Sample records for line chemotherapy syringes

  1. Warming of infusion syringes caused by electronic syringe pumps.

    PubMed

    Cornelius, A; Frey, B; Neff, T A; Gerber, A C; Weiss, M

    2003-05-01

    To evaluate inadvertent warming of the infusion syringe in four different types of electronic syringe pumps. Ambient temperature and syringe surface temperature were simultaneously measured by two electronic temperature probes in four different models of commercially available syringe pumps. Experiments were performed at an infusion rate of 1 ml h(-1) using both battery-operated and main power-operated pumps. Measurements were repeated four times with two pumps from each of the four syringe pump types at a room temperature of approximately 23 degrees C. Differences among the four syringe pump brands regarding ambient to syringe temperature gradient were compared using ANOVA. A P-value of less than 0.05 was considered statistically significant. Syringe warming differed significantly between the four syringe brands for both the battery-operated and main power-operated mode (ANOVA, P< 0.001 for both modes). Individual differences between syringe surface and ambient temperature ranged from 0.3 to 1.9 degrees C for battery operation and from 0.5 to 11.2 degrees C during main-power operation. Infusion solutions can be significantly warmed by syringe pumps. This has potential impact on bacterial growth and the stability of drug solutions and blood products infused, as well as on the susceptibility to hydrostatic pressure changes within the infusion syringe.

  2. Qualitative study of patients’ decision-making when accepting second-line treatment after failure of first-line chemotherapy

    PubMed Central

    Roch, Benoît; Roth, Caroline; Mérel, Jean-Pierre

    2018-01-01

    Objective Treatment failures in advanced lung cancer are frequent events affecting patients during or after first-line chemotherapy. International guidelines recommend second-line chemotherapy. However, around one half of patients who experience disease progression enter a systemic second-line therapy. In the herein qualitative study, we investigated patients' thoughts and attitudes determining the decision to undergo a second-line chemotherapy. Methods Thirty-three purposively selected patients who recently accepted second-line or palliative chemotherapy were invited to participate in this survey consisting of semi-structured in-depth interviews. Grounded theory was applied to investigate participants’ perceptions of the context that have surrounded their decision to undergo palliative chemotherapy. Results For most patients, tumor burden and reduced quality of life in relation with lung cancer itself were major drivers of the decision-making process. There was a balance between two different attitudes: making a decision to undergo a new line of chemotherapy or starting a psychological process in order to accept end of life. Choosing between these two attitudes allowed the patient to keep the matter of palliative care at a distance. Even in case of low chance of success, many patients who worried about their life partner's future would accept a new chemotherapy line. Some patients experienced ambivalent thoughts regarding social network, particularly about their family as daily function impairment required an increased need for relative's support. The initial "Worrying about others" thoughts left place to in an increasing self-need of care as those provided by relatives; this phenomenon might increase patients' self- perception of being a burden for others. Confidence previously established with formal caregiver support was another major decision driver: some patients with sustained confidence in their medical staff may have privileged this formal support rather

  3. Metastatic melanoma: results of 'classical' second-line treatment with cytotoxic chemotherapies.

    PubMed

    Perrin, Christophe; Pracht, Marc; Talour, Karen; Adamski, Henri; Cumin, Isabelle; Porneuf, Marc; Talarmin, Marie; Mesbah, Habiba; Audrain, Odile; Moignet, Aline; Lefeuvre-Plesse, Claudia; Lesimple, Thierry

    2014-10-01

    Metastatic melanoma is one of the most aggressive tumours, with a median survival that does not exceed 12 months. None of the cytotoxic first-line therapies have shown survival benefit in randomised clinical trials. To describe clinical benefit of second-line cytotoxic chemotherapy in the second line of treatment for metastatic melanoma. In a retrospective study, we analyse the outcome of patients with metastatic melanoma who had received two lines or more of cytotoxic treatments in four French dermato-oncology departments between 1999 and 2009. We describe the outcomes for 109 patients. Most of these patients received dacarbazine for the first line of chemotherapy and fotemustine for the second line of chemotherapy (67.0 and 64.2%, respectively). A clinical benefit was observed in 24.1% of the patients and overall survival was 4.1 months after the second-line treatment. At least 23.8% of patients suffered from grade 3 or 4 toxicities. The presence of more than two sites of metastasis and an M1c staging according to the AJCC classification represented negative predictive factors of clinical benefit. This study shows the modest benefit of a second line of cytotoxic chemotherapy in a nonselected population. If eligible, these patients should be proposed for ongoing clinical trials or for targeted therapies.

  4. Combination Therapy with Capecitabine and Cisplatin as Second-Line Chemotherapy for Advanced Biliary Tract Cancer.

    PubMed

    Jung, Jang Han; Lee, Hee Seung; Jo, Jung Hyun; Cho, In Rae; Chung, Moon Jae; Bang, Seungmin; Park, Seung Woo; Song, Si Young; Park, Jeong Youp

    2017-01-01

    Palliative chemotherapy is the main treatment for advanced biliary tract cancer (BTC). However, there is a lack of established second-line chemotherapy to treat disease progression after first-line chemotherapy. We examined combination therapy with capecitabine and cisplatin for advanced BTC as a second-line regimen. We analyzed the medical records of 40 patients diagnosed with BTC who received palliative second-line chemotherapy with capecitabine and cisplatin. The median overall survival from the start of second-line chemotherapy was 6.3 months. The median overall survival from diagnosis was 17.9 months. The median progression-free survival during second-line chemotherapy was 2.3 months. Nine (30%) patients experienced adverse events of grade ≥3. Eastern Cooperative Oncology Group performance score was an independent predictor of adverse events. Combination therapy with capecitabine and cisplatin may be an option for second-line chemotherapy in some of patients with advanced BTC. © 2017 S. Karger AG, Basel.

  5. Hypertensive Crisis During Norepinephrine Syringe Exchange: A Case Report.

    PubMed

    Snijder, Roland A; Knape, Johannes T A; Egberts, Toine C G; Timmerman, Annemoon M D E

    2017-04-01

    A 67-year critically ill patient suffered from a hypertensive crisis (200 mm Hg) because of a norepinephrine overdose. The overdose occurred when the clinician exchanged an almost-empty syringe and the syringe pump repeatedly reported an error. We hypothesized that an object between the plunger and the syringe driver may have caused the exertion of too much force on the syringe. Testing this hypothesis in vitro showed significant peak dosing errors (up to +572%) but moderate overdose (0.07 mL, +225%) if a clamp was used on the intravenous infusion line and a large overdose (0.8 mL, +2700%) if no clamp was used. Clamping and awareness are advised.

  6. The syringe gap: an assessment of sterile syringe need and acquisition among syringe exchange program participants in New York City

    PubMed Central

    Heller, Daliah I; Paone, Denise; Siegler, Anne; Karpati, Adam

    2009-01-01

    Background Programmatic data from New York City syringe exchange programs suggest that many clients visit the programs infrequently and take few syringes per transaction, while separate survey data from individuals using these programs indicate that frequent injecting – at least daily – is common. Together, these data suggest a possible "syringe gap" between the number of injections performed by users and the number of syringes they are receiving from programs for those injections. Methods We surveyed a convenience sample of 478 injecting drug users in New York City at syringe exchange programs to determine whether program syringe coverage was adequate to support safer injecting practices in this group. Results Respondents reported injecting a median of 60 times per month, visiting the syringe exchange program a median of 4 times per month, and obtaining a median of 10 syringes per transaction; more than one in four reported reusing syringes. Fifty-four percent of participants reported receiving fewer syringes than their number of injections per month. Receiving an inadequate number of syringes was more frequently reported by younger and homeless injectors, and by those who reported public injecting in the past month. Conclusion To improve syringe coverage and reduce syringe sharing, programs should target younger and homeless drug users, adopt non-restrictive syringe uptake policies, and establish better relationships with law enforcement and homeless services. The potential for safe injecting facilities should be explored, to address the prevalence of public injecting and resolve the 'syringe gap' for injecting drug users. PMID:19138414

  7. Syringe sociology.

    PubMed

    Vitellone, Nicole

    2015-06-01

    In this article I consider the impact of social epistemologies for understanding the object of the syringe. My aim is to examine the process through which the syringe transforms from an injecting device to a tool of social and political inquiry. Paying particular attention to the uses of Foucault, Becker, Bourdieu, Freud and Latour in empirical studies of injecting heroin use, I examine the sociology of the syringe through the lens of habit and habitus, discourse and deviance, mourning and melancholia, attachment and agencement. In pursuing the theory behind the object my goal is to address a sociological object in the making. In so doing I show how the syringe has been significant for social research, social theory, and sociology. It is the difference the object makes that this article seeks to describe. In tracing the epistemology of the syringe I show how the object is important not just for knowledge of addiction but sociology itself. © London School of Economics and Political Science 2015.

  8. Who purchases nonprescription syringes? Characterizing customers of the Expanded Syringe Access Program (ESAP).

    PubMed

    Battles, Haven B; Rowe, Kirsten A; Ortega-Peluso, Christina; Klein, Susan J; Tesoriero, James M

    2009-11-01

    This study represents the first attempt in the USA to survey pharmacy nonprescription syringe customers at their point of purchase. We surveyed 62 individuals purchasing nonprescription syringes in seven pharmacies located in NYC and Albany, NY, USA. Three quarters of respondents purchased for illicit use, and 36% purchased for medical use, with differences found by race and gender. Half got their syringes from pharmacies "most of the time." Half had ever been refused a syringe purchase in a NYS pharmacy, with men, Blacks, and Hispanics reporting higher levels of refusals than women or whites. Two thirds reported syringe reuse but very few reported sharing. While approximately one quarter safely obtained and disposed of syringes "most of the time," two thirds used both safe and unsafe methods. Pharmacy-based syringe access programs are essential in areas not served by syringe exchanges.

  9. The effect on syringe performance of fluid storage and repeated use: implications for syringe pumps.

    PubMed

    Capes, D F; Herring, D; Sunderland, V B; McMillan, D; McDonald, C

    1996-01-01

    Syringe stiction has been reported to cause syringe pump malfunction, hence the effect on syringe performance of syringe use and the formulations used in the syringe were investigated. The force required for syringe plunger motion (at 2.5 mm min-1), when filled with soybean oil emulsion (SBOE) and with water, and the extraction of silicone oil from syringes by these fluids, were measured for Primo, Talus and Terumo 10 mL, and Terumo 50 mL syringes. The breakloose, average extrusion and maximum force required to maintain plunger motion increased after storage of SBOE for 7 days in all syringes tested (p < 0.05). The storage of water increased the breakloose force of all syringes, but only increased the maximum force of Talus syringes, and both the average extrusion and maximum forces of Terumo 10 mL syringes. The mechanism for this is most likely swelling of the elastomer of the piston due to sorption of fluid. The force was found to increase logarithmically with repeated syringe use. Electrothermal atomization atomic absorption spectroscopy was used to measure the silicone oil content of syringe extractions. Three extractions were performed: repeated flushing, vigorous washing, and storage for 7 days with occasional agitation. Up to 69.4% of the silicone oil present in the syringes was extracted with both water and SBOE when they were stored or washed. In contrast to water, SBOE also extracted the lubricant when the syringe was filled and flushed immediately. If syringes are refilled, stored filled before use, or used over a prolonged period, particularly with a SBOE formulation, syringe striction may occur during infusion with a syringe pump.

  10. Third-Line Chemotherapy for Metastatic Urothelial Cancer: A Retrospective Observational Study

    PubMed Central

    Di Lorenzo, Giuseppe; Buonerba, Carlo; Bellelli, Teresa; Romano, Concetta; Montanaro, Vittorino; Ferro, Matteo; Benincasa, Alfonso; Ribera, Dario; Lucarelli, Giuseppe; De Cobelli, Ottavio; Sonpavde, Guru; De Placido, Sabino

    2015-01-01

    Abstract The prognosis of locally advanced (T3/T4 or N1) and metastatic disease urothelial carcinoma is poor. In this retrospective study, we reviewed data about patients receiving third-line chemotherapy for metastatic disease, in view of the lack of data in this setting. We retrospectively analyzed medical records of patients with a pathologic diagnosis of urothelial carcinoma treated with systemic chemotherapy for metastatic disease at 4 participating Institutions between January, 2010, and January, 2015. Cox proportional hazards regression was used to evaluate the association of the chemotherapy agent used versus others with overall survival, adjusted for 5 externally validated prognostic factors in advanced urothelial carcinoma. Of 182 patients that received first-line chemotherapy/adjuvant chemotherapy as defined above, 116 patients (63.73%) received second-line salvage treatment. Fifty-two patients were finally included in this analysis, whereas 9 were excluded due to missing data. Third-line chemotherapy was based on cyclophosphamide, platinum, vinflunine, taxanes, and gemcitabine in 16, 12, 11, 10, and 3 patients, respectively. Median PFS (progression-free survival) and OS (overall survival) of the population were 13 (10–17) and 31 (28–36) weeks. Single-agent cyclophosphamide was associated with a PFS of 18 (13–22) and an OS of 38 (33–41) weeks, whereas platinum-based combinations were associated with a PFS of 5 weeks and an OS of 8 weeks. Multivariate analysis showed improved survival in patients treated with cyclophosphamide (hazard ratio (HR) = 0.42; 95% CI: 0.20–0.89; P = 0.025) and a worse survival in those treated with platinum-based regimens (HR: 4.37; 95% CI = 1.95–9.77; P < 0.01). We observed a significantly longer overall survival in patients receiving single-agent cyclophosphamide, with few grade 3 to 4 toxicities. Further studies should assess the efficacy of metronomic single-agent cyclophosphamide in advanced lines

  11. Comparative evaluation of endodontic pressure syringe, insulin syringe, jiffy tube, and local anesthetic syringe in obturation of primary teeth: An in vitro study.

    PubMed

    Hiremath, Mallayya C; Srivastava, Pooja

    2016-01-01

    The purpose of this in vitro study was to compare four methods of root canal obturation in primary teeth using conventional radiography. A total of 96 root canals of primary molars were prepared and obturated with zinc oxide eugenol. Obturation methods compared were endodontic pressure syringe, insulin syringe, jiffy tube, and local anesthetic syringe. The root canal obturations were evaluated by conventional radiography for the length of obturation and presence of voids. The obtained data were analyzed using Chi-square test. The results showed significant differences between the four groups for the length of obturation (P < 0.05). The endodontic pressure syringe showed the best results (98.5% optimal fillings) and jiffy tube showed the poor results (37.5% optimal fillings) for the length of obturation. The insulin syringe (79.2% optimal fillings) and local anesthetic syringe (66.7% optimal fillings) showed acceptable results for the length of root canal obturation. However, minor voids were present in all the four techniques used. Endodontic pressure syringe produced the best results in terms of length of obturation and controlling paste extrusion from the apical foramen. However, insulin syringe and local anesthetic syringe can be used as effective alternative methods.

  12. First-line crizotinib versus chemotherapy in ALK-positive lung cancer.

    PubMed

    Solomon, Benjamin J; Mok, Tony; Kim, Dong-Wan; Wu, Yi-Long; Nakagawa, Kazuhiko; Mekhail, Tarek; Felip, Enriqueta; Cappuzzo, Federico; Paolini, Jolanda; Usari, Tiziana; Iyer, Shrividya; Reisman, Arlene; Wilner, Keith D; Tursi, Jennifer; Blackhall, Fiona

    2014-12-04

    The efficacy of the ALK inhibitor crizotinib as compared with standard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer (NSCLC) is unknown. We conducted an open-label, phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease. Patients were randomly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy (pemetrexed, 500 mg per square meter of body-surface area, plus either cisplatin, 75 mg per square meter, or carboplatin, target area under the curve of 5 to 6 mg per milliliter per minute) every 3 weeks for up to six cycles. Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy. The primary end point was progression-free survival as assessed by independent radiologic review. Progression-free survival was significantly longer with crizotinib than with chemotherapy (median, 10.9 months vs. 7.0 months; hazard ratio for progression or death with crizotinib, 0.45; 95% confidence interval [CI], 0.35 to 0.60; P<0.001). Objective response rates were 74% and 45%, respectively (P<0.001). Median overall survival was not reached in either group (hazard ratio for death with crizotinib, 0.82; 95% CI, 0.54 to 1.26; P=0.36); the probability of 1-year survival was 84% with crizotinib and 79% with chemotherapy. The most common adverse events with crizotinib were vision disorders, diarrhea, nausea, and edema, and the most common events with chemotherapy were nausea, fatigue, vomiting, and decreased appetite. As compared with chemotherapy, crizotinib was associated with greater reduction in lung cancer symptoms and greater improvement in quality of life. Crizotinib was superior to standard first-line pemetrexed-plus-platinum chemotherapy in patients with previously untreated advanced ALK-positive NSCLC. (Funded by

  13. Physician control of needle and syringe during aspiration-injection procedures with the new reciprocating syringe.

    PubMed

    Sibbitt, Wilmer; Sibbitt, Randy R; Michael, Adrian A; Fu, Druce I; Draeger, Hilda T; Twining, Jon M; Bankhurst, Arthur D

    2006-04-01

    To evaluate physician control of needle and syringe during aspiration-injection syringe procedures by comparing the new reciprocating procedure syringe to a traditional conventional syringe. Twenty-six physicians were tested for their individual ability to control the reciprocating and conventional syringes in typical aspiration-injection procedures using a novel quantitative needle-based displacement procedure model. Subsequently, the physicians performed 48 clinical aspiration-injection (arthrocentesis) procedures on 32 subjects randomized to the reciprocating or conventional syringes. Clinical outcomes included procedure time, patient pain, and operator satisfaction. Multivariate modeling methods were used to determine the experimental variables in the syringe control model most predictive of clinical outcome measures. In the model system, the reciprocating syringe significantly improved physician control of the syringe and needle, with a 66% reduction in unintended forward penetration (p < 0.001) and a 68% reduction in unintended retraction (p < 0.001). In clinical arthrocentesis, improvements were also noted: 30% reduction in procedure time (p < 0.03), 57% reduction in patient pain (p < 0.001), and a 79% increase in physician satisfaction (p < 0.001). The variables in the experimental system--unintended forward penetration, unintended retraction, and operator satisfaction--independently predicted the outcomes of procedure time, patient pain, and physician satisfaction in the clinical study (p < or = 0.001). The reciprocating syringe reduces procedure time and patient pain and improves operator satisfaction with the procedure syringe. The reciprocating syringe improves physician performance in both the validated quantitative needle-based displacement model and in real aspiration-injection syringe procedures, including arthrocentesis.

  14. [The effect of colored syringes and a colored sheet on the incidence of syringe swaps during anesthetic management].

    PubMed

    Hirabayashi, Yoshihiro; Kawakami, Takayuki; Suzuki, Hideo; Igarashi, Takashi; Saitoh, Kazuhiko; Seo, Norimasa

    2005-09-01

    Syringe swap is an important problem in anesthetic care, causing harm to patients. We examined the effect of colored syringe and a colored sheet on the incidence of syringe swaps during anesthetic management. We determined the color code. The blue-syringe contains local anesthetics; yellow-syringe, sympathomimetic drugs; and white-syringe with a red label fixed opposite the scale, muscle relaxants. The colored sheet displays the photographs of the syringe with drug name, dose and volume. The colored syringe and colored sheet were supplied for use from February 2004. We compared the incidence of syringe swaps during the period from February 2004 to January 2005 with that from February 2003 to January 2004. Although five syringe swaps were recorded from February 2003 to January 2004, in 5901 procedures, we encountered no syringe swaps from February 2004 to January 2005, in 6078 procedures. The colored syringe and colored sheet significantly decreased the incidence of syringe swaps during anesthetic management (P <0.05). The use of the sheet together with colored syringes can prevent syringe swaps during anesthesia.

  15. Oral syringe use survey.

    PubMed

    Baldwin, J N; Wedemeyer, H F

    1980-09-01

    Use of oral syringes at children's and ASHP-accredited residency hospitals in the United States was surveyed. Questionnaires were mailed to 131 hospitals; 117 (89.3%) were returned. Of the responding hospitals, 54.5% of children's hospitals and 67.1% of residency hospitals used oral syringes. There was no definite preference for a particular brand or type (glass vs. plastic) of syringe. Patients who often required liquid dosage forms, including pediatric and geriatric patients and patients with nasogastric tubes, were most frequently included in oral syringe distribution systems. Twenty-six of the 73 hospitals utilizing oral syringes used them for most unit dose liquids in all drug distribution systems. The remainder reported use for specific medications or circumstances. Expiration dating policies varied from 24 hours to one year to the manufacturer's expiration dating. The survey indicates widespread use of oral syringes and identifies a need for evaluation of medication stability in these devices.

  16. Second-line chemotherapy in advanced biliary cancer progressed to first-line platinum-gemcitabine combination: a multicenter survey and pooled analysis with published data.

    PubMed

    Fornaro, Lorenzo; Vivaldi, Caterina; Cereda, Stefano; Leone, Francesco; Aprile, Giuseppe; Lonardi, Sara; Silvestris, Nicola; Santini, Daniele; Milella, Michele; Caparello, Chiara; Musettini, Gianna; Pasquini, Giulia; Falcone, Alfredo; Brandi, Giovanni; Sperduti, Isabella; Vasile, Enrico

    2015-12-23

    After progression to a standard first-line platinum and gemcitabine combination (GP), there is no established second-line therapy for patients with advanced biliary tract cancers (aBTC). Indeed, literature data suggest limited activity of most second-line agents evaluated so far. We collected a large retrospective series of aBTC patients treated with second-line chemotherapy after progression to a first-line GP regimen at different Italian institutions. We then pooled the data with those reported in previous studies, which were identified with a Medline search and the on-line abstract datasets of major international oncology meetings. A total of 174 patients were included in the multicenter survey: response rate (RR) with second-line chemotherapy was low (3.4 %), with median PFS and OS of 3.0 months and 6.6 months, respectively. At multivariate analysis, preserved performance status, low CA19.9 levels and absence of distant metastases were favorable prognostic factors. Data from other five presented or published series were identified, for a total of 499 patients included in the pooled analysis. The results confirmed marginal activity of second-line chemotherapy (RR: 10.2 %), with limited efficacy in unselected patient populations (median PFS: 3.1 months; median OS: 6.3 months). The current analysis highlights the limited value of second-line chemotherapy after a first-line GP combination in aBTC. While waiting for effective biologic agents in this setting, ongoing randomized trials will identify the optimal second-line chemotherapy regimen and validate prognostic factors for individual patient management.

  17. Comparison of injection drug users accessing syringes from pharmacies, syringe exchange programs, and other syringe sources to inform targeted HIV prevention and intervention strategies

    PubMed Central

    Rudolph, Abby E.; Crawford, Natalie D.; Ompad, Danielle C.; Benjamin, Ebele O.; Stern, Rachel J.; Fuller, Crystal M.

    2011-01-01

    Objective In New York, syringe exchange programs (SEPs) and pharmacies provide syringe access for IDUs but may be unable to meet the needs of all IDUs. This analysis aims to describe IDUs who access syringes through different outlets to help inform the prevention needs of IDUs who under-utilize safe syringe sources in a city where syringe availability is high relative to other U.S. cities. Design Cross-sectional study Setting New York City (2005–2007) Participants 285 IDUs recruited using street-intercept sampling Intervention(s) Not Applicable Main outcome measure(s) IDUs using SEPs, pharmacies, or other outlets as a primary syringe source were compared by sociodemographic characteristics, injection practices and medical service utilization. Results Chi-square tests and polytomous logistic regression were used to compare IDUs with different self-reported primary syringe sources used 6 months prior to study entry. Compared with IDUs using other syringe sources, those using primarily SEPs were less likely to be Black (AOR:0.26 95%CI:0.11–0.57), more likely to inject daily (AOR:3.32; 95%CI:1.58–6.98), and more likely to inject with a new syringe (AOR:2.68; 95%CI:1.30–5.54). Compared with IDUs using other syringe sources, those using primarily pharmacies were less likely to be Black (AOR:0.39; 95%CI0.17–0.90). Conclusion These data suggest that pharmacies and SEPs may be reaching different populations of IDUs and highlight a sub-population of highly marginalized IDUs (Black and infrequent injectors) who are under-utilizing safe syringe sources in New York City. Targeted interventions are needed to reduce racial disparities and increase utilization of safe syringe outlets. PMID:20199954

  18. Syringe possession arrests are associated with receptive syringe sharing in two Mexico-US border cities

    PubMed Central

    Pollini, Robin A.; Brouwer, Kimberly C.; Lozada, Remedios M.; Ramos, Rebeca; Cruz, Michelle F.; Magis-Rodriguez, Carlos; Case, Patricia; Burris, Scott; Pu, Minya; Frost, Simon D. W.; Palinkas, Lawrence A.; Miller, Cari; Strathdee, Steffanie A.

    2008-01-01

    Aims To identify factors associated with receptive syringe sharing among injection drug users (IDUs) and elucidate the association between syringe possession arrests and syringe sharing. Design Cross-sectional study. Setting Mexican border cities of Tijuana, Baja California and Ciudad Juarez, Chihuahua. Participants IDUs in Tijuana (n = 222) and Ciudad Juarez (n = 206) were recruited using respondent-driven sampling (RDS). IDUs were ≥18 years and had injected illicit drugs in the past month. Measurements An interviewer-administered survey was used to collect quantitative data on socio-demographic, behavioral and contextual characteristics, including self-reported syringe sharing and arrests for syringe possession. Associations with receptive syringe sharing were investigated using logistic regression with RDS adjustment. Findings Overall, 48% of participants reported ever being arrested for carrying an unused/sterile syringe, even though syringe purchase and possession is legal in Mexico. Arrest for possessing unused/sterile syringes was associated independently with receptive syringe sharing [adjusted odds ratio (AOR) = 2.05; 95% confidence interval (CI): 1.26, 3.35], as was injecting in a shooting gallery (AOR = 3.60; 95% CI: 2.21, 5.87), injecting in the street (AOR = 2.05; 95% CI: 1.18, 3.54) and injecting methamphetamine (AOR = 2.77; 95% CI: 1.41, 5.47) or cocaine (AOR = 1.96; 95% CI: 1.15, 3.36). More than half of participants (57%) had been arrested for possessing a used syringe; in a second model, arrest for used syringe possession was also associated independently with receptive sharing (AOR = 2.87; 95% CI: 1.76, 4.69). Conclusions We documented high levels of syringe-related arrests in two Mexican–US border cities and an independent association between these arrests and risky injection practices. Public health collaborations with law enforcement to modify the risk environment in which drug use occurs are essential to facilitate safer injection

  19. Highly controlled vascular syringes for pericardiocentesis.

    PubMed

    Ricciardi, Mark; Roldan, Carlos; Sibbitt, Randy; Sibbitt, Wilmer; Michael, Adrian; Palmer, Dennis

    2010-12-01

    The present study determined the utility and needle control characteristics of highly controlled vascular syringes for image-guided pericardiocentesis. Vascular syringes have been integrated into invasive cardiovascular procedures with improved patient safety, but to date have not been used in pericardiocentesis. To address this issue, we determined the method of use of vascular syringes for pericardiocentesis. A vascular syringe with reciprocating plungers, the reciprocating procedure device (RPD syringe), replaced the corresponding 10 ml and 20 ml conventional syringes in a standard pericardiocentesis tray. The vascular syringe is controlled with one hand, and can either aspirate or inject by pushing the corresponding aspiration or injection plunger. Four hundred and thirty seven subjects underwent vascular syringe procedures. The linear displacement method was used to precisely measure control of the needle tip in millimeters (mm) in vascular syringes compared to conventional syringes in 20 individual operators. Relative to the corresponding 10 ml and 20 ml conventional syringes, vascular syringes significantly reduced unintended forward penetration of the needle tip by 44% (7.0 ± 4.3 mm; p < 0.0001) and 53% (10.1 ± 5.5 mm; p < 0.0001), respectively, and reduced unintended retraction of the needle by 56% (2.7 ± 2.2 mm; p < 0.001) and 60% (3.5 ± 2.5 mm; p < 0.001), respectively. During pericardiocentesis, the mechanical syringe permitted facile one-handed aspiration and maintained the operator's ability to clear the needle. In the 437 vascular syringe procedures, there were no complications, with an estimated cost savings of $10-65 per procedure. Vascular syringes improve needle control in pericardiocentesis, promote patient safety and permit one-handed aspiration and injection.

  20. Safe syringe disposal is related to safe syringe access among HIV-positive injection drug users.

    PubMed

    Coffin, Phillip O; Latka, Mary H; Latkin, Carl; Wu, Yingfeng; Purcell, David W; Metsch, Lisa; Gomez, Cynthia; Gourevitch, Marc N

    2007-09-01

    We evaluated the effect of syringe acquisition on syringe disposal among HIV-positive injection drug users (IDUs) in Baltimore, New York City, and San Francisco (N = 680; mean age 42 years, 62% male, 59% African-American, 21% Hispanic, 12% White). Independent predictors of safe disposal were acquiring syringes through a safe source and ever visiting a syringe exchange program. Weaker predictors included living in San Francisco, living in the area longer, less frequent binge drinking, injecting with an HIV+ partner, peer norms supporting safe injection, and self-empowerment. Independent predictors of safe "handling"-both acquiring and disposing of syringes safely-also included being from New York and being older. HIV-positive IDUs who obtain syringes from a safe source are more likely to safely dispose; peer norms contribute to both acquisition and disposal. Interventions to improve disposal should include expanding sites of safe syringe acquisition while enhancing disposal messages, alternatives, and convenience.

  1. Pharmacy access to sterile syringes for injection drug users: attitudes of participants in a syringe exchange program.

    PubMed

    Junge, B; Vlahov, D; Riley, E; Huettner, S; Brown, M; Beilenson, P

    1999-01-01

    To examine attitudes of participants of a van-based syringe exchange program (SEP) toward the hypothetical prospect of pharmacy-based syringe access. One-time, cross-sectional survey. Baltimore, Maryland. 206 injection drug users who participate in the Baltimore SEP. Face-to-face interviews. Location preferred for obtaining syringes, drug and syringe use, past experience with pharmacies, and willingness to pay. The sample was 67% men, 95% African American, and 95% unemployed; mean age was 39.8 years. A total of 19% of respondents had bought syringes at a pharmacy during the prior six months. Some 37% reported having been turned down when asking for syringes at a pharmacy, most commonly due to lack of identification to prove diabetic status (50%). If legal restrictions were lifted, 92% of respondents would obtain syringes from pharmacies, and would be willing to pay a mean price of $0.80 (median = $1.00) per syringe. Women were more likely than men to report the intention to switch from van-based SEP to pharmacy (57% versus 38%, p = .045). If current legal restrictions were lifted, pharmacies would be a viable syringe source appealing particularly to women, suggesting gender-specific access issues that should be addressed. The per-syringe price that study participants would be willing to pay exceeds typical retail prices, suggesting that pharmacists could charge enough per syringe to recoup operational costs.

  2. Expanding access to sterile syringes through pharmacies: assessment of New York's Expanded Syringe Access Program.

    PubMed

    Tesoriero, James M; Battles, Haven B; Klein, Susan J; Kaufman, Erin; Birkhead, Guthrie S

    2009-01-01

    To investigate the evolution of pharmacist practices, attitudes, and experiences with the Expanded Syringe Access Program (ESAP), which permits over-the-counter sale of syringes by registered pharmacies in New York State. Longitudinal study. New York State in 2002 and 2006. 506 (2002) and 682 (2006) managing pharmacists (response rates approximately 70%) at ESAP-registered pharmacies (n = 346 in both years). Mailed surveys (2002 and 2006). Pharmacist practices, attitudes, and experiences with ESAP over time. Approximately 75% of pharmacists reported that ESAP had facilitated timely/emergency access to syringes, and more than 90% in each year reported no problems or very few problems administering ESAP. The practice of placing additional requirements on the sale of syringes decreased from 2002 (51.4%) to 2006 (45.1%), while a 55% increase in syringe sales was reported between 2002 (43.3/month) and 2006 (67.1/month). The sale of sharps containers also increased between 2002 (85.2%) and 2006 (92.8%). Community independent pharmacies and those located outside New York City generally expressed more favorable attitudes and experiences with ESAP, although these differences decreased over time. Pharmacy-based syringe access is a viable harm-reduction alternative in the fight against blood-borne diseases, with ESAP now equaling the number of syringes being distributed by syringe exchange programs in New York State. Continued education/training is necessary to increase participation in ESAP and to further reduce barriers to ESAP use.

  3. Access to syringes for HIV prevention for injection drug users in St. Petersburg, Russia: syringe purchase test study

    PubMed Central

    2013-01-01

    Background The HIV epidemic in Russia is concentrated among injection drug users (IDUs). This is especially true for St. Petersburg where high HIV incidence persists among the city’s estimated 80,000 IDUs. Although sterile syringes are legally available, access for IDUs may be hampered. To explore the feasibility of using pharmacies to expand syringe access and provide other prevention services to IDUs, we investigated the current access to sterile syringes at the pharmacies and the correlation between pharmacy density and HIV prevalence in St. Petersburg. Methods 965 pharmacies citywide were mapped, classified by ownership type, and the association between pharmacy density and HIV prevalence at the district level was tested. We selected two districts among the 18 districts – one central and one peripheral – that represented two major types of city districts and contacted all operating pharmacies by phone to inquire if they stocked syringes and obtained details about their stock. Qualitative interviews with 26 IDUs provided data regarding syringe access in pharmacies and were used to formulate hypotheses for the pharmacy syringe purchase test wherein research staff attempted to purchase syringes in all pharmacies in the two districts. Results No correlation was found between the density of pharmacies and HIV prevalence at the district level. Of 108 operating pharmacies, 38 (35%) did not sell syringes of the types used by IDUs; of these, half stocked but refused to sell syringes to research staff, and the other half did not stock syringes at all. Overall 70 (65%) of the pharmacies did sell syringes; of these, 49 pharmacies sold single syringes without any restrictions and 21 offered packages of ten. Conclusions Trainings for pharmacists need to be conducted to reduce negative attitudes towards IDUs and increase pharmacists’ willingness to sell syringes. At a structural level, access to safe injection supplies for IDUs could be increased by including syringes

  4. Efficacy of air/water syringe tip sterilization.

    PubMed

    Inger, M; Bennani, V; Farella, M; Bennani, F; Cannon, R D

    2014-03-01

    Dental procedures involve contact between instruments and the patient's tissues, blood or saliva. This study evaluated the efficacy of the standardized sterilization of non-disposable air/water syringe tips and corrosion and contaminant build-up in these tips. The bacterial contamination of single-use and multiple-use non-disposable air/water syringe tips after routine use and sterilization was compared to that of single-use disposable tips by microbial culturing on PCA and blood agar plates. The effect of flushing the syringe tips prior to sterilization was also measured. The amount of corrosion in single-use and multiple-use non-disposable syringes was measured by SEM and EDS analyses. Non-disposable syringe tips had significantly (p < 0.05) greater bacterial contamination than single-use disposable tips. There were no statistically different levels of contamination between flushed and non-flushed non-disposable syringes or between single-use and multiple-use non-disposable syringes. SEM and EDS analyses showed greater evidence of corrosion and contaminant build-up in multiple-use syringes compared to single-use non-disposable syringes. Sterilization of non-disposable air/water syringes is not completely effective and rinsing, or the number of uses, does not affect the effectiveness of sterilization. There may be a lower risk of cross-infection from the use of disposable air/water syringe tips, instead of non-disposable ones. © 2014 Australian Dental Association.

  5. Extractables and leachables considerations for prefilled syringes.

    PubMed

    Jenke, Dennis R

    2014-10-01

    Use of pre-filled syringes as both a packaging and delivery system for pharmaceutical drug products is accelerating. Pre-filled syringes must meet the quality and suitability for use requirements for both systems, including compatibility with the drug product. Relevant incompatibilities between pre-filled syringes and drug products include the safety of syringe-based leachables that accumulate in drug products and the ability of leachables to interact with the drug product's ingredients as such interactions can affect safety, efficacy, stability and physical viability. Relevant suitability considerations for pre-filled syringes are discussed herein and specific examples of suitability for use issues for pre-filled syringes are cited, focusing on extractables associated with pre-filled syringes and leachables derived from such syringes. Aspects considered include the toxicological impact of leachables, their ability to alter the efficacy of drug products and to produce other undesirable outcomes such as aggregation and immunogenic responses. Materials used in pre-filled syringes and the conditions of use minimize the traditional safety risk associated with leachables. However, drug products that use pre-filled syringes are prone to non-traditional interactions such as disruption of protein conformation, leading to potential efficacy, safety and quality issues. In order to qualify pre-filled syringes for use, the traditional approach of measuring extractables and leachables and inferring their effect must be augmented by rigorous compatibility testing. Research into the fundamental relationship between leachables and drug substances will be necessary so the more time- and cost-efficient 'measure and infer' approach can be widely implemented.

  6. The cleaning of instruments and syringes

    PubMed Central

    Darmady, E. M.; Hughes, K. E. A.; Drewett, S. E.; Prince, D.; Tuke, Winifred; Verdon, Patricia

    1965-01-01

    The dangers to the handler of syringes used for routine injections were found to be negligible, but known infected syringes and those contaminated with antibiotics should be autoclaved before handling as a high proportion of these carry pathogenic organisms. Mechanical methods of cleaning syringes and instruments are assessed. The use of an artificial soil for testing purposes is described. Using this soil, ultrasonics by themselves are inadequate for cleaning syringes and instruments. Agitation with ultrasonics is essential for syringes, but is insufficient for instruments. Detergents are therefore an essential adjunct to the cleaning process. For syringes Pyroneg proved to be the most satisfactory, particularly if they had been previously siliconized. The best detergent for instruments contaminated with these types of soil was Penesolve 814 at a temperature of 95°C. but the instruments must be adequately rinsed after this treatment. A number of other detergents and cleaning agents are discussed. PMID:14247708

  7. Pharmacy syringe purchase test of nonprescription syringe sales in San Francisco and Los Angeles in 2010.

    PubMed

    Lutnick, Alexandra; Cooper, Erin; Dodson, Chaka; Bluthenthal, Ricky; Kral, Alex H

    2013-04-01

    The two main legal sources of clean needles for illicit injection drug users (IDUs) in California are syringe exchange programs (SEPs) and nonprescription syringe sales (NPSS) at pharmacies. In 2004, California became one of the last states to allow NPSS. To evaluate the implementation of NPSS and the California Disease Prevention Demonstration Project (DPDP), we conducted syringe purchase tests in San Francisco (SF) and Los Angeles (LA) between March and July of 2010. Large differences in implementation were observed in the two cities. In LA, less than one-quarter of the enrolled pharmacies sold syringes to our research assistant (RA), and none sold a single syringe. The rate of successful purchase in LA is the lowest reported in any syringe purchase test. In both sites, there was notable variation among the gauge size available, and price and quantity of syringes required for a purchase. None of the DPDP pharmacies in LA or SF provided the requisite health information. The findings suggest that more outreach needs to be conducted with pharmacists and pharmacy staff. The pharmacies' failure to disseminate the educational materials may result in missed opportunities to provide needed harm reduction information to IDUs. The varied prices and required quantities may serve as a barrier to syringe access among IDUs. Future research needs to examine reasons why pharmacies do not provide the mandated information, whether the omission of disposal options is indicative of pharmacies' reluctance to serve as disposal sites, and if the dual opt-in approach of NPSS/DPDP is a barrier to pharmacy enrollment.

  8. Stability of sodium bicarbonate injection 8.4% in syringes over a six-week period in refrigerated temperature.

    PubMed

    Seki, Jack T; Wang, Tian Q; Yip, Paul M; Mazzulli, Tony; Minden, Mark D

    2018-04-01

    Background Dysfunctional central venous catheter prohibits the administration of potential life-saving chemotherapy and the delivery of essential supportive care needs to patients. Sodium bicarbonate injection has been shown to impede against fibrin clot formation and prolong prothrombin time and thrombin clotting time. Sodium bicarbonate injection has been tried as a second-line agent with good results in a small number of patients (internal data not published) when alteplase failed. We assessed whether the pre-filled sodium bicarbonate injection in 5 mL syringes would not only preserve sterility and retain its pH and concentration but also amount to the potential cost savings for future use when stored in a refrigerated environment. Methodology Twelve pre-filled 5 mL syringes were prepared aseptically, of which four each were tested for pH, sodium bicarbonate injection concentration and sterility when stored in refrigerated temperature over a six-week period. A standard pH meter, enzymatic carbon dioxide analyzer, and a 14-day incubation for microbial detection were employed for this study. Results Sodium bicarbonate concentration measured in the form of carbon dioxide ranged from 923 mmol/L or (1846 mosol/L) to 1006 mmol/L or (2012 mosmol/L), and pH ranged from (7.88 to 8.05) were reported over the duration of the study period. The 14-day incubation period resulted in no microbial growth. Conclusion Our study results have indicated that the pH and sodium bicarbonate injection concentration values were stable and within range, comparable to those reported by the manufacturer within the study period. The contents of the subdivided sodium bicarbonate injection 5 mL syringes retained sterility over a 14-day incubation period.

  9. In vitro Development of Chemotherapy and Targeted Therapy Drug-Resistant Cancer Cell Lines: A Practical Guide with Case Studies

    PubMed Central

    McDermott, Martina; Eustace, Alex J.; Busschots, Steven; Breen, Laura; Crown, John; Clynes, Martin; O’Donovan, Norma; Stordal, Britta

    2014-01-01

    The development of a drug-resistant cell line can take from 3 to 18 months. However, little is published on the methodology of this development process. This article will discuss key decisions to be made prior to starting resistant cell line development; the choice of parent cell line, dose of selecting agent, treatment interval, and optimizing the dose of drug for the parent cell line. Clinically relevant drug-resistant cell lines are developed by mimicking the conditions cancer patients experience during chemotherapy and cell lines display between two- and eight-fold resistance compared to their parental cell line. Doses of drug administered are low, and a pulsed treatment strategy is often used where the cells recover in drug-free media. High-level laboratory models are developed with the aim of understanding potential mechanisms of resistance to chemotherapy agents. Doses of drug are higher and escalated over time. It is common to have difficulty developing stable clinically relevant drug-resistant cell lines. A comparative selection strategy of multiple cell lines or multiple chemotherapeutic agents mitigates this risk and gives insight into which agents or type of cell line develops resistance easily. Successful selection strategies from our research are presented. Pulsed-selection produced platinum or taxane-resistant large cell lung cancer (H1299 and H460) and temozolomide-resistant melanoma (Malme-3M and HT144) cell lines. Continuous selection produced a lapatinib-resistant breast cancer cell line (HCC1954). Techniques for maintaining drug-resistant cell lines are outlined including; maintaining cells with chemotherapy, pulse treating with chemotherapy, or returning to master drug-resistant stocks. The heterogeneity of drug-resistant models produced from the same parent cell line with the same chemotherapy agent is explored with reference to P-glycoprotein. Heterogeneity in drug-resistant cell lines reflects the heterogeneity that can occur in clinical

  10. Second-Line Intraperitoneal Chemotherapy for Recurrent Epithelial Ovarian, Tubal and Peritoneal Cancer: A Propensity Score-Matching Study.

    PubMed

    Lu, Chien-Hsing; Chang, Yen-Hou; Lee, Wai-Hou; Chang, Yi; Peng, Chia-Wen; Chuang, Chi-Mu

    2016-01-01

    The superiority of frontline intraperitoneal (IP) over intravenous (IV) chemotherapy is well established in the treatment of epithelial ovarian cancer. However, the role of IP chemotherapy in the second-line setting has rarely been investigated. Consecutive patients diagnosed with recurrent epithelial, tubal and peritoneal cancers between January 2000 and December 2012 were recruited using a propensity score-matching technique to adjust relevant risk factors. In total, 310 patients were included in the final analysis (94 for platinum-refractory/resistant disease and 216 for platinum-sensitive disease). IP chemotherapy demonstrated significantly longer median progression-free survival than IV chemotherapy (4.9 vs. 2.4 months, p < 0.001, for platinum-refractory/resistant disease, and 9.8 vs. 6.9 months, p < 0.001, for platinum-sensitive disease). Second-line IP chemotherapy confers longer progression-free survival than IV chemotherapy. Large-scale clinical trials should be conducted to validate the true efficacy. © 2016 S. Karger AG, Basel.

  11. Safety syringes and anti-needlestick devices in orthopaedic surgery.

    PubMed

    Sibbitt, Wilmer L; Band, Philip A; Kettwich, Lawrence G; Sibbitt, Cristina R; Sibbitt, Lori J; Bankhurst, Arthur D

    2011-09-07

    The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting

  12. Ifosfamide, mesna and epirubicin as second-line chemotherapy in advanced breast cancer.

    PubMed

    Kiraz, S; Baltali, E; Güler, N; Barista, I; Benekli, M; Celik, I; Güllü, I H; Kars, A; Tekuzman, G; Firat, D

    1996-08-01

    The ifosfamide, mesna and epirubicin (IMEpi) combination is administered to 16 patients having advanced metastatic breast carcinoma as second-line chemotherapy. We observed complete response in 6%, partial response in 44% (total overall response rate of 50%), stable disease in 12% and progressive disease in the remaining 38% of the patients. The median remission duration in responders was calculated to be 9.6 months. IMEpi regimen had a tolerable toxicity profile including alopecia, nausea and vomiting, microscopic hematuria, leukopenia and neurotoxicity in which serious complications necessitating discontinuation of the chemotherapy were not encountered. It might be concluded that IMEpi chemotherapy combination is an effective alternative among schedules in the management of patients with stage IV breast carcinoma without serious side effects.

  13. Cisplatin- Versus Non-Cisplatin-based First-Line Chemotherapy for Advanced Urothelial Carcinoma Previously Treated With Perioperative Cisplatin.

    PubMed

    Locke, Jennifer A; Pond, Gregory Russell; Sonpavde, Guru; Necchi, Andrea; Giannatempo, Patrizia; Paluri, Ravi Kumar; Niegisch, Guenter; Albers, Peter; Buonerba, Carlo; Di Lorenzo, Giuseppe; Vaishampayan, Ulka N; North, Scott A; Agarwal, Neeraj; Hussain, Syed A; Pal, Sumanta; Eigl, Bernhard J

    2016-08-01

    The optimal choice of first-line chemotherapy for patients with relapse of urothelial carcinoma (UC) after perioperative cisplatin-based chemotherapy (PCBC) is unclear. We investigated the outcomes with cisplatin rechallenge versus a non-cisplatin regimen in patients with recurrent metastatic UC after PCBC in a multicenter retrospective study. Individual patient-level data were collected for patients who had received various first-line chemotherapy regimens for advanced UC after previous PCBC. Cox proportional hazards models were used to investigate the prognostic ability of the type of perioperative and first-line chemotherapy to independently affect overall survival (OS) and progression-free survival (PFS) after accounting for known prognostic factors. Data were available for 145 patients (12 centers). The mean age was 62 years; the Eastern Cooperative Oncology Group (ECOG) performance status (PS) was > 0 for 42.0% of the patients. Of the 145 patients, 63% had received cisplatin-based first-line chemotherapy. The median time from previous chemotherapy (TFPC) was 6.2 months (range, 1-154 months). The median OS was 22 months (95% confidence interval [CI], 18-27 months), and the median PFS was 6 months (95% CI, 5-7 months). A better ECOG PS and a longer TFPC (> 12 months vs. ≤ 12 months; hazard ratio [HR], 0.32; 95% CI, 0.20-0.52; P < .001) was prognostic for OS and PFS. Cisplatin-based chemotherapy was associated with poor OS (HR, 1.86; 95% CI, 1.13-3.06; P = .015), which appeared to be pronounced in those patients with a TFPC of ≤ 12 months. Retreatment with cisplatin in the first-line setting was associated with worse OS (HR, 3.38; P < .001). The results of the present retrospective analysis suggest that for patients who have undergone previous PCBC for UC, rechallenging with cisplatin might confer a poorer OS, especially for those with progression within < 1 year. Copyright © 2015 Elsevier Inc. All rights reserved.

  14. New York City pharmacists' attitudes toward sale of needles/syringes to injection drug users before implementation of law expanding syringe access.

    PubMed

    Coffin, P O; Linas, B P; Factor, S H; Vlahov, D

    2000-12-01

    In May 2000, New York State passed legislation permitting the sale, purchase, and possession of up to 10 needles and syringes (hereafter "syringes") without a prescription, intended to reduce blood-borne pathogen transmission among injection drug users (IDUs). To obtain baseline data on pharmacists' attitudes and practices related to human immunodeficiency virus (HIV) prevention and IDUs, a telephone survey was administered to 130 pharmacists systematically selected in New York City. Less than half of pharmacists were aware of the new law; 49.6% were willing to or supported providing nonprescription sales of syringes to IDUs. Pharmacists in support tended to be less likely to consider customer appearance "very important." Managing and supervising pharmacists were more likely than staff pharmacists to support syringe sales to IDUs. Managing and supervising pharmacists who stocked packs of 10 syringes and personal sharps disposal containers, pharmacists who supported syringe exchange in the pharmacy, and pharmacists who were willing to sell syringes to diabetics without a prescription were more likely to support syringe sales to IDUs. Syringe disposal was a prominent concern among all pharmacists. Those not in support of syringe sales to IDUs tended to be more likely to believe the practice would increase drug use. These data suggest the need for initiatives to address concerns about syringe disposal and tailored continuing education classes for pharmacists on HIV and viral hepatitis prevention among IDUs.

  15. Factors associated with buying and selling syringes among injection drug users in a setting of one of North America's largest syringe exchange programs.

    PubMed

    Kuyper, Laura M; Kerr, Thomas; Li, Kathy; Hogg, Robert S; Tyndall, Mark W; Montaner, Julio S G; Wood, Evan

    2006-01-01

    We performed analyses of syringe buying and syringe selling among Vancouver injection drug users, recruited from May 1996 and followed up between November 2002 and August 2003, in the context of one of North America's largest syringe exchange programs (SEPs). An interviewer-administered questionnaire, approximately 45 minutes in duration, was used to collect information regarding risk factors for HIV infection and sources of sterile syringes. Seventy participants (15%) reported syringe selling and 122 (26%) reported syringe buying. Syringe sellers were more likely to be female, reside in unstable housing, need help injecting, and have visited the SEP at least once weekly. Syringe buyers were more likely to need help injecting, have difficulty finding new syringes, have binged on drugs, and have visited the SEP at least once weekly. Syringe buying most frequently occurred when the SEP was closed.

  16. Syringe disposal among injection drug users in Harlem and the Bronx during the New York State Expanded Syringe Access Demonstration Program.

    PubMed

    Cleland, Charles M; Deren, Sherry; Fuller, Crystal M; Blaney, Shannon; McMahon, James M; Tortu, Stephanie; Des Jarlais, Don C; Vlahov, David

    2007-04-01

    Effective January 1, 2001, New York State enacted the Expanded Syringe Access Demonstration Program (ESAP), allowing syringes to be sold in pharmacies without a prescription or dispensed through doctors, hospitals, and clinics to adults. A concern in the assessment of ESAP is its effects on syringe disposal practices. Syringe use data regarding the last injection episode were combined from three projects (N = 1,030) recruiting injection drug users. Disposal of syringes by methods known to be safe decreased significantly over time after the implementation of ESAP. Syringes obtained either from syringe exchange programs or ESAP sources were more likely to be disposed of safely than syringes obtained from other sources. Efforts to enlist pharmacists and others involved in ESAP implementation to encourage safe disposal are needed. More detailed information on disposal practices is needed to capture the continuum from least to most safe practices and variation within individuals.

  17. Syringe Disposal Among Injection Drug Users in San Francisco

    PubMed Central

    Martinez, Alexis N.; Carpenter, Lisa; Geckeler, Dara; Colfax, Grant; Kral, Alex H.

    2011-01-01

    To assess the prevalence of improperly discarded syringes and to examine syringe disposal practices of injection drug users (IDUs) in San Francisco, we visually inspected 1000 random city blocks and conducted a survey of 602 IDUs. We found 20 syringes on the streets we inspected. IDUs reported disposing of 13% of syringes improperly. In multivariate analysis, obtaining syringes from syringe exchange programs was found to be protective against improper disposal, and injecting in public places was predictive of improper disposal. Few syringes posed a public health threat. PMID:20466956

  18. Local anesthetic syringe ergonomics and student preferences.

    PubMed

    Wiener, R Constance; Crout, Richard J; Sandell, Joan; Howard, Brandi; Ouassa, Lydia; Wearden, Stanley; Wiener, Michael A

    2009-04-01

    With a diverse population of dentists, dental hygienists, and dental assistants, there is a wide range of sizes and shapes of individuals. Ergonomic considerations have resulted in the design of many adjustable delivery systems, chairs, and pieces of equipment. Companies have marketed instrumentation specifically for people with small hands, yet little research has been done regarding the advertising claims. The objective of this study was to compare the perceptions of dental and dental hygiene students after they used a conventional syringe and a petite syringe that has been marketed as advantageous for individuals with smaller hands. The two syringes were compared for aspiration, injection, and sense of control. A total of 181 students were invited to serve as subjects in the study, and ninety participated. The study involved two phases. During phase I, students used conventional and petite syringes to give a simulated inferior alveolar nerve block injection. In phase II, students gave a simulated palatal injection using both sizes of syringes. After performing the simulations, the students responded to a questionnaire. The students reported that the petite syringe gave them control, and 62.2 percent of them preferred it to the conventional syringe. There were differences in preferences between female and male students and also differences in preferences based on students' glove sizes. The female students preferred the petite syringe when aspiration was required. Overall, the students who wore small and extra small gloves had a preference for the petite syringe and felt it provided a sense of control, a key component when learning to provide injections.

  19. Syringe Exchange, Injecting and Intranasal Drug Use

    PubMed Central

    Arasteh, Kamyar; McKnight, Courtney; Ringer, Martin; Friedman, Samuel R.

    2016-01-01

    Objective To assess trends in injecting and non-injecting drug use after implementation of large-scale syringe exchange in New York City. The belief that implementation of syringe exchange will lead to increased drug injecting has been a persistent argument against syringe exchange. Methods Administrative data on route of administration for primary drug of abuse among patients entering the Beth Israel methadone maintenance program from 1995 – 2007. Approximately 2000 patients enter the program each year. Results During and after the period of large scale implementation of syringe exchange, the numbers of methadone program entrants reporting injecting drug use decreased while the numbers of entrants reporting intranasal drug use increased (p < .001). Conclusion While assessing possible effects of syringe exchange on trends in injecting drug use is inherently difficult, this may be the strongest data collected to date showing a lack of increase in drug injecting following implementation of syringe exchange. PMID:19891668

  20. Syringe Disposal among Injection Drug Users in Harlem and the Bronx during the New York State Expanded Syringe Access Demonstration Program

    ERIC Educational Resources Information Center

    Cleland, Charles M.; Deren, Sherry; Fuller, Crystal M.; Blaney, Shannon; McMahon, James M.; Tortu, Stephanie; Des Jarlais, Don C.; Vlahov, David

    2007-01-01

    Effective January 1, 2001, New York State enacted the Expanded Syringe Access Demonstration Program (ESAP), allowing syringes to be sold in pharmacies without a prescription or dispensed through doctors, hospitals, and clinics to adults. A concern in the assessment of ESAP is its effects on syringe disposal practices. Syringe use data regarding…

  1. Outcome and prognostic factors in metastatic urothelial carcinoma patients receiving second-line chemotherapy: an analysis of real-world clinical practice data in Japan.

    PubMed

    Matsumoto, Ryuji; Abe, Takashige; Ishizaki, Junji; Kikuchi, Hiroshi; Harabayashi, Toru; Minami, Keita; Sazawa, Ataru; Mochizuki, Tango; Akino, Tomoshige; Murakumo, Masashi; Osawa, Takahiro; Maruyama, Satoru; Murai, Sachiyo; Shinohara, Nobuo

    2018-06-25

    The objective of the present study was to investigate the survival outcome and prognostic factors of metastatic urothelial carcinoma patients treated with second-line systemic chemotherapy in real-world clinical practice. Overall, 114 patients with metastatic urothelial carcinoma undergoing second-line systemic chemotherapy were included in this retrospective analysis. The dominant second-line chemotherapy was a paclitaxel-based combination regimen (60%, 68/114). We assessed the progression-free survival and overall survival times using the Kaplan-Meier method. The Cox proportional hazards model was applied to identify the factors affecting overall survival. The median progression-free survival and overall survival times were 4 and 9 months, respectively. In the multivariate analysis, an Eastern Cooperative Oncology Group performance status score greater than 0 at presentation, C-reactive protein level ≧1 mg/dl and poor response to prior chemotherapy were adverse prognostic indicators. Patients with 0, 1, 2 and 3 of those risk factors had a median overall survival of 17, 12, 7 and 3 months, respectively. The Eastern Cooperative Oncology Group performance status at presentation, C-reactive protein level and response to prior chemotherapy were prognostic factors for metastatic urothelial carcinoma patients undergoing second-line chemotherapy. In the future, this information might help guide the choice of salvage treatment, such as second-line chemotherapy or immune checkpoint inhibitors, after the failure of first-line chemotherapy.

  2. 21 CFR 872.6770 - Cartridge syringe.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device... cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the...

  3. 21 CFR 872.6770 - Cartridge syringe.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device... cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the...

  4. 21 CFR 872.6770 - Cartridge syringe.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device... cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the...

  5. 21 CFR 872.6770 - Cartridge syringe.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device... cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the...

  6. 21 CFR 872.6770 - Cartridge syringe.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device... cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the...

  7. Genetic heterogeneity after first-line chemotherapy in high-grade serous ovarian cancer.

    PubMed

    Lambrechts, Sandrina; Smeets, Dominiek; Moisse, Matthieu; Braicu, Elena Ioana; Vanderstichele, Adriaan; Zhao, Hui; Van Nieuwenhuysen, Els; Berns, Els; Sehouli, Jalid; Zeillinger, Robert; Darb-Esfahani, Silvia; Cacsire Castillo-Tong, Dan; Lambrechts, Diether; Vergote, Ignace

    2016-01-01

    Most high-grade serous ovarian carcinoma (HGSOC) patients benefit from first-line platinum-based chemotherapy, but progressively develop resistance during subsequent lines. Re-activating BRCA1 or MDR1 mutations can underlie platinum resistance in end-stage patients. However, little is known about resistance mechanisms occurring after a single line of platinum, when patients still qualify for other treatments. In 31 patients with primary platinum-sensitive HGSOC, we profiled tumours collected during debulking surgery before and after first-line chemotherapy using whole-exome sequencing and single nucleotide polymorphism profiling. Besides germline BRCA1/2 mutations, we observed frequent loss-of-heterozygosity in homologous recombination (HR) genes and mutation spectra characteristic of HR-deficiency in all tumours. At relapse, tumours differed considerably from their primary counterparts. There was, however, no evidence of events reactivating the HR pathway, also not in tumours resistant to second-line platinum. Instead, a platinum score of 13 copy number regions, among other genes including MECOM, CCNE1 and ERBB2, correlated with platinum-free interval (PFI) after first-line therapy, whereas an increase of this score in recurrent tumours predicted the change in PFI during subsequent therapy. Already after a single line of platinum, there is huge variability between primary and recurrent tumours, advocating that in HGSOC biopsies need to be collected at relapse to tailor treatment options to the underlying genetic profile. Nevertheless, all primary platinum-sensitive HGSOCs remained HR-deficient, irrespective of whether they became resistant to second-line platinum, further suggesting these tumours qualify for second-line Poly APD ribose polymerase (PARP) inhibitor treatment. Finally, chromosomal instability contributes to acquired resistance after a single line of platinum therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. Impact of increased syringe access: preliminary findings on injection drug user syringe source, disposal, and pharmacy sales in Harlem, New York.

    PubMed

    Fuller, Crystal M; Ahern, Jennifer; Vadnai, Liza; Coffin, Phillip O; Galea, Sandro; Factor, Stephanie H; Vlahov, David

    2002-01-01

    To evaluate the New York State Expanded Syringe Access Demonstration Program (ESAP) through injection drug user (IDU) surveys, discarded needles and syringes studies, and pharmacy sales and experiences surveys. Pre-post comparison. In Harlem, New York City, risk surveys among street-recruited IDUs, needle/syringe street counts on 27 systematically sampled city blocks, and Harlem pharmacist reports of sales and experiences. Number and types of IDU syringe sources, block mean counts of discarded needles and syringes, level of pharmacy nonprescription syringe sales (NPSS), and pharmacists' experiences. Comparing 209 pre-ESAP with 396 post-ESAP IDUs, pharmacies as a primary syringe source increased: 3.4% to 5.3% (P < .001, and ever pharmacy use increased: 4.9% to 12.5% (P < .001), respectively. Compared with pre-ESAP IDUs, post-ESAP IDUs tended to be younger and more often black. Harlem pharmacy participation in ESAP increased considerably from March 1, 2001, to March 1, 2002, 49% to 79%, respectively. Among three Harlem pharmacies, there was a modest increase in NPSS; pharmacists reported no problems, and no discarded needles and syringes were observed in pharmacy areas. In the three pharmacies, the proportion of syringe sales that were NPSS was 46% (110 to 240 NPSS/month), 3% (25 to 90 NPSS/month), and 0%. The mean ratios of needles/syringes to background trash have not increased in Harlem since ESAP began. To date, no evidence of harmful effects discarded needles/syringes, pharmacy altercations) resulting from ESAP were observed. While NPSS have increased in Harlem, pharmacy use among IDUs remains low. In Harlem, efforts are underway to increase ESAP awareness and reduce socioenvironmental barriers to ESAP.

