects of perceived adherence to the Bobath concept on intervention choice, clinical grade, experience and the type of patient treated. Most physiotherapists perceived their practice to be eclectic but the interventions used followed a traditional Bobath model. Perceived adherence to the Bobath concept had little effect on the choice of intervention. The only significant difference was that 'preparation for treatment' techniques were used more frequently by 'strongly Bobath' physiotherapists then 'eclectic' physiotherapists. There were no other significant differences, nor were there any differences in the physiotherapists' clinical grade, post-graduate training or the type of patient treated except that 'eclectic' physiotherapists' patients were older. Most of the 'strongly Bobath' physiotherapists were experienced and most of the 'eclectic' physiotherapists were novices (p<0.023). Although most physiotherapists perceived themselves to be eclectic, their actual practice followed a traditional Bobath model; recent developments of the Bobath concept were not incorporated into clinical practice. The reasons for the mismatch between physiotherapists' perception and their actual practice are discussed.

The Efficacy of Radiotherapy in the Treatment of Orbital Pseudotumor

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

Matthiesen, Chance, E-mail: chance-matthiesen@ouhsc.ed; Bogardus, Carl; Thompson, J. Spencer

Purpose: To review institutional outcomes for patients treated with external-beam radiotherapy (EBRT) for orbital pseudotumor. Methods and Materials: This is a single-institution retrospective review of 20 orbits in 16 patients diagnosed with orbital pseudotumor that received EBRT at the University of Oklahoma, Department of Radiation Oncology. Treated patients had a median follow-up of 16.5 months. Results: Fifteen patients (93.7%) were initially treated with corticosteroids. Eight had recurrence after steroid cessation, six were unable to taper corticosteroids completely or partially, and one experienced progression of symptoms despite corticosteroid therapy. Fourteen patients (87.5%) initially responded to radiotherapy indicated by clinical improvement ofmore » preradiation symptoms and/or tapering of corticosteroid dose. Mean EBRT dose was 20 Gy (range, 14-30 Gy). Thirteen patients (81.2%) continued to improve after radiation therapy. Patient outcomes were complete cessation of corticosteroid therapy in nine patients (56.3%) and reduced corticosteroid dose in four patients (25%). Radiotherapy did not achieve long-term control for three patients (18.7%), who still required preradiation corticosteroid dosages. Three patients received retreatment(s) of four orbits, of which two patients achieved long-term symptom control without corticosteroid dependence. One patient received retreatment to an orbit three times, achieving long-term control without corticosteroid dependence. No significant late effects have been observed in retreated patients. Conclusions: Radiotherapy is an effective treatment for acute symptomatic improvement and long-term control of orbital pseudotumor. Orbital retreatment can be of clinical benefit, without apparent increase in morbidity, when initial irradiation fails to achieve complete response.« less

Acetabular Reconstruction With Femoral Head Autograft After Intraarticular Resection of Periacetabular Tumors is Durable at Short-term Followup.

PubMed

Tang, Xiaodong; Guo, Wei; Yang, Rongli; Yan, Taiqiang; Tang, Shun; Li, Dasen

2017-12-01

Pelvic reconstruction after periacetabular tumor resection is technically difficult and characterized by a high complication rate. Although endoprosthetic replacement can result in immediate postoperative functional recovery, biologic reconstructions with autograft may provide an enhanced prognosis in patients with long-term survival; however, little has been published regarding this approach. We therefore wished to evaluate whether whole-bulk femoral head autograft that is not contaminated by tumor can be used to reconstruct segmental bone defects after intraarticular resection of periacetabular tumors. In a pilot study, we evaluated (1) local tumor control, (2) complications, and (3) postoperative function as measured by the Musculoskeletal Tumor Society score. Between 2009 and 2015, we treated 13 patients with periacetabular malignant or aggressive benign tumors with en bloc resection, bulk femoral head autograft, and cemented THA (with or without a titanium acetabular reconstruction cup), and all were included for analysis here. During that time, the general indications for this approach were (1) patients anticipated to have a good oncologic prognosis and adequate surgical margins to allow this approach, (2) patients whose pelvic bone defects did not exceed two types (Types I + II or Types II + III as defined by Enneking and Dunham), and (3) patients whose medical insurance would not cover what otherwise might have been a pelvic tumor prosthesis. During this period, another 91 patients were treated with pelvic prosthetic replacement, which was our preferred approach. Median followup in this study was 36 months (range, 24-99 months among surviving patients; one patient died 8 months after surgery); no patients were lost to followup. Bone defects were Types II + III in five patients, and Types I + II in eight. After intraarticular resection, ipsilateral femoral head autograft combined with THA was used to reconstruct the segmental bone defect of the acetabulum. In patients with Types I + II resections, the connection between the sacrum and the acetabulum was reestablished with a fibular autograft or a titanium cage filled with dried bone-allograft particles which was enhanced by using a pedicle screw and rod system. Functional evaluation was done in 11 patients who remained alive and maintained the femoral head autograft at final followup; one other patient received secondary resection involving removal of the femoral head autograft and internal fixation, and was excluded from functional evaluation. Endpoints were assessed by chart review. Two patients experienced local tumor recurrence. Finally, eight patients did not show signs of the disease, one patient died of disease for local and distant tumor relapse, and four patients survived, but still had the disease. Three of these four patients had distant metastases without local recurrence and one had local control after secondary resection but still experienced system relapse. We observed the following complications: hematoma (one patient; treated surgically with hematoma clearance), delayed wound healing (one patient; treated by débridement), deep vein thrombosis (one patient), and hip dislocation (one patient; treated with open reduction). The median 1993 Musculoskeletal Tumor Society score was 83% (25 of 30 points; range, 19-29 points), and all patients were community ambulators; one used a cane, three used a walker, and nine did not use any assistive devices. In this small series at short-term followup, we found that reconstruction of segmental bone defects after intraarticular resection of periacetabular tumors with femoral head autograft does not appear to impede local tumor control; complications were in the range of what might be expected in a series of large pelvic reconstructions, and postoperative function was generally good. Level IV, therapeutic study.

Outcome after anal intrasphincteric Botox injection in children with surgically treated Hirschsprung disease.

PubMed

Han-Geurts, Ingrid J M; Hendrix, Vivian C; de Blaauw, Ivo; Wijnen, Marc H W A; van Heurn, Ernest L W

2014-11-01

A nonrelaxing internal anal sphincter is present in a relatively large proportion of children with surgically treated Hirschsprung disease (HD) and can cause obstructive gastrointestinal symptoms. The short- and long-term outcome and adverse effects of intrasphincteric botulinum toxin (Botox) injections in children with obstruction after surgically treated HD are evaluated. The outcome of children with surgically treated HD treated with intrasphincteric Botox injections for obstructive symptoms was analyzed with a retrospective chart review between 2002 and 2013 in the University Medical Centers of Maastricht and Nijmegen. A total of 33 patients were included. The median time of follow-up was 7.3 years (range 1-24). A median of 2 (range 1-5) injections were given. Initial improvement was achieved in 76%, with a median duration of 4.1 months (range 1.7-58.8). Proportion of children hospitalized for enterocolitis decreased after treatment from 19 to 7. A good long-term response was found in 49%. Two children experienced complications: transient pelvic muscle paresis with impairment of walking. In both children symptoms resolved within 4 months without treatment. Intrasphincteric Botox injections in surgically treated HD are an effective long-term therapy in approximately half of our patients with obstructive symptoms. The possibility of adverse effects should be noticed.

Curing the historically incurable: treatment success with ledipasvir/sofosbuvir for chronic hepatitis C virus in a heavily treatment-experienced individual.

PubMed

Johnson, S W; Davis, M M; Stever, L M; Priest, D H

2016-12-01

Significant progression in the treatment of chronic hepatitis C virus has been made with the introduction of direct-acting antivirals (DAAs). However, limited data are available for the retreatment of individuals who have failed multiple prior DAAs. We report a single case of an individual who was unsuccessfully treated with five prior hepatitis C virus treatment regimens including simeprevir plus sofosbuvir who was successfully cured after treatment with ledipasvir/sofosbuvir. Ledipasvir/sofosbuvir may be an option for treating patients who have failed multiple prior DAA regimens; however, further research is warranted. © 2016 John Wiley & Sons Ltd.

Stroke After Radiation Therapy for Head and Neck Cancer: What Is the Risk?

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

Arthurs, Erin; Hanna, Timothy P.; Department of Oncology, Queen's University, Kingston, Ontario

Purpose: A retrospective population-based cohort study was conducted to determine the risk of ischemic stroke with respect to time, associated with curative radiation therapy in head and neck squamous cell carcinomas (HNSCC). Methods and Materials: On the basis of data from the Ontario Cancer Registry and regional cancer treatment centers, 14,069 patients were identified with diagnoses of squamous cell carcinoma of the oral cavity, larynx, and pharynx who were treated for cure between 1990 and 2010. Hazards of stroke and time to stroke were examined, accounting for the competing risk of death. Stroke risk factors identified through diagnostic and proceduralmore » administrative codes were adjusted for in the comparison between treatment regimens, which included surgery alone versus radiation therapy alone and surgery alone versus any exposure to radiation therapy. Results: Overall, 6% of patients experienced an ischemic stroke after treatment, with 5% experiencing a stroke after surgery, 8% after radiation therapy alone, and 6% after any exposure to radiation therapy. The cause-specific hazard ratios of ischemic stroke after radiation therapy alone and after any exposure to radiation therapy compared with surgery were 1.70 (95% confidence interval [CI]: 1.41-2.05) and 1.46 (95% CI: 1.23-1.73), respectively, after adjustment for stroke risk factors, patient factors, and disease-related factors. Conclusions: Radiation therapy was associated with an increased risk of ischemic stroke compared with surgery alone: for both radiation therapy alone and after all treatment modalities that included any radiation treatment were combined. Because of a shift toward a younger HNSCC patient population, our results speak to the need for adequate follow-up and survivorship care among patients who have been treated with radiation therapy. Advances in treatment that minimize chronic morbidity also require further evaluation.« less

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

Wong, Philip; Lambert, Christine, E-mail: christine.lambert@muhc.mcgill.ca; Agnihotram, Ramanakumar V.

Purpose: Local recurrence (LR) of ductal carcinoma in situ (DCIS) is reduced by whole-breast irradiation after breast-conserving surgery (BCS). However, the benefit of adding a radiotherapy boost to the surgical cavity for DCIS is unclear. We sought to determine the impact of the boost on LR in patients with DCIS treated at the McGill University Health Centre. Methods and Materials: A total of 220 consecutive cases of DCIS treated with BCS and radiotherapy between January 2000 and December 2006 were reviewed. Of the patients, 36% received a radiotherapy boost to the surgical cavity. Median follow-up was 46 months for themore » boost and no-boost groups. Kaplan-Meier survival analyses and Cox regression analyses were performed. Results: Compared with the no-boost group, patients in the boost group more frequently had positive and <0.1-cm margins (48% vs. 8%) (p < 0.0001) and more frequently were in higher-risk categories as defined by the Van Nuys Prognostic (VNP) index (p = 0.006). Despite being at higher risk for LR, none (0/79) of the patients who received a boost experienced LR, whereas 8 of 141 patients who did not receive a boost experienced an in-breast LR (log-rank p = 0.03). Univariate analysis of prognostic factors (age, tumor size, margin status, histological grade, necrosis, and VNP risk category) revealed only the presence of necrosis to significantly correlate with LR (log-rank p = 0.003). The whole-breast irradiation dose and fractionation schedule did not affect LR rate. Conclusions: Our results suggest that the use of a radiotherapy boost improves local control in DCIS and may outweigh the poor prognostic effect of necrosis.« less

Longitudinal effect of eteplirsen versus historical control on ambulation in Duchenne muscular dystrophy

PubMed Central

Goemans, Nathalie; Lowes, Linda P.; Alfano, Lindsay N.; Berry, Katherine; Shao, James; Kaye, Edward M.; Mercuri, Eugenio; Hamid, Hoda Abdel; Byrne, Barry J.; Connolly, Anne M.; Dracker, Robert A.; Matthew Frank, L.; Heydemann, Peter T.; O'Brien, Kevin C.; Sparks, Susan E.; Specht, Linda A.; Rodino‐Klapac, Louise; Sahenk, Zarife; Al‐Zaidy, Samiah; Cripe, Linda H.; Lewis, Sarah; M, Pane; E, Mazzone; S, Messina; GL, Vita; Bertini, D Amico A; Casimiro, Berardinelli A; Y, Torrente; F, Magri; GP, Comi; G, Baranello; T, Mongini; A, Pini; R, Battini; E, Pegoraro; C, Bruno; L, Politano; S, Previtali

2016-01-01

Objective To continue evaluation of the long‐term efficacy and safety of eteplirsen, a phosphorodiamidate morpholino oligomer designed to skip DMD exon 51 in patients with Duchenne muscular dystrophy (DMD). Three‐year progression of eteplirsen‐treated patients was compared to matched historical controls (HC). Methods Ambulatory DMD patients who were ≥7 years old and amenable to exon 51 skipping were randomized to eteplirsen (30/50mg/kg) or placebo for 24 weeks. Thereafter, all received eteplirsen on an open‐label basis. The primary functional assessment in this study was the 6‐Minute Walk Test (6MWT). Respiratory muscle function was assessed by pulmonary function testing (PFT). Longitudinal natural history data were used for comparative analysis of 6MWT performance at baseline and months 12, 24, and 36. Patients were matched to the eteplirsen group based on age, corticosteroid use, and genotype. Results At 36 months, eteplirsen‐treated patients (n = 12) demonstrated a statistically significant advantage of 151m (p < 0.01) on 6MWT and experienced a lower incidence of loss of ambulation in comparison to matched HC (n = 13) amenable to exon 51 skipping. PFT results remained relatively stable in eteplirsen‐treated patients. Eteplirsen was well tolerated. Analysis of HC confirmed the previously observed change in disease trajectory at age 7 years, and more severe progression was observed in patients with mutations amenable to exon skipping than in those not amenable. The subset of patients amenable to exon 51 skipping showed a more severe disease course than those amenable to any exon skipping. Interpretation Over 3 years of follow‐up, eteplirsen‐treated patients showed a slower rate of decline in ambulation assessed by 6MWT compared to untreated matched HC. Ann Neurol 2016;79:257–271 PMID:26573217

Treatment results in localized primary gastric lymphoma: data of patients registered within the German multicenter study (GIT NHL 02/96).

PubMed

Koch, Peter; Probst, Andreas; Berdel, Wolfgang E; Willich, Normann A; Reinartz, Gabriele; Brockmann, Jens; Liersch, Rüdiger; del Valle, Francisco; Clasen, Hermann; Hirt, Carsten; Breitsprecher, Regine; Schmits, Rudolf; Freund, Mathias; Fietkau, Rainer; Ketterer, Peter; Freitag, Eva-Maria; Hinkelbein, Margit; Heinecke, Achim; Parwaresch, Reza; Tiemann, Markus

2005-10-01

In the prospective study 02/96 on primary GI lymphoma, we have collected data on histology, clinical features, and treatment results. In particular, in stages I and II localized primary gastric lymphoma (PGL), our objectives were to reduce treatment intensity and to confirm our hypothesis from study 01/92, which maintained that an organ-preserving approach is not inferior to primary surgery. Patients receiving radiotherapy and/or chemotherapy were stratified for histologic grade, stage, and whether surgery had been carried out or not (as decided by each participating center). Patients with aggressive PGL received six cycles of CHOP-14 (cyclophosphamide, doxorubicin, vincristine, and prednisone) followed by involved-field radiotherapy (40 Gy). Patients with indolent PGL (including patients experiencing treatment failure with antibiotic therapy for Helicobacter pylori) were treated with extended-field radiotherapy. The volume depended on stage. The irradiation dose was 30 Gy, followed by a boost of 10 Gy (the latter omitted after complete resection) to the tumor region. Seven hundred forty-seven patients were accrued. Of these patients, 393 with localized PGL were treated with radiotherapy and/or chemotherapy only or additional surgery between December 1996 and December 2003. The survival rate at 42 months for patients treated with surgery was 86% compared with 91.0% for patients without surgery. In this nonrandomized study (02/96), we reproduced the previous results of study 01/92 showing no disadvantage for an organ-preserving treatment. Therefore, primary stomach resection should be questioned.

Final report of the 70.2-Gy and 75.6-Gy dose levels of a phase I dose escalation study using three-dimensional conformal radiotherapy in the treatment of inoperable non-small cell lung cancer.

PubMed

Rosenzweig, K E; Mychalczak, B; Fuks, Z; Hanley, J; Burman, C; Ling, C C; Armstrong, J; Ginsberg, R; Kris, M G; Raben, A; Leibel, S

2000-01-01

Three-dimensional conformal radiotherapy (3D-CRT) is a mode of high-precision radiotherapy designed to increase the tumor dose and decrease the dose to normal tissues. This study reports the final results of the first two dose levels (70.2 Gy and 75.6 Gy) of a phase I dose-escalation study using 3D-CRT for the treatment of non-small cell lung cancer. Fifty-two patients were treated with 3D-CRT without chemotherapy. The median age was 67 years (range, 39-82 years). The majority of patients had locally advanced cancer. Tumor was staged as I/II in 10%, IIIA in 40%, and IIIB in 50%. Radiation was delivered in daily fractions of 1.8 Gy, 5 days a week. A radiation dose level was considered complete when 10 patients received the intended dose without unacceptable acute morbidity. Toxicity was scored according to the Radiation Therapy Oncology Group grading scheme. Twenty patients were initially assigned to the 70.2-Gy level; 14 of them received the intended dose. Three patients experienced severe acute toxicity, two with grade 3 (requiring steroids or oxygen) and a third with grade 5 (fatal) acute radiation pneumonitis. Because of the grade 5 pulmonary toxicity, the protocol was modified, and only patients with a calculated risk of normal tissue complication of less than 25% were eligible for dose escalation. Patients who had a normal tissue complication probability (NTCP) of greater than 25% received a lower dose of radiation. An additional 18 patients were entered on the modified study; 11 of them received 70.2 Gy. One patient experienced grade 3 acute pneumonitis. Despite dose reduction in four patients because of an unacceptably high NTCP, two additional patients developed grade 3 pulmonary toxicity. Fourteen patients were accrued to the 75.6-Gy dose level, and 10 received the intended dose. One of the 10 patients experienced grade 3 pulmonary toxicity and one developed grade 3 esophageal toxicity. Three patients were treated to lower doses as a result of their calculated NTCP without toxicity, and one patient refused treatment. The 2-year local control, disease-free survival, and overall survival rates were 37%, 12%, and 24%, respectively. The median survival time was 11 months. Treatment to 70.2 Gy and 75.6 Gy using 3D-CRT was delivered with acceptable morbidity when NTCP constraints were observed. Local control was encouraging in these patients with locally advanced disease. Patients are currently being accrued to the 81-Gy level of the study.