  9. The salvage therapy in lung adenocarcinoma initially harbored susceptible EGFR mutation and acquired resistance occurred to the first-line gefitinib and second-line cytotoxic chemotherapy.

    PubMed

    Yang, Chih-Jen; Hung, Jen-Yu; Tsai, Ming-Ju; Wu, Kuan-Li; Liu, Ta-Chih; Chou, Shah-Hwa; Lee, Jui-Ying; Hsu, Jui-Sheng; Huang, Ming-Shyan; Chong, Inn-Wen

    2017-05-10

    Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) such as gefitinib can provide better efficacy and prolonged progression free survival (PFS) than cytotoxic chemotherapy for metastatic lung non-squamous cell carcinoma harboring susceptible EGFR mutations when used as first-line therapy. Cytotoxic chemotherapy is regarded as being the standard therapy to overcome acquired resistance to an initial EGFR TKI. However, there is currently no consensus on how best to treat patients who develop resistance to both an initial EGFR TKI and chemotherapy. We enrolled stage IV lung adenocarcinoma patients with an EGFR mutation and who had developed acquired resistance to gefitinib and cytotoxic chemotherapy from two university-affiliated hospitals in Taiwan from June 2011 to December 2014. Basic demographic data, included Eastern Cooperative Oncology Group (ECOG) performance status were collected, and the response rate, progression-free survival (PFS) and overall survival (OS) were analyzed. Two hundred and nine patients with mutated EGFR and who took gefitinib as the first-line therapy were identified in the study period, of whom 86 received second-line cytotoxic chemotherapy, and 60 who received third-line therapy were eligible for this study. The patients who received cytotoxic chemotherapy had a significantly higher disease control rate than those who received erlotinib (73% vs. 46%, p = 0.0363), however there were no significant differences in PFS (2.9 months vs. 3.1 months, p = 0.9049) and OS (8.9 months vs. 7.9 months, p = 0.4956). Platinum- or pemetrexed-based chemotherapy provided similar PFS and OS as others did. The only significant poor prognostic factors for OS were old age (≥65 years) (HR = 5.97 [2.65-13.44], p < 0.0001) and poor performance status (ECOG ≥2) (HR = 5.84 [2.61-13.09], p < 0.0001). Retreatment with an EGFR TKI is not inferior to cytotoxic chemotherapy when used as salvage therapy for patients

  10. How does the use of multiple needles/syringes per injecting episode impact on the measurement of individual level needle and syringe program coverage?

    PubMed

    O'Keefe, Daniel; McCormack, Angus; Cogger, Shelley; Aitken, Campbell; Burns, Lucinda; Bruno, Raimondo; Stafford, Jenny; Butler, Kerryn; Breen, Courtney; Dietze, Paul

    2017-08-01

    Recent work by McCormack et al. (2016) showed that the inclusion of syringe stockpiling improves the measurement of individual-level syringe coverage. We explored whether including the use of a new parameter, multiple sterile syringes per injecting episode, further improves coverage measures. Data comes from 838 people who inject drugs, interviewed as part of the 2015 Illicit Drug Reporting System. Along with syringe coverage questions, the survey recorded the number of sterile syringes used on average per injecting episode. We constructed three measures of coverage: one adapted from Bluthenthal et al. (2007), the McCormack et al. measure, and a new coverage measure that included use of multiple syringes. Predictors of multiple syringe use and insufficient coverage (<100% of injecting episodes using a sterile syringe) using the new measure, were tested in logistic regression and the ability of the measures to discriminate key risk behaviours was compared using ROC curve analysis. 134 (16%) participants reported needing multiple syringes per injecting episode. Women showed significantly increased odds of multiple syringe use, as did those reporting injection related injuries/diseases and injecting of opioid substitution drugs or pharmaceutical opioids. Levels of insufficient coverage across the three measures were substantial (20%-28%). ROC curve analysis suggested that our new measure was no better at discriminating injecting risk behaviours than the existing measures. Based on our findings, there appears to be little need for adding a multiple syringe use parameter to existing coverage formulae. Hence, we recommend that multiple syringe use is not included in the measurement of individual-level syringe coverage. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. Nonprescription syringe sales: Resistant pharmacists' attitudes and practices.

    PubMed

    Chiarello, Elizabeth

    2016-09-01

    To examine barriers to nonprescription syringe sales (NPSS) in pharmacies by examining resistant pharmacists' willingness to provide syringes to people who inject drugs (PWID) and their current practices for provision or refusal. Qualitative, semi-structured, in-depth interviews with community pharmacists in California, Kansas, Mississippi, and New Jersey. Participants include seventeen community pharmacists who expressed ethical concerns about providing syringes drawn from a larger sample of 71 community pharmacists participating in a study of ethical decision-making. Analysis captures pharmacists' descriptions of their experiences providing syringes to suspected PWID. Pharmacists who identified syringes as a key ethical issue exhibited significant ambivalence about providing syringes to PWID. Most of these pharmacists were aware of harm reduction logics, but endorsed them to varying degrees. Moral concerns about supplying PWID with syringes were mediated by law and organizational policy. Many pharmacists who considered syringes an ethical challenge allayed their concerns by creating informal policy and engaging in deterrence practices designed to dissuade PWID from coming to the pharmacy. As heroin abuse rates continue to rise, pharmacists are undoubtedly integral allies in the fight to prevent the spread of communicable diseases like HIV/AIDS and Hepatitis C. Education should be aimed at identifying barriers to NPSS resulting from resistant pharmacists' attitudes and practices. Increased education paired with favorable law and organizational policy and decentralization of syringe provision could increase access to clean needles and decrease public health risks. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  12. Patient-derived orthotopic xenograft models for cancer of unknown primary precisely distinguish chemotherapy, and tumor-targeting S. typhimurium A1-R is superior to first-line chemotherapy.

    PubMed

    Miyake, Kentaro; Kiyuna, Tasuku; Miyake, Masuyo; Kawaguchi, Kei; Yoon, Sang Nam; Zhang, Zhiying; Igarashi, Kentaro; Razmjooei, Sahar; Wangsiricharoen, Sintawat; Murakami, Takashi; Li, Yunfeng; Nelson, Scott D; Russell, Tara A; Singh, Arun S; Hiroshima, Yukihiko; Momiyama, Masashi; Matsuyama, Ryusei; Chishima, Takashi; Singh, Shree Ram; Endo, Itaru; Eilber, Fritz C; Hoffman, Robert M

    2018-01-01

    Cancer of unknown primary (CUP) is a recalcitrant disease with poor prognosis because it lacks standard first-line therapy. CUP consists of diverse malignancy groups, making personalized precision therapy essential. The present study aimed to identify an effective therapy for a CUP patient using a patient-derived orthotopic xenograft (PDOX) model. This paper reports the usefulness of the PDOX model to precisely identify effective and ineffective chemotherapy and to compare the efficacy of S. typhimurium A1-R with first-line chemotherapy using the CUP PDOX model. The present study is the first to use a CUP PDOX model, which was able to precisely distinguish the chemotherapeutic course. We found that a carboplatinum (CAR)-based regimen was effective for this CUP patient. We also demonstrated that S. typhimurium A1-R was more effective against the CUP tumor than first-line chemotherapy. Our results indicate that S. typhimurium A1-R has clinical potential for CUP, a resistant disease that requires effective therapy.

  13. Delayed response to maintenance therapy after first-line chemotherapy in metastatic intrahepatic cholangiocarcinoma: a case report.

    PubMed

    Marciano, Roberta; Servetto, Alberto; Bianco, Cataldo; Bianco, Roberto

    2017-09-26

    Intrahepatic cholangiocarcinoma is an aggressive tumor originating in the epithelium of the bile duct, often associated with distant dissemination. The prognosis is poor and treatment is challenging due to low response rate to standard chemotherapy and lack of targeted therapies. Here we report the case of a 74-year-old white woman affected by intrahepatic cholangiocarcinoma with metastatic involvement of spleen, lung, peritoneum, and intra-abdominal lymph nodes. As first-line chemotherapy, she was given cisplatin-gemcitabine chemotherapy. The treatment was well tolerated with the exception of grade 1 constipation and a single episode of grade 4 thrombocytopenia occurring after the fourth course. After the first three courses of chemotherapy a computed tomography scan evaluation demonstrated no change; her CA19-9 levels were slightly decreased. However, after the sixth course of chemotherapy a computed tomography scan revealed a dimensional enlargement of the lung metastases; her CA19-9 levels increased. She was then treated with gemcitabine alone. After 2 months of gemcitabine monotherapy a significant regression of lung and spleen metastases, as well a CA19-9 level reduction, occurred. Eight months after the start of gemcitabine monotherapy no signs of progression were reported. Treatment of metastatic intrahepatic cholangiocarcinoma with gemcitabine as maintenance therapy after first-line chemotherapy could be continued until clear evidence of disease progression since delayed responses are possible.

  14. Syringe injectable electronics

    PubMed Central

    Hong, Guosong; Zhou, Tao; Jin, Lihua; Duvvuri, Madhavi; Jiang, Zhe; Kruskal, Peter; Xie, Chong; Suo, Zhigang; Fang, Ying; Lieber, Charles M.

    2015-01-01

    Seamless and minimally-invasive three-dimensional (3D) interpenetration of electronics within artificial or natural structures could allow for continuous monitoring and manipulation of their properties. Flexible electronics provide a means for conforming electronics to non-planar surfaces, yet targeted delivery of flexible electronics to internal regions remains difficult. Here, we overcome this challenge by demonstrating syringe injection and subsequent unfolding of submicrometer-thick, centimeter-scale macroporous mesh electronics through needles with a diameter as small as 100 micrometers. Our results show that electronic components can be injected into man-made and biological cavities, as well as dense gels and tissue, with > 90% device yield. We demonstrate several applications of syringe injectable electronics as a general approach for interpenetrating flexible electronics with 3D structures, including (i) monitoring of internal mechanical strains in polymer cavities, (ii) tight integration and low chronic immunoreactivity with several distinct regions of the brain, and (iii) in vivo multiplexed neural recording. Moreover, syringe injection enables delivery of flexible electronics through a rigid shell, delivery of large volume flexible electronics that can fill internal cavities and co-injection of electronics with other materials into host structures, opening up unique applications for flexible electronics. PMID:26053995

  15. Methods To Determine the Silicone Oil Layer Thickness in Sprayed-On Siliconized Syringes.

    PubMed

    Loosli, Viviane; Germershaus, Oliver; Steinberg, Henrik; Dreher, Sascha; Grauschopf, Ulla; Funke, Stefanie

    2018-01-01

    The silicone lubricant layer in prefilled syringes has been investigated with regards to siliconization process performance, prefilled syringe functionality, and drug product attributes, such as subvisible particle levels, in several studies in the past. However, adequate methods to characterize the silicone oil layer thickness and distribution are limited, and systematic evaluation is missing. In this study, white light interferometry was evaluated to close this gap in method understanding. White light interferometry demonstrated a good accuracy of 93-99% for MgF 2 coated, curved standards covering a thickness range of 115-473 nm. Thickness measurements for sprayed-on siliconized prefilled syringes with different representative silicone oil distribution patterns (homogeneous, pronounced siliconization at flange or needle side, respectively) showed high instrument (0.5%) and analyst precision (4.1%). Different white light interferometry instrument parameters (autofocus, protective shield, syringe barrel dimensions input, type of non-siliconized syringe used as base reference) had no significant impact on the measured average layer thickness. The obtained values from white light interferometry applying a fully developed method (12 radial lines, 50 mm measurement distance, 50 measurements points) were in agreement with orthogonal results from combined white and laser interferometry and 3D-laser scanning microscopy. The investigated syringe batches (lot A and B) exhibited comparable longitudinal silicone oil layer thicknesses ranging from 170-190 nm to 90-100 nm from flange to tip and homogeneously distributed silicone layers over the syringe barrel circumference (110- 135 nm). Empty break-loose (4-4.5 N) and gliding forces (2-2.5 N) were comparably low for both analyzed syringe lots. A silicone oil layer thickness of 100-200 nm was thus sufficient for adequate functionality in this particular study. Filling the syringe with a surrogate solution including short

  16. Syringe size: does it matter in physician-performed procedures?

    PubMed

    Michael, Adrian A; Moorjani, Gautam R; Peisajovich, Andres; Park, Kye S; Sibbitt, Wilmer L; Bankhurst, Arthur D

    2009-03-01

    We hypothesized that the size of syringe influenced needle control in physician-performed procedures. Operators were tested for their ability to control a 1-, 3-, 5-, 10-, and 20-mL syringe and equivalent sizes of the new safety device, the reciprocating procedure device (RPD), using the quantitative needle-based displacement method. Three hundred twenty clinical syringe procedures were then randomized to either a 3- or 10-mL conventional syringe or to a 3- or 10-mL RPD. Patient pain was measured with the Visual Analog Pain Scale (VAPS). Increasing syringe size was associated with the undesirable characteristic of unintended forward penetration (loss of control of the needle in the forward direction) (r(2) = 0.97, slope = 2.14, 95% CI: 1.54-2.76, P < 0.002), and unintended retraction (loss of control of the needle in the reverse direction) (r(2) = 0.97, slope 2.15, 95% CI: 1.54-2.76, P < 0.002). In addition, 2-handed operation of a syringe resulted in greater control than 1-handed operation of a syringe (P < 0.001). When 1-handed operation was required, the RPD control syringe reduced unintended penetration by 52.3% (P >or= 0.001), unintended retraction by 56.8% (P >or= 0.001), and patient pain by 54.7% (P >or= 0.001) at each device size. For greater safety and control when operating the conventional syringe, smaller syringe sizes and 2 hands instead of 1 hand should be used whenever possible. If 1-handed operation of a syringe is necessary, a safety technology like the RPD control syringe should be used.

  17. Wrap spring clutch syringe ram and frit mixer

    DOEpatents

    Simpson, Frank B.

    2006-07-25

    A wrap spring clutch syringe ram pushes at least one syringe with virtually instantaneous starting and stopping, and with constant motion at a defined velocity during the intervening push. The wrap spring clutch syringe ram includes an electric motor, a computer, a flywheel, a wrap spring clutch, a precision lead screw, a slide platform, and syringe reservoirs, a mixing chamber, and a reaction incubation tube. The electric motor drives a flywheel and the wrap spring clutch couples the precision lead screw to the flywheel when a computer enables a solenoid of the wrap spring clutch. The precision lead screw drives a precision slide which causes syringes to supply a portion of solution into the mixing chamber and the incubation tube. The wrap spring clutch syringe ram is designed to enable the quantitative study of solution phase chemical and biochemical reactions, particularly those reactions that occur on the subsecond time scale.

  18. [Economic impact of strategies using ephedrine prefilled syringes].

    PubMed

    Crégut-Corbaton, J; Malbranche, C; Guignard, M-H; Fagnoni, P

    2013-11-01

    Ephedrine is an emergency drug available in ampules and syringes need to be prepared in advance according to one of two strategies in our establishment: strategy 1 (S1: 1 ampule per patient) and strategy 2 (S2: 1 ampule per operating room). There are also prefilled syringes. Because of their high cost and conflicting results in the literature, we assessed the economic interest of using prefilled syringes compared with strategies S1 and S2. This was a prospective observational study. The consumption of ephedrine was recorded over two periods of 14 days: P1 with syringes prepared in advance according to S1 or S2 and P2 with the on-demand use of prefilled syringes. The cost of a syringe of ephedrine prepared in advance (nurse time preparation included) was evaluated at €1.65 vs. €3.57 for a prefilled syringe. In operating rooms using S1, the use of prefilled syringes reduced overall the cost per patient about €1.22 and global annual costs by 72% (€2830), while the decrease was about €0.32 for the cost per patient and about 47% (€2760) for global annual costs for operating rooms using S2. The interest of our study is that we investigated different supply strategies for ephedrine within a large number of operating rooms. In our establishment, it was decided to use prefilled syringes in operating rooms that used S1. As well as the economic interest, prefilled syringes contributed to improved safety and saved nursing time. Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.

  19. Greater Drug Injecting Risk for HIV, HBV, and HCV Infection in a City Where Syringe Exchange and Pharmacy Syringe Distribution are Illegal

    PubMed Central

    Zhao, Mingfang; Gyarmathy, V. Anna; Cisek, Linda; Friedman, Samuel R.; Baxter, Robert C.

    2008-01-01

    Comparing drug-injecting risk between cities that differ in the legality of sterile syringe distribution for injection drug use provides a natural experiment to assess the efficacy of legalizing sterile syringe distribution as a structural intervention to prevent human immunodeficiency virus (HIV) and other parenterally transmitted infections among injection drug users (IDUs). This study compares the parenteral risk for HIV and hepatitis B (HBV) and C (HCV) infection among IDUs in Newark, NJ, USA, where syringe distribution programs were illegal during the period when data were collected, and New York City (NYC) where they were legal. IDUs were nontreatment recruited, 2004–2006, serotested, and interviewed about syringe sources and injecting risk behaviors (prior 30 days). In multivariate logistic regression, adjusted odds ratios (AOR) and 95% confidence intervals (95% CI) for city differences are estimated controlling for potential city confounders. IDUs in Newark (n = 214) vs. NYC (n = 312) were more likely to test seropositive for HIV (26% vs. 5%; AOR = 3.2; 95% CI = 1.6, 6.1), antibody to the HBV core antigen (70% vs. 27%; AOR = 4.4; 95% CI = 2.8, 6.9), and antibody to HCV (82% vs. 53%; AOR = 3.0; 95% CI = 1.8, 4.9), were less likely to obtain syringes from syringe exchange programs or pharmacies (AOR = 0.004; 95% CI = 0.001, 0.01), and were more likely to obtain syringes from street sellers (AOR = 74.0; 95% CI = 29.9, 183.2), to inject with another IDU’s used syringe (AOR = 2.3; 95% CI = 1.1, 5.0), to reuse syringes (AOR = 2.99; 95% CI = 1.63, 5.50), and to not always inject once only with a new, sterile syringe that had been sealed in a wrapper (AOR = 5.4; 95% CI = 2.9, 10.3). In localities where sterile syringe distribution is illegal, IDUs are more likely to obtain syringes from unsafe sources and to engage in injecting risk behaviors. Legalizing and rapidly implementing sterile

  20. Protein aggregation and particle formation in prefilled glass syringes.

    PubMed

    Gerhardt, Alana; Mcgraw, Nicole R; Schwartz, Daniel K; Bee, Jared S; Carpenter, John F; Randolph, Theodore W

    2014-06-01

    The stability of therapeutic proteins formulated in prefilled syringes (PFS) may be negatively impacted by the exposure of protein molecules to silicone oil-water interfaces and air-water interfaces. In addition, agitation, such as that experienced during transportation, may increase the detrimental effects (i.e., protein aggregation and particle formation) of protein interactions with interfaces. In this study, surfactant-free formulations containing either a monoclonal antibody or lysozyme were incubated in PFS, where they were exposed to silicone oil-water interfaces (siliconized syringe walls), air-water interfaces (air bubbles), and agitation stress (occurring during end-over-end rotation). Using flow microscopy, particles (≥2 μm diameter) were detected under all conditions. The highest particle concentrations were found in agitated, siliconized syringes containing an air bubble. The particles formed in this condition consisted of silicone oil droplets and aggregated protein, as well as agglomerates of protein aggregates and silicone oil. We propose an interfacial mechanism of particle generation in PFS in which capillary forces at the three-phase (silicone oil-water-air) contact line remove silicone oil and gelled protein aggregates from the interface and transport them into the bulk. This mechanism explains the synergistic effects of silicone oil-water interfaces, air-water interfaces, and agitation in the generation of particles in protein formulations. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  1. Open-Source Syringe Pump Library

    PubMed Central

    Wijnen, Bas; Hunt, Emily J.; Anzalone, Gerald C.; Pearce, Joshua M.

    2014-01-01

    This article explores a new open-source method for developing and manufacturing high-quality scientific equipment suitable for use in virtually any laboratory. A syringe pump was designed using freely available open-source computer aided design (CAD) software and manufactured using an open-source RepRap 3-D printer and readily available parts. The design, bill of materials and assembly instructions are globally available to anyone wishing to use them. Details are provided covering the use of the CAD software and the RepRap 3-D printer. The use of an open-source Rasberry Pi computer as a wireless control device is also illustrated. Performance of the syringe pump was assessed and the methods used for assessment are detailed. The cost of the entire system, including the controller and web-based control interface, is on the order of 5% or less than one would expect to pay for a commercial syringe pump having similar performance. The design should suit the needs of a given research activity requiring a syringe pump including carefully controlled dosing of reagents, pharmaceuticals, and delivery of viscous 3-D printer media among other applications. PMID:25229451

  2. Consequences of a restrictive syringe exchange policy on utilization patterns of a syringe exchange program in Baltimore, Maryland: Implications for HIV risk

    PubMed Central

    Sherman, Susan G.; Patel, Shivani A.; Ramachandran, Daesha V.; Galai, Noya; Chaulk, Patrick; Serio-Chapman, Chris; Gindi, Renee M.

    2016-01-01

    Background Syringe distribution policies continue to be debated in many jurisdictions throughout the U.S. The Baltimore Needle and Syringe Exchange Program (NSP) operated under a 1-for-1 syringe exchange policy from its inception in 1994 through 1999, when it implemented a restrictive policy (2000–2004) that dictated less than 1-for-1 exchange for non-program syringes. Methods Data were derived from the Baltimore NSP, which prospectively collected data on all client visits. We examined the impact of this restrictive policy on program-level output measures (i.e., distributed:returned syringe ratio, client volume) before, during, and after the restrictive exchange policy. Through multiple logistic regression, we examined correlates of less than 1-for-1 exchange ratios at the client-level before and during the restrictive exchange policy periods. Results During the restrictive policy period, the average annual program-level ratio of total syringes distributed:returned dropped from 0.99 to 0.88, with a low point of 0.85 in 2000. There were substantial decreases in the average number of syringes distributed, syringes returned, the total number of clients, and new clients enrolling during the restrictive compared to the preceding period. During the restrictive period, 33,508 more syringes were returned to the needle exchange than were distributed. In the presence of other variables, correlates of less than 1-for-1 exchange ratio were being white, female, and less than 30 years old. Discussion With fewer clean syringes in circulation, restrictive policies could increase the risk of exposure to HIV among IDUs and the broader community. The study provides evidence to the potentially harmful effects of such policies. PMID:25919590

  3. Syringe-injectable electronics.

    PubMed

    Liu, Jia; Fu, Tian-Ming; Cheng, Zengguang; Hong, Guosong; Zhou, Tao; Jin, Lihua; Duvvuri, Madhavi; Jiang, Zhe; Kruskal, Peter; Xie, Chong; Suo, Zhigang; Fang, Ying; Lieber, Charles M

    2015-07-01

    Seamless and minimally invasive three-dimensional interpenetration of electronics within artificial or natural structures could allow for continuous monitoring and manipulation of their properties. Flexible electronics provide a means for conforming electronics to non-planar surfaces, yet targeted delivery of flexible electronics to internal regions remains difficult. Here, we overcome this challenge by demonstrating the syringe injection (and subsequent unfolding) of sub-micrometre-thick, centimetre-scale macroporous mesh electronics through needles with a diameter as small as 100 μm. Our results show that electronic components can be injected into man-made and biological cavities, as well as dense gels and tissue, with >90% device yield. We demonstrate several applications of syringe-injectable electronics as a general approach for interpenetrating flexible electronics with three-dimensional structures, including (1) monitoring internal mechanical strains in polymer cavities, (2) tight integration and low chronic immunoreactivity with several distinct regions of the brain, and (3) in vivo multiplexed neural recording. Moreover, syringe injection enables the delivery of flexible electronics through a rigid shell, the delivery of large-volume flexible electronics that can fill internal cavities, and co-injection of electronics with other materials into host structures, opening up unique applications for flexible electronics.

  4. Syringe-injectable electronics

    NASA Astrophysics Data System (ADS)

    Liu, Jia; Fu, Tian-Ming; Cheng, Zengguang; Hong, Guosong; Zhou, Tao; Jin, Lihua; Duvvuri, Madhavi; Jiang, Zhe; Kruskal, Peter; Xie, Chong; Suo, Zhigang; Fang, Ying; Lieber, Charles M.

    2015-07-01

    Seamless and minimally invasive three-dimensional interpenetration of electronics within artificial or natural structures could allow for continuous monitoring and manipulation of their properties. Flexible electronics provide a means for conforming electronics to non-planar surfaces, yet targeted delivery of flexible electronics to internal regions remains difficult. Here, we overcome this challenge by demonstrating the syringe injection (and subsequent unfolding) of sub-micrometre-thick, centimetre-scale macroporous mesh electronics through needles with a diameter as small as 100 μm. Our results show that electronic components can be injected into man-made and biological cavities, as well as dense gels and tissue, with >90% device yield. We demonstrate several applications of syringe-injectable electronics as a general approach for interpenetrating flexible electronics with three-dimensional structures, including (1) monitoring internal mechanical strains in polymer cavities, (2) tight integration and low chronic immunoreactivity with several distinct regions of the brain, and (3) in vivo multiplexed neural recording. Moreover, syringe injection enables the delivery of flexible electronics through a rigid shell, the delivery of large-volume flexible electronics that can fill internal cavities, and co-injection of electronics with other materials into host structures, opening up unique applications for flexible electronics.

  5. Post-Progression Survival Associated with Overall Survival in Patients with Advanced Non-Small-Cell Lung Cancer Receiving Docetaxel Monotherapy as Second-Line Chemotherapy.

    PubMed

    Kotake, Mie; Miura, Yosuke; Imai, Hisao; Mori, Keita; Sakurai, Reiko; Kaira, Kyoichi; Tomizawa, Yoshio; Minato, Koichi; Saito, Ryusei; Hisada, Takeshi

    2017-01-01

    In patients with non-small-cell lung cancer (NSCLC), the effects of second-line chemotherapy on overall survival (OS) might be confounded by subsequent therapies. Therefore, using individual-level data, we aimed to determine the relationships between progression-free survival (PFS) and post-progression survival (PPS) with OS in patients with advanced NSCLC treated with docetaxel monotherapy as second-line chemotherapy. Between April 2002 and December 2014, data from 86 patients with advanced NSCLC who underwent second-line docetaxel monotherapy following first-line treatment with platinum combination chemotherapy were analyzed. The relationships of PFS and PPS with OS were analyzed at the individual level. Spearman rank correlation and linear regression analyses showed that PPS was strongly associated with OS (r = 0.86, p < 0.05, R2 = 0.93), whereas PFS was moderately correlated with OS (r = 0.50, p < 0.05, R2 = 0.21). Performance status at the end of second-line treatment and the number of regimens after progression beyond second-line chemotherapy were significantly associated with PPS (p < 0.05). In patients with advanced NSCLC with unknown oncogenic driver mutations undergoing docetaxel monotherapy as second-line chemotherapy, when compared with PFS, PPS had a stronger association with OS. This finding suggests that subsequent treatment after disease progression following second-line docetaxel monotherapy has a significant influence on OS. © 2017 S. Karger AG, Basel.

  6. Decision aids for second-line palliative chemotherapy: a randomised phase II multicentre trial.

    PubMed

    Oostendorp, Linda J M; Ottevanger, Petronella B; Donders, A Rogier T; van de Wouw, Agnes J; Schoenaker, Ivonne J H; Smilde, Tineke J; van der Graaf, Winette T A; Stalmeier, Peep F M

    2017-08-31

    There is increasing recognition of the delicate balance between the modest benefits of palliative chemotherapy and the burden of treatment. Decision aids (DAs) can potentially help patients with advanced cancer with these difficult treatment decisions, but providing detailed information could have an adverse impact on patients' well-being. The objective of this randomised phase II study was to evaluate the safety and efficacy of DAs for patients with advanced cancer considering second-line chemotherapy. Patients with advanced breast or colorectal cancer considering second-line treatment were randomly assigned to usual care (control group) or usual care plus a DA (intervention group) in a 1:2 ratio. A nurse offered a DA with information on adverse events, tumour response and survival. Outcome measures included patient-reported well-being (primary outcome: anxiety) and quality of the decision-making process and the resulting choice. Of 128 patients randomised, 45 were assigned to the control group and 83 to the intervention group. Median age was 62 years (range 32-81), 63% were female, and 73% had colorectal cancer. The large majority of patients preferred treatment with chemotherapy (87%) and subsequently commenced treatment with chemotherapy (86%). No adverse impact on patients' well-being was found and nurses reported that consultations in which the DAs were offered went well. Being offered the DA was associated with stronger treatment preferences (3.0 vs. 2.5; p=0.030) and increased subjective knowledge (6.7 vs. 6.3; p=0.022). Objective knowledge, risk perception and perceived involvement were comparable between the groups. DAs containing detailed risk information on second-line palliative treatment could be delivered to patients with advanced cancer without having an adverse impact on patient well-being. Surprisingly, the DAs only marginally improved the quality of the decision-making process. The effectiveness of DAs for palliative treatment decisions needs

  7. Structure of the syringeal muscles in jungle crow (Corvus macrorhynchos).

    PubMed

    Tsukahara, Naoki; Yang, Qian; Sugita, Shoei

    2008-09-01

    Birds' vocalizations are produced by the syrinx, which is located between the trachea and the two primary bronchi. Oscine birds have multiple pairs of syringeal muscles in the syrinx. To determine the detailed structure of the syringeal muscle in jungle crows, an oscine bird, a histological study and gross examination of the syrinx were performed. In the histological study, sections of the syrinxes from four jungle crows were stained with Azan and observed. Each syringeal muscle was classified by the limit of the fascia from neighbor fascicules. From the gross examination a 3-D image of the structure of the syringeal muscles was generated. The combined histological and anatomical results show that there are seven pairs of syringeal muscles in jungle crows. Muscle fusions were observed in some of the syringeal muscles. It is likely that each syringeal muscle has a specific role. Jungle crows may be able to generate various calls because they have several pairs of syringeal muscles.

  8. Bevacizumab-based first-line chemotherapy in elderly patients with metastatic colorectal cancer: an individual patient data based meta-analysis.

    PubMed

    Koch, Christine; Schwing, Anna M; Herrmann, Eva; Borner, Markus; Diaz-Rubio, Eduardo; Dotan, Efrat; Feliu, Jaime; Okita, Natsuko; Souglakos, John; Arkenau, Hendrik T; Porschen, Rainer; Koopman, Miriam; Punt, Cornelis J A; de Gramont, Aimery; Tournigand, Christophe; Zeuzem, Stefan; Trojan, Joerg

    2018-02-13

    The aim of this meta-analysis was to evaluate efficacy and safety of first-line chemotherapy with or without a monoclonal antibody in elderly patients (≥ 70 years) with metastatic colorectal cancer (mCRC), since they are frequently underrepresented in clinical trials. Individual data from 10 studies were included. From a total of 3271 patients, 604 patients (18%) were ≥ 70 years (median 73 years, range 70-88). Of these, 335 patients were treated with a bevacizumab-based first-line regimen and 265 were treated with chemotherapy only. The median PFS was 8.2 vs. 6.5 months and the median OS was 16.7 vs. 13.0 months in patients treated with and without bevacizumab, respectively. The safety profile of bevacizumab in combination with first-line chemotherapy did not differ from published clinical trials. PubMed and Cochrane Library searches were performed on 29 April 2013 and studies published to this date were included. Authors were contacted to request progression-free survival (PFS), overall survival (OS) data, patient data on treatment regimens, age, sex and potential signs of toxicity in patients ≥ 70 years of age. This meta-analysis suggests that the addition of bevacizumab to standard first-line chemotherapy improves clinical outcome in elderly patients with mCRC and is well tolerated.

  9. Cost and acceptability of three syringe-pump infusion systems.

    PubMed

    Johnson, M S; Pesko, L J; Wood, C F; Reinders, T P

    1990-08-01

    The fiscal impact and acceptability of implementing a syringe-pump infusion system at a 900-bed university teaching hospital where the minibag system has been in use is reported. Researchers selected three models of syringe pumps for evaluation: the Bard Harvard Mini-Infuser 150XL, the Becton Dickinson 360 Infuser, and the Strato Stratofuse System. Each pump was evaluated for three weeks on a medical-surgical unit and a hematology-oncology unit. Drugs to be infused were chosen after a literature review to determine which drugs had been successfully infused via syringe pump; 22 formulary medications were selected. Syringes were prepared as singly packaged doses or as doses prepared in bulk and packaged frozen. Control of the syringe pumps and microbore tubing was assigned to the inpatient pharmacy staff. Nurses and pharmacy personnel were apprised of the study and taught how to use the syringe pumps. Time-and-motion studies were performed in the sterile products preparation area, and a cost analysis was done. Nurses preferred syringe pumps over the minibag system because the pumps reduced the nursing time needed to infuse a drug, administered less fluid, provided consistent infusion rates, had alarms, and were relatively easy to use. The time required to prepare syringes did not differ substantially among syringe-pump models. It was estimated that using any of the evaluated pumps in place of the minibag system would save $126,500 during the three-year period 1988-91, primarily because of differences in the cost of disposable items. The syringe-pump infusion system is an acceptable and cost-effective alternative to the minibag system.

  10. Potency and stability of frozen urokinase solutions in syringes.

    PubMed

    Dedrick, Stephen C; Ramirez-Rico, José

    2004-08-01

    The stability and potency of frozen urokinase solutions in syringes were studied. To determine the stability and potency of compounded urokinase dilutions after multiple freeze-thaw cycles, a total of 160 syringes containing five urokinase concentrations (2,500, 5,000, 7,500, 12,500, and 25,000 IU/mL) were prepared. For each of the five concentrations tested, two syringes per concentration were reserved for baseline testing. The remaining 150 syringes were frozen at -30 degrees C. After 7 days, half of the syringes (group 1) were thawed at room temperature, tested, and left at room temperature for 12 hours before refreezing. The other half of the syringes (group 2) were kept frozen for 30 days. Thirty days after initial compounding, all syringes were thawed, and the samples' urokinase potency, pH, and physical appearance were evaluated. Syringes were visually inspected for color, clarity, and precipitation. Descriptive statistics were computed for each concentration group and testing day. The compounded dilutions were stable under each experimental condition, with no physical deterioration or loss of in vitro potency after two freeze-thaw cycles. The reduced waste associated with the ability to refreeze unused urokinase could substantially lower the cost of procedures such as thrombolysis after intraventricular hemorrhage and catheter clearance by as much as 95%. Dilutions of urokinase 2,500-25,000 IU/mL were stable in single-use syringes after being frozen for 7 days, thawed, and refrozen for another 23 days.

  11. Second-line single-agent versus doublet chemotherapy as salvage therapy for metastatic urothelial cancer: a systematic review and meta-analysis.

    PubMed

    Raggi, D; Miceli, R; Sonpavde, G; Giannatempo, P; Mariani, L; Galsky, M D; Bellmunt, J; Necchi, A

    2016-01-01

    The efficacy and safety of a combination of chemotherapeutic agent compared with single-agent chemotherapy in the second-line setting of advanced urothelial carcinoma (UC) are unclear. We aimed to study the survival impact of single-agent compared with doublet chemotherapy as second-line chemotherapy of advanced UC. Literature was searched for studies including single-agent or doublet chemotherapy in the second-line setting after platinum-based chemotherapy. Random-effects models were used to pool trial-level data according to treatment arm, including median progression-free survival (PFS), overall survival (OS), objective response rate (ORR) probability, and grade 3-4 toxicity. Univariable and multivariable analyses, including sensitivity analyses, were carried out, adjusting for the percent of patients with ECOG performance status ≥1 and hepatic metastases. Forty-six arms of trials including 1910 patients were selected: 22 arms with single agent (n = 1202) and 24 arms with doublets (n = 708). The pooled ORR with single agents was 14.2% [95% confidence interval (CI) 11.1-17.9] versus 31.9% [95% CI 27.3-36.9] with doublet chemotherapy. Pooled median PFS was 2.69 and 4.05 months, respectively. The pooled median OS was 6.98 and 8.50 months, respectively. Multivariably, the odds ratio for ORR and the pooled median difference of PFS were statistically significant (P < 0.001 and P = 0.002) whereas the median difference in OS was not (P = 0.284). When including single-agent vinflunine or taxanes only, differences were significant only for ORR (P < 0.001) favoring doublet chemotherapy. No statistically significant differences in grade 3-4 toxicity were seen between the two groups. Despite significant improvements in ORR and PFS, doublet regimens did not extend OS compared with single agents for the second-line chemotherapy of UC. Prospective trials are necessary to elucidate the role of combination chemotherapy, with or without targeted agents, in the salvage setting

  12. Botulinum Toxin Therapy: Is Syringe Type Related to Cost-Effectiveness?

    PubMed

    Foglietti, Mark Anthony; Wright, Lauren; Foglietti-Fostyk, Alanna

    2018-03-01

    Clostridium botulinum toxin is effective through cleaving presynaptic proteins at the neuromuscular junction, which prevents the release of acetylcholine and inhibits muscle contraction. Several serotypes of botulinum toxin (BT) exist; however, only 2 types have been approved by the US Food and Drug Administration for commercial and medical use, A and B. Both types of BT must be administered intramuscularly with a syringe, but the type of syringe is the injector's preference. Which syringe type is most efficient in minimizing product waste and most cost-effective for the patient and provider? We performed a single-center, open-label, analytical study using BT therapy and 2 types of syringes for analytics of cost-effectiveness. OnabotulinumtoxinA was the neuromodulator used in this report. Vials (100 U) of BT A were each reconstituted with 2.5 mL of 0.9% sodium chloride, for a final concentration of 4 U/0.1 mL. High-dead-space syringes are compared with low-dead-space syringes: 1-mL tuberculin (TB) luer slip syringe with detachable 25-gauge needle and 1-mL ultrafine insulin syringe with an attached 31-gauge needle, respectively. After each syringe was evacuated, the TB syringe was noted to contain 0.05 mL of the remaining product in the hub. Providers are discarding approximately 2 U of BT per TB syringe product injection. If the physician uses 30 syringes per day, 3 days a week, for 1 year, it equals to a lost revenue of approximately $155,500 per year. To individualize the cost-effective analysis, average quantity of syringes used per patient and overall patient volume must be considered, with corresponding adjustment of cost and units discarded. The American Society of Plastic Surgeons reported that the use of neuromodulators has increased by approximately 797% from 2000 to 2016. During that period, the price of neuromodulators has also increased by approximately 85%. Considering these statistics, the type of syringe used for BT neuromodular injection is a

  13. The effectiveness and safety of syringe vending machines as a component of needle syringe programmes in community settings.

    PubMed

    Islam, Mofizul; Wodak, Alex; Conigrave, Katherine M

    2008-12-01

    Syringe vending machines (SVMs) have been introduced in Europe and Australasia as part of the effort to increase the availability of sterile needles and syringes to injecting drug users (IDUs). This qualitative review of 14 published and grey literature studies examines whether community-based SVMs as a component of a comprehensive needle syringe programme (NSP) assist to reduce the spread of HIV and other blood-borne viruses amongst IDUs. The available evidence suggests that SVMs increase access to sterile injecting equipment, reduce needle and syringe sharing, and are likely to be cost efficient. SVMs also complement other modes of NSP delivery as they are used by IDUs who are less likely to attend staffed NSPs or pharmacies. If installed and properly maintained in a well-chosen location and with the local community well prepared, SVMs can enhance the temporal and geographical availability of sterile injecting equipment.

  14. Efficacy and safety of cytotoxic drug chemotherapy after first-line EGFR-TKI treatment in elderly patients with non-small-cell lung cancer harboring sensitive EGFR mutations.

    PubMed

    Imai, Hisao; Minemura, Hiroyuki; Sugiyama, Tomohide; Yamada, Yutaka; Kaira, Kyoichi; Kanazawa, Kenya; Kasai, Takashi; Kaburagi, Takayuki; Minato, Koichi

    2018-05-08

    Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is effective as first-line chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive EGFR mutations. However, whether the efficacy of second-line cytotoxic drug chemotherapy after first-line EGFR-TKI treatment is similar to that of first-line cytotoxic drug chemotherapy in elderly patients aged ≥ 75 years harboring sensitive EGFR mutations is unclear. Therefore, we aimed to investigate the efficacy and safety of cytotoxic drug chemotherapy after first-line EGFR-TKI treatment in elderly patients with NSCLC harboring sensitive EGFR mutations. We retrospectively evaluated the clinical effects and safety profiles of second-line cytotoxic drug chemotherapy after first-line EGFR-TKI treatment in elderly patients with NSCLC harboring sensitive EGFR mutations (exon 19 deletion/exon 21 L858R mutation). Between April 2008 and December 2015, 78 elderly patients with advanced NSCLC harboring sensitive EGFR mutations received first-line EGFR-TKI at four Japanese institutions. Baseline characteristics, regimens, responses to first- and second-line treatments, whether or not patients received subsequent treatment, and if not, the reasons for non-administration were recorded. Overall, 20 patients with a median age of 79.5 years (range 75-85 years) were included in our analysis. The overall response, disease control, median progression-free survival, and overall survival rates were 15.0, 60.0%, 2.4, and 13.2 months, respectively. Common adverse events included leukopenia, neutropenia, anemia, thrombocytopenia, malaise, and anorexia. Major grade 3 or 4 toxicities included leukopenia (25.0%) and neutropenia (45.0%). No treatment-related deaths were noted. Second-line cytotoxic drug chemotherapy after first-line EGFR-TKI treatment among elderly patients with NSCLC harboring sensitive EGFR mutations was effective and safe and showed equivalent outcomes to first-line

  15. Introducing auto-disable syringes to the national immunization programme in Madagascar.

    PubMed Central

    Drain, Paul K.; Ralaivao, Josoa S.; Rakotonandrasana, Alexander; Carnell, Mary A.

    2003-01-01

    OBJECTIVE: To evaluate the safety and coverage benefits of auto-disable (AD) syringes, weighed against the financial and logis- tical costs, and to create appropriate health policies in Madagascar. METHODS: Fifteen clinics in Madagascar, trained to use AD syringes, were randomized to implement an AD syringe only, mixed (AD syringes used only on non-routine immunization days), or sterilizable syringe only (control) programme. During a five-week period, data on administered vaccinations were collected, interviews were conducted, and observations were recorded. FINDINGS: The use of AD syringes improved coverage rates by significantly increasing the percentage of vaccines administered on non-routine immunization days (AD-only 4.3%, mixed 5.7%, control 1.1% (P<0.05)). AD-only clinics eliminated sterilization sessions for vaccinations, whereas mixed clinics reduced the number of sterilization sessions by 64%. AD syringes were five times more expensive than sterilizable syringes, which increased AD-only and mixed clinics' projected annual injection costs by 365% and 22%, respectively. However, introducing AD syringes for all vaccinations would only increase the national immunization budget by 2%. CONCLUSION: The use of AD syringes improved vaccination coverage rates by providing ready-to-use sterile syringes on non-routine immunization days and decreasing the number of sterilization sessions, thereby improving injection safety. The mixed programme was the most beneficial approach to phasing in AD syringes and diminishing logistical complications, and it had minimal costs. AD syringes, although more expensive, can feasibly be introduced into a developing country's immunization programme to improve vaccination safety and coverage. PMID:14576886

  16. Nonprescription Syringe Sales: A Missed Opportunity for HIV Prevention in California

    PubMed Central

    Pollini, Robin A.; Rudolph, Abby E.; Case, Patricia

    2014-01-01

    Background California Senate Bill 41 (SB41), effective January 2012, is an HIV prevention measure designed to expand syringe access among injection drug users (IDUs) by allowing pharmacists to sell up to 30 syringes without a prescription. Objective We assessed SB41 implementation in two inland California counties where prevalence of injection drug use is among the highest in the nation. Design Syringe purchase trial. Setting Fresno and Kern counties, California. Participants All retail pharmacies (N=248). Main outcome measure Successful or unsuccessful syringe purchase attempt. Results Only 52 (21.0%) syringe purchase attempts were successful. The proportion of successful attempts did not vary by county or by data collector ethnicity. The most common reasons for unsuccessful syringe purchase attempts were prescription requirements (45.7%), the requested syringe size was not available (10.7%), and the pharmacy did not sell syringes (9.7%). In addition, some syringe purchase attempts (4.1%) were unsuccessful because the data collector was asked to purchase more syringes than allowed by law. Although 80% and 78% of Fresno and Kern residents, respectively, live within a 5-minute drive of a retail pharmacy, less than half live within a 5-minute drive of a pharmacy that sold syringes. Conclusion SB41 has not resulted in broad pharmacy-based syringe access in California's inland counties, where a disproportionate number of HIV/AIDS cases are associated with injection drug use. Additional steps by legislative bodies, regulatory agencies, and professional organizations are needed to actively engage pharmacies in expanding nonprescription syringe sales to reduce HIV transmission among IDUs. PMID:25575149

  17. Needle and syringe sharing among Iranian drug injectors

    PubMed Central

    Rafiey, Hassan; Narenjiha, Hooman; Shirinbayan, Peymaneh; Noori, Roya; Javadipour, Morteza; Roshanpajouh, Mohsen; Samiei, Mercedeh; Assari, Shervin

    2009-01-01

    Objective The role of needle and syringe sharing behavior of injection drug users (IDUs) in spreading of blood-borne infections – specially HIV/AIDS – is well known. However, very little is known in this regard from Iran. The aim of our study was to determine the prevalence and associates of needle and syringe sharing among Iranian IDUs. Methods In a secondary analysis of a sample of drug dependents who were sampled from medical centers, prisons and streets of the capitals of 29 provinces in the Iran in 2007, 2091 male IDUs entered. Socio-demographic data, drug use data and high risk behaviors entered to a logistic regression to determine independent predictors of lifetime needle and syringe sharing. Results 749(35.8%) reported lifetime experience of needle and syringe sharing. The likelihood of lifetime needle and syringe sharing was increased by female gender, being jobless, having illegal income, drug use by family members, pleasure/enjoyment as causes of first injection, first injection in roofless and roofed public places, usual injection at groin, usual injection at scrotum, lifetime experience of nonfatal overdose, and history of arrest in past year and was decreased by being alone at most injections. Conclusion However this data has been extracted from cross-sectional design and we can not conclude causation, some of the introduced variables with association with needle and syringe sharing may be used in HIV prevention programs which target reducing syringe sharing among IDUs. PMID:19643014

  18. [Morphine self-administration by rats using a pneumatic syringe].

    PubMed

    Akiyama, Y; Takayama, S

    1988-06-01

    An apparatus for drug self-administration by rats using a pneumatic syringe was developed by Weeks. A microliter syringe operated by a pneumatic cylinder supplies an accurate volume of drug solution within one second. When coefficient of variation of infusion volume was compared among pneumatic syringe, infusion pump, and peristaltic pump, pneumatic syringe showed higher accuracy in infusion volume than the other two pumps. Since the infusion speed by a pneumatic syringe is very rapid (less than one second per infusion), the effect of infusion speed on reinforcing property of morphine was investigated. When rats self-administered 0.1, 0.3, 1.0, and 3.0 mg/kg/infusion of morphine by pneumatic syringes, the patterns of self-infusion were more stable, the number of self-infusions and the amount self-administered were larger, and a dose-response relationship was clearer in comparison with those self-infused the same doses of morphine for 5.6 seconds by infusion pumps or peristaltic pumps.

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

    PubMed

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

    2015-12-01

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

  20. Vacuum aspiration with the IPAS Modified Gynecologic Syringe.

    PubMed

    Balogh, S A

    1983-01-01

    The IPAS Modified Gynecologic Syringe was compared with the electric pump and standard hand pump in a clinical trial of 1227 women undergoing vacuum aspiration. This modified double-valve syringe was designed to fit larger 8 mm, 10 mm and 12 mm cannulae, which are more suitable for late first trimester procedures. The study was conducted at four centers in which the double-valve syringe was used alternately with the vacuum source normally used at each clinic. Although there were notable inter-center differences with respect to certain outcome variables, results were similar for procedures performed at the same center. The only significant finding was the lower proportion of women requiring D & C to complete uterine evacuation among double-valve syringe patients than among hand pump cases at one center. The data indicate that the double-valve syringe is safe and effective for uterine aspiration in women up to 14 weeks' gestation and may be preferable for use in clinics with limited facilities.

  1. Bevacizumab-based first-line chemotherapy in elderly patients with metastatic colorectal cancer: an individual patient data based meta-analysis

    PubMed Central

    Koch, Christine; Schwing, Anna M.; Herrmann, Eva; Borner, Markus; Diaz-Rubio, Eduardo; Dotan, Efrat; Feliu, Jaime; Okita, Natsuko; Souglakos, John; Arkenau, Hendrik T.; Porschen, Rainer; Koopman, Miriam; Punt, Cornelis J.A.; de Gramont, Aimery; Tournigand, Christophe; Zeuzem, Stefan; Trojan, Joerg

    2018-01-01

    Background The aim of this meta-analysis was to evaluate efficacy and safety of first-line chemotherapy with or without a monoclonal antibody in elderly patients (≥ 70 years) with metastatic colorectal cancer (mCRC), since they are frequently underrepresented in clinical trials. Results Individual data from 10 studies were included. From a total of 3271 patients, 604 patients (18%) were ≥ 70 years (median 73 years, range 70–88). Of these, 335 patients were treated with a bevacizumab-based first-line regimen and 265 were treated with chemotherapy only. The median PFS was 8.2 vs. 6.5 months and the median OS was 16.7 vs. 13.0 months in patients treated with and without bevacizumab, respectively. The safety profile of bevacizumab in combination with first-line chemotherapy did not differ from published clinical trials. Materials and Methods PubMed and Cochrane Library searches were performed on 29 April 2013 and studies published to this date were included. Authors were contacted to request progression-free survival (PFS), overall survival (OS) data, patient data on treatment regimens, age, sex and potential signs of toxicity in patients ≥ 70 years of age. Conclusions This meta-analysis suggests that the addition of bevacizumab to standard first-line chemotherapy improves clinical outcome in elderly patients with mCRC and is well tolerated. PMID:29535805

  2. Tumescent and syringe liposculpture: a logical partnership.

    PubMed

    Hunstad, J P

    1995-01-01

    Liposuction has been traditionally performed under general anesthesia. Standard instrumentation for the procedure has included blunt-tipped suction cannulae connected to an electric vacuum pump by noncollapsible tubing. A subcutaneous injection of Lidocaine with Epinephrine is routinely employed to minimize blood loss during the procedure. This infiltration has been described as the "wet technique," but it is not a method to supplant general anesthesia. The tumescent technique, a method of infusing very large volumes of dilute lidocaine with epinephrine solutions, has been advocated as a satisfactory means for providing conscious anesthesia for liposuction procedures, avoiding the need for general anesthesia. The syringe technique employs blunt-tipped suction cannulae connected to a syringe. Drawing back the syringe plunger generates the negative pressures needed to remove fat during liposuction and replaces the electric vacuum pump and connecting tubing traditionally used for this procedure. This study evaluates the combined tumescent and syringe techniques for liposuction. One hundred consecutive patients were treated with the tumescent technique as the sole means of anesthesia and the syringe technique as the sole means of performing liposuction. A modified tumescent formula is presented. A comparison of liposuction aspirates using this modified tumescent technique is compared and contrasted to liposuction aspirates obtained using the "dry technique" and the "wet technique." A historical review of the syringe technique and its perceived attributes is also presented. Technical descriptions of the tumescent infusion method, tumescent fluid formulation, and suggested patient sedation and monitoring is presented. Photographic documentation of patients who underwent the combined tumescent and syringe liposculpture treating various body areas is shown. A critical analysis of the limitations of this combined technique is also described noting added time requirements

  3. Nonprescription syringe sales: a missed opportunity for HIV prevention in California.

    PubMed

    Pollini, Robin A; Rudolph, Abby E; Case, Patricia

    2015-01-01

    To assess implementation of California Senate Bill SB41 in two inland California counties where prevalence of injection drug use is among the highest in the nation. Syringe purchase trial. Fresno and Kern counties, California. All 248 community pharmacies in the counties. Successful or unsuccessful syringe purchase attempt. Only 52 (21.0%) syringe purchase attempts were successful. The proportion of successful attempts did not vary by county or by data collector ethnicity. The most common reasons for unsuccessful syringe purchase attempts were prescription requirements (45.7%), the requested syringe size was not available (10.7%), and the pharmacy did not sell syringes (9.7%). In addition, some syringe purchase attempts (4.1%) were unsuccessful because the data collector was asked to purchase more syringes than allowed by law. Although 80% and 78% of Fresno and Kern residents, respectively, live within a 5-minute drive of a community pharmacy, less than one-half live within a 5-minute drive of a community pharmacy that sold syringes. SB41 has not resulted in broad pharmacy-based syringe access in California's inland counties, where a disproportionate number of cases of human immunodeficiency virus (HIV) infections are associated with injection drug use. Additional steps by legislative bodies, regulatory agencies, and professional organizations are needed to actively engage pharmacies in expanding nonprescription syringe sales to reduce HIV transmission among injection drug users.

  4. Predicting pharmacy syringe sales to people who inject drugs: Policy, practice and perceptions.

    PubMed

    Meyerson, Beth E; Davis, Alissa; Agley, Jon D; Shannon, David J; Lawrence, Carrie A; Ryder, Priscilla T; Ritchie, Karleen; Gassman, Ruth

    2018-06-01

    Pharmacies have much to contribute to the health of people who inject drugs (PWID) and to community efforts in HIV and hepatitis C (HCV) prevention through syringe access. However, little is known about what predicts pharmacy syringe sales without a prescription. To identify factors predicting pharmacy syringes sales to PWID. A hybrid staggered online survey of 298 Indiana community pharmacists occurred from July-September 2016 measuring pharmacy policy, practice, and pharmacist perceptions about syringe sales to PWID. Separate bivariate logistical regressions were followed by multivariable logistic regression to predict pharmacy syringe sales and pharmacist comfort dispensing syringes to PWID. Half (50.5%) of Indiana pharmacies sold syringes without a prescription to PWID. Pharmacy syringe sales was strongly associated with pharmacist supportive beliefs about syringe access by PWID and their comfort level selling syringes to PWID. Notably, pharmacies located in communities with high rates of opioid overdose mortality were 56% less likely to sell syringes without a prescription than those in communities with lower rates. Pharmacist comfort dispensing syringes was associated with being male, working at a pharmacy that sold syringes to PWID and one that stocked naloxone, having been asked about syringe access by medical providers, and agreement that PWID should be able to buy syringes without a prescription. As communities with high rates of opioid overdose mortality were less likely to have pharmacies that dispensed syringes to PWID, a concerted effort with these communities and their pharmacies should be made to understand opportunities to increase syringe access. Future studies should explore nuances between theoretical support for syringe access by PWID without a prescription and actual dispensing behaviors. Addressing potential policy conflicts and offering continuing education on non-prescription syringe distribution for pharmacists may improve comfort

  5. Second-line chemotherapy of disseminated malignant melanoma with cystemustine at 60 mg/m2: a phase II trial.

    PubMed

    Thivat, Emilie; Durando, Xavier; D'Incan, Michel; Cure, Hervé; Mouret-Reynier, Marie-Ange; Madelmont, Jean-Claude; Souteyrand, Pierre; Chollet, Philippe

    2005-10-01

    Nitrosoureas possess some anti-tumor activity as a single agent in metastatic melanoma (MM). In a phase II trial, we evaluated the anti-tumor effects of cystemustine chemotherapy, a new nitrosourea, as a second-line treatment. Patients were required to have histologic evidence of disseminated MM and had failed in first-line chemotherapy. Treatment comprised cystemustine given at a dose of 60 mg/m every 2 weeks by a 15-min infusion. From February 1997 to September 1999, 22 patients (median age 66 years) were enrolled and were assessable. Two complete responses, one partial response, three stable diseases and 16 progressions were observed, giving an overall response rate of 13.6%. Median duration of response was 10 months (range 4-63). Median survival of responders and non-responders was 11 and 4 months, respectively. However, hematological toxicity, particularly thrombopenia, was a limiting factor for one-third of patients. We conclude that cystemustine at 60 mg/m is active in patients who progressed after one line of chemotherapy in advanced disease, and offers the possibility of complete responses and long durations of these responses.

  6. [Systematic review and Meta-analysis of Shenqi Fuzheng injection combined with first-line chemotherapy for non-small cell lung cancer].

    PubMed

    Hao, Teng-teng; Xie, Yan-ming; Liao, Xing; Wang, Jing

    2015-10-01

    The paper is to systematically evaluate the effect and safety of Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy for non-small cell lung cancer (NSCLC). Randomized controlled trials (RCTs) on Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy (experiment group) and chemotherapy alone group ( control group) were electronically retrieved from Medline, EMbase, Clinical Trials, Cochrane Library, CBM, CNKI, VIP, and Wanfang Data base. All trials were assessed for quality according to the Cochrane Reviewer's Handbook for Systematic Reviews of Intervention and then Meta-analysis was performed withRevMan5. 2 Software. A total of 43 RCTs (3433 patients) were included after screening and selecting. Results of Meta-analysis showed that: Objective remission rate (ORR): ORR of experimental group was about 20% higher than that of control group [RR = 1.23, 95% CI (1.11,1.35), P < 0.0001]. Disease control rate (DCR):DCR of SFI combined with first-line chemotherapy was 11% higher than that of first-line chemotherapy alone [RR = 1.11, 95% CI (1.07, 1.16), P < 0.000 01]. Life quality evaluated by Kosovan performance status (KPS) showed that: life quality improvement rate of experimental group was about twice of that in control group [RR = 2.02, 95% CI (1.81, 2.26), P < 0.000 01]. Toxic and side reaction analysis showed that: the incidence of side reactions in experimental group was about 50% lower than that in control group [RR = 0.59, 95% CI (0.53, 0.66), P < 0.000 01]. Immune function test showed that: the function of experimental group was 3.2 (standard deviations) times greater than that of control group [MD = 3.23, 95% CI (2.86, 3.60), P < 0.000 01]. We can see that SFI combined with first-line chemotherapy for NSCLC can increase objective efficacy, improve life quality, decrease toxic and side reactionsinduced by chemotherapy, and improve the immune functions. As most of the included studies in this systematic evaluation had poor quality

  7. Efficacy of Capecitabine Plus Oxaliplatin Combination Chemotherapy for Advanced Pancreatic Cancer after Failure of First-Line Gemcitabine-Based Therapy.

    PubMed

    Chung, Kwang Hyun; Ryu, Ji Kon; Son, Jun Hyuk; Lee, Jae Woo; Jang, Dong Kee; Lee, Sang Hyub; Kim, Yong-Tae

    2017-03-15

    Second-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma (PDAC) that progresses following gemcitabine-based treatment has not been established. This study aimed to investigate the efficacy and safety of second-line combination chemotherapy with capecitabine and oxaliplatin (XELOX) in these patients. Between August 2011 and May 2014, all patients who received at least one cycle of XELOX (capecitabine, 1,000 mg/m 2 twice daily for 14 days; oxaliplatin, 130 mg/m 2 on day 1 of a 3-week cycle) combination chemotherapy for unresectable or recurrent PDAC were retrospectively recruited. The response was evaluated every 9 weeks, and the tumor response rate, progression-free survival and overall survival, and adverse events were assessed. Sixty-two patients were included; seven patients (11.3%) had a partial tumor response, and 20 patients (32.3%) had stable disease. The median progression-free and overall survival were 88 days (range, 35.1 to 140.9 days) and 158 days (range, 118.1 to 197.9 days), respectively. Patients who remained stable longer with frontline therapy (≥120 days) exhibited significantly longer progression-free and overall survival. The most common grade 3 to 4 adverse events in patients were vomiting (8.1%) and anorexia (6.5%). There was one treatment-related mortality caused by severe neutropenia and typhlitis. Second-line XELOX combination chemotherapy demonstrated an acceptable response and survival rate in patients with advanced PDAC who had failed gemcitabine-based chemotherapy.

  8. [Comparison of the Efficacy and Safety of Icotinib with Standard Second-lineChemotherapy in Previously Treated Advanced Non-small Cell Lung Cancer].

    PubMed

    Yao, Shuyang; Qian, Kun; Wang, Ruotian; Li, Yuanbo; Zhang, Yi

    2015-06-01

    This study compared the efficacy and safety of icotinib with standard second-line chemotherapy (single-agent docetaxel or pemetrexed) in previously treated advanced non-small cell lung cancer (NSCLC). Thirty-two consecutive patients treated with icotinib and 33 consecutive patients treated with standard second-line chemotherapy in Xuanwu Hospital from January 2012 to July 2013 were enrolled in our retrospective research. The Response Evaluation Criteria in Solid Tumors were used to evaluate the tumor responses, and the progression-free survival (PFS) was evaluated by Kaplan-Meier method. Icotinib was comparable with standard second-line chemotherapy for advanced NSCLC in terms of overall response rate (ORR) (28.1% vs 18.2%, P=0.341), disease control rate (DFS)(43.8% vs 45.5%, P=0.890), and PFS (4.3 months vs 3.8 months, P=0.506). In the icotinib group, the ORR of epidermal growth factor receptor (EGFR) mutant was significantly higher than that of EGFR unknown or wild type (P=0.017). In multivariate analysis, age, gender, histology, and the optimum first-line treatment response were dependent prognostic factors based on the PFS of the icotinib group. The incidence of adverse events was significantly fewer in the icotinib group than in the chemotherapy group (P=0.001). Compared with the standard second-line chemotherapy, icotinib is active in the treatment of advanced NSCLC patients, especially with EGFR unknown in the second line, with an acceptable adverse event profile.

  9. Evaluation of nonprescription syringe sales in San Francisco.

    PubMed

    Rose, Valerie J; Raymond, H Fisher

    2010-01-01

    To determine the experiences, practices, and challenges associated with nonprescription syringe sales (NPSS) among pharmacists whose pharmacies were enrolled in the Disease Prevention Demonstration Project in San Francisco, CA. Self-administered survey mailed to 69 pharmacies and interviews with pharmacists and technicians. A total of 55 of 69 pharmacies (80%) returned the survey, and eight pharmacy managers and three pharmacy technicians were interviewed in person. Of pharmacists, 72% reported none or very few problems with NPSS in the previous year, although surveys and interviews illustrated challenges associated with NPSS in terms of time management, educating patients about syringe disposal, and understanding patient preferences for syringes. Of pharmacists, 62% reported NPSS to no more than 10 to 20 patients per week and 67% collected more than 400 syringes in the previous year. One-third of pharmacists perceived that their pharmacies were located in areas where drug activity was high and that the majority of NPSS patients injected illegal drugs. Access to sterile syringes is a prominent public health issue, and pharmacists can play an important role in injection drug user (IDU) education and disease prevention. This evaluation suggests that pharmacies are selling nonprescription syringes to individuals perceived to be IDUs with no major problems. Additional evaluations from health department programs are needed to demonstrate the efficacy of NPSS in California.

  10. [Embolic complications by ink clots removed from syringes during cerebral angiography].

    PubMed

    Kohyama, Shinya; Ishihara, Shoichiro; Yamane, Fumitaka; Ishihara, Hideaki; Kanazawa, Ryuzaburo; Suzuki, Masanori; Neki, Hiroaki; Ohkawara, Mai

    2009-01-01

    We noted, during cerebral angiography, that the contrast medium was contaminated with numerous small black ink clots from gradation marks on syringes. In this report, we show that ink can be removed from syringes in solid form, and that they may result in embolic complications during cerebral angiography. To demonstrate that the ink from gradation marks on syringes can come off in a solid form and attach itself to the gloves during cerebral angiography, syringes were gripped many times (just as in an angiographic procedure) after immersion in contrast medium or 0.9% saline for 10 minutes. To see if difference of contrast medium and syringes could affect the removing of ink, five types of nonangiographic syringes and one type of angiographic syringe were rubbed with gauze after certain time periods after immersing them in four kinds of contrast medium or 0.9% saline. Ink attached itself to the gloves in a solid form by repeated gripping due to adherence of contrast medium. Ink was removed from all nonangiographic syringes by rubbing after immersion in any type of contrast medium for two hours. Gradation marks on angiographic syringes were stable with all types of contrast medium. Thus, ink for gradation marks on nonangiographic syringes, which is easily removed in a solid form due to contrast medium, can be the source of embolic complication during cerebral angiography.

  11. Solute-Filled Syringe For Formulating Intravenous Solution

    NASA Technical Reports Server (NTRS)

    Owens, Jim; Bindokas, AL; Dudar, Tom; Finley, Mike; Scharf, Mike

    1993-01-01

    Prefilled syringe contains premeasured amount of solute in powder or concentrate form used to deliver solute to sterile interior of large-volume parenteral (LVP) bag. Predetermined amount of sterile water also added to LVP bag through sterilizing filter, and mixed with contents of syringe, yielding sterile intravenous solution of specified concentration.

  12. Cost-Effectiveness Analysis of Second-Line Chemotherapy Agents for Advanced Gastric Cancer.

    PubMed

    Lam, Simon W; Wai, Maya; Lau, Jessica E; McNamara, Michael; Earl, Marc; Udeh, Belinda

    2017-01-01

    Gastric cancer is the fifth most common malignancy and second leading cause of cancer-related mortality. Chemotherapy options for patients who fail first-line treatment are limited. Thus the objective of this study was to assess the cost-effectiveness of second-line treatment options for patients with advanced or metastatic gastric cancer. Cost-effectiveness analysis using a Markov model to compare the cost-effectiveness of six possible second-line treatment options for patients with advanced gastric cancer who have failed previous chemotherapy: irinotecan, docetaxel, paclitaxel, ramucirumab, paclitaxel plus ramucirumab, and palliative care. The model was performed from a third-party payer's perspective to compare lifetime costs and health benefits associated with studied second-line therapies. Costs included only relevant direct medical costs. The model assumed chemotherapy cycle lengths of 30 days and a maximum number of 24 cycles. Systematic review of literature was performed to identify clinical data sources and utility and cost data. Quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) were calculated. The primary outcome measure for this analysis was the ICER between different therapies, where the incremental cost was divided by the number of QALYs saved. The ICER was compared with a willingness-to-pay (WTP) threshold that was set at $50,000/QALY gained, and an exploratory analysis using $160,000/QALY gained was also used. The model's robustness was tested by using 1-way sensitivity analyses and a 10,000 Monte Carlo simulation probabilistic sensitivity analysis (PSA). Irinotecan had the lowest lifetime cost and was associated with a QALY gain of 0.35 year. Docetaxel, ramucirumab alone, and palliative care were dominated strategies. Paclitaxel and the combination of paclitaxel plus ramucirumab led to higher QALYs gained, at an incremental cost of $86,815 and $1,056,125 per QALY gained, respectively. Based on our prespecified

  13. Sterilizable syringes: excessive risk or cost-effective option?

    PubMed Central

    Battersby, A.; Feilden, R.; Nelson, C.

    1999-01-01

    In recent years, many poorer countries have chosen to use disposable instead of sterilizable syringes. Unfortunately, the infrastructure and management systems that are vital if disposables are to be used safely do not exist. WHO estimates that up to 30% of injections administered are unsafe. The traditional sterilizable syringe had many disadvantages, some of which have been minimized through better design and the use of modern materials; others have been overcome because staff are able to demonstrate that they have performed safely. For example, the time-steam saturation-temperature (TST) indicator has enabled staff to demonstrate that a sterilizing cycle has been successfully completed. Health facility staff must be able to sterilize equipment, and the sterilizable syringe remains the least costly means of administering an injection. Data from countries that have acceptable systems for processing clinical waste indicate that safe and environmentally acceptable disposal, destruction and final containment cost nearly as much as the original cost of a disposable syringe. By careful supervision of staff behaviour and good management, some countries have demonstrated that they are able to administer safe injections with sterilizable syringes at a price they can afford. PMID:10593029

  14. Exploring the characteristics of patients with mesothelioma who chose active symptom control over chemotherapy as first-line treatment: a prospective, observational, single centre study.

    PubMed

    Bibby, Anna C; De Fonseka, Duneesha; Morley, Anna J; Keenan, Emma; Addeo, Alfredo; Smith, Sarah; Edey, Anthony J; Maskell, Nick A

    2017-12-08

    Mesothelioma is an aggressive thoracic tumour with a poor prognosis. The only treatment that extends survival is chemotherapy. However, in the UK, up to 50% of patients who are suitable for chemotherapy choose not to receive it, opting for active symptom control instead. The aim of this prospective, single-centre observational study was to describe the characteristics of patients who chose active symptom control over chemotherapy and explore their reasons for doing so. Two hundred consecutive patients with mesothelioma from one UK centre were included. Eligibility for chemotherapy and choice of first-line treatment were recorded prospectively. Patient characteristics and outcomes were compared using descriptive statistics, regression analysis and survival analysis. Reasons for choosing active symptom control over chemotherapy were extracted, retrospectively. People who chose active symptom control were older, more likely to be female and had worse performance statuses than patients who received front-line chemotherapy. Concern over side effects, the modest survival benefit and previous adverse experiences with chemotherapy were reported as reasons for the decision. Median survival was 13.9 months in the chemotherapy group compared with 6.7 months in the active symptom control group. This is the first study to describe the characteristics of patients with mesothelioma who chose active symptom control over chemotherapy, in the front-line setting. Important differences were seen between this group and patients who received chemotherapy, although confounding is likely to have affected some outcomes. Future research could use qualitative methods to explore patients' reasons for choosing active symptom control, and to further elucidate the decision-making process.

  15. Telepharmacy and bar-code technology in an i.v. chemotherapy admixture area.

    PubMed

    O'Neal, Brian C; Worden, John C; Couldry, Rick J

    2009-07-01

    A program using telepharmacy and bar-code technology to increase the presence of the pharmacist at a critical risk point during chemotherapy preparation is described. Telepharmacy hardware and software were acquired, and an inspection camera was placed in a biological safety cabinet to allow the pharmacy technician to take digital photographs at various stages of the chemotherapy preparation process. Once the pharmacist checks the medication vials' agreement with the work label, the technician takes the product into the biological safety cabinet, where the appropriate patient is selected from the pending work list, a queue of patient orders sent from the pharmacy information system. The technician then scans the bar code on the vial. Assuming the bar code matches, the technician photographs the work label, vials, diluents and fluids to be used, and the syringe (before injecting the contents into the bag) along with the vial. The pharmacist views all images as a part of the final product-checking process. This process allows the pharmacist to verify that the correct quantity of medication was transferred from the primary source to a secondary container without being physically present at the time of transfer. Telepharmacy and bar coding provide a means to improve the accuracy of chemotherapy preparation by decreasing the likelihood of using the incorrect product or quantity of drug. The system facilitates the reading of small product labels and removes the need for a pharmacist to handle contaminated syringes and vials when checking the final product.

  16. Auto-disable syringes for immunization: issues in technology transfer.

    PubMed Central

    Lloyd, J. S.; Milstien, J. B.

    1999-01-01

    WHO and its partners recommend the use of auto-disable syringes, "bundled" with the supply of vaccines when donor dollars are used, in all mass immunization campaigns, and also strongly advocate their use in routine immunization programmes. Because of the relatively high price of auto-disable syringes, WHO's Technical Network for Logistics in Health recommends that activities be initiated to encourage the transfer of production technology for these syringes as a means of promoting their use and enhancing access to the technology. The present article examines factors influencing technology transfer, including feasibility, corporate interest, cost, quality assurance, intellectual property considerations, and probable time frames for implementation. Technology transfer activities are likely to be complex and difficult, and may not result in lower prices for syringes. Guidelines are offered on technology transfer initiatives for auto-disable syringes to ensure the quality of the product, the reliability of the supply, and the feasibility of the technology transfer activity itself. PMID:10680248

  17. Cyclophosphamide-hydroxycamptothecin as second-line chemotherapy for advanced Ewing's sarcoma: experience of a single institution.

    PubMed

    Han, Kun; Sun, Yuanjue; Zhang, Jianjun; He, Aina; Zheng, Shui'er; Shen, Zan; Yao, Yang

    2014-06-01

    To investigate the feasibility and efficacy of cyclophosphamide (CTX)-hydroxycamptothecin (HCPT) as second-line chemotherapy on advanced Ewing's sarcoma. From April 2009 to November 2010, 27 patients with advanced Ewing's sarcoma who had progressive disease after the first-line chemotherapy regimen of vincristine, dactinomycin and cyclophosphamide and ifosfamide and etoposide were retrospectively reviewed in this analysis. CTX was given (0.6 g/m(2), i.v. push day 1) and HCPT (6 mg/m(2), i.v. drip days 1-5) as second-line chemotherapy every 3 weeks. The primary end-point was overall response rate, the secondary end-point included progression-free, overall survival, disease control rate and toxicities. A total of 134 cycles were given, median four cycles per patient (range 2-6). Overall response rate was 30% and disease control rate was 82%, with two complete response (8%), six partial remission (22%) and 14 stable disease (52%). The median time to progression and overall survival time were 7 months (95% CI 3-10) and 11 months (95% CI 5-18), respectively. Major severe toxicities (grade 3 and 4) were: nausea/vomiting (17%), alopecia (17%); leukopenia (27%) in total cycles. Mild toxicities (grade 1 or 2) were leukopenia (73%), nausea/vomiting (83%), hepatic lesion (14%) and anemia (44%). A CTX-HCPT regimen can control disease progression effectively and the side effects can be tolerable for Chinese advanced Ewing's sarcoma patients. Further assessment is necessary to confirm the safety and efficacy of this treatment. © 2012 Wiley Publishing Asia Pty Ltd.

  18. Disinfection of syringes contaminated with hepatitis C virus by rinsing with household products.

    PubMed

    Binka, Mawuena; Paintsil, Elijah; Patel, Amisha; Lindenbach, Brett D; Heimer, Robert

    2015-01-01

    Background.  Hepatitis C virus (HCV) transmission among people who inject drugs (PWID) is associated with the sharing of injection paraphernalia. People who inject drugs often "disinfect" used syringes with household products when new syringes are unavailable. We assessed the effectiveness of these products in disinfecting HCV-contaminated syringes. Methods.  A genotype-2a reporter virus assay was used to assess HCV infectivity in syringes postrinsing. Hepatitis C virus-contaminated 1 mL insulin syringes with fixed needles and 1 mL tuberculin syringes with detachable needles were rinsed with water, Clorox bleach, hydrogen peroxide, ethanol, isopropanol, Lysol, or Dawn Ultra at different concentrations. Syringes were either immediately tested for viable virus or stored at 4°C, 22°C, and 37°C for up to 21 days before viral infectivity was determined. Results.  Most products tested reduced HCV infectivity to undetectable levels in insulin syringes. Bleach eliminated HCV infectivity in both syringes. Other disinfectants produced virus recovery ranging from high (5% ethanol, 77% ± 12% HCV-positive syringes) to low (1:800 Dawn Ultra, 7% ± 7% positive syringes) in tuberculin syringes. Conclusions.  Household disinfectants tested were more effective in fixed-needle syringes (low residual volume) than in syringes with detachable needles (high residual volume). Bleach was the most effective disinfectant after 1 rinse, whereas other diluted household products required multiple rinses to eliminate HCV. Rinsing with water, 5% ethanol (as in beer), and 20% ethanol (as in fortified wine) was ineffective and should be avoided. Our data suggest that rinsing of syringes with household disinfectants may be an effective tool in preventing HCV transmission in PWID when done properly.

  19. Disinfection of Syringes Contaminated With Hepatitis C Virus by Rinsing With Household Products

    PubMed Central

    Binka, Mawuena; Paintsil, Elijah; Patel, Amisha; Lindenbach, Brett D.; Heimer, Robert

    2015-01-01

    Background. Hepatitis C virus (HCV) transmission among people who inject drugs (PWID) is associated with the sharing of injection paraphernalia. People who inject drugs often “disinfect” used syringes with household products when new syringes are unavailable. We assessed the effectiveness of these products in disinfecting HCV-contaminated syringes. Methods. A genotype-2a reporter virus assay was used to assess HCV infectivity in syringes postrinsing. Hepatitis C virus-contaminated 1 mL insulin syringes with fixed needles and 1 mL tuberculin syringes with detachable needles were rinsed with water, Clorox bleach, hydrogen peroxide, ethanol, isopropanol, Lysol, or Dawn Ultra at different concentrations. Syringes were either immediately tested for viable virus or stored at 4°C, 22°C, and 37°C for up to 21 days before viral infectivity was determined. Results. Most products tested reduced HCV infectivity to undetectable levels in insulin syringes. Bleach eliminated HCV infectivity in both syringes. Other disinfectants produced virus recovery ranging from high (5% ethanol, 77% ± 12% HCV-positive syringes) to low (1:800 Dawn Ultra, 7% ± 7% positive syringes) in tuberculin syringes. Conclusions. Household disinfectants tested were more effective in fixed-needle syringes (low residual volume) than in syringes with detachable needles (high residual volume). Bleach was the most effective disinfectant after 1 rinse, whereas other diluted household products required multiple rinses to eliminate HCV. Rinsing with water, 5% ethanol (as in beer), and 20% ethanol (as in fortified wine) was ineffective and should be avoided. Our data suggest that rinsing of syringes with household disinfectants may be an effective tool in preventing HCV transmission in PWID when done properly. PMID:26034767

  20. Recovering Infectious HIV from Novel Syringe-Needle Combinations with Low Dead Space Volumes.

    PubMed

    Abdala, Nadia; Patel, Amisha; Heimer, Robert

    This study determines if detachable syringe-needle combinations redesigned to reduce their dead space volume may substantially reduce the burden of exposure to infectious HIV among people who inject drugs. Two novel, low dead space (LDS) syringe-needle designs-one added a piston to the plunger (LDS syringe) and the other added a filler to the needle (LDS needle) to reduce their dead space-were compared to standard detachable needle-syringe combinations and to syringes with fixed needles. LDS and standard syringes attached to LDS and standard needles of 23-, 25-, and 27-gauge size were contaminated with HIV-infected blood in the laboratory. The proportion of syringe-needle combinations containing infectious HIV was analyzed after syringes were (1) stored up to 7 days at 22°C or (2) rinsed with water. Detachable syringes attached to 25-gauge needles yielded comparable proportions of syringes with infectious HIV, whether the needle was standard or LDS. Among needles of greater diameter (23 gauge), LDS needles tended to reduce recoverable HIV to a greater extent than standard needles. Syringes with fixed needles showed superior results to LDS syringes attached to needles of equivalent diameter and were less likely to get clogged by blood. Detachable LDS syringe-needle designs must be recommended with caution since they still pose potential risk for HIV transmission. Distribution of LDS syringes and needles must be accompanied by recommendations and instructions for their proper rinsing and disinfection in order to reduce viral burden and chances of needle clogging.

  1. A retrospective analysis of efficacy and safety of adding bevacizumab to chemotherapy as first- and second-line therapy in advanced non-small-cell lung cancer (NSCLC).

    PubMed

    Quan, Rencui; Huang, Jiaxing; Chen, Nan; Fang, Wenfeng; Hu, Zhihuang; Zhan, Jianhua; Zhou, Ting; Zhang, Li; Zhang, Hongyu

    2016-08-01

    Several phase III clinical trials had authenticated that the addition of bevacizumab to paclitaxel plus carboplatin or gemcitabine plus cisplatin showed encouraging efficacy as first-line therapy for advanced NSCLC patients. However, the benefits of adding bevacizumab to other chemotherapy regimens in first- or second-line therapy have not been reported. To compare the clinical efficacy and safety of bevacizumab concomitant with chemotherapy regimens in patients with advanced NSCLC as first- or second-line therapy, we retrospectively reviewed the effects of adding bevacizumab to chemotherapy regimens in naive-chemotherapy and pre-chemotherapy patients with advanced non-squamous NSCLC. A total of 79 patients with advanced non-squamous NSCLC received at least two cycles of bevacizumab with chemotherapy between October 2010 and December 2013 were selected. Our primary end points were overall response rate (ORR) and disease control rate (DCR). The secondary objective was overall survival (OS) and safety. Seventy-nine patients were included in this study. Overall response rates at first evaluation (after 2 cycles) were 23.1 % (9/39) and 5.0 % (2/40) in first- and second-line therapy (P = 0.020), respectively. And disease control rates were 84.6 % (33/39) and 50 % (20/40), respectively (P = 0.001). The median OS were 27.2 months (95 % CI 13.3-41.1 months) and 29.6 months (95 % CI 6.7-52.5 months), respectively (P = 0.740). Grade 3-4 adverse events included leukopenia (2/39), and neutropenia (3/39) in first-line therapy versus neutropenia (1/40) and thrombocytopenia (2/40) in second-line treatment. In our experience, combination of bevacizumab and chemotherapy had encouraging anti-tumor efficacy as both first- and second-line therapy.

  2. Volumetric Lattice Boltzmann Simulation for Fluid dynamics and Turbulence in Practical Syringes

    NASA Astrophysics Data System (ADS)

    Lima, Everton; Deep, Debanjan; Yu, Huidan (Whitney)

    2012-11-01

    We conduct numerical experiments to study fluid dynamics and turbulence in syringes using volumetric lattice Boltzmann method (VLBM) that is developed for dealing with arbitrary moving boundaries. Several common used medical syringes are used to predict the efficiency and safety of syringes experiencing low flow infusion rates. It is found that smaller size syringes reach a steady flow rate much sooner than larger ones, which are in quantitative agreement with experimental results. The relation between the syringe size and its steady flow rate is revealed. At low flow rates, corner vortices are observed. We explore conditions that lead to turbulent flow aiming to aid safer syringe application in nursing practices.

  3. Not sold here: limited access to legally available syringes at pharmacies in Tijuana, Mexico

    PubMed Central

    2011-01-01

    Background Sterile syringe access is a critical component of HIV prevention programs. Although retail pharmacies provide convenient outlets for syringe access, injection drug users (IDUs) may encounter barriers to syringe purchase even where purchase without a prescription is legal. We sought to obtain an objective measure of syringe access in Tijuana, Mexico, where IDUs report being denied or overcharged for syringes at pharmacies. Methods Trained "mystery shoppers" attempted to buy a 1 cc insulin syringe according to a predetermined script at all retail pharmacies in three Tijuana neighborhoods. The same pharmacies were surveyed by telephone regarding their syringe sales policies. Data on purchase attempts were analyzed using basic statistics to obtain an objective measure of syringe access and compared with data on stated sales policies to ascertain consistency. Results Only 46 (28.4%) of 162 syringe purchase attempts were successful. Leading reasons for unsuccessful attempts were being told that the pharmacy didn't sell syringes (35.3%), there were no syringes in stock (31.0%), or a prescription was required (20.7%). Of 136 pharmacies also surveyed by telephone, a majority (88.2%) reported selling syringes but only one-third (32.5%) had a successful mystery shopper purchase; the majority of unsuccessful purchases were attributed to being told the pharmacy didn't sell syringes. There was similar discordance regarding prescription policies: 74 pharmacies said in the telephone survey that they did not require a prescription for syringes, yet 10 of these pharmacies asked the mystery shopper for a prescription. Conclusions IDUs in Tijuana have limited access to syringes through retail pharmacies and policies and practices regarding syringe sales are inconsistent. Reasons for these restrictive and inconsistent practices must be identified and addressed to expand syringe access, reduce syringe sharing and prevent HIV transmission. PMID:21609471

  4. Not sold here: limited access to legally available syringes at pharmacies in Tijuana, Mexico.

    PubMed

    Pollini, Robin A; Rosen, Perth C; Gallardo, Manuel; Robles, Brenda; Brouwer, Kimberly C; Macalino, Grace E; Lozada, Remedios

    2011-05-24

    Sterile syringe access is a critical component of HIV prevention programs. Although retail pharmacies provide convenient outlets for syringe access, injection drug users (IDUs) may encounter barriers to syringe purchase even where purchase without a prescription is legal. We sought to obtain an objective measure of syringe access in Tijuana, Mexico, where IDUs report being denied or overcharged for syringes at pharmacies. Trained "mystery shoppers" attempted to buy a 1 cc insulin syringe according to a predetermined script at all retail pharmacies in three Tijuana neighborhoods. The same pharmacies were surveyed by telephone regarding their syringe sales policies. Data on purchase attempts were analyzed using basic statistics to obtain an objective measure of syringe access and compared with data on stated sales policies to ascertain consistency. Only 46 (28.4%) of 162 syringe purchase attempts were successful. Leading reasons for unsuccessful attempts were being told that the pharmacy didn't sell syringes (35.3%), there were no syringes in stock (31.0%), or a prescription was required (20.7%). Of 136 pharmacies also surveyed by telephone, a majority (88.2%) reported selling syringes but only one-third (32.5%) had a successful mystery shopper purchase; the majority of unsuccessful purchases were attributed to being told the pharmacy didn't sell syringes. There was similar discordance regarding prescription policies: 74 pharmacies said in the telephone survey that they did not require a prescription for syringes, yet 10 of these pharmacies asked the mystery shopper for a prescription. IDUs in Tijuana have limited access to syringes through retail pharmacies and policies and practices regarding syringe sales are inconsistent. Reasons for these restrictive and inconsistent practices must be identified and addressed to expand syringe access, reduce syringe sharing and prevent HIV transmission.

  5. Drug residues in used syringes in Switzerland: A comparative study.

    PubMed

    Lefrançois, Elodie; Augsburger, Marc; Esseiva, Pierre

    2018-05-01

    Harm reduction services, including needle-exchange programmes, have been implemented in Switzerland for over 20 years. Their main aim is to lessen the negative social and/or physical consequences associated with illicit drug consumption and, therefore, improve prevention messages. To this end, knowledge of illicit drug consumption practices is necessary. Periodic self-report surveys are the primary source of data for monitoring drug users' behaviour. Analysis of residual content of used syringes can bring further and objective knowledge about consumed products through analytically confirmed data. Used syringes were sampled in 2 syringe-exchange facilities in Lausanne. These structures are a bus where the users bring back their syringes (ABS) and an automatic injecting kit dispenser (AIKD). Once syringes were collected, a validated gas chromatography-mass spectrometry (GC-MS) method was implemented in order to detect drugs (licit or illicit) contained in the residual content of used syringes. Cocaine was the most common drug detected alone (39% in ABS and 31% in AIKD), followed by the simultaneous detection of heroin and cocaine (12% and 17%) and heroin and midazolam (12% and 17%). The differences between the illicit drugs distribution of used syringes collected in AIKD and ABS were not statistically significant. Analysis of residual content of used syringes as a monitoring tool is an original approach that has already led to a better understanding of the habits of drug-injection users. Over the long term, this approach is a powerful tool to track and detect new consumption practices in a quasi-real-time. Copyright © 2017 John Wiley & Sons, Ltd.

  6. The Washington Needle Depot: fitting healthcare to injection drug users rather than injection drug users to healthcare: moving from a syringe exchange to syringe distribution model

    PubMed Central

    2010-01-01

    Needle exchange programs chase political as well as epidemiological dragons, carrying within them both implicit moral and political goals. In the exchange model of syringe distribution, injection drug users (IDUs) must provide used needles in order to receive new needles. Distribution and retrieval are co-existent in the exchange model. Likewise, limitations on how many needles can be received at a time compel addicts to have multiple points of contact with professionals where the virtues of treatment and detox are impressed upon them. The centre of gravity for syringe distribution programs needs to shift from needle exchange to needle distribution, which provides unlimited access to syringes. This paper provides a case study of the Washington Needle Depot, a program operating under the syringe distribution model, showing that the distribution and retrieval of syringes can be separated with effective results. Further, the experience of IDUs is utilized, through paid employment, to provide a vulnerable population of people with clean syringes to prevent HIV and HCV. PMID:20047690

  7. [Trial manufacture of a plunger shield for a disposable plastic syringe].

    PubMed

    Murakami, Shigeki; Emoto, Takashi; Mori, Hiroshige; Fujita, Katsuhisa; Kubo, Naoki

    2008-08-20

    A syringe-type radiopharmaceutical being supplied by a manufacturer has a syringe shield and a plunger shield, whereas an in-hospital labeling radiopharmaceutical is administered by a disposable plastic syringe without the plunger shield. In cooperation with Nihon Medi-Physics Co. Ltd., we have produced a new experimental plunger shield for the disposable plastic syringe. In order to evaluate this shielding effect, we compared the leaked radiation doses of our plunger shield with those of the syringe-type radiopharmaceutical (Medi shield type). Our plunger shield has a lead plate of 21 mm in diameter and 3 mm thick. This shield is equipped with the plunger-end of a disposal plastic syringe. We sealed 99mTc solution into a plastic syringe (Terumo Co.) of 5 ml with our plunger shield and Medi shield type of 2 ml. We measured leaked radiation doses around syringes using fluorescent glass dosimeters (Dose Ace). The number of measure points was 18. The measured doses were converted to 70 microm dose equivalent at 740 MBq of radioactivity. The results of our plunger shield and the Medi shield type were as follows: 4-13 microSv/h and 3-14 microSv/h at shielding areas, 3-545 microSv/h and 6-97 microSv/h at non-shielding areas, 42-116 microSv/h and 88-165 microSv/h in the vicinity of the syringe shield, and 1071 microSv/h and 1243 microSv/h at the front of the needle. For dose rates of shielding areas around the syringe, the shielding effects were approximately the same as those of the Medi shield type. In conclusion, our plunger shield may be useful for reducing finger exposure during the injection of an in-hospital labeled radiopharmaceutical.

  8. Adverse event associated with a change in nonprescription syringe sale policy.

    PubMed

    Zaller, Nickolas D; Yokell, Michael A; Jeronimo, Alexandra; Bratberg, Jeffrey P; Case, Patricia; Rich, Josiah D

    2010-01-01

    To report and describe the possible correlation of a change in syringe sale policy at a community pharmacy with an adverse clinical outcome. Providence, RI, in summer 2009. 27-year-old white woman with a long-standing history of chronic relapsing opiate addiction and human immunodeficiency virus (HIV)/hepatitis C virus (HCV) coinfection. The patient presented to the hospital emergency department with 5 days of severe diffuse pain, swelling in her hands and feet, and several days of rigors with fevers, sweats, and chills. She was diagnosed with sepsis resulting from a disseminated methicillin-resistant Staphylococcus aureus (MRSA) infection. The patient was treated with intravenous antibiotics, neurosurgical drainage of an epidural abscess, intensive care unit care for 1 week, and acute hospitalization for 8 weeks. Not applicable. A few weeks before the patient was hospitalized, pharmacists at her local neighborhood pharmacy decided to stop selling syringes in packages of 10. Instead, syringes were sold at a minimum quantity of 100. The patient did not know where to obtain sterile syringes and began reusing syringes. The patient introduced pathogenic bacteria from her skin into her bloodstream through unsafe injection practices. The change in syringe sale policy at her local pharmacy likely inadvertently contributed to this severe and life-threatening situation. Consideration of the implications of syringe sale policy must include an understanding of the barriers that influence individual pharmacist's decisions regarding particular store policies that affect over-the-counter syringe sales. Legalized sale of nonprescription syringes in community pharmacies alone is not enough to curb the epidemic of unsafe injection practices in the United States. All medical risks that are inherent in the use of unsafe syringes, including blood-borne viral pathogens (e.g., HIV, HCV) and bacterial infections (e.g., MRSA), should be considered.

  9. Pemetrexed Singlet Versus Nonpemetrexed-Based Platinum Doublet as Second-Line Chemotherapy after First-Line Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor Failure in Non-small Cell Lung Cancer Patients with EGFR Mutations.

    PubMed

    Park, Sehhoon; Keam, Bhumsuk; Kim, Se Hyun; Kim, Ki Hwan; Kim, Yu Jung; Kim, Jin-Soo; Kim, Tae Min; Lee, Se-Hoon; Kim, Dong-Wan; Lee, Jong Seok; Heo, Dae Seog

    2015-10-01

    Platinum-based doublet chemotherapy is the treatment of choice for patients with non-small cell lung cancer (NSCLC); however, the role of a platinum-based doublet as second-line therapy after failure of an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for NSCLC patients has not yet been elucidated. The purpose of this study was to compare the clinical efficacy of pemetrexed versus a platinum-based doublet as second-line therapy after failure of EGFR TKI used as first-line therapy for NSCLC patients with EGFR mutations. We designed a multicenter retrospective cohort study of 314 NSCLC patients with EGFR mutations who received an EGFR TKI as first-line palliative chemotherapy. Our analysis included 83 patients who failed EGFR TKI therapy and received second-line cytotoxic chemotherapy. Forty-six patients were treated using a platinum-based doublet and 37 patients were treated using singlet pemetrexed. The overall response rates of patients receiving a platinum-based doublet and patients receiving pemetrexed were17.4% and 32.4%, respectively (p=0.111). The median progression-free survival (PFS) of patients receiving pemetrexed was significantly longer than that of patients receiving a platinum-based doublet (4.2 months vs. 2.7 months, respectively; p=0.008). The hazard ratio was 0.54 (95% confidence interval, 0.34 to 0.86; p=0.009). Our retrospective analysis found that second-line pemetrexed singlet therapy provided significantly prolonged PFS compared to second-line platinum-based doublet chemotherapy for NSCLC patients with EGFR mutations who failed first-line EGFR TKI. Conduct of prospective studies for confirmation of our results is warranted.

  10. Don't Throw Away Syringes!

    ERIC Educational Resources Information Center

    John, E.

    1975-01-01

    Describes a variety of laboratory experiments including carbon dioxide reduction, animal respiration, atmospheric pressure determination, and others, that can be performed using discarded syringes. (GS)

  11. First-line chemotherapy in low-risk gestational trophoblastic neoplasia

    PubMed Central

    Alazzam, Mo’iad; Tidy, John; Hancock, Barry W; Osborne, Raymond; Lawrie, Theresa A

    2014-01-01

    Background This is an update of a Cochrane review that was first published in Issue 1, 2009. Gestational trophoblastic neoplasia (GTN) is a rare but curable disease arising in the fetal chorion during pregnancy. Most women with low-risk GTN will be cured by evacuation of the uterus with or without single-agent chemotherapy. However, chemotherapy regimens vary between treatment centres worldwide and the comparable benefits and risks of these different regimens are unclear. Objectives To determine the efficacy and safety of first-line chemotherapy in the treatment of low-risk GTN. Search methods In September 2008, we electronically searched the Cochrane Gynaecological Cancer Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL Issue 3, 2008), MEDLINE and EMBASE. In addition, we searched online trial registers, conference proceedings and reference lists of identified studies. We re-ran these searches in February 2012 for this updated review. Selection criteria For the original review, we included randomised controlled trials (RCTs), quasi-RCTs and non-RCTs that compared first-line chemotherapy for the treatment of low-risk GTN. For this updated version of the review, we included only RCTs. Data collection and analysis Two review authors independently assessed studies for inclusion and extracted data to a pre-designed data extraction form. Meta-analysis was performed by pooling the risk ratio (RR) of individual trials. Main results We included five moderate to high quality RCTs (517 women) in the updated review. These studies all compared methotrexate with dactinomycin. Three studies compared weekly intramuscular (IM) methotrexate with bi-weekly pulsed intravenous (IV) dactinomycin (393 women), one study compared five-day IM methotrexate with bi-weekly pulsed IV dactinomycin (75 women) and one study compared eight-day IM methotrexate-folinic acid (MTX-FA) with five-day IV dactinomycin (49 women). Overall, dactinomycin was associated

  12. Options for reducing HIV transmission related to the dead space in needles and syringes.

    PubMed

    Zule, William A; Pande, Poonam G; Otiashvili, David; Bobashev, Georgiy V; Friedman, Samuel R; Gyarmathy, V Anna; Des Jarlais, Don C

    2018-01-15

    When shared by people who inject drugs, needles and syringes with different dead space may affect the probability of HIV and hepatitis C virus (HCV) transmission differently. We measured dead space in 56 needle and syringe combinations obtained from needle and syringe programs across 17 countries in Europe and Asia. We also calculated the amounts of blood and HIV that would remain in different combinations following injection and rinsing. Syringe barrel capacities ranged from 0.5 to 20 mL. Needles ranged in length from 8 to 38 mm. The average dead space was 3 μL in low dead space syringes with permanently attached needles, 13 μL in high dead space syringes with low dead space needles, 45 μL in low dead space syringes with high dead space needles, and 99 μL in high dead space syringes with high dead space needles. Among low dead space designs, calculated volumes of blood and HIV viral burden were lowest for low dead space syringes with permanently attached needles and highest for low dead space syringes with high dead space needles. The dead space in different low dead space needle and syringe combinations varied substantially. To reduce HIV transmission related to syringe sharing, needle and syringe programs need to combine this knowledge with the needs of their clients.

  13. EGFR tyrosine kinase inhibitors versus chemotherapy as first-line therapy for non-small cell lung cancer patients with the L858R point mutation.

    PubMed

    Xu, Jianlin; Yang, Haitang; Jin, Bo; Lou, Yuqing; Zhang, Yanwei; Zhang, Xueyan; Zhong, Hua; Wang, Huiming; Wu, Dan; Han, Baohui

    2016-11-04

    The efficacy of EGFR tyrosine kinase inhibitors (TKIs) varies among different EGFR mutations. Here, we directly compared the efficacy of first-line TKIs to chemotherapy for non-small cell lung cancer (NSCLC) patients with the L858R mutation. The progression-free survival (PFS) for patients receiving TKIs as first-line therapy was longer than those who received chemotherapy (hazard ratio [HR]: 0.44, P < 0.001). Subgroup analyses showed that first-line TKI therapy resulted in longer PFS among non-smokers (HR: 0.41, P < 0.001), male (HR: 0.49, P = 0.002), female (HR: 0.39, P < 0.001), and patients with adenocarcinoma histology (HR: 0.41, P < 0.001). However, among patients with non-adenocarcinoma histology (HR: 1.11, P = 0.824) and those who used to smoke (HR: 0.55, P = 0.093), first-line TKI therapy failed to demonstrate statistically longer PFS compared to chemotherapy. Our results demonstrated that for patients with L858R mutation, first-line TKI therapy provided better survival benefits. However, among non-adenocarcinoma patients and those who used to smoke, the PFS in cohorts receiving first-line chemotherapy or TKI were not significantly different. The results of the current study will be helpful for decision-making in the treatment of patients with L858R mutation.

  14. Neutropaenia as a prognostic factor in metastatic colorectal cancer patients undergoing chemotherapy with first-line FOLFOX.

    PubMed

    Shitara, Kohei; Matsuo, Keitaro; Takahari, Daisuke; Yokota, Tomoya; Inaba, Yoshitaka; Yamaura, Hidekazu; Sato, Yozo; Najima, Mina; Ura, Takashi; Muro, Kei

    2009-07-01

    We retrospectively analysed 153 patients with metastatic colorectal cancer who received FOLFOX with or without bevacizumab as first-line chemotherapy. Several background characteristics and chemotherapy features (grade of neutropaenia, use of bevacizumab or irinotecan, re-introduction of FOLFOX, and tumour progression) as time-varying covariates were analysed as potential prognostic factors. Of the 153 patients, mild neutropaenia (grade 1-2) occurred in 60 patients (39%) and severe neutropaenia (grade 3-4) occurred in 46 patients (30%). The other 47 patients (31%) did not experience neutropaenia. According to a multivariate Cox model with time-varying covariates, hazard ratios (HRs) of death were 0.55 (95% confidence interval (CI), 0.31-0.98; P=0.044) for patients with mild neutropaenia and 0.35 (95% CI, 0.18-0.66; P=0.002) for those with severe neutropaenia. Both mild and severe neutropaenia during chemotherapy are associated with improved survival in patients with MCRC. Prospective trials are required to assess whether dosing adjustments based on neutropaenia may improve chemotherapy efficacy.

  15. Effect of Legal Status of Pharmacy Syringe Sales on Syringe Purchases by Persons Who Inject Drugs in San Francisco and San Diego, CA

    PubMed Central

    Siddiqui, Saira S.; Armenta, Richard; Evans, Jennifer L.; Yu, Michelle; Cuevas-Mota, Jazmine; Page, Kimberly; Davidson, Peter; Garfein, Richard S.

    2015-01-01

    Sharing blood-contaminated syringes is the main risk factor for acquiring and transmitting blood-borne infections among persons who inject drugs (PWID). To reduce this risk, in 2005, California enacted legislation allowing local health jurisdictions to legalize non-prescription syringe sales after approving a disease prevention demonstration project (DPDP). With San Francisco approving a DPDP immediately and San Diego never approving one, we compared PWID across cities for their use of pharmacies PWID to obtain syringes. PWID age 18–30 years old were recruited into separate studies in San Francisco (n=243) and San Diego (n=338) between 2008 and 2011. We used multivariable logistic regression to compare the proportions of PWID who obtained syringes from pharmacies by city while controlling for socio-demographics, injection practices and other risk behaviors. Overall, most PWID were white (71%), male (63%), and between the ages of 18–25 years (55%). Compared to San Francisco, a smaller proportion of PWID in San Diego had bought syringes from pharmacies in the prior three months (16.9% vs. 49.8%; p<0.001), which remained statistically significant after adjusting for socio-demographic and behavioral factors (adjusted odds ratio=4.45, 95% confidence interval: 2.98, 6.65). Use of pharmacies to obtain syringes was greater where it was legal to do so. Public health policy can influence HIV and hepatitis C associated risk among PWID; however, implementation of these policies is crucial for the benefits to be realized. PMID:26252980

  16. Impact of the number of prior lines of therapy and prior perioperative chemotherapy in patients receiving salvage therapy for advanced urothelial carcinoma: implications for trial design.

    PubMed

    Pond, G R; Bellmunt, J; Rosenberg, J E; Bajorin, D F; Regazzi, A M; Choueiri, T K; Qu, A Q; Niegisch, G; Albers, P; Necchi, A; Di Lorenzo, G; Fougeray, R; Wong, Y-N; Sridhar, S S; Ko, Y-J; Milowsky, M I; Galsky, M D; Sonpavde, G

    2015-02-01

    The differential impact of the number of prior lines of therapy and the setting of prior therapy (perioperative or metastatic) is unclear in advanced urothelial carcinoma. Ten phase II trials of salvage chemotherapy, biologic agent therapy, or both, enrolling 731 patients, were available. Data on the number of prior lines of therapy and the setting of prior therapy were required in addition to known previously recognized prognostic factors: time from prior chemotherapy, hemoglobin level, performance status, and liver metastasis status. Cox proportional hazards regression was used to evaluate the association of the number of prior lines and prior perioperative therapy with overall survival (OS) as the primary clinical endpoint. Trial was a stratification factor. A total of 711 patients were evaluable. The overall median progression-free survival and OS were 2.7 and 6.8 months, respectively. The number of prior lines was 1 in 559 patients (78.6%), 2 in 111 (15.6%), 3 in 29 (4.1%), 4 in 10 (1.4%), and 5 in 2 (0.3%). Prior perioperative chemotherapy was given to 277 (39.1%) and chemotherapy for metastatic disease to 454 (64.1%). The number of prior lines was not independently associated with OS (hazard ratio, 0.99; 95% CI, 0.86-1.14). Prior perioperative chemotherapy was a favorable factor for OS on univariate but not multivariate analysis. The number of prior lines of therapy and prior perioperative chemotherapy were not independently prognostic in patients with urothelial carcinoma receiving salvage therapy. Adoption of these data in salvage therapy trials should enhance accrual, the interpretability of results, and drug development. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Sterile Basics of Compounding: Relationship Between Syringe Size and Dosing Accuracy.

    PubMed

    Kosinski, Tracy M; Brown, Michael C; Zavala, Pedro J

    2018-01-01

    The purpose of this study was to investigate the accuracy and reproducibility of a 2-mL volume injection using a 3-mL and 10-mL syringe with pharmacy student compounders. An exercise was designed to assess each student's accuracy in compounding a sterile preparation with the correct 4-mg strength using a 3-mL and 10-mL syringe. The average ondansetron dose when compounded with the 3-mL syringe was 4.03 mg (standard deviation ± 0.45 mg), which was not statistically significantly different than the intended 4-mg desired dose (P=0.497). The average ondansetron dose when compounded with the 10-mL syringe was 4.18 mg (standard deviation + 0.68 mg), which was statistically significantly different than the intended 4-mg desired dose (P=0.002). Additionally, there also was a statistically significant difference in the average ondansetron dose compounded using a 3-mL syringe (4.03 mg) and a 10-mL syringe (4.18 mg) (P=0.027). The accuracy and reproducibility of the 2-mL desired dose volume decreased as the compounding syringe size increased from 3 mL to 10 mL. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  18. Efficacy trial of Camouflage Syringe to reduce dental fear and anxiety.

    PubMed

    Ujaoney, S; Mamtani, M; Thakre, T; Tote, J; Hazarey, V; Hazarey, P; Kulkarni, H

    2013-12-01

    Dental fear and anxiety in early childhood are widely prevalent and contribute to dental problems and behaviour in adulthood. Novel ways to reduce dental fear and anxiety in children are needed. Our aim was to conduct an efficacy trial of a novel Camouflage Syringe to reduce dental fear and anxiety in children. randomised controlled trial of efficacy of the Camouflage Syringe. We designed a Camouflage Syringe with a toy-like appearance that veils the conventional syringe to permit topical application and injection of local anaesthesia and ensure more involvement of the patient in the treatment process. We conducted a concurrent parallel, randomised controlled trial (NCT01398007) on the efficacy of this Camouflage Syringe to reduce the dental fear and anxiety in children seeking dental treatment who required the use of local anaesthesia. Using Venham's clinical rating scale, Venham's picture test, parental stress questionnaire and recall questionnaire, the efficacy of the Camouflage Syringe to reduce dental fear and anxiety ranged from 82% to 97% for various outcomes and from 60% to 100% for prevention of related adverse outcomes. For all outcomes, the number needed to treat was close to unity. Our results strongly favour the use of Camouflage Syringe to reduce dental fear and anxiety in children.

  19. Attitudes of North Carolina law enforcement officers toward syringe decriminalization

    PubMed Central

    Davis, Corey S.; Johnston, Jill; Zerden, Lisa de Saxe; Clark, Katie; Castillo, Tessie; Childs, Robert

    2015-01-01

    Background North Carolina, like much of the U.S. South, is disproportionately affected by HIV and hepatitis. This persistently high disease burden may be driven in part by laws that criminalize the possession and distribution of syringes for illicit drug use. Legal change to decriminalize syringes may reduce infection rates in the state, but is unlikely absent support from law enforcement actors. Methods We analyzed the responses of 350 North Carolina law enforcement officers to a confidential, anonymous survey. The survey instrument collected data regarding self-reported needle-stick injury (NSI), blood borne disease risk perception and attitudes toward syringe decriminalization. Results 82% of respondents reported that contracting HIV was a “big concern” for them. 3.8% of respondents reported ever receiving a job-related NSI, a rate of 36 NSI per 10,000 officer-years. Majorities of respondents reported positive views regarding syringe decriminalization, with approximately 63% agreeing that it would be “good for the community” and 60% agreeing that it would be “good for law enforcement.” Black and female officers were significantly less likely to agree that on-the-job NSI was a “big concern” and significantly more likely to agree that it would be good for law enforcement. Conclusions These findings suggest that many North Carolina LEOs understand the public health benefits of syringe access programs and may be inclined to support syringe decriminalization legislation. Further research is indicated to determine the causes of observed differences in perceptions of bloodborne disease risk and attitudes toward syringe decriminalization by race and sex. PMID:25193720

  20. Attitudes of North Carolina law enforcement officers toward syringe decriminalization.

    PubMed

    Davis, Corey S; Johnston, Jill; de Saxe Zerden, Lisa; Clark, Katie; Castillo, Tessie; Childs, Robert

    2014-11-01

    North Carolina, like much of the U.S. South, is disproportionately affected by HIV and hepatitis. This persistently high disease burden may be driven in part by laws that criminalize the possession and distribution of syringes for illicit drug use. Legal change to decriminalize syringes may reduce infection rates in the state, but is unlikely absent support from law enforcement actors. We analyzed the responses of 350 North Carolina law enforcement officers to a confidential, anonymous survey. The survey instrument collected data regarding self-reported needle-stick injury (NSI), blood borne disease risk perception and attitudes toward syringe decriminalization. 82% of respondents reported that contracting HIV was a "big concern" for them. 3.8% of respondents reported ever receiving a job-related NSI, a rate of 36 NSI per 10,000 officer-years. Majorities of respondents reported positive views regarding syringe decriminalization, with approximately 63% agreeing that it would be "good for the community" and 60% agreeing that it would be "good for law enforcement." Black and female officers were significantly less likely to agree that on-the-job NSI was a "big concern" and significantly more likely to agree that it would be good for law enforcement. These findings suggest that many North Carolina LEOs understand the public health benefits of syringe access programs and may be inclined to support syringe decriminalization legislation. Further research is indicated to determine the causes of observed differences in perceptions of bloodborne disease risk and attitudes toward syringe decriminalization by race and sex. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Quality evaluation of radiographic contrast media in large-volume prefilled syringes and vials.

    PubMed

    Sendo, T; Hirakawa, M; Yaginuma, M; Aoyama, T; Oishi, R

    1998-06-01

    The authors compared the particle contaminations of radiographic contrast media packaged in large-volume prefilled syringes and vials. Particle counting was performed for four contrast media packaged in large-volume prefilled syringes (iohexol, ioversol, ioversol for angiography, and ioxaglate) and three contrast media packaged in vials (iohexol, ioversol, and ioxaglate). X-ray emission spectrometry was performed to characterize the individual particles. The amount of silicone oil in the syringe was quantified with infrared spectrophotometry. The particle contamination in syringes containing ioversol was higher than that in syringes containing iohexol or ioxaglate. Particle contamination in the vials was relatively low, except with ioxaglate. X-ray emission spectrometry of the components of the syringe and vial showed that the source of particles was internal material released from the rubber stopper or inner surface. The particle counts for contrast media packaged in syringes and vials varied considerably among the different contrast media and were related to the amount of silicone oil on the inner surface and rubber piston of the syringe.

  2. Prevalence and predictors of transitions to and away from syringe exchange use over time in 3 US cities with varied syringe dispensing policies

    PubMed Central

    Green, Traci C.; Bluthenthal, Ricky N.; Singer, Merrill; Beletsky, Leo; Grau, Lauretta E.; Marshall, Patricia; Heimer, Robert

    2010-01-01

    Syringe exchange programs (SEPs) can reduce HIV risk among injecting drug users (IDUs) but their use may depend heavily on contextual factors such as local syringe policies. The frequency and predictors of transitioning over time to and from direct, indirect, and non-use of SEPs are unknown. We sought, over one year, to: (1) quantify and characterize transition probabilities of SEP attendance typologies; (2) identify factors associated with (a) change in typology, and (b) becoming and maintaining direct SEP use; and (3) quantify and characterize transition probabilities of SEP attendance before and after changes in policy designed to increase access. Using data collected from 583 IDUs participating in a three-city cohort study of SEPs, we conducted a latent transition analysis and multinomial regressions. Three typologies were detected: Direct SEP users, Indirect SEP users and Isolated IDUs. Transitions to direct SEP use were most prevalent. Factors associated with becoming or maintaining direct SEP use were female sex, Latino ethnicity, fewer injections per syringe, homelessness, recruitment city, injecting speedballs (cocaine and heroin), and police contact involving drug paraphernalia possession. Similar factors influenced transitions in the syringe policy change analysis. Policy change cities experienced an increase in Indirect SEP users (43% to 51%) with little increased direct use (29% to 31%). We found that, over time, IDUs tended to become Direct SEP users. Policies improving syringe availability influenced SEP use by increasing secondary syringe exchange. Interactions with police around drug paraphernalia may encourage SEP use for some IDUs and may provide opportunities for other health interventions. PMID:20537814

  3. Effect of legal status of pharmacy syringe sales on syringe purchases by persons who inject drugs in San Francisco and San Diego, CA.

    PubMed

    Siddiqui, Saira S; Armenta, Richard F; Evans, Jennifer L; Yu, Michelle; Cuevas-Mota, Jazmine; Page, Kimberly; Davidson, Peter; Garfein, Richard S

    2015-11-01

    Sharing blood-contaminated syringes is the main risk factor for acquiring and transmitting blood-borne infections among persons who inject drugs (PWID). To reduce this risk, in 2005, California enacted legislation allowing local health jurisdictions to legalize non-prescription syringe sales after approving a disease prevention demonstration project (DPDP). With San Francisco approving a DPDP immediately and San Diego never approving one, we compared PWID across cities for their use of pharmacies PWID to obtain syringes. PWID age 18-30 years old were recruited into separate studies in San Francisco (n=243) and San Diego (n=338) between 2008 and 2011. We used multivariable logistic regression to compare the proportions of PWID who obtained syringes from pharmacies by city while controlling for sociodemographics, injection practices and other risk behaviors. Overall, most PWID were White (71%), male (63%), and between the ages of 18-25 years (55%). Compared to San Francisco, a smaller proportion of PWID in San Diego had bought syringes from pharmacies in the prior three months (16.9% vs. 49.8%; p<0.001), which remained statistically significant after adjusting for sociodemographic and behavioral factors (adjusted odds ratio=4.45, 95% confidence interval: 2.98, 6.65). Use of pharmacies to obtain syringes was greater where it was legal to do so. Public health policy can influence HIV and hepatitis C associated risk among PWID; however, implementation of these policies is crucial for the benefits to be realized. Copyright © 2015 Elsevier B.V. All rights reserved.

  4. Stability of acetylcysteine solution repackaged in oral syringes and associated cost savings.

    PubMed

    Kiser, Tyree H; Oldland, Alan R; Fish, Douglas N

    2007-04-01

    The physical and chemical stability of repackaged acetylcysteine 600 mg/3 mL solution in oral syringes stored under refrigeration or at room temperature was studied for six months; a cost analysis was also conducted. Acetylcysteine 20% solution for inhalation was repackaged undiluted as 600 mg/3 mL in capped oral syringes and stored either under refrigeration or at room temperature exposed to fluorescent light. Four samples for each storage condition were analyzed in duplicate on day zero, weekly for the first month, and then every two weeks during months 2-6. Physical stability was assessed, and the chemical stability of acetylcysteine was evaluated by high-performance liquid chromatography. Acetylcysteine solution in syringes was physically stable during the entire six-month study period. When stored at room temperature, acetylcysteine retained 99% of the original concentration at three months and 95% at six months after preparation of the syringes. Loss of acetylcysteine was <2% at six months when stored under refrigeration. Packaging acetylcysteine in batches of 100 syringes instead of preparing individual syringes reduced wastage to zero syringes, saving an estimated $247 in drug costs. The estimated pharmacy time savings was 30 hours ($702). Acetylcysteine 20% solution repackaged as 600 mg/3 mL in oral syringes is both physically and chemically stable under refrigeration or at room temperature under normal fluorescent lighting for six months. The total loss of acetylcysteine was approximately 5% at room temperature under fluorescent lighting and <2% under refrigeration. Repackaging the solution in syringes in bulk rather than in single doses demonstrated a measurable cost saving.

  5. 21 CFR 870.1670 - Syringe actuator for an injector.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Syringe actuator for an injector. 870.1670 Section 870.1670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1670 Syringe...

  6. 21 CFR 870.1670 - Syringe actuator for an injector.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Syringe actuator for an injector. 870.1670 Section 870.1670 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1670 Syringe...

  7. Efficacy of chemotherapy after first-line gefitinib therapy in EGFR mutation-positive advanced non-small cell lung cancer-data from a randomized Phase III study comparing gefitinib with carboplatin plus paclitaxel (NEJ002).

    PubMed

    Miyauchi, Eisaku; Inoue, Akira; Kobayashi, Kunihiko; Maemondo, Makoto; Sugawara, Shunichi; Oizumi, Satoshi; Isobe, Hiroshi; Gemma, Akihiko; Saijo, Yasuo; Yoshizawa, Hirohisa; Hagiwara, Koichi; Nukiwa, Toshihiro

    2015-07-01

    Epidermal growth factor receptor tyrosine kinase inhibitors are effective as first-line therapy for advanced non-small cell lung cancer patients harboring epidermal growth factor receptor mutations. However, it is unknown whether second-line platinum-based chemotherapy after epidermal growth factor receptor tyrosine kinase inhibitor therapy could lead to better outcomes. We evaluated the efficacy of second-line platinum-based chemotherapy after gefitinib for advanced non-small cell lung cancers harboring epidermal growth factor receptor mutations (the NEJ002 study). Seventy-one non-small cell lung cancers, treated with gefitinib as first-line therapy and then receiving platinum-based chemotherapy as second-line therapy were evaluated in NEJ002. Patients were evaluated for antitumor response to second-line chemotherapy by computed tomography according to the criteria of the Response Evaluation Criteria in Solid Tumors group (version 1.0). Of the 71 patients receiving platinum-based chemotherapy after first-line gefitinib, a partial response was documented in 25.4% (18/71), stable disease in 43.7% (31/71) and progression of disease in 21.1% (15/71). The objective response and disease control rates were 25.4% (18/71) and 69% (49/71), respectively. There was no significant difference between first- and second-line chemotherapy in objective response and disease control rates for advanced non-small cell lung cancer harboring activating epidermal growth factor receptor mutations. In the analysis of epidermal growth factor receptor mutation types, the objective responses of deletions in exon 19 and a point mutation in exon 21 (L858R) were 27.3% (9/33) and 28.1% (9/32), respectively, but these differences between objective response rates were not significant. The efficacy of second-line platinum-based chemotherapy followed at progression by gefitinib was similar to first-line platinum-based chemotherapy, and epidermal growth factor receptor mutation types did not influence

  8. Syringe Access, Syringe Sharing, and Police Encounters among People Who Inject Drugs in New York City: A Community-Level Perspective

    PubMed Central

    Beletsky, Leo; Heller, Daliah; Jenness, Samuel M.; Neaigus, Alan; Gelpi-Acosta, Camila; Hagan, Holly

    2013-01-01

    Background Injection drug user (IDU) experience and perceptions of police practices may alter syringe exchange program (SEP) use or influence risky behaviour. Previously, no community-level data had been collected to identify the prevalence or correlates of police encounters reported by IDUs in the United States. Methods New York City IDUs recruited through respondent-driven sampling were asked about past-year police encounters and risk behaviours, as part of the National HIV Behavioural Surveillance study. Data were analysed using multiple logistic regression. Results A majority (52%) of respondents (n=514) reported being stopped by police officers; 10% reported syringe confiscation. In multivariate modelling, IDUs reporting police stops were less likely to use SEPs consistently (adjusted odds ratio [AOR]=0.59; 95% confidence interval [CI]=0.40–0.89), and IDUs who had syringes confiscated may have been more likely to share syringes (AOR=1.76; 95% CI=0.90–3.44), though the finding did not reach statistical significance. Conclusions Findings suggest that police encounters may influence consistent SEP use. The frequency of IDU-police encounters highlights the importance of including contextual and structural measures in infectious disease risk surveillance, and the need to develop approaches harmonizing structural policing and public health. PMID:23916801

  9. Targeting chemotherapy-resistant leukemia by combining DNT cellular therapy with conventional chemotherapy.

    PubMed

    Chen, Branson; Lee, Jong Bok; Kang, Hyeonjeong; Minden, Mark D; Zhang, Li

    2018-04-24

    While conventional chemotherapy is effective at eliminating the bulk of leukemic cells, chemotherapy resistance in acute myeloid leukemia (AML) is a prevalent problem that hinders conventional therapies and contributes to disease relapse, and ultimately patient death. We have recently shown that allogeneic double negative T cells (DNTs) are able to target the majority of primary AML blasts in vitro and in patient-derived xenograft models. However, some primary AML blast samples are resistant to DNT cell therapy. Given the differences in the modes of action of DNTs and chemotherapy, we hypothesize that DNT therapy can be used in combination with conventional chemotherapy to further improve their anti-leukemic effects and to target chemotherapy-resistant disease. Drug titration assays and flow-based cytotoxicity assays using ex vivo expanded allogeneic DNTs were performed on multiple AML cell lines to identify therapy-resistance. Primary AML samples were also tested to validate our in vitro findings. Further, a xenograft model was employed to demonstrate the feasibility of combining conventional chemotherapy and adoptive DNT therapy to target therapy-resistant AML. Lastly, blocking assays with neutralizing antibodies were employed to determine the mechanism by which chemotherapy increases the susceptibility of AML to DNT-mediated cytotoxicity. Here, we demonstrate that KG1a, a stem-like AML cell line that is resistant to DNTs and chemotherapy, and chemotherapy-resistant primary AML samples both became more susceptible to DNT-mediated cytotoxicity in vitro following pre-treatment with daunorubicin. Moreover, chemotherapy treatment followed by adoptive DNT cell therapy significantly decreased bone marrow engraftment of KG1a in a xenograft model. Mechanistically, daunorubicin increased the expression of NKG2D and DNAM-1 ligands on KG1a; blocking of these pathways attenuated DNT-mediated cytotoxicity. Our results demonstrate the feasibility and benefit of using DNTs as

  10. First-line therapy for advanced non-small cell lung cancer with activating EGFR mutation: is combined EGFR-TKIs and chemotherapy a better choice?