Long-term follow-up of Dupuytren disease after injection of triamcinolone acetonide in Chinese patients in Taiwan.

PubMed

Yin, C-Y; Yu, H-H M; Wang, J-P; Huang, Y-C; Huang, T-F; Chang, M-C

2017-09-01

Injection of triamcinolone acetonide is a non-operative treatment for early-stage Dupuytren disease in Caucasians, but its effectiveness in non-Caucasians is unclear. We report averaged 5-year follow-up results of 37 patients (49 affected hands) with early-stage Dupuytren disease for patients in Taiwan (non-Caucasian) who received a single dose of 5 mg triamcinolone acetonide injection into nodules monthly for 3 months. Using ultrasound, we recorded no progression of sizes of the modules following injection after 6 months. After an average 5-year follow-up, two patients with three hands (6%) experienced reactivation of the treated nodules. None required surgical intervention. Ultrasound examination showed that sizes of the treated Dupuytren nodules decreased significantly by 40% 6 months after injection and 56% at the final follow-up. We conclude that in these Chinese patients in Taiwan with early Dupuytren nodules, triamcinolone acetonide injection was effective in reducing the size of the Dupuytren nodules and maintaining long-term durable control of the nodular growth. III.

Ultrasound diagnosis and percutaneous treatment of Achilles tendon tethering: a case series.

PubMed

He, Lulu; Genin, Jason; Delzell, Patricia

2016-09-01

The purpose of this article is to report 3 cases of Kager's fat pad scarring and tethering to the deep surface of the Achilles tendon in patients with Achilles tendinosis symptomatology. The 3 patients were diagnosed sonographically by the use of a dynamic maneuver we described and named the "Kager's squeeze" technique. The key finding for diagnosis is the deformation and bowing of the deep fibers of the Achilles tendon during dynamic squeezing of Kager's fat pad. After diagnosis, the patients were treated with ultrasound-guided hydrodissection and scar release to restore normal motion between Kager's fat pad and the Achilles tendon. All 3 patients experienced significant clinical improvement shortly after treatment. Therefore, we suspect that Kager's fat pad scarring with Achilles tendon tethering may mimic or exacerbate Achilles tendinosis symptomatology and should be considered a possible diagnosis when conservative treatments for Achilles tendinosis fail. We demonstrate that Kager's fat pad scarring with Achilles tendon tethering can be diagnosed and treated with a simple in-office hydrodissection technique, leading to improved patient outcomes.

Safety of Methylphenidate and Atomoxetine in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): Data from the Italian National ADHD Registry.

PubMed

Cortese, Samuele; Panei, Pietro; Arcieri, Romano; Germinario, Elena A P; Capuano, Annalisa; Margari, Lucia; Chiarotti, Flavia; Curatolo, Paolo

2015-01-01

The aim of this study was to assess the type and frequency of adverse events (AEs) in children with attention-deficit/hyperactivity disorder (ADHD) treated with methylphenidate or atomoxetine over a 5-year period in a large naturalistic study. We draw on data from the Italian ADHD Registry, a national database for postmarketing phase IV pharmacovigilance of ADHD medications across 90 centers. AEs were defined as severe or mild as per the classification of the Italian Medicines Agency. AE frequency in the two treatment groups was compared using incidence rates per 100 person-years (IR100PY) and incidence rate ratios (IRRs). Mantel-Haenszel adjusted IRRs were calculated to control for psychiatric comorbidity. A total of 1350 and 753 participants (aged 6-18 years, mean age 10.7 ± 2.8) were treated with methylphenidate and atomoxetine, respectively, from 2007 to 2012. Ninety participants (7 %) were switched from methylphenidate to atomoxetine, and 138 (18 %) from atomoxetine to methylphenidate. Thirty-seven children treated with atomoxetine and 12 with methylphenidate had their medication withdrawn. Overall, 645 patients (26.8 %) experienced at least one mild AE (including decreased appetite and irritability, for both drugs) and 95 patients (3.9 %) experienced at least one severe AE (including severe gastrointestinal events). IR100PY were significantly higher in the atomoxetine-treated group compared with the methylphenidate-treated group for a number of mild and severe AEs and for any severe or mild AEs. After controlling for comorbidities, IRR was still significantly higher in the atomoxetine group compared with the methylphenidate group for a number of mild (decreased appetite, weight loss, abdominal pain, dyspepsia, stomach ache, irritability, mood disorder and dizziness) and severe (gastrointestinal, neuropsychiatric, and cardiovascular) AEs. In this naturalistic study, methylphenidate had a better safety profile than atomoxetine.

Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation.

PubMed

Tzannou, Ifigeneia; Papadopoulou, Anastasia; Naik, Swati; Leung, Kathryn; Martinez, Caridad A; Ramos, Carlos A; Carrum, George; Sasa, Ghadir; Lulla, Premal; Watanabe, Ayumi; Kuvalekar, Manik; Gee, Adrian P; Wu, Meng-Fen; Liu, Hao; Grilley, Bambi J; Krance, Robert A; Gottschalk, Stephen; Brenner, Malcolm K; Rooney, Cliona M; Heslop, Helen E; Leen, Ann M; Omer, Bilal

2017-11-01

Purpose Improvement of cure rates for patients treated with allogeneic hematopoietic stem-cell transplantation (HSCT) will require efforts to decrease treatment-related mortality from severe viral infections. Adoptively transferred virus-specific T cells (VSTs) generated from eligible, third-party donors could provide broad antiviral protection to recipients of HSCT as an immediately available off-the-shelf product. Patient and Methods We generated a bank of VSTs that recognized five common viral pathogens: Epstein-Barr virus (EBV), adenovirus (AdV), cytomegalovirus (CMV), BK virus (BKV), and human herpesvirus 6 (HHV-6). The VSTs were administered to 38 patients with 45 infections in a phase II clinical trial. Results A single infusion produced a cumulative complete or partial response rate of 92% (95% CI, 78.1% to 98.3%) overall and the following rates by virus: 100% for BKV (n = 16), 94% for CMV (n = 17), 71% for AdV (n = 7), 100% for EBV (n = 2), and 67% for HHV-6 (n = 3). Clinical benefit was achieved in 31 patients treated for one infection and in seven patients treated for multiple coincident infections. Thirteen of 14 patients treated for BKV-associated hemorrhagic cystitis experienced complete resolution of gross hematuria by week 6. Infusions were safe, and only two occurrences of de novo graft-versus host disease (grade 1) were observed. VST tracking by epitope profiling revealed persistence of functional VSTs of third-party origin for up to 12 weeks. Conclusion The use of banked VSTs is a feasible, safe, and effective approach to treat severe and drug-refractory infections after HSCT, including infections from two viruses (BKV and HHV-6) that had never been targeted previously with an off-the-shelf product. Furthermore, the multispecificity of the VSTs ensures extensive antiviral coverage, which facilitates the treatment of patients with multiple infections.

Quality of life and growth after childhood craniopharyngioma: results of the multinational trial KRANIOPHARYNGEOM 2007.

PubMed

Heinks, Kerstin; Boekhoff, Svenja; Hoffmann, Anika; Warmuth-Metz, Monika; Eveslage, Maria; Peng, Junxiang; Calaminus, Gabriele; Müller, Hermann L

2018-02-01

Quality of life (QoL) after childhood-onset craniopharyngioma (CP) is frequently impaired due to tumor and/or treatment-related factors such as endocrine deficits and hypothalamic involvement/lesions. In a multinational trial, we prospectively analyzed parental and self-assessment of CP patient QoL at 3 months, 1 and 3 years after CP diagnosis related to growth hormone (GH) substitution. 47 of 194 CP recruited between 2007 and 2015 in KRANIOPHARYNGEOM 2007 were analyzed for QoL 1 and 3 years after CP diagnosis. QoL was assessed by Pediatric Quality of Life (PEDQOL) questionnaire and PEDQOL scores of parental and self-assessed QoL during 3 years follow-up after CP diagnosis were analyzed. Parents estimated QoL of their children worse than patients did themselves. GH substitution had no relevant effect on short-term weight and height development. CP patients GH-treated at 3 years follow-up presented at baseline (1 year after diagnosis, before GH substitution) with reduced self-assessed QoL when compared with GH non-treated CP. QoL stabilized during 1-3 years of follow-up in GH-treated patients, whereas non GH-treated patients experienced decreases in autonomy (p = 0.03), cognition (p = 0.01), and physical function (p = 0.04). Parents assess QoL in CP survivors worse than their children. GH substitution should be considered as a therapeutic option to ameliorate imminent impairments of QoL after CP.

Probiotic mix VSL#3 is effective adjunctive therapy for mild to moderately active ulcerative colitis: a meta-analysis.

PubMed

Mardini, Houssam E; Grigorian, Alla Y

2014-09-01

VSL#3 is a probiotic mix preparation reported to be effective in the treatment of mild to moderately active ulcerative colitis. We aimed to perform a systematic review of the literature and a meta-analysis of studies on its efficacy. The searched databases included PubMed, Scopus, and ScienceDirect. The Mantel-Haenszel method was used to pool the effect- ize across studies, and the odds ratios (ORs) and 95% confidence intervals (CIs) of experiencing a specific outcome were calculated. Five studies with 441 patients were identified. The pooled remission rate was 49.4% (95% CI, 42.7-56.1). Only 3 low risk of bias studies with 319 patients met the inclusion criteria for further analysis. A total of 162 patients received 3.6 × 10 CFU/d VSL#3, and 157 patients received placebo. A total of 95% of patients received concomitant therapies with 5-ASA and/or immunomodulators. The Ulcerative Colitis Disease Activity Index was used to define response and remission. A >50% decrease in the Ulcerative Colitis Disease Activity Index was achieved in 44.6% of the VSL#3-treated patients versus 25.1% of the patients given placebo (P = 0008; OR, 2.793; 95% CI, 1.375-5.676; number needed to treat = 4-5). The response rate was 53.4% in VSL#3-treated patients versus 29.3% in patients given placebo (P < 0001; OR, 3.03; 95% CI, 1.89-4.83; number needed to treat = 3-4). The remission rate was 43.8% in VSL#3-treated patients versus 24.8% in patients given placebo (P = 0007; OR, 2.4; 95% CI, 1.48-3.88; number needed to treat = 4-5). No serious side effects were reported. VSL#3, when added to conventional therapy at a daily dose of 3.6 × 10 CFU/d, is safe and more effective than conventional therapy alone in achieving higher response and remission rates in mild to moderately active ulcerative colitis.

4-step 4-h carboplatin desensitization protocol for patients with gynecological malignancies showing platinum hypersensitivity: a retrospective study.

PubMed

Takase, Naoto; Matsumoto, Koji; Onoe, Takuma; Kitao, Akihito; Tanioka, Maki; Kikukawa, Yoshitaka; Yamaguchi, Satoshi; Fujiwara, Kiyoshi; Negoro, Shunichi

2015-06-01

Platinum agents are essential for treating gynecological malignancies, particularly ovarian cancer. However, multiple carboplatin doses may cause hypersensitivity reactions (HSRs). Carboplatin desensitization prevents life-threatening HSRs and promotes the successful completion of planned chemotherapy. Since January 2010, carboplatin desensitization was performed at our institution. Solutions with 1/1000, 1/100, and 1/10 dilutions of carboplatin and an undiluted solution were prepared in 250 mL of 5% glucose. Each solution was administered as a 1-h intravenous infusion (4-step 4-h protocol). This retrospective analysis was approved by the institutional review board. From January 2010 to December 2013, 20 patients with gynecological malignancies (median age 62 years, range 43-74 years) received desensitization treatment. The International Federation of Gynecology and Obstetrics stages at presentation were I, II, III, and IV in 1, 1, 15, 13 patients, respectively. During first-line and second-line treatments, 3 and 17 patients, respectively, experienced carboplatin-induced HSRs. The median carboplatin cycle number was 11 (range 2-16). In the first desensitization cycle, 17 (85%) patients completed treatment without adverse events, 2 experienced Grade 1 HSRs but completed treatment, and 1 experienced Grade 3 HSR and discontinued treatment. The first desensitization cycle completion rate was 95%. Of 83 desensitization cycles administered, 79 (95.2%) were completed. No treatment-related deaths occurred. Most patients completed the planned chemotherapy. Our protocol could be conducted safely with shorter duration and simpler procedures than previous protocols. Carboplatin desensitization seems beneficial for patients with a history of carboplatin-induced HSRs; however, the risk of HSR recurrence still remains. Desensitization should therefore be performed only by well-trained staff.

Low-Dose Ketamine Infusion for Adjunct Management during Vaso-occlusive Episodes in Adults with Sickle Cell Disease: A Case Series.

PubMed

Palm, Nicole; Floroff, Catherine; Hassig, Tanna B; Boylan, Alice; Kanter, Julie

2018-05-23

The optimal management of recurrent painful episodes in individuals living with sickle cell disease (SCD) remains unclear. Currently, the primary treatment for these episodes remains supportive, using fluids and intravenous opioid and anti-inflammatory medications. Few reports have described the use of adjunct subanesthetic doses of ketamine to opioids for treatment of refractory pain in SCD. This article reports a retrospective case series of five patients admitted to the intensive care unit (ICU) with prolonged vaso-occlusive episodes (VOEs). Patients were treated with a continuous-infusion of low-dose ketamine (up to 5 µg/kg/min) after insufficient pain control with opioid analgesic therapy. Outcomes studied included impact on opioid analgesic use, a description of ketamine dosing strategy, and an analysis of adverse events due to opioid or ketamine analgesia. Descriptive statistics are provided. During ketamine infusion, patients experienced a lower reported pain score (mean numeric rating scale [NRS] score 7.2 vs. 6.4), reduced opioid-induced adverse effects, and decreased opioid dosing requirements (median reduction of 90 mg morphine equivalents per patient). The average duration of severe pain during admission prior to ketamine therapy was 8 days. Only one of five patients reported an adverse effect (vivid dreams) secondary to ketamine infusion. The Richmond Agitation Sedation Scale (RASS) was assessed throughout therapy, with only one patient experiencing light drowsiness. Low-dose ketamine infusion may be considered as an adjunct analgesic agent in patients with vaso-occlusive episodes who report continued severe pain despite high-dose opioid therapy, particularly those experiencing opioid-induced adverse effects.

Impact of Diabetes, Insulin, and Metformin Use on the Outcome of Patients With Human Epidermal Growth Factor Receptor 2-Positive Primary Breast Cancer: Analysis From the ALTTO Phase III Randomized Trial.

PubMed

Sonnenblick, Amir; Agbor-Tarh, Dominique; Bradbury, Ian; Di Cosimo, Serena; Azim, Hatem A; Fumagalli, Debora; Sarp, Severine; Wolff, Antonio C; Andersson, Michael; Kroep, Judith; Cufer, Tanja; Simon, Sergio D; Salman, Pamela; Toi, Masakazu; Harris, Lyndsay; Gralow, Julie; Keane, Maccon; Moreno-Aspitia, Alvaro; Piccart-Gebhart, Martine; de Azambuja, Evandro

2017-05-01

Purpose Previous studies have suggested an association between metformin use and improved outcome in patients with diabetes and breast cancer. In the current study, we aimed to explore this association in human epidermal growth factor receptor 2 (HER2 ) -positive primary breast cancer in the context of a large, phase III adjuvant trial. Patients and Methods The ALTTO trial randomly assigned patients with HER2-positive breast cancer to receive 1 year of either trastuzumab alone, lapatinib alone, their sequence, or their combination. In this substudy, we evaluated whether patients with diabetes at study entry-with or without metformin treatment-were associated with different disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS) compared with patients without diabetes. Results A total of 8,381 patients were included in the current analysis: 7,935 patients (94.7%) had no history of diabetes at diagnosis, 186 patients (2.2%) had diabetes with no metformin treatment, and 260 patients (3.1%) were diabetic and had been treated with metformin. Median follow-up was 4.5 years (0.16 to 6.31 years), at which 1,205 (14.38%), 929 (11.08%), and 528 (6.3%) patients experienced DFS, DDFS, and OS events, respectively. Patients with diabetes who had not been treated with metformin experienced worse DFS (multivariable hazard ratio [HR], 1.40; 95% CI, 1.01 to 1.94; P = .043), DDFS (multivariable HR, 1.56; 95% CI, 1.10 to 2.22; P = .013), and OS (multivariable HR, 1.87; 95% CI, 1.23 to 2.85; P = .004). This effect was limited to hormone receptor-positive patients. Whereas insulin treatment was associated with a detrimental effect, metformin had a salutary effect in patients with diabetes who had HER2-positive and hormone receptor-positive breast cancer. Conclusion Metformin may improve the worse prognosis that is associated with diabetes and insulin treatment, mainly in patients with primary HER2-positive and hormone receptor-positive breast cancer.

Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study.

PubMed

Khunti, K; Alsifri, S; Aronson, R; Cigrovski Berković, M; Enters-Weijnen, C; Forsén, T; Galstyan, G; Geelhoed-Duijvestijn, P; Goldfracht, M; Gydesen, H; Kapur, R; Lalic, N; Ludvik, B; Moberg, E; Pedersen-Bjergaard, U; Ramachandran, A

2016-09-01

To determine the global extent of hypoglycaemia experienced by patients with diabetes using insulin, as there is a lack of data on the prevalence of hypoglycaemia in developed and developing countries. This non-interventional, multicentre, 6-month retrospective and 4-week prospective study using self-assessment questionnaire and patient diaries included 27 585 patients, aged ≥18 years, with type 1 diabetes (T1D; n = 8022) or type 2 diabetes (T2D; n = 19 563) treated with insulin for >12 months, at 2004 sites in 24 countries worldwide. The primary endpoint was the proportion of patients experiencing at least one hypoglycaemic event during the observational period. During the prospective period, 83.0% of patients with T1D and 46.5% of patients with T2D reported hypoglycaemia. Rates of any, nocturnal and severe hypoglycaemia were 73.3 [95% confidence interval (CI) 72.6-74.0], 11.3 (95% CI 11.0-11.6) and 4.9 (95% CI 4.7-5.1) events/patient-year for T1D and 19.3 (95% CI 19.1-19.6), 3.7 (95% CI 3.6-3.8) and 2.5 events/patient-year (95% CI 2.4-2.5) for T2D, respectively. The highest rates of any hypoglycaemia were observed in Latin America for T1D and Russia for T2D. Glycated haemoglobin level was not a significant predictor of hypoglycaemia. We report hypoglycaemia rates in a global population, including those in countries without previous data. Overall hypoglycaemia rates were high, with large variations between geographical regions. Further investigation into these differences may help to optimize therapy and reduce the risk of hypoglycaemia. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Normal Tissue Complication Probability Modeling of Acute Hematologic Toxicity in Patients Treated With Intensity-Modulated Radiation Therapy for Squamous Cell Carcinoma of the Anal Canal

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

Bazan, Jose G.; Luxton, Gary; Mok, Edward C.