    PubMed

    Wang, Shuyun; Gao, Aiqin; Liu, Jie; Sun, Yuping

    2018-03-01

    As the standard first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutation, EGFR-tyrosine kinase inhibitors (EGFR-TKIs) have significantly improved the median progression-free survival (PFS) up to 18.9 months. However, almost all patients eventually develop acquired resistance to EGFR-TKIs, which limits the first-line PFS. To overcome the resistance and improve overall survival, researchers have tried to identify the resistance mechanisms and develop new treatment strategies, among which a combination of EGFR-TKIs and cytotoxic chemotherapy is one of the hotspots. The data from preclinical and clinical studies on combined EGFR-TKIs and chemotherapy have shown very interesting results. Here, we reviewed the available preclinical and clinical studies on first-line EGFR-TKIs-chemotherapy combination in patients with advanced NSCLC harboring activating EGFR mutation, aiming to provide evidences for more potential choices and shed light on clinical treatment.

  11. Prefilled syringes: An innovation in parenteral packaging

    PubMed Central

    Makwana, Sagar; Basu, Biswajit; Makasana, Yogita; Dharamsi, Abhay

    2011-01-01

    Parenteral administration of pharmaceutical products is one of the most popular methods used to produce quick onset of action and also 100% bioavailability. Main problem occurs with the parenteral drug delivery is lack of convenience, affordability, accuracy, sterility, safety etc. Such drawbacks with this delivery system makes it less preferable. Hence, all the disadvantages of these systems can be easily overcome by use of prefilled syringes. The objective of this review article is to provide information regarding prefilled syringes; it's method of preparation, direction to use, advantages, its future scope, and development. PMID:23071944

  12. Epinephrine syringe exchange events in a paediatric cardiovascular ICU: analysing the storm.

    PubMed

    Achuff, Barbara-Jo; Achuff, Jameson C; Park, Hwan H; Moffett, Brady; Acosta, Sebastian; Rusin, Craig G; Checchia, Paul A

    2018-03-01

    Introduction Haemodynamically unstable patients can experience potentially hazardous changes in vital signs related to the exchange of depleted syringes of epinephrine to full syringes. The purpose was to determine the measured effects of epinephrine syringe exchanges on the magnitude, duration, and frequency of haemodynamic disturbances in the hour after an exchange event (study) relative to the hours before (control). Materials and methods Beat-to-beat vital signs recorded every 2 seconds from bedside monitors for patients admitted to the paediatric cardiovascular ICU of Texas Children's Hospital were collected between 1 January, 2013 and 30 June, 2015. Epinephrine syringe exchanges without dose/flow change were obtained from electronic records. Time, magnitude, and duration of changes in systolic blood pressure and heart rate were characterised using Matlab. Significant haemodynamic events were identified and compared with control data. In all, 1042 syringe exchange events were found and 850 (81.6%) had uncorrupted data for analysis. A total of 744 (87.5%) exchanges had at least 1 associated haemodynamic perturbation including 2958 systolic blood pressure and 1747 heart-rate changes. Heart-rate perturbations occurred 37% before exchange and 63% after exchange, and 37% of systolic blood pressure perturbations happened before syringe exchange, whereas 63% occurred after syringe exchange with significant differences found in systolic blood pressure frequency (p<0.001), duration (p<0.001), and amplitude (p<0.001) compared with control data. This novel data collection and signal processing analysis showed a significant increase in frequency, duration, and magnitude of systolic blood pressure perturbations surrounding epinephrine syringe exchange events.

  13. Vinorelbine and paclitaxel as first-line chemotherapy in metastatic breast cancer.

    PubMed

    Romero Acuña, L; Langhi, M; Pérez, J; Romero Acuña, J; Machiavelli, M; Lacava, J; Vallejo, C; Romero, A; Fasce, H; Ortiz, E; Grasso, S; Amato, S; Rodríguez, R; Barbieri, M; Leone, B

    1999-01-01

    To evaluate the efficacy and toxicity of a combination of vinorelbine (VNB) and paclitaxel (PTX) as first-line chemotherapy in metastatic breast carcinoma (MBC). Between August 1995 and August 1997, 49 patients with untreated MBC received a regimen that consisted of VNB 30 mg/m2 in a 20-minute intravenous (IV) infusion on days 1 and 8 and PTX 135 mg/m2 in a 3-hour IV infusion (starting 1 hour after VNB) on day 1. Cycles were repeated every 28 days. The median age of the patients was 52 years, and 59% of patients were postmenopausal. Median performance status was 1. Dominant sites of disease were soft tissue in 6%, bone in 29%, and viscera in 65%. Objective responses were recorded in 27 of 45 assessable patients (60%; 95% confidence interval, 46% to 74%). Complete remissions occurred in three patients (7%), and partial remissions occurred in 24 patients (53%). No change was recorded in 12 patients (27%), and progressive disease occurred in six patients (13%). The median time to treatment failure was 7 months, and median survival duration was 17 months. The limiting toxicity was myelosuppression, mainly leukopenia in 49 patients (100%) (grade 1 to grade 2, four patients; grade 3, 30 patients; and grade 4, 15 patients). Neutropenia was observed in 100% of patients (grade 1 to grade 2, three patients; grade 3, 11 patients; grade 4, 35 patients). Two treatment-related deaths due to febrile neutropenia were observed in patients with massive liver involvement. Peripheral neurotoxicity developed in 33 patients (67%) (grade 1, 25 patients; grade 2, eight patients); there were no grade 3 or grade 4 episodes. The combination of VNB-PTX showed significant activity as first-line chemotherapy for patients with MBC. Myelosuppression was the dose-limiting side effect, whereas neurotoxicity was mild to moderate.

  14. Subcutaneous morphine infusion by syringe driver for terminally ill patients.

    PubMed

    Cools, H J; Berkhout, A M; De Bock, G H

    1996-05-01

    The study aimed to find whether subcutaneous morphine administration by syringe driver for terminally ill patients in a Dutch nursing home led to higher morphine doses and earlier death than routine morphine administration. The data comprised the files of all patients dying over a 2 year period in a 355-bed nursing home in Delft in the Netherlands. Thirty-eight per cent of the patients had been given morphine, 29% by continuous subcutaneous syringe driver. In comparing the patients given morphine with and without a syringe driver no differences emerged in mean age, sex, length of admission, type of ward, diagnosis, duration of morphine administration and mean dose. The data indicate that subcutaneous morphine administration by syringe driver decreases dose frequency problems and improves the control of pain and other symptoms in the last week before death. There was no evidence that administration of morphine in this way shortens survival.

  15. Experiments with Disposable Hypodermic Syringes.

    ERIC Educational Resources Information Center

    Clayton, G. T.; And Others

    1988-01-01

    Lists five experiments or demonstrations involving hypodermic syringes. The titles of experiments are Boyle's Law, Charles' Law, Atmospheric Pressure, Expansion of Gases, and Boiling at Reduced Pressure. Provides a list of materials, the typical data, and graphs where appropriate. (YP)

  16. Barriers to Pharmacy-Based Syringe Purchase Among Injection Drug Users in Tijuana, Mexico: A Mixed Methods Study

    PubMed Central

    Lozada, Remedios; Gallardo, Manuel; Rosen, Perth; Vera, Alicia; Macias, Armando; Palinkas, Lawrence A.; Strathdee, Steffanie A.

    2010-01-01

    Injection drug users (IDUs) may be denied purchase of sterile syringes even where purchase without a prescription is legal. This study examined barriers to over-the-counter (OTC) syringe purchase among IDUs in Tijuana, Mexico. A quantitative survey and subsequent focus groups were used to quantify barriers to purchase, identify their correlates and provide in-depth exploration of syringe purchase experiences. Of 627 IDUs, 81% purchased a syringe in the past 6 months and 16% were refused or overcharged. Factors independently associated with refusal/overcharging were homelessness, receptive syringe sharing, >5 uses per syringe, and number of lifetime abscesses. Few pharmacies sold syringes to IDUs, who adapted by limiting purchase attempts to pharmacies known to sell syringes consistently. Failed purchases occurred when drug withdrawal required purchase at unusual times or locations, often following release from jail. IDUs reported syringe sharing, syringe reuse, and searching through unsecured medical waste for syringes in response to failed purchase attempts. Interventions to expand OTC syringe sales to IDUs, particularly near detention facilities, will facilitate safer injection practices. PMID:20300820

  17. Making Nasopalatine Blocks Comfortable: A Randomised Prospective Clinical Comparison of Pain Associated with the Injection Using an Insulin Syringe and a Standard Disposable 3 mL Syringe.

    PubMed

    Prabhu, Sundararaman; Faizel, Syed; Pahlajani, Vedant; Prabhu, Shweta Jha

    2013-12-01

    This study was conducted to compare and evaluate the pain associated with administration of Nasopalatine blocks using a disposable insulin syringe and the conventional disposable 3 mL syringe. Forty patients requiring intraalveolar extractions of maxillary central incisors were randomly assigned to two groups of 20 patients each; one (Group A) received the nasopalatine block with a standard 3mL syringe and the other (Group B) received the block with an insulin syringe. Patients were asked to rate the pain associated with the injection on a visual analog scale (VAS) and the results were analysed using a Chi Square Test. The mean VAS score for Group A and B was 1.55 and 1 respectively. Chi Square value was calculated to be 8.603 (degree of freedom= 3, P value= 0.0351). There were no differences in the effectiveness of anesthesia between the groups. Pain associated with administration of the nasopalatine blocks may be significantly mitigated by using the Insulin syringe.

  18. Syringe access for the prevention of blood borne infections among injection drug users

    PubMed Central

    Stancliff, Sharon; Agins, Bruce; Rich, Josiah D; Burris, Scott

    2003-01-01

    Background Approximately one-third of acquired immunodeficiency syndrome cases in the United States are associated with the practice of sharing of injection equipment and are preventable through the once-only use of syringes, needles and other injection equipment. Discussion Sterile syringes may be obtained legally by 4 methods depending on the state. They may be purchased over the counter, prescribed, obtained at syringe exchange programs or furnished by authorized agencies. Each of these avenues has advantages and disadvantages; therefore, legal access through all means is the most likely way to promote the use of sterile syringes. Summary By assisting illicit drug injectors to obtain sterile syringes the primary care provider is able to reduce the incidence of blood borne infections, and educate patients about safe syringe disposal. The provider is also able to initiate discussion about drug use in a nonjudgmental manner and to offer care to patients who are not yet ready to consider drug treatment. PMID:14633286

  19. Adrenaline in cardiac arrest: Prefilled syringes are faster.

    PubMed

    Helm, Claire; Gillett, Mark

    2015-08-01

    Standard ampoules and prefilled syringes of adrenaline are widely available in Australasian EDs for use in cardiac arrest. We hypothesise that prefilled syringes can be administered more rapidly and accurately when compared with the two available standard ampoules. This is a triple arm superiority study comparing the time to i.v. administration and accuracy of dosing of three currently available preparations of adrenaline. In their standard packaging, prefilled syringes were on average more than 12 s faster to administer than the 1 mL 1:1000 ampoules and more than 16 s faster than the 10 mL 1:10,000 ampoules (P < 0.01 in both comparisons). With packaging removed, the time to administration was equal for the 1 mL (1:1000) ampoule and the prefilled syringe. Accuracy of dosing was excellent with both the 10 mL (1:10 000) ampoules and prefilled syringes. The 1 mL (1:1000) ampoules delivered a small number of markedly inaccurate doses, but these did not reach statistical significance. The speed of administration of adrenaline utilising a Minijet (CSL Limited, Parkville, Victoria, Australia) is faster than using adrenaline in glass ampoules presented in their plastic packaging. Removing the plastic packaging from the 1 mL (1 mg) ampoule might result in more rapid administration similar to the Minijet. Resuscitation personnel requiring rapid access to adrenaline should consider storing it as either Minijets or ampoules devoid of packaging. These results might be extrapolatable to other clinical scenarios, including pre-hospital and anaesthesia, where other drugs are required for rapid use. © 2015 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  20. RNA disruption is associated with response to multiple classes of chemotherapy drugs in tumor cell lines.

    PubMed

    Narendrula, Rashmi; Mispel-Beyer, Kyle; Guo, Baoqing; Parissenti, Amadeo M; Pritzker, Laura B; Pritzker, Ken; Masilamani, Twinkle; Wang, Xiaohui; Lannér, Carita

    2016-02-24

    Cellular stressors and apoptosis-inducing agents have been shown to induce ribosomal RNA (rRNA) degradation in eukaryotic cells. Recently, RNA degradation in vivo was observed in patients with locally advanced breast cancer, where mid-treatment tumor RNA degradation was associated with complete tumor destruction and enhanced patient survival. However, it is not clear how widespread chemotherapy induced "RNA disruption" is, the extent to which it is associated with drug response or what the underlying mechanisms are. Ovarian (A2780, CaOV3) and breast (MDA-MB-231, MCF-7, BT474, SKBR3) cancer cell lines were treated with several cytotoxic chemotherapy drugs and total RNA was isolated. RNA was also prepared from docetaxel resistant A2780DXL and carboplatin resistant A2780CBN cells following drug exposure. Disruption of RNA was analyzed by capillary electrophoresis. Northern blotting was performed using probes complementary to the 28S and 18S rRNA to determine the origins of degradation bands. Apoptosis activation was assessed by flow cytometric monitoring of annexin-V and propidium iodide (PI) binding to cells and by measuring caspase-3 activation. The link between apoptosis and RNA degradation (disruption) was investigated using a caspase-3 inhibitor. All chemotherapy drugs tested were capable of inducing similar RNA disruption patterns. Docetaxel treatment of the resistant A2780DXL cells and carboplatin treatment of the A2780CBN cells did not result in RNA disruption. Northern blotting indicated that two RNA disruption bands were derived from the 3'-end of the 28S rRNA. Annexin-V and PI staining of docetaxel treated cells, along with assessment of caspase-3 activation, showed concurrent initiation of apoptosis and RNA disruption, while inhibition of caspase-3 activity significantly reduced RNA disruption. Supporting the in vivo evidence, our results demonstrate that RNA disruption is induced by multiple chemotherapy agents in cell lines from different tissues and is

  1. Pharmacy student knowledge, attitudes, and beliefs about selling syringes to injection drug users.

    PubMed

    Blumenthal, Wendy J; Springer, Kristen W; Jones, T Stephen; Sterk, Claire E

    2002-01-01

    To explore pharmacy school education and pharmacy students' knowledge, attitudes, and beliefs about human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS), drug use, and syringe sales to injection drug users (IDUs). Qualitative study of a convenience sample of pharmacy school students. A pharmacy school in the southeastern United States. Two focus groups and nine in-depth interviews were conducted about HIV/AIDS education and counseling, syringe sales to possible IDUs, and related pharmacy school education. 19 Doctor of Pharmacy students, including 88 students in their third professional year and 11 in their fourth professional year. Most participants believed that they would benefit from more class time on HIV/AIDS topics, including AIDS treatment medications and HIV prevention. Most participants believed that the laws and regulations governing syringe sales in their state were vague, leaving syringe sale decisions to pharmacists' discretion. Nine study participants supported selling syringes to possible IDUs, five opposed it, and five were undecided or ambivalent. Classroom education focused on addiction to prescription drugs, with limited attention to illicit drug use. Pharmacy students have divided opinions about selling syringes to IDUs. To prepare students for helping their patients with drug-use problems, pharmacy schools should increase training about HIV/AIDS and addiction. Policy makers should consider changing laws and regulations of syringe sales to recognize prevention of blood-borne infections as a legitimate medical purpose for selling syringes to IDUs.

  2. A Self-Contained Pole Syringe Array for Closed-Interval Water Sampling.

    DTIC Science & Technology

    1982-10-19

    L AD-R12l 265 R SELF-CONTAINED POLE SYRINGE ARRAY FOR CLOSDITRR Va WATER SANPLING4U) NAVAL RESEARCH LAB WASHINGTON DC I R E PELLENBARG ET AL. 19 OCT...PERIOD COVERED A SELF-CONTAINED POLE SYRINGE ARRAY FOR Interim report on one phase of CLOSED-INTERVAL WATER SAMPLING an NRL problem. 6. PERFORMING ORG...1473 EDITION OF I NOv ,, IS OMSOLCT S/N 0102-014- 6601 SECURITY CLASSIFICATION OF THIS PAGE (Wm Dle Et ere d A SELF-CONTAINED POLE SYRINGE ARRAY FOR

  3. Racial differences in acquisition of syringes from pharmacies under conditions of legal but restricted sales.

    PubMed

    Costenbader, Elizabeth C; Zule, William A; Coomes, Curtis C

    2010-09-01

    Injecting drug users (IDUs) are at increased risk of acquiring and transmitting HIV and other bloodborne pathogens through the multi-person use of syringes. Although research has shown that increased access to syringes through syringe exchange programs (SEPs) is an effective strategy to reduce risky injection practices many areas of the United States still do not have SEPs. In the absence of SEPs, legislation allowing pharmacies over-the-counter sales of syringes has also been shown to reduce syringe sharing. The success of pharmacy sales however is limited by other legal stipulations, such as drug paraphernalia laws, which in turn may contribute to fear among IDUs about being caught purchasing and carrying syringes. Between 2003 and 2006, 851 out-of-treatment IDUs were recruited using street outreach in the Raleigh-Durham (North Carolina) area. Data were collected using audio-computer assisted interview (ACASI) technology. Multiple logistic regression analyses were performed to assess factors associated with purchasing syringes from pharmacies. In our study sample, African-American IDUs were one-fifth as likely as white IDUs to report pharmacies as their primary source of syringes. Given the absence of syringe exchange programs and the relatively high prevalence of HCV and HIV among IDUs in the Raleigh-Durham area, the limited use of pharmacies as a source of syringes among African-American IDUs in this study sample is problematic. The study findings support the need for effective multilevel interventions to increase access to clean needles in this population, as well as for policy interventions, such as legalization of SEPs and elimination of penalties for carrying syringes, to reduce harm and eliminate the health threats posed by receptive syringe sharing. Copyright 2010 Elsevier B.V. All rights reserved.

  4. Variability in syringe components and its impact on functionality of delivery systems.

    PubMed

    Rathore, Nitin; Pranay, Pratik; Eu, Bruce; Ji, Wenchang; Walls, Ed

    2011-01-01

    Prefilled syringes and autoinjectors are becoming increasingly common for parenteral drug administration primarily due to the convenience they offer to the patients. Successful commercialization of such delivery systems requires thorough characterization of individual components. Complete understanding of various sources of variability and their ranking is essential for robust device design. In this work, we studied the impact of variability in various primary container and device components on the delivery forces associated with syringe injection. More specifically, the effects of barrel size, needle size, autoinjector spring force, and frictional forces have been evaluated. An analytical model based on underlying physics is developed that can be used to fully characterize the design space for a product delivery system. Use of prefilled syringes (syringes prefilled with active drug) is becoming increasingly common for injectable drugs. Compared to vials, prefilled syringes offer higher dose accuracy and ease of use due to fewer steps required for dosage. Convenience to end users can be further enhanced through the use of prefilled syringes in combination with delivery devices such as autoinjectors. These devices allow patients to self-administer the drug by following simple steps such as pressing a button. These autoinjectors are often spring-loaded and are designed to keep the needle tip shielded prior to injection. Because the needle is not visible to the user, such autoinjectors are perceived to be less invasive than syringes and help the patient overcome the hesitation associated with self-administration. In order to successfully develop and market such delivery devices, we need to perform an in-depth analysis of the components that come into play during the activation of the device and dose delivery. Typically, an autoinjector is activated by the press of a button that releases a compressed spring; the spring relaxes and provides the driving force to push the

  5. Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes.

    PubMed

    Lu, Xujin; Lloyd, David K; Klohr, Steven E

    2016-01-01

    A feasibility study was conducted for a sensitive and robust dye immersion method for the measurement of container closure integrity of unopened prefilled syringes using fluorescence spectrophotometry as the detection method. A Varian Cary Eclipse spectrofluorometer was used with a custom-made sample holder to position the intact syringe in the sample compartment for fluorescence measurements. Methylene blue solution was initially evaluated as the fluorophore in a syringe with excitation at 607 nm and emission at 682 nm, which generated a limit of detection of 0.05 μg/mL. Further studies were conducted using rhodamine 123, a dye with stronger fluorescence. Using 480 nm excitation and 525 nm emission, the dye in the syringe could be easily detected at levels as low as 0.001 μg/mL. The relative standard deviation for 10 measurements of a sample of 0.005 μg/mL (with repositioning of the syringe after each measurement) was less than 1.1%. A number of operational parameters were optimized, including the photomultiplier tube voltage, excitation, and emission slit widths. The specificity of the testing was challenged by using marketed drug products and a protein sample, which showed no interference to the rhodamine detection. Results obtained from this study demonstrated that using rhodamine 123 for container closure integrity testing with in-situ (in-syringe) fluorescence measurements significantly enhanced the sensitivity and robustness of the testing and effectively overcame limitations of the traditional methylene blue method with visual or UV-visible absorption detection. Ensuring container closure integrity of injectable pharmaceutical products is necessary to maintain quality throughout the shelf life of a sterile drug product. Container closure integrity testing has routinely been used to evaluate closure integrity during product development and production line qualification of prefilled syringes, vials, and devices. However, container closure integrity testing

  6. Crizotinib in patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer versus chemotherapy as a first-line treatment.

    PubMed

    Zhou, Jianya; Zheng, Jing; Zhang, Xiaochen; Zhao, Jing; Zhu, Yanping; Shen, Qian; Wang, Yuehong; Sun, Ke; Zhang, Zeying; Pan, Zhijie; Shen, Yihong; Zhou, Jianying

    2018-01-03

    To compare the efficacy of crizotinib, pemetrexed and other chemotherapy regimens as a first-line treatment in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in real world clinical use and to evaluate the +86-571-87,236,876 predictive clinical factors of the efficacy of crizotinib. The 73 patients with ALK-positive advanced NSCLC were divided into three groups based on the first-line treatment: first-line crizotinib group (1-CRZ group, n = 32); first-line platinum-based pemetrexed treatment group (1-PP group, n = 28), and first-line chemotherapy platinum-based non-pemetrexed group (N1-PP, n = 12). Sixty eight of the 73 patients received crizotinib treatment and followed up in our hospital. Differences in the objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS) were compared in the different groups. The clinical factors were evaluated to predict the efficacy of crizotinib by the Kaplan-Meier survival analysis and Cox proportional hazards model. The PFS, ORR, DCR were 16.1 months, 78.1% (25/32) and 100% (32/32) in the 1-CRZ group; were 6.0 months, 17.9% (5/28) and 57.2% (16/28) in the 1-PP group; and were 2.9 months, 15.4% (2/13) and 46.2% (6/13) in the N1-PP group. The PFS of the 1-CRZ group was significantly longer than that of the 1-PP group (P < 0.001) and the N1-PP group (P < 0.001). The ORR and DCR of the 1-CRZ group was significantly greater than that of the 1-PP group and the N1-PP group (all the P < 0.001). Higher Eastern Cooperative Oncology Group (ECOG) performance status score (> = 2) (HR 2.345, 95% CI 1.137-4.834, P = 0.021) and patients received crizotinib after N1-PP chemotherapy (HR 2.345, 95% CI 1.137-4.834, P = 0.021) were two factors associated with shorter PFS after crizotinib treatment. In patients with ALK-positive NSCLC who did not receive previous treatment, crizotinib was superior to standard chemotherapy for the longer PFS and greater

  7. Active silicone oil removal with a modified vacuum syringe.

    PubMed

    Bajaire, Boris J; Oudovitchenko, Elena; Salguero, Andrés E; Paipilla, Diego F

    2012-01-01

    At present, the number of clinical indications for the use of silicone oil (SO) has increased in intraocular surgery because of the advent of new techniques in vitreoretinal surgery, availability of better quality oils, and greater experience in its use. Consequently, the number of procedures for SO removal has increased, and support technologies for these procedures are always a concern. A simple active technique for SO removal based on a 5-mL standard syringe with an 18G cannula was developed. The oil is suctioned into the syringe by the pulling effect of a spring assembled along the axis of the piston. No abrupt change in the intraocular pressure is produced because of the oil viscosity and the reduced diameter of the cannula. A technique for SO removal that has been used successfully during the past 7 years is presented in this article. During the 7-year period, 234 SO removals were performed without any complication or device failure. Using the present method, the average time for SO removal was 4 minutes. The average extraction time with the technique is 4 minutes, which is in the range of other active techniques, and it is faster than passive methods that are performed between 8 and 9 minutes. The technique is in line with the advantages of more elaborated active methods without using complex technology. It is considered to be highly successful and easy to implement.

  8. Outcome of Molecular Targeted Agents Plus Chemotherapy for Second-Line Therapy of Metastatic Colorectal Cancer: A Meta-Analysis of Randomized Trials.

    PubMed

    Pei, Xueqing; Liu, Yu; Sun, Liwei; Zhang, Jun; Fang, Yuanyuan; Liao, Xin; Liu, Jian; Zhang, Cuntai; Yin, Tiejun

    2016-12-01

    The aim of this study was to evaluate the efficacy and toxicity of molecular targeted agents plus chemotherapy compared with chemotherapy alone as second-line therapy for patients with metastatic colorectal cancer (mCRC). We identified randomized controlled trials that compared molecular targeted agents plus chemotherapy with chemotherapy alone by searching the PubMed and Embase databases for articles published between January 2000 and September 2015. The outcome measures included progression-free survival, overall survival, objective response rate, and adverse events. Two investigators independently performed the information retrieval, screening, and data extraction. Stata 10.0 software was used to statistically analyze the extracted data. In accordance with our inclusion criteria, 11 trials, with a total of 7440 patients, were included in this meta-analysis through rounds of selection. We divided the biologic agents used into 3 subgroups based on the type of biologic agents-vascular endothelial growth factor (VEGF) inhibitor, epidermal growth factor receptor inhibitor, and other pathway inhibitors. Our results suggested that the regimen of a molecular targeted agent plus chemotherapy had a significant advantage in progression-free survival, overall survival, and objective response rate over chemotherapy alone (hazard ratio, 0.74; 95% confidence interval [CI], 0.70-0.78; hazard ratio, 0.88; 95% CI, 0.83-0.93; risk ratio, 2.24; 95% CI: 1.58-3.17, respectively). However, the rate of grade ≥ 3 adverse events was also higher in the combination therapy arm (risk ratio, 1.25; 95% CI, 1.17-1.33). Subgroup analysis showed that the combination of VEGF inhibitor with chemotherapy had a significant advantage in PFS, OS, and ORR over chemotherapy alone, but there was also a higher risk ratio in adverse events for this combination compared with the control group. In conclusion, a molecular targeted agent, especially VEGF inhibitor, plus chemotherapy is a worthwhile

  9. In vitro synergistic antitumor efficacy of sequentially combined chemotherapy/icotinib in non‑small cell lung cancer cell lines.

    PubMed

    Wang, Min-Cong; Liang, Xuan; Liu, Zhi-Yan; Cui, Jie; Liu, Ying; Jing, Li; Jiang, Li-Li; Ma, Jie-Qun; Han, Li-Li; Guo, Qian-Qian; Yang, Cheng-Cheng; Wang, Jing; Wu, Tao; Nan, Ke-Jun; Yao, Yu

    2015-01-01

    The concurrent administration of chemotherapy and epidermal growth factor receptor‑tyrosine kinase inhibitors (EGFR‑TKIs) has previously produced a negative interaction and failed to confer a survival benefit to non‑small cell lung cancer (NSCLC) patients compared with first‑line cytotoxic chemotherapy. The present study aimed to investigate the optimal schedule of the combined treatment of cisplatin/paclitaxel and icotinib in NSCLC cell lines and clarify the underlying mechanisms. HCC827, H1975, H1299 and A549 human NSCLC cell lines with wild‑type and mutant EGFR genes were used as in vitro models to define the differential effects of various schedules of cisplatin/paclitaxel with icotinib treatments on cell growth, proliferation, cell cycle distribution, apoptosis, and EGFR signaling pathway. Sequence‑dependent antiproliferative effects differed among the four NSCLC cell lines, and were not associated with EGFR mutation, constitutive expression levels of EGFR or downstream signaling molecules. The antiproliferative effect of cisplatin plus paclitaxel followed by icotinib was superior to that of cisplatin or paclitaxel followed by icotinib in the HCC827, H1975, H1299 and A549 cell lines, and induced more cell apoptosis and G0/G1 phase arrest. Cisplatin and paclitaxel significantly increased the expression of EGFR phosphorylation in the HCC827 cell line. However, only paclitaxel increased the expression of EGFR phosphorylation in the H1975 cell line. Cisplatin/paclitaxel followed by icotinib influenced the expression of p‑EGFR and p‑AKT, although the expression of p‑ERK1/2 remained unchanged. The results suggest that the optimal schedule of the combined treatment of cisplatin/paclitaxel and icotinib differed among the NSCLC cell lines. The results also provide molecular evidence to support clinical treatment strategies for NSCLC patients.

  10. Neighborhood History as a Factor Shaping Syringe Distribution Networks Among Drug Users at a U.S. Syringe Exchange1

    PubMed Central

    Braine, Naomi; Acker, Caroline; Goldblatt, Cullen; Yi, Huso; Friedman, Samuel; DesJarlais, Don C.

    2008-01-01

    Throughout the US, high-visibility drug markets are concentrated in neighborhoods with few economic opportunities, while drug buyers/users are widely dispersed. A study of Pittsburgh Syringe Exchange participants provides data on travel between and network linkages across neighborhoods with different levels of drug activity. There are distinct racial patterns to syringe distribution activity within networks and across neighborhoods. Pittsburgh’s history suggests these patterns emerge from historical patterns of social and economic development. Study data demonstrate the ability of IDUs to form long term social ties across racial and geographic boundaries and use them to reduce the risk of HIV transmission. PMID:19578475

  11. Demographic, Risk, and Spatial Factors Associated With Over-the-Counter Syringe Purchase Among Injection Drug Users

    PubMed Central

    Stopka, Thomas J.; Lutnick, Alexandra; Wenger, Lynn D.; DeRiemer, Kathryn; Geraghty, Estella M.; Kral, Alex H.

    2012-01-01

    Since 2005, California law allowed over-the-counter (OTC) syringe sales pending local authorization. Although pharmacy sales of OTC syringes are associated with reduced injection-mediated risks and decreases in human immunodeficiency virus infection rates, little is known about the factors associated with syringe purchase among injection drug users (IDUs). Using a cross-sectional design, the authors applied targeted sampling to collect quantitative survey data from IDUs (n = 563) recruited in San Francisco, California, during 2008. They also compiled a comprehensive list of retail pharmacies, their location, and whether they sell OTC syringes. They used a novel combination of geographic information system and statistical analyses to determine the demographic, behavioral, and spatial factors associated with OTC syringe purchase by IDUs. In multivariate analyses, age, race, injection frequency, the type of drug injected, and the source of syringe supply were independently associated with OTC syringe purchases. Notably, the prevalence of OTC syringe purchase was 53% lower among African-American IDUs (adjusted prevalence ratio = 0.47, 95% confidence interval: 0.33, 0.67) and higher among injectors of methamphetamine (adjusted prevalence ratio = 1.35, 95% confidence interval: 1.07, 1.70). Two neighborhoods with high densities of IDUs had limited access to OTC syringes. Increased access to OTC syringes would potentially prevent blood-borne infectious diseases among IDUs. PMID:22562660

  12. Stability of cyclosporine solutions stored in polypropylene-polyolefin bags and polypropylene syringes.

    PubMed

    Li, Mengqing; Forest, Jean-Marc; Coursol, Christian; Leclair, Grégoire

    2011-09-01

    The stability of cyclosporine diluted to 0.2 or 2.5 mg/mL with 0.9% sodium chloride injection or 5% dextrose injection and stored in polypropylene-polyolefin containers or polypropylene syringes was evaluated. Intravenous cyclosporine solutions (0.2 and 2.5 mg/mL) were aseptically prepared and transferred to 250-mL polypropylene-polyolefin bags or 60-mL polypropylene syringes. Chemical stability was measured using a stability-indicating high-performance liquid chromatography (HPLC) assay. Physical stability was assessed by visual inspection and a dynamic light scattering (DLS) method. After 14 days, HPLC assay showed that the samples of i.v. cyclosporine stored in polypropylene-polyolefin bags remained chemically stable (>98% of initial amount remaining); the physical stability of the samples was confirmed by DLS and visual inspection. The samples stored in polypropylene syringes were found to contain an impurity (attributed to leaching of a syringe component by the solution) that could be detected by HPLC after 1 day; on further investigation, no leaching was detected when the syringes were exposed to undiluted i.v. cyclosporine 50 mg/mL for 10 minutes. Samples of i.v. cyclosporine solutions of 0.2 and 2.5 mg/mL diluted in 0.9% sodium chloride injection or 5% dextrose injection and stored at 25 °C in polypropylene-polyolefin bags were physically and chemically stable for at least 14 days. When stored in polypropylene syringes, the samples were contaminated by an impurity within 1 day; however, the short-term (i.e., ≤10 minutes) use of the syringes for the preparation and transfer of i.v. cyclosporine solution is considered safe.

  13. Economic evaluation of first-line adjuvant chemotherapies for resectable gastric cancer patients in China.

    PubMed

    Tan, Chongqing; Peng, Liubao; Zeng, Xiaohui; Li, Jianhe; Wan, Xiaomin; Chen, Gannong; Yi, Lidan; Luo, Xia; Zhao, Ziying

    2013-01-01

    First-line postoperative adjuvant chemotherapies with S-1 and capecitabine and oxaliplatin (XELOX) were first recommended for resectable gastric cancer patients in the 2010 and 2011 Chinese NCCN Clinical Practice Guidelines in Oncology: Gastric Cancer; however, their economic impact in China is unknown. The aim of this study was to compare the cost-effectiveness of adjuvant chemotherapy with XELOX, with S-1 and no treatment after a gastrectomy with extended (D2) lymph-node dissection among patients with stage II-IIIB gastric cancer. A Markov model, based on data from two clinical phase III trials, was developed to analyse the cost-effectiveness of patients in the XELOX group, S-1 group and surgery only (SO) group. The costs were estimated from the perspective of Chinese healthcare system. The utilities were assumed on the basis of previously published reports. Costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICER) were calculated with a lifetime horizon. One-way and probabilistic sensitivity analyses were performed. For the base case, XELOX had the lowest total cost ($44,568) and cost-effectiveness ratio ($7,360/QALY). The relative scenario analyses showed that SO was dominated by XELOX and the ICERs of S-1 was $58,843/QALY compared with XELOX. The one-way sensitivity analysis showed that the most influential parameter was the utility of disease-free survival. The probabilistic sensitivity analysis predicted a 75.8% likelihood that the ICER for XELOX would be less than $13,527 compared with S-1. When ICER was more than $38,000, the likelihood of cost-effectiveness achieved by S-1 group was greater than 50%. Our results suggest that for patients in China with resectable disease, first-line adjuvant chemotherapy with XELOX after a D2 gastrectomy is a best option comparing with S-1 and SO in view of our current study. In addition, S-1 might be a better choice, especially with a higher value of willingness-to-pay threshold.

  14. Syringe vending machines for injection drug users: an experiment in Marseille, France.

    PubMed Central

    Obadia, Y; Feroni, I; Perrin, V; Vlahov, D; Moatti, J P

    1999-01-01

    OBJECTIVES: This study evaluated the usefulness of vending machines in providing injection drug users with access to sterile syringes in Marseille, France. METHODS: Self-administered questionnaires were offered to 485 injection drug users obtaining syringes from 32 pharmacies, 4 needle exchange programs, and 3 vending machines. RESULTS: Of the 343 respondents (response rate = 70.7%), 21.3% used the vending machines as their primary source of syringes. Primary users of vending machines were more likely than primary users of other sources to be younger than 30 years, to report no history of drug maintenance treatment, and to report no sharing of needles or injection paraphernalia. CONCLUSIONS: Vending machines may be an appropriate strategy for providing access to syringes for younger injection drug users, who have typically avoided needle exchange programs and pharmacies. PMID:10589315

  15. Over-the-counter but out of reach: a pharmacy-based survey of OTC syringe sales in Tijuana, Mexico.

    PubMed

    Pollini, Robin A; Gallardo, Manuel; Ruiz, Serena; Case, Patricia; Zaller, Nickolas; Lozada, Remedios

    2014-05-01

    Sterile syringe access is critical to HIV prevention efforts targeting injection drug users (IDUs) but some pharmacies do not sell syringes over-the-counter (OTC) even where such sales are legal. We conducted a pharmacy survey in Tijuana, Mexico (where OTC sales are legal) to characterize attitudes toward syringe sales and to explore support for expanding pharmacy-based HIV prevention efforts. Of 203 respondents, 28% supported OTC syringe sales to IDUs and 74% said their pharmacy required a prescription for at least some syringe sales. Support for OTC syringe sales was independently associated with selling OTC syringes, understanding the role of sterile syringes in HIV prevention, and recognizing pharmacies as an important health resource for IDUs. Most respondents supported an expanded role for pharmacies in HIV prevention, exclusive of OTC syringe sales. Our study provides information for developing interventions to promote OTC syringe sales and expanding pharmacy-based distribution of HIV-related information and resources.

  16. Syringe Sharing Among a Prospective Cohort of Street-Involved Youth: Implications for Needle Distribution Programs.

    PubMed

    Bozinoff, Nikki; Wood, Evan; Dong, Huiru; Richardson, Lindsey; Kerr, Thomas; DeBeck, Kora

    2017-09-01

    The sharing of previously used syringes is associated with the transmission of Hepatitis C and HIV. This longitudinal study examines syringe borrowing and syringe lending within a prospective cohort of street-involved youth in Vancouver, Canada. From September 2005 to May 2014, data were collected from the At-Risk Youth Study, a cohort of street-involved youth age 14-26 at enrollment, and analyzed using generalized estimating equations. Among 505 participants, 142 (28.1%) reported syringe borrowing and 132 (26.1%) reported syringe lending during the study period. In separate multivariable analyses, having difficulty finding clean needles and homelessness were significantly associated with syringe borrowing (Adjusted Odds Ratio (AOR) = 2.28, 95% CI 1.66-3.12 and AOR = 1.52, CI 1.05-2.21, respectively) and syringe lending (AOR = 1.89, 95% CI 1.32-2.71 and AOR = 1.65, 95% CI 1.11-2.44, respectively) (all p values < 0.05). Findings highlight gaps in syringe access for vulnerable young injectors and suggest that service delivery for youth may be suboptimal. Further examination of how needle distribution efforts might be improved to better meet the needs of young people is warranted.

  17. Gas ampoule-syringe

    DOEpatents

    Gay, D.D.

    1985-02-02

    A gas ampoule for the shipment and delivery of radioactive gases. The gas ampoule having a glass tube with serum bottle stopper on one and a plunger tip in the opposite end all fitting in a larger plastic tube threaded on each end with absorbent between the tubes, is seated onto the internal needle assembly via a bushing associated with the plunger and locked into the syringe barrel via barrel-bushing locking caps. The design practically eliminates the possibility of personnel contamination due to an inadvertent exposure of such personnel to the contained radioactive gas.

  18. A Method To Determine the Kinetics of Solute Mixing in Liquid/Liquid Formulation Dual-Chamber Syringes.

    PubMed

    Werk, Tobias; Mahler, Hanns-Christian; Ludwig, Imke Sonja; Luemkemann, Joerg; Huwyler, Joerg; Hafner, Mathias

    Dual-chamber syringes were originally designed to separate a solid substance and its diluent. However, they can also be used to separate liquid formulations of two individual drug products, which cannot be co-formulated due to technical or regulatory issues. A liquid/liquid dual-chamber syringe can be designed to achieve homogenization and mixing of both solutions prior to administration, or it can be used to sequentially inject both solutions. While sequential injection can be easily achieved by a dual-chamber syringe with a bypass located at the needle end of the syringe barrel, mixing of the two fluids may provide more challenges. Within this study, the mixing behavior of surrogate solutions in different dual-chamber syringes is assessed. Furthermore, the influence of parameters such as injection angle, injection speed, agitation, and sample viscosity were studied. It was noted that mixing was poor for the commercial dual-chamber syringes (with a bypass designed as a longitudinal ridge) when the two liquids significantly differ in their physical properties (viscosity, density). However, an optimized dual-chamber syringe design with multiple bypass channels resulted in improved mixing of liquids. Dual-chamber syringes were originally designed to separate a solid substance and its diluent. However, they can also be used to separate liquid formulations of two individual drug products. A liquid/liquid dual-chamber syringe can be designed to achieve homogenization and mixing of both solutions prior to administration, or it can be used to sequentially inject both solutions. While sequential injection can be easily achieved by a dual-chamber syringe with a bypass located at the needle end of the syringe barrel, mixing of the two fluids may provide more challenges. Within this study, the mixing behavior of surrogate solutions in different dual-chamber syringes is assessed. Furthermore, the influence of parameters such as injection angle, injection speed, agitation, and

  19. The benefits and drawbacks of syringe drivers in palliative care.

    PubMed

    Costello, John; Nyatanga, Brian; Mula, Carole; Hull, Jenny

    2008-03-01

    This article will outline the use of continuous subcutaneous infusion pumps, known as syringe drivers, including their benefits and drawbacks in a palliative care context. There have been over 5000 articles published globally describing syringe drivers in the medical and nursing literature within the last decade. Many provide guidance on their use, although much of the data are repetitious, disease or age-group specific, and focused on pragmatic issues to do with clinical application. Several trusts and hospices across the UK are carrying out trials of the recently launched McKinley T34 syringe driver. Therefore, it seems timely to consider their wider use internationally. Globally, practitioners in palliative care are very familiar with their use, although the literature lacks specific guidance and, at times, the information is ambiguous. Having briefly reviewed their benefits, the article considers the limitations of using syringe drivers and comments on some of the lesser known/reported practical and patient-focused drawbacks associated with their use. We conclude by considering why, when so much education and training exists to help practitioners use these devices effectively, so many human errors occur.

  20. Bilateral innervation of syringeal muscles by the hypoglossal nucleus in the jungle crow (Corvus macrorhynchos).

    PubMed

    Tsukahara, Naoki; Kamata, Naoki; Nagasawa, Miyuki; Sugita, Shoei

    2009-08-01

    Bird vocalizations are produced by contractions of syringeal muscles, which are controlled by the hypoglossal nucleus. In oscines, syringeal muscles are controlled by the hypoglossal nucleus ipsilaterally, whereas syringeal innervation is bilateral in non-oscines. We have determined the course of hypoglossal nerves in the jungle crow Corvus macrorhynchos. Our results indicate a cross-over of the hypoglossal nerve from the left side to the right side on the trachea 7 mm rostral to the Musculus sternotrachealis. We also investigated the innervation of the syringeal muscles of jungle crows from the hypoglossal nucleus using the horseradish peroxidase (HRP) method. After HRP was injected into the syringeal muscles on each side, HRP-labeled cells were found bilaterally in the hypoglossal nerve. These results suggest that the syringeal muscles of jungle crows are innervated bilaterally from the hypoglossal nucleus, although these birds are categorized as oscines.

  1. Bilateral innervation of syringeal muscles by the hypoglossal nucleus in the jungle crow (Corvus macrorhynchos)

    PubMed Central

    Tsukahara, Naoki; Kamata, Naoki; Nagasawa, Miyuki; Sugita, Shoei

    2009-01-01

    Bird vocalizations are produced by contractions of syringeal muscles, which are controlled by the hypoglossal nucleus. In oscines, syringeal muscles are controlled by the hypoglossal nucleus ipsilaterally, whereas syringeal innervation is bilateral in non-oscines. We have determined the course of hypoglossal nerves in the jungle crow Corvus macrorhynchos. Our results indicate a cross-over of the hypoglossal nerve from the left side to the right side on the trachea 7 mm rostral to theMusculus sternotrachealis. We also investigated the innervation of the syringeal muscles of jungle crows from the hypoglossal nucleus using the horseradish peroxidase (HRP) method. After HRP was injected into the syringeal muscles on each side, HRP-labeled cells were found bilaterally in the hypoglossal nerve. These results suggest that the syringeal muscles of jungle crows are innervated bilaterally from the hypoglossal nucleus, although these birds are categorized as oscines. PMID:19490396

  2. Excellent response to chemotherapy post immunotherapy

    PubMed Central

    Dwary, Ashish D.; Master, Samip; Patel, Abhishek; Cole, Constance; Mansour, Richard; Mills, Glenn; Koshy, Nebu; Peddi, Prakash; Burton, Gary; Hammoud, Dalia; Beedupalli, Kavitha

    2017-01-01

    Introduction Immunotherapy in the form of immune checkpoint inhibitors has changed the landscape of cancer treatment. Newer monoclonal antibodies are coming up and are being tested in various cancers during different stages of treatment. With the increasing use of immune checkpoint inhibitors in the management of various types of cancers, the question is raised as to what next can be offered to a patient who has progressed on this newer treatment. Does Sequence matter? There have been reports of improved responses to chemotherapy after immunotherapy in the form of vaccines. Here we present a case series of 6 patients who progressed on immunotherapy with immune checkpoint inhibitors after initial modality of treatment (chemotherapy/radiation), subsequently received chemotherapy with excellent response. Methods We have a cohort of six patients who had disease progression on second line Immunotherapy for solid or hematological malignancies and had ECOG < 2. All these patients received third line salvage chemotherapy. Three patients had metastatic head and neck cancer, 2 had non-small cell lung cancer (NSCLC), and one had T -cell rich B- cell lymphoma. Prior review and approval were obtained from our institutional review board. Results All patients had an excellent response to chemotherapy in third line setting, after immune checkpoint inhibitors and most of them achieved a complete response. Conclusion Targeting cancer with chemotherapy after failure of immunotherapy is a valid option and can lead to better response rates and PFS which may lead to OS. This effect may be secondary to immunotherapy removing the inhibition exerted by tumor cells or other immune cells initially followed by cytotoxic chemotherapy mediated killing of tumor cells. PMID:29207685

  3. Reuse prevention syringes for reconstitution of lyophilized vaccines: Operational study and UNICEF plans for expanding introduction.

    PubMed

    Fleming, Jessica A; Hoekstra, Edward John; Moniaga, Vanda; Widjaya, Anton; Soepardi, Jane; Supartha, Nyoman; Salovaara, Annika; Khamassi, Selma; Nelson, Carib

    2009-01-01

    Since the 1990s, the United Nation's Children's Fund has encouraged injection safety for immunizations through bundling vaccines with appropriate amounts of supporting equipment and by supplying autodisable (AD) syringes for injections. However, poor vaccine reconstitution practices continue to be reported worldwide. By 2009, UNICEF will begin to phase out the distribution of standard disposable syringes for vaccine reconstitution and replace them with reuse prevention (RUP) syringes, with a full transition expected by the end of 2010. A field evaluation in Indonesia was conducted to identify introduction requirements, issues with healthcare worker training and acceptance, and RUP syringe performance and safety. Managers and health workers felt that RUP syringes improved injection safety and fit easily into country logistical systems. Healthcare workers felt they were intuitive to use, but recommended special training. The integration of RUP reconstitution syringes by UNICEF could increase injection safety by preventing the reuse of syringes and reducing vaccine contamination.

  4. Syringe Pump Performance Maintained with IV Filter Use During Low Flow Rate Delivery for Pediatric Patients.

    PubMed

    Chau, Destiny F; Vasilopoulos, Terrie; Schoepf, Miriam; Zhang, Christina; Fahy, Brenda G

    2016-09-01

    Complex surgical and critically ill pediatric patients rely on syringe infusion pumps for precise delivery of IV medications. Low flow rates and in-line IV filter use may affect drug delivery. To determine the effects of an in-line filter to remove air and/or contaminants on syringe pump performance at low flow rates, we compared the measured rates with the programmed flow rates with and without in-line IV filters. Standardized IV infusion assemblies with and without IV filters (filter and control groups) attached to a 10-mL syringe were primed and then loaded onto a syringe pump and connected to a 16-gauge, 16-cm single-lumen catheter. The catheter was suspended in a normal saline fluid column to simulate the back pressure from central venous circulation. The delivered infusate was measured by gravimetric methods at predetermined time intervals, and flow rate was calculated. Experimental trials for initial programmed rates of 1.0, 0.8, 0.6, and 0.4 mL/h were performed in control and filter groups. For each trial, the flow rate was changed to double the initial flow rate and was then returned to the initial flow rate to analyze pump performance for titration of rates often required during medication administration. These conditions (initial rate, doubling of initial rate, and return to initial rate) were analyzed separately for steady-state flow rate and time to steady state, whereas their average was used for percent deviation analysis. Differences between control and filter groups were assessed using Student t tests with adjustment for multiplicity (using n = 3 replications per group). Mean time from 0 to initial flow (startup delay) was <1 minute in both groups with no statistical difference between groups (P = 1.0). The average time to reach steady-state flow after infusion startup or rate changes was not statistically different between the groups (range, 0.8-5.5 minutes), for any flow rate or part of the trial (initial rate, doubling of initial rate, and

  5. High dead-space syringe use among people who inject drugs in Tijuana, Mexico

    PubMed Central

    Rafful, Claudia; Zule, William; González-Zúñiga, Patricia E.; Werb, Dan; Elena Medina-Mora, María; Magis-Rodriguez, Carlos; Strathdee, Steffanie A.

    2015-01-01

    Background High dead-space syringes (HDSS) are believed to confer an elevated risk of acquiring HIV and other blood-borne infections. Objectives We identified prevalence and correlates of HDSS use among injection drug users (IDU) in Tijuana, Mexico, where syringe purchase and possession is legal without a prescription. Methods Beginning in 2011, IDU who reported being 18 years or older, who injected drugs within the last month were recruited into a prospective study. At baseline and semi-annually, 557 IDU underwent HIV-testing and interviewer-administered surveys. Logistic regression was used to identify correlates of using HDSS. Results Of 557 IDU, 40% had ever used HDSS, mostly because no other syringe type was available (72%), or because they were easier to get (20%). Controlling for sex and age at first injection, use of HDSS was associated with cocaine as the first drug injected (Adjusted Odds Ratio [AOR]:2.68; Confidence Interval 95% [CI]:1.15-6.22), having been stopped or arrested by police (AOR:1.84; 95% CI:1.11-3.07), being deported from the US (AOR:1.64; 95%CI:1.06-2.53), and believing it is illegal to carry syringes (AOR:1.78; 95%CI:1.01-3.15). Conclusion Use of HDSS is surprisingly common among IDU in Tijuana. Efforts are needed to expand coverage of low-dead space syringes through existing syringe exchange programs. Education is required to increase awareness of the harms associated with HDSS, and to inform IDU that syringe possession is legal across Mexico. PMID:25695145

  6. High dead-space syringe use among people who inject drugs in Tijuana, Mexico.

    PubMed

    Rafful, Claudia; Zule, William; González-Zúñiga, Patricia E; Werb, Dan; Medina-Mora, María Elena; Magis-Rodriguez, Carlos; Strathdee, Steffanie A

    2015-05-01

    High dead-space syringes (HDSS) are believed to confer an elevated risk of acquiring HIV and other blood-borne infections. We identified prevalence and correlates of HDSS use among injection drug users (IDU) in Tijuana, Mexico, where syringe purchase and possession is legal without a prescription. Beginning in 2011, IDU who reported being 18 years or older and injected drugs within the last month were recruited into a prospective study. At baseline and semi-annually, 557 IDU underwent HIV-testing and interviewer-administered surveys. Logistic regression was used to identify correlates of using HDSS. Of 557 IDU, 40% had ever used HDSS, mostly because no other syringe type was available (72%), or because they were easier to get (20%). Controlling for sex and age at first injection, use of HDSS was associated with cocaine as the first drug injected (Adjusted Odds Ratio [AOR]: 2.68; Confidence Interval 95% [CI]: 1.15-6.22), having been stopped or arrested by police (AOR: 1.84; 95% CI: 1.11-3.07), being deported from the US (AOR: 1.64; 95% CI:1.06-2.53), and believing it is illegal to carry syringes (AOR:1.78; 95% CI: 1.01-3.15). Use of HDSS is surprisingly common among IDU in Tijuana. Efforts are needed to expand coverage of low-dead space syringes through existing syringe exchange programs. Education is required to increase awareness of the harms associated with HDSS, and to inform IDU that syringe possession is legal across Mexico.

  7. LINE-1 Methylation Status Correlates Significantly to Post-Therapeutic Recurrence in Stage III Colon Cancer Patients Receiving FOLFOX-4 Adjuvant Chemotherapy

    PubMed Central

    Fan, Yun-Ching; Chang, Wei-Chiao; Lu, Chien-Yu; Wu, I-Chen; Hsu, Wen-Hung; Huang, Ching-Wen; Wang, Jaw-Yuan

    2015-01-01

    Background Methylation levels of long interspersed nucleotide elements (LINE-1) are representative of genome-wide methylation status and crucial in maintaining genomic stability and expression. Their prognostic impact on colon cancer patients receiving adjuvant chemotherapy has not been well established. We evaluated the association between LINE-1 methylation status and clinicopathologic features and postoperative oncological outcomes in stage III colon cancer patients. Materials and Methods 129 UICC stage III colon cancer patients who had received radical resection and FOLFOX adjuvant chemotherapy were enrolled. Global methylation was estimated by analyzing tumor LINE-1 methylation status using bisulfite-polymerase chain reaction (PCR) and pyrosequencing assay. Demographics, clinicopathological data, and postoperative outcomes were recorded by trained abstractors. Outcome measurements included postoperative recurrence and disease-free survival. Univariate, multivariate, and survival analyses were conducted to identify prognostic factors of oncological outcomes. Results The LINE-1 methylation of all 129 patients was measured on a 0–100 scale (mean 63.3; median 63.7, standard deviation 7.1), LINE-1 hypomethylation was more common in patients aged 65 years and above (61.7%±7.6% vs. 64.6±6.4, p=0.019) and those with post-therapeutic recurrence (61.7±7.4 vs 64.3±6.7, p=0.041). Considering risk adjustment, LINE-1 hypomethylation was found to be an independent risk factor of post-therapeutic recurrence (Adjusted OR=14.1, p=0.012). Kaplan-Meier analysis indicated that patients in the low methylation group had shorter period of disease free survival (p=0.01). In a stratified analysis that included 48 patients with post-therapeutic recurrence, it was found that those who experienced shorter period of disease free survival (≦6 months) appeared to have lower LINE-1 methylation levels than patients who reported of recurrence after 6 months (56.68±15.75 vs. 63.55±7

  8. An introduction to the Micrel Micropump MP Daily portable syringe driver.

    PubMed

    Groves, Karen E

    2003-11-01

    In this article the author describes the Micrel Micropump MP Daily (MP Daily) portable syringe driver. This follows the author's experience of a 4-month pilot of the device by an inpatient palliative care unit. Portable syringe drivers are commonly used to deliver continuous subcutaneous infusions in palliative care situations. Those in current use are not without problems and serious adverse events have occasionally been reported, mainly resulting from confusion between models. The MP Daily syringe driver addresses some of these issues while remaining small, lightweight and inexpensive, with a long battery life and fitting into the pocket of a shirt of pyjama jacket. Improvements over current models include an on/off button, the absence of facilities to set a zero rate or change the rate once the syringe driver is running, and the absence of a boost button. In addition, there are improved alarms, a message display system and a configuration menu. Although confusion remains a problem, and the ideal has not yet been reached, the MP Daily goes some considerable way towards reducing risks and opportunities for human error.

  9. Hormonal therapy followed by chemotherapy or the reverse sequence as first-line treatment of hormone-responsive, human epidermal growth factor receptor-2 negative metastatic breast cancer patients: results of an observational study.

    PubMed

    Bighin, Claudia; Dozin, Beatrice; Poggio, Francesca; Ceppi, Marcello; Bruzzi, Paolo; D'Alonzo, Alessia; Levaggi, Alessia; Giraudi, Sara; Lambertini, Matteo; Miglietta, Loredana; Vaglica, Marina; Fontana, Vincenzo; Iacono, Giuseppina; Pronzato, Paolo; Del Mastro, Lucia

    2017-07-04

    Introduction Although hormonal-therapy is the preferred first-line treatment for hormone-responsive, HER2 negative metastatic breast cancer, no data from clinical trials support the choice between hormonal-therapy and chemotherapy.Methods Patients were divided into two groups according to the treatment: chemotherapy or hormonal-therapy. Outcomes in terms of clinical benefit and median overall survival (OS) were retrospectively evaluated in the two groups. To calculate the time spent in chemotherapy with respect to OS in the two groups, the proportion of patients in chemotherapy relative to those present in either group was computed at every day from the start of therapy.Results From 1999 to 2013, 119 patients received first-line hormonal-therapy (HT-first group) and 100 first-line chemotherapy (CT-first group). Patients in the CT-first group were younger and with poorer prognostic factors as compared to those in HT-first group. Clinical benefit (77 vs 81%) and median OS (50.7 vs 51.1 months) were similar in the two groups. Time spent in chemotherapy was significantly longer during the first 3 years in CT-first group (54-34%) as compared to the HT-first group (11-18%). This difference decreased after the third year and overall was 28% in the CT-first group and 18% in the HT-first group.Conclusions The sequence first-line chemotherapy followed by hormonal-therapy, as compared with the opposite sequence, is associated with a longer time of OS spent in chemotherapy. However, despite the poorer prognostic factors, patients in the CT-first group had a superimposable OS than those in the HT-first group.

  10. The evaluation of a trial of syringe vending machines in Canberra, Australia.

    PubMed

    McDonald, David

    2009-07-01

    Syringe vending machines (SVMs) have been trialled in Canberra, Australian Capital Territory, Australia, as an intervention aiming to increase the availability of sterile injecting equipment for use by IDUs. This study evaluated the 12-month trial. A utilisation-focused evaluation model, with both formative and summative components, was employed. Four SVMs were installed, each dispensing packs containing four 1 mL syringes and associated injecting paraphernalia. The trial participants were the clients of the SVMs and other key informants. The core measurements used were the number of syringes dispensed in Canberra by SVMs and other outlets, SVM clients' demographics and experiences of and attitudes towards SVMs, perceived impacts of SVMs on needle sharing, unsafe disposal of used syringes in the vicinity of SVMs, and community and stakeholder attitudes. The trial was implemented successfully, with no adverse consequences identified. The SVMs appear to be serving both the usual clients of the other outlets for sterile injecting equipment (community pharmacies and the Needle Syringe Program outlets) and others who are reluctant to use such outlets or find them inconvenient. The out-of-business-hours provision of syringes through the SVMs was particularly welcomed by both SVM clients and other stakeholders. The continuing operation of the initial four SVMs is widely supported, and additional machines are requested by clients and others. Owing to the success of the trial in terms of feasibility and outcomes for both IDUs and for the broader community, it is desirable that providing sterile injecting equipment through SVMs continues and be expanded as an integral component of harm reduction strategies.

  11. A cost analysis of first-line chemotherapy for low-risk gestational trophoblastic neoplasia.

    PubMed

    Shah, Neel T; Barroilhet, Lisa; Berkowitz, Ross S; Goldstein, Donald P; Horowitz, Neil

    2012-01-01

    To determine the optimal approach to first-line treatment for low-risk gestational trophoblastic neoplasia (GTN) using a cost analysis of 3 commonly used regimens. A decision tree of the 3 most commonly used first-line low-risk GTN treatment strategies was created, accounting for toxicities, response rates and need for second- or third-line therapy. These strategies included 8-day methotrexate (MTX)/folinic acid, weekly MTX, and pulsed actinomycin-D (act-D). Response rates, average number of cycles needed for remission, and toxicities were determined by review of the literature. Costs of each strategy were examined from a societal perspective, including the direct total treatment costs as well as the indirect lost labor production costs from work absences. Sensitivity analysis on these costs was performed using both deterministic and probabilistic cost-minimization models with the aid of decision tree software (TreeAge Pro 2011, TreeAge Inc., Williamstown, Massachusetts). We found that 8-day MTX/folinic acid is the least expensive to society, followed by pulsed act-D ($4,867 vs. $6,111 average societal cost per cure, respectively), with act-D becoming more favorable only with act-D per-cycle cost <$231, or response rate to first-line therapy > 99%. Weekly MTX is the most expensive first-line treatment strategy to society ($9,089 average cost per cure), despite being least expensive to administer per cycle, based on lower first-line response rate. Absolute societal cost of each strategy is driven by the probability of needing expensive third-line multiagent chemotherapy, however relative cost differences are robust to sensitivity analysis over the reported range of cycle number and response rate for all therapies. Based on similar efficacy and lower societal cost, we recommend 8-day MTX/folinic acid for first-line treatment of low-risk GTN.

  12. Gas ampoule-syringe

    DOEpatents

    Gay, Don D.

    1986-01-01

    A gas ampoule for the shipment and delivery of radioactive gases. The gas ampoule having a glass tube with serum bottle stopper on one end and a plunger tip in the opposite end all fitting in a larger plastic tube threaded on each end with absorbent between the tubes, is seated onto the internal needle assembly via a bushing associated with the plunger and locked into the syringe barrel via barrel-bushing locking caps. The design practically eliminates the possibility of personnel contamination due to an inadvertent exposure of such personnel to the contained radioactive gas.

  13. Stability of nitroglycerin 110 mcg/mL stored in polypropylene syringes.

    PubMed

    McCluskey, Susan V; Vu, Nicole; Rueter, John

    2013-01-01

    Various angiography procedures at Mayo Clinic (Rochester campus) require small bolus doses of injectable nitroglycerin. Commercially acquired containers of injectable nitroglycerin provide excessive amounts of drug for these procedural needs, so syringes were chosen as a container for dispensing of the dose needed. Due to nitroglycerin's known chemical attributes of volatility and sorption to plastic surfaces, careful consideration of the stability needs to be taken into account when storing in a syringe. Since there is a lack of stability information in the literature, we studied the stability of nitroglycerin in polypropylene syringes over 90 days. Methods used for this study consisted of a validated stability-indicating high-performance liquid chromatographic assay, visual appearance, and pH. Samples were stored protected from light at ambient controlled temperature and consisted of nitroglycerin 110 mcg/mL in 5% dextrose injection 10.1 mL in 12 mL Terumo polypropylene syringes. Samples were tested at intervals up to 90 days. Results from the visual portion of the study showed clear, colorless, and particulate-free solutions throughout the 90-day study period. The pH results started at 4.27 +/- 0.13 (day 0) and ranged from 4.19 +/- 0.17 to 4.92 +/- 0.43 throughout the study period. Potency test results revealed a day 0 concentration of 104.242 +/- 0.193 mcg/mL (batch 1) and 122.483 +/- 0.168 mcg/mL (batch 2). Results trended downward with percentage of day 0 concentration of 92.2% +/- 2.4% at day 14 and of 81.4% +/- 4.9% at day 90. Chromatographic profiles of the samples exhibited insignificant changes over the study period. The nitroglycerin peak was spectrally pure based on peak-purity analysis, suggesting that sorption to the polypropylene syringe is one possible reason for the concentration decline over time, but nitroglycerin is a volatile compound and loss through vaporization cannot be ruled out. Nitroglycerin 110 mcg/mL in 5% dextrose injection, packaged

  14. Expediting red blood cell transfusions by syringing causes significant hemolysis.

    PubMed

    De Villiers, Willem Lambertus; Murray, Adriaan Albertus; Levin, Andrew Ian

    2017-11-01

    Techniques commonly used to expedite blood transfusions include pneumatically pressurizing red blood cell (RBC) bags or manual syringing its contents. We compared these techniques on RBC hemolysis using a simulated transfusion model. Fifteen warmed RBC units that were 12.3 ± 4.3 (95% confidence interval [CI], 10.1-14.5) days old were each subjected to two experimental rapid transfusion techniques. RBCs from each technique were directed through 18- and 22-gauge cannulas attached to blood administration sets. One technique involved RBC bag pressurization to 300 mmHg. The other employed a 20-mL syringe to effect forceful, manual aspiration from the RBC bag followed by forceful, manual RBC injection. The control group was gravity driven without cannulas. Free hemoglobin (Hb) concentrations were measured and percent hemolysis was calculated. Free Hb concentrations and percent hemolysis (median [95% CI]) were similar in the control (0.05 [0.03-0.08] g/dL and 0.13% [0.09%-0.17%], respectively) and pressurized experiments (0.06 [0.05-0.09] g/dL; 0.14% [0.12%-0.22%]), respectively. Syringing resulted in 10-fold higher free Hb concentrations (0.55 [0.38-0.92] g/dL) and percent hemolysis (1.28% [1.03%-2.15%]) than when employing the control (p < 0.0001) or pressurization (p < 0.0001) techniques. Cannula sizes studied did not affect hemolysis. Forceful manual syringing caused significant hemolysis and high free Hb concentrations. Pressurizing RBC bags induced no more hemolysis than after gravity-facilitated transfusions. Syringing to expedite RBC transfusions should be avoided in favor of pneumatic RBC bag pressurization. © 2017 AABB.

  15. Is crime associated with over-the-counter pharmacy syringe sales? Findings from Los Angeles, California.

    PubMed

    Stopka, Thomas J; Geraghty, Estella M; Azari, Rahman; Gold, Ellen B; DeRiemer, Kathryn

    2014-03-01

    More than 50,000 new HIV infections occur annually in the United States. Injection drug users represent twelve percent of incident HIV infections each year. Pharmacy sales of over-the-counter (OTC) syringes have helped prevent HIV transmission among injection drug users in many states throughout the United States. However, concerns exist among some law enforcement officials, policymakers, pharmacists, and community members about potential links between OTC syringe sales and crime. We used a geographic information system and novel spatial and longitudinal analyses to determine whether implementation of pharmacy-based OTC syringe sales were associated with reported crime between January 2006 and December 2008 in Los Angeles Police Department Reporting Districts. We assessed reported crime pre- and post-OTC syringe sales initiation as well as longitudinal associations between crime and OTC syringe-selling pharmacies. By December 2008, 9.3% (94/1010) of Los Angeles Police Department Reporting Districts had at least one OTC syringe-selling pharmacy. Overall reported crime counts and reported crime rates decreased between 2006 and 2008 in all 1010 Reporting Districts. Using generalized estimating equations and adjusting for potential confounders, reported crime rates were negatively associated with OTC syringe sales (adjusted rate ratio: 0.89; 95% confidence interval: 0.81, 0.99). Our findings demonstrate that OTC pharmacy syringe sales were not associated with increases in reported crime in local communities in Los Angeles during 2006-2008. Copyright © 2014 Elsevier B.V. All rights reserved.

  16. Evaluation of child preference for dentist attire and usage of camouflage syringe in reduction of anxiety.

    PubMed

    Babaji, Prashant; Chauhan, Pavni P; Rathod, Vikram; Mhatre, Swapnil; Paul, Uttam; Guram, Guneet

    2017-01-01

    The aim of this study is to evaluate the child preference for dentist attire and camouflage versus conventional syringe in reduction of anxiety. A total of 600 children aged 6-14 years were made to look at a set of six photos of an individual dressed with different colored apron of pink, green, blue, white colors, formal dress, and cartoon character along with conventional syringe and camouflage syringe with a toy-like appearance to permit injection of local anesthesia. Children's anxiety level during injections and with colored coat was assessed and recorded using the Modified Child Dental Anxiety Scale faces version. SPSS statistical software version 21 and using Chi-square test. Among age group of 6-8 years, 65.33% selected colorful apron, while other age groups 9-10, 11-12 years, and 13-14 years selected 47.34%, 57.34%, and 50.67% white coat, respectively ( P < 0.05). For syringe, 78% of younger age group (6-10 years) preferred camouflage syringe, whereas 71% of older age group (11-14 years) preferred conventional syringe. Anxiety level of all children for syringe was more compared to that of white coat. Younger children prefer colorful attire of dentist and camouflage syringe over conventional compared to older one.

  17. Is point of access to needles and syringes related to needle sharing? Comparing data collected from pharmacies and needle and syringe programs in south-east Sydney.

    PubMed

    Bryant, Joanne; Topp, Libby; Hopwood, Max; Iversen, Jenny; Treloar, Carla; Maher, Lisa

    2010-07-01

    The comprehensive needle and syringe distribution system in New South Wales is partly based on the premise that different points of access to injecting equipment may attract different groups of injecting drug users. This paper examines patterns of equipment acquisition and risk for blood-borne virus transmission among injecting drug users who use pharmacies and needle and syringe programs (NSP) in south-east Sydney. Clients obtaining injecting equipment from four NSP (n = 147) and eight pharmacies (n = 227) in 2006 voluntarily completed a self-administered questionnaire. Respondents were grouped into three categories based on their needle and syringe acquisition patterns: exclusive use of NSP, exclusive use of pharmacies and use of both. Although it was common for respondents to report using both pharmacies and NSP to obtain needles and syringes (57%), a proportion reported exclusive use of pharmacies (17%) and NSP (14%). Exclusive pharmacy users were more likely to have never received treatment for their drug use and the least likely to have had a recent test for hepatitis C. Compared with respondents who exclusively used NSP, respondents who exclusively used pharmacies were more likely to report receptive sharing of injecting equipment (adjusted odds ratio 5.9, 95% confidence interval 2.02-17.14), as were respondents who reported using both sources (adjusted odds ratio 5.8, 95% confidence interval 2.35-14.40). The high prevalence of receptive equipment sharing among pharmacy clients indicates a need to improve access to needles and syringes and ancillary equipment, possibly by including ancillary equipment at no cost in existing pre-packaged pharmacy products.

  18. Plausible authentication of manuka honey and related products by measuring leptosperin with methyl syringate.

    PubMed

    Kato, Yoji; Fujinaka, Rie; Ishisaka, Akari; Nitta, Yoko; Kitamoto, Noritoshi; Takimoto, Yosuke

    2014-07-09

    Manuka honey, obtained from Leptospermum scoparium flowers in New Zealand, has strong antibacterial properties. In this study, plausible authentication of the manuka honey was inspected by measuring leptosperin, methyl syringate 4-O-β-D-gentiobiose, along with methyl syringate. Despite a gradual decrease in methyl syringate content over 30 days at 50 °C, even at moderate 37 °C, leptosperin remained stable. A considerable correlation between nonperoxide antibacterial activity and leptosperin content was observed in 20 certified manuka honey samples. Leptosperin and methyl syringate in manuka honey and related products were analyzed using HPLC connected with mass spectrometry. One noncertified brand displayed significant variations in the leptosperin and methyl syringate contents between two samples obtained from different regions. Therefore, certification is clearly required to protect consumers from disguised and/or low-quality honey. Because leptosperin is stable during storage and specific to manuka honey, its measurement may be applicable for manuka honey authentication.

  19. Access to Sterile Syringes through San Francisco Pharmacies and the Association with HIV Risk Behavior among Injection Drug Users

    PubMed Central

    Kral, Alex H.; Stopka, Thomas J.; Garfein, Richard S.; Reuckhaus, Paul; Bluthenthal, Ricky N.

    2010-01-01

    Increased options for syringe acquisition and disposal have been associated with reductions in high-risk behaviors. This study determined the extent of pharmacy uptake in accessing syringes among injection drug users (IDUs) and estimated associations between pharmacy uptake and safer injection/disposal practices. Two years after the implementation of California’s Disease Prevention Demonstration Project, which removed restrictions to non-prescription syringe sales through pharmacies with local authorization, IDUs were recruited through street outreach in San Francisco and interviewed regarding recent syringe acquisition, use, and disposal. The sample of 105 persons included a high proportion of men (67%), people of color (49%), and homeless persons (71%). The most common syringe source was a syringe exchange program (SEP) (80%), with pharmacies being accessed by 39% of respondents. The most commonly cited source of disposal was a SEP (65%), with very few reports of pharmacy disposal (2%). Adjusted analysis showed that unsuccessful attempts to purchase syringes at a pharmacy increased the odds of both injecting with a used syringe and giving away a used syringe. Using a SEP decreased the odds of unsafe injection and disposal practices. Thus, 2 years after the initiation of the California Disease Prevention Demonstration Project, results from this small study suggest that SEPs still provide the majority of syringe distribution and disposal services to San Francisco IDUs; however, pharmacies now augment syringe access. In addition, unsafe injection behavior is reported more often among those who do not use these syringe sources. These results are consistent with prior studies in suggesting that increasing the availability of syringes through SEPs and pharmacies, and developing bridges between them, may further reduce syringe-related risk. PMID:20526690

  20. Adiabatic Compression in a Fire Syringe.

    ERIC Educational Resources Information Center

    Hayn, Carl H.; Baird, Scott C.

    1985-01-01

    Suggests using better materials in fire syringes to obtain more effective results during demonstrations which show the elevation in temperature upon a very rapid (adiabatic) compression of air. Also describes an experiment (using ignition temperatures) which introduces students to the use of thermocouples for high temperature measurements. (DH)

  1. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study.

    PubMed

    Ciuleanu, Tudor; Stelmakh, Lilia; Cicenas, Saulius; Miliauskas, Skaidrius; Grigorescu, Alexandru Calin; Hillenbach, Carina; Johannsdottir, Hrefna Kristin; Klughammer, Barbara; Gonzalez, Emilio Esteban

    2012-03-01

    Erlotinib, docetaxel, and pemetrexed are approved for the second-line treatment of non-small-cell lung cancer (NSCLC), but no head-to-head data from large clinical trials are available. We undertook the Tarceva In Treatment of Advanced NSCLC (TITAN) study to assess the efficacy and tolerability of second-line erlotinib versus chemotherapy in patients with refractory NSCLC. TITAN was an international, randomised multicentre, open-label, phase 3 study that was done at 77 sites in 24 countries. Chemotherapy-naive patients with locally advanced, recurrent, or metastatic NSCLC received up to four cycles of first-line platinum doublet chemotherapy, after which patients with disease progression during or immediately after chemotherapy were offered enrolment into TITAN. Enrolled patients were randomly assigned (1:1) by a minimisation method to ensure balanced stratification, to receive erlotinib 150 mg/day or chemotherapy (standard docetaxel or pemetrexed regimens, at the treating investigators' discretion), until unacceptable toxicity, disease progression, or death. Patients were stratified by disease stage, Eastern Cooperative Oncology Group performance status, smoking history, and region of residence. The primary endpoint was overall survival in the intention-to-treat population. TITAN was halted prematurely because of slow recruitment. This study is registered with ClinicalTrials.gov, number NCT00556322. Between April 10, 2006, and Feb 24, 2010, 2590 chemotherapy-naive patients were treated with first-line platinum doublet chemotherapy, of whom 424 had disease progression and were enrolled into TITAN. 203 patients were randomly assigned to receive erlotinib and 221 were assigned to receive chemotherapy. Median follow-up was 27·9 months (IQR 11·0-36·0) in the erlotinib group and 24·8 months (12·1-41·6) in the chemotherapy group. Median overall survival was 5·3 months (95% CI 4·0-6·0) with erlotinib and 5·5 months (4·4-7·1) with chemotherapy (hazard ratio [HR

  2. A method for the determination of syringe needle punctures in rubber stoppers using stereoscopic light microscopy.

    PubMed

    Platek, S Frank; Keisler, Mark A; Ranieri, Nicola; Reynolds, Todd W; Crowe, John B

    2002-09-01

    The ability to accurately determine the number of syringe needle penetration holes through the rubber stoppers in pharmaceutical vials and rubber septa in intravenous (i.v.) line and bag ports has been a critical factor in a number of forensic cases involving the thefts of controlled substances or suspected homicide by lethal injection. In the early 1990s, the microscopy and microanalysis group of the U.S. Food and Drug Administration's Forensic Chemistry Center (FCC) developed and implemented a method (unpublished) to locate needle punctures in rubber pharmaceutical vial stoppers. In 1996, as part of a multiple homicide investigation, the Indiana State Police Laboratory (ISPL) contacted the FCC for information on a method to identify and count syringe needle punctures through rubber stoppers in pharmaceutical vials. In a joint project and investigation using the FCC's needle hole location method and applying a method of puncture site mapping developed by the ISPL, a systematic method was developed to locate, identify, count, and map syringe punctures in rubber bottle stoppers or i.v. bag ports using microscopic analysis. The method requires documentation of punctures on both sides of the rubber stoppers and microscopic analysis of each suspect puncture site. The final result of an analysis using the method is a detailed diagram of puncture holes on both sides of a questioned stopper and a record of the minimum number of puncture holes through a stopper.

  3. Influence of Syringe Volume on Foam Stability in Sclerotherapy for Varicose Vein Treatment.

    PubMed

    Bai, Taoping; Jiang, Wentao; Fan, Yubo

    2018-05-01

    Despite the popularity of sclerotherapy for treating varicose veins, it still exhibits various problems, such as pulmonary embolism, deep-vein thrombosis, phlebitis, and visual disorders. To investigate syringe volume influence on foam stability, obtain the foam decay rule, and provide a reference for clinics. Five types of syringes are used to prepare foam at room temperature with various liquid-gas ratios. Foam decay process experiments were performed 5 times and recorded by video. The stability indices used include drainage time, half-life, bubble diameter, bubble surface density, and drainage rate. The 30 and 2-mL syringes, respectively, recorded the highest and lowest drainage speeds. Foam drainage time and half-life, differences varied between 15 and 70 seconds, and 20 and 100 seconds, respectively. Foam bubble diameters were distributed over 0.1 to 2.0 mm with roughly 200 to 700 bubbles per square centimeter. Increased syringe volume causes the bubble diameter to increase. Thus, foam dispersion increases and foam half-life decreases; hence, foam becomes unstable. It is, thus, better to use a small syringe several times to prepare foam in clinics using segmented injections.

  4. Stability of stabilized 99mTc-D,L-HMPAO stored in vials and syringes.

    PubMed

    Del Carmen Plancha-Mansanet, Maria; Caballero-Calabuig, Elisa; Félix-Fontestad, Jesús; Reyes-Ojeda, María Dolores; Sopena-Novales, Pablo; Abreu-Sánchez, Pedro; Del Carmen Cano-Terol, Maria; Sopena-Monforte, Ramón

    2008-12-01

    Our objective was to determine the stability of stabilized (99m)Tc-hexamethylpropylene amine oxime ((99m)Tc-d,l-HMPAO) dispensed by vial and syringe, with the storage time and labeling activity varied. (99m)Tc-d,l-HMPAO was labeled according to the manufacturer's instructions, but with modification of the (99m)TcO(4)Na activity. Two groups were prepared: 1,110 MBq (30 mCi) and 2,600-3,700 MBq (70.3-100 mCi). Five minutes after labeling, the radiochemical purity (RCP) of the vial content was determined. Afterward, the same activity was distributed into two 2-mL syringes and into the manufacturer's vial. In one of the syringes, the radiopharmaceutical stayed in contact with the needle for 4 h. At 2 and 4 h after labeling, the RCP of the vial and syringe content was checked and compared. The mean RCP of stabilized (99m)Tc-d,l-HMPAO labeled with 1,110 MBq (30 mCi) and stored in a vial decreased from 93.1% at 5 min to 92.1% at 2 h and to 91.1% at 4 h. With storage in a syringe, the RCP decreased from 89.8% at 2 h to 88.7% at 4 h. This diminution increased for labeling with higher activities (2,600-3,700 MBq [70.3-100 mCi]), ranging from 91.4% at 5 min, 89.0% at 2 h, and 85.3% at 4 h in a vial and from 85.9% at 2 h to 80.2% in a syringe. (99m)TcO(2) and secondary (99m)Tc-HMPAO were the main impurities at t = 0. (99m)TcO(4)(-) was an impurity that increased with time in both vials and syringes but significantly so in syringes. All these impurities were higher with labeling activities in the range of 2,600-3,700 MBq (70.3-100 mCi). Contact of the needle with (99m)Tc-d,l-HMPAO sharply decreased the RCP to 57.1% at 4 h. The RCP of stabilized (99m)Tc-d,l-HMPAO decreases significantly in both vials and syringes with high labeling activities. The product is less stable when stored in a syringe than in a vial. The fraction of dose in contact with the needle affects the RCP results.

  5. Stability of extemporaneously compounded dexamethasone in glass and plastic bottles and plastic syringes.

    PubMed

    Ensom, Mary H H; Décarie, Diane

    2014-07-01

    Dexamethasone is widely used to treat rheumatic and endocrine disorders and chemotherapy-induced nausea and vomiting. A palatable, alcohol-free liquid formulation, with a suitable concentration to allow reasonable administration volume, is available only via extemporaneous compounding. To evaluate the stability of dexamethasone suspensions in commercially available vehicles (Oral Mix and Oral Mix SF) in various types of containers after storage at 25°C and 4°C for up to 91 days. Dexamethasone suspensions (1 mg/mL) were prepared in Oral Mix and Oral Mix SF and then transferred to amber glass and plastic prescription bottles and plastic oral syringes. Suspensions in all 3 types of containers were stored at 25°C; suspensions in glass and plastic bottles were also stored at 4°C. Samples were collected weekly from each container up to 28 days and then every 2 weeks up to 91 days. The samples were analyzed by a validated, stability-indicating high-performance liquid chromatography - ultraviolet detection method. A suspension was considered stable if it maintained at least 90% of its initial dexamethasone concentration. Changes in colour, taste, odour, precipitation (and ease of resuspension), and pH were used to assess physical compatibility. All suspensions maintained at least 96% of the original concentration for up to 91 days with storage at 25°C or at 4°C. No notable changes in colour, taste, odour, precipitation, or pH were observed over the 91-day period. Dexamethasone suspensions (1 mg/mL) in Oral Mix and Oral Mix SF, stored in amber glass or plastic bottles or plastic syringes at 25°C or in amber glass or plastic bottles at 4°C can be expected to remain stable for up to 91 days.

  6. Stability of Extemporaneously Compounded Dexamethasone in Glass and Plastic Bottles and Plastic Syringes

    PubMed Central

    Ensom, Mary H H; Décarie, Diane

    2014-01-01

    Background Dexamethasone is widely used to treat rheumatic and endocrine disorders and chemotherapy-induced nausea and vomiting. A palatable, alcohol-free liquid formulation, with a suitable concentration to allow reasonable administration volume, is available only via extemporaneous compounding. Objective: To evaluate the stability of dexamethasone suspensions in commercially available vehicles (Oral Mix and Oral Mix SF) in various types of containers after storage at 25°C and 4°C for up to 91 days. Methods: Dexamethasone suspensions (1 mg/mL) were prepared in Oral Mix and Oral Mix SF and then transferred to amber glass and plastic prescription bottles and plastic oral syringes. Suspensions in all 3 types of containers were stored at 25°C; suspensions in glass and plastic bottles were also stored at 4°C. Samples were collected weekly from each container up to 28 days and then every 2 weeks up to 91 days. The samples were analyzed by a validated, stability-indicating high-performance liquid chromatography − ultraviolet detection method. A suspension was considered stable if it maintained at least 90% of its initial dexamethasone concentration. Changes in colour, taste, odour, precipitation (and ease of resuspension), and pH were used to assess physical compatibility. Results: All suspensions maintained at least 96% of the original concentration for up to 91 days with storage at 25°C or at 4°C. No notable changes in colour, taste, odour, precipitation, or pH were observed over the 91-day period. Conclusion: Dexamethasone suspensions (1 mg/mL) in Oral Mix and Oral Mix SF, stored in amber glass or plastic bottles or plastic syringes at 25°C or in amber glass or plastic bottles at 4°C can be expected to remain stable for up to 91 days. PMID:25214658

  7. Maintenance treatment of Uracil and Tegafur (UFT) in responders following first-line fluorouracil-based chemotherapy in metastatic gastric cancer: a randomized phase II study.

    PubMed

    Li, Wenhua; Zhao, Xiaoying; Wang, Huijie; Liu, Xin; Zhao, Xinmin; Huang, Mingzhu; Qiu, Lixin; Zhang, Wen; Chen, Zhiyu; Guo, Weijian; Li, Jin; Zhu, Xiaodong

    2017-06-06

    Maintenance therapy proves to be effective in advanced lung and breast cancer after initial chemotherapy. The purpose of this phase II study was to evaluate the efficacy and safety of Uracil and Tegafur (UFT) maintenance in metastatic gastric cancer patients following the first-line fluorouracil-based chemotherapy. Metastatic gastric cancer patients with stable disease or a better response after the completion of first-line chemotherapy were randomized to oral UFT (360mg/m2 × 2 weeks) every 3 weeks until disease progression/intolerable toxicity or to observation (OBS). The primary endpoint was progression-free survival (PFS); the secondary endpoints were overall survival (OS) and safety. The trial was closed after the interim analysis of the 58 enrolled (120 planned) patients. Median PFS was not improved in the UFT group compared with the OBS group (3.2 months versus 3.6 months, P = 0.752), as well as the median OS (14.2 months for both, P = 0.983). However, subgroup analysis showed that low baseline hemoglobin (< 120 g/L) was associated with poorer PFS with maintenance therapy (P = 0.032), while the normal hemoglobin patients benefit from the UFT treatment (P = 0.008). Grade 3 to 4 toxicities in the UFT group were anemia (3.4%), thrombocytopenia (3.4%) and diarrhea (6.9%). This trial did not show superiority of UFT maintenance in non-selected patients responding to fluorouracil-based first-line chemotherapy. The normal hemoglobin level at baseline is a predictive biomarker for favorable patient subsets from the maintenance treatment.

  8. Adsorption of (99m)Tc-radiopharmaceuticals onto injection vials and syringes.

    PubMed

    Mushtaq, Ahmad; Ur Rehman, Taj; Safdar Mansur, Muhammad; Jehangir, Mustanser

    2008-06-01

    Many groups have reported the adsorption or retention of (99m)Tc-radiopharmaceuticals on injection vials and disposable plastic syringes. Such an enormously high loss of radioactivity would result in poor images, radiation exposure, waste, and economic burdens. We therefore decided to investigate the extent of adsorption or retention of several (99m)Tc-radiopharmaceuticals on injection vials, rubber stoppers, and plastic syringes. These radiopharmaceuticals are produced as lyophilized kits in our department and supplied to various hospitals practicing nuclear medicine in Pakistan. A vial containing lyophilized material was reconstituted with 3 mL of freshly eluted Na(99m)TcO(4). A 1-mL aliquot of the resulting solution was withdrawn into a syringe at 0.25, 0.5, 1, 3, and 5 h after preparation. All preparations were stored at room temperature ( approximately 22 degrees C). After each withdrawal, the vial was reweighed and the activity remaining in the vial was measured using a radioisotope calibrator. The sample was reinjected into the vial. From the original weight and activity of solution in the vial, the initial activity per gram was calculated. From the weight and activity remaining in the vial after withdrawal of the sample, the activity per gram of the sample was calculated. From the difference between the initial activity per gram and the activity per gram of the sample, the percentage of (99m)Tc adsorbed on the vial was calculated. All preparations were kept in the syringe for 15 min, and the activity was measured before and after the syringe was emptied. The needle and plunger of the syringe were separated, and activity in the needle and plunger was also measured. The labeling efficiency of all radiopharmaceuticals used during these studies was more than 95%. In most cases, the activity of (99m)Tc found on the rubber stopper was less than 1%. Adsorption of (99m)Tc onto vials increased gradually with storage time. Adsorption was minimal at the initial stages

  9. Retraction of the Plunger on a Syringe of Hyaluronic Acid Before Injection: Are We Safe?

    PubMed

    Carey, Wayne; Weinkle, Susan

    2015-12-01

    Controversy exists concerning the need for aspiration before injection with hyaluronic acid (HA) fillers. The authors undertook a study of HA products to determine if blood could be aspirated back into a syringe of HA when the needle has been primed or filled with HA. Two studies were set up to determine if or when blood could be withdrawn from a heparinized fresh tube of blood into the HA syringe. Two different techniques were tested; one using a slow-pull retraction of the plunger and up to a 5-second waiting time before release versus a rapid pullback and quick release. Review of these data demonstrates that the usual clinical method, which involves quick withdrawal and instant release of the syringe plunger does not allow for sufficient removal of the filler found intraluminal in the needle and may give rise to false negative results in vitro and likely in vivo with the exception being the Galderma/Medicis products. In summary, withdrawal of the syringe plunger with no visible blood in the syringe does not eliminate the possibility of intravascular placement of the syringe needle.

  10. [The impact of ascorbic acid on the concentrations of antioxidative vitamins in the plasma of patients with non-small cell lung cancer undergoing first-line chemotherapy].

    PubMed

    Tokarski, Sławomir; Rutkowski, Maciej; Godala, Małgorzata; Mejer, Anna; Kowalski, Jan

    2013-09-01

    One of the main after-effects of chemotherapy used in cancer treatment is an augmented production of reactive oxygen species (ROS). In turn ROS become a source of unwanted side effects of chemotherapy, often forcing the discontinuation of the therapy. Ascorbic acid (vitamin C), being an antioxidant, can strengthen the antioxidative barrier of an organism. The aim of the study was an assessment of the concentrations of A, C and E vitamins in the plasma of NSCLC patients undergoing chemotherapy supplemented with vitamin C. 25 first-line chemotherapy patients with inoperable NSCLC, including 19 men and 6 women aged between 37-73 years (average age 60.1 +/- 8.8 years) have undergone the examination. Their chemotherapy has been supplemented with ascorbic acid (vitamin C dose of 600 mg per 24 hours). Control group consisted of 24 healthy individuals, including 18 men and 6 women aged between 49-71 years (average age 59.5 +/- 6.6 years). In cancer patients the concentration of A, C and E vitamins was assessed by spectrophotometry using T60V spectrophotometer (PG Instruments) before and after first-line chemotherapy which was supplemented with vitamin C. In control group the concentrations of antioxidative vitamins was assessed only once. In comparison to the control group the concentrations of the A, C and E vitamins in the plasma of NSCLC patients was significantly lower (p < 0.05). After 6 weeks of chemotherapy supplemented with vitamin C a significant rise of concentrations (p < 0.05) of all the vitamins tested for was observed. The biggest rise was noted for vitamin C (99.8%). The supplementation of the chemotherapy of NSCLC patients with C vitamin leads to rise of the low concentrations of A, C and E vitamins in the plasma. This suggests strengthening of the antioxidative barrier in patients.

  11. Hydrodynamic comparison of the Penumbra system and commonly available syringes in forced-suction thrombectomy.

    PubMed

    Simon, Scott Douglas; Grey, Casey Paul

    2014-04-01

    The Penumbra system uses a coaxial separator and continuous extracorporeal suction to remove a clot from a cerebral artery. Forced-suction thrombectomy (FST) involves aspirating clots through the same reperfusion catheter using only a syringe, decreasing the procedure time and supplies needed. To evaluate multiple combinations of catheters and syringes to determine the optimal pairing for use in FST. Tests were performed using both the Penumbra system and syringes to aspirate water through Penumbra 0.041 inch (041), 4Max, 0.054 inch (054) and 5Max reperfusion catheters and a shuttle sheath. Dynamic pressure and flow at the catheter tip were calculated from the fill times for each system. Static pressure and force for each aspiration source were determined with a vacuum gauge. All syringes provided significantly higher dynamic pressure at the catheter tip than the Penumbra system (p<0.001). Increasing syringe volume significantly increased static pressure (p<0.001). Both flow and aspiration force significantly increased with catheter size (p<0.001). Cases are presented to demonstrate the clinical value of the laboratory principles. Maximizing static and dynamic pressure when performing FST is achieved by aspirating with a syringe possessing both the largest volume and the largest inlet diameter available. Maximizing aspiration force and flow rate is achieved by using the largest catheter possible.

  12. Patient Comprehension and Attitudes toward Maintenance Chemotherapy for Lung Cancer

    PubMed Central

    Gerber, David E.; Hamann, Heidi A.; Rasco, Drew W.; Woodruff, Sharon; Craddock Lee, Simon J.

    2012-01-01

    Objective Maintenance chemotherapy is a recently approved approach to the treatment of advanced non-small cell lung cancer (NSCLC). We sought to gain insight into patients’ perceptions of maintenance chemotherapy using qualitative methods. Methods We conducted thematic content analysis of focus groups at a freestanding cancer center and at an associated safety-net county hospital. Patients with advanced NSCLC who had started but not yet completed first-line platinum doublet chemotherapy were provided visual and written explanations of maintenance chemotherapy before being guided in group discussion. Results Key themes to emerge for consideration of maintenance chemotherapy included (1) survival benefits, disease control, and “buying time”; (2) the importance of “doing something”; (3) quality of life concerns; (4) the role of provider opinion/preference; and (5) the importance of logistics. Conclusions Patients undergoing first-line chemotherapy for advanced NSCLC were able to understand the concept of maintenance chemotherapy, distinguish it from traditional treatment paradigms, identify pros and cons of this approach, and convey reasons for considering it. Practice Implications Advances in oncology care that alter therapy modalities and delivery may significantly impact patient perceptions and treatment experiences. Clinical team members may wish to elicit treatment preferences of first-line patients through clinical discussions that anticipate these considerations. PMID:22632736

  13. SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design.

    PubMed

    Scott, Ingrid U; Oden, Neal L; VanVeldhuisen, Paul C; Ip, Michael S; Blodi, Barbara A; Antoszyk, Andrew N

    2009-11-01

    To evaluate the incidence of intravitreal silicone oil (SO) droplets associated with intravitreal injections using a staked-on vs luer cone syringe design in the SCORE (Standard Care vs COrticosteroid in REtinal Vein Occlusion) Study. Prospective, randomized, phase III clinical trial. The incidence of intravitreal SO was compared among participants exposed to the staked-on syringe design, the luer cone syringe design, or both of the syringe designs in the SCORE Study, which evaluated intravitreal triamcinolone acetonide injection(s) for vision loss secondary to macular edema associated with central or branch retinal vein occlusion. Injections were given at baseline and 4-month intervals, based on treatment assignment and study-defined retreatment criteria. Because intravitreal SO was observed following injections in some participants, investigators were instructed, on September 22, 2006, to look for intravitreal SO at all study visits. On November 1, 2007, the luer cone syringe design replaced the staked-on syringe design. A total of 464 participants received a total of 1,205 injections between November 4, 2004 and February 28, 2009. Intravitreal SO was noted in 141 of 319 participants (44%) exposed only to staked-on syringes, 11 of 87 (13%) exposed to both syringe designs, and 0 of 58 exposed only to luer cone syringes (P < .0001). Among participants with first injections after September 22, 2006, intravitreal SO was noted in 65 of 114 (57%) injected only with staked-on syringes compared with 0 of 58 injected only with luer cone syringes. Differential follow-up is unlikely to explain these results. In the SCORE Study, luer cone syringe design is associated with a lower frequency of intravitreal SO droplet occurrence compared with the staked-on syringe design, likely attributable to increased residual space in the needle hub with the luer cone design.

  14. [Oral complications of chemotherapy of malignant neoplasms].

    PubMed

    Obralić, N; Tahmiscija, H; Kobaslija, S; Beslija, S

    1999-01-01

    Function and integrity disorders of the oral cavity fall into the most frequent complication of the chemotherapy of leucemias, malignant lymphomas and solid tumors. Complications associated with cancer chemotherapy can be direct ones, resulting from the toxic action of antineoplastic agents on the proliferative lining of the mouth, or indirect, as a result of myelosuppression and immunosuppression. The most frequent oral complications associated with cancer chemotherapy are mucositis, infection and bleeding. The principles of prevention and management of oral complications during cancer chemotherapy are considered in this paper.

  15. Barriers to Access to Sterile Syringes as Perceived by Pharmacists and Injecting Drug Users: Implications for Harm Reduction in Lebanon.

    PubMed

    Ghaddar, Ali; Nassar, Karine; Elsoury, Ghadier

    2017-09-19

    Access to sterile syringes to injecting drug users (IDU) reduces sharing behavior and prevents the transmission of HIV. To describe the barriers to access to sterile syringes for IDUs in Lebanon from the perspectives of pharmacists and IDUs. in this qualitative study conducted in Lebanon, data were collected from 72 syringe purchase tests at pharmacies, 64 interviewees with pharmacists and 2 focus groups with injecting drug users. Two independent researchers analyzed the verbatim transcripts. Results revealed that pharmacists often deny access to sterile syringes to IDUs who are frequently stigmatized and intimidated at pharmacies. While no large gender differences in pharmacists' attitudes and practices were observed, inequalities in syringe access were noticed with men IDUs more often denied purchase. Pharmacists had several barriers to sell syringes to IDUs including fear of disease spread, increased drug use, inappropriately discarded syringes, staff and customer safety, and business concerns. IDUs had several challenges to purchase syringes including stigmatization, intimidation, physical harassment, concern to reveal identity, fear of arrest and syringe price abuse. Identifying the barriers to and facilitators of access to sterile syringes to IDUs is important to guide the development of efficient policies. Findings implicate the importance of empowering IDUs to purchase syringes at pharmacies through reducing the negative attitude towards IDUs and strengthening pharmacists' role in the promotion of health of IDUs. Findings also suggest that the habit of syringe sharing would decrease if the legal and cultural barriers to access are reduced.

  16. Does a simple syringe applicator enhance bone cement set up time in knee arthroplasty?

    PubMed Central

    Sodhi, Nipun; Dalton, Sarah E.; Khlopas, Anton; Sultan, Assem A.; Curtis, Gannon L.; Harb, Matthew A.; Naziri, Qais; Barrington, John W.; Mont, Michael A.

    2017-01-01

    Background The time required for polymethylmethacrylate (PMMA) cement curing or hardening can be modified by a number of variables including the mixing technique, and the temperature and pressure at which the process is taking place. Therefore, the purpose of this study was to evaluate two different methods of PMMA application in terms of set up time. Specifically, we (I) compared the PMMA set up time of cement that remained in the mixing bowl to cement that was placed in a syringe and (II) extrapolated the associated annual cost difference on the national and individual surgeon levels. Methods The cement set up time was measured for a total of 146 consecutive patients who underwent either unicompartmental knee arthroplasty (n=136) or patellofemoral arthroplasty (n=10) between January 2016 and April 2017. One pack of PMMA powder and monomer were mixed, placed in a 300 mL small plastic bowl, and mixed with a tongue depressor. Then, 50 mL of the mixed PMMA was placed in a sterile 60 mL syringe with the tip cut to a 6-mm opening, and the syringe was used to apply the cement to the bone and the prosthesis surface. The remaining unused cement in the syringe (syringe group) and the remaining unused cement in the plastic bowl (bowl group) were removed and formed into a two separate 2 cm diameter cubes that were allowed to cure at room temperature on a sterile set of osteotomes. The two cubes of cement were timed for complete PMMA curing. A two-tailed student’s t-test was used to compare the curing time for the two groups. Annual cost differences were calculated on the national and individual surgeon level. The total number of daily cases performed and the operative time savings using the syringe applicator was used to find daily and annual cost savings. Results The mean time for the cement to set up in the bowl group was 16.8±2.1 minutes, and the mean time for cement set up in the syringe group was 15.1±1.7 minutes. Compared to the bowl group cement set up time, the

  17. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug... and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical... supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with...

  18. 21 CFR 880.6920 - Syringe needle introducer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Syringe needle introducer. 880.6920 Section 880.6920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... depth below the skin surface. (b) Classification. Class II (performance standards). ...

  19. 21 CFR 880.6920 - Syringe needle introducer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Syringe needle introducer. 880.6920 Section 880.6920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... depth below the skin surface. (b) Classification. Class II (performance standards). ...

  20. Syringe Sharing in Drug Injecting Dyads: A Cross-Classified Multilevel Analysis of Social Networks.

    PubMed

    Shahesmaeili, Armita; Mirzazadeh, Ali; McFarland, Willi; Sharifi, Hamid; Haghdoost, Ali Akbar; Soori, Hamid

    2018-05-15

    We examined the association of dyadic-level factors with syringe sharing among people who inject drugs (PWID) in Kerman, Iran. In a cross-sectional study, we collected data on 329 drug-injecting dyads by individual face-to-face interviews. An injecting dyad was defined as 2 PWID who knew each other and injected drugs together during the last 6 months. If they reported at least 1 occasion of syringe sharing, the dyad was considered high-risk. Dyadic-level factors associated with syringe sharing were assessed using cross-classified multilevel logistic regression. The rate of syringe sharing was significantly higher for dyads who were more intimate (adjusted odds ratio [AOR] 4.5, CI 95%, 2.3-8.6), who had instrumental support (AOR 2.1, 95% CI 1.1-4.5), and who pooled money for drugs (AOR 4.1, 95% CI 2.0-8.3). The rate was lower in same-sex dyads (AOR 0.4, 95% CI 0.2-0.9) and in dyads who shared health information (AOR 0.5, 95% CI 0.2-0.9). Findings highlight close-peer influences on syringe-sharing behavior.

  1. Impact on Medical Cost, Cumulative Survival, and Cost-Effectiveness of Adding Rituximab to First-Line Chemotherapy for Follicular Lymphoma in Elderly Patients: An Observational Cohort Study Based on SEER-Medicare

    PubMed Central

    Griffiths, Robert I.; Gleeson, Michelle L.; Mikhael, Joseph; Danese, Mark D.

    2012-01-01

    Rituximab improves survival in follicular lymphoma (FL), but is considerably more expensive than conventional chemotherapy. We estimated the total direct medical costs, cumulative survival, and cost-effectiveness of adding rituximab to first-line chemotherapy for FL, based on a single source of data representing routine practice in the elderly. Using surveillance, epidemiology, and end results (SEER) registry data plus Medicare claims, we identified 1,117 FL patients who received first-line CHOP (cyclophosphamide (C), doxorubicin, vincristine (V), and prednisone (P)) or CVP +/− rituximab. Multivariate regression was used to estimate adjusted cumulative cost and survival differences between the two groups over four years after beginning treatment. The median age was 73 years (minimum 66 years), 56% had stage III-IV disease, and 67% received rituximab. Adding rituximab to first-line chemotherapy was associated with higher adjusted incremental total cost ($18,695; 95% Confidence Interval (CI) $9,302–$28,643) and longer adjusted cumulative survival (0.18 years; 95% CI 0.10–0.27) over four years of followup. The expected cost-effectiveness was $102,142 (95% CI $34,531–296,337) per life-year gained. In routine clinical practice, adding rituximab to first-line chemotherapy for elderly patients with FL results in higher direct medical costs to Medicare and longer cumulative survival after four years. PMID:22969803

  2. Comparison of first-line chemotherapy including escalated BEACOPP versus chemotherapy including ABVD for people with early unfavourable or advanced stage Hodgkin lymphoma.

    PubMed

    Skoetz, Nicole; Will, Andrea; Monsef, Ina; Brillant, Corinne; Engert, Andreas; von Tresckow, Bastian

    2017-05-25

    There are two different international standards for the treatment of early unfavourable and advanced stage Hodgkin lymphoma (HL): chemotherapy with escalated BEACOPP (bleomycin/etoposide/doxorubicin/cyclophosphamide/vincristine/procarbazine/prednisone) regimen and chemotherapy with ABVD (doxorubicin/bleomycin/vinblastine/dacarbazine) regimen. To determine the advantages and disadvantages of chemotherapy including escalated BEACOPP compared to chemotherapy including ABVD in the treatment of early unfavourable or advanced stage HL as first-line treatment. We searched for randomised controlled trials in MEDLINE, CENTRAL and conference proceedings (January 1985 to July 2013 and for the update to March 2017) and Embase (1985 to November 2008). Moreover we searched trial registries (March 2017; www.controlled-trials.com, www.clinicaltrialsregister.eu/ctr-search/search, clinicaltrials.gov, www.eortc.be, www.ghsg.org, www.ctc.usyd.edu.au, www.trialscentral.org/index.html) SELECTION CRITERIA: We included randomised controlled trials examining chemotherapy including at least two cycles of escalated BEACOPP regimens compared with chemotherapy including at least four cycles of ABVD regimens as first-line treatment for patients with early unfavourable stage or advanced stage HL. The effect measures we used were hazard ratios (HRs) for overall survival (OS), progression-free survival (PFS) and freedom from first progression.We used risk ratios (RRs) relative risks to analyse harms: treatment-related mortality, secondary malignancies (including myeloid dysplastic syndrome (MDS) or acute myeloid leukaemia (AML)), infertility and adverse events.Quality of life was not reported in any trial, therefore not analysed. Two review authors independently extracted data and assessed quality of trials. We screened 1796 records and identified five eligible trials in total i.e. one trial could be added on the previous review. These trials included only adults (16 to 65 years of age). We

  3. Characterization of the initial level and migration of silicone oil lubricant in empty prefilled syringes for biologics using infrared spectroscopy.

    PubMed

    Bee, Jared S; Frey, Vadim V; Javed, Urooj; Chung, Jonathan; Corcoran, Marta L; Roussel, Paul S; Krause, Stephan O; Cash, Patricia W; Bishop, Steven M; Dimitrova, Mariana N

    2014-01-01

    Glass prefillable syringes are lubricated with silicone oil to ensure functionality and a consistent injection for the end user. If excessive silicone is applied, droplets could potentially result in aggregation of sensitive biopharmaceuticals or clouding of the solution. Therefore, monitoring and optimization of the applied silicone layer is critical for prefilled syringe development. The hydrophobic properties of silicone oil, the potential for assay interference, and the very small quantities applied to prefilled syringes present a challenge for the development of a suitable assay. In this work we present a rapid and simple Fourier transform infrared (FTIR) spectroscopy method for quantitation of total silicone levels applied to prefilled syringes. Level-dependent silicone oil migration occurred over time for empty prefilled syringes stored tip-up. However, migration from all prefilled syringes with between 0.25 and 0.8 mg of initial silicone oil resulted in a stable limiting minimum level of between 0.15 and 0.26 mg of silicone in the syringe reached after 1 to 4 years of empty tip-up storage. The results of the FTIR assay correlated well with non-destructive reflectometry characterization of the syringes. This assay can provide valuable data for selection of a robust initial silicone oil target and quality control of prefilled syringes intended for biopharmaceuticals. Glass prefillable syringes are lubricated with silicone oil to ensure functionality and a consistent injection for the end user. If excessive silicone is applied, droplets could potentially result in aggregation of sensitive biopharmaceuticals or clouding of the solution. Therefore, monitoring and optimization of the applied silicone layer is critical for prefilled syringe development. The hydrophobic properties of silicone oil, the potential for assay interference, and the very small quantities applied to prefilled syringes present a challenge for the development of a suitable assay. In this

  4. [The development tendencies of infusion pumps/syringe pumps].

    PubMed

    Zhang, Peng; Wang, Shu-Yi; Yu, Chuan-Yi; Zhang, Min-Yan

    2009-07-01

    Through the investigation about the current infusion pumps, the development tendencies of the next generation infusion pumps/Syringe Pumps with regarding to human-factors, practicality and application under MRI (Magnetic resonance imaging) were put forward.

  5. Comparison of efficacy and tolerance between combination therapy and monotherapy as first-line chemotherapy in elderly patients with advanced gastric cancer: Study protocol for a randomized controlled trial.

    PubMed

    Lee, Keun-Wook; Zang, Dae Young; Ryu, Min-Hee; Kim, Ki Hyang; Kim, Mi-Jung; Han, Hye Sook; Koh, Sung Ae; Park, Jin Hyun; Kim, Jin Won; Nam, Byung-Ho; Choi, In Sil

    2017-12-01

    The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy. This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety. We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.

  6. Negotiating access: Social barriers to purchasing syringes at pharmacies in Tijuana, Mexico

    PubMed Central

    Davidson, Peter J.; Lozada, Remedios; Rosen, Perth C.; Macias, Armando; Gallardo, Manuel; Pollini, Robin A.

    2012-01-01

    Background One common public health response to the emergence of HIV has been the provision of sterile syringes to people who inject drugs. In Mexico specialized syringe exchanges are rare, and the sale of needles through pharmacies is often the only way people who inject drugs can obtain sterile syringes. However, people who inject drugs in Tijuana, Mexico report considerable social barriers to successfully purchasing syringes at pharmacies. Methods Between October 2008 and March 2009 we conducted seven in-depth focus groups with 47 people who inject drugs in Tijuana, Mexico. Focus group transcripts were analysed using a descriptive and thematic approach rooted in grounded theory. Results We found that injectors offered a number of explanations for why pharmacies were reluctant to sell them syringes, including fear of police; attitudes toward drug use; fear of stereotypical drug user behaviour such as petty theft, violence, or distressing behaviour; and related fears that an obvious drug using clientèle would drive away other customers. Injectors described a range of ways of attempting to re-frame or negotiate interactions with pharmacy staff so that these and related concerns were ameliorated. These included tactics as simple as borrowing cleaner clothing, through to strategies for becoming ‘known’ to pharmacy staff as an individual rather than as a member of a stigmatized group. Conclusion Increasing the ability of pharmacy staff and people who inject drugs to successfully negotiate syringe sales are highly desirable. Interventions designed to improve this likelihood need to capitalize on existing solutions developed ad-hoc by people who inject drugs and pharmacy staff, and should focus on broadening the range of ‘identities’ which pharmacy staff are able to accept as legitimate customers. Approaches to achieve this end might include sensitizing pharmacy staff to the needs of people who inject drugs; facilitating individual drug users meeting individual

  7. Negotiating access: social barriers to purchasing syringes at pharmacies in Tijuana, Mexico.

    PubMed

    Davidson, Peter J; Lozada, Remedios; Rosen, Perth C; Macias, Armando; Gallardo, Manuel; Pollini, Robin A

    2012-07-01

    One common public health response to the emergence of HIV has been the provision of sterile syringes to people who inject drugs. In Mexico specialized syringe exchanges are rare, and the sale of needles through pharmacies is often the only way people who inject drugs can obtain sterile syringes. However, people who inject drugs in Tijuana, Mexico report considerable social barriers to successfully purchasing syringes at pharmacies. Between October 2008 and March 2009 we conducted seven in-depth focus groups with 47 people who inject drugs in Tijuana, Mexico. Focus group transcripts were analysed using a descriptive and thematic approach rooted in grounded theory. We found that injectors offered a number of explanations for why pharmacies were reluctant to sell them syringes, including fear of police; attitudes toward drug use; fear of stereotypical drug user behaviour such as petty theft, violence, or distressing behaviour; and related fears that an obvious drug using clientèle would drive away other customers. Injectors described a range of ways of attempting to re-frame or negotiate interactions with pharmacy staff so that these and related concerns were ameliorated. These included tactics as simple as borrowing cleaner clothing, through to strategies for becoming 'known' to pharmacy staff as an individual rather than as a member of a stigmatized group. Increasing the ability of pharmacy staff and people who inject drugs to successfully negotiate syringe sales are highly desirable. Interventions designed to improve this likelihood need to capitalize on existing solutions developed ad hoc by people who inject drugs and pharmacy staff, and should focus on broadening the range of 'identities' which pharmacy staff are able to accept as legitimate customers. Approaches to achieve this end might include sensitizing pharmacy staff to the needs of people who inject drugs; facilitating individual drug users meeting individual pharmacy staff; and working with drug users

  8. First-line trastuzumab plus taxane-based chemotherapy for metastatic breast cancer: cost-minimization analysis.

    PubMed

    Nerich, Virginie; Chelly, Jennifer; Montcuquet, Philippe; Chaigneau, Loïc; Villanueva, Cristian; Fiteni, Frédéric; Meneveau, Nathalie; Perrin, Sophie; Voidey, Aline; Monnot, Tess; Pivot, Xavier; Limat, Samuel

    2014-10-01

    To carry out a cost-minimization analysis including a comparison of the costs arising from first-line treatment by trastuzumab plus docetaxel versus trastuzumab plus paclitaxel in patients with metastatic breast cancer. All consecutive patients with human epidermal growth receptor 2-postive metastatic breast cancer who were treated at Besançon University Hospital and Saint Vincent private hospital between 2001 and 2010 by first-line therapy containing trastuzumab plus taxane were retrospectively studied. Economic analysis took into account costs related to drugs, hospitalization, and healthcare travel. Progression-free survival difference between the two treatments was not significant (p = 0.65). First-line treatment by trastuzumab plus taxane was estimated at approximately €68,000 (p = 0.74). The drug costs represented around 70-75% of the total cost, mainly related to the use of trastuzumab. Our economic analysis shows that although the costs of the two trastuzumab plus taxane regimens are similar, they may contribute to the on-going debate about the availability and use of innovative chemotherapy drugs, in particular in human epidermal growth factor receptor 2-positive metastatic breast cancer with new therapies such as trastuzumab-DM1 and pertuzumab. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  9. Syringe Decriminalization Advocacy in Red States: Lessons from the North Carolina Harm Reduction Coalition.

    PubMed

    Cloud, David H; Castillo, Tessie; Brinkley-Rubinstein, Lauren; Dubey, Manisha; Childs, Robert

    2018-05-08

    Syringe access programs (SAPs) are cornerstone harm reduction interventions for combatting the national opioid epidemic. The goal of this paper is to describe effective advocacy strategies for enacting syringe decriminalization legislation to foster the expansion of SAPs in high-need areas amidst political opposition. Decades or research shows that SAPs prevent the transmission of HIV among people who inject drugs (PWID) and are a cost-effective tool for linking PWID to medical care, health education, and social services. In the USA, state laws criminalizing distribution and possession of syringes impede the expansion of SAPs into areas where they are sorely needed. In 2016, North Carolina became the first state to legalize SAPs with a Republican super majority. This paper distills strategies for community organizations seeking to advance syringe decriminalization legislation in politically conservative states with histories of prioritizing punitive sanctions over public health responses to drug use.

  10. Freeze-drying in novel container system: Characterization of heat and mass transfer in glass syringes.

    PubMed

    Patel, Sajal M; Pikal, Michael J

    2010-07-01

    This study is aimed at characterizing and understanding different modes of heat and mass transfer in glass syringes to develop a robust freeze-drying process. Two different holder systems were used to freeze-dry in syringes: an aluminum (Al) block and a plexiglass holder. The syringe heat transfer coefficient was characterized by a sublimation test using pure water. Mannitol and sucrose (5% w/v) were also freeze-dried, as model systems, in both the assemblies. Dry layer resistance was determined from manometric temperature measurement (MTM) and product temperature was measured using thermocouples, and was also determined from MTM. Further, freeze-drying process was also designed using Smart freeze-dryer to assess its application for freeze-drying in novel container systems. Heat and mass transfer in syringes were compared against the traditional container system (i.e., glass tubing vial). In the Al block, the heat transfer was via three modes: contact conduction, gas conduction, and radiation with gas conduction being the dominant mode of heat transfer. In the plexiglass holder, the heat transfer was mostly via radiation; convection was not involved. Also, MTM/Smart freeze-drying did work reasonably well for freeze-drying in syringes. When compared to tubing vials, product temperature decreases and hence drying time increases in syringes. (c) 2010 Wiley-Liss, Inc. and the American Pharmacists Association

  11. Sterile syringe access and disposal among injection drug users newly enrolled in methadone maintenance treatment: a cross-sectional survey

    PubMed Central

    McNeely, Jennifer; Arnsten, Julia H; Gourevitch, Marc N

    2006-01-01

    Background We sought to assess injection practices, means of acquiring and disposing of syringes, and utilization and knowledge of harm reduction resources among injection drug users (IDUs) entering methadone maintenance treatment (MMT). Methods Interviews with 100 consecutive patients, including 35 IDUs, entering a MMT program in the Bronx, NY. Results Utilization of unsafe syringe sources was reported by 69% of IDUs in our sample. Most (80%) IDUs reused syringes, and syringe sharing was also common. Fewer than half knew that non-prescription pharmacy purchase of syringes was possible. The most common means of disposing of injecting equipment were the trash (63%) and syringe exchange programs (49%). Conclusions These findings indicate that drug users entering treatment under-utilize sanctioned venues to obtain sterile syringes or safely dispose of used injection equipment. Programs providing services to drug users should adopt a proactive stance to address the safety and health issues faced by injectors. PMID:16503997

  12. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials.

    PubMed

    Wasan, Harpreet S; Gibbs, Peter; Sharma, Navesh K; Taieb, Julien; Heinemann, Volker; Ricke, Jens; Peeters, Marc; Findlay, Michael; Weaver, Andrew; Mills, Jamie; Wilson, Charles; Adams, Richard; Francis, Anne; Moschandreas, Joanna; Virdee, Pradeep S; Dutton, Peter; Love, Sharon; Gebski, Val; Gray, Alastair; van Hazel, Guy; Sharma, Ricky A

    2017-09-01

    Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival. FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA). Chemotherapy-naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation were randomly assigned (1:1) to either oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy. In FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy; 85 mg/m 2 oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin 350 mg infusion over 2 h, and 400 mg/m 2 bolus fluorouracil followed by a 2400 mg/m 2 continuous fluorouracil infusion over 46 h). In SIRFLOX and FOXFIRE-Global, FOLFOX chemotherapy was modified FOLFOX6 (85 mg/m 2 oxaliplatin infusion over 2 h, 200 mg leucovorin, and 400 mg/m 2 bolus fluorouracil followed by a 2400 mg/m 2 continuous fluorouracil infusion over 46 h). Randomisation was done by central minimisation with four factors: presence of extrahepatic metastases, tumour involvement of the liver, planned use of a biological agent, and investigational centre. Participants and investigators were not masked to treatment. The primary

  13. Homicide by Sch from a syringe-like dart ejected by a compound crossbow.

    PubMed

    Guo, Wei; Luo, Guochang; Wang, Hao; Meng, Xiangzhi

    2015-02-01

    The compound crossbow can be used to eject syringe-like dart loaded with poisonous solution. Succinylcholine (Sch) is a short-acting neuromuscular blocker medically used to achieve complete relaxation of muscle for a good intubation condition. Without the help of an artificial respirator, intramuscular injection of a large dose of Sch can paralyze the respiratory muscle and result in the receiver's death. In this paper, we present the homicide case of a young male killed by Sch from a syringe-like dart ejected by a compound crossbow. The subcutaneous and muscular hemorrhages observed around the entry were more severe than that caused by a medical injection. Additionally, other autopsy results showed the external appearance of a pinhole, general asphyxia signs and pathological findings which were not characteristic. The discovery of a syringe-like dart at the scene is the critical clue and reason for analyzing for Sch, which is commonly used to load syringe-like dart to paralyze and steal dog in the countryside of China. Copyright © 2014 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  14. Dump the pump: manual aspiration thrombectomy (MAT) with a syringe is technically effective, expeditious, and cost-efficient.

    PubMed

    Gross, Bradley A; Jadhav, Ashutosh P; Jovin, Tudor G; Jankowitz, Brian Thomas

    2018-04-01

    Syringe aspiration for manual aspiration thrombectomy (MAT) is a cost- and time-efficient alternative to an aspiration pump with likely similar efficacy. It is counterintuitive to expect the pump to perform better than direct vacuum with a syringe, as the pump must deliver vacuum additionally through a canister and meters of tubing. To present in vitro and clinical results of MAT with a syringe. An in vitro analysis was performed comparing vacuum pressures generated by syringe aspiration and with pump aspiration. This was then complemented with prospective clinical data providing details of angiographic and clinical outcomes for syringe MAT. The in vitro analysis demonstrated that equal to slightly greater vacuum pressures were generated by a 60 cc syringe as compared with the pump in both static and partial flow conditions. In our clinical series, 106/113 acute stroke thrombectomies over a 6-month period were performed with syringe MAT on the first pass. Syringe usage instead of pump tubing and a canister led to a total savings of $58 300. The rate of Thrombolysis in Cerebral Infarction 2b/3 recanalization was 93%. Adjunctive stentriever usage was performed in 23% of cases. Median puncture to reperfusion time was 25 min; mean change in National Institute of Health Stroke Scale score at 24 hours was an improvement of 5.1 (median 6). The in-hospital mortality rate was 10%. Seventy percent of patients were discharged to home (modified Rankin Scale (mRS) score 0-2) or a rehabilitation facility (mRS score 2-4). MAT using a syringe is a safe, fast, and more cost-effective approach than using an aspiration pump. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. A randomized assessment of adding the kinase inhibitor lestaurtinib to first-line chemotherapy for FLT3-mutated AML.

    PubMed

    Knapper, Steven; Russell, Nigel; Gilkes, Amanda; Hills, Robert K; Gale, Rosemary E; Cavenagh, James D; Jones, Gail; Kjeldsen, Lars; Grunwald, Michael R; Thomas, Ian; Konig, Heiko; Levis, Mark J; Burnett, Alan K

    2017-03-02

    The clinical benefit of adding FMS-like tyrosine kinase-3 (FLT3)-directed small molecule therapy to standard first-line treatment of acute myeloid leukemia (AML) has not yet been established. As part of the UK AML15 and AML17 trials, patients with previously untreated AML and confirmed FLT3-activating mutations, mostly younger than 60 years, were randomly assigned either to receive oral lestaurtinib (CEP701) or not after each of 4 cycles of induction and consolidation chemotherapy. Lestaurtinib was commenced 2 days after completing chemotherapy and administered in cycles of up to 28 days. The trials ran consecutively. Primary endpoints were overall survival in AML15 and relapse-free survival in AML17; outcome data were meta-analyzed. Five hundred patients were randomly assigned between lestaurtinib and control: 74% had FLT3 -internal tandem duplication mutations, 23% FLT3 -tyrosine kinase domain point mutations, and 2% both types. No significant differences were seen in either 5-year overall survival (lestaurtinib 46% vs control 45%; hazard ratio, 0.90; 95% CI 0.70-1.15; P = .3) or 5-year relapse-free survival (40% vs 36%; hazard ratio, 0.88; 95% CI 0.69-1.12; P = .3). Exploratory subgroup analysis suggested survival benefit with lestaurtinib in patients receiving concomitant azole antifungal prophylaxis and gemtuzumab ozogamicin with the first course of chemotherapy. Correlative studies included analysis of in vivo FLT3 inhibition by plasma inhibitory activity assay and indicated improved overall survival and significantly reduced rates of relapse in lestaurtinib-treated patients who achieved sustained greater than 85% FLT3 inhibition. In conclusion, combining lestaurtinib with intensive chemotherapy proved feasible in younger patients with newly diagnosed FLT3 -mutated AML, but yielded no overall clinical benefit. The improved clinical outcomes seen in patients achieving sustained FLT3 inhibition encourage continued evaluation of FLT3-directed therapy alongside

  16. A syringe-sharing model for the spread of HIV: application to Omsk, Western Siberia.

    PubMed

    Artzrouni, Marc; Leonenko, Vasiliy N; Mara, Thierry A

    2017-03-01

    A system of two differential equations is used to model the transmission dynamics of human immunodeficiency virus between 'persons who inject drugs' (PWIDs) and their syringes. Our vector-borne disease model hinges on a metaphorical urn from which PWIDs draw syringes at random which may or may not be infected and may or may not result in one of the two agents becoming infected. The model's parameters are estimated with data mostly from the city of Omsk in Western Siberia. A linear trend in PWID prevalence in Omsk could only be fitted by considering a time-dependent version of the model captured through a secular decrease in the probability that PWIDs decide to share a syringe. A global sensitivity analysis is performed with 14 parameters considered random variables in order to assess their impact on average numbers infected over a 50-year projection. With obvious intervention implications the drug injection rate and the probability of syringe-cleansing are the only parameters whose coefficients of correlations with numbers of infected PWIDs and infected syringes have an absolute value close to or larger than 0.40. © The authors 2015. Published by Oxford University Press on behalf of the Institute of Mathematics and its Applications. All rights reserved.