2012-11-01

Purpose: To identify dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with squamous cell carcinoma of the anal canal treated with definitive chemoradiotherapy (CRT). Methods and Materials: We analyzed 33 patients receiving CRT. Pelvic bone (PBM) was contoured for each patient and divided into subsites: ilium, lower pelvis (LP), and lumbosacral spine (LSS). The volume of each region receiving at least 5, 10, 15, 20, 30, and 40 Gy was calculated. Endpoints included grade {>=}3 HT (HT3+) and hematologic event (HE), defined as any grade {>=}2 HT with a modification in chemotherapy dose. Normal tissue complication probabilitymore » (NTCP) was evaluated with the Lyman-Kutcher-Burman (LKB) model. Logistic regression was used to test associations between HT and dosimetric/clinical parameters. Results: Nine patients experienced HT3+ and 15 patients experienced HE. Constrained optimization of the LKB model for HT3+ yielded the parameters m = 0.175, n = 1, and TD{sub 50} = 32 Gy. With this model, mean PBM doses of 25 Gy, 27.5 Gy, and 31 Gy result in a 10%, 20%, and 40% risk of HT3+, respectively. Compared with patients with mean PBM dose of <30 Gy, patients with mean PBM dose {>=}30 Gy had a 14-fold increase in the odds of developing HT3+ (p = 0.005). Several low-dose radiation parameters (i.e., PBM-V10) were associated with the development of HT3+ and HE. No association was found with the ilium, LP, or clinical factors. Conclusions: LKB modeling confirms the expectation that PBM acts like a parallel organ, implying that the mean dose to the organ is a useful predictor for toxicity. Low-dose radiation to the PBM was also associated with clinically significant HT. Keeping the mean PBM dose <22.5 Gy and <25 Gy is associated with a 5% and 10% risk of HT, respectively.« less

Effect of intravenous amiodarone on QT and T peak-T end dispersions in patients with nonischemic heart failure treated with cardiac resynchronization-defibrillator therapy and electrical storm.

PubMed

Ogiso, Masataka; Suzuki, Atsushi; Shiga, Tsuyoshi; Nakai, Kenji; Shoda, Morio; Hagiwara, Nobuhisa

2015-02-01

The effect of intravenous amiodarone on spatial and transmural dispersion of ventricular repolarization in patients receiving cardiac resynchronization therapy (CRT) remains unclear. We studied 14 patients with nonischemic heart failure who received CRT with a defibrillator, experienced electrical storm and were treated with intravenous amiodarone. Each patient underwent 12-lead electrocardiography (ECG) and 187-channel repolarization interval-difference mapping electrocardiography (187-ch RIDM-ECG) before and during the intravenous administration of amiodarone infusion. A recurrence of ventricular tachyarrhythmia was observed in 2 patients during the early period of intravenous amiodarone therapy. Intravenous amiodarone increased the corrected QT interval (from 470±52 ms to 508±55 ms, P=0.003), but it significantly decreased the QT dispersion (from 107±35 ms to 49±27 ms, P=0.001), T peak-T end (Tp-e) dispersion (from 86±17 ms to 28±28 ms, P=0.001), and maximum inter-lead difference between corrected Tp-e intervals as measured by using the 187-ch RIDM-ECG (from 83±13 ms to 50±19 ms, P=0.001). Intravenous amiodarone suppressed the electrical storm and decreased the QT and Tp-e dispersions in patients treated by using CRT with a defibrillator.

Prevalence and impact of baseline resistance-associated substitutions on the efficacy of ledipasvir/sofosbuvir or simeprevir/sofosbuvir against GT1 HCV infection.

PubMed

Wang, Gary P; Terrault, Norah; Reeves, Jacqueline D; Liu, Lin; Li, Eric; Zhao, Lisa; Lim, Joseph K; Morelli, Giuseppe; Kuo, Alexander; Levitsky, Josh; Sherman, Kenneth E; Frazier, Lynn M; Ramani, Ananthakrishnan; Peter, Joy; Akuskevich, Lucy; Fried, Michael W; Nelson, David R

2018-02-16

Baseline resistance-associated substitutions (RASs) have variable impacts in clinical trials but their prevalence and impact in real-world patients remains unclear. We performed baseline resistance testing using a commercial assay (10% cutoff) for 486 patients treated with LDV/SOF or SMV/SOF, with or without ribavirin, in the multi-center, observational HCV-TARGET cohort. Linkage of RASs was evaluated in selected samples using a novel quantitative single variant sequencing assay. Our results showed that the prevalence of NS3, NS5A, NS5B RASs was 45%, 13%, and 8%, respectively, and 10% of patients harbored RASs in 2 or more drug classes. Baseline LDV RASs in GT1a, TE, and cirrhosis LDV/SOF subgroup was associated with 2-4% lower SVR12 rates. SMV RASs was associated with lower SVR12 rates in GT1a, treatment-experienced, cirrhotics SMV/SOF subgroup. Pooled analysis of all patients with baseline RASs revealed that SVR12 was 100% (19/19) in patients treated for longer than 98 days but was 87% (81/93) in patients treated for shorter than 98 days. These results demonstrate that RASs prevalence and their impact in real world practice are in general agreement with registration trials, and suggest that longer treatment duration may overcome the negative impact of baseline RASs on SVR12 rates in clinical practice.

Systemic and local reactions of bee venom immunotherapy in Iran.

PubMed

Bemanian, Mohammad Hassan; Farhoudi, Abolhassan; Pourpak, Zahra; Gharagozlou, Mohammad; Movahedi, Masoud; Nabavi, Mohammad; Mozafari, Habibeh; Mohammadzadeh, Iraj; Chavoshzadeh, Zahra; Shirkhoda, Zahra

2007-12-01

Severe allergic reactions during specific immunotherapy may occur in the treatment of hymenoptera sting allergy. The objective of the present study was to examine the characteristics of allergic reactions during specific immunotherapy in patients with allergy towards hymenoptera venom in the Iranian population. A prospective study was performed using the clinical reports of 27 patients with anaphylaxis to bee venom (Apis melifera, Geupes vespula and Geupes Polites). Ten patients treated with Cluster protocol during 2002 and 2006 After diagnosis of hymenoptera sting allergy according to history and intradermal tests, the patient were treated with Cluster protocol immunotherapy. The protocol lasted 6 weeks with an increase in the concentration of venom from 0.01 microg/ml to 100 microg/ml. None of the patient received premedication. All patients with hymenoptera venom allergy received 120 injections. Anaphylactic reactions were classified according to the Mueller-classification. The frequencies of systemic reactions during Cluster protocol were 8.33% and 5% for yellow jacket and honey bee venom respectively. No patient experienced severe systemic reaction. Cluster protocol for hymenoptera immunotherapy is a reliable method for the treatment of anaphylactic reactions to bee venom. It is safe with low cost and do not need hospitalization.

Morphological characteristics in peritoneum in patients with neutral peritoneal dialysis solution.

PubMed

Hamada, Chieko; Honda, Kazuho; Kawanishi, Kunio; Nakamoto, Hirotaka; Ito, Yasuhiko; Sakurada, Tsutomu; Tanno, Yudo; Mizumasa, Toru; Miyazaki, Masanobu; Moriishi, Misaki; Nakayama, Masaaki

2015-09-01

Peritoneal dialysis solution (PDS) plays a role in functional and morphological damage to the peritoneum. This study aimed to clarify the effect of neutral PDS in preventing morphological changes by assessing peritoneal damage and comparing morphological alterations between PD patients treated with neutral PDS and acidic PDS. Sixty-one patients participated from seven hospitals. All patients were treated with neutral PDS excluding icodextrin, during their entire PD treatment, and experienced no episode of peritonitis. The thickness of submesothelial compact (SMC) zone and the presence of vasculopathy in the anterior parietal abdominal peritoneum were assessed. The impact of icodextrin, hybrid therapy, and peritoneal rest and lavage in morphological alterations were determined. There was no significant difference in the average SMC thickness between neutral and acidic PDS. The vessel patency in patients using neutral PDS was significantly higher compared to that in acidic PDS at any time during PD. There were no significant suppressive effects from interventions or use of icodextrin with respect to peritoneal morphological injury. A monolayer of mesothelial cell was observed in approximately half the patients, especially in their receiving lavage patients. Neutral PDS, accompanied by other preventive approaches against peritoneal injury, might suppress the development of peritoneal morphological alterations.

Pembrolizumab Plus Pegylated Interferon alfa-2b or Ipilimumab for Advanced Melanoma or Renal Cell Carcinoma: Dose-Finding Results from the Phase Ib KEYNOTE-029 Study.

PubMed

Atkins, Michael B; Hodi, F Stephen; Thompson, John A; McDermott, David F; Hwu, Wen-Jen; Lawrence, Donald P; Dawson, Nancy A; Wong, Deborah J; Bhatia, Shailender; James, Marihella; Jain, Lokesh; Robey, Seth; Shu, Xinxin; Homet Moreno, Blanca; Perini, Rodolfo F; Choueiri, Toni K; Ribas, Antoni

2018-04-15

Purpose: Pembrolizumab monotherapy, ipilimumab monotherapy, and pegylated interferon alfa-2b (PEG-IFN) monotherapy are active against melanoma and renal cell carcinoma (RCC). We explored the safety and preliminary antitumor activity of pembrolizumab combined with either ipilimumab or PEG-IFN in patients with advanced melanoma or RCC. Experimental Design: The phase Ib KEYNOTE-029 study (ClinicalTrials.gov, NCT02089685) included independent pembrolizumab plus reduced-dose ipilimumab and pembrolizumab plus PEG-IFN cohorts. Pembrolizumab 2 mg/kg every 3 weeks (Q3W) plus 4 doses of ipilimumab 1 mg/kg Q3W was tolerable if ≤6 of 18 patients experienced a dose-limiting toxicity (DLT). The target DLT rate for pembrolizumab 2 mg/kg Q3W plus PEG-IFN was 30%, with a maximum of 14 patients per dose level. Response was assessed per RECIST v1.1 by central review. Results: The ipilimumab cohort enrolled 22 patients, including 19 evaluable for DLTs. Six patients experienced ≥1 DLT. Grade 3 to 4 treatment-related adverse events occurred in 13 (59%) patients. Responses occurred in 5 of 12 (42%) patients with melanoma and 3 of 10 (30%) patients with RCC. In the PEG-IFN cohort, DLTs occurred in 2 of 14 (14%) patients treated at dose level 1 (PEG-IFN 1 μg/kg/week) and 2 of 3 (67%) patients treated at dose level 2 (PEG-IFN 2 μg/kg/week). Grade 3 to 4 treatment-related adverse events occurred in 10 of 17 (59%) patients. Responses occurred in 1 of 5 (20%) patients with melanoma and 2 of 12 (17%) patients with RCC. Conclusions: Pembrolizumab 2 mg/kg Q3W plus ipilimumab 1 mg/kg Q3W was tolerable and provided promising antitumor activity in patients with advanced melanoma or RCC. The maximum tolerated dose of pembrolizumab plus PEG-IFN had limited antitumor activity in this population. Clin Cancer Res; 24(8); 1805-15. ©2018 AACR . ©2018 American Association for Cancer Research.

Not so benign haematology: anaemia of the elderly

PubMed Central

Merchant, Akil A.; Roy, Cindy N.

2011-01-01

Summary Developed countries, such as the United Kingdom, are experiencing a change in demographics resulting in the largest proportion of adults over 65 years of age that our health systems have ever experienced. As such, haematologists must be prepared to evaluate and treat anaemia in a more complicated patient population, but sufficient evidence-based guidelines are lacking. Critical next steps that must be taken to ensure the best care of this population include the determination of appropriate haemoglobin concentrations for older adults in light of age, gender, race, and comorbidities; the development of interventional trials that address physical performance outcomes in addition to haemoglobin targets; and translational studies which address the molecular pathogenesis of anaemia in older adults with the most advanced scientific approaches. PMID:22050828

Salvage of Ear Framework Exposure in Total Auricular Reconstruction.

PubMed

Kim, Young Soo; Yun, In Sik; Chung, Seum

2017-02-01

One of the most common complications of total auricular reconstruction is delayed wound healing, which results in skin necrosis and exposure of the ear framework. Various options exist for salvage of the exposed ear framework. From January 2009 to May 2014, 149 patients underwent total auricular reconstruction using an autogenous cartilage framework or porous polyethylene framework (Medpor; Stryker, USA). An autogenous cartilage framework was used in 48 patients, and a Medpor framework was used in 101 cases. Three cases of framework exposure (3/48, 6.3%) were observed among the patients treated with an autogenous cartilage framework. In contrast, framework exposure took place in 11 patients who were treated with a Medpor framework (11/101, 10.9%). Depending on the method of total ear reconstruction and the location of exposure, the authors used local skin flaps, temporoparietal fascia flaps, deep temporal fascia (DTF) flaps, or mastoid fascia (MF) flaps with skin grafting. Among the 11 patients who experienced framework exposure after being treated with a Medpor framework, a DTF flap with skin grafting was used in 6 patients and an MF flap with skin grafting in 6 patients; 1 patient was treated with both a DTF flap and an MF flap. All 3 cases of cartilage framework exposure were salvaged using a temporoparietal fascia flap with skin grafting, and a local skin flap was used in 1 case. In all 3 cases, the exposed framework was completely covered with the flap, and the reconstructed ears showed well-defined convolutions. Salvage of framework exposure remains a challenging issue in total auricular reconstruction. However, appropriate wound management using various flaps allows the reconstructed ear to be safely preserved.

Rationale and early outcomes for the management of thymoma with proton therapy.

PubMed

Zhu, He J; Hoppe, Bradford S; Flampouri, Stella; Louis, Debbie; Pirris, John; Nichols, R Charles; Henderson, Randal H; Mercado, Catherine E

2018-04-01

Radiotherapy for thymic malignancies is technically challenging due to their close proximity to the heart, lungs, esophagus, and breasts, raising concerns about significant acute and late toxicities from conventional photon radiotherapy. Proton therapy (PT) may reduce the radiation dose to these vital organs, leading to less toxicity. We reviewed the dosimetry and outcomes among patients treated with PT for thymic malignancies at our institution. From January 2008 to March 2017, six patients with de novo Masaoka stages II-III thymic malignancies were treated with PT on an IRB-approved outcomes tracking protocol. Patients were evaluated weekly during treatment, then every 3 months for 2 years, then every 6 months for 3 more years, and then annually for CTCAE vs. four toxicities and disease recurrence. Comparison intensity-modulated radiotherapy (IMRT) plans were developed for each patient. Mean doses to the heart, esophagus, bilateral breasts, lungs, and V20 of bilateral lungs were evaluated for the two treatment plans. At last follow-up (median follow-up, 2.6 years), there were two patients with recurrences, including metastatic disease in the patient treated definitively with chemotherapy and PT without surgery and a local-regional recurrence in the lung outside the proton field in one of the post-operative cases. No patients with de novo disease experienced grade ≥3 toxicities after PT. The mean dose to the heart, lung, and esophagus was reduced on average by 36.5%, 33.5%, and 60%, respectively, using PT compared with IMRT (P<0.05 for each dose parameter). PT achieved superior dose sparing to the heart, lung, and esophagus compared to IMRT for thymic malignancies. Patients treated with PT had few radiation-induced toxicities and similar survival compared to historic proton data.

Clinical trial of a novel surface cooling system for fever control in neurocritical care patients.

PubMed

Mayer, Stephan A; Kowalski, Robert G; Presciutti, Mary; Ostapkovich, Noeleen D; McGann, Elaine; Fitzsimmons, Brian-Fred; Yavagal, Dileep R; Du, Y Evelyn; Naidech, Andrew M; Janjua, Nazli A; Claassen, Jan; Kreiter, Kurt T; Parra, Augusto; Commichau, Christopher

2004-12-01

To compare the efficacy of a novel water-circulating surface cooling system with conventional measures for treating fever in neuro-intensive care unit patients. Prospective, unblinded, randomized controlled trial. Neurologic intensive care unit in an urban teaching hospital. Forty-seven patients, the majority of whom were mechanically ventilated and sedated, with fever > or =38.3 degrees C for >2 consecutive hours after receiving 650 mg of acetaminophen. Subjects were randomly assigned to 24 hrs of treatment with a conventional water-circulating cooling blanket placed over the patient (Cincinnati SubZero, Cincinnati OH) or the Arctic Sun Temperature Management System (Medivance, Louisville CO), which employs hydrogel-coated water-circulating energy transfer pads applied directly to the trunk and thighs. Diagnoses included subarachnoid hemorrhage (60%), cerebral infarction (23%), intracerebral hemorrhage (11%), and traumatic brain injury (4%). The groups were matched in terms of baseline variables, although mean temperature was slightly higher at baseline in the Arctic Sun group (38.8 vs. 38.3 degrees C, p = .046). Compared with patients treated with the SubZero blanket (n = 24), Arctic Sun-treated patients (n = 23) experienced a 75% reduction in fever burden (median 4.1 vs. 16.1 C degrees -hrs, p = .001). Arctic Sun-treated patients also spent less percent time febrile (T > or =38.3 degrees C, 8% vs. 42%, p < .001), spent more percent time normothermic (T < or =37.2 degrees C, 59% vs. 3%, p < .001), and attained normothermia faster than the SubZero group median (2.4 vs. 8.9 hrs, p = .008). Shivering occurred more frequently in the Arctic Sun group (39% vs. 8%, p = .013). The Arctic Sun Temperature Management System is superior to conventional cooling-blanket therapy for controlling fever in critically ill neurologic patients.

Hypnosis in contemporary medicine.