  17. The Disposable Syringe: More Experiments and Uses

    ERIC Educational Resources Information Center

    Farmer, Andrew

    1973-01-01

    Describes a variety of experiments that can be performed using the disposable syringe. Among others, these include the removal of oxygen during rusting, convection in a liquid and in air, gas collection in an electrolysis cell, small scale production of a fog, and hydrogen/oxygen extraction from a voltameter. (JR)

  18. Stability of micafungin sodium solutions at different concentrations in glass bottles and syringes.

    PubMed

    Briot, Thomas; Vrignaud, Sandy; Lagarce, Frédéric

    2015-08-15

    Micafungin is a costly treatment and packaging of 50 mg or 100 mg bottles only are available, while doses lower than 5 mg and 20 mg are often necessary in neonates and paediatrics patients, respectively. The stability of micafungin sodium in polypropylene syringes and glass bottles was studied at different concentrations. Solutions of micafungin diluted with NaCl 0.9% were prepared in glass bottles (20 and 10 mg/mL) or syringes (1 and 0.5 mg/mL) and stored at 25 °C, 60% humidity (RH), in the dark (ICH conditions). Solutions were also exposed to heat (70 °C) or alkaline solution (NaOH) in order to force degradation. Samples were analysed at days 1, 5, 8 (for bottles) and also 15 (for syringes) after the preparation and assayed in triplicate. Stability was studied using a stability-indicating high-performance liquid chromatographic method. Syringes stored at 25 °C retained over 90% of their initial concentration over the study period. Temperature and alkaline conditions had significant effect on the stability of micafungin, leading to apparition of degradation products. Moreover, sub visible particles were in the specification of the European Pharmacopeia along 15 days. To conclude, micafungin diluted in NaCl 0.9% and stored in polypropylene syringes was chemically stable for at least 15 days at 25 °C in the dark. Copyright © 2015 Elsevier B.V. All rights reserved.

  19. Plastic-Syringe Induced Silicone Contamination in Organic Photvoltaic Fabrication: Implications for Small-Volume Additives

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

    Carr, John A.; Nalwa, Kanwar S.; Mahadevapuram, Rakesh

    Herein, the implications of silicone contamination found in solution-processed conjugated polymer solar cells are explored. Similar to a previous work based on molecular cells, we find this contamination as a result of the use of plastic syringes during fabrication. However, in contrast to the molecular case, we find that glass-syringe fabricated devices give superior performance than plastic-syringe fabricated devices in poly(3-hexylthiophene)-based cells. We find that the unintentional silicone addition alters the solution’s wettability, which translates to a thinner, less absorbent film on spinning. With many groups studying the effects of small-volume additives, this work should be closely considered as manymore » of these additives may also directly alter the solutions’ wettability, or the amount of silicone dissolved off the plastic syringes, or both. Thereby, film thickness, which generally is not reported in detail, can vary significantly from device to device.« less

  20. Survival after failure of first-line chemotherapy in advanced gastric cancer patients: differences between Japan and the rest of the world.

    PubMed

    Takashima, Atsuo; Iizumi, Sakura; Boku, Narikazu

    2017-07-01

    In this review, we focus on post-progression survival after first-line chemotherapy of advanced gastric cancer, and particularly the differences between Japan and the rest of the world. We reviewed 15 recent phase III trials of which 4 were solely recruited from Japanese and 11 from rest of the world. The patient characteristics age, performance status, previous gastrectomy and the number of metastatic sites were similar in Japan and rest of the world. However, the diffuse histological type was more common in Japan. While overall survival was longer in Japan (10.5-14.1 vs. 7.9-12.2 months), progression-free survival tended to be shorter in Japan (3.6-6.0 vs. 3.1-7.4 months). Post-progression survival calculated as the difference between median overall survival and progression-free survival was clearly longer in Japan (6.9-8.6 vs. 2.4-6.2 months). The proportion of patients receiving second-line chemotherapy (%2nd-CX) was quite different in Japan and rest of the world (69-85% vs. 11-59%). Correlations between %2nd-CX and post-progression survival were strong (Spearman's rank correlation coefficient; ρ = 0.86, P < 0.001). Correlations between %2nd-CX and ratio of post-progression survival to total overall survival were also strong (ρ = 0.84, P < 0.001). Because a survival benefit of second-CX was documented in several phase III trials, it can be concluded that higher %2nd-CX partly contributed to extended post-progression survival. However, considering that second-CX increased survival only by ~1.5 months at median, other factors such as third-line chemotherapy may have some influences to prolonged post-progression survival. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Correlation between TS, MTHFR, and ERCC1 gene polymorphisms and the efficacy of platinum in combination with pemetrexed first-line chemotherapy in mesothelioma patients.

    PubMed

    Powrózek, Tomasz; Kowalski, Dariusz M; Krawczyk, Paweł; Ramlau, Rodryg; Kucharczyk, Tomasz; Kalinka-Warzocha, Ewa; Knetki-Wróblewska, Magdalena; Winiarczyk, Kinga; Dyszkiewicz, Wojciech; Krzakowski, Maciej; Milanowski, Janusz

    2014-11-01

    The combination of pemetrexed and platinum compound represents the standard regimen for first-line chemotherapy in malignant pleural mesothelioma patients. Pemetrexed is a multitarget antifolate agent that inhibits folate-dependent enzymes (eg, thymidylate synthase [TS]) and thus synthesis of nucleotides and DNA. Expression of TS and folate availability, regulated by gene polymorphisms, have implications for effectiveness of chemotherapy and the outcome of mesothelioma patients. The aim of this retrospective multicenter study was to assess the correlation between TS, 5,10-methylenetetrahydrofolate reductase (MTHFR) and excision repair cross-complementing group 1 (ERCC1) gene polymorphisms and the efficacy of pemetrexed-based first-line chemotherapy of mesothelioma patients. Fifty-nine mesothelioma patients (31 men with a median age of 62 years) treated in first-line chemotherapy with platinum in combination with pemetrexed or pemetrexed monotherapy were enrolled. Genomic DNA was isolated from peripheral blood. Using polymerase chain reaction and high resolution melt methods, the variable number of tandem repeat, the G>C single nucleotide polymorphism (SNP) in these repeats, and 6-base pair (bp) insertion/deletion polymorphism of the TS gene, the SNP of 677C>T in MTHFR, and 19007C>T in the ERCC1 gene were analyzed and correlated with disease control rate, progression-free survival (PFS), and overall survival (OS) of mesothelioma patients. Greater risk of early disease progression (PD), and shortening of PFS and OS were associated with several clinical factors (eg, anemia for early PD and OS), weight loss (for PFS and OS), and previous surgical treatment (for early PD, PFS, and OS). Insertion of 6-bp in both alleles of the TS gene (1494del6) was the only genetic factor that increased the incidence of early progression (P = .028) and shortening of median PFS (P = .06) in patients treated with pemetrexed-based chemotherapy. In multivariate analysis, the 1494del6 in the

  2. Measuring individual-level needle and syringe coverage among people who inject drugs in Myanmar.

    PubMed

    O'Keefe, Daniel; Aung, Soe Moe; Pasricha, Naanki; Wun, Thu; Linn, Soe Khaing; Lin, Nay; Aitken, Campbell; Hughes, Chad; Dietze, Paul

    2018-05-10

    Myanmar has prioritised people who inject drugs (PWID) as a key population for HIV mitigation efforts, with targets for needle and syringe distribution set at a population level. However, individual-level coverage, defined as the percentage of an individual's injecting episodes covered by a sterile syringe, is a more sensitive measure of intervention coverage. We sought to examine individual-level coverage in a sample of PWID in Myanmar. We recruited 512 PWID through urban drop-in-centres in Yangon, Mandalay and Pyin Oo Lwin. Participants were administered a quantitative questionnaire covering five domains: demographics, drug use, treatment and coverage, and injecting risk behaviour. We calculated past fortnight individual-level syringe coverage, estimating levels of sufficient (≥100% of injecting episodes covered by a sterile syringe) and insufficient (<100%) coverage, and examined associations between key variables and insufficient coverage via logistic regression. Our sample was predominately male (97%), employed (76%), and living in stable accommodation (96%), with a median age of 27. All participants reported heroin as the drug most frequently injected, and injected a median of 27 times in the past two weeks. Nineteen per cent of participants had insufficient coverage in the two weeks before interview. Insufficient coverage was positively associated with syringe re-use (AOR: 5.19, 95% CIs: 2.57, 10.48) and acquiring sterile syringes from a location other than a formal drop-in-centre (AOR: 2.04, 95% CIs: 1.08, 3.82). Participants recruited in Mandalay (AOR: 0.30, 95% CIs: 0.11, 0.80) and Pyin Oo Lwin (AOR: 0.39, 95% CIs: 0.18, 0.87) had lower odds of insufficient coverage than those recruited in Yangon. Our study shows coverage in selected areas of Myanmar was comparable with studies in other countries. Our results inform the delivery of harm reduction services for PWID, specifically by encouraging the use of formal drop-in-centres, over other sources of

  3. Investigating Liquid Leak from Pre-Filled Syringes upon Needle Shield Removal: Effect of Air Bubble Pressure.

    PubMed

    Chan, Edwin; Maa, Yuh-Fun; Overcashier, David; Hsu, Chung C

    2011-01-01

    This study is to investigate the effect of headspace air pressure in pre-filled syringes on liquid leak (dripping) from the syringe needle upon needle shield removal. Drip tests to measure drip quantity were performed on syringes manually filled with 0.5 or 1.0 mL of various aqueous solutions. Parameters assessed included temperature (filling and test), bulk storage conditions (tank pressure and the type of the pressurized gas), solution composition (pure water, 0.9% sodium chloride, and a monoclonal antibody formulation), and testing procedures. A headspace pressure analyzer was used to verify the drip test method. Results suggested that leakage is indeed caused by headspace pressure increase, and the temperature effect (ideal gas expansion) is a major, but not the only, factor. The dissolved gases in the liquid bulk prior to or during filling may contribute to leakage, as these gases could be released into the headspace due to solubility changes (in response to test temperature and pressure conditions) and cause pressure increase. Needle shield removal procedures were found to cause dripping, but liquid composition played little role. Overall, paying attention to the processing history (pressure and temperature) of the liquid bulk is the key to minimize leakage. The headspace pressure could be reduced by decreasing liquid bulk storage pressure, filling at a higher temperature, or employing lower solubility gas (e.g., helium) for bulk transfer and storage. Leakage could also be mitigated by simply holding the syringe needle pointing upward during needle shield removal. Substantial advances in pre-filled syringe technology development, particularly in syringe filling accuracy, have been made. However, there are factors, as subtle as how the needle shield (or tip cap) is removed, that may affect dosing accuracy. We recently found that upon removal of the tip cap from a syringe held vertically with needle pointed downwards, a small amount of solution, up to 3-4% of

  4. The pneumatic syringe: a simple apparatus for self-administration of drugs by rats.

    PubMed

    Weeks, J R

    1977-12-01

    Drug solution is delivered by a syringe operated by a pneumatic cylinder. Recommended delivery volumes are from 10 to 200 microliter. A solid-state control unit is described which can operate two syringes (drug injection and flush), has outputs for recording responses and injections, and can be programmed to provide several schedules of reinforcement. All components are readily commercially available.

  5. Determination of the Specific Heat Ratio of a Gas in a Plastic Syringe

    ERIC Educational Resources Information Center

    Chamberlain, Jeff

    2010-01-01

    The rapid compression or expansion of a gas in a plastic syringe is a poor approximation of an adiabatic process. Heat exchange with the walls of the syringe brings the gas to equilibrium in an amount of time that is not significantly greater than the length of the compression or expansion itself. Despite this limitation, it is still possible to…

  6. Low-cost feedback-controlled syringe pressure pumps for microfluidics applications.

    PubMed

    Lake, John R; Heyde, Keith C; Ruder, Warren C

    2017-01-01

    Microfluidics are widely used in research ranging from bioengineering and biomedical disciplines to chemistry and nanotechnology. As such, there are a large number of options for the devices used to drive and control flow through microfluidic channels. Commercially available syringe pumps are probably the most commonly used instruments for this purpose, but are relatively high-cost and have inherent limitations due to their flow profiles when they are run open-loop. Here, we present a low-cost ($110) syringe pressure pump that uses feedback control to regulate the pressure into microfluidic chips. Using an open-source microcontroller board (Arduino), we demonstrate an easily operated and programmable syringe pump that can be run using either a PID or bang-bang control method. Through feedback control of the pressure at the inlets of two microfluidic geometries, we have shown stability of our device to within ±1% of the set point using a PID control method and within ±5% of the set point using a bang-bang control method with response times of less than 1 second. This device offers a low-cost option to drive and control well-regulated pressure-driven flow through microfluidic chips.

  7. Low-cost feedback-controlled syringe pressure pumps for microfluidics applications

    PubMed Central

    Lake, John R.; Heyde, Keith C.

    2017-01-01

    Microfluidics are widely used in research ranging from bioengineering and biomedical disciplines to chemistry and nanotechnology. As such, there are a large number of options for the devices used to drive and control flow through microfluidic channels. Commercially available syringe pumps are probably the most commonly used instruments for this purpose, but are relatively high-cost and have inherent limitations due to their flow profiles when they are run open-loop. Here, we present a low-cost ($110) syringe pressure pump that uses feedback control to regulate the pressure into microfluidic chips. Using an open-source microcontroller board (Arduino), we demonstrate an easily operated and programmable syringe pump that can be run using either a PID or bang-bang control method. Through feedback control of the pressure at the inlets of two microfluidic geometries, we have shown stability of our device to within ±1% of the set point using a PID control method and within ±5% of the set point using a bang-bang control method with response times of less than 1 second. This device offers a low-cost option to drive and control well-regulated pressure-driven flow through microfluidic chips. PMID:28369134

  8. Nonprescription naloxone and syringe sales in the midst of opioid overdose and hepatitis C virus epidemics: Massachusetts, 2015.

    PubMed

    Stopka, Thomas J; Donahue, Ashley; Hutcheson, Marguerite; Green, Traci C

    To determine the prevalence of nonprescription naloxone and sterile syringe sales, factors associated with nonprescription sales, geospatial access to nonprescription naloxone and syringe-selling pharmacies, and targets for potential interventions. Cross-sectional study. Massachusetts has experienced steep increases in reported opioid overdoses and hepatitis C virus cases in the past decade. Pharmacists have the potential to play a substantial role in increasing access to nonprescription naloxone and sterile syringes, which can reverse opioid overdoses and decrease hepatitis C virus transmission, respectively. We completed brief telephone surveys with 809 of 1042 retail pharmacies across Massachusetts (response rate = 77.6%) during 2015 to assess experience with nonprescription sales of naloxone and sterile syringes. Our primary outcomes were the stocking and selling of naloxone in the pharmacy (yes or no) for nonprescription sales and nonprescription syringe sales (yes or no). We conducted multivariable regression analyses and created maps using a geographic information system to identify factors associated with nonprescription sales of naloxone and sterile syringes, and to improve our understanding of geospatial access to pharmacy-based naloxone and syringe sales. More than 97% of pharmacies reported selling sterile syringes without requiring a prescription, and 45% of pharmacies reported stocking and selling naloxone. Factors associated with nonprescription sales included hours of operation, experience with and interest in harm reduction activities, and presence in an opioid overdose hotspot. Geographic access to nonprescription sale of sterile syringes is widespread, whereas geospatial access to naloxone is limited. Training to understand the benefits, applications, and distribution needs of naloxone is of interest to surveyed pharmacists. Access to sterile syringes through nonprescription sales is strong across Massachusetts, and although more than 350

  9. Microbial contamination of syringes during preparation: the direct influence of environmental cleanliness and risk manipulations on end-product quality.

    PubMed

    Stucki, Cyril; Sautter, Anna-Maria; Favet, Jocelyne; Bonnabry, Pascal

    2009-11-15

    The direct influence of environmental cleanliness and risk manipulations on prepared syringes was evaluated. Media-fill testing was used to estimate potential microbial contamination. Syringes were prepared in three different environments using four different uncontrolled high-risk manipulations. The three environments included an International Organization for Standardization (ISO) class 5 horizontal laminar-airflow hood in an ISO class 6 cleanroom (in accordance with United States Pharmacopeia [USP] chapter 797), an ISO class 7 drug preparation area of an operating room, and an uncontrolled decentralized pharmacy in a ward. For each combination of environment and manipulation, 100 syringes were filled by a single operator. The four high-risk manipulations used included simple filling of syringes with trypticase soy broth, three-second contact by the ungloved fingers of the operator with the hub of the syringe, three-second contact between an object and the hub of the syringe, and exposure of the filled syringes to ambient air for 10 minutes. Of the 1500 syringes prepared in three different environments, none produced within the cleanroom contained microorganisms, 6% were contaminated in the operating room, and 16% were contaminated in the ward (p < 0.0001). Certain high-risk manipulations were associated with a significant increase in the contamination of the surrogate syringes, including exposure to nonsterile ambient air and nonsterile objects or fingers (p < 0.0001). High contamination rates were measured when the hub of syringes touched nonsterile environmental surfaces and fingers, whereas the drawn-air manipulation was associated with a lower risk of contamination. Working within a properly operating unidirectional airflow primary engineering control in an ISO class 5 cleanroom in accordance with USP chapter 797 requirements was demonstrated to be the best way to avoid bacterial or fungal contamination of injectable drugs directly resulting in patient

  10. Development of a Mechatronic Syringe Pump to Control Fluid Flow in a Microfluidic Device Based on Polyimide Film

    NASA Astrophysics Data System (ADS)

    Sek Tee, Kian; Sharil Saripan, Muhammad; Yap, Hiung Yin; Fhong Soon, Chin

    2017-08-01

    With the advancement in microfluidic technology, fluid flow control for syringe pump is always essential. In this paper, a mechatronic syringe pump will be developed and customized to control the fluid flow in a poly-dimethylsiloxane (PDMS) microfluidic device based on a polyimide laminating film. The syringe pump is designed to drive fluid with flow rates of 100 and 1000 μl/min which intended to drive continuous fluid in a polyimide based microfluidic device. The electronic system consists of an Arduino microcontroller board and a uni-polar stepper motor. In the system, the uni-polar stepper motor was coupled to a linear slider attached to the plunger of a syringe pump. As the motor rotates, the plunger pumps the liquid out of the syringe. The accuracy of the fluid flow rate was determined by adjusting the number of micro-step/revolution to drive the stepper motor to infuse fluid into the microfluidic device. With the precise control of the electronic system, the syringe pump could accurately inject fluid volume at 100 and 1000 μl/min into a microfluidic device.

  11. Efficacy of Pemetrexed-based Chemotherapy in Comparison to Non-Pemetrexed-based Chemotherapy in Advanced, ALK+ Non-Small Cell Lung Cancer.

    PubMed

    Jo, Jaemin; Kim, Se Hyun; Kim, Yu Jung; Lee, Juhyun; Kim, Miso; Keam, Bhumsuk; Kim, Tae Min; Kim, Dong Wan; Heo, Dae Seog; Chung, Jin Haeng; Jeon, Yoon Kyung; Lee, Jong Seok

    2018-03-01

    Previous retrospective studies suggest that anaplastic lymphoma kinase (ALK) mutation-positive (ALK+) non-small cell lung cancer (NSCLC) patients are sensitive to pemetrexed. To determine its efficacy, we retrospectively evaluated clinical outcomes of pemetrexed-based chemotherapy in patients with ALK+ NSCLC. We identified 126 patients with advanced, ALK+ NSCLC who received first-line cytotoxic chemotherapy. We compared response, progression-free survival (PFS), and overall survival (OS) rates according to chemotherapy regimens. Furthermore, we evaluated intracranial time to tumor progression (TTP) and proportion of ALK+ cells as prognostic factors. Forty-eight patients received pemetrexed-based chemotherapy, while 78 received other regimens as first-line treatment. The pemetrexed-based chemotherapy group showed superior overall response (44.7% vs. 14.3%, p<0.001) and disease control (85.1% vs. 62.3%, p=0.008) rates. The pemetrexed-based chemotherapy group also exhibited longer PFS (6.6 months vs. 3.8 months, p<0.001); OS rates were not significantly different. The lack of exposure to second-generation ALK inhibitors and intracranial metastasis on initial diagnosis were independent negative prognostic factors of OS. Intracranial TTP was similar between the treatment groups (32.7 months vs. 35.7 months, p=0.733). Patients who harbored a greater number of ALK+ tumor cells (≥70%) showed prolonged OS on univariate analysis (not reached vs. 44.8 months, p=0.041), but not on multivariate analysis (hazard ratio: 0.19, 95% confidence interval: 0.03-1.42; p=0.106). Pemetrexed-based regimens may prolong PFS in patients with ALK+ NSCLC as a first-line treatment, but are not associated with prolonged OS. Exposure to second-generation ALK inhibitors may improve OS rates in patients with ALK+ NSCLC. © Copyright: Yonsei University College of Medicine 2018

  12. Increased Access to Unrestricted Pharmacy Sales of Syringes in Seattle–King County, Washington: Structural and Individual-Level Changes, 1996 Versus 2003

    PubMed Central

    Deibert, Ryan J.; Goldbaum, Gary; Parker, Theodore R.; Hagan, Holly; Marks, Robert; Hanrahan, Michael; Thiede, Hanne

    2006-01-01

    We examined pharmacists’ attitudes and practices related to syringe sales to injection drug users before and after legal reform and local programming to enhance sterile syringe access. We replicated a 1996 study by conducting pharmacist phone surveys and syringe test-buys in randomly selected pharmacies. Test-buy success increased from 48% in 1996 to 65% in 2003 (P=.04). Pharmacists agreeing that syringes should be available to injection drug users through pharmacy purchase increased from 49% to 71% (P<.01). Pharmacy policies and pharmacist attitudes were strongly associated with syringe access. Structural changes, including policy reform and pharmacy outreach, appear to increase syringe access. Interventions should address pharmacy policies and pharmacist attitudes and policies. PMID:16809607

  13. MO19390 (SAiL): bleeding events in a phase IV study of first-line bevacizumab with chemotherapy in patients with advanced non-squamous NSCLC.

    PubMed

    Dansin, Eric; Cinieri, Saverio; Garrido, Pilar; Griesinger, Frank; Isla, Dolores; Koehler, Manfred; Kohlhaeufl, Martin

    2012-06-01

    The clinical benefit and safety profile associated with first-line bevacizumab with doublet chemotherapy in patients with advanced non-squamous non-small cell lung cancer (NSCLC) was established in two large phase III studies, E4599 and AVAiL. SAiL, a single-arm phase IV study, was conducted to evaluate bevacizumab with a range of first-line chemotherapy regimens in a routine oncology practice setting. This analysis of the SAiL data was undertaken to specifically evaluate bleeding adverse events (AEs) in this study, and to explore potential associations between bleeding and baseline patient and disease characteristics. In total, 2212 patients were evaluated. Bleeding AEs (any grade) occurred in 38.2% of patients (grade ≥ 3 bleeding AEs: 3.6%). Grade ≥ 3 pulmonary hemorrhage and central nervous system bleeding events were observed in 0.7% and 0.1% of patients, respectively. The incidence of grade ≥ 3 bleeding AEs was comparable across patient subgroups defined by central tumor location, tumor cavitation, histology, concomitant anticoagulation therapy and age. The majority (88.6%) of bleeding events resolved or improved, 10.2% persisted and 1.3% led to death; 10.2% of bleeding events required bevacizumab interruption or discontinuation. This analysis from the SAiL trial reaffirms a comparable incidence of clinically significant bleeding associated with first-line bevacizumab and chemotherapy as previous phase III studies in NSCLC patients despite less stringent first-line selection criteria. Grade ≥ 3 bleeding appears to be comparable when analyzed for patient and tumor characteristics, including tumor cavitation and concomitant anticoagulation therapy. Most bleeding events resolved or improved, and interruption/discontinuation of bevacizumab was infrequent in a standard oncology practice setting. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  14. A strategy for the prevention of protein oxidation by drug product in polymer-based syringes.

    PubMed

    Nakamura, Koji; Abe, Yoshihiko; Kiminami, Hideaki; Yamashita, Arisa; Iwasaki, Kazuhiro; Suzuki, Shigeru; Yoshino, Keisuke; Dierick, William; Constable, Kevin

    2015-01-01

    Recently, new and advanced ideas have been presented on the value of polymer-based syringes for improved safety, better strength, reduced aggregation, and the prevention of drug degradation. In this report, our findings on drug degradation from protein oxidation will be presented and discussed. Commonly, dissolved oxygen is one of the factors for causing protein degradation. Due to the nature of higher gas permeability in polymer-based syringes, it was thought to be difficult to control the oxygen level during storage. However, this report demonstrates the appropriateness of combining the use of an oxygen absorber within the secondary packaging as a deoxygenated packaging system. In addition, this report suggests that another factor to enhance protein oxidization is related to radicals on the syringe barrel from sterilization by irradiation. We demonstrate that steam sterilization can minimize protein oxidization, as the protein filled in steam sterilized syringe is much more stable. In conclusion, the main oxidation pathway of a protein has been identified as dissolved oxygen and radical generation within a polymer container. Possible solutions are herewith presented for controlling oxidation by means of applying a deoxygenated packaging system as well as utilizing steam sterilization as a method of sterilization for prefillable polymer syringes. There have been many presentations and discussions about the risks associated with glass prefilled syringes. Advanced ideas are being presented on the value of polymer-based syringes for improved safety, better strength, reduced protein aggregation, and the prevention of drug degradation. Drug degradation based on protein oxidation is discussed in this report. Identification of the main factors causing this degradation and possible solutions available by using polymer-based syringes will be presented. The causes of protein oxidation have been identified as dissolved oxygen and radicals generated by the applied method of

  15. Syringe Injectable Electronics: Precise Targeted Delivery with Quantitative Input/Output Connectivity.

    PubMed

    Hong, Guosong; Fu, Tian-Ming; Zhou, Tao; Schuhmann, Thomas G; Huang, Jinlin; Lieber, Charles M

    2015-10-14

    Syringe-injectable mesh electronics with tissue-like mechanical properties and open macroporous structures is an emerging powerful paradigm for mapping and modulating brain activity. Indeed, the ultraflexible macroporous structure has exhibited unprecedented minimal/noninvasiveness and the promotion of attractive interactions with neurons in chronic studies. These same structural features also pose new challenges and opportunities for precise targeted delivery in specific brain regions and quantitative input/output (I/O) connectivity needed for reliable electrical measurements. Here, we describe new results that address in a flexible manner both of these points. First, we have developed a controlled injection approach that maintains the extended mesh structure during the "blind" injection process, while also achieving targeted delivery with ca. 20 μm spatial precision. Optical and microcomputed tomography results from injections into tissue-like hydrogel, ex vivo brain tissue, and in vivo brains validate our basic approach and demonstrate its generality. Second, we present a general strategy to achieve up to 100% multichannel I/O connectivity using an automated conductive ink printing methodology to connect the mesh electronics and a flexible flat cable, which serves as the standard "plug-in" interface to measurement electronics. Studies of resistance versus printed line width were used to identify optimal conditions, and moreover, frequency-dependent noise measurements show that the flexible printing process yields values comparable to commercial flip-chip bonding technology. Our results address two key challenges faced by syringe-injectable electronics and thereby pave the way for facile in vivo applications of injectable mesh electronics as a general and powerful tool for long-term mapping and modulation of brain activity in fundamental neuroscience through therapeutic biomedical studies.

  16. Solitomab, an epithelial cell adhesion molecule/CD3 bispecific antibody (BiTE), is highly active against primary chemotherapy-resistant ovarian cancer cell lines in vitro and fresh tumor cells ex vivo.

    PubMed

    English, Diana P; Bellone, Stefania; Schwab, Carlton L; Roque, Dana M; Lopez, Salvatore; Bortolomai, Ileana; Cocco, Emiliano; Bonazzoli, Elena; Chatterjee, Sudeshna; Ratner, Elena; Silasi, Dan-Arin; Azodi, Masoud; Schwartz, Peter E; Rutherford, Thomas J; Santin, Alessandro D

    2015-02-01

    Solitomab is a novel, bispecific, single-chain antibody that targets epithelial cell adhesion molecule (EpCAM) on tumor cells and also contains a cluster of differentiation 3 (CD3) (T-cell coreceptor) binding region. The authors evaluated the in vitro activity of solitomab against primary chemotherapy-resistant epithelial ovarian carcinoma cell lines as well as malignant cells in ascites. EpCAM expression was evaluated by flow cytometry in 5 primary ovarian cancer cell lines and in 42 fresh ovarian tumor cell cultures in ascites from patients with mainly advanced or recurrent, chemotherapy-resistant disease. The potential activity of solitomab against EpCAM-positive tumor cells was evaluated by flow cytometry, proliferation, and 4-hour chromium-release, cell-mediated cytotoxicity assays. EpCAM expression was detected by flow cytometry in approximately 80% of the fresh ovarian tumors and primary ovarian tumor cell lines tested. EpCAM-positive, chemotherapy-resistant cell lines were identified as resistant to natural killer cell-mediated or T-cell-mediated killing after exposure to peripheral blood lymphocytes in 4-hour chromium-release assays (mean±standard error of the mean, 3.6%±0.7% of cells killed after incubation of EpCAM-positive cell lines with control bispecific antibody). In contrast, after incubation with solitomab, EpCAM-positive, chemotherapy-resistant cells became highly sensitive to T-cell cytotoxicity (mean±standard error of the mean, 28.2%±2.05% of cells killed; P<.0001) after exposure to peripheral blood lymphocytes. Ex vivo incubation of autologous tumor-associated lymphocytes with EpCAM-expressing malignant cells in ascites with solitomab resulted in a significant increase in T-cell activation markers and a reduction in the number of viable ovarian tumor cells in ascites (P<.001). Solitomab may represent a novel, potentially effective agent for the treatment of chemotherapy-resistant ovarian cancers that overexpress EpCAM. © 2014 American

  17. Decreased Odds of Injection Risk Behavior Associated With Direct Versus Indirect Use of Syringe Exchange: Evidence From Two California Cities.

    PubMed

    Behrends, Czarina N; Li, Chin-Shang; Gibson, David R

    2017-07-29

    While there is substantial evidence that syringe exchange programs (SEPs) are effective in preventing HIV among people who inject drugs (PWID), nearly all the evidence comes from PWID who obtain syringes from an SEP directly. Much less is known about the benefits of secondary exchange to PWID who get syringes indirectly from friends or acquaintances who visit an SEP for them. We evaluated the effectiveness of direct versus indirect syringe exchange in reducing HIV-related high-risk injecting behavior among PWID in two separate studies conducted in Sacramento and San Jose, California, cities with quite different syringe exchange models. In both studies associations between direct and indirect syringe exchange and self-reported risk behavior were examined with multivariable logistic regression models. Study 1 assessed effects of a "satellite" home-delivery syringe exchange in Sacramento, while Study 2 evaluated a conventional fixed-site exchange in San Jose. Multivariable analyses revealed 95% and 69% reductions, respectively, in high-risk injection associated with direct use of the SEPs in Sacramento and San Jose, and a 46% reduction associated with indirect use of the SEP in Sacramento. Conclusions/Importance: The very large effect of direct SEP use in Sacramento was likely due in part to home delivery of sterile syringes. While more modest effects were associated with indirect use, such use nevertheless is valuable in reducing the risk of HIV transmission of PWID who are unable or unwilling to visit a syringe exchange.

  18. Effectiveness of gabapentin pharmacotherapy in chemotherapy-induced peripheral neuropathy.

    PubMed

    Magnowska, Magdalena; Iżycka, Natalia; Kapoła-Czyż, Joanna; Romała, Anna; Lorek, Jakub; Spaczyński, Marek; Nowak-Markwitz, Ewa

    2018-01-01

    Chemotherapy-induced peripheral neuropathy (CIPN) is a common chemotherapy side effect, but its prevention and treatment remains a challenge. Neurotoxicity may lead to dose limitation or even treatment discontinuation, and therefore potentially affect the efficacy of anticancer treatment and long term outcomes. The practice to administer gabapentin for neuropathy may be applicable, but is limited by insufficient studies. The aim of our study was to assess the presence of chemotherapy-induced peripheral neuropathy in ovarian cancer patients treated with first-line paclitaxel and carboplatin chemotherapy and evaluate the effectiveness of gabapentin in treatment of this condition. 61 ovarian cancer patients treated with first line chemotherapy were included in the study. The first phase of the study was to assess neurological condition of each patient by: neuropathy symptoms scale, McGill's scale, neurological deficit and quality of life, during the chemotherapy. In the second phase of the study we evaluated the response to gabapentin treatment in a group of patients who developed neuropathy. 78.7% of the patients developed chemotherapy related neuropathy. During the course of chemotherapy these patients experienced significant exacerbation of neuropathy symptoms (p < 0.0001), neuropathic pain (p < 0.0001), neurologic deficit (p < 0.0012) and worsening of quality of life (p < 0.0002). Patients who were qualified to undergo the gabapentin treatment observed improvement in symptoms (p < 0.027), pain (p < 0.027) and neurologic deficit (p < 0.019). Quality of life did not change significantly after gabapentin treatment (p < 0.128). Chemotherapy substantially deteriorates the neurologic condition of the patients and the quality of life. Paclitaxel and carboplatin treated patients may benefit from gabapentin therapy in chemotherapy-induced peripheral neuropathy.

  19. 21 CFR 870.1650 - Angiographic injector and syringe.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Angiographic injector and syringe. 870.1650 Section 870.1650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1650 Angiographic...

  20. 21 CFR 870.1650 - Angiographic injector and syringe.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Angiographic injector and syringe. 870.1650 Section 870.1650 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1650 Angiographic...

  1. Making a difference? Applying Vitellone's Social Science of the Syringe to performance and image enhancing drug injecting.

    PubMed

    Hart, Aaron

    2018-04-18

    Vitellone's Social Science of the Syringe investigates epistemologies of injecting drug use. She argues for a methodology that can be simultaneously sensitive to biopolitical power regimes; the trajectories of social stratification; and the resistance, creativity and dignity of human agency. She proposes a methodological focus on the syringe-in-use as an active participant in these dynamics. Harm reduction policy and service provision frameworks have paid little attention to the phenomena of performance and image enhancing drug (PIEDs) injection. One way of assessing the merit of Vitellone's proposal is to use it to investigate these phenomena. I argue that Vitellone's method can be used to articulate a range of significant differences between people who inject PIEDs and other people who inject drugs, and that these differences can inform harm reduction initiatives. When compared to the heroin syringe, the PIED syringe participates in different socio-economic and material contexts, gendered identities, and biopolitical governance regimes. These differences materialise in different rates of syringe sharing and blood-borne virus transmission; and different experiences of needle exchange services. I offer a thought experiment demonstrating how a different syringe might alter the structural dynamics, biopolitical governance, and the agentic choices of people who inject PIEDs. Judging by the productive effects of diffracting Vitellone's analysis through an empirical concern with PIED injecting, I concur with Vitellone's proposition that 'something objective may be gained from an empirical investigation of the syringe-in-use' (p. 33). Copyright © 2018 Elsevier B.V. All rights reserved.

  2. Sharing of Needles and Syringes among Men Who Inject Drugs: HIV Risk in Northwest Bangladesh.

    PubMed

    Pasa, M Kamal; Alom, Kazi Robiul; Bashri, Zubaida; Vermund, Sten H

    2016-01-01

    Injection drug use is prevalent in northwestern Bangladesh. We sought to explore the context of needle/syringe sharing among persons who inject drugs (PWID), examining risk exposures to blood-borne infections like the human immunodeficiency virus (HIV) and hepatitis in a region where these dual epidemics are likely to expand. We used a qualitative research approach to learn about injection practices, conducting 60 in-depth interviews among PWID. We then conducted 12 focus group discussions (FGDs) that generated a checklist of salient issues, and followed up with personal observations of typical days at the drug-use venues. Content and interpretative frameworks were used to analyze qualitative information and socio-demographic information, using SPSS software. We found that needle/syringe-sharing behaviours were integrated into the overall social and cultural lives of drug users. Sharing behaviours were an central component of PWID social organization. Sharing was perceived as an inherent element within reciprocal relationships, and sharing was tied to beliefs about drug effects, economic adversity, and harassment due to their drug user status. Carrying used needles/syringes to drug-use venues was deemed essential since user-unfriendly needle-syringe distribution schedules of harm reduction programmes made it difficult to access clean needles/syringes in off-hours. PWID had low self-esteem. Unequal power relationships were reported between the field workers of harm reduction programmes and PWID. Field workers expressed anti-PWID bias and judgmental attitudes, and also had had misconceptions about HIV and hepatitis transmission. PWID were especially disturbed that no assistance was forthcoming from risk reduction programme staff when drug users manifested withdrawal symptoms. Interventions must take social context into account when scaling up programmes in diverse settings. The social organization of PWID include values that foster needle-syringe sharing. Utilization

  3. Vinorelbine as first-line chemotherapy for metastatic breast carcinoma.

    PubMed

    Romero, A; Rabinovich, M G; Vallejo, C T; Perez, J E; Rodriguez, R; Cuevas, M A; Machiavelli, M; Lacava, J A; Langhi, M; Romero Acuña, L

    1994-02-01

    A phase II trial was performed to evaluate the efficacy and toxicity of vinorelbine (VNB) as first-line chemotherapy for metastatic breast carcinoma. Between August 1991 and February 1993, 45 patients with metastatic breast cancer were entered onto the study. Therapy consisted of VNB 30 mg/m2 diluted in 500 mL of normal saline administered as a 1-hour intravenous infusion. Injections were repeated weekly until evidence of progressive disease (PD) or severe toxicity developed. One patient was considered not assessable for response. An objective response (OR) was observed in 18 of 44 patients (41%; 95% confidence interval, 26% to 56%). Three patients (7%) had a complete response (CR) and 15 (34%) had a partial response (PR). The median time to treatment failure for the entire group was 6 months (range, 1 to 15), and the median duration of response was 9 months (range, 1 to 15). The median survival duration has not been reached yet. There were no treatment-related deaths. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 35 patients (78%) and was grade 3 or 4 in 16 (36%). Phlebitis was observed in 19 of 29 patients (66%) who did not have central implantable venous systems. Fifteen patients (33%) developed peripheral neurotoxicity. Myalgia occurred in 20 patients (44%). VNB is an active drug against metastatic breast cancer with moderate toxicity, which justifies further evaluation in association with other agents.

  4. Stability of erythropoietin repackaging in polypropylene syringes for clinical use.

    PubMed

    Marsili, Angela; Puorro, Giorgia; Pane, Chiara; de Rosa, Anna; Defazio, Giovanni; Casali, Carlo; Cittadini, Antonio; de Michele, Giuseppe; Florio, Brunello Ettore; Filla, Alessandro; Saccà, Francesco

    2017-02-01

    Introduction: Epoetin alfa (Eprex®) is a subcutaneous, injectable formulation of short half-life recombinant human erythropoietin (rHuEPO). To current knowledge there are no published studies regarding the stability of rHuEPO once repackaging occurs (r-EPO) for clinical trial purposes. Materials and methods: We assessed EPO concentration in Eprex® and r-EPO syringes at 0, 60, 90, and 120 days after repackaging in polypropylene syringes. R-EPO was administered to 56 patients taking part in a clinical trial in Friedreich Ataxia. Serum EPO levels were measured at baseline and 48 h after r-EPO administration. Results: No differences were found between r-EPO and Eprex® syringes, but both globally decreased in total EPO content during storage at 4 °C. Patients receiving r-EPO had similar levels in EPO content as expected from previous trials in Friedreich Ataxia and from pharmacokinetics studies in healthy volunteers. Discussion: We demonstrate that repackaging of EPO does not alter its concentration if compared to the original product (Eprex®). This is true both for repackaging procedures and for the stability in polypropylene tubes. The expiration date of r-EPO can be extended from 1 to 4 months after repackaging, in accordance with pharmacopeia rules.

  5. Leukemia following cisplatin-based chemotherapy for ovarian carcinoma at Roswell Park.

    PubMed

    Sprance, H E; Hempling, R E; Piver, M S

    1992-01-01

    Three cases of leukemia following cisplatin-based chemotherapy are reported. All three patients received cyclophosphamide, a known leukemogen. In two cases, the leukemia was diagnosed after second line chemotherapy with intraperitoneal cisplatin and cytarabine, one of which is the first report of a chronic granulocytic leukemia as a result of cytotoxic chemotherapy.

  6. Investigation of Two Prototypes of Novel Noncontact Technologies for Automated Real-Time Capture of Incremental Drug Administration Data From Syringes.

    PubMed

    Eagle, Benjamin; Williams, David J; Dingley, John

    2017-08-01

    An ideal electronic anesthesia recording system would be capable of not only recording physiological data but also injectable drug doses given, including those given incrementally from one syringe, without recourse to manual data entry. We compared 2 prototype devices which wirelessly recognized individual syringes and measured changes in their plunger positions via 2 different optical noncontact means, allowing calculation of incremental drug doses given. Both devices incorporated a radio-frequency identification reader, which wirelessly read a unique code from a radio-frequency identification tag within syringe drug labels. A custom-designed cradle oriented any inserted 1-mL to 20-mL syringe in a repeatable position. The "laser" device had a moving laser beam broken by the end of the syringe plunger. The infrared (IR) device measured time of travel of IR light from a sender to a syringe plunger and back to a receiver. Both devices could therefore determine the drug and volume administered since the previous occasion when any syringe had been used. For each syringe size of 1, 2, 5, 10, and 20 mL, 121 plunger-length measurements were made over their full range, with each machine against a reference method of water filling and weighing using a randomized de Bruijn sequence. For every syringe size, the laser device showed greater accuracy and precision, lower bias, and narrower limits of agreement (95% confidence intervals = bias ± 1.96 SD) than the IR device when compared to the reference method. For all syringe sizes, the range of bias was -0.05 to 0.32 mL for the laser and -2.42 to 1.38 mL for the IR. Lin concordance correlation coefficient values for the IR versus reference methods ranged from 0.6259 to 0.9255, with the lowest coefficients seen in syringes with the shortest distance of plunger travel (2 and 5 mL), while in laser versus reference comparisons, these coefficients were similar (0.9641-0.9981) over all syringe lengths. Both devices measured syringe

  7. Non-Prescription Naloxone and Syringe Sales in the Midst of Opioid Overdose and Hepatitis C Virus Epidemics: Massachusetts, 2015

    PubMed Central

    Stopka, Thomas J.; Donahue, Ashley; Hutcheson, Marguerite; Green, Traci C.

    2017-01-01

    Objectives To determine the prevalence of non-prescription naloxone and sterile syringe sales, factors associated with non-prescription sales, geospatial access to non-prescription naloxone and syringe selling pharmacies, and targets for potential interventions. Design Cross-sectional study. Setting and Participants Massachusetts has experienced steep increases in reported opioid overdoses and hepatitis C virus (HCV) cases in the past decade. Pharmacists have the potential to play a substantial role in increasing access to non-prescription naloxone and sterile syringes, which can reverse opioid overdoses and decrease HCV transmission, respectively. We completed brief telephone surveys with 809 of 1,042 retail pharmacies across Massachusetts (response rate=77.6%) during 2015 to assess experience with non-prescription sales of naloxone and sterile syringes. Outcome Measures Our primary outcomes were the stocking and selling of naloxone in the pharmacy (yes/no) for non-prescription sales, and non-prescription syringe sales (yes/no). We conducted multivariable regression analyses and created maps using a geographic information system (GIS) to identify factors associated with non-prescription sales of naloxone and sterile syringes, and to improve our understanding geospatial access to pharmacy-based naloxone and syringe sales. Results Over 97% of pharmacies reported selling sterile syringes without requiring a prescription and 45% of pharmacies reported stocking and selling naloxone. Factors associated with non-prescription sales included: hours of operation, experience with and interest in harm reduction activities, and presence in an opioid overdose hotspot. Geographic access to non-prescription sale of sterile syringes is wide-spread, while geospatial access to naloxone is more limited. Training to better understand the benefits, applications, and distribution needs of naloxone is of interest to surveyed pharmacists. Conclusion Access to sterile syringes through non

  8. Mutational Landscape of cfDNA Identifies Distinct Molecular Features Associated With Therapeutic Response to First-Line Platinum-Based Doublet Chemotherapy in Patients with Advanced NSCLC

    PubMed Central

    Jiang, Tao; Li, Xuefei; Wang, Jianfei; Su, Chunxia; Han, Wenbo; Zhao, Chao; Wu, Fengying; Gao, Guanghui; Li, Wei; Chen, Xiaoxia; Li, Jiayu; Zhou, Fei; Zhao, Jing; Cai, Weijing; Zhang, Henghui; Du, Bo; Zhang, Jun; Ren, Shengxiang; Zhou, Caicun; Yu, Hui; Hirsch, Fred R.

    2017-01-01

    Rationale To investigate whether the mutational landscape of circulating cell-free DNA (cfDNA) could predict and dynamically monitor the response to first-line platinum-based chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). Methods Eligible patients were included and blood samples were collected from a phase III trial. Both cfDNA fragments and fragmented genomic DNA were extracted for enrichment in a 1.15M size panel covering exon regions of 1,086 genes. Molecular mutational burden (MMB) was calculated to investigate the relationship between molecular features of cfDNA and response to chemotherapy. Results In total, 52 eligible cases were enrolled and their blood samples were prospectively collected at baseline, every cycle of chemotherapy and time of disease progression. At baseline, alterations of 17 genes were found. Patients with partial response (PR) had significantly lower baseline MMB of these genes than those patients with either stable disease (SD) (P = 0.0006) or progression disease (PD) (P = 0.0074). Further analysis revealed that the mutational landscape of cfDNA from pretreatment blood samples were distinctly different among patients with PR vs. SD/PD. For patients with baseline TP53 mutation, those with PR experienced a significant reduction in MMB whereas patients with SD or PD experienced an increase after two, three or four cycles of chemotherapy. Furthermore, patients with low MMB had superior response rate and significantly longer progression-free survival than those with high MMB. Conclusion This study indicated that the mutational landscape of cfDNA has potential clinical value to predict the therapeutic response to first-line platinum-based doublet chemotherapy in NSCLC patients. At the single gene level, dynamic change of molecular mutational burden of TP53 is valuable to monitor efficacy (and, therefore, might aid in early recognition of resistance and relapse) in patients harboring this mutation at baseline. PMID

  9. Clinical value of circulating endothelial cell levels in metastatic colorectal cancer patients treated with first-line chemotherapy and bevacizumab.

    PubMed

    Malka, D; Boige, V; Jacques, N; Vimond, N; Adenis, A; Boucher, E; Pierga, J Y; Conroy, T; Chauffert, B; François, E; Guichard, P; Galais, M P; Cvitkovic, F; Ducreux, M; Farace, F

    2012-04-01

    We investigated whether circulating endothelial cells (CECs) predict clinical outcome of first-line chemotherapy and bevacizumab in metastatic colorectal cancer (mCRC) patients. In a substudy of the randomized phase II FNCLCC ACCORD 13/0503 trial, CECs (CD45- CD31+ CD146+ 7-amino-actinomycin- cells) were enumerated in 99 patients by four-color flow cytometry at baseline and after one cycle of treatment. We correlated CEC levels with objective response rate (ORR), 6-month progression-free survival (PFS) rate (primary end point of the trial), PFS, and overall survival (OS). Multivariate analyses of potential prognostic factors, including CEC counts and Köhne score, were carried out. By multivariate analysis, high baseline CEC levels were the only independent prognostic factor for 6-month PFS rate (P < 0.01) and were independently associated with worse PFS (P = 0.02). High CEC levels after one cycle were the only independent prognostic factor for ORR (P = 0.03). High CEC levels at both time points independently predicted worse ORR (P = 0.025), 6-month PFS rate (P = 0.007), and PFS (P = 0.02). Köhne score was the only variable associated with OS. CEC levels at baseline and after one treatment cycle may independently predict ORR and PFS in mCRC patients starting first-line bevacizumab and chemotherapy.

  10. Potential air contamination during CO2 angiography using a hand-held syringe: theoretical considerations and gas chromatography.

    PubMed

    Cho, David R; Cho, Kyung J; Hawkins, Irvin F

    2006-01-01

    To assess air contamination in the hand-held syringes currently used for CO2 delivery and to determine whether there is an association between their position and the rate of air contamination. Assessment of air contamination in the syringe (20 ml) included theoretical modeling, mathematical calculation, and gas chromatography (GC). The model was used with Fick's first law to calculate the diffusion of CO2 and the amount of air contamination. For GC studies, the syringes were placed in the upright, horizontal, and inverted positions and gas samples were obtained after 5, 10, 20, 30, and 60 min. All trials with each position for each sampling time were performed five times. The amounts of air contamination with time calculated mathematically were 5-10% less than those of GC. With the diffusivity of air-CO2 at 0.1599 cm2/sec (9.594 cm2/min), air contamination was calculated to be 60% at 60 min. With GC air contamination was 13% at 5 min, 31% at 20 min, 43% at 30 min, and 68% at 60 min. There was no difference in air contamination between the different syringe positions. Air contamination occurs in hand-held syringes filled with CO2 when they are open to the ambient air. The amounts of air contamination over time are similar among syringes placed in the upright, horizontal, and inverted positions.

  11. InfuShield: a shielded enclosure for administering therapeutic radioisotope treatments using standard syringe pumps

    PubMed Central

    Pratt, Brenda E.; Chittenden, Sarah J.; Murray, Iain S.; Causer, Louise; Grey, Matthew J.; Gear, Jonathan I.; Du, Yong; Flux, Glenn D.

    2017-01-01

    The administration of radionuclide therapies presents significant radiation protection challenges. The aim of this work was to develop a delivery system for intravenous radioisotope therapies to substantially moderate radiation exposures to staff and operators. A novel device (InfuShield) was designed and tested before being used clinically. The device consists of a shielded enclosure which contains the therapeutic activity and, through the hydraulic action of back-to-back syringes, allows the activity to be administered using a syringe pump external to the enclosure. This enables full access to the pump controls while simultaneously reducing dose to the operator. The system is suitable for use with all commercially available syringe pumps and does not require specific consumables, maximising both the flexibility and economy of the system. Dose rate measurements showed that at key stages in an 131I mIBG treatment procedure, InfuShield can reduce dose to operators by several orders of magnitude. Tests using typical syringes and infusion speeds show no significant alteration in administered flow rates (maximum of 1.2%). The InfuShield system provides a simple, safe and low cost method of radioisotope administration. PMID:28187040

  12. OPTIMAL and ENSURE trials-based combined cost-effectiveness analysis of erlotinib versus chemotherapy for the first-line treatment of Asian patients with non-squamous non-small-cell lung cancer

    PubMed Central

    Zhang, Pengfei; Hutton, David; Li, Qiu

    2018-01-01

    Objectives Erlotinib, the first generation of epidermoid growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has been recommended as an essential treatment in patients with non-small-cell lung cancer (NSCLC) with EGFR mutation. Although it has improved progression-free survival (PFS), overall survival (OS) was limited and erlotinib can be expensive. This cost-effectiveness analysis compares erlotinib monotherapy with gemcitabine-included doublet chemotherapy. Setting First-line treatment of Asian patients with NSCLC with EGFR mutation. Methods A Markov model was created based on the results of the ENSURE (NCT01342965) and OPTIMAL (CTONG-0802) trials which evaluated erlotinib and chemotherapy. The model simulates cancer progression and all causes of death. All medical costs were calculated from the perspective of the Chinese healthcare system. Main outcome measures The primary outcomes are costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Results The combined PFS was 11.81 months and 5.1 months for erlotinib and chemotherapy, respectively, while the OS was reversed at 24.68 months for erlotinib and 26.16 months for chemotherapy. The chemotherapy arm gained 0.13 QALYs compared with erlotinib monotherapy (1.17 QALYs vs 1.04 QALYs), while erlotinib had lower costs ($55 230 vs $77 669), resulting in an ICER of $174 808 per QALY for the chemotherapy arm, which exceeds three times the Chinese GDP per capita. The most influential factors were the health utility of PFS, the cost of erlotinib and the health utility of progressed disease. Conclusion Erlotinib monotherapy may be acceptable as a cost-effective first-line treatment for NSCLC compared with gemcitabine-based chemotherapy. The results were robust to changes in assumptions. Trial registration number NCT01342965 and CTONG-0802. PMID:29654023

  13. Bevacizumab continuation versus no continuation after first-line chemotherapy plus bevacizumab in patients with metastatic colorectal cancer: a randomized phase III non-inferiority trial (SAKK 41/06).

    PubMed

    Koeberle, D; Betticher, D C; von Moos, R; Dietrich, D; Brauchli, P; Baertschi, D; Matter, K; Winterhalder, R; Borner, M; Anchisi, S; Moosmann, P; Kollar, A; Saletti, P; Roth, A; Frueh, M; Kueng, M; Popescu, R A; Schacher, S; Hess, V; Herrmann, R

    2015-04-01

    Chemotherapy plus bevacizumab is a standard option for first-line treatment in metastatic colorectal cancer (mCRC) patients. We assessed whether no continuation is non-inferior to continuation of bevacizumab after completing first-line chemotherapy. In an open-label, phase III multicentre trial, patients with mCRC without disease progression after 4-6 months of standard first-line chemotherapy plus bevacizumab were randomly assigned to continuing bevacizumab at a standard dose or no treatment. CT scans were done every 6 weeks until disease progression. The primary end point was time to progression (TTP). A non-inferiority limit for hazard ratio (HR) of 0.727 was chosen to detect a difference in TTP of 6 weeks or less, with a one-sided significance level of 10% and a statistical power of 85%. The intention-to-treat population comprised 262 patients: median follow-up was 36.7 months. The median TTP was 4.1 [95% confidence interval (CI) 3.1-5.4] months for bevacizumab continuation versus 2.9 (95% CI 2.8-3.8) months for no continuation; HR 0.74 (95% CI 0.58-0.96). Non-inferiority could not be demonstrated. The median overall survival was 25.4 months for bevacizumab continuation versus 23.8 months (HR 0.83; 95% CI 0.63-1.1; P = 0.2) for no continuation. Severe adverse events were uncommon in the bevacizumab continuation arm. Costs for bevacizumab continuation were estimated to be ∼30,000 USD per patient. Non-inferiority could not be demonstrated for treatment holidays versus continuing bevacizumab monotheray, after 4-6 months of standard first-line chemotherapy plus bevacizumab. Based on no impact on overall survival and increased treatment costs, bevacizumab as a single agent is of no meaningful therapeutic value. More efficient treatment approaches are needed to maintain control of stabilized disease following induction therapy. ClinicalTrials.gov, number NCT00544700. © The Author 2015. Published by Oxford University Press on behalf of the European Society for

  14. Romiplostim for Immune Thrombocytopenia in Neuroblastoma Patients Receiving Chemotherapy.

    PubMed

    Fassel, Hannah; Bussel, James B; Roberts, Stephen S; Modak, Shakeel

    2018-04-20

    Thrombocytopenia, a serious complication of myelosuppressive chemotherapy in cancer patients, is managed with platelet transfusions until recovery of platelet counts. However, children receiving chemotherapy can rarely develop immune thrombocytopenia (ITP) that is refractory to transfused platelets. This limits the ability to achieve adequate platelet counts and administer further myelosuppressive chemotherapy safely, especially if first-line ITP therapy is ineffective. We report 2 cases of intravenous immunoglobulin refractory ITP in children receiving chemotherapy for high-risk neuroblastoma. ITP was successfully treated with the thrombopoietin-receptor-agonist romiplostim, allowing safe and timely continuation of antineuroblastoma therapies in these high-risk patients.

  15. Effects of police confiscation of illicit drugs and syringes among injection drug users in Vancouver.

    PubMed

    Werb, Daniel; Wood, Evan; Small, Will; Strathdee, Steffanie; Li, Kathy; Montaner, Julio; Kerr, Thomas

    2008-08-01

    Drug market policing has been associated with various harms among injection drug users (IDU). However, little is known about instances in which drugs and injecting equipment are confiscated from IDU in the absence of a formal arrest. We examined factors associated with being stopped, searched, or detained by police among participants in the Vancouver Injection Drug Users Study (VIDUS) using logistic regression. We also examined actions taken by study participants immediately following instances in which drugs or syringes were confiscated by police. Among 465 active IDU, 130 (28.0%) reported being detained by police in the last 6 months without being arrested. In multivariate logistic regression analysis, factors associated with being stopped, searched or detained by police included homelessness (Adjusted Odds Ratio [AOR]=3.96, 95% CI: 1.86-8.45), recent incarceration (AOR=3.52, 95% CI: 1.75-7.10), frequent crack use (AOR=2.24, 95% CI: 1.34-3.74), requiring help injecting (AOR=5.20, 95% CI: 1.21-22.39), and lending syringes (AOR=3.18, 95% CI: 1.09-9.30). Of those who reported being detained, 34% participants reported having had drugs confiscated, and 70% of these reported that they immediately acquired more drugs. Fifty-one percent of participants who reported being detained also reported having had syringes confiscated, and of this group, 6% reported immediately borrowing used syringes. Our study demonstrates that the IDU most affected by street-level policing tend to possess various characteristics, such as homelessness, that place them at heightened risk for various adverse health outcomes. Our findings also suggest that the confiscation of drugs and/or needles and syringes through discretionary policing practices have the potential to exacerbate drug market activity or prompt increased syringe borrowing. These findings indicate the need for ongoing evaluation of the public health impacts of discretionary policing approaches.

  16. The predictive value of 53BP1 and BRCA1 mRNA expression in advanced non-small-cell lung cancer patients treated with first-line platinum-based chemotherapy

    PubMed Central

    Bonanno, Laura; Costa, Carlota; Majem, Margarita; Sanchez, Jose Javier; Gimenez-Capitan, Ana; Rodriguez, Ignacio; Vergenegre, Alain; Massuti, Bartomeu; Favaretto, Adolfo; Rugge, Massimo; Pallares, Cinta; Taron, Miquel; Rosell, Rafael

    2013-01-01

    Platinum-based chemotherapy is the standard first-line treatment for non-oncogene-addicted non-small cell lung cancers (NSCLCs) and the analysis of multiple DNA repair genes could improve current models for predicting chemosensitivity. We investigated the potential predictive role of components of the 53BP1 pathway in conjunction with BRCA1. The mRNA expression of BRCA1, MDC1, CASPASE3, UBC13, RNF8, 53BP1, PIAS4, UBC9 and MMSET was analyzed by real-time PCR in 115 advanced NSCLC patients treated with first-line platinum-based chemotherapy. Patients expressing low levels of both BRCA1 and 53BP1 obtained a median progression-free survival of 10.3 months and overall survival of 19.3 months, while among those with low BRCA1 and high 53BP1 progression-free survival was 5.9 months (P <0.0001) and overall survival was 8.2 months (P=0.001). The expression of 53BP1 refines BRCA1-based predictive modeling to identify patients most likely to benefit from platinum-based chemotherapy. PMID:24197907

  17. Smart syringe pumps for drug infusion during dental intravenous sedation

    PubMed Central

    Lee, Kiyoung

    2016-01-01

    Dentists often sedate patients in order to reduce their dental phobia and stress during dental treatment. Sedatives are administered through various routes such as oral, inhalation, and intravenous routes. Intravenous administration has the advantage of rapid onset of action, predictable duration of action, and easy titration. Typically, midazolam, propofol or dexmedetomidine are used as intravenous sedatives. Administration of these sedatives via infusion by using a syringe pump is more effective and successful than infusing them as a bolus. However, during intravenous infusion of sedatives or opioids using a syringe pump, fatal accidents may occur due to the clinician's carelessness. To prevent such risks, smart syringe pumps have been introduced clinically. They allow clinicians to perform effective sedation by using a computer to control the dose of the drug being infused. To ensure patient safety, various alarm features along with a drug library, which provides drug information and prevents excessive infusion by limiting the dose, have been added to smart pumps. In addition, programmed infusion systems and target-controlled infusion systems have also been developed to enable effective administration of sedatives. Patient-controlled infusion, which allows a patient to control his/her level of sedation through self-infusion, has also been developed. Safer and more successful sedation may be achieved by fully utilizing these new features of the smart pump. PMID:28884149

  18. Efficacy of icotinib versus traditional chemotherapy as first-line treatment for preventing brain metastasis from advanced lung adenocarcinoma in patients with epidermal growth factor receptor-sensitive mutation.