PubMed

Stewart, James H

2005-04-01

Hypnosis became popular as a treatment for medical conditions in the late 1700s when effective pharmaceutical and surgical treatment options were limited. To determine whether hypnosis has a role in contemporary medicine, relevant trials and a few case reports are reviewed. Despite substantial variation in techniques among the numerous reports, patients treated with hypnosis experienced substantial benefits for many different medical conditions. An expanded role for hypnosis and a larger study of techniques appear to be indicated.

Delirium following fesoterodine treatment for urgency incontinence in an 89-year old man.

PubMed

Charbonneau, Jeannie Medeiros; Bisset, Rania; Nguyen, Patrick Viet-Quoc

2016-01-01

We describe the case of an 89-year-old man who developed delirium following the introduction of fesoterodine to treat his urgency incontinence. The patient started experiencing visual hallucinations approximately five days after starting fesoterodine 4 mg once daily. Delirium resolved after fesoterodine was stopped. Despite the apparent safe cognitive profile due to its pharmacodynamic properties, fesoterodine should be used with caution in the elderly, frail population.

Role of IL-17-producing lymphocytes in severity of multiple sclerosis upon natalizumab treatment.

PubMed

Bühler, Ulrike; Fleischer, Vinzenz; Luessi, Felix; Rezk, Ayman; Belikan, Patrick; Graetz, Christiane; Gollan, René; Wolf, Christina; Lutz, Jens; Bar-Or, Amit; Siffrin, Volker; Zipp, Frauke

2017-04-01

Natalizumab is known to prevent T-helper cells entering the central nervous system (CNS). We hypothesize that more pathogenic T-helper cells are present outside the CNS and a possible relationship to disease severity. Characterization and enrichment of human CD4+IL-17+ cells were performed ex vivo using peripheral blood mononuclear cells from natalizumab-treated relapsing-remitting multiple sclerosis (RRMS) patients ( n = 33), untreated RRMS patients ( n = 13), and healthy controls ( n = 33). Magnetic resonance imaging (MRI) scans were performed routinely for patients. Lymphocytes were elevated in peripheral blood of natalizumab-treated patients compared to untreated patients and healthy controls. Whereas group comparison for CD4+IL-17+ numbers also differed, CD4+IFN-γ+ and CD4+IL-22+ counts were not increased. CD4+IL-17+ cells not only expressed but also secreted IL-17. In natalizumab-treated patients, IL-17+ cell frequency was found to correlate with T1-hypointense lesions, but was not an indicator for rebound activity after treatment discontinuation, except in one patient who experienced a fulminant rebound, and interestingly, in whom the highest IL-17+ cell levels were observed. Increased lymphocytes and CD4+IL-17+ cells in the blood of RRMS patients receiving natalizumab corroborate the drug's mechanism of action, that is, blocking transmigration to CNS. Correlation between IL-17-expressing lymphocytes and T1-hypointense lesions underlines the important role of these cells in the disease pathology.

Selective serotonin reuptake inhibitor discontinuation: side effects and other factors that influence medication adherence.

PubMed

Goethe, John W; Woolley, Stephen B; Cardoni, Alex A; Woznicki, Brenda A; Piez, Deborah A

2007-10-01

Patients with major depression discontinue taking their antidepressants for many reasons. Although side effects are often cited as the reason for discontinuation, few prospective studies have addressed this question, and none has specifically examined discontinuation in patients with severe depression. Inpatients and outpatients treated with a selective serotonin reuptake inhibitor for major depressive disorder were identified after admission. Three months later, patients were contacted and interviewed to determine antidepressant usage and the side effects experienced, including when these were experienced and their severity. Between October 2001 and April 2003, 406 English- or Spanish-speaking patients aged 18 to 75 years were followed up. One in 4 patients discontinued the index antidepressant. Among specific side effects noted, only "change in weight" and "anxiety" were significant predictors of discontinuation after controlling for confounders. Experiencing 1 or more "extremely" bothersome side effects was associated with more than a doubling of the risk of discontinuation, but the presence of side effects and side effects less severe than "extremely" bothersome were not significant predictors. There were no differences among selective serotonin reuptake inhibitor antidepressants in either the presence/absence of side effects or in the discontinuation rates. The results suggest that the contribution of side effects to antidepressant discontinuation is more complex than previously suggested. Disparate findings from earlier studies may reflect aspects of study design, such as examining populations whose severity of depression varied widely or not controlling for important confounding factors. Future research should separately examine high-risk groups (or control for severity of depression) and carefully rule out other potential contributors to discontinuation.

Treatment of HIV-related fatigue with armodafinil: a placebo-controlled randomized trial.

PubMed

Rabkin, Judith G; McElhiney, Martin C; Rabkin, Richard

2011-01-01

To evaluate the efficacy and safety of armodafinil in the treatment of fatigue in HIV+ patients, and to assess its effect on depressive symptoms and behavior once fatigue remitted. HIV+ patients with clinically significant fatigue were treated in a placebo-controlled randomized double-blind trial for 4 weeks. Armodafinil responders and placebo non-responders or relapsers were treated openly for a total of 16 weeks with armodafinil. The primary outcome measure for fatigue and depression was the Clinical Global Impressions-Improvement Scale, supplemented by the Fatigue Severity Scale, the Hamilton Depression Rating Scale, and the Beck Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV RNA viral load and the SAFTEE side effects rating scale. Maximum trial dose of armodafinil was 250 mg/d. Seventy patients were enrolled. Attrition was 9%. In intention-to-treat analyses, fatigue response rate to armodafinil was 75% and to placebo, 26%. Armodafinil did not reduce depressive symptoms in the absence of improved energy, but of those patients with an Axis I depressive disorder at study entry whose energy improved, 82% experienced improved mood as well. Markers of immunologic suppression did not change during treatment. At 6 months, those still taking armodafinil had more energy and fewer depressive symptoms than those who were no longer taking it. As we found in our RCT of modafinil, armodafinil appears effective and well tolerated in treating fatigue in HIV+ patients. Side effects were minimal and most patients reported substantially improved energy and mood. Copyright © 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Treatment of HIV-Related Fatigue with Armodafinil: A Placebo-controlled Randomized Trial

PubMed Central

Rabkin, Judith G.; McElhiney, Martin C.; Rabkin, Richard

2011-01-01

Objective To evaluate the efficacy and safety of armodafinil in the treatment of fatigue in HIV+ patients, and to assess effect on depressive symptoms and behavior once fatigue remitted. Method HIV+ patients with clinically significant fatigue were treated in a placebo controlled randomized double-blind trial for 4 weeks. Armodafinil responders and placebo non-responders or relapsers were treated openly for a total of 16 weeks of armodafinil. The primary outcome measure for fatigue and depression was the Clinical Global Impressions-Improvement Scale, supplemented by the Fatigue Severity Scale, Hamilton Depression Rating Scale and Beck Depression Inventory. Safety was assessed with assays of CD4 cell count and HIV RNA viral load and the SAFTEE side effects rating scale. Maximum trial dose of armodafinil was 250 mg/day. Results 70 patients were enrolled. Attrition was 9%. In Intention-to-treat analyses, fatigue response rate to armodafinil was 75% and to placebo, 26%. Armodafinil did not reduce depressive symptoms in the absence of improved energy, but of those patients with an Axis I depressive disorder at study entry whose energy improved, 82% experienced improved mood as well. Markers of immunologic suppression did not change during treatment. At 6 months, those still taking armodafinil had more energy and fewer depressive symptoms than those who were no longer taking it. Conclusions As we found in our RCT of modafinil, armodafinil appears effective and well tolerated in treating fatigue in HIV+ patients. Side effects were minimal and most patients reported substantially improved energy and mood. PMID:21777715

A randomized, double-blind, placebo-controlled study of acetaminophen 1000 mg versus acetaminophen 650 mg for the treatment of postsurgical dental pain.

PubMed

Qi, Daniel S; May, Lisa G; Zimmerman, Brenda; Peng, Penny; Atillasoy, Evren; Brown, Jean D; Cooper, Stephen A

2012-12-01

Although acetaminophen is one of the oldest and most widely used of all analgesic drugs, the incremental benefit of the 1000-mg dose compared with the 650-mg dose has been questioned. The aim of this study was to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a 6-hour period in patients experiencing at least moderate postsurgical dental pain. This single-center, randomized, double-blind, placebo-controlled, single-dose study enrolled patients aged 16 to 50 years who experienced at least moderate pain after surgical removal of impacted third molars. Each patient received either acetaminophen 1000 mg (n = 239), acetaminophen 650 mg (n = 241), or placebo (n = 60) when they had at least moderate pain and a score ≥50 on the 100-mm Visual Analog Scale (VAS) postsurgically. Pain intensity and pain relief were measured over 6 hours (VAS 0-100 mm). All 540 patients (52% female; age range, 16-30 years; 95% white) were included in the efficacy analysis. For the primary efficacy endpoint (weighted sum of the pain intensity difference from baseline [PID] and pain relief [PAR] scores over 6 hours [SPRID6]), acetaminophen 1000 mg demonstrated a 24% improvement compared with acetaminophen 650 mg (529.4 vs 427.3; P = 0.001). In addition, acetaminophen 650 mg was significantly superior compared with placebo (P < 0.001). The weighted sum of PID over 6 hours (SPID6), the weighted total pain relief over 6 hours (TOTPAR6), and the percentage of patients with >50% of the maximum possible TOTPAR6 score were significantly greater for patients treated with acetaminophen 1000 mg compared with those receiving acetaminophen 650 mg (P ≤ 0.006) or placebo (P < 0.001) and for patients treated with acetaminophen 650 mg compared with placebo (P < 0.001). Time to rescue, rescue rates through 4 and 6 hours, and patient global assessment demonstrated similar findings. Patients treated with acetaminophen 1000 mg or 650 mg had a significantly different distribution in times to confirmed perceptible and meaningful pain relief compared with those receiving placebo (P < 0.001). Adverse events were reported by 18.5% of patients, with no clinically important difference between active treatment groups and placebo. Acetaminophen 1000 mg provided clinically meaningful and statistically significantly greater efficacy in treating postsurgical dental pain compared with acetaminophen 650 mg and placebo. The outcomes of this study are limited to the single-dose design of this study. ClinicalTrials.gov identifier: NCT01115673. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

[A case of acute pancreatitis caused by 5-aminosalicylic acid suppositories in a patient with ulcerative colitis].

PubMed

Kim, Kook Hyun; Kim, Tae Nyeun; Jang, Byung Ik

2007-12-01

Oral 5-aminosalicylic acid (5-ASA) has been known as a first-choice drug for ulcerative colitis. However, hypersensitivity reactions, including pancreatitis, hepatitis, and skin rash, have been reported with 5-ASA. Topical formulations of 5-ASA like suppositories have been rarely reported to induce adverse reactions because of their limited absorption rate. We recently experienced a case of acute pancreatitis caused by 5-ASA suppositories in a patient with ulcerative colitis. A 26-year-old male was admitted with abdominal pain and diagnosed as ulcerative colitis. Acute pancreatitis occurred soon after 24 hours of treatment with oral mesalazine. Drug-induced pancreatitis was suspected and administration of mesalazine was discontinued. Then 5-ASA suppositories were started instead of oral mesalazine. Twenty-four hours after taking 5-ASA suppositories, he experienced severe abdominal pain, fever, and elevation of amylase levels. The suppositories were immediately stopped and symptoms resolved over next 48 hours. Herein, we suggest that, in patients treated with 5-ASA suppositories who complain of severe abdominal pain, drug-induced pancreatitis should be suspected.

Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial.

PubMed

Pianko, Stephen; Flamm, Steven L; Shiffman, Mitchell L; Kumar, Sonal; Strasser, Simone I; Dore, Gregory J; McNally, John; Brainard, Diana M; Han, Lingling; Doehle, Brian; Mogalian, Erik; McHutchison, John G; Rabinovitz, Mordechai; Towner, William J; Gane, Edward J; Stedman, Catherine A M; Reddy, K Rajender; Roberts, Stuart K

2015-12-01

Effective treatment options are needed for patients with genotype 1 or 3 hepatitis C virus (HCV) infection in whom previous therapy has failed. To assess the efficacy and safety of sofosbuvir plus velpatasvir, with and without ribavirin, in treatment-experienced patients. Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT01909804). 58 sites in Australia, New Zealand, and the United States. Treatment-experienced adults with genotype 3 HCV infection without cirrhosis (cohort 1) and with compensated cirrhosis (cohort 2) and patients with genotype 1 HCV infection that was unsuccessfully treated with a protease inhibitor with peginterferon and ribavirin (50% could have compensated cirrhosis) (cohort 3). All patients received 12 weeks of treatment that included 400 mg of sofosbuvir once daily. Patients in each cohort were randomly assigned to 25 mg of velpatasvir once daily with or without ribavirin or 100 mg of velpatasvir once daily with or without ribavirin. Proportion of patients with sustained virologic response at week 12 after treatment (SVR12). In cohort 1, SVR12 rates were 85% with 25 mg of velpatasvir, 96% with 25 mg of velpatasvir plus ribavirin, 100% with 100 mg of velpatasvir, and 100% with 100 mg of velpatasvir plus ribavirin. In cohort 2, SVR12 rates were 58% with 25 mg of velpatasvir, 84% with 25 mg of velpatasvir plus ribavirin, 88% with 100 mg of velpatasvir, and 96% with 100 mg of velpatasvir plus ribavirin. In cohort 3, SVR12 rates were 100% with 25 mg of velpatasvir, 97% with 25 mg of velpatasvir plus ribavirin, 100% with 100 mg of velpatasvir, and 96% with 100 mg of velpatasvir plus ribavirin. The most common adverse events were headache, fatigue, and nausea. Treatment assignments were not blinded, and no inferential statistics were planned. Treatment with 400 mg of sofosbuvir plus 100 mg of velpatasvir for 12 weeks was well-tolerated and highly effective in treatment-experienced patients with genotype 1 or 3 HCV infection. Gilead Sciences.

Neutropenia induced by high-dose intravenous benzylpenicillin in treating neurosyphilis: Does it really matter?

PubMed Central

Zhao, Wei; Qi, Tengfei; Shi, Mei; Guan, Zhifang; Lu, Haikong; Long, Fuquan; Gao, Zixiao; Zhang, Sufang; Zhou, Pingyu

2017-01-01

Background Prompt therapy with high-dose intravenous benzylpenicillin for a prolonged period is critical for neurosyphilis patients to avoid irreversible sequelae. However, life-threatening neutropenia has been reported as a complication of prolonged therapy with high doses of benzylpenicillin when treating other diseases. This study aimed to investigate the incidence, presentation, management and prognosis of benzylpenicillin-induced neutropenia in treating neurosyphilis based on a large sample of syphilis patients in Shanghai. Methodology/Principal findings Between 1st January 2013 and 31st December 2015, 1367 patients with neurosyphilis were treated with benzylpenicillin, 578 of whom were eligible for recruitment to this study. Among patients without medical co-morbidities, the total incidence of benzylpenicillin-induced neutropenia and severe neutropenia was 2.42% (95% CI: 1.38–4.13%) and 0.35% (95% CI: 0.06–1.39%), respectively. The treatment duration before onset of neutropenia ranged from 10 to 14 days, with a total cumulative dose of between 240 and 324 megaunits of benzylpenicillin. Neutropenia was accompanied by symptoms of chills and fever (5 patients), fatigue (2 patients), cough (1 patient), sore throat (1 patient), diarrhea (1 patient) and erythematous rash (1 patient). The severity of neutropenia was not associated with age, gender or type of neurosyphilis (p>0.05). Neutropenia, even when severe, was often tolerated and normalized within one week. A more serious neutropenia did not occur when reinstituting benzylpenicillin in patients with mild or moderate neutropenia nor when ceftriaxone was used three months after patients had previously experienced severe neutropenia. Conclusions/Significance Benzylpenicillin-induced neutropenia was uncommon in our cohort of patients. Continuation of therapy was possible with intensive surveillance for those with mild or moderate neutropenia. For severe neutropenia, it is not essential to aggressively use hematopoietic growth factors or broad-spectrum antibiotics for patients in good physical condition after withdrawing anti-neurosyphilis regimen. We did not see an exacerbation of neutropenia in patients with the readministration of benzylpenicillin. PMID:28288165

Neutropenia induced by high-dose intravenous benzylpenicillin in treating neurosyphilis: Does it really matter?

PubMed

Peng, Rui-Rui; Wu, Juan; Zhao, Wei; Qi, Tengfei; Shi, Mei; Guan, Zhifang; Lu, Haikong; Long, Fuquan; Gao, Zixiao; Zhang, Sufang; Zhou, Pingyu

2017-03-01

Prompt therapy with high-dose intravenous benzylpenicillin for a prolonged period is critical for neurosyphilis patients to avoid irreversible sequelae. However, life-threatening neutropenia has been reported as a complication of prolonged therapy with high doses of benzylpenicillin when treating other diseases. This study aimed to investigate the incidence, presentation, management and prognosis of benzylpenicillin-induced neutropenia in treating neurosyphilis based on a large sample of syphilis patients in Shanghai. Between 1st January 2013 and 31st December 2015, 1367 patients with neurosyphilis were treated with benzylpenicillin, 578 of whom were eligible for recruitment to this study. Among patients without medical co-morbidities, the total incidence of benzylpenicillin-induced neutropenia and severe neutropenia was 2.42% (95% CI: 1.38-4.13%) and 0.35% (95% CI: 0.06-1.39%), respectively. The treatment duration before onset of neutropenia ranged from 10 to 14 days, with a total cumulative dose of between 240 and 324 megaunits of benzylpenicillin. Neutropenia was accompanied by symptoms of chills and fever (5 patients), fatigue (2 patients), cough (1 patient), sore throat (1 patient), diarrhea (1 patient) and erythematous rash (1 patient). The severity of neutropenia was not associated with age, gender or type of neurosyphilis (p>0.05). Neutropenia, even when severe, was often tolerated and normalized within one week. A more serious neutropenia did not occur when reinstituting benzylpenicillin in patients with mild or moderate neutropenia nor when ceftriaxone was used three months after patients had previously experienced severe neutropenia. Benzylpenicillin-induced neutropenia was uncommon in our cohort of patients. Continuation of therapy was possible with intensive surveillance for those with mild or moderate neutropenia. For severe neutropenia, it is not essential to aggressively use hematopoietic growth factors or broad-spectrum antibiotics for patients in good physical condition after withdrawing anti-neurosyphilis regimen. We did not see an exacerbation of neutropenia in patients with the readministration of benzylpenicillin.