    PubMed

    Zhao, Xiao; Zhu, Guangqin; Chen, Huoming; Yang, Ping; Li, Fang; Du, Nan

    2016-01-01

    This study aimed to investigate the potential use of icotinib as first-line treatment to prevent brain metastasis from advanced lung adenocarcinoma. This investigation was designed as a retrospective nonrandomized controlled study. Enrolled patients received either icotinib or traditional chemotherapy as their first-line treatment. The therapeutic efficacy was compared among patients with advanced. (stages IIIB and IV) lung adenocarcinoma with epidermal growth factor receptor (EGFR)-sensitive mutation. The primary endpoint was the cumulative incidence of brain metastasis, whereas, the secondary endpoint was overall survival(OS). Death without brain metastasis was considered a competitive risk to calculate the cumulative risk of brain metastasis. Survival analysis was conducted using the Kaplan-Meier method and statistical significance was determined using the log-rank test. The present study included 396 patients with 131 in the icotinib group and 265 in the chemotherapy group. Among those with EGFR-sensitive mutation, the cumulative risk of brain metastasis was lower in the icotinib group than in the chemotherapy group. However, no significant difference in OS was observed between the two groups. Icotinib can effectively reduce the incidence of brain metastasis and therefore improve prognosis in advanced lung adenocarcinoma patients with EGFR.sensitive mutation.

  19. Efficacy of icotinib versus traditional chemotherapy as first-line treatment for preventing brain metastasis from advanced lung adenocarcinoma in patients with epidermal growth factor receptor-sensitive mutation.

    PubMed

    Zhao, Xiao; Zhu, Guangqin; Chen, Huoming; Yang, Ping; Li, Fang; Du, Nan

    2014-11-01

    This study aimed to investigate the potential use of icotinib as first-line treatment to prevent brain metastasis from advanced lung adenocarcinoma. This investigation was designed as a retrospective nonrandomized controlled study. Enrolled patients received either icotinib or traditional chemotherapy as their first-line treatment. The therapeutic efficacy was compared among patients with advanced (stages IIIB and IV) lung adenocarcinoma with epidermal growth factor receptor (EGFR)-sensitive mutation. The primary endpoint was the cumulative incidence of brain metastasis, whereas the secondary endpoint was overall survival (OS). Death without brain metastasis was considered a competitive risk to calculate the cumulative risk of brain metastasis. Survival analysis was conducted using the Kaplan-Meier method and statistical significance were determined using the log-rank test. The present study included 396 patients with 131 in the icotinib group and 265 in the chemotherapy group. Among those with EGFR-sensitive mutation, the cumulative risk of brain metastasis was lower in the icotinib group than in the chemotherapy group. However, no significant difference in OS was observed between the two groups. Icotinib can effectively reduce the incidence of brain metastasis and therefore improve prognosis in advanced lung adenocarcinoma patients with EGFR-sensitive mutation.

  20. Pistol-grip Syringe holder (Cameco syringe pistol) in fine needle aspiration Biopsy: any advantages over the use of direct finger grip?

    PubMed

    Mayun, A A; Nggada, H A; Abdulazzez, J O; Musa, A B; Pindiga, U H; Khalil, M I

    2013-06-01

    The study seeks to determine the advantages of using the pistol-grip syringe holder in the performance of FNAB over the use of direct finger grip method. The skin is cleaned with gauze soaked in methylated spirit and the lump is located and firmly held between the thumb and fore finger of the free hand. The syringe is held by the out side of the barrel or by pistol-grip, and the needle tip pushed into the lesion. The plunger is partially retracted, creating a negative pressure. The cutting edge of the needle tip frees the cells inside the lesion which are sucked into the fine bore of the needle. The contents of the needle are then emptied on a microscopic slide and thinly smeared. The slides are then fixed in alcohol and later stained. These were examined under the microscope and a comparison between the aspirations using pistol-grip and direct finger grip was made. A total of 266 cases of FNABs were carried out from 1st January to 31st December, 2008. There were 89 breast cases out of which 42 (47%) had pistol-grip method and 47 (53%) had direct finger grip method; 74 thyroid cases out of which 28 (38%) were pistol-grip and 46 (62%) were direct finger grip cases; 56 cases of lymph node FNABs of which 18(32%) and 38 (68%) had pistol-grip and direct finger grip methods respectively. There were 23 cases of salivary gland FNABs having 8 (35%) and 15 (65%) as pistol-grip and direct finger grip methods respectively. Marked cellularity was observed in the majority of cases using both methods of FNABs. This study has shown that the use of pistol-grip syringe holder in the performance of FNABs has no significant advantage compared to the direct finger grip method.

  1. A phase II, multicenter, single-arm trial of eribulin as first- or second-line chemotherapy for HER2-negative advanced or metastatic breast cancer: evaluation of efficacy, safety, and patient-reported outcomes.

    PubMed

    Kimura, Kosei; Iwamoto, Mitsuhiko; Tanaka, Satoru; Yamamoto, Daigo; Yoshidome, Katsuhide; Ogura, Hiroyuki; Terasawa, Risa; Matsunami, Nobuki; Takahashi, Yuko; Nitta, Toshikatsu; Morimoto, Takashi; Fujioka, Hiroya; Kawaguchi, Kanako; Uchiyama, Kazuhisa

    2018-05-01

    Although eribulin is a suitable option for early-line treatment of metastatic breast cancer (MBC), data on first- or second-line use of eribulin for human epidermal growth factor receptor 2 (HER2)-negative MBC are still limited. Therefore, we conducted a phase II trial to investigate the efficacy and safety of eribulin for first- or second-line chemotherapy for HER2-negative MBC. We performed a phase II, open-label, single-arm, multicenter study in Japan. Eligible patients were women with histologically confirmed HER2-negative MBC without chemotherapy or only one chemotherapy line for MBC. The primary endpoint was the overall response rate (ORR) and the secondary endpoints included the clinical benefit rate (ORR + stable disease for 6 months; CBR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), safety, and health-related quality of life (HRQoL). A total of 35 patients with HER2-negative MBC were enrolled between March 2013 and February 2017 (data cut-off July 31, 2017). The ORR was 37.1% (95% CI 21.1-53.2%). The CBR was 54.3% (95% CI 37.8-70.8%). The median PFS was 6.2 months (95% CI 2.7-9.4 months) and median OS was 21.4 months (95% CI 11.5-32.9 months). Common grade 3/4 adverse events were neutropenia (42.9%) but febrile neutropenia (2.9%). Although the majority of non-hematological adverse events were mild in severity, one patient died of pneumonitis. In HRQoL analysis, eribulin appeared to maintain HRQoL of many patients. Eribulin as first- or second-line chemotherapy is effective and has manageable toxicity for patients with HER2-negative MBC.

  2. Pharmacy-randomized intervention delivering HIV prevention services during the syringe sale to people who inject drugs in New York City.

    PubMed

    Lewis, Crystal Fuller; Rivera, Alexis V; Crawford, Natalie D; DeCuir, Jennifer; Amesty, Silvia

    2015-08-01

    Pharmacy syringe access may be an opportunity to provide HIV prevention resources to persons who inject drugs (PWID). We examined the impact of a pharmacy-randomized intervention to reduce injection risk among PWID in New York City. Pharmacies (n=88) were randomized into intervention, primary control, and secondary control arms. Intervention pharmacies received in-depth harm reduction training, recruited syringe customers who inject drugs into the study, and provided additional services (i.e., HIV prevention/medical/social service referrals, syringe disposal containers, and harm reduction print materials). Primary control pharmacies recruited syringe customers who inject drugs and did not offer additional services, and secondary control pharmacies did not recruit syringe customers (and are not included in this analysis) but participated in a pharmacy staff survey to evaluate intervention impact on pharmacy staff. Recruited syringe customers underwent a baseline and 3-month follow-up ACASI. The intervention effect on injection risk/protective behavior of PWID was examined. A total of 482 PWID completed baseline and follow-up surveys. PWID were mostly Hispanic/Latino, male, and mean age of 43.6 years. After adjustment, PWID in the intervention arm were more likely to report always using a sterile syringe vs. not (PR=1.24; 95% CI: 1.04-1.48) at 3-month follow-up. These findings present evidence that expanded pharmacy services for PWID can encourage sterile syringe use which may decrease injection risk in high HIV burdened Black and Latino communities. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. Health Outcomes for Clients of Needle and Syringe Programs in Prisons.

    PubMed

    Lazarus, Jeffrey V; Safreed-Harmon, Kelly; Hetherington, Kristina L; Bromberg, Daniel J; Ocampo, Denise; Graf, Niels; Dichtl, Anna; Stöver, Heino; Wolff, Hans

    2018-04-12

    High levels of drug dependence have been observed in the prison population globally, and the sharing of injecting drug equipment in prisons has contributed to higher prevalence of bloodborne diseases in prisoners than in the general population. Few prison needle and syringe programs (PNSPs) exist. We conducted a systematic review to assess evidence regarding health outcomes of PNSPs. We searched peer-reviewed databases for data relating to needle and syringe programs in prisons. The search methodology was conducted in accordance with accepted guidelines. Five studies met review inclusion criteria, and all presented evidence associating PNSPs with one or more health benefits, but the strength of the evidence was low. The outcomes for which the studies collectively demonstrated the strongest evidence were prevention of human immunodeficiency virus and viral hepatitis. Few negative consequences from PNSPs were observed, consistent with previous evidence assessments. More research is needed on PNSP effectiveness, and innovative study designs are needed to overcome methodological limitations of previous research. Until stronger evidence becomes available, policymakers are urged to recognize that not implementing PNSPs has the potential to cause considerable harm, in light of what is currently known about the risks and benefits of needle and syringe programs and PNSPs and about the high prevalence of human immunodeficiency virus and viral hepatitis in prisons.

  4. Drugs given by a syringe driver: a prospective multicentre survey of palliative care services in the UK.

    PubMed

    Wilcock, Andrew; Jacob, Jayin K; Charlesworth, Sarah; Harris, Elayne; Gibbs, Margaret; Allsop, Helen

    2006-10-01

    The use of a syringe driver to administer drugs by continuous subcutaneous infusion is common practice in the UK. Over time, drug combinations used in a syringe driver are likely to change and the aim of this survey was to obtain a more recent snapshot of practice. On four separate days, at two-week intervals, a questionnaire was completed for every syringe driver in use by 15 palliative care services. Of 336 syringe drivers, the majority contained either two or three drugs, but one-fifth contained only one drug. The median (range) volume of the infusions was 15 (9.5-48) mL, and duration of infusion was generally 24 hours. Only one combination was reported as visually incompatible, and there were 13 site reactions (4% of total). Laboratory physical and chemical compatibility data are available for less than half of the most frequently used combinations.

  5. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial

    PubMed Central

    Kesari, Santosh; Ram, Zvi

    2017-01-01

    Background: This post hoc analysis of the EF-14 trial (NCT00916409) of tumor-treating fields (TTFields) plus temozolomide versus temozolomide alone in newly diagnosed glioblastoma compared the efficacy of TTFields plus chemotherapy (physician’s choice) versus chemotherapy alone after first recurrence. Methods: Patients on TTFields plus temozolomide continued TTFields plus second-line chemotherapy after first recurrence. Some patients on temozolomide alone crossed over after approval of TTFields for recurrent GBM. The primary efficacy outcome was overall survival (OS). Results: After disease progression, 131 patients received TTFields plus chemotherapy and 73 chemotherapy alone. Thirteen patients in the original temozolomide-alone group crossed over to receive TTFields plus chemotherapy after disease progression, resulting in 144 patients receiving TTFields plus chemotherapy and 60 chemotherapy alone. Median follow-up was 12.6 months. Bevacizumab, alone or with cytotoxic chemotherapy, was the most frequent treatment. Median OS in the TTFields plus chemotherapy group was significantly longer versus chemotherapy alone (11.8 vs 9.2 months; HR: 0.70; 95% CI, 0.48–1.00; p=0.049). TTFields showed a low toxicity safety profile, as previously reported, with no grade 3/4 device-related adverse events. Conclusion: TTFields plus chemotherapy after first disease recurrence on TTFields plus temozolomide or temozolomide alone prolonged OS in patients in the EF-14 trial. PMID:28399638

  6. Efficacy of plasma vascular endothelial growth factor in monitoring first-line chemotherapy in patients with advanced non-small cell lung cancer

    PubMed Central

    2009-01-01

    Background Along with the development of new cancer therapeutics, more effective tools for the estimation of response to therapy and prediction of disease progression are required for the better management of inoperable cancer patients. Methods We studied 134 newly diagnosed and primarily untreated advanced non-small cell lung cancer patients and 100 controls. Forty two patients received platinum-based chemotherapy. Plasma VEGF levels were quantified in all samples at baseline and also before second and third chemotherapy cycle in 42 patients and correlated with response to therapy as assessed by computed tomography after the third chemotherapy cycle. Results We observed that, patients who went into remission had significantly lower baseline VEGF levels before second and third cycles of chemotherapy when compared with patients with no change and progression. Plasma VEGF levels showed a greater decrease from cycle 1 to 2 and from cycle 1 to 3 in patients who showed remission in comparison to those with no change or progression. Plasma VEGF levels before the second cycle detected poor response to therapy with a sensitivity and specificity of 76.9% and 75.0%, respectively (area under the ROC curve = 0.724). Early prediction of disease progression was achieved with a sensitivity and specificity of 71.4% for plasma VEGF before cycle 2 (area under the ROC curve = 0.805). The kinetics of VEGF form cycle 1 to 2 and cycle 1 to 3 also gave significant information for predicting disease progression as well as insufficient therapy response. Conclusion Monitoring of plasma VEGF levels during the course of first-line chemotherapy could identify patients who are likely to have insufficient response to therapy and disease progression at an early stage. This may help in individualizing treatment and could lead to better management of the advanced stage lung cancer. PMID:19958548

  7. A clinical evaluation of four non-Luer spinal needle and syringe systems.

    PubMed

    Kinsella, S M; Goswami, A; Laxton, C; Kirkham, L; Wharton, N; Bowen, M

    2012-11-01

    We performed an evaluation of non-Luer spinal devices supplied by four manufacturers or suppliers: Polymedic; Pajunk; Sarstedt; and Smiths. For each supplier, 100 evaluations were performed using a 25-G 90-mm spinal needle, 3-ml syringe, 5-ml syringe and filter needle; for comparison, 100 evaluations were performed with our standard Luer equipment. The non-Luer devices were associated with more qualitative problems compared with the Luer devices, for example, poor feel of dural puncture (9-32% vs 10%, respectively), poor observation of cerebrospinal fluid in the hub (3-27% vs 0%), and connection problem of the syringe to the spinal needle (7-33% vs 0%). There was also more frequent failure to achieve the spinal injection due to equipment-related causes (4-7% vs 0%, respectively). Median (IQR [range]) numeric satisfaction scores for the spinal needles were: Luer 10 (9-10 [7-10]); Polymedic 7 (4-8 [0-10]; Pajunk 7 (5-8 [0-10]); Sarstedt 7 (6-8 [0-10]); and Smiths 9 (7-10 [0-10]) (p<0.0001). Satisfaction scores for all spinal equipment were: Luer 10 (9-10 [5-10]); Polymedic 8 (6-8 [0-10]); Pajunk 7 (5-7 [1-9]); Sarstedt 8 (6-8 [0-10]); and Smiths 8 (8-9 [2-10]) (p<0.0001). Between 21% and 75% of non-Luer evaluations were rated with satisfaction worse than the usual Luer needle compared with 0-10% rated better, depending on the needle type. Between 22% and 76% of non-Luer evaluations were rated with satisfaction worse than the usual Luer equipment compared with 0-14% rated better. Specific concerns included poor feel of tissue planes and observation of cerebrospinal fluid (Polymedic), difficulty with connection of the syringe to the spinal needle and trocar removal (Pajunk), poor feel of tissue planes and needle flexibility (Sarstedt) and difficulty with connection of the syringe to the spinal needle (Smiths). We could not demonstrate a short-term learning curve for the new devices. Decisions on purchasing and implementation of the new non-Luer equipment will have to

  8. Correlates of syringe coverage for heroin injection in 35 large metropolitan areas in the US in which heroin is the dominant injected drug

    PubMed Central

    Tempalski, Barbara; Cooper, Hannah L.; Friedman, Samuel R.; Des Jarlais, Don C.; Brady, Joanne; Gostnell, Karla

    2009-01-01

    Background Scientific consensus holds that if, at the outset of the HIV/AIDS epidemic, injection drug users (IDUs) had had better access to sterile syringes, much of the epidemic among IDUs in the U.S. could have been prevented. In the context of preventing infectious diseases, 100% syringe coverage—that is, one sterile syringe per injector for each injection—is a public health goal. Notably, we know little about variations in syringe coverage within the U.S. and elsewhere, or about the social and political factors that might determine this coverage. Methods Using data from Holmberg (AJPH, 1996), the 1990 United States Census, the 2000 Beth Israel National Syringe Exchange Survey (n=72), and estimates of IDUs in metropolitan areas (MSAs); (Friedman et al., 2004), we explore the impact of (1) political factors (ACT UP, outreach, early syringe exchange programme (SEP) presence, men who have sex with men (MSM) per capita, drug arrests, and police per capita); (2) local resources for SEPs; and (3) indicators of socioeconomic inequality on SEP coverage. We define “syringe coverage” as the ratio of syringes distributed at SEPs to the number of syringes heroin injectors need in a year. We calculated the number of syringes heroin injectors need in a year by multiplying an estimate of the number of IDUs in each MSA by an estimate of the average number of times heroin injectors inject heroin per year (2.8 times per day times 365 days). In this analysis, the sample was limited to 35 MSAs in which the primary drug of choice among injectors was heroin. Results SEP coverage varies greatly across MSAs, with an average of 3 syringes distributed per 100 injection events (std dev = 0.045; range: 2 syringes per 10 injection events, to 3 syringes per 10,000 injection events). In bivariate regression analyses, a 1 unit difference in the proportion of the population that was MSM per 1,000 was associated with a difference of 0.002 in SEP coverage (p=0.052); early SEP presence was

  9. Autologous fat grafting: use of closed syringe microcannula system for enhanced autologous structural grafting

    PubMed Central

    Alexander, Robert W; Harrell, David B

    2013-01-01

    Objectives Provide background for use of acquiring autologous adipose tissue as a tissue graft and source of adult progenitor cells for use in cosmetic plastic surgery. Discuss the background and mechanisms of action of closed syringe vacuum lipoaspiration, with emphasis on accessing adipose-derived mesenchymal/stromal cells and the stromal vascular fraction (SVF) for use in aesthetic, structural reconstruction and regenerative applications. Explain a proven protocol for acquiring high-quality autologous fat grafts (AFG) with use of disposable, microcannula systems. Design Explain the components and advantage of use of the patented super luer-lock and microcannulas system for use with the closed-syringe system. A sequential explanation of equipment selection for minimally traumatic lipoaspiration in small volumes is presented, including use of blunt injection cannulas to reduce risk of embolism. Results Thousands of AFG have proven safe and efficacious for lipoaspiration techniques for large and small structural fat grafting procedures. The importance and advantages of gentle harvesting of the adipose tissue complex has become very clear in the past 5 years. The closed-syringe system offers a minimally invasive, gentle system with which to mobilize subdermal fat tissues in a suspension form. Resulting total nuclear counting of undifferentiated cells of the adipose-derived -SVF suggests that the yield achieved is better than use of always-on, constant mechanical pump applied vacuum systems. Conclusion Use of a closed-syringe lipoaspiration system featuring disposable microcannulas offers a safe and effective means of harvesting small volumes of nonmanipulated adipose tissues and its accompanying progenitor cells within the SVF. Closed syringes and microcannulas are available as safe, sterile, disposable, compact systems for acquiring high-quality AFG. Presented is a detailed, step-by-step, proven protocol for performing quality autologous structural adipose

  10. A phase III randomized trial of adding topical nitroglycerin to first-line chemotherapy for advanced nonsmall-cell lung cancer: the Australasian lung cancer trials group NITRO trial.

    PubMed

    Davidson, A; Veillard, A-S; Tognela, A; Chan, M M K; Hughes, B G M; Boyer, M; Briscoe, K; Begbie, S; Abdi, E; Crombie, C; Long, J; Boyce, A; Lewis, C R; Varma, S; Broad, A; Muljadi, N; Chinchen, S; Espinoza, D; Coskinas, X; Pavlakis, N; Millward, M; Stockler, M R

    2015-11-01

    We sought to determine whether the substantial benefits of topical nitroglycerin with first-line, platinum-based, doublet chemotherapy in advanced nonsmall-cell lung cancer (NSCLC) seen in a phase II trial could be corroborated in a rigorous, multicenter, phase III trial. Patients starting one of five, prespecified, platinum-based doublets as first-line chemotherapy for advanced NSCLC were randomly allocated treatment with or without nitroglycerin 25 mg patches for 2 days before, the day of, and 2 days after, each chemotherapy infusion. Progression-free survival (PFS) was the primary end point. Accrual was stopped after the first interim analysis of 270 events. Chemotherapy was predominantly with carboplatin and gemcitabine (79%) or carboplatin and paclitaxel (18%). The final analysis included 345 events in 372 participants with a median follow-up of 33 months. Topical nitroglycerin had no demonstrable effect on PFS [median 5.0 versus 4.8 months, hazard ratio (HR) = 1.07, 95% confidence interval (CI) 0.86-1.32, P = 0.55], overall survival (median 11.0 versus 10.3 months, HR = 0.99, 95% CI 0.79-1.24, P = 0.94), or objective tumor response (31% versus 30%, relative risk = 1.03, 95% CI 0.82-1.29, P = 0.81). Headache, hypotension, syncope, diarrhea, dizziness, and anorexia were more frequent in those allocated nitroglycerin. The addition of topical nitroglycerin to carboplatin-based, doublet chemotherapy in NSCLC had no demonstrable benefit and should not be used or pursued further. Australian New Zealand Clinical Trials Registry Number ACTRN12608000588392. © The Author 2015. 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.

  11. Syringe confiscation as an HIV risk factor: the public health implications of arbitrary policing in Tijuana and Ciudad Juarez, Mexico.

    PubMed

    Beletsky, Leo; Lozada, Remedios; Gaines, Tommi; Abramovitz, Daniela; Staines, Hugo; Vera, Alicia; Rangel, Gudelia; Arredondo, Jaime; Strathdee, Steffanie A

    2013-04-01

    Female sex workers who inject drugs (FSW-IDUs) face elevated risk for HIV/STIs and constitute a key population for public health prevention. Through direct and indirect pathways including human rights violations, policing practices like syringe confiscation can compound FSW-IDU health risk and facilitate the spread of disease. We studied correlates of experiencing syringe confiscation among FSW-IDUs in northern Mexico, where formal policy allows for syringes to be available over the counter without a prescription, but police practices are often at odds with the law. FSW-IDUs reporting recent syringe sharing and unprotected sex with clients in Tijuana and Ciudad Juarez were administered surveys and HIV/STI testing. Logistic regression was used to identify correlates of syringe confiscation. Among 624 respondent FSW-IDUs, prevalence of syringe confiscation in the last 6 months was 48%. The following factors were positively associated with syringe confiscation: testing positive for HIV (adjusted odds ratio [aOR] = 2.54, 95% confidence interval [CI] = 1.11-5.80), reporting sexual abuse by police (aOR = 12.76, 95% CI = 6.58-24.72), engaging in groin injection (aOR = 1.84, 95% CI = 1.15-2.93), injecting in public (aOR = 1.64; 95% CI = 1.14-2.36), and obtaining syringes from pharmacies (aOR = 1.54; 95% CI = 1.06-2.23). Higher education level was negatively associated with syringe confiscation (aOR = 0.92, 95% CI = 0.87-0.98) as was frequent injection with clients within the last month (aOR = 0.64, 95% CI = 0.44-0.94). This analysis adds to the body of evidence linking unauthorized law enforcement actions targeting high-risk groups with HIV and other adverse health outcomes. Using a public health lens to conceptualize abuse as a structural risk factor, we advocate for multi-prong prevention, systematic monitoring, and evidence-based intervention response to deleterious police practices.

  12. Correlation of MSH3 polymorphisms with response and survival in advanced non-small cell lung cancer patients treated with first-line platinum-based chemotherapy.

    PubMed

    Xu, X-L; Yao, Y-L; Xu, W-Z; Feng, J-G; Mao, W-M

    2015-04-15

    Mismatch repair (MMR) genes, as well as the nucleotide excision repair genes, play an important role in removing cisplatin-DNA adducts, and the mutation of MMR genes in tumors can lead to a decreased response to platinum-based therapies. We examined MutS homolog 3 (MSH3), a mismatch repair gene, and whether polymorphisms of MSH3 were associated with response and survival in advanced non-small cell lung cancer (NCSLC) patients who were treated with platinum-based chemotherapy. The peripheral blood of 180 advanced NCSLC patients who were treated with first-line platinum-based chemotherapy was collected to determine the patients' genotypes of MSH3. The three genotypes of the MSH3 polymorphisms rs26279, rs1650697 and rs1105524 were investigated. A statistically significant association was observed between the polymorphism rs26279 (Ala1054Thr) and sensitivity to platinum-based chemotherapy (P = 0.014). A significant correlation was found between rs1105524 and progression-free survival (PFS), with the G/A and A/A genotypes (median survival time: 14.27 months; 95%CI = 9.80-18.75) suffering shorter survival than patients with the G/G genotype (median survival time: 26.37 months; 95%CI = 15.03-37.71) (P = 0.04). Our results showed that single nucleotide polymorphisms in MSH3 had an impact on the chemotherapy response and prognosis of advanced NCSLC patients who were treated with platinum-based chemotherapy.

  13. Non-prescription Syringe Sales in California: A Qualitative Examination of Practices among 12 Local Health Jurisdictions

    PubMed Central

    Backes, Glenn; Martinez, Alexis; McFarland, Willi

    2010-01-01

    Legislation permitting non-prescription syringe sales (NPSS) was passed in 2004 in California as a structural intervention designed to expand access to syringes for injection drug users. As of December 2009, 19 of California’s 61 local health jurisdictions (LHJs) have approved policies to authorize pharmacies to sell non-prescription syringes. The legislation faces termination in 2010 if current evaluation efforts fail to demonstrate outcomes defined in the legislation. Using qualitative methods, we examined the systems and procedures associated with implementation; identified facilitators and barriers to implementation among 12 LHJs, and documented the role of public health in initiating and sustaining local programs. We identified consistent activities that led to policy implementation among LHJs and discovered several barriers that were associated with failure to implement local programs. Factors leading to NPSS were public health leadership; an inclusive planning process, marketing the program as a public health initiative; learning from others’ efforts, successes, and failures; and identifying acceptable syringe disposal options in advance of program implementation. Health departments that were confronted with political and moral arguments lost momentum and ultimately assigned a lower priority to the initiative citing the loss of powerful public health advocates or a lack of human resources. Additional barriers were law enforcement, elected officials, and pharmacy opposition, and failure to resolve syringe disposal options to the satisfaction of important stakeholders. The lessons learned in this study should provide useful guidance for the remaining LHJs in California without NPSS programs. PMID:20405227

  14. Non-prescription syringe sales in California: a qualitative examination of practices among 12 local health jurisdictions.

    PubMed

    Rose, Valerie J; Backes, Glenn; Martinez, Alexis; McFarland, Willi

    2010-07-01

    Legislation permitting non-prescription syringe sales (NPSS) was passed in 2004 in California as a structural intervention designed to expand access to syringes for injection drug users. As of December 2009, 19 of California's 61 local health jurisdictions (LHJs) have approved policies to authorize pharmacies to sell non-prescription syringes. The legislation faces termination in 2010 if current evaluation efforts fail to demonstrate outcomes defined in the legislation. Using qualitative methods, we examined the systems and procedures associated with implementation; identified facilitators and barriers to implementation among 12 LHJs, and documented the role of public health in initiating and sustaining local programs. We identified consistent activities that led to policy implementation among LHJs and discovered several barriers that were associated with failure to implement local programs. Factors leading to NPSS were public health leadership; an inclusive planning process, marketing the program as a public health initiative; learning from others' efforts, successes, and failures; and identifying acceptable syringe disposal options in advance of program implementation. Health departments that were confronted with political and moral arguments lost momentum and ultimately assigned a lower priority to the initiative citing the loss of powerful public health advocates or a lack of human resources. Additional barriers were law enforcement, elected officials, and pharmacy opposition, and failure to resolve syringe disposal options to the satisfaction of important stakeholders. The lessons learned in this study should provide useful guidance for the remaining LHJs in California without NPSS programs.

  15. Prolonged response without prolonged chemotherapy: a lesson from PCV chemotherapy in low-grade gliomas

    PubMed Central

    Peyre, Matthieu; Cartalat-Carel, Stéphanie; Meyronet, David; Ricard, Damien; Jouvet, Anne; Pallud, Johan; Mokhtari, Karima; Guyotat, Jacques; Jouanneau, Emmanuel; Sunyach, Marie-Pierre; Frappaz, Didier; Honnorat, Jérôme; Ducray, François

    2010-01-01

    Previous studies with temozolomide suggest that a prolonged duration of chemotherapy is important for treating low-grade gliomas (LGGs). PCV (procarbazine, CCNU, vincristine) chemotherapy has demonstrated efficacy in treating LGGs, but this therapy cannot be used for a prolonged period because of the cumulative toxicity. The aim of the present study was to evaluate the impact of first-line PCV chemotherapy on LGGs growth kinetics. The mean tumor diameter (MTD) of 21 LGGs was measured on serial magnetic resonance images before (n=13), during, and after PCV onset (n=21). During PCV treatment, a decrease in the MTD was observed in all patients. After PCV discontinuation, an ongoing decrease in MTD was observed in 20 of the 21 patients. Median duration of the MTD decrease was 3.4 years (range, 0.8–7.7) after PCV onset and 2.7 years (range, 0–7) after the end of PCV treatment with 60% of LGGs, demonstrating an ongoing and prolonged (>2 years) response despite chemotherapy no longer being administered. According to McDonald's criteria, the rates of partial and minor responses were 5% and 38% at the end of PCV but 38% and 42% at the time of maximal MTD decrease, which occurred after a median period of 3.4 years after PCV onset. These results challenge the idea that a prolonged duration of chemotherapy is necessary for treating LGGs and raise the issue of understanding the mechanisms involved in the persistent tumor volume decrease once chemotherapy is terminated. PMID:20488959

  16. Real-world cost analysis of chemotherapy for colorectal cancer in Japan: detailed costs of various regimens during the entire course of chemotherapy.

    PubMed

    Yajima, Shuichi; Shimizu, Hisanori; Sakamaki, Hiroyuki; Ikeda, Shunya; Ikegami, Naoki; Murayama, Jun-Ichiro

    2016-01-04

    Various chemotherapy regimens for advanced colorectal cancer have been introduced to clinical practice in Japan over the past decade. The cost profiles of these regimens, however, remain unclear in Japan. To explore the detailed costs of different regimens used to treat advanced colorectal cancer during the entire course of chemotherapy in patients treated in a practical setting, we conducted a so-called "real-world" cost analysis. A detailed cost analysis was performed retrospectively. Patients with advanced colorectal cancer who had received chemotherapy in a practical healthcare setting from July 2004 through October 2010 were extracted from the ordering system database of Showa University Hospital. Direct medical costs of chemotherapy regimens were calculated from the hospital billing data of the patients. The analysis was conducted from a payer's perspective. A total of 30 patients with advanced colorectal cancer were identified. Twenty patients received up to second-line treatment, and 8 received up to third-line treatment. The regimens identified from among all courses of treatment in all patients were 13 oxaliplatin-based regimens, 31 irinotecan-based regimens, and 11 regimens including molecular targeted agents. The average (95% confidence interval [95% CI]) monthly cost during the overall period from the beginning of treatment to the end of treatment was 308,363 (258,792 to 357,933) Japanese yen (JPY). According to the type of regimen, the average monthly cost was 418,463 (357,413 to 479,513) JPY for oxaliplatin-based regimens, 215,499 (188,359 to 242,639) JPY for irinotecan-based regimens, and 705,460 (586,733 to 824,187) JPY for regimens including molecular targeted agents. Anticancer drug costs and hospital fees accounted for 50 to 77% and 11 to 25% of the overall costs of chemotherapy, respectively. The costs of irinotecan-based regimens were lower than those of oxaliplatin-based regimens and regimens including molecular targeted agents in Japan

  17. Chemotherapy

    MedlinePlus

    ... person getting treatment swallows a pill, capsule, or liquid form of chemo medication. By injection. Using a needle or syringe, the drugs are injected into a muscle or under the skin. Intrathecally. A needle is inserted into the fluid-filled space surrounding the spinal cord and the chemo drugs ...

  18. Changes in hepatic perfusion assessed by dynamic contrast enhanced MRI, associated with morphologic evaluation, in patients with liver metastases from colorectal cancer treated with first-line chemotherapy.

    PubMed

    Tampellini, Marco; Gned, Dario; Baratelli, Chiara; Brizzi, Maria Pia; Ottone, Azzurra; Alabiso, Irene; Bertaggia, Chiara; Di Maio, Massimo; Scagliotti, Giorgio Vittorio; Veltri, Andrea

    2016-12-01

    Blood perfusion of liver metastases can be non-invasively assessed by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). The aim of this study was to explore whether the ratio of hepatic arterial to total liver blood flow (Hepatic Perfusion Index-HPI) and the area under the enhancement curve (AUC) of selected liver areas in patients with hepatic metastases from colorectal cancer treated with first-line chemotherapy could predict response and/or be a prognostic variable. Sequential liver DCE-MRI studies with morphological imaging reconstruction were performed in 43 consecutive patients at baseline and every 3 months during oxaliplatin-based first-line chemotherapy. Data about HPI of the whole liver, and AUC of metastatic and healthy areas were calculated at each time-point and compared both at baseline and sequentially during the treatment. Baseline HPI and AUC values did not discriminate patients responsive to chemotherapy, nor those with better survival outcomes. HPI and AUC values at 3 months decreased significantly more in responders than non-responders. AUCs calculated from areas of the liver with or without neoplastic lesions varied consistently, being increased in progressing patients and decreased in responding patients. Our results did not support the hypothesis of a predictive or prognostic role of HPI and AUCs calculated by DCE-MRI in liver metastatic CRC patients, thus the primary endpoint of the study was not reached. However, reduced arterial blood flow in metastatic liver can be obtained by chemotherapy alone, without any anti-angiogenic agent; interestingly, HPI and AUC data suggest a possible relationship between tumor metabolism and entire liver perfusion.

  19. Community Impact of Pharmacy-Randomized Intervention to Improve Access to Syringes and Services for Injection Drug Users

    ERIC Educational Resources Information Center

    Crawford, Natalie D.; Amesty, Silvia; Rivera, Alexis V.; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M.

    2014-01-01

    Objectives: In an effort to reduce HIV transmission among injection drug users (IDUs), New York State deregulated pharmacy syringe sales in 2001 through the Expanded Syringe Access Program by removing the requirement of a prescription. With evidence suggesting pharmacists' ability to expand their public health role, a structural, pharmacy-based…

  20. A simple device to convert a small-animal PET scanner into a multi-sample tissue and injection syringe counter.

    PubMed

    Green, Michael V; Seidel, Jurgen; Choyke, Peter L; Jagoda, Elaine M

    2017-10-01

    We describe a simple fixture that can be added to the imaging bed of a small-animal PET scanner that allows for automated counting of multiple organ or tissue samples from mouse-sized animals and counting of injection syringes prior to administration of the radiotracer. The combination of imaging and counting capabilities in the same machine offers advantages in certain experimental settings. A polyethylene block of plastic, sculpted to mate with the animal imaging bed of a small-animal PET scanner, is machined to receive twelve 5-ml containers, each capable of holding an entire organ from a mouse-sized animal. In addition, a triangular cross-section slot is machined down the centerline of the block to secure injection syringes from 1-ml to 3-ml in size. The sample holder is scanned in PET whole-body mode to image all samples or in one bed position to image a filled injection syringe. Total radioactivity in each sample or syringe is determined from the reconstructed images of these objects using volume re-projection of the coronal images and a single region-of-interest for each. We tested the accuracy of this method by comparing PET estimates of sample and syringe activity with well counter and dose calibrator estimates of these same activities. PET and well counting of the same samples gave near identical results (in MBq, R 2 =0.99, slope=0.99, intercept=0.00-MBq). PET syringe and dose calibrator measurements of syringe activity in MBq were also similar (R 2 =0.99, slope=0.99, intercept=- 0.22-MBq). A small-animal PET scanner can be easily converted into a multi-sample and syringe counting device by the addition of a sample block constructed for that purpose. This capability, combined with live animal imaging, can improve efficiency and flexibility in certain experimental settings. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Culbertson holds a syringe kit in Destiny during Expedition Three

    NASA Image and Video Library

    2001-08-29

    ISS003-E-5475 (29 August 2001) --- Astronaut Frank L. Culbertson, Expedition Three mission commander, holds a syringe kit to be used in the Quad Tissue Culture Module Assemblies (QTCMA) for the Biotechnology Specimen Temperature Controller (BSTC) experiment in the U.S. Laboratory.

  2. Metastatic Urothelial Carcinoma with Glandular Differentiation That Confirmed the Response by Autopsy Specimen to Second-Line mFOLFOX6 (Fluorouracil, Oxaliplatin, and Leucovorin) plus Bevacizumab Chemotherapy

    PubMed Central

    Naiki, Taku; Etani, Toshiki; Naiki-Ito, Aya; Fujii, Kana; Ando, Ryosuke; Iida, Keitaro; Nagai, Takashi; Sugiyama, Yosuke; Nakagawa, Motoo; Kawai, Noriyasu; Yasui, Takahiro

    2017-01-01

    The prognostic significance of glandular differentiation in urothelial carcinoma (UC) is controversial, and thus far there is no established treatment strategy against metastasis of glandular component. We describe here a case of metastatic UC with glandular differentiation that had histological disappearance of adenocarcinoma components at autopsy after sequential chemotherapy with S-1 and cisplatin (CDDP) and with mFOLFOX6 (fluorouracil, oxaliplatin, and leucovorin) plus bevacizumab (mFOLFOX6+Bev). A 62-year-old Asian male was diagnosed with invasive UC with glandular differentiation (T2N0M0) by radical cystectomy and ileal conduit, and careful follow-up observation was made. Eight years after radical operation, peritoneal metastases occurred, and a biopsy specimen using colon fiber revealed high-grade adenocarcinomas with an immunohistochemical profile that included positivity for cytokeratin 7 (CK7) and negativity for cytokeratin 20 (CK20) and uroplakin, which was identical to the radical cystectomy specimen. Thus, he received combination chemotherapy consisting of S-1 and CDDP; however, the peritoneal metastasis worsened after 2 cycles. Therefore, second-line mFOLFOX6+Bev chemotherapy was performed for a total of 5 courses. In spite of this, the patient died, and the final diagnosis by autopsy was multiple metastases of infiltrating pure UC to the lung, bone, and peritoneum. Interestingly, there were no pathological findings of adenocarcinoma, and the immunohistochemical profile of the metastatic lesions was identical to that of the previous specimens from the bladder and colon. This suggests that sequential chemotherapy of S-1 and CDDP and second-line mFOLFOX6+Bev might be a feasible option in metastatic UC with glandular differentiation. PMID:29515396

  3. EGFR-TKIs plus chemotherapy demonstrated superior efficacy than EGFR-TKIs alone as first-line setting in advanced NSCLC patients with EGFR mutation and BIM deletion polymorphism.

    PubMed

    Liu, Sangtian; He, Yayi; Jiang, Tao; Ren, Shengxiang; Zhou, Fei; Zhao, Chao; Li, Xuefei; Zhang, Jie; Su, Chunxia; Chen, Xiaoxia; Cai, Weijing; Gao, Guanghui; Li, Wei; Wu, Fengying; Li, Jiayu; Zhao, Jing; Hu, Qiong; Zhao, Mingchuan; Zhou, Caicun; Hirsch, Fred R

    2018-06-01

    Non-small-cell lung cancer (NSCLC) patients with both epidermal growth factor receptor (EGFR) positive mutation and B-cell chronic lymphocytic leukemia/lymphoma-like 11 (BIM) deletion polymorphism had a poor clinical response to EGFR-tyrosine kinase inhibitors (TKIs). The current study aimed to investigate the clinical efficacy and tolerability of EGFR-TKIs plus chemotherapy versus EGFR-TKIs alone as first-line treatment in advanced NSCLC patients with EGFR mutations and BIM deletion polymorphism. A retrospective, non-randomized analysis was conducted. BIM deletion polymorphism was detected using polymerase chain reaction (PCR) analysis and direct sequencing of DNA from peripheral blood cells. Clinical characteristics, overall survival (OS), progress-free-survival (PFS), objective response rate (ORR) and treatment-related adverse events were compared between EGFR-TKIs alone versus EGFR-TKIs plus chemotherapy group. 65 patients were enrolled. 36 of them received EGFR-TKIs and 29 received EGFR-TKIs plus chemotherapy. EGFR-TKIs plus chemotherapy had significantly higher ORR than TKIs alone (65.5% vs. 38.9%, P = 0.046). Median PFS was significantly longer in EGFR-TKIs plus chemotherapy group than in TKIs group (7.2 vs 4.7 m; P = 0.008). Median OS was numerically longer in EGFR-TKIs plus chemotherapy group than in TKIs alone (18.5 vs 14.2 m; P = 0.107). EGFR-TKIs plus chemotherapy was associated with more grade 3 or 4 hematological toxic effects than EGFR-TKIs alone. EGFR-TKIs plus chemotherapy conferred a significantly higher ORR, prolonged PFS and numerically longer OS in advanced NSCLC patients with EGFR mutation and BIM deletion polymorphism. Further prospective studies are needed to validate these findings. Copyright © 2018 Elsevier B.V. All rights reserved.

  4. Cost Effectiveness Analysis of Different Management Strategies between Best Supportive Care and Second-line Chemotherapy for Platinum-resistant or Refractory Ovarian Cancer.

    PubMed

    Luealon, Phanida; Khempech, Nipon; Vasuratna, Apichai; Hanvoravongchai, Piya; Havanond, Piyalamporn

    2016-01-01

    There is no standard treatment for patients with platinum-resistant or refractory epithelial ovarian cancer. Single agent chemotherapies have evidence of more efficacy and less toxicity than combination therapy. Most are very expensive, with appreciable toxicity and minimal survival. Since it is difficult to make comparison between outcomes, economic analysis of single-agent chemotherapy regimens and best supportive care may help to make decisions about an appropriate management for the affected patients. To evaluate the cost effectiveness of second-line chemotherapy compared with best supportive care for patients with platinum-resistant or refractory epithelial ovarian cancer. A Markov model was used to estimate the effectiveness and total costs associated with treatments. The hypothetical patient population comprised women aged 55 with platinum-resistant or refractory epithelial ovarian cancer. Four types of alternative treatment options were evaluated: 1) gemcitabine followed by BSC; 2) pegylated liposomal doxorubicin (PLD) followed by BSC; 3) gemcitabine followed by topotecan; and 4) PLD followed by topotecan. Baseline comparator of alternative treatments was BSC. Time horizon of the analysis was 2 years. Health care provider perspective and 3% discount rate were used to determine the costs of medical treatment in this study. Quality-adjusted life-years (QALY) were used to measure the treatment effectiveness. Treatment effectiveness data were derived from the literature. Costs were calculated from unit cost treatment of epithelial ovarian cancer patients at various stages of disease in King Chulalongkorn Memorial Hospital (KCMH) in the year 2011. Parameter uncertainty was tested in probabilistic sensitivity analysis by using Monte Carlo simulation. One-way sensitivity analysis was used to explore each variable's impact on the uncertainty of the results. Approximated life expectancy of best supportive care was 0.182 years and its total cost was 26,862 Baht. All

  5. Container Closure Integrity Testing of Prefilled Syringes.

    PubMed

    Peláez, Sarah S; Mahler, Hanns-Christian; Matter, Anja; Koulov, Atanas; Singh, Satish K; Germershaus, Oliver; Mathaes, Roman

    2018-04-05

    Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems (CCSs) for injectable drug products when facilitated or self-administration is required. However, PFSs are more complex compared to CCSs consisting of vial, rubber stopper, and crimp cap. Container closure integrity (CCI) assurance and verification has been a specific challenge for PFSs as they feature several sealing areas. A comprehensive understanding of the CCS is necessary for an appropriate CCI assessment as well as for packaging development and qualification. A comprehensive CCI assessment of 6 different PFSs from 3 different manufacturers (including 1 polymeric PFS) was conducted using helium leak testing. PFS components were manipulated to systematically assess the contribution of the different sealing areas to CCI, namely rigid needle shield (RNS)/needle, RNS/tip cone, and the individual ribs of a syringe plunger. The polymeric PFS required an equilibrium measurement for accurate container closure integrity testing. The different sealing areas and a single plunger rib were shown to provide adequate CCI. Acceptable tip cap movement until the point of CCI failure was estimated. The assessment of acceptable tip cap movement demonstrated the importance of considering the RNS/tip cone seal design to ensure CCI of the PFS upon post assembly possesses and shipment. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  6. Liquid drugs and high dead space syringes may keep HIV and HCV prevalence high - a comparison of Hungary and Lithuania.

    PubMed

    Gyarmathy, V Anna; Neaigus, Alan; Li, Nan; Ujhelyi, Eszter; Caplinskiene, Irma; Caplinskas, Saulius; Latkin, Carl A

    2010-01-01

    Despitevery similar political, drug policy and HIV prevention backgrounds, HIV and HCV prevalence is considerably different in Hungary (low HIV and moderate HCV prevalence) and Lithuania (high HCV and moderate HIV prevalence). Wecompared the drug use profile of Hungarian (n = 215) and Lithuanian (n = 300) injecting drug users (IDUs). Overall, compared with IDUs in Hungary, IDUs in Lithuania often injected opiates purchased in liquid form ('shirka'), used and shared 2-piece syringes (vs. 1-piece syringes) disproportionately more often, were less likely to acquire their syringes from legal sources and had significantly more experience with injected and less experience with non-injected drugs. It may not be liquid drugs per se that contribute to a higher prevalence of HCV and/or HIV, but it is probably factors associated with the injecting of liquid drugs, such as the wide-spread use and sharing of potentially contaminated 2-piece syringes acquired often from non-legal sources, and syringe-mediated drug sharing with 2-piece syringes. Scaling up substitution therapy, especially heroin replacement, combined with reducing the supply of liquid drugs may decrease the prevalence of high-risk injecting behaviours related to the injecting of liquid drugs and drug injecting-related infections among IDUs in Lithuania. Copyright © 2010 S. Karger AG, Basel.

  7. Do older patients with non-small cell lung cancer also benefit from first-line platinum-based doublet chemotherapy? Observations from a pooled analysis of 730 prospectively-treated patients (Alliance Study A151622).

    PubMed

    Feliciano, Josephine L; Le-Rademacher, Jennifer G; Gajra, Ajeet; Edelman, Martin J; Zemla, Tyler; McMurray, Ryan; Chen, Hongbin; Hurria, Arti; Muss, Hyman; Cohen, Harvey J; Lilenbaum, Rogerio; Jatoi, Aminah

    2018-05-27

    This study sought to define the role of first-line platinum-based doublet chemotherapy in older patients with non-small cell lung cancer (NSCLC). We analyzed three first-line NSCLC trials: CALGB 9730, CALGB 30203, and CALGB 30801, which tested carboplatin and paclitaxel; carboplatin and gemcitabine; and carboplatin with either pemetrexed or gemcitabine, respectively. Overall survival was the primary endpoint. Age-based comparisons with a cutpoint of 65 years were performed with Cox proportional hazards models with adjustments for sex, tumor histology, cancer stage, chemotherapy, and smoking history and after stratifying by performance score. Secondary endpoints were grade 3-5 adverse events, chemotherapy cycles completed, and whether toxicity prompted chemotherapy discontinuation. 730 patients were included; 337 (46%) were 65+ years of age. No statistically significant difference in survival was observed for older (≥65) versus younger patients (HR = 1.096; 95% CI = (0.94, 1.28); p = 0.25). A trend emerged with increased odds of a grade 3-5 adverse event for patients ≥65 years versus <65 years (OR = 1.52; 95% CI = (0.99, 2.31); p = 0.05). The proportion of completed chemotherapy cycles was marginally lower in older patients (difference = -5%; 95% CI = (-9, 0.2); p = 0.06) for those ≥65 years versus <65 years, but no statistically significant difference occurred in the rate of chemotherapy discontinuation for toxicity (OR = 1.4; 95% CI = (0.85, 2.19); p = 0.21) for patients ≥65 years versus <65 years. A cutpoint of 70 years yielded similar results. These findings support carboplatin doublet-based chemotherapy in select older patients with advanced NSCLC. Copyright © 2018 Elsevier Inc. All rights reserved.

  8. Using Pharmacies in a Structural Intervention to Distribute Low Dead Space Syringes to Reduce HIV and HCV Transmission in People Who Inject Drugs.

    PubMed

    Oramasionwu, Christine U; Johnson, Terence L; Zule, William A; Carda-Auten, Jessica; Golin, Carol E

    2015-06-01

    Ongoing injection drug use contributes to the HIV and HCV epidemics in people who inject drugs. In many places, pharmacies are the primary source of sterile syringes for people who inject drugs; thus, pharmacies provide a viable public health service that reduces blood-borne disease transmission. Replacing the supply of high dead space syringes with low dead space syringes could have far-reaching benefits that include further prevention of disease transmission in people who inject drugs and reductions in dosing inaccuracies, medication errors, and medication waste in patients who use syringes. We explored using pharmacies in a structural intervention to increase the uptake of low dead space syringes as part of a comprehensive strategy to reverse these epidemics.

  9. [Chemotherapy in epithelial ovarian cancer].

    PubMed

    Tazi, Y; Pautier, P; Leary, A; Lhomme, C

    2013-10-01

    Chemotherapy is fundamental in the management of epithelial ovarian carcinomas both for early and advanced stages (rarely surgical treatment alone) and in almost every step of the disease. The reference schema combines carboplatin and paclitaxel intravenously. Intraperitoneal chemotherapy also proved its efficacy after complete surgery for advanced disease and should be reserved to trained teams due to its technical constraints and toxicity issues. Modalities of treatment in relapsed and progressive disease depend mainly on the free interval between this diagnosis and the last dose of platinum. Bevacizumab has proven its effectiveness in prolonging progression-free survival in 1st line setting in association with chemotherapy followed by maintenance and in case of relapse or progression both fore platinum sensitive or resistant disease. Finally, a better understanding of ovarian cancer biology will allow us to consider new molecular-targeted agents guided by the specific characteristics of each patient and each tumor. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  10. Comparison of clinical outcome after first-line platinum-based chemotherapy in different types of KRAS mutated advanced non-small-cell lung cancer.

    PubMed

    Mellema, Wouter W; Masen-Poos, Lucie; Smit, Egbert F; Hendriks, Lizza E L; Aerts, Joachim G; Termeer, Arien; Goosens, Martijn J; Smit, Hans J M; van den Heuvel, Michel M; van der Wekken, Anthonie J; Herder, Gerarda J M; Krouwels, Frans H; Stigt, Jos A; van den Borne, Ben E E M; Haitjema, Tjeerd J; Staal-Van den Brekel, Agnes J; van Heemst, Robbert C; Pouw, Ellen; Dingemans, Anne-Marie C

    2015-11-01

    As suggested by in-vitro data, we hypothesize that subtypes of KRAS mutated non-small cell lung cancer (NSCLC) respond differently to chemotherapy regimens. Patients with advanced NSCLC and known KRAS mutation, treated with first-line platinum-based chemotherapy, were retrieved from hospital databases. to investigate overall response rate (ORR), progression free survival (PFS) and overall survival (OS) between different types of platinum-based chemotherapy per type of KRAS mutation. 464 patients from 17 hospitals, treated between 2000 and 2013, were included. The majority of patients had stage IV disease (93%), had a history of smoking (98%) and known with an adenocarcinoma (91%). Most common types of KRAS mutation were G12C (46%), G12V (20%) and G12D (10%). Platinum was combined with pemetrexed (n=334), taxanes (n=68) or gemcitabine (n=62). Patients treated with taxanes had a significant improved ORR (50%) compared to pemetrexed (21%) or gemcitabine (25%; p<0.01). Patients treated with bevacizumab in addition to taxanes (n=38) had the highest ORR (62%). The PFS was significantly improved in patients treated with taxanes compared to pemetrexed (HR=0.72, p=0.02), but not OS (HR=0.87, p=0.41). In patients with G12V, significantly improved ORR (p<0.01) was observed for taxanes, but not PFS or OS. Patients with G12C or G12D mutation had comparable ORR, PFS and OS in all treatment groups. KRAS mutated NSCLC patients treated with taxane-based chemotherapy had best ORR. Response to chemotherapy regimens was different in types of KRAS mutation. Especially patients with G12V had better response to taxane treatment. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  11. Reversal of ethanol-induced hepatotoxicity by cinnamic and syringic acids in mice.

    PubMed

    Yan, Sheng-Lei; Wang, Zhi-Hong; Yen, Hsiu-Fang; Lee, Yi-Ju; Yin, Mei-Chin

    2016-12-01

    Ethanol was used to induce acute hepatotoxicity in mice. Effects of cinnamic acid (CA) and syringic acid (SA) post-intake for hepatic recovery from alcoholic injury was investigated. Ethanol treated mice were supplied by CA or SA at 40 or 80 mg/kg BW/day for 5 days. Results showed that ethanol stimulated protein expression of CYP2E1, p47 phox , gp91 phox , cyclooxygenase-2 and nuclear factor kappa B in liver. CA or SA post-intake restricted hepatic expression of these molecules. Ethanol suppressed nuclear factor erythroid 2-related factor (Nrf2) expression, and CA or SA enhanced Nrf2 expression in cytosolic and nuclear fractions. Ethanol increased the release of reactive oxygen species, oxidized glutathione, interleukin-6, tumor necrosis factor-alpha, nitric acid and prostaglandin E 2 . CA or SA lowered hepatic production of these oxidative and inflammatory factors. Histological data revealed that ethanol administration caused obvious foci of inflammatory cell infiltration, and CA or SA post-intake improved hepatic inflammatory infiltration. These findings support that cinnamic acid and syringic acid are potent nutraceutical agents for acute alcoholic liver disease therapy. However, potential additive or synergistic benefits of cinnamic and syringic acids against ethanol-induced hepatotoxicity need to be investigated. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Pain associated with local anesthetic injection in eyelid procedures: Comparison of microprocessor-controlled versus traditional syringe techniques.

    PubMed

    Lee, Edward W; Tucker, Nancy A

    2007-01-01

    To evaluate the pain associated with local infiltration of the eyelid, using a microprocessor-controlled delivery system (CompuMed, using the Wand), as compared with traditional manual syringe infiltration technique. A randomized clinical trial of 30 patients undergoing minor eyelid surgical procedures was performed. Fifteen patients were injected by use of the CompuMed system and 15 patients were injected by the traditional manual syringe technique. The severity of pain was recorded from each patient by using a visual analog scale (0 to 10). The duration of pain experienced by the patient was also recorded. The mean pain level reported was 1.5 in the Wand group and 3.2 in the syringe group (p < 0.01). The mean duration of pain experienced was 1.5 seconds in the Wand group and 34 seconds in the syringe group (p < 0.01). The Wand was effective at significantly reducing the pain associated with local anesthetic infiltration in minor eyelid surgical procedures. Patients appear to feel pain from the initial needle stick but not during the actual injection.

  13. Primary and secondary analysis of local elected officials' decisions to support or oppose pharmacy sale of syringes in California.

    PubMed

    Backes, Glenn; Rose, Valerie J

    2010-07-01

    Under California law, local governments may authorize pharmacies within their jurisdictions to sell ten or fewer syringes to an adult without prescription, proof of identity, or proof of medical need. Local governments may simultaneously exempt adults from prosecution for violation of state drug paraphernalia codes for possession of ten or fewer syringes for personal use. Both of these provisions are temporary and sunset on December 31, 2010, unless subsequent state legislation amends that date. The objective of our study was to ascertain how and why local policymakers made their decisions regarding non-prescription syringe sale (NPSS). We examined influences on their decisions, including specific messengers and the arguments that were most salient to their decision making. We selected jurisdictions that were geographically representative of California counties; those with and without syringe exchange programs, and those that had passed or rejected NPSS. We conducted nine semi-structured interviews in five jurisdictions. To enrich primary data collection, we analyzed secondary data by reviewing audio, video, and written transcripts of public hearings and newspaper coverage in five jurisdictions, including three jurisdictions without primary interview data. Among proponents of NPSS, we identified common themes, including: (1) public health research provided conclusive evidence for reduction in HIV and hepatitis transmission without problems of crime, drug use, or unsafe discard of syringes; (2) the local health officer was the key to influencing local policymakers; (3) recall of prior debates over syringe exchange served to inform their decision making; and (4) a lack of local opposition or controversy. Common concerns among opponents of NPSS included: (1) that there would be an increase in unsafe discard of syringes; (2) loss of an important law enforcement tool; (3) that drug users were incapable of desired behavior change; and (4) that research was inconclusive

  14. Primary and Secondary Analysis of Local Elected Officials’ Decisions to Support or Oppose Pharmacy Sale of Syringes in California

    PubMed Central

    Rose, Valerie J.

    2010-01-01

    Under California law, local governments may authorize pharmacies within their jurisdictions to sell ten or fewer syringes to an adult without prescription, proof of identity, or proof of medical need. Local governments may simultaneously exempt adults from prosecution for violation of state drug paraphernalia codes for possession of ten or fewer syringes for personal use. Both of these provisions are temporary and sunset on December 31, 2010, unless subsequent state legislation amends that date. The objective of our study was to ascertain how and why local policymakers made their decisions regarding non-prescription syringe sale (NPSS). We examined influences on their decisions, including specific messengers and the arguments that were most salient to their decision making. We selected jurisdictions that were geographically representative of California counties; those with and without syringe exchange programs, and those that had passed or rejected NPSS. We conducted nine semi-structured interviews in five jurisdictions. To enrich primary data collection, we analyzed secondary data by reviewing audio, video, and written transcripts of public hearings and newspaper coverage in five jurisdictions, including three jurisdictions without primary interview data. Among proponents of NPSS, we identified common themes, including: (1) public health research provided conclusive evidence for reduction in HIV and hepatitis transmission without problems of crime, drug use, or unsafe discard of syringes; (2) the local health officer was the key to influencing local policymakers; (3) recall of prior debates over syringe exchange served to inform their decision making; and (4) a lack of local opposition or controversy. Common concerns among opponents of NPSS included: (1) that there would be an increase in unsafe discard of syringes; (2) loss of an important law enforcement tool; (3) that drug users were incapable of desired behavior change; and (4) that research was inconclusive

  15. Measurement of intraosseous pressures generated by the Wand, high-pressure periodontal ligament syringe, and the Stabident system.

    PubMed

    Shepherd, P A; Eleazer, P D; Clark, S J; Scheetz, J P

    2001-06-01

    Intraosseous pressure generated by the use of three anesthetic systems-the Wand; a hand-operated high-pressure periodontal ligament (PDL) syringe; and the Stabident system-were studied in fresh mandibles of 14 large swine. The mandibles were drilled and tapped in one area of both the right and left posterior molar regions. Pressure gauges were attached via threaded fittings. Pressures during injection were recorded for the Wand first, then the PDL syringe, and finally Stabident. Results showed averages of 8.3 mm Hg generated by the Wand, 16.3 mm Hg with the high-pressure PDL syringe, and 43.7 mm Hg from the Stabident system. Results were corroborated with data from three human cadaver mandibles.

  16. Needle and Syringe Cleaning Practices among Injection Drug Users.

    ERIC Educational Resources Information Center

    Fisher, Dennis G.; Harbke, Colin R.; Canty, John R.; Reynolds, Grace L.

    2002-01-01

    Evaluates the effect of needle exchange on the bleach-mediated disinfection (BMD) practices of 176 needle and syringe sharing injection drug users (IDUs). Results reveal that IDUs who traded sex for money or drugs were less likely to practice BMD, and IDUs who reported a reduced number of sex partners were more likely to practice BMD. (Contains 36…

  17. Using Pharmacies in a Structural Intervention to Distribute Low Dead Space Syringes to Reduce HIV and HCV Transmission in People Who Inject Drugs

    PubMed Central

    Johnson, Terence L.; Zule, William A.; Carda-Auten, Jessica; Golin, Carol E.