Benefits/Risks of Sodium–Glucose Co-Transporter 2 Inhibitor Canagliflozin in Women for the Treatment of Type 2 Diabetes

PubMed Central

2016-01-01

Sodium–glucose co-transporter 2 (SGLT2) inhibitors, such as canagliflozin, are used in patients with Type 2 diabetes mellitus (T2DM). In clinical studies, canagliflozin significantly reduced A1C, bodyweight and blood pressure, and was generally well tolerated with no increased risk of hypoglycemia. Most common adverse effects observed were genital mycotic infections and urinary tract infections, and increased urination. Approximately 10% of women treated with canagliflozin experienced a genital mycotic infection compared with 3% treated with placebo; those with a prior history were at greater risk. Approximately 9% of women treated with canagliflozin reported a urinary tract infection compared with 7% treated with placebo. Most adverse events were considered mild to moderate in intensity and responded to standard therapy. Treatment with canagliflozin was effective and generally well tolerated in both women (and men) with T2DM. PMID:26928259

Ileocolic perforation secondary to sodium polystyrene sulfonate in sorbitol use: A case report

PubMed Central

Trottier, Vincent; Drolet, Sébastien; Morcos, Mohib W

2009-01-01

Hyperkalemia is a common condition encountered in medical and surgical patients. It can lead to various complications including cardiac arrhythmias. Sodium polystyrene sulfonate (SPS) in sorbitol is an ion-exchange resin that can be used to treat hyperkalemia. It can be used in enema or in oral form. The present article describes the case of an intensive care unit patient who experienced severe, diffuse, intestinal perforation induced by the use of SPS-sorbitol, requiring multiple laparotomies, followed by a brief review of the relevant literature and recommendations regarding the use of SPS-sorbitol. PMID:19826644

Addition of a Medial Locking Plate to an In Situ Lateral Locking Plate Results in Healing of Distal Femoral Nonunions.

PubMed

Holzman, Michael A; Hanus, Bryan D; Munz, John W; O'Connor, Daniel P; Brinker, Mark R

2016-06-01

Nonunion of the distal femur after lateral plating is associated with axial malalignment, chronic pain, loss of ambulatory function, and decreased knee ROM. The addition of a medial locking plate with autogenous bone grafting can provide greater stability to allow bone healing and may be used to achieve union in these challenging cases. We wished to determine (1) the proportion of patients who achieve radiographic signs of osseous union for distal femoral nonunions with an in situ lateral plate after treatment with addition of a medial locking plate and autogenous bone grafting, and (2) the frequency and types of complications associated with this treatment. Between 2007 and 2013, we treated 22 patients for 23 distal femoral nonunions, defined as an unhealed fracture with no radiographic signs of osseous union at a mean of 16 months (SD, 13 months) after injury. During that time, we used a treatment algorithm consisting of treatment in one or two stages. The single-stage procedure performed in 16 aseptic nonunions with a stable lateral plate involved addition of a medial locking plate and autogenous bone graft. A two-stage treatment performed in seven nonunions with lateral plate failure involved placement of a new lateral locking plate followed by addition of a medial locking plate with autogenous bone graft at least 2 months after the first procedure. Of the 22 patients treated, 20 had a median followup of 18 months (SD, 6-94 months). We defined osseous union by bridging bone on three of four cortices with absence of a radiolucent line or more than 25% cross-sectional area of bridging bone via CT. Twenty of the 21 nonunions attained radiographic signs of osseous union by 12 months. Six of the 20 patients experienced complications: one patient had a persistent nonunion; four patients underwent removal of symptomatic hardware; and one patient experienced skin breakdown at the bone graft harvest site. A very high proportion of patients achieve union when using medial locking plates to treat distal femoral nonunions after lateral plating of the original injury. Addition of bone graft, staged reconstruction, and revision of the initial lateral plate is indicated when the nonunion is associated with fatigue failure of the initial lateral plate. Level IV, therapeutic study.

Aneurysmal subarachnoid hemorrhage in patients under 35-years-old: a single-center experience.

PubMed

Chalouhi, Nohra; Teufack, Sonia; Chandela, Sid; Dalyai, Richard; Tjoumakaris, Stavropoula; Hasan, David M; Dumont, Aaron S; Gonzalez, L Fernando; Rosenwasser, Robert H; Jabbour, Pascal M

2013-06-01

Aneurysmal subarachnoid hemorrhage (SAH) is relatively uncommon in young adults. There is a paucity of data pertaining to the management of aneurysmal SAH in young patients, especially with endovascular therapy. We reviewed all SAH patients under the age of 35 years treated at Jefferson Hospital for Neuroscience, Philadelphia, USA, from 2004 to 2009. A total of 40 patients (15 males and 25 females) under the age of 35 were treated for aneurysmal SAH. The average patient age was 30 years (17-35 yo); 25 (62.5%) were smokers. Seventeen patients presented with a Hunt and Hess Grade I or II (42.5%), 20 with a Grade III (50%), and 3 with a Grade IV (7.5%). Thirty-two aneurysms (80%) were located in the anterior circulation and 8 (20%) in the posterior circulation. Thirty-five patients (87.5%) were treated with coil embolization versus 5 with craniotomy and clipping. The endovascular and microsurgical occlusion rates were 90.6% and 100%, respectively. There were no procedural complications with endovascular therapy. Of 35 patients undergoing endovascular treatment, 24 (68.6%) had excellent outcomes at time of discharge with a Glasgow outcome scale of 5. There were no deaths in the series. No patient experienced a rehemorrhage after endovascular treatment. Smoking, female sex, and anterior circulation aneurysms are highly prevalent in young adults with SAH. Endovascular treatment resulted in an overall favorable outcome with no rehemorrhages in patients under the age of 35 years. Our results suggest that endovascular therapy is a reasonable treatment for young patients with SAH. Copyright © 2012 Elsevier B.V. All rights reserved.

Effects of vildagliptin relative to sulfonylureas in Muslim patients with type 2 diabetes fasting during Ramadan: influence of age and treatment with/without metformin in the VIRTUE study.

PubMed

Hassoun, Ahmed Ak; Pathan, Md Faruque; Medlej, Rita C; Alarouj, Monira; Shaltout, Inass; Chawla, Manoj S; Knap, Ditte; Vaz, Julius A

2016-01-01

VIRTUE was a prospective, observational study assessing the effectiveness and safety of vildagliptin vs sulfonylureas (SUs) (both as monotherapy and in combination with metformin) in patients with type 2 diabetes mellitus who fasted during Ramadan. A post hoc analysis was carried out to assess the effect of treatment with/without metformin and age (<65 years or ≥65 years). Patients were recruited from the Middle East and Asia. The primary end point was proportion of patients with one or more hypoglycemic event (HE) during Ramadan. Secondary end points included change from baseline in glycated hemoglobin (HbA1c), body weight, and safety. Overall, 684 patients received vildagliptin and 631 received SUs. Most patients received dual therapy with metformin (n=1,148) and were aged <65 years (n=1,189). A few patients experienced one or more HE with vildagliptin vs SU monotherapy (6.5% vs 14.5%) and with vildagliptin + metformin vs SUs + metformin (5.3% vs 20.6%); the latter achieved statistical significance (P<0.001) in both age subgroups (<65 years: 5.5% vs 18.4%, P<0.001; ≥65 years: 2.8% vs 30.9%, P<0.001). Vildagliptin was associated with numerically greater HbA1c and body weight reductions vs SUs, regardless of the therapy type or age. A higher proportion of SU- vs vildagliptin-treated patients experienced adverse events across all subgroups. A few patients experienced HEs with vildagliptin vs SUs regardless of age, and in patients on dual therapy. Vildagliptin ± metformin was also associated with good glycemic and weight control and was well tolerated. Vildagliptin might be a useful treatment option for patients with type 2 diabetes mellitus, particularly high-risk populations such as the elderly fasting during Ramadan.

Idiopathic Chronic Parotitis: Imaging Findings and Sialendoscopic Response.

PubMed

Heineman, Thomas E; Kacker, Ashutosh; Kutler, David I

2015-01-01

The purpose of this study was to correlate imaging and sialendoscopic findings to therapeutic response in patients with idiopathic chronic parotitis. We retrospectively reviewed 122 consecutive sialendoscopies performed in an academic medical center by two surgeons between 2008 and 2013. Forty-one (34%) and 54 (44%) patients were excluded on the basis of having parotid or submandibular sialolith, respectively. Nineteen cases were included in the study with idiopathic chronic parotitis. There was a median follow-up of 5 months. Computed tomography (CT) imaging had a sensitivity and specificity of 80.0 and 71.4%, respectively, for predicting abnormal findings on sialendoscopy, while magnetic resonance imaging (MRI) had 100% accuracy in a small set of cases. In glands with noticeable pathology present on preoperative imaging or sialendoscopy, 11 out of 12 glands (92%) treated experienced symptomatic improvement, while 3 out of 7 glands (43%) without pathology on imaging or endoscopy experienced symptomatic improvement (p = 0.038). Sialendoscopy for the treatment of idiopathic chronic parotid disease can improve pain and swelling with a higher frequency of success in patients with abnormalities noted on endoscopy. CT and MRI have a moderate degree of accuracy in predicting which patients will benefit from therapeutic sialendoscopy. © 2015 S. Karger AG, Basel.

Surgical treatment for male prolactinoma

PubMed Central

Song, Yi-Jun; Chen, Mei-Ting; Lian, Wei; Xing, Bing; Yao, Yong; Feng, Ming; Wang, Ren-Zhi

2017-01-01

Abstract A total of 184 cases of surgically treated male prolactinoma were analyzed retrospectively to summarize the outcome of this surgical intervention. We analyzed the general characteristics, clinical manifestations, hormone levels, imaging features, preoperative treatments, surgical outcomes, pathology results, and follow-up records for all included patients. The most common clinical manifestations included sexual dysfunction (47.4%), headache (55.9%), and visual disturbance (46.7%). Serum prolactin levels ranged from 150 to 204,952 ng/mL. Tumor size varied from 6 to 70 mm. Pituitary adenomas grew in a parasellar pattern with visual deficits occurring 40.7% of the time. After surgical therapy, 88.6% of patients achieved symptom relief, and 98.4% experienced an immediate postoperative decline in prolactin level. Fifty-seven patients (31.0%) achieved initial remission, and 26 patients (45.6%) experienced recurrence. Hence, our results suggest that in male prolactinoma characterized by a large pituitary diameter and high serum prolactin level, tumor size predicts the degree of gross resection. The prognostic predictors included preoperative tumor growth pattern and Ki-67 index. Citation: Yi-jun S, Mei-ting C, Wei L, Bing X, Yong Y, Ming F, Ren-zhi W. (2016) Surgical treatment for male prolactinoma: a retrospective study of 184 cases PMID:28079813

IgG4 anti-infliximab in treated patients: clinical impact and temporal evolution.

PubMed

Vultaggio, Alessandra; Nencini, Francesca; Carraresi, Alessia; Pratesi, Sara; Movérare, Robert; Eriksson, Camilla; Venemalm, Lennart; Maggi, Enrico; Matucci, Andrea

2018-05-02

Infliximab (IFX) carries potential risk of immunogenicity with the production of anti-drug antibodies (ADA). ADA may belong to different isotypes and are usually measured by ELISA bridging assay. This test is not designed to detect IgG4 antibodies. The aim was to measure IgG4 anti-IFX antibodies in a cohort of IFX-treated patients and to evaluate their relationship with ADA and their clinical impact. ADA were detected by using a bridging ELISA in the serum of 222 treated patients with different clinical outcomes to IFX. The same samples were analysed for IgG4 anti-IFX antibodies using an experimental ImmunoCAP assay with reduced serum IgG4 background levels. A longitudinal evaluation was performed in a subgroup of 38 patients to define the temporal evolution of IgG4 anti-IFX. IgG4 anti-IFX was found in 26.6% of patients. Eigthy out of 222 patients were ADA+ (36%) and the majority (57/80, 71.3%) had IgG4 anti-IFX. Two IgG4-positive but ADA-negative patients were identified. IgG4 anti-IFX levels correlated with the serum levels of ADA. IgG4 anti-IFX was more common in both reactive and non-responder patients than in tolerant/responder patients. Patients who had experienced IgE-mediated reactions displayed significantly higher IgG4 anti-IFX than IgE-negative reactive patients. The majority of patients tested positive for IgG4 anti-IFX after the first seven infusions. IgG4 anti-IFX is common in treated patients and a large part of ADA producing patients produce IgG4 antibodies. The IgG4 anti-IFX response does not prevent hypersensitivity reactions to IFX and correlates with the IgE anti-IFX response. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Botulinum toxin alleviates dysphagia of patients with inclusion body myositis.

PubMed

Schrey, Aleksi; Airas, Laura; Jokela, Manu; Pulkkinen, Jaakko

2017-09-15

Oropharyngeal dysphagia is a disabling and undertreated symptom that often occurs in patients with sporadic inclusion body myositis (s-IBM). In this study, we examined the effect of botulinum neurotoxin A (BoNT-A) injections to the cricopharyngeus muscle (CPM) of patients with s-IBM and dysphagia. A single-center retrospective study involving 40 biopsy-proven s-IBM-patients treated in the District of Southwest Finland from 2000 to 2013. The incidence of dysphagia, rate of aspirations, rate of aspiration pneumonias and treatment results of dysphagia were analyzed. Patients treated for dysphagia were evaluated before and after surgery by video-fluoroscopy and/or using a questionnaire. Twenty-five of the 40 s-IBM patients (62.5%) experienced dysphagia. BoNT-A was injected a median of 2 times (range 1-7) in 12 patients with dysphagia. Before the injections 7 patients reported aspiration, none afterwards. The corresponding figures for aspiration pneumonia were 3 and 0. All of these patients had normal swallowing function 12months (median, range 2-60) after the last injection. BoNT-A injections to the CPM alleviate the dysphagia of s-IBM patients reversibly and appear to reduce the rate of aspiration effectively. Copyright © 2017 Elsevier B.V. All rights reserved.

Clinical presentation and course of acute hepatitis C infection in HIV-infected patients.

PubMed

Luetkemeyer, Annie; Hare, C Bradley; Stansell, John; Tien, Phyllis C; Charlesbois, Edwin; Lum, Paula; Havlir, Diane; Peters, Marion

2006-01-01

Hepatitis C virus (HCV) has become a significant source of morbidity and mortality in HIV-infected patients. However, little is known about the clinical presentation and course of acute HCV infection in this population. This study reports the outcomes of acute HCV infection in 9 HIV-infected men. Sex with men was the only reported risk factor for HCV infection in 6 of the subjects. Clinical presentation of acute HCV ranged from incidentally discovered elevated transaminases to severe liver dysfunction requiring hospitalization. At the time of HCV diagnosis, 8 of 9 patients had CD4+ counts >250 cells/mm(3), and 6 had HIV viral loads of < or =5000 copies/mL. Eight patients were receiving antiretroviral therapy. Outcome of these acute HCV infections varied. Five patients experienced virologic clearance, 2 in whom virus cleared spontaneously and 3 who were treated with pegylated interferon and ribavirin. Four patients developed chronic infection, one of whom had a relapse during HCV treatment and 3 of whom were untreated. All 4 patients to whom HCV therapy was administered experienced significant anemia or neutropenia, necessitating dose reduction or support with growth factors. Prompt recognition of acute HCV infection may minimize antiretroviral treatment interruption and will allow early treatment, which may improve virologic clearance. Unexplained transaminase elevations in HIV-infected patients, including men who have sex with men, should trigger an evaluation for acute HCV infection.

Open-label Bendamustine Monotherapy for Pediatric Patients With Relapsed or Refractory Acute Leukemia: Efficacy and Tolerability

PubMed Central

Brown, Patrick; Megason, Gail; Ahn, Hyo Seop; Cho, Bin; Kirov, Ivan; Frankel, Lawrence; Aplenc, Richard; Bensen-Kennedy, Debra; Munteanu, Mihaela; Weaver, Jennifer; Harker-Murray, Paul

2014-01-01

This open-label, single-arm, phase I/II, dose-escalation study was designed to determine the recommended phase II dose (RP2D), pharmacokinetics, tolerability, and efficacy of bendamustine in pediatric patients (age ranging from 1 to 20 y) with histologically proven relapsed/refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). Patients (27 with ALL, 16 with AML) received intravenous bendamustine on days 1 and 2 of each treatment cycle. Phase I involved planned dose escalation of bendamustine to establish the RP2D for phase II. Objectives included overall response rate, duration of response, and tolerability. Eleven patients were treated in phase I, and the RP2D was 120 mg/m2. In phase II, 32 patients received bendamustine 120 mg/m2. Two patients with ALL (bendamustine 90 mg/m2) experienced complete response (CR). Among patients who received bendamustine 120 mg/m2, 2 experienced partial response (PR); 7 had stable disease. The overall response rate (CR+CR without platelet recovery [CRp]) was 4.7% and biological activity rate (CR+CRp+PR) was 9.3%. No AML patients responded. The most common adverse events were anemia, neutropenia, thrombocytopenia, pyrexia, nausea, vomiting, and diarrhea. Bendamustine monotherapy has acceptable tolerability in heavily pretreated children with relapsed/refractory ALL or AML and appears to have some activity in ALL, warranting further studies in combination trials. PMID:24072240

Retrospective analysis of obstetric and anesthetic management of patients with placenta accreta spectrum disorders.

PubMed

Riveros-Perez, Efrain; Wood, Cristina

2018-03-01

To assess the management and maternal outcomes of placenta accreta spectrum (PAS) disorders. A retrospective chart review was conducted of patients diagnosed with PAS disorders (placenta creta, increta, or percreta) who were treated at a US tertiary care center between February 1, 2011, and January 31, 2016. Obstetric management, anesthetic management, and maternal outcomes were analyzed. A total of 43 cases were identified; placenta previa was diagnosed among 33 (77%). Median age was 33 years (range 23-42). Median blood loss was 1500 mL (interquartile range 1000-2500); blood loss was greatest among the 10 patients with placenta percreta (3250 mL, interquartile range 2200-6000). Transfusion of blood products was necessary among 14 (33%) patients, with no difference in frequency according to the degree of placental invasion (P=0.107). Surgical complications occurred among 10 (23%) patients. Overall, 30 (70%) patients received combined spinal-epidural plus general anesthesia, 4 (9%) received only general anesthesia, and 9 (21%) underwent surgery with combined spinal-epidural anesthesia. One patient experienced difficult airway and another experienced accidental dural puncture. Placenta previa and accreta coexist in many patients, leading to substantial bleeding related to the degree of myometrial invasion. An interdisciplinary team approach plus the use of combined spinal-epidural anesthesia, transitioning to general anesthesia, were advisable and safe. © 2017 International Federation of Gynecology and Obstetrics.

Adjunctive α-lipoic acid reduces weight gain compared with placebo at 12 weeks in schizophrenic patients treated with atypical antipsychotics: a double-blind randomized placebo-controlled study.

PubMed

Kim, Nam Wook; Song, Yul-Mai; Kim, Eosu; Cho, Hyun-Sang; Cheon, Keun-Ah; Kim, Su Jin; Park, Jin Young

2016-09-01

α-Lipoic acid (ALA) has been reported to be effective in reducing body weight in rodents and obese patients. Our previous open trial showed that ALA may play a role in reducing weight gain in patients with schizophrenia on atypical antipsychotics. The present study evaluated the efficacy of ALA in reducing weight and BMI in patients with schizophrenia who had experienced significant weight gain since taking atypical antipsychotics. In a 12-week, double-blind randomized placebo-controlled study, 22 overweight and clinically stable patients with schizophrenia were randomly assigned to receive ALA or placebo. ALA was administered at 600-1800 mg, as tolerated. Weight, BMI, abdomen fat area measured by computed tomography, and metabolic values were determined. Adverse effects were also assessed to examine safety. Overall, 15 patients completed 12 weeks of treatment. There was significant weight loss and decreased visceral fat levels in the ALA group compared with the placebo group. There were no instances of psychopathologic aggravation or severe ALA-associated adverse effects. ALA was effective in reducing weight and abdominal obesity in patients with schizophrenia who had experienced significant weight gain since beginning an atypical antipsychotic regimen. Moreover, ALA was well tolerated throughout this study. ALA might play an important role as an adjunctive treatment in decreasing obesity in patients who take atypical antipsychotics.

Severe radiotherapy-induced extracutaneous toxicity under vemurafenib.

PubMed

Peuvrel, Lucie; Ruellan, Anne-Lise; Thillays, François; Quereux, Gaëlle; Brocard, Anabelle; Saint-Jean, Mélanie; Aumont, Maud; Drouet, Franck; Dreno, Brigitte

2013-01-01

Vemurafenib is a BRAF inhibitor indicated for the treatment of metastatic melanoma. We report the two first cases of severe and prolonged radiotherapy-induced visceral toxicity in patients treated concomitantly with vemurafenib: a brain radionecrosis and an anorectitis. It raises the question of both the risks of this association and its benefit in melanoma. The first patient, a female aged 32, treated with vemurafenib for three months, presented a steroid-dependent radionecrosis after brain stereotactic radiosurgery. Symptoms persisted until her death six months later. The second patient, a male aged 64 and treated with vemurafenib for nineteen days, presented a radiation-induced anorectitis complicated by diarrhoea, anorexia and weight loss following the concomitant radiation of a primary rectal tumour. A colostomy was needed after ten months in order to improve local status and general health. In our patients, the radiotherapy-induced toxicity under vemurafenib was unusual in its intensity and duration, suggesting a radiosensitization phenomenon. This hypothesis is reinforced by the publication of six cases of severe radiodermatitis under vemurafenib and by in vitro data. The combination of vemurafenib and radiotherapy should thus lead to discussion of a transient cessation of vemurafenib, given the severity of the adverse events experienced. Meanwhile, further studies are needed to determine the potential benefit of this combined treatment in metastatic melanoma.

A case of chemotherapy-induced congestive heart failure successfully treated with Chinese herbal medicine.

PubMed

Wu, Bei-Yu; Liu, Chun-Ting; Chen, Shih-Yu; Tsai, Ming-Yen

2015-04-01

A case is presented to illustrate a potential effect of Chinese herbal medicine (CHM) formulas in treating chemotherapy-induced cardiotoxicity. An 18-year-old adolescent male with refractory acute lymphoblastic leukemia (ALL) had experienced anthracycline-induced congestive heart failure (CHF) for 3 weeks. Under intensive care with conventional therapy, the patient still had exercise intolerance and depended on supplemental oxygen all day. Therefore, he consented to treatment with traditional Chinese medicine (TCM) for alternative therapy. This patient was treated with modified Zhi Gan Cao Tang (ZGCT), three times a day for 2 months. After 6 days of CHM treatment, the patient could tolerate daily activity without supplemental oxygen. After 2 months of CHM treatment, the follow-up chest X-ray showed great improvements in pulmonary edema and cardiomegaly. In this case, anthracycline-induced cardiotoxicity resolved slowly following the administration of modified ZGCT. It is suggested that the CHM formula has a protective effect on the progression of CHF secondary to the use of anthracyclines in pediatric cancer. Further studies to determine the mechanism and clinical trials are warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Dentists' opinions on knowledge, attitudes and barriers in providing oral health care to older people living independently in the Netherlands and Flanders (Belgium).

PubMed

Bots-VantSpijker, P C; Bruers, J J M; Bots, C P; De Visschere, L M J; Schols, J M G A

2017-01-01

The aim of this study was to investigate how dentists in the Netherlands and Flanders assessed their knowledge on oral health care to older people, what their attitude was and what barriers they experienced in rendering care to older people. The survey data was collected from a random sample of Dutch and Flemish dentists. Five hundred ninety-five dentists (37%) of the Dutch sample and 494 dentists of the Flemish sample (41%) completed the online questionnaire. Dentists were asked to respond to 15 Likert type items, representing opinions on provision of oral health care to older people and to give information about the number of older patients treated and about some profession-specific and personal characteristics. The average number of patients treated per week was nearly twice as high in the Netherlands as in Flanders. Nevertheless, differences of opinions between dentists in the Netherlands and Flanders were relatively limited. This survey shows that in particular the actual number of older patients treated appears to be related with differences of opinions between Dutch and Flemish dentists about oral health care provided to (vulnerable) older people who live at home.

Contrasting weight changes with LY2605541, a novel long-acting insulin, and insulin glargine despite similar improved glycaemic control in T1DM and T2DM.

PubMed

Jacober, S J; Rosenstock, J; Bergenstal, R M; Prince, M J; Qu, Y; Beals, J M

2014-04-01

The basal insulin analogue LY2605541, a PEGylated insulin lispro with prolonged duration of action, was previously shown to be associated with modest weight loss in Phase 2, randomized, open-label trials in type 2 (N=288) and type 1 (N=137) diabetes mellitus (T2DM and T1DM), compared with modest weight gain with insulin glargine. Exploratory analyses were conducted to further characterize these findings. Pearson correlations between change in body weight and other variables were calculated. Continuous variables were analysed using a mixed linear model with repeated measurements. Proportions of subjects with weight loss were analysed using Fisher's exact test for T2DM and Nagelkerke's method for T1DM. Weight loss was more common in LY2605541-treated patients than in patients treated with insulin glargine (T2DM: 56.9 vs. 40.2%, p=0.011; T1DM: 66.1 vs. 40.3%, p<0.001). More LY2605541-treated patients experienced ≥5% weight loss compared to patients treated with glargine (T2DM: 4.8 vs. 0%, p=0.033; T1DM: 11.9 vs. 0.8%, p<0.001). In both the T1DM and T2DM studies, weight change did not correlate with baseline body mass index (BMI), or change in HDL-cholesterol in either treatment group. No consistent correlations were found across both studies between weight change and any of the variables assessed; however, weight change was significantly correlated with hypoglycaemia rate in glargine-treated T2DM patients. In two Phase 2 trials, improved glycaemic control with long-acting basal insulin analogue LY2605541 is associated with weight loss in previously insulin-treated patients. This weight change is independent of baseline BMI or hypoglycaemia.

Using exercise to treat patients with severe mental illness: how and why?

PubMed

Tetlie, Trine; Heimsnes, Maria Charlotte; Almvik, Roger

2009-02-01

In this study, one focus group and five individual semi-structured interviews were conducted to investigate nursing staff's ways of using exercise as part of the routine treatment for patients with severe mental illness (SMI). The study also explored the patients' experiences and views of the exercise program given in this secure hospital. The organization and delivery of the exercise program are also discussed. The findings indicate that successful outcomes and adherence to exercise programs for patients with SMI in a secure setting rely on therapeutic relationships, having exercise as a mandatory part of the treatment, positive reinforcement, and experienced instructors. More research is needed to identify effective exercise interventions and feasible delivery models for individuals with SMI in secure settings.

Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Harrington, Kevin; Temam, Stephane; Mehanna, Hisham; D'Cruz, Anil; Jain, Minish; D'Onofrio, Ida; Manikhas, Georgy; Horvath, Zsuzsanna; Sun, Yan; Dietzsch, Stefan; Dubinsky, Pavol; Holeckova, Petra; El-Hariry, Iman; Franklin, Natalie; Biswas-Baldwin, Nigel; Legenne, Philippe; Wissel, Paul; Netherway, Thelma; Farrell, John; Ellis, Catherine; Wang-Silvanto, Jing; Amonkar, Mayur; Ahmed, Nazma; Santillana, Sergio; Bourhis, Jean

2015-12-10

This multicenter phase III study evaluated the efficacy and safety of lapatinib, an epidermal growth factor receptor/ErbB2 inhibitor, administered concomitantly with chemoradiotherapy and as maintenance monotherapy in patients with high-risk surgically treated squamous cell carcinoma of the head and neck (SCCHN). Patients with resected stage II to IVA SCCHN, with a surgical margin ≤ 5 mm and/or extracapsular extension, were randomly assigned to chemoradiotherapy (66 Gy total radiation dose and cisplatin 100 mg/m(2) per day administered on days 1, 22, and 43) plus placebo or lapatinib (1,500 mg per day) before and during chemoradiotherapy, followed by 12 months of maintenance monotherapy. Six hundred eighty-eight patients were enrolled (lapatinib, n = 346; placebo, n = 342). With a median follow-up time of 35.3 months, the study ended early because of the apparent plateauing of disease-free survival (DFS) events. Median DFS assessed by an independent review committee was 53.6 months and not reached for lapatinib and placebo, respectively (hazard ratio, 1.10; 95% CI, 0.85 to 1.43). Investigator-assessed results confirmed the independent review committee assessment. No significant differences in DFS by human papillomavirus status or overall survival were observed between treatment arms. Similar numbers of patients in both treatment arms experienced adverse events (AEs), with more patients in the lapatinib arm than the placebo arm experiencing serious AEs (48% v 40%, respectively). The most commonly observed treatment-related AEs were diarrhea and rash, both predominantly in the lapatinib arm. Addition of lapatinib to chemoradiotherapy and its use as long-term maintenance therapy does not offer any efficacy benefits and had additional toxicity compared with placebo in patients with surgically treated high-risk SCCHN. © 2015 by American Society of Clinical Oncology.

Treatment of out-of-hospital supraventricular tachycardia: adenosine vs verapamil.

PubMed

Brady, W J; DeBehnke, D J; Wickman, L L; Lindbeck, G

1996-06-01

To compare the use of adenosine and the use of verapamil as out-of-hospital therapy for supraventricular tachycardia (SVT). A period of prospective adenosine use (March 1993 to February 1994) was compared with a historical control period of verapamil use (March 1990 to February 1991) for SVT. Data were obtained for SVT patients treated in a metropolitan, fire-department-based paramedic system serving a population of approximately 1 million persons. Standard drug protocols were used and patient outcomes (i.e., conversion rates, complications, and recurrences) were monitored. During the adenosine treatment period, 105 patients had SVT; 87 (83%) received adenosine, of whom 60 (69%) converted to a sinus rhythm (SR). Vagal maneuvers (VM) resulted in restoration of SR in 8 patients (7.6%). Some patients received adenosine for non-SVT rhythms: 7 sinus tachycardia, 18 atrial fibrilation, 7 wide-complex tachycardia (WCT), and 2 ventricular tachycardia; no non-SVT rhythm converted to SR and none of these patients experienced an adverse effect. Twenty-five patients were hemodynamically unstable (systolic blood pressure < 90 mm Hg), with 20 receiving drug and 13 converting to SR; 8 patients required electrical cardioversion. Four patients experienced adverse effects related to adenosine (chest pain dyspnea, prolonged bradycardia, and ventricular tachycardia). In the verapamil period, 106 patients had SVT: 52 (49%) received verapamil (p < 0.001, compared with the adenosine period), of whom 43 (88%) converted to SR (p = 0.11). Two patients received verapamil for WCT; neither converted to SR and both experienced cardiovascular collapse. VM resulted in restoration of SR in 12 patients (11.0%) (p = 0.52). Sixteen patients were hemodynamically unstable, with 5 receiving drug (p = 0.005) and 5 converting to SR; 9 patients required electrical cardioversion (p = 0.48). Four patients experienced adverse effects related to verapamil (hypotension ventricular tachycardia, ventricular fibrillation). Recurrence of SVT was noted in 2 adenosine patients and 2 verapamil patients in the out-of-hospital setting and in 23 adenosine patients and 15 verapamil patients after ED arrival, necessitating additional therapy (p = 0.48 and 0.88, for recurrence rates and types of additional therapies, respectively). Hospital diagnoses, outcomes, and ED dispositions were similar for the 2 groups. Adenosine and verapamil were equally successful in converting out-of-hospital SVT in patients with similar etiologies responsible for the SVT. Recurrence of SVT occurred at similar rates for the 2 medications. Rhythm misidentification remains a common issue in out-of-hospital cardiac care in this emergency medical services system.

NS5A resistance-associated substitutions in patients with genotype 1 hepatitis C virus: Prevalence and effect on treatment outcome.

PubMed

Zeuzem, Stefan; Mizokami, Masashi; Pianko, Stephen; Mangia, Alessandra; Han, Kwang-Hyub; Martin, Ross; Svarovskaia, Evguenia; Dvory-Sobol, Hadas; Doehle, Brian; Hedskog, Charlotte; Yun, Chohee; Brainard, Diana M; Knox, Steven; McHutchison, John G; Miller, Michael D; Mo, Hongmei; Chuang, Wan-Long; Jacobson, Ira; Dore, Gregory J; Sulkowski, Mark

2017-05-01

The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). We analyzed data from 35 phase I, II, and III studies in 22 countries to determine the pretreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with ledipasvir-sofosbuvir in patients with genotype 1 HCV. NS5A gene deep sequencing analysis was performed on samples from 5397 patients in Gilead clinical trials. The effect of baseline RASs on sustained virologic response (SVR) rates was assessed in the 1765 patients treated with regimens containing ledipasvir-sofosbuvir. Using a 15% cut-off, pretreatment NS5A and ledipasvir-specific RASs were detected in 13% and 8% of genotype 1a patients, respectively, and in 18% and 16% of patients with genotype 1b. Among genotype 1a treatment-naïve patients, SVR rates were 91% (42/46) vs. 99% (539/546) for those with and without ledipasvir-specific RASs, respectively. Among treatment-experienced genotype 1a patients, SVR rates were 76% (22/29) vs. 97% (409/420) for those with and without ledipasvir-specific RASs, respectively. Among treatment-naïve genotype 1b patients, SVR rates were 99% for both those with and without ledipasvir-specific RASs (71/72 vs. 331/334), and among treatment-experienced genotype 1b patients, SVR rates were 89% (41/46) vs. 98% (267/272) for those with and without ledipasvir-specific RASs, respectively. Pretreatment ledipasvir-specific RASs that were present in 8-16% of patients have an impact on treatment outcome in some patient groups, particularly treatment-experienced patients with genotype 1a HCV. The efficacy of treatments using NS5A inhibitors for patients with chronic hepatitis C virus (HCV) infection can be affected by the presence of NS5A resistance-associated substitutions (RASs). We reviewed results from 35 clinical trials where patients with genotype 1 HCV infection received treatments that included ledipasvir-sofosbuvir to determine how prevalent NS5A RASs are in patients at baseline, and found that ledipasvir-specific RASs were present in 8-16% of patients prior to treatment and had a negative impact on treatment outcome in subset of patient groups, particularly treatment-experienced patients with genotype 1a HCV. Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Practices and outcomes of self-treatment with helminths based on physicians' observations.

PubMed

Liu, J; Morey, R A; Wilson, J K; Parker, W

2017-05-01

The successful use of helminths as therapeutic agents to resolve inflammatory disease was first recorded 40 years ago. Subsequent work in animal models and in humans has demonstrated that the organisms might effectively treat a wide range of inflammatory diseases, including allergies, autoimmune disorders and inflammation-associated neuropsychiatric disorders. However, available information regarding the therapeutic uses and effects of helminths in humans is limited. This study probes the practices and experiences of individuals 'self-treating' with helminths through the eyes of their physicians. Five physicians monitoring more than 700 self-treating patients were interviewed. The results strongly support previous indications that helminth therapy can effectively treat a wide range of allergies, autoimmune conditions and neuropsychiatric disorders, such as major depression and anxiety disorders. Approximately 57% of the self-treating patients observed by physicians in the study had autism. Physicians reported that the majority of patients with autism and inflammation-associated co-morbidities responded favourably to therapy with either of the two most popular organisms currently used by self-treaters, Hymenolepis diminuta and Trichuris suis. However, approximately 1% of paediatric patients experienced severe gastrointestinal pains with the use of H. diminuta, although the symptoms were resolved with an anti-helminthic drug. Further, exposure to helminths apparently did not affect the impaired comprehension of social situations that is the hallmark of autism. These observations point toward potential starting points for clinical trials, and provide further support for the importance of such trials and for concerted efforts aimed at probing the potential of helminths, and perhaps other biologicals, for therapeutic use.

Frequency, risk factors, and outcomes of central nervous system relapse in lymphoma patients treated with dose-adjusted EPOCH plus rituximab.

PubMed

Malecek, Mary-Kate; Petrich, Adam M; Rozell, Shaina; Chu, Benjamin; Trifilio, Steven; Galanina, Natalie; Maurer, Matthew; Farooq, Umar; Link, Brian K; Nowakowski, Grzegorz S; Nabhan, Chadi; Ayed, Ayed O

2017-11-01

Central nervous system (CNS) relapse in non-Hodgkin lymphoma (NHL) is a rare but serious complication that carries a poor prognosis. The use of infusional etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) for frontline treatment of diffuse large B cell lymphoma (DLBCL) is increasing, though little is known about incidence of and risk factors for CNS relapse with this regimen PATIENTS AND METHODS: We completed a chart review of patients with NHL who received EPOCH-R as front line therapy. Data obtained included baseline and treatment characteristics including if patients received CNS directed therapy. We measured overall survival (OS), progression free survival (PFS), and progression to CNS involvement. We identified 223 patients who met the inclusion criteria, 72% had DLBCL. Of all the patients, 5.8% experienced CNS relapse, and 38.6% were treated with CNS prophylaxis. There was no difference in rate of CNS relapse, OS, or PFS between patients who had and had not received CNS prophylaxis. Patients whose serum lactate dehydrogenase was greater than twice the upper limit of normal at diagnosis and those with extranodal disease were significantly more likely to have CNS relapse (P = .0247 and 0.022, respectively) than their counterparts. The rate of CNS relapse in this patient population approaches 6%, not significantly different from reports on those receiving R-CHOP. The results of this study suggest that CNS prophylaxis might be more selectively used among patients treated with EPOCH-R with certain high-risk features. © 2017 Wiley Periodicals, Inc.

Idiopathic Early-Onset Scoliosis: Growing Rods Versus Vertically Expandable Prosthetic Titanium Ribs at 5-Year Follow-up.

PubMed

Bachabi, Malick; McClung, Anna; Pawelek, Jeff B; El Hawary, Ron; Thompson, George H; Smith, John T; Vitale, Michael G; Akbarnia, Behrooz A; Sponseller, Paul D

2018-06-08

Distraction-based techniques allow spinal growth until skeletal maturity while preventing curve progression. Two multicenter early-onset scoliosis databases were used to identify patients with idiopathic spine abnormalities treated with traditional growing rods (TGR) or vertically expandable titanium ribs (VEPTR). Patients underwent at least 4 lengthenings and had at least 5-year follow-up. Significance was set at P<0.05. In total, 50 patients treated with TGR and 22 treated with VEPTR were included. Mean (±SD) age at surgery was 5.5 (±2.0) years for the TGR group versus 4.3 (±1.9) years for the VEPTR group (P=0.044); other demographic parameters were similar. VEPTR patients had more procedures (mean 15±4.2) than TGR patients (mean 10±4.0) (P=0.001). Unilateral constructs were present in 18% (4 of 22) of VEPTR and 16% (8 of 50) of TGR patients. Bilateral constructs spanned a mean 2.1 additional surgical levels and exposed patients to 1.6 fewer procedures than unilateral constructs. Curve correction was similar between bilateral and unilateral constructs. TGR patients experienced greater curve correction (50%) than VEPTR patients (27%) (P<0.001) and achieved a greater percentage of thoracic height gain (24%) than VEPTR patients (12%) (P=0.024). At latest follow-up, TGR patients had better maintenance of curve correction, less kyphosis, and 15% greater absolute gain in thoracic height versus VEPTR patients. TGR patients had a lower rate of wound complications (14%) than VEPTR patients (41%) (P=0.011). In patients with idiopathic early-onset scoliosis, TGRs produced greater initial curve correction, greater thoracic height gains, less kyphosis, and lower incidence of wound complications compared with VEPTR. Level III.

Recurrent neuroma formation after lateral arm free flap coverage with neurorraphy to the posteroantebrachial nerve.

PubMed

Peterson, Steven L; Gordon, Michael J

2004-09-01

We report a patient with previous wrist trauma and development of a symptomatic neuroma of the palmar cutaneous branch of the median nerve. The patient had previously been successfully treated with lateral arm free flap coverage with neurorrhaphy to a segment of the posteroantebrachial cutaneous nerve carried with the flap. Two years following this procedure the patient experienced re-onset of symptoms prompting surgical exploration of the area. At the time of operation a recurrent neuroma was found at the free distal terminus of the transferred posteroantebrachial cutaneous nerve. The neuroma was repositioned into the distal radius via a burr hole with relief of symptoms.

The Anatomy of the Medial Patellofemoral Ligament.

PubMed

Trinh, Thai Q; Ferrel, Jason R; Bentley, Jared C; Steensen, Robert N

2017-07-01

Recurrent patellar dislocation is observed in many patients treated nonoperatively following primary dislocation. Injury to the medial patellofemoral ligament (MPFL) is reported in the majority of patients following dislocation. There is an increased interest in repair or reconstruction of the MPFL for patients experiencing recurrent instability. The femoral attachment of the MPFL is critical in determining graft behavior following reconstruction. The femoral attachment can be determined by referencing local anatomy, fluoroscopic imaging or on the basis of desired graft-length changes. This article reviews the anatomy of the MPFL, with a focus on its femoral insertion site as it pertains to anatomic, isometric, and anisometric reconstruction. [Orthopedics. 2017; 40(4):e583-e588.]. Copyright 2017, SLACK Incorporated.

Methotrexate management for placenta accreta: a prospective study.

PubMed

Lin, Kaiqing; Qin, Jiale; Xu, Kaihong; Hu, Wen; Lin, Jun

2015-06-01

To observe efficacy following methotrexate (MTX) management in women with placenta accreta. Twenty-four stable patients with placenta accreta were treated with MTX. Beta-hCG values, vascular indices of the residual placenta, and other clinical characteristics were collected prospectively and were compared between the success and failure groups. After MTX management, the residual placentas were expulsed spontaneously in 33.3% of the patients. This was done through dilatation and curettage (D & C) in 45.8% of the patients. The residuals in the uterine wall were completely absorbed within 5.7 months. In the patients who were successfully treated with MTX, their beta-hCG values and vascular indices of the placentas decreased faster than those of failure patients (P < 0.05). Those (20.8%) failing MTX management and subsequent D & C showed that their vascular indices persisted high levels and some even experienced elevations despite significantly decreased hCG values. MTX management, when the beta-hCG value and vascular indices of placenta decreased significantly, is a conservative option for a stable patient with placenta accreta in China. 3D power Doppler ultrasound should be utilized for the follow-up of this condition.

Dofetilide in Overdose: A Case Series from Poison Center Data.

PubMed

Hieger, M A; Maskell, K F; Moss, M J; Powell, S W; Cumpston, K L

2017-07-01

Dofetilide is a class III antiarrhythmic used for treating atrial dysrhythmias. Though its adverse effects are well described in routine use, very little is known about dofetilide toxicity in overdose. This is a retrospective case series of consecutive patients reported to our poison center after dofetilide overdose. Twenty-seven cases were included. Seventeen patients were treated at a healthcare facility, and of these, eight were admitted. Twenty-one patients took one extra capsule, four took someone else's medication, one took three extra capsules, and one had a large intentional overdose. Ten patients had co-ingestants reported, including three QT-prolonging agents. No one required cardioversion, defibrillation, CPR, or overdrive pacing. The patient who reported taking 90 times his usual dose in suicide attempt was the only patient to have significant clinical effects. He experienced an 8-beat run of non-sustained ventricular tachycardia, frequent multifocal PVCs, and ventricular bigeminy. He received magnesium sulfate and potassium chloride supplementation. In this series, unintentional small overdoses did not result in significant clinical effects and were often managed successfully at home, despite the fact that information showing a single capsule can cause torsades. This study is limited by its small sample size, retrospective design, and reliance on incomplete information.

Ferguson Smith type multiple keratoacanthomas and a keratoacanthoma centrifugum marginatum in a woman from Japan.

PubMed

Kato, N; Ito, K; Kimura, K; Shibata, M

2003-10-01

We report a case of multiple keratoacanthomas on the sun-exposed skin of a 37-year-old woman from Japan. She had experienced 4 similar episodes of evolution and involution of multiple keratoacanthomas during a period of 10 years since she was 27 years old. She was given the diagnosis of Ferguson Smith type keratoacanthoma. This is the seventh Japanese case of Ferguson Smith type keratoacanthoma described in detail in the literature. In addition, the patient was found to have an annular, coral reef-like eruption on the front of her neck, which was diagnosed as a keratoacanthoma centrifugum marginatum. A combination of different variants of keratoacanthoma in 1 patient is uncommon, and only 2 patients with the same combination of lesions, as that seen in our patient, have been reported. Our patient was treated by a relatively low dose (0.5 mg/kg body weight) of etretinate. Both variants of keratoacanthoma showed good response to the treatment. Effectiveness of etretinate for treating keratoacanthoma centrifugum marginatum has only been reported in a few cases. Our patient had no relapse during a period of 15 months after cessation of etretinate treatment.

Can encouraging substance abuse patients to participate in self-help groups reduce demand for health care? A quasi-experimental study.

PubMed

Humphreys , K; Moos, R

2001-05-01

Twelve-step-oriented inpatient treatment programs emphasize 12-step treatment approaches and the importance of ongoing attendance at 12-step self-help groups more than do cognitive-behavioral (CB) inpatient treatment programs. This study evaluated whether this difference in therapeutic approach leads patients who are treated in 12-step programs to rely less on professionally provided services and more on self-help groups after discharge, thereby reducing long-term health care costs. A prospective, quasi-experimental comparison of 12-step-based (N = 5) and cognitive-behavioral (n = 5) inpatient treatment programs was conducted. These treatments were compared on the degree to which their patients participated in self-help groups, used outpatient and inpatient mental health services, and experienced positive outcomes (e.g., abstinence) in the year following discharge. Using a larger sample from an ongoing research project, 887 male substance-dependent patients from each type of treatment program were matched on pre-intake health care costs (N = 1774). At baseline and 1-year follow-up, patients' involvement in self-help groups (e.g., Alcoholics Anonymous), utilization and costs of mental health services, and clinical outcomes were assessed. Compared with patients treated in CB programs, patients treated in 12-step programs had significantly greater involvement in self-help groups at follow-up. In contrast, patients treated in CB programs averaged almost twice as many outpatient continuing care visits after discharge (22.5 visits) as patients treated in 12-step treatment programs (13.1 visits), and also received significantly more days of inpatient care (17.0 days in CB versus 10.5 in 12-step), resulting in 64% higher annual costs in CB programs ($4729/patient, p < 0.001). Psychiatric and substance abuse outcomes were comparable across treatments, except that 12-step patients had higher rates of abstinence at follow-up (45.7% versus 36.2% for patients from CB programs, p < 0.001). Professional treatment programs that emphasize self-help approaches increase their patients' reliance on cost-free self-help groups and thereby lower subsequent health care costs. Such programs therefore represent a cost-effective approach to promoting recovery from substance abuse.

The effect of silicone implants on the diagnosis, prognosis, and treatment of breast cancer.

PubMed

Handel, Neal

2007-12-01

Because of the prevalence of breast cancer, many augmented women eventually will develop the disease. This article reviews what is known about the effect of implants on the detection, prognosis, and treatment of carcinoma of the breast. Observations were made on 4082 breast cancer patients (3953 nonaugmented and 129 augmented) treated over a 23-year time span. Findings in the two groups were compared and differences analyzed statistically. Mammograms of all women with palpable lesions were reviewed to assess mammographic sensitivity in patients with and without implants. Cosmetic outcomes in augmented patients treated with breast conservation therapy were reviewed. Augmented patients presented more frequently with palpable lesions, invasive tumors, axillary nodal metastases, and false-negative mammograms. However, there was no significant difference in stage of disease, tumor size, recurrence rates, or survival between the two groups. Augmented patients treated with breast conservation therapy often experienced poor cosmetic results and frequently required reoperation. Despite the diminished sensitivity of mammography in women with implants, augmented and nonaugmented patients are diagnosed at a similar stage of disease and have a comparable prognosis. Implants may impair mammography but appear to facilitate tumor detection on physical examination. Magnetic resonance imaging and breast ultrasound may be useful adjuncts, but conventional mammography remains the most reliable tool for diagnosing early breast cancer in augmented patients. Breast implants do not interfere with mastectomy or breast reconstruction but may compromise the outcome of breast conservation therapy.

First Indian single center experience with pipeline embolization device for complex intracranial aneurysms.

PubMed

Cherian, Mathew P; Yadav, Manish Kumar; Mehta, Pankaj; Vijayan, K; Arulselvan, V; Jayabalan, Suresh

2014-01-01

Flow diversion is a novel method of therapy wherein an endoluminal sleeve, the flow diverter stent is placed across the neck of complex aneurysms to curatively reconstruct abnormal vasculature. We present the first Indian single center experience with the pipeline embolization device (PED) and 6 months follow-up results of 5 patients. Five complex or recurrent intracranial aneurysms in five patients were treated with PED. The patients were followed-up with magnetic resonance angiography (MRA) after 4 weeks and conventional angiography after 6 months. Feasibility, complications, clinical outcome, early 1-month MRA and 6 months conventional angiographic follow-up results were analyzed. Of the five aneurysms treated, four were in the anterior circulation and one in the posterior circulation. All five patients were treated with a single PED in each, and additionally coils were used in one patient. At 1-month MRA follow-up, complete occlusion was seen in 2 (40%) of the five cases. Post 6 months conventional angiography showed complete occlusion of the aneurysm sac in all five cases (100%). Side branch ostia were covered in three patients, all of which were patent (100%). There was no incidence of major neurological morbidity or mortality. One patient (20%) who had basilar top aneurysm experienced minor neurological disability after 5 days which partially improved. Pipeline embolization device for complex and recurrent aneurysms is technically feasible, safe, offers low complication rate, and definitive vascular reconstruction. PED can be used without fear of occlusion of covered eloquent side branches and perforators.

A 14-Year Experience in the Management of Patients with Acquired Immune Thrombotic Thrombocytopenic Purpura in Northern Israel.

PubMed

Rinott, Nadav; Mashiach, Tatiana; Horowitz, Netanel A; Schliamser, Liliana; Sarig, Galit; Keren-Politansky, Anat; Dann, Eldad J

2015-01-01

Acquired idiopathic thrombotic thrombocytopenic purpura (I-TTP) is a life-threatening microangiopathic disorder usually treated with therapeutic plasma exchange (TPE). The current study assessed the role of rituximab in the treatment of complicated I-TTP. The sequence of TTP events was compared in a group of I-TTP patients treated with TPE and a cohort of refractory or relapsed patients who also received rituximab. This retrospective evaluation included 45 I-TTP patients, treated between January 2000 and October 2013, who underwent at least 3 TPE procedures and were followed up until December 2013 or death. Thirty-one patients with an uncomplicated course received TPE only. Fourteen patients had a complicated course due to either a primary refractory/exacerbated disease (n = 5) or relapse (n = 9) and received rituximab together with TPE. The median number of TPE procedures performed in the first TTP episode in the uncomplicated cohort and groups with primary refractory or relapsed TTP was 11, 27 and 45, respectively. The relapse rates per follow-up year in the uncomplicated I-TTP, primary refractory and relapsed I-TTP groups were 0.18, 0.2 and 0.6 episodes, respectively. After rituximab therapy this rate dropped to 0.2 per year in the relapsed subgroup. In conclusion, about a quarter of patients with I-TTP had a complicated course and experienced a major benefit from rituximab in terms of effectiveness and safety. © 2015 S. Karger AG, Basel.

Impaired quality and efficiency of sleep impairs cognitive functioning in Addison's disease.

PubMed

Henry, Michelle; Ross, Ian Louis; Wolf, Pedro Sofio Abril; Thomas, Kevin Garth Flusk

2017-04-01

Standard replacement therapy for Addison's disease (AD) does not restore a normal circadian rhythm. Periods of sub- and supra- physiological cortisol levels experienced by patients with AD likely induce disrupted sleep. Given that healthy sleep plays an important role in memory consolidation, the novelty of the current study was to characterise, using objective measures, the relationship between sleep and memory in patients with AD, and to examine the hypothesis that poor sleep is a biological mechanism underlying memory impairment in those patients. We used a within-subjects design. Ten patients with AD and 10 matched healthy controls completed standardised neuropsychological tests assessing declarative memory (Rey Auditory Verbal Learning Test) and procedural memory (Finger Tapping Task) before and after a period of actigraphy-measured sleep, and before and after a period of waking. Relative to healthy controls, patients with AD experienced disrupted sleep characterised by poorer sleep efficiency and more time spent awake. Patients also showed impaired verbal learning and memory relative to healthy controls (p=0.007). Furthermore, whereas healthy controls' declarative memory performance benefited from a period of sleep compared to waking (p=0.032), patients with AD derived no such benefit from sleep (p=0.448). Regarding the procedural memory task, analyses detected no significant between-group differences (all p's<0.065), and neither group showed significant sleep-enhanced performance. We demonstrated, using actigraphy and standardized measures of memory performance, an association between sleep disturbances and cognitive deficits in patients with AD. These results suggest that, in patients with AD, the source of memory deficits is, at least to some extent, disrupted sleep patterns that interfere with optimal consolidation of previously-learned declarative information. Hence, treating the sleep disturbances that are frequently experienced by patients with AD may improve their cognitive functioning. Copyright © 2017 Elsevier Ltd. All rights reserved.

"I struggle to count my blessings": recovery after hip fracture from the patients' perspective.

PubMed

Bruun-Olsen, Vigdis; Bergland, Astrid; Heiberg, Kristi Elisabeth

2018-01-19

Recovery outlooks of physical functioning and quality of life after hip fracture have not changed significantly over the past 25 years. Previous research has mainly dealt with causalities and acute treatment, while the recovery process from the patients' perspective has been less comprehensively described. Expanded knowledge of what the patients consider important in their recovery process may have important consequences for how these patients are treated in the future and thereby on future patient outcomes. The aim presently is therefore to explore how elderly patients with hip fracture enrolled in an ongoing RCT have experienced their recovery process. The study was qualitative in design. Eight frail elderly in recovery after hip fracture (aged 69-91) were interviewed in their home four months after their fracture. The interviews covered issues related to their experiences of facilitators and barriers throughout the different stages in the recovery process. The patients were already enrolled in an ongoing randomized controlled trial, examining the effects of habitual functional training during their short term stays at nursing homes. The patients were chosen strategically according to age, gender, and participation in rehabilitation. The interviews were recorded, transcribed and subjected to a method of systematic text condensation inspired by Giorgi's phenomenological method. The results revealed that the patients' experiences of the recovery process fell into three main themes: "Feeling vulnerable", "A span between self-reliance and dependency" and "Disruption from a normal life". The feeling of gloominess and vulnerability persisted throughout. Being in recovery was also experienced as a tension between self-reliance and dependency; a disrupted life where loss of mobility and the impact of age was profoundly present. Being in recovery after hip fracture was experienced as a life breaking event. Based on these findings, increased focus on individualized treatment to each patient through each stage of the recovery process should be emphasized.

Local Recurrence After Complete Clinical Response and Watch and Wait in Rectal Cancer After Neoadjuvant Chemoradiation: Impact of Salvage Therapy on Local Disease Control

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

Habr-Gama, Angelita, E-mail: gamange@uol.com.br; University of São Paulo School of Medicine, São Paulo; Gama-Rodrigues, Joaquim

Purpose: To review the risk of local recurrence and impact of salvage therapy after Watch and Wait for rectal cancer with complete clinical response (cCR) after chemoradiation therapy (CRT). Methods and Materials: Patients with cT2-4N0-2M0 distal rectal cancer treated with CRT (50.4-54 Gy + 5-fluorouracil-based chemotherapy) and cCR at 8 weeks were included. Patients with cCR were enrolled in a strict follow-up program with no immediate surgery (Watch and Wait). Local recurrence-free survival was compared while taking into account Watch and Wait strategy alone and Watch and Wait plus salvage. Results: 90 of 183 patients experienced cCR at initial assessment after CRT (49%). Whenmore » early tumor regrowths (up to and including the initial 12 months of follow-up) and late recurrences were considered together, 28 patients (31%) experienced local recurrence (median follow-up time, 60 months). Of those, 26 patients underwent salvage therapy, and 2 patients were not amenable to salvage. In 4 patients, local re-recurrence developed after Watch and Wait plus salvage. The overall salvage rate for local recurrence was 93%. Local recurrence-free survival at 5 years was 69% (all local recurrences) and 94% (after salvage procedures). Thirteen patients (14%) experienced systemic recurrence. The 5-year cancer-specific overall survival and disease-free survival for all patients (including all recurrences) were 91% and 68%, respectively. Conclusions: Local recurrence may develop in 31% of patients with initial cCR when early regrowths (≤12 months) and late recurrences are grouped together. More than half of these recurrences develop within 12 months of follow-up. Salvage therapy is possible in ≥90% of recurrences, leading to 94% local disease control, with 78% organ preservation.« less

Carotid Artery Stent Placement and Carotid Endarterectomy: A Challenge for Urgent Treatment after Stroke-Early and 12-Month Outcomes in a Comprehensive Stroke Center.

PubMed

Rocco, Alessandro; Sallustio, Fabrizio; Toschi, Nicola; Rizzato, Barbara; Legramante, Jacopo; Ippoliti, Arnaldo; Marchetti, Andrea Ascoli; Pampana, Enrico; Gandini, Roberto; Diomedi, Marina

2018-06-20

To compare feasibility, 12-month outcome, and periprocedural and postprocedural risks between carotid artery stent (CAS) placement and carotid endarterectomy (CEA) performed within 1 week after transient ischemic attack (TIA) or mild to severe stroke onset in a single comprehensive stroke center. Retrospective analysis of prospective data collected from 1,148 patients with ischemic stroke admitted to a single stroke unit between January 2013 and July 2015 was conducted. Among 130 consecutive patients with symptomatic carotid stenosis, 110 (10 with TIA, 100 with stroke) with a National Institutes of Health Stroke Scale (NIHSS) score < 20 and a prestroke modified Rankin Scale (mRS) score < 2 were eligible for CAS placement or CEA and treated according to the preference of the patient or a surrogate. Periprocedural (< 48 h) and postprocedural complications, functional outcome, stroke, and death rate up to 12 months were analyzed. Sixty-two patients were treated with CAS placement and 48 were treated with CEA. Several patients presented with moderate or major stroke (45.8% CEA, 64.5% CAS). NIHSS scores indicated slightly greater severity at onset in patients treated with a CAS vs CEA (6.6 ± 5.7 vs 4.2 ± 3.4; P = .08). Complication rates were similar between groups. mRS scores showed a significant improvement over time and a significant interaction with age in both groups. Similar incidences of death or stroke were shown on survival analysis. A subanalysis in patients with NIHSS scores ≥ 4 showed no differences in complication rate and outcome. CAS placement and CEA seem to offer early safe and feasible secondary stroke prevention treatments in experienced centers, even after major atherosclerotic stroke. Copyright © 2018 SIR. Published by Elsevier Inc. All rights reserved.

Antiapoptotic effects of Phe140Asn, a novel human granulocyte colony-stimulating factor mutant in H9c2 rat cardiomyocytes.

PubMed

Chung, Hee Kyoung; Ko, Eun Mi; Kim, Sung Woo; Byun, Sung-June; Chung, Hak-Jae; Kwon, Moosik; Lee, Hwi-Cheul; Yang, Byoung-Chul; Han, Deug-Woo; Park, Jin-Ki; Hong, Sung-Gu; Chang, Won-Kyong; Kim, Kyung-Woon

2012-12-01

Granulocyte colony-stimulating factor (G-CSF) is used for heart failure therapy and promotes myocardial regeneration by inducing mobilization of bone marrow stem cells to the injured heart after myocardial infarction; however, this treatment has one weakness in that its biological effect is transient. In our previous report, we generated 5 mutants harboring N-linked glycosylation to improve its antiapoptotic activities. Among them, one mutant (Phe140Asn) had higher cell viability than wild-type hG-CSF in rat cardiomyocytes, even after treatment with an apoptotic agent (H2O2). Cells treated with this mutant significantly upregulated the antiapoptotic proteins, and experienced reductions in caspase 3 activity and PARP cleavage. Moreover, the total number of apoptotic cells was dramatically lower in cultures treated with mutant hG-CSF. Taken together, these results suggest that the addition of an N-linked glycosylation was successful in improving the antiapoptotic activity of hG-CSF, and that this mutated product will be a feasible therapy for patients who have experienced heart failure.

Primary Adult Renal Ewing's Sarcoma: A Rare Entity

PubMed Central

Mukkunda, Ravindra; Venkitaraman, Ramachandran; Thway, Khin; Min, Toon; Fisher, Cyril; Horwich, Alan; Judson, Ian

2009-01-01

Background. Ewing's sarcoma of extraskeletal origin is uncommon and that is of primary renal origin in adults are rare. There is no consensus on the optimal management of Ewing's tumors of renal origin. Methods. A retrospective review of the clinical features, treatment, and outcome of adult patients with primary renal extra-skeletal Ewing's sarcoma who were treated at the Royal Marsden hospital from January 1993–December 2007 is reported. Results. Seven adult patients with primary renal Ewing's sarcoma were identified. All four patients with nonmetastatic disease had radical nephrectomy and received adjuvant chemotherapy +/− radiotherapy. Two developed metastatic disease while on adjuvant chemotherapy, and one patient relapsed after 55 months. The three patients with metastatic disease at presentation did not have nephrectomy and were treated with chemotherapy. All three patients had disease progression with a dismal outcome. Only one patient in the whole group is alive and disease free. The median overall survival was 62.8 months, and the median disease-free survival in patients with nonmetastatic disease after combined modality treatment was 30.3 months. Conclusion. Primary adult renal Ewing's sarcoma is an aggressive tumor with a propensity for early metastasis. Radical nephrectomy with adjuvant combination chemotherapy produced the best results but the outlook remained poor with only one patient experiencing long disease-free survival. PMID:19478963

Systemic rapamycin to prevent in-stent stenosis in peripheral pulmonary arterial disease: early clinical experience.

PubMed

Hallbergson, Anna; Esch, Jesse J; Tran, Trang X; Lock, James E; Marshall, Audrey C

2016-10-01

We have taken a novel approach using oral rapamycin - sirolimus - as a medical adjunct to percutaneous therapy in patients with in-stent stenosis and high risk of right ventricular failure. Peripheral pulmonary artery stenosis can result in right ventricular hypertension, dysfunction, and death. Percutaneous pulmonary artery angioplasty and stent placement acutely relieve obstructions, but patients frequently require re-interventions due to re-stenosis. In patients with tetralogy of Fallot or arteriopathy, the problem of in-stent stenosis contributes to the rapidly recurrent disease. Rapamycin was administered to 10 patients (1.5-18 years) with peripheral pulmonary stenosis and in-stent stenosis and either right ventricular hypertension, pulmonary blood flow maldistribution, or segmental pulmonary hypertension. Treatment was initiated around the time of catheterisation and continued for 1-3 months. Potential side-effects were monitored by clinical review and blood tests. Target serum rapamycin level (6-10 ng/ml) was accomplished in all patients; eight of the nine patients who returned for clinically indicated catheterisations demonstrated reduction in in-stent stenosis, and eight of the 10 patients experienced no significant side-effects. Among all, one patient developed diarrhoea requiring drug discontinuation, and one patient experienced gastrointestinal bleeding while on therapy that was likely due to an indwelling feeding tube and this patient tolerated rapamycin well following tube removal. Our initial clinical experience supports that patients with peripheral pulmonary artery stenosis can be safely treated with rapamycin. Systemic rapamycin may provide a novel medical approach to reduce in-stent stenosis.

The sodium hypochlorite accident: experience of diplomates of the American Board of Endodontics.

PubMed

Kleier, Donald J; Averbach, Robert E; Mehdipour, Omid

2008-11-01

To better understand the etiology associated with sodium hypochlorite accidents, we surveyed diplomates of the American Board of Endodontics. Of the 314 diplomates who responded, 132 reported experiencing a sodium hypochlorite accident. Questions were asked about the age and sex of the patient as well as the tooth being treated, preoperative signs, symptoms, diagnosis, and radiographic appearance. Data were analyzed by chi-square tests. Significantly more women experienced sodium hypochlorite accidents compared with men (p < 0.0001). More maxillary teeth than mandibular teeth (p < 0.0001) and more posterior than anterior teeth (p < 0.0001) were involved. A diagnosis of pulp necrosis with radiographic findings of periradicular radiolucency were positively associated with such accidents (p < 0.0001). Most respondents reported that patient signs and symptoms completely resolved within a month. The occurrence of an accident, by itself, did not adversely affect the endodontic prognosis of the involved tooth. Anatomic variations may contribute significantly to the occurrence of a sodium hypochlorite accident.

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

Trifiletti, Daniel M., E-mail: daniel.trifiletti@gmail.com; Lee, Cheng-Chia; Kano, Hideyuki

Purpose: To pool data across multiple institutions internationally and report on the cumulative experience of brainstem stereotactic radiosurgery (SRS). Methods and Materials: Data on patients with brainstem metastases treated with SRS were collected through the International Gamma Knife Research Foundation. Clinical, radiographic, and dosimetric characteristics were compared for factors prognostic for local control (LC) and overall survival (OS) using univariate and multivariate analyses. Results: Of 547 patients with 596 brainstem metastases treated with SRS, treatment of 7.4% of tumors resulted in severe SRS-induced toxicity (grade ≥3, increased odds with increasing tumor volume, margin dose, and whole-brain irradiation). Local control at 12 monthsmore » after SRS was 81.8% and was improved with increasing margin dose and maximum dose. Overall survival at 12 months after SRS was 32.7% and impacted by age, gender, number of metastases, tumor histology, and performance score. Conclusions: Our study provides additional evidence that SRS has become an option for patients with brainstem metastases, with an excellent benefit-to-risk ratio in the hands of experienced clinicians. Prior whole-brain irradiation increases the risk of severe toxicity in brainstem metastasis patients undergoing SRS.« less

Tofacitinib for the treatment of alopecia areata and variants in adolescents.

PubMed

Craiglow, Brittany G; Liu, Lucy Y; King, Brett A

2017-01-01

There are no reliably effective therapies for alopecia areata (AA). We sought to evaluate the benefit and adverse effects of the Janus kinase 1/3 inhibitor, tofacitinib, in a series of adolescent patients with AA. We reviewed the records of 13 adolescent patients with AA treated with tofacitinib. Severity of disease was assessed using the Severity of Alopecia Tool (SALT). Adverse events were evaluated by laboratory monitoring, physical examinations, and review of systems. Thirteen patients, aged 12 to 17 years, with AA were treated with tofacitinib. Nine patients experienced clinically significant hair regrowth. Median percent change in SALT score was 93% (mean 61%; 1%-100%) at an average of 6.5 months of treatment. Adverse events were mild. Limitations include the retrospective nature of the data, small sample size, and lack of a control group. Tofacitinib is a promising therapy for AA in adolescents. The use of tofacitinib and other Janus kinase inhibitors for the treatment of AA in this age group should be further evaluated in prospective clinical trials. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Bell's palsy during interferon alpha 2a treatment in a case with Behçet uveitis.

PubMed

Yalçindağ, Fatime Nilüfer; Alay, Cem

2013-01-01

To present a case who developed Bell's palsy while using interferon alpha 2a for Behçet uveitis. A patient with Behçet disease presented with decreased vision in his right eye. Ophthalmic examination, fundus fluorescein angiography and optical coherence tomography were performed. After developing facial paralysis while on interferon therapy, the patient was referred to our neurology service for differential diagnosis and treatment. Examination of right eye revealed panuveitis with branch retinal vein occlusion, so high dose steroids were prescribed. In three days there was no improvement in terms of vitreous inflammation and so steroids were replaced with interferon. At the seventh month, patient experienced a facial paralysis. After eliminating other causes, including viral infections, trauma, cold exposure and neurological evaluation with cranial MRI, the patient was diagnosed to have Bell's palsy by a neurologist. Interferon was replaced with mycophenolate mofetil and the Bell's palsy was treated with oral steroids. It is important to be alert to both common and rare complications while treating with interferon.

Comparing intracerebral hemorrhages associated with direct oral anticoagulants or warfarin

PubMed Central

Kurogi, Ryota; Nishimura, Kunihiro; Nakai, Michikazu; Kada, Akiko; Kamitani, Satoru; Nakagawara, Jyoji; Toyoda, Kazunori; Ogasawara, Kuniaki; Ono, Junichi; Shiokawa, Yoshiaki; Aruga, Toru; Miyachi, Shigeru; Nagata, Izumi; Matsuda, Shinya; Yoshimura, Shinichi; Okuchi, Kazuo; Suzuki, Akifumi; Nakamura, Fumiaki; Onozuka, Daisuke; Ido, Keisuke; Kurogi, Ai; Mukae, Nobutaka; Nishimura, Ataru; Arimura, Koichi; Kitazono, Takanari; Hagihara, Akihito

2018-01-01

Objectives This cross-sectional survey explored the characteristics and outcomes of direct oral anticoagulant (DOAC)–associated nontraumatic intracerebral hemorrhages (ICHs) by analyzing a large nationwide Japanese discharge database. Methods We analyzed data from 2,245 patients who experienced ICHs while taking anticoagulants (DOAC: 227; warfarin: 2,018) and were urgently hospitalized at 621 institutions in Japan between April 2010 and March 2015. We compared the DOAC- and warfarin-treated patients based on their backgrounds, ICH severities, antiplatelet therapies at admission, hematoma removal surgeries, reversal agents, mortality rates, and modified Rankin Scale scores at discharge. Results DOAC-associated ICHs were less likely to cause moderately or severely impaired consciousness (DOAC-associated ICHs: 31.3%; warfarin-associated ICHs: 39.4%; p = 0.002) or require surgical removal (DOAC-associated ICHs: 5.3%; warfarin-associated ICHs: 9.9%; p = 0.024) in the univariate analysis. Propensity score analysis revealed that patients with DOAC-associated ICHs also exhibited lower mortality rates within 1 day (odds ratio [OR] 4.96, p = 0.005), within 7 days (OR 2.29, p = 0.037), and during hospitalization (OR 1.96, p = 0.039). Conclusions This nationwide study revealed that DOAC-treated patients had less severe ICHs and lower mortality rates than did warfarin-treated patients, probably due to milder hemorrhages at admission and lower hematoma expansion frequencies. PMID:29490916

A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors.

PubMed

Salzberg, Marc; Kirson, Eilon; Palti, Yoram; Rochlitz, Christoph

2008-07-01

The transmission of electric fields using insulated electrodes has demonstrated that very low-intensity, properly tuned, intermediate-frequency electric fields, termed tumor-treating fields (TTFields), selectively stunts tumor cell growth and is accompanied by a decrease in tumor angiogenesis. This open, prospective pilot study was designed to evaluate the safety, tolerability, and efficacy profile of TTFields treatment in patients with locally advanced and/or metastatic solid tumors using the NovoTTF100A(TM) device. All 6 patients were heavily pre-treated with several lines of therapy; no additional standard treatment option was available to them. TTFields treatment using continuous NovoTTF-100A lasted a minimum of 14 days and was very well tolerated. No related serious adverse events occurred. Outcomes showed 1 partial response of a treated skin metastasis from a primary breast cancer, 3 cases where tumor growth was arrested during treatment, and 1 case of disease progression. One mesothelioma patient experienced lesion regression near TTFields with simultaneous tumor stability or progression in distal areas. Although the number of patients in this study is small, the lack of therapy toxicity and the efficacy observed in data gathered to date indicate the potential of TTFields as a new treatment modality for solid tumors, definitely warranting further investigation. (c) 2008 S. Karger AG, Basel

[The use of teicoplanin in neutropenic patients: values and limits].

PubMed

Espinouse, D; Chomarat, M

1990-06-01

The efficacy and the safety of teicoplanin were evaluated for the treatment of febrile episodes in neutropenic patients. A total of 18 patients received teicoplanin once daily as an intravenous injection of 200 mg in 6 patients (after a loading dose of 400 mg) or 400 mg in 12 patients (loading dose: 800 mg). The mean duration of therapy was 15.9 days (range 9 to 39 days). In all patients teicoplanin was combined with another antibiotic usually a beta-lactam. Thirteen of 18 patients were successfully treated. Three febrile episodes proved to be microbiologically documented infections and were cured by teicoplanin: one Streptococcus mitis and two methicillin-resistant (methi-R) Staphylococcus epidermidis bacteremias. Neither toxicity nor side effects were observed in the reported group. Six patients experiencing reactions to vancomycin (2 cases of cutaneous allergy) or to vancomycin and amphotericin B combination (4 cases of nephrotoxicity) were subsequently treated with teicoplanin without any evidence of cross-sensitivity. We observed emergence of teicoplanin-resistant coagulase-negative Staphylococcus in 3 patients receiving teicoplanin: 20, 18 and 8 days after a first febrile episode cured by teicoplanin and a beta-lactam, they developed fever while receiving the same antibiotic regimen. Methi-R Staphylococcus epidermidis was isolated from blood cultures in the first patient and methi-R Staphylococcus haemolyticus in the two other patients. In one patient, successfully treated by teicoplanin for a first febrile episode related to a methi-R Staphylococcus epidermidis, emergence of Staphylococcus haemolyticus occurred 8 days later while the patient was on teicoplanin therapy (6 mg/kg). MICs of teicoplanin were 16 mg/l for the two Staphylococcus strains isolated in this patient.(ABSTRACT TRUNCATED AT 250 WORDS)