    2015-01-01

    Ongoing injection drug use contributes to the HIV and HCV epidemics in people who inject drugs. In many places, pharmacies are the primary source of sterile syringes for people who inject drugs; thus, pharmacies provide a viable public health service that reduces blood-borne disease transmission. Replacing the supply of high dead space syringes with low dead space syringes could have far-reaching benefits that include further prevention of disease transmission in people who inject drugs and reductions in dosing inaccuracies, medication errors, and medication waste in patients who use syringes. We explored using pharmacies in a structural intervention to increase the uptake of low dead space syringes as part of a comprehensive strategy to reverse these epidemics. PMID:25880955

  18. PI3K/Akt inhibition and down-regulation of BCRP re-sensitize MCF7 breast cancer cell line to mitoxantrone chemotherapy

    PubMed Central

    Komeili-Movahhed, Tahereh; Fouladdel, Shamileh; Barzegar, Elmira; Atashpour, Shekoufeh; Hossein Ghahremani, Mohammad; Nasser Ostad, Seyed; Madjd, Zahra; Azizi, Ebrahim

    2015-01-01

    Objective(s): Multidrug resistance (MDR) of cancer cells is a major obstacle to successful chemotherapy. Overexpression of breast cancer resistance protein (BCRP) is one of the major causes of MDR. In addition, it has been shown that PI3K/Akt signaling pathway involves in drug resistance. Therefore, we evaluated the effects of novel approaches including siRNA directed against BCRP and targeted therapy against PI3K/Akt signaling pathway using LY294002 (LY) to re-sensitize breast cancer MCF7 cell line to mitoxantrone (MTX) chemotherapy. Materials and Methods: Anticancer effects of MTX, siRNA, and LY alone and in combination were evaluated in MCF7 cells using MTT cytotoxicity assay and flow cytometry analysis of cell cycle distribution and apoptosis induction. Results: MTT and apoptosis assays showed that both MTX and LY inhibited cell proliferation and induced apoptosis in MCF7 cells. Results indicated that inhibition of BCRP by siRNA or PI3K/Akt signaling pathway by LY significantly increased sensitivity of MCF7 cells to antiproliferation and apoptosis induction of MTX. Furthermore, MTX showed G2/M arrest, whereas LY induced G0/G1 arrest in cell cycle distribution of MCF7 cells. Combination of siRNA or LY with MTX chemotherapy significantly increased accumulation of MCF7 cells in the G2/M phase of cell cycle. Conclusion: Combination of MTX chemotherapy with BCRP siRNA and PI3K/Akt inhibition can overcome MDR in breast cancer cells. This study furthermore suggests that novel therapeutic approaches are needed to enhance anticancer effects of available drugs in breast cancer. PMID:26124933

  19. Antimicrobial Effect of Ozone Made by KP Syringe of High-Frequency Ozone Generator

    PubMed Central

    Prebeg, Domagoj; Katunarić, Marina; Budimir, Ana; Šegović, Sanja; Anić, Ivica

    2016-01-01

    Aim The aim of this study was to evaluate in vitro the antibacterial effect of ozone on suspension of three different bacteria inoculated in prepared canals of extracted human teeth. Material and methods Ozone was produced by special KP syringe of high frequency ozone generator Ozonytron (Biozonix, München, Germany) from aspirated atmospheric air by dielectric barrier discharge and applied through the tip of the syringe to the prepared root canal. The microorganisms used were Enterococcus faecalis, Staphylococcus aureus and Staphylococcus epidermidis. Results However, none of the methods was 100% effective against the three bacterial types in suspension. Application of ozone significantly decreased the absolute count of microorganisms (89.3%), as well as the count of each type of bacteria separately (Staphylococcus aureus 94.0%; Staphylococcus epidermidis 88.6% and Enterococcus faecalis 79.7%). Ozone generated by KP syringe was statistically more effective compared to NaOCl as positive control, for Staphylococcus aureus and Staphylococcus epidermidis. Conclusion The absolute count of Enterococcus faecalis was statistically decreased without a statistically significant difference between the tested group and positive control, respectively. Among the three types of bacteria in suspension, KP probe had the lowest antimicrobial effect against Enterococcus faecalis. PMID:27789911

  20. Cost-utility analysis of adjuvant chemotherapy in patients with stage III colon cancer in Thailand.

    PubMed

    Lerdkiattikorn, Panattharin; Chaikledkaew, Usa; Lausoontornsiri, Wirote; Chindavijak, Somjin; Khuhaprema, Thirawud; Tantai, Narisa; Teerawattananon, Yot

    2015-01-01

    In Thailand, there has been no economic evaluation study of adjuvant chemotherapy for stage III colon cancer patients after resection. This study aims to evaluate the cost-utility of all chemotherapy regimens currently used in Thailand compared with the adjuvant 5-fluorouracil/leucovorin (5-FU/LV) plus capecitabine as the first-line therapy for metastatic disease in patients with stage III colon cancer after resection. A cost-utility analysis was performed to estimate the relevant lifetime costs and health outcomes of chemotherapy regimens based on a societal perspective using a Markov model. The results suggested that the adjuvant 5-FU/LV plus capecitabine as the first-line therapy for metastatic disease would be the most cost-effective chemotherapy. The adjuvant FOLFOX and FOLFIRI as the first-line treatment for metastatic disease would be cost-effective with an incremental cost-effectiveness ratio of 299,365 Thai baht per QALY gained based on a societal perspective if both prices of FOLFOX and FOLFIRI were decreased by 40%.

  1. Stability of thiopental sodium and propofol in polypropylene syringes at 23 and 4 degrees C.

    PubMed

    Chernin, E L; Stewart, J T; Smiler, B

    1996-07-01

    The stability of thiopental sodium and propofol in an admixture stored in polypropylene syringes at room temperature and under refrigeration was studied. Propofol injection 10 mg/ mL and thiopental sodium 25 mg/mL were mixed to final concentrations of 5 and 12.5 mg/mL, respectively. The admixture was put into 60-mL polypropylene syringes, and two syringes were stored at 23 degrees C and two at 4 degrees C. For solutions stored at 23 degrees C, samples were taken at 0, 4, 8, 24, 48, 72, 120, 168, 216, 240, and 264 hours, and for samples stored at 4 degrees C, samples were taken at 0, 4, 8, 24, 48, 72, 120, 168, 216, and 312 hours. Drug concentrations were determined by high-performance liquid chromatography. Thiopental sodium and propofol retained > 90% of their initial concentrations for up to 312 hours at 4 degrees C. At 23 degrees C, > 90% of the initial concentration was retained by propofol for up to 120 hours and by thiopental sodium for up to 240 hours. No visual changes or significant change in pH occurred in any sample. When mixed and stored in polypropylene syringes, propofol 5 mg/mL and thiopental sodium 12.5 mg/mL were stable for up to 312 hours at 4 degrees C and for up to 120 hours at 23 degrees C.

  2. The effect of on-site and outreach-based needle and syringe programs in people who inject drugs in Kermanshah, Iran.

    PubMed

    Nazari, Seyed Saeed Hashemi; Noroozi, Mehdi; Soori, Hamid; Noroozi, Alireza; Mehrabi, Yadollah; Hajebi, Ahmad; Sharifi, Hamid; Higgs, Peter; Mirzazadeh, Ali

    2016-01-01

    Needle and syringe programs (NSPs) are widely used to reduce harms associated with drug injecting. This study assessed the effect of facility-based (on-site services at drop-in centre) and outreach models of NSP on injection risk behaviours. Self-reported data from 455 people who injected drugs (PWID) during 2014 in Kermanshah, Iran, were examined to measure demographic characteristics and risk behaviors. Self-reported and program data were also assessed to identify their main source of injection equipment. Participants were divided into three sub-groups: facility-based NSP users, outreach NSP users and non-users (comparison group). Coarsened exact matching was used to make the three groups statistically equivalent based on age, place of residence, education and income, and groups were compared regarding the proportion of borrowing or lending of syringes/cookers, reusing syringes and recent HIV testing. Overall, 76% of participants reported any NSP service use during the two months prior to interview. Only 23% (95%CI: 17-27) reported outreach NSP as their main source of syringes. Using facility-based NSP significantly decreased recent syringe borrowing (OR: 0.27, 95%CI: 0.10-0.70), recent syringe reuse (OR: 0.38, 95%CI: 0.23-0.68) and increased recent HIV testing (OR: 2.60, 95%CI: 1.48-4.56). Similar effects were observed among outreach NSP users; in addition, the outreach NSP model significantly reduced the chance of lending syringes (OR: 0.31, 95%CI: 0.15-0.60), compared to facility-based NSP (OR: 1.25, 95%CI: 0.74-2.17). These findings suggest that the outreach NSP model is as effective as facility-based NSP in reducing injection risk behaviours and increasing the rate of HIV testing. Outreach NSP was even more effective than facility-based in reducing the lending of syringes to others. Scaling up outreach NSP is an effective intervention to further reduce transmission of HIV via needle sharing. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. An Evaluation of the Effectiveness of a Vibrating Syringe Attachment in Decreasing Intraoral Injection Pain Perception

    DTIC Science & Technology

    2012-06-01

    mucosa penetrations to periosteum by a 27-gauge short needle attached to a dental cartridge syringe . New needles were used for each injection, and the...of the American Dental Association, 134(2), 228-234. 7. Bonjar AHS. (2011) Syringe micro vibrator (SMV) a new device being introduced in dentistry...Lautenbacher S. (2004) Pathophysiology of Pain Perception. New York , New York : Kluwer and Plenum. 16 Flanagan T, Wahl MJ, Schmitt MM, Wahl JA. (2007) Size

  4. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: prospective evaluation of activity, safety, and quality of life.

    PubMed

    Palumbo, Raffaella; Sottotetti, Federico; Trifirò, Giuseppe; Piazza, Elena; Ferzi, Antonella; Gambaro, Anna; Spinapolice, Elena Giulia; Pozzi, Emma; Tagliaferri, Barbara; Teragni, Cristina; Bernardo, Antonio

    2015-01-01

    A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC). Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m(2) as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal. All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48% (95% CI, 31.5%-61.3%) and included complete responses from 13.5%. Disease stabilization was obtained in 19 patients and lasted >6 months in 15 of them; the overall clinical benefit rate was 77%. The median time to response was 70 days (range 52-86 days). The median progression-free survival time was 8.9 months (95% CI, 8.0-11.6 months, range 5-21+ months). The median overall survival point has not yet been reached. Toxicities were expected and manageable with good patient compliance and preserved quality of life in patients given long-term treatment. Our results showed that single-agent nab-paclitaxel 260 mg/m(2) every 3 weeks is an effective and well tolerated regimen as second-line chemotherapy in HER2-negative, taxane-pretreated MBC patients, and that it produced interesting values of objective response rate and progression-free survival without the concern of significant toxicity. Specifically, the present study shows that such a regimen is a valid therapeutic option for that 'difficult to

  5. Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial

    PubMed Central

    Maughan, Timothy S; Adams, Richard A; Smith, Christopher G; Meade, Angela M; Seymour, Matthew T; Wilson, Richard H; Idziaszczyk, Shelley; Harris, Rebecca; Fisher, David; Kenny, Sarah L; Kay, Edward; Mitchell, Jenna K; Madi, Ayman; Jasani, Bharat; James, Michelle D; Bridgewater, John; Kennedy, M John; Claes, Bart; Lambrechts, Diether; Kaplan, Richard; Cheadle, Jeremy P

    2011-01-01

    Summary Background In the Medical Research Council (MRC) COIN trial, the epidermal growth factor receptor (EGFR)-targeted antibody cetuximab was added to standard chemotherapy in first-line treatment of advanced colorectal cancer with the aim of assessing effect on overall survival. Methods In this randomised controlled trial, patients who were fit for but had not received previous chemotherapy for advanced colorectal cancer were randomly assigned to oxaliplatin and fluoropyrimidine chemotherapy (arm A), the same combination plus cetuximab (arm B), or intermittent chemotherapy (arm C). The choice of fluoropyrimidine therapy (capecitabine or infused fluouroracil plus leucovorin) was decided before randomisation. Randomisation was done centrally (via telephone) by the MRC Clinical Trials Unit using minimisation. Treatment allocation was not masked. The comparison of arms A and C is described in a companion paper. Here, we present the comparison of arm A and B, for which the primary outcome was overall survival in patients with KRAS wild-type tumours. Analysis was by intention to treat. Further analyses with respect to NRAS, BRAF, and EGFR status were done. The trial is registered, ISRCTN27286448. Findings 1630 patients were randomly assigned to treatment groups (815 to standard therapy and 815 to addition of cetuximab). Tumour samples from 1316 (81%) patients were used for somatic molecular analyses; 565 (43%) had KRAS mutations. In patients with KRAS wild-type tumours (arm A, n=367; arm B, n=362), overall survival did not differ between treatment groups (median survival 17·9 months [IQR 10·3–29·2] in the control group vs 17·0 months [9·4–30·1] in the cetuximab group; HR 1·04, 95% CI 0·87–1·23, p=0·67). Similarly, there was no effect on progression-free survival (8·6 months [IQR 5·0–12·5] in the control group vs 8·6 months [5·1–13·8] in the cetuximab group; HR 0·96, 0·82–1·12, p=0·60). Overall response rate increased from 57% (n=209

  6. Social network-related risk factors for bloodborne virus infections among injection drug users receiving syringes through secondary exchange.

    PubMed

    De, Prithwish; Cox, Joseph; Boivin, Jean-François; Platt, Robert W; Jolly, Ann M

    2008-01-01

    Secondary syringe exchange (SSE) refers to the exchange of sterile syringes between injection drug users (IDUs). To date there has been limited examination of SSE in relation to the social networks of IDUs. This study aimed to identify characteristics of drug injecting networks associated with the receipt of syringes through SSE. Active IDUs were recruited from syringe exchange and methadone treatment programs in Montreal, Canada, between April 2004 and January 2005. Information on each participant and on their drug-injecting networks was elicited using a structured, interviewer-administered questionnaire. Subjects' network characteristics were examined in relation to SSE using regression models with generalized estimating equations. Of 218 participants, 126 were SSE recipients with 186 IDUs in their injecting networks. The 92 non-recipients reported 188 network IDUs. Networks of SSE recipients and non-recipients were similar with regard to network size and demographics of network members. In multivariate analyses adjusted for age and gender, SSE recipients were more likely than non-recipients to self-report being HIV-positive (OR=3.56 [1.54-8.23]); require or provide help with injecting (OR=3.74 [2.01-6.95]); have a social network member who is a sexual partner (OR=1.90 [1.11-3.24]), who currently attends a syringe exchange or methadone program (OR=2.33 [1.16-4.70]), injects daily (OR=1.77 [1.11-2.84]), and shares syringes with the subject (OR=2.24 [1.13-4.46]). SSE is associated with several injection-related risk factors that could be used to help focus public health interventions for risk reduction. Since SSE offers an opportunity for the dissemination of important prevention messages, SSE-based networks should be used to improve public health interventions. This approach can optimize the benefits of SSE while minimizing the potential risks associated with the practice of secondary exchange.

  7. Stability of Dalteparin 1,000 Unit/mL in 0.9% Sodium Chloride for Injection in Polypropylene Syringes.

    PubMed

    Kirkham, Kylian; Munson, Jessica M; McCluskey, Susan V; Graner, Kevin K

    2017-01-01

    The stability of dalteparin 1,000 units/mL in 0.9% sodium chloride for injection stored in polypropylene syringes under refrigeration was examined. Dalteparin 1,000-units/mL syringes were prepared by adding 9 mL of 0.9% sodium chloride for injection to 1 mL of dalteparin sodium 10,000 unit/mL from commercial single-use syringes. Compounded solutions in 0.5-mL aliquots were transferred to 1-mL polypropylene syringes and sealed with a Luer lock tip cap and stored at refrigerated temperatures (2°C to 8°C) with ambient fluorescent light exposure. Syringes from three batches of dalteparin 1,000 units/mL were potency tested in duplicate by a stability-indicating high-performance liquid chromatography assay using a 0.5-mL sample at specified intervals. Visual and pH testing were performed on each batch. Samples were visually inspected for container integrity, color, and clarity. Samples for pH testing were prepared using a 1:1 dilution of dalteparin 1,000 units/mL in sterile water for injection and underwent duplicate analysis at each time point. High-performance liquid chromatography analyses showed a remaining percent of the initial dalteparin content at day 30 of 94.88% ± 2.11%. Samples remained colorless and clear with no signs of container compromise and no visual particulate matter at each time point. Throughout the 30-day study period, pH values remained within 0.3-pH units from the initial value of 5.84. Dalteparin 1,000 unit/mL in 0.9% sodium chloride for injection, packaged in 1-mL polypropylene syringes was stable for at least 30 days while stored at refrigerated conditions with ambient fluorescent light exposure. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  8. Syringe Port: A Convenient, Safe, and Cost-Effective Tubular Retractor for Transportal Removal of Deep-Seated Lesions of the Brain.

    PubMed

    Singh, Harnarayan; Patir, Rana; Vaishya, Sandeep; Miglani, Rahul; Kaur, Amandeep

    2018-06-01

    Minimally invasive transportal resection of deep intracranial lesions has become a widely accepted surgical technique. Many disposable, mountable port systems are available in the market for this purpose, like the ViewSite Brain Access System. The objective of this study was to find a cost-effective substitute for these systems. Deep-seated brain lesions were treated with a port system made from disposable syringes. The syringe port could be inserted through minicraniotomies placed and planned with navigation. All deep-seated lesions like ventricular tumours, colloid cysts, deep-seated gliomas, and basal ganglia hemorrhages were treated with this syringe port system and evaluated for safety, operative site hematomas, and blood loss. 62 patients were operated on during the study period from January 2015 to July 2017, using this innovative syringe port system for deep-seated lesions of the brain. No operative site hematoma or contusions were seen along the port entry site and tract. Syringe port is a cost-effective and safe alternative to the costly disposable brain port systems, especially for neurosurgical setups in developing countries for minimally invasive transportal resection of deep brain lesions. Copyright © 2018 Elsevier Inc. All rights reserved.

  9. Final Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer.

    PubMed

    Cinieri, Saverio; Chan, Arlene; Altundag, Kadri; Vandebroek, An; Tubiana-Mathieu, Nicole; Barnadas, Agusti; Dodyk, Patricia; Lazzarelli, Silvia; Botha, Michiel; Rauch, Daniel; Villanova, Gustavo; Coskun, Ugur

    2017-04-01

    The purpose of this study was to evaluate the efficacy of 3 first-line chemotherapy combination regimens for HER2-negative metastatic breast cancer (mBC). In this open-label, 3-arm, randomized phase II trial, patients were randomized to all-oral NORCAP (vinorelbine/capecitabine), GEMPAC (gemcitabine/paclitaxel), or GEMDOC (gemcitabine/docetaxel) as first-line chemotherapy for HER2-negative mBC. Stratification factors were center, previous (neo)adjuvant anthracycline, and age. The primary end point was disease control rate (DCR; complete or partial response, or stable disease for ≥3 months). The DCR was 73% (95% confidence interval [CI], 59-85) with NORCAP (36 of 49 patients), 78% (95% CI, 64-88) with GEMPAC (39 of 50 patients), and 80% (95% CI, 66-90) with GEMDOC (40 of 50 patients). Objective response rates were 33% (16 of 49 patients), 24% (12 of 50 patients), and 50% (25 of 50 patients), respectively; median progression-free survival was 7.6, 9.0, and 11.4 months, respectively. Median overall survival was 30 to 31 months with all regimens. The most common Grade ≥3 adverse event with each regimen was neutropenia (24 patients [50%], 23 patients [46%], and 43 patients [86%], respectively). The most common nonhematological Grade ≥3 adverse event was fatigue. Grade 2 alopecia occurred in 36 patients (72%) who received GEMPAC and 38 patients (76%) who received GEMDOC, but only 4 patients (8%) who received NORCAP. There was no evidence of a detrimental effect of NORCAP on quality of life. All-oral NORCAP is an active first-line chemotherapy regimen and might be offered as an alternative to first-line taxane-based therapy for HER2-negative mBC, particularly if patients wish to avoid alopecia or frequent intravenous administrations. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Efficacy of tegafur-uracil in advanced urothelial cancer patients after the treatment failure of platinum-based chemotherapy.

    PubMed

    Maolake, Aerken; Izumi, Kouji; Takahashi, Rie; Itai, Shingo; Machioka, Kazuaki; Yaegashi, Hiroshi; Nohara, Takahiro; Kitagawa, Yasuhide; Kadono, Yoshifumi; Konaka, Hiroyuki; Mizokami, Atsushi; Namiki, Mikio

    2015-03-01

    Platinum-based chemotherapy is the first-line treatment for advanced urinary tract urothelial cancers. However, the optimal second-line treatment is unclear. Although tegafur-uracil is sometimes used for advanced urothelial cancer patients after the treatment failure of platinum-based chemotherapy, there is little evidence regarding its use as a second-line treatment. Advanced urothelial cancer patients previously treated with platinum-based chemotherapy were retrospectively analyzed. Overall survival (OS) was compared between patients with and without tegafur-uracil treatment. Thirty-one patients (27 and 4 patients with and without tegafur-uracil treatment, respectively) were analyzed. OS from the last day of the final chemotherapy course was better in patients with tegafur-uracil treatment than in those without (p<0.001, 358 and 66.5 days of the median survival time, respectively). Tegafur-uracil may be a candidate for the secondary treatment of advanced urothelial cancer patients after the treatment failure of platinum-based chemotherapy. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  11. DETERMINING SERUM BICARBONATE—A Simple Syringe Titrator and Colorimeter

    PubMed Central

    Boone, Charles W.; Field, John B.

    1953-01-01

    The use of a tuberculin syringe as a burette has made possible an easy bedside technique for the determination of serum bicarbonate. By combining it with the use of a simple colorimeter, a relatively untrained person can do numerous bicarbonate determinations with a high degree of accuracy. The same technique also lends itself to other colorimetric clinical procedures such as determination of gastric acidity. PMID:13106724

  12. Determining serum bicarbonate; a simple syringe titrator and colorimeter.

    PubMed

    BOONE, C W; FIELD, J B

    1953-12-01

    The use of a tuberculin syringe as a burette has made possible an easy bedside technique for the determination of serum bicarbonate. By combining it with the use of a simple colorimeter, a relatively untrained person can do numerous bicarbonate determinations with a high degree of accuracy. The same technique also lends itself to other colorimetric clinical procedures such as determination of gastric acidity.

  13. Study of small-cell lung cancer cell-based sensor and its applications in chemotherapy effects rapid evaluation for anticancer drugs.

    PubMed

    Guohua, Hui; Hongyang, Lu; Zhiming, Jiang; Danhua, Zhu; Haifang, Wan

    2017-11-15

    Small cell lung cancer (SCLC) is a smoking-related cancer disease. Despite improvement in clinical survival, SCLC outcome remains extremely poor. Cisplatin (DDP) is the first-line chemotherapy drug for SCLC, but the choice of second-line chemotherapy drugs is not clear. In this paper, a SCLC cell-based sensor was proposed, and its applications in chemotherapy effects rapid evaluation for anticancer drugs were investigated. SCLC cell lines lung adenocarcinoma cell (LTEP-P) and DDP-resistant lung adenocarcinoma cell (LTEP-P/DDP-1.0) are cultured on carbon screen-printed electrode (CSPE) to fabricate integrated cell-based sensor. Several chemotherapy anticancer drugs, including cisplatin, ifosmamide, gemcitabine, paclitaxel, docetaxel, vinorelbine, etoposide, camptothecin, and topotecan, are selected as experimental chemicals. 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) tests are conducted to evaluate chemotherapy drug effects on LTEP-P and LTEP-P/DDP-1.0 cell lines. Electrical cell-substrate impedance sensing (ECIS) responses to anti-tumor chemicals are measured and processed by double-layered cascaded stochastic resonance (DCSR). Cisplatin solutions in different concentrations measurement results demonstrate that LTEP-P cell-based sensor presents quantitative analysis abilities for cisplatin and topotecan. Cisplatin and its mixtures can also be discriminated. Results demonstrate that LTEP-P cell-based sensor sensitively evaluates chemotherapy drugs' apoptosis function to SCLC cells. LTEP-P/DDP-1.0 cell-based sensor responses demonstrate that gemcitabine, vinorelbine, and camptothecin are ideal second-line drugs for clinical post-cisplatin therapy than other drugs according to MTT test results. This work provides a novel way for SCLC second-line clinical chemotherapy drug screening. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. On-line lab-in-syringe cloud point extraction for the spectrophotometric determination of antimony.

    PubMed

    Frizzarin, Rejane M; Portugal, Lindomar A; Estela, José M; Rocha, Fábio R P; Cerdà, Victor

    2016-02-01

    Most of the procedures for antimony determination require time-consuming sample preparation (e.g. liquid-liquid extraction with organic solvents), which are harmful to the environment. Because of the high antimony toxicity, a rapid, sensitive and greener procedure for its determination becomes necessary. The goal of this work was to develop an analytical procedure exploiting for the first time the cloud point extraction on a lab-in-syringe flow system aiming at the spectrophotometric determination of antimony. The procedure was based on formation of an ion-pair between the antimony-iodide complex and H(+) followed by extraction with Triton X-114. The factorial design showed that the concentrations of ascorbic acid, H2SO4 and Triton X-114, as well as second and third order interactions were significant at the 95% confidence level. A Box-Behnken design was applied to obtain the response surfaces and to identify the critical values. System is robust at the 95% confidence level. A linear response was observed from 5 to 50 µg L(-1), described by the equation A=0.137+0.050C(Sb) (r=0.998). The detection limit (99.7% confidence level), the coefficient of variation (n=5; 15 µg L(-1)) and the sampling rate was estimated at 1.8 µg L(-1), 1.6% and 16 h(-1), respectively. The procedure allows quantification of antimony in the concentrations established by environmental legislation (6 µg L(-1)) and it was successfully applied to the determination of antimony in freshwater samples and antileishmanial drugs, yielding results in agreement with those obtained by HGFAAS at the 95% confidence level. Copyright © 2015 Elsevier B.V. All rights reserved.

  15. Professional ideologies and the development of syringe exchange: Wales as a case study.

    PubMed

    Keene, J M; Stimson, G V

    1997-12-01

    This paper is derived from an evaluative study of HIV prevention programs for drug injectors across Wales. It considers how different professional territories and ideologies, concepts of drug misuse and models of HIV prevention may influence policy development. The research involved monitoring the introduction and development of agency and community based syringe exchange schemes and initiatives taken by community pharmacists. Interviews with staff, managers and administrators, and descriptions of service history, development and delivery inform the discussion. HIV prevention varied in different areas of Wales depending on the particular professional group involved, local ideologies regarding drug use treatment, and the extent to which HIV prevention was seen either as a specialist area of expertise and specific remit of drug workers or a generic health care task. Drug agencies with an abstinence policy rejected syringe exchange; instead, prevention in those areas developed in ad hoc ways as health care workers and pharmacists attempted to develop a community based service. Drug agencies with a pre-existing harm minimisation model easily integrated syringe exchange into their work and played the major part in establishing the service, but there was difficulty in extending it beyond their professional caseloads. As there were disincentives to use treatment agencies, and their catchment areas were limited, these factors influenced effective service provision.

  16. Intraductal collagenase delivery into the human pancreas using syringe loading or controlled perfusion.

    PubMed

    Lakey, J R; Warnock, G L; Shapiro, A M; Korbutt, G S; Ao, Z; Kneteman, N M; Rajotte, R V

    1999-01-01

    Effective intraductal delivery of the enzyme collagenase into the pancreas is crucial to the subsequent ability to isolate viable islets. Most clinical islet transplant centers load the enzyme into the pancreas by retrograde injection using a syringe following cannulation of the pancreatic duct. An alternative approach is to perfuse the pancreas via the pancreatic duct with collagenase solution using a recirculating perfusion device system. This provides control over perfusion pressures and collagenase temperature. This study reports on our evaluation of the delivery of Liberase-HI into the pancreas of 14 consecutive adult multiorgan cadaveric donors. Alternate glands were procured and processed using an identical protocol with the exception of collagenase delivery. The first group of pancreases was loaded using the perfusion technique where cold (4 degrees C) Liberase-HI was perfused at 80 mmHg for 5 min after which the pressure was increased to 180 mmHg. The collagenase solution was then slowly warmed to 35 degrees C, transferred to the dissociation chamber and mechanically dissociated, and then purified using discontinuous gradients of Ficoll. Pancreases in the second group were loaded with collagenase (28-32 degrees C) using the syringe technique before mechanical dissociation and purification. There were no significant differences in pancreas cold ischemia, donor age, body mass index, maximum blood glucose, or serum amylase of the donors between the two groups. Mean collagenase digestion time in the digestion chamber was not different between the two groups; however, the amount of undigested tissue remaining after dissociation was significantly higher in the syringe-loaded group (15.3 +/- 2.6 g vs. 4.6 +/- 2.1 g, mean +/- SEM, p < 0.05). Postdigestion recovery of islets was 471 +/- 83 x 10(3) IE in the perfusion group compared with 391 +/- 57 x 10(3) IE for the syringe-loaded group. Postpurification recovery was higher in the perfused group (379 +/- 45 vs. 251

  17. Economic analysis of conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer.

    PubMed

    Schulman, K A; Stadtmauer, E A; Reed, S D; Glick, H A; Goldstein, L J; Pines, J M; Jackman, J A; Suzuki, S; Styler, M J; Crilley, P A; Klumpp, T R; Mangan, K F; Glick, J H

    2003-02-01

    We performed an economic analysis of data from 180 women in a clinical trial of conventional-dose chemotherapy vs high-dose chemotherapy plus stem-cell transplantation for metastatic breast cancer responding to first-line chemotherapy. Data on resource use, including hospitalizations, medical procedures, medications, and diagnostic tests, were abstracted from subjects' clinical trial records. Resources were valued using the Medicare Fee Schedule for inpatient costs at one academic medical center and average wholesale prices for medications. Monthly costs were calculated and stratified by treatment group and clinical phase. Mean follow-up was 690 days in the transplantation group and 758 days in the conventional-dose chemotherapy group. Subjects in the transplantation group were hospitalized for more days (28.6 vs 17.8, P=0.0041) and incurred higher costs (US dollars 84055 vs US dollars 28169) than subjects receiving conventional-dose chemotherapy, with a mean difference of US dollars 55886 (95% CI, US dollars 47298-US dollars 63666). Sensitivity analyses resulted in cost differences between the treatment groups from US dollars 36528 to US dollars 75531. High-dose chemotherapy plus stem-cell transplantation resulted in substantial additional morbidity and costs at no improvement in survival. Neither the survival results nor the economic findings support the use of this procedure outside of the clinical trial setting.

  18. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes.

    PubMed

    Boven, Katia; Stryker, Scott; Knight, John; Thomas, Adrian; van Regenmortel, Marc; Kemeny, David M; Power, David; Rossert, Jerome; Casadevall, Nicole

    2005-06-01

    The incidence of pure red cell aplasia (PRCA) in chronic kidney disease patients treated with epoetins increased substantially in 1998, was shown to be antibody mediated, and was associated predominantly with subcutaneous administration of Eprex. A technical investigation identified organic compounds leached from uncoated rubber stoppers in prefilled syringes containing polysorbate 80 as the most probable cause of the increased immunogenicity. This study investigated whether the incidence of PRCA was higher for exposure to the product form containing leachates than for leachate-free product forms. Antibody-mediated PRCA cases were classified according to indication, product form, and route of administration. Exposure estimates were obtained by country, indication, route of administration, and product form. For 2001 to 2003, the PRCA incidence rate for patients with subcutaneous exposure to Eprex in prefilled syringes with polysorbate 80 and uncoated rubber stoppers (leachates present) was 4.61/10,000 patient years (95% CI 3.88-5.43) versus 0.26/10,000 patient years (95% CI 0.007-1.44) for syringes with coated stoppers (leachates absent). The rate difference was 4.35/10,000 patient years (95% CI 3.44-5.26; P < 0.0001); the rate ratio was 17 (95% CI 3.14-707). A substantial rate difference remained in sensitivity analyses that adjusted for exposure to multiple product forms. The epidemiologic data, together with the chemical and immunologic data, support the hypothesis that leachates from uncoated rubber syringe stoppers caused the increased incidence of PRCA associated with Eprex. Currently, all Eprex prefilled syringes contain fluoro-resin coated stoppers, which has contributed to decreased incidence of PRCA with continued surveillance.

  19. 41 CFR 109-27.5009 - Control of hypodermic needles and syringes.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Control of hypodermic... SUPPLY AND PROCUREMENT 27-INVENTORY MANAGEMENT 27.50-Inventory Management Policies, Procedures, and Guidelines § 109-27.5009 Control of hypodermic needles and syringes. Effective procedures and practices shall...

  20. Updated Prognostic Model for Predicting Overall Survival in First-Line Chemotherapy for Patients With Metastatic Castration-Resistant Prostate Cancer

    PubMed Central

    Halabi, Susan; Lin, Chen-Yen; Kelly, W. Kevin; Fizazi, Karim S.; Moul, Judd W.; Kaplan, Ellen B.; Morris, Michael J.; Small, Eric J.

    2014-01-01

    Purpose Prognostic models for overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC) are dated and do not reflect significant advances in treatment options available for these patients. This work developed and validated an updated prognostic model to predict OS in patients receiving first-line chemotherapy. Methods Data from a phase III trial of 1,050 patients with mCRPC were used (Cancer and Leukemia Group B CALGB-90401 [Alliance]). The data were randomly split into training and testing sets. A separate phase III trial served as an independent validation set. Adaptive least absolute shrinkage and selection operator selected eight factors prognostic for OS. A predictive score was computed from the regression coefficients and used to classify patients into low- and high-risk groups. The model was assessed for its predictive accuracy using the time-dependent area under the curve (tAUC). Results The model included Eastern Cooperative Oncology Group performance status, disease site, lactate dehydrogenase, opioid analgesic use, albumin, hemoglobin, prostate-specific antigen, and alkaline phosphatase. Median OS values in the high- and low-risk groups, respectively, in the testing set were 17 and 30 months (hazard ratio [HR], 2.2; P < .001); in the validation set they were 14 and 26 months (HR, 2.9; P < .001). The tAUCs were 0.73 (95% CI, 0.70 to 0.73) and 0.76 (95% CI, 0.72 to 0.76) in the testing and validation sets, respectively. Conclusion An updated prognostic model for OS in patients with mCRPC receiving first-line chemotherapy was developed and validated on an external set. This model can be used to predict OS, as well as to better select patients to participate in trials on the basis of their prognosis. PMID:24449231

  1. [Pneumocystis Pneumonia during Adjuvant Chemotherapy for Advanced Colon Cancer - A Case Report].

    PubMed

    Fujiwara, Yushi; Lee, Shigeru; Kishida, Satoru; Hashiba, Ryoya; Gyobu, Ken; Osugi, Harushi

    2015-11-01

    We report a case of pneumocystis pneumonia (PCP) during adjuvant chemotherapy for advanced sigmoid colon cancer. A 70-year-old Japanese man was referred to our hospital after complaining of bloody stools. He was diagnosed with advanced sigmoid colon cancer, T2N2aM1b, Stage IV B. After 3 cycles of mFOLFOX6 plus panitumumab as first-line chemotherapy, he received FOLFIRI plus bevacizumab as second-line chemotherapy because of progressive disease. Aprepitant and steroids were administered as antiemetic agents for a short period during each chemotherapy session. During the 2 cycle of FOLFIRI plus bevacizumab, he developed a high fever without respiratory symptoms. Chest CT revealed ground-glass opacities in both the lungs. We first treated him with antibiotics (PIPC/TAZ plus GRNX), suspecting bacterial pneumonia. However, based on the elevation of serum b -D-glucan (148 pg/mL), we diagnosed PCP and initiated SMX/TMP in addition to PIPC/TAZ. The inflammation promptly decreased, and follow-up chest CT revealed the disappearance of the ground-glass opacities. If a patient develops a fever or respiratory symptoms during a course of chemotherapy, we should consider the possibility of PCP and perform careful examinations.

  2. Public support for safe consumption sites and syringe services programs to combat the opioid epidemic.

    PubMed

    McGinty, Emma E; Barry, Colleen L; Stone, Elizabeth M; Niederdeppe, Jeff; Kennedy-Hendricks, Alene; Linden, Sarah; Sherman, Susan G

    2018-06-01

    We examine Americans' support for two evidence-based harm reduction strategies - safe consumption sites and syringe exchange programs - and their attitudes about individuals who use opioids. We conducted a web-based survey of a nationally representative sample of U.S. adults in July-August 2017 (N = 1004). We measured respondents' support for legalizing safe consumption sites and syringe services programs in their communities and their attitudes toward people who use opioids. We used ordered logistic regression to assess how stigmatizing attitudes toward people who use opioids, political party identification, and demographic characteristics correlated with support for the two harm reduction strategies. Twenty-nine percent of Americans supported legalizing safe consumption sites and 39% supported legalizing syringe services programs. Respondents reported high levels of stigmatizing attitudes toward people who use opioids: 16% of respondents were willing to have a person using opioids marry into their family and 28% were willing to have a person using opioids start working closely with them on a job, and 27% and 10% of respondents rated persons who use opioids as deserving (versus worthless) and strong (versus weak). Stigmatizing attitudes were associated with lower support for legalizing safe consumption sites and syringe services programs. Democrats and Independents were more likely than Republicans to support both strategies. Stigmatizing attitudes toward people who use opioids are a key modifiable barrier to garnering the public support needed to fully implement evidence-based harm reduction strategies to combat the opioid epidemic. Dissemination and evaluation of stigma reduction campaigns are a public health priority. Copyright © 2018 Elsevier Inc. All rights reserved.

  3. Longitudinal analysis of change in individual-level needle and syringe coverage amongst a cohort of people who inject drugs in Melbourne, Australia.

    PubMed

    O'Keefe, Daniel; Scott, Nick; Aitken, Campbell; Dietze, Paul

    2017-07-01

    Needle and syringe program (NSP) coverage is often calculated at the individual level. This method relates sterile needle and syringe acquisition to injecting frequency, resulting in a percentage of injecting episodes that utilise a sterile syringe. Most previous research using this method was restricted by their cross-sectional design, calling for longitudinal exploration of coverage. We used the data of 518 participants from an ongoing cohort of people who inject drugs in Melbourne, Australia. We calculated individual-level syringe coverage for the two weeks prior to each interview, then dichotomised the outcome as either "sufficient" (≥100% of injecting episodes covered by at least one reported sterile syringe) or "insufficient" (<100%). Time-variant predictors of change in recent coverage (from sufficient to insufficient coverage) were estimated longitudinally using logistic regression with fixed effects for each participant. Transitioning to methamphetamine injection (AOR:2.16, p=0.004) and a newly positive HCV RNA test result (AOR:4.93, p=0.001) were both associated with increased odds of change to insufficient coverage, whilst change to utilising NSPs as the primary source of syringe acquisition (AOR: 0.41, p=0.003) and opioid substitution therapy (OST) enrolment (AOR:0.51, p=0.013) were protective against a change to insufficient coverage. We statistically tested the transitions between time-variant exposure sub-groups and transitions in individual-level syringe coverage. Our results give important insights into means of improving coverage at the individual level, suggesting that methamphetamine injectors should be targeted, whilst both OST prescription and NSP should be expanded. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents - A single blind randomized trial

    PubMed Central

    Pavia-Ruz, Noris; Abarca, Katia; Lepetic, Alejandro; Cervantes-Apolinar, Maria Yolanda; Hardt, Karin; Jayadeva, Girish; Kuriyakose, Sherine; Han, Htay Htay; de la O, Manuel

    2015-01-01

    Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™, is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10–15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine. PMID:26075317

  5. Pretreatment neutrophil to lymphocyte ratio is associated with response to therapy and prognosis of advanced non-small cell lung cancer patients treated with first-line platinum-based chemotherapy.

    PubMed

    Yao, Yanwen; Yuan, Dongmei; Liu, Hongbing; Gu, Xiaoling; Song, Yong

    2013-03-01

    Neutrophil to lymphocyte ratio (NLR) has been shown to be a prognosis indicator in different types of cancer. We aimed to investigate the association between NLR and therapy response, progression free survival (PFS) and overall survival (OS) in advanced non-small cell lung cancer (NSCLC) patients treated with first-line platinum-based chemotherapy. Patients who were hospitalized between January 2007 and December 2010 were enrolled and eliminated according to the inclusion and exclusion criteria. The NLR was defined as the absolute neutrophil count divided by the absolute lymphocyte count. Logistic regression analysis was applied for response rate and Cox regression analysis was adopted for PFS and OS. A P value of ≤0.05 was considered to be statistically significant. A total of 182 patients were enrolled in the current study. The median PFS was 164.5 days and median OS was 439.5 days. The statistical analysis data indicated that low pretreatment NLR (≤ 2.63) (OR = 2.043, P = 0.043), decreased posttreatment NLR (OR = 2.368, P = 0.013), well and moderate differentiation (OR = 2.773, P = 0.021) and normal CEA level (≤ 9.6 ng/ml) (OR = 2.090, P = 0.046) were associated with response to first-line platinum-based chemotherapy. A high pretreatment NLR (HR = 1.807, P = 0.018 for PFS, HR = 1.761, P = 0.020 for OS) and distant metastasis (HR = 2.118, P = 0.008 for PFS, HR = 2.753, P = 0.000 for OS) were independent prognostic factors for PFS and OS. Elevated pretreatment NLR might be a potential biomarker of worse response to first-line platinum-based chemotherapy and shorter PFS and OS for advanced NSCLC patients. To confirm these findings, larger, prospective and randomized studies are needed.

  6. Palliative chemotherapy for non-transitional cell carcinomas of the urothelial tract.

    PubMed

    Hong, Jung Yong; Choi, Moon Ki; Uhm, Ji Eun; Park, Min Jae; Lee, Jeeyun; Park, Se Hoon; Park, Joon Oh; Kim, Won Seog; Kang, Won Ki; Lee, Hyun Moo; Choi, Han Yong; Lim, Hoyeong

    2009-01-01

    Non-transitional cell carcinomas of the urothelial tract comprise 5-10% of urothelial cancers. Clinical information regarding the clinical behavior and chemotherapy outcome of non-transitional cell carcinomas of the urothelial tract are incomplete due to their rarity. The object of this study was to evaluate the clinical features and the efficacy of palliative chemotherapy in advanced non-transitional cell carcinomas of the urothelial tract. We analyzed the clinical records of 21 consecutive patients who received palliative chemotherapy for unresectable or metastatic non-transitional cell carcinomas of the urothelial tract between January 1995 and November 2007. All the 21 patients received first-line chemotherapy with platinum-based regimens which are known to be effective in transitional cell urothelial carcinomas. The median age of the patients was 57 years (range, 27-71 years). The primary sites of involvement were the bladder, urethra, urachus, and ureter in 43%, 29%, 19%, and 10% of the patients, respectively. Adenocarcinoma was the most common histological type (67%); squamous cell carcinoma and small cell carcinoma comprised 24 and 10% of the histologic types, respectively. With a median duration of follow-up of 32 months (range, 12-71 months), the median overall survival for all 21 patients from the day of first-line chemotherapy was 13 months (95% CI, 6.8-19.2). The expected 1-year survival rate was 50.6% (95% CI, 28.6-72.5). Univariate analysis showed a better median overall survival in patients with adenocarcinoma, compared to non-adenocarcinomas (47 vs. 10 months, P = 0.049). The median overall survival of patients who received platinum-based palliative chemotherapy for advanced non-transitional cell carcinomas was comparable to previous studies for patients with transitional cell carcinomas. Adenocarcinomas appear to have a favorable prognosis for the survival of the patients who received platinum-based chemotherapy for advanced non-transitional cell

  7. The Prison Economy of Needles and Syringes: What Opportunities Exist for Blood Borne Virus Risk Reduction When Prices Are so High?

    PubMed

    Treloar, Carla; McCredie, Luke; Lloyd, Andrew R

    2016-01-01

    A formal Needle and Syringe Program (NSP) is not provided in Australian prisons. Injecting equipment circulates in prisons as part of an informal and illegal economy. This paper examined how this economy generates blood-borne virus (BBV) risk and risk mitigation opportunities for inmates. The HITS-p cohort recruited New South Wales inmates who had reported ever injecting drugs and who had a negative HCV serological test within 12 months prior to enrolment. For this study, qualitative interviews were conducted with 30 participants enrolled in HITS-p. Participants included 10 women and were incarcerated in 12 prisons. A needle/syringe was nominated as being typically priced in the 'inside' prison economy at $100-$150, with a range of $50-$350. Purchase or hire of equipment was paid for in cash (including transactions that occurred outside prison) and in exchange for drugs and other commodities. A range of other resources was required to enable successful needle/syringe economies, especially relationships with visitors and other prisoners, and violence to ensure payment of debts. Strategies to mitigate BBV risk included retaining one needle/syringe for personal use while hiring out others, keeping drug use (and ownership of equipment) "quiet", stealing used equipment from the prison health clinic, and manufacture of syringes from other items available in the prison. The provision of prison NSP would disrupt the inside economies built around contraband needles/syringes, as well as minimise BBV risk. However, any model of prison NSP should be interrogated for any unanticipated markets that could be generated as a result of its regulatory practices.

  8. Weekly and every 2 weeks cetuximab maintenance therapy after platinum-based chemotherapy plus cetuximab as first-line treatment for non-small cell lung cancer: randomized non-comparative phase IIIb NEXT trial.

    PubMed

    Heigener, David F; Pereira, José Rodrigues; Felip, Enriqueta; Mazal, Juraj; Manzyuk, Lyudmila; Tan, Eng Huat; Merimsky, Ofer; Sarholz, Barbara; Esser, Regina; Gatzemeier, Ulrich

    2015-06-01

    The First-Line Erbitux in Lung Cancer (FLEX) trial showed that the addition of cetuximab to chemotherapy followed by weekly cetuximab maintenance significantly improved survival in the first-line treatment of advanced non-small cell lung cancer (NSCLC). The phase IIIb NSCLC Erbitux Trial (NEXT) trial (NCT00820755) investigated the efficacy and safety of weekly and every 2 weeks cetuximab maintenance therapy in this setting. Patients were treated with platinum-based chemotherapy plus cetuximab, and those progression-free after four to six cycles were randomized to every 2 weeks (500 mg/m(2)) or weekly (250 mg/m(2)) cetuximab maintenance. Randomization was stratified for tumor histology and response status. The primary endpoint for a regimen would be reached if the lower boundary of the 95 % confidence interval (CI) for the 1-year survival rate exceeded 55 %. A planned 480 patients were to be randomized. However, enrollment was curtailed following a negative opinion from the European Medicines Agency with regard to the use of cetuximab in this setting. After combination therapy, 311/583 (53.3 %) patients without progression were randomized to maintenance therapy: 157 to every 2 weeks cetuximab and 154 to weekly cetuximab. Baseline characteristics were balanced between these groups and exposure to cetuximab was similar. The 1-year survival rate was 62.8 % (95 % CI, 54.7-70.0) for every 2 weeks cetuximab and 64.4 % (95 % CI, 56.2-71.4) for weekly cetuximab. Safety profiles were similar, manageable, and in line with expectations. Therefore, in patients with advanced NSCLC who were progression-free after four to six cycles of first-line chemotherapy plus cetuximab, weekly and every 2 weeks cetuximab maintenance therapy were associated with similar survival outcomes.

  9. Effectiveness of needle/syringe exchange program in Tbilisi.

    PubMed

    Otiashvili, D; Gambashidze, N; Kapanadze, E; Lomidze, G; Usharidze, D

    2006-11-01

    IDUs are under the high risk of HIV and other blood born diseases. In Georgia injecting drug use is associated with two third of registered HIV/AIDS cases. Majority of them are also infected with B and C Hepatitis. One of the main components of HIV/AIDS prevention among drug users is considered to be harm reduction programs, among them syringe exchange program. We conducted observational cohort study and performed interviewing participants of syringe exchange program using structured questionnaire. The interviewing was conducted at intake, after 3 months and at the end of the program. During interviewing we used risk assessment questionnaire which we have little adapted (Risk Assessment Battery, Navaline, et al, 1994). The data were statistically analysed using SPPS-11, 5 program. The aim of the study was to assess the efficacy of outreach and needle exchange programs in terms of reduction of HIV risk behavior of injection drug users in Tbilisi. The results of the study show visible reduction in injection risk behavior for clients being in the program for at least three months. There was not seen any significant change in the level of sexual risk behavior, which might suggest the need for targeting this behavior during the further interventions. The results of the study suggest a visible potential benefit to drug users and communities that could be gained through the wide scale implementation of harm reduction programs in Georgia.

  10. Maintenance Chemotherapy for Advanced Non–Small-Cell Lung Cancer: New Life for an Old Idea

    PubMed Central

    Gerber, David E.; Schiller, Joan H.

    2013-01-01

    Although well established for the treatment of certain hematologic malignancies, maintenance therapy has only recently become a treatment paradigm for advanced non–small-cell lung cancer. Maintenance therapy, which is designed to prolong a clinically favorable state after completion of a predefined number of induction chemotherapy cycles, has two principal paradigms. Continuation maintenance therapy entails the ongoing administration of a component of the initial chemotherapy regimen, generally the nonplatinum cytotoxic drug or a molecular targeted agent. With switch maintenance (also known as sequential therapy), a new and potentially non–cross-resistant agent is introduced immediately on completion of first-line chemotherapy. Potential rationales for maintenance therapy include increased exposure to effective therapies, decreasing chemotherapy resistance, optimizing efficacy of chemotherapeutic agents, antiangiogenic effects, and altering antitumor immunity. To date, switch maintenance therapy strategies with pemetrexed and erlotinib have demonstrated improved overall survival, resulting in US Food and Drug Administration approval for this indication. Recently, continuation maintenance with pemetrexed was found to prolong overall survival as well. Factors predicting benefit from maintenance chemotherapy include the degree of response to first-line therapy, performance status, the likelihood of receiving further therapy at the time of progression, and tumor histology and molecular characteristics. Several aspects of maintenance therapy have raised considerable debate in the thoracic oncology community, including clinical trial end points, the prevalence of second-line chemotherapy administration, the role of treatment-free intervals, quality of life, economic considerations, and whether progression-free survival is a worthy therapeutic goal in this disease setting. PMID:23401441

  11. Apical pressure created during irrigation with the GentleWave™ system compared to conventional syringe irrigation.

    PubMed

    Haapasalo, Markus; Shen, Ya; Wang, Zhejun; Park, Ellen; Curtis, Allison; Patel, Payal; Vandrangi, Prashanthi

    2016-09-01

    The purpose of this study is to compare pressures at the apical foramen created by conventional syringe irrigation and the GentleWave™ System, which releases high-velocity degassed irrigants to the pulp chamber and uses broad-spectrum sound energy for cleaning. The apical pressure generated during irrigation was measured for palatal and distobuccal root canals of four extracted maxillary molars after no instrumentation, minimal instrumentation to a size #15/.04, instrumentation to a size #40/.04 taper, and after perforating the apical foramen to size #40. The root canals opened into an air-tight custom fixture coupled to a piezoresistive pressure transducer. Apical pressures were measured for the GentleWave™ System and syringe-needle irrigation at different irrigant flow rates, with the needle tip at 1 and 3 mm from the apical foramen using 30-gauge (G) open-ended or side-vented safety tip needles. The GentleWave™ System generated negative apical pressures (P < 0.001 compared with syringe irrigation); the mean pressures were between -13.07 and -17.19 mmHg. The 30 G needles could not reach the 1 and 3 mm from the working length in uninstrumented and 1 mm in minimally instrumented canals. The mean positive pressures between 6.46 and 110.34 mmHg were measured with needle irrigation depending on the flow rate, needle insertion depth, and size of the root canal. The GentleWave™ System creates negative pressure at the apical foramen during root canal cleaning irrespective of the size of canal instrumentation. Positive apical pressures were measured for syringe irrigation. Negative pressure during irrigation contributes to improved safety as compared to high-positive pressure.

  12. Patterns of Chemotherapy Use in a U.S.-Based Cohort of Patients with Metastatic Pancreatic Cancer.

    PubMed

    Abrams, Thomas A; Meyer, Gary; Meyerhardt, Jeffrey A; Wolpin, Brian M; Schrag, Deborah; Fuchs, Charles S

    2017-08-01

    Few population studies have examined patterns of systemic therapy administration in metastatic pancreatic cancer (MPC) or the predictors associated with specific treatment choices. We assessed 4,011 consecutive MPC patients who received chemotherapy between January 2005 and December 2015 at academic, private, and community-based oncology practices subscribing to a U.S.-wide chemotherapy order entry system capturing disease, patient, provider, and treatment data. Multivariate analyses of these prospectively recorded characteristics identified significant predictors of specific therapeutic choices. Overall, 100 different regimens were used in first-line treatment of MPC. First-line gemcitabine monotherapy usage fell steadily from 72% in 2006 to 16% in 2015. This steep decline mirrored increases in first-line usage of both 5 fluorouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) and gemcitabine + nab-paclitaxel. Younger male patients were more likely to receive FOLFIRINOX as first-line treatment, whereas patients treated at community practices and by oncologists with lower MPC patient volume were more likely to receive gemcitabine plus nab-paclitaxel (all p  ≤ .05). Among all patients receiving first-line chemotherapy for MPC, 49% went on to receive second-line therapy and 19% received third-line therapy; administration of second- and third-line therapies increased steadily over the time course of follow-up. Younger patients and those treated by oncologists with higher MPC patient volume were more likely to receive second- and third-line therapies. This population-based study provides insight into treatment patterns of MPC in the U.S. Usage patterns varied greatly according to patient and provider characteristics. This study examined real world metastatic pancreatic cancer treatment patterns in the United States with the goals of understanding changes in chemotherapy treatment frequencies over time and determining the individual predictors that

  13. Prospective evaluation of [11C]Choline PET/CT in therapy response assessment of standardized docetaxel first-line chemotherapy in patients with advanced castration refractory prostate cancer.

    PubMed

    Schwarzenböck, Sarah M; Eiber, Matthias; Kundt, Günther; Retz, Margitta; Sakretz, Monique; Kurth, Jens; Treiber, Uwe; Nawroth, Roman; Rummeny, Ernst J; Gschwend, Jürgen E; Schwaiger, Markus; Thalgott, Mark; Krause, Bernd J

    2016-11-01

    The aim of this study was to prospectively evaluate the value of [ 11 C] Choline PET/CT in monitoring early and late response to a standardized first-line docetaxel chemotherapy in castration refractory prostate cancer (mCRPC) patients. Thirty-two patients were referred for [ 11 C] Choline PET/CT before the start of docetaxel chemotherapy, after one and ten chemotherapy cycles (or - in case of discontinuation - after the last administered cycle) for therapy response assessment. [ 11 C] Choline uptake (SUV max , SUV mean ), CT derived Houndsfield units (HU max , HU mean ), and volume of bone, lung, and nodal metastases and local recurrence were measured semi-automatically at these timepoints. Change in SUV max , SUV mean , HU max , HU mean, and volume was assessed between PET 2 and 1 (early response assessment, ERA) and PET 3 and 1 (late response assessment, LRA) on a patient and lesion basis. Results of PET/CT were compared to clinically used RECIST 1.1 and clinical criteria based therapy response assessment including PSA for defining progressive disease (PD) and non-progressive disease (nPD), respectively. Relationships between changes of SUV max and SUV mean (early and late) and changes of PSA early and PSA late were evaluated. Prognostic value of initial SUV max and SUV mean was assessed. Statistical analyses were performed using SPSS. In the patient-based ERA and LRA there were no statistically significant differences in change of choline uptake, HU, and volume between PD and nPD applying RECIST or clinical response criteria. In the lesion-based ERA, decrease in choline uptake of bone metastases was even higher in PD (applying RECIST criteria), whereas in LRA the decrease was higher in nPD (applying clinical criteria). There were only significant correlations between change in choline uptake and PSA in ERA in PD, in LRA no significant correlations were discovered. Initial SUV max and SUV mean were statistically significantly higher in nPD (applying clinical

  14. Treatment of a Solid Tumor Using Engineered Drug-Resistant Immunocompetent Cells and Cytotoxic Chemotherapy

    PubMed Central

    Dasgupta, Anindya; Shields, Jordan E.

    2012-01-01

    Abstract Multimodal therapy approaches, such as combining chemotherapy agents with cellular immunotherapy, suffers from potential drug-mediated toxicity to immune effector cells. Overcoming such toxic effects of anticancer cellular products is a potential critical barrier to the development of combined therapeutic approaches. We are evaluating an anticancer strategy that focuses on overcoming such a barrier by genetically engineering drug-resistant variants of immunocompetent cells, thereby allowing for the coadministration of cellular therapy with cytotoxic chemotherapy, a method we refer to as drug-resistant immunotherapy (DRI). The strategy relies on the use of cDNA sequences that confer drug resistance and recombinant lentiviral vectors to transfer nucleic acid sequences into immunocompetent cells. In the present study, we evaluated a DRI-based strategy that incorporates the immunocompetent cell line NK-92, which has intrinsic antitumor properties, genetically engineered to be resistant to both temozolomide and trimetrexate. These immune effector cells efficiently lysed neuroblastoma cell lines, which we show are also sensitive to both chemotherapy agents. The antitumor efficacy of the DRI strategy was demonstrated in vivo, whereby neuroblastoma-bearing NOD/SCID/γ-chain knockout (NSG) mice treated with dual drug-resistant NK-92 cell therapy followed by dual cytotoxic chemotherapy showed tumor regression and significantly enhanced survival compared with animals receiving either nonengineered cell-based therapy and chemotherapy, immunotherapy alone, or chemotherapy alone. These data show there is a benefit to using drug-resistant cellular therapy when combined with cytotoxic chemotherapy approaches. PMID:22397715

  15. Adsorption of 99mTc-sestamibi onto plastic syringes: evaluation of factors affecting the degree of adsorption and their impact on clinical studies.

    PubMed

    Swanson, Tiffinee N; Troung, Duong T; Paulsen, Andrew; Hruska, Carrie B; O'Connor, Michael K

    2013-12-01

    The purpose of this study was to document the extent of adhesion of (99m)Tc-sestamibi to syringes in patient procedures, determine factors that influence the degree of adhesion, and evaluate alternatives to our current practice that would either result in a more reproducible degree of adhesion or, ideally, eliminate adhesion. The extent of adhesion was documented in 216 patient procedures and evaluated in detail in an additional 73 patient procedures. We evaluated the nature of the adhesion and its possible causes, including the location of adhesion in injection sets, the effect of syringe type, and the effect of prerinsing of syringes with various solutions of nonradiolabeled sestamibi and (99m)Tc-sestamibi. The extent of adhesion was reevaluated in 50 procedures performed using the syringe type that demonstrated the lowest adhesion rate. The degree of adhesion of (99m)Tc-sestamibi to the injection set was found to be 20.1% ± 8.0%, with a range (10th-90th percentiles) of 9%-31%. The primary cause of adhesion appeared to be the lubricant used inside the syringe barrel. Evaluation of 6 different syringe types identified a brand with a lower adhesion rate. Reevaluation in patient procedures using this brand showed a 5.2% ± 2.5% degree of adhesion, with a range (10th-90th percentiles) of 2.5%-7.7%. Selection of the appropriate type of syringe can significantly reduce the magnitude and variability of residual (99m)Tc-sestamibi activity. With more reproducible residual activities, we have been able to achieve an approximately 20% reduction in the dispensed dose of (99m)Tc-sestamibi used in clinical procedures and a more consistent injected dose with less interpatient variation. The frequent changes in syringe design by manufacturers require that a quality control program for monitoring of residual activity be incorporated into clinical practice. This program has allowed us to maintain image quality and achieve more consistent injected patient doses in clinical

  16. [2000-year history of the ear syringe and its relationship to the enema. Images from the history of otorhinolaryngology, represented by instruments from the collection of the Ingolstadt Medical History Museum].

    PubMed

    Feldmann, H

    1999-08-01

    SYRINGES WITH A PISTON AND THEIR USE AS "CLYSTER ORICULARIUS" IN THE ANCIENT ROME: Syringes with a piston were already known in ancient times and have been mentioned as a device for spraying rose water (Philon of Byzantium, about 230 BC), and for fighting fires (Heron of Alexandria about 110 AD). Celsus mentions it several times in his grand opus "De Medicina" (1st century AD) in the treatment of purulent discharge from the ear and for removing foreign bodies from the external ear canal. He always calls it "clyster oricularius", i.e. ear syringe, even when he describes its use in applications other than otological, such as in urology. Later the ear syringe fell from favor for a very long time and was reinvented only at the beginning of the 19th century. IRRIGATION OF THE BOWELS, FROM THE BAG SYRINGE TO THE PISTON SYRINGE: Irrigations of the bowels, clysters, were performed from ancient times to the 18th century with a baglike syringe using the bladder of animals as a pouch. Syringes with a piston were used by barbers and surgeons only for cleansing wounds or irrigating natural cavities of the body. Irrigation of the external ear canal had completely fallen from favor. In France in the 18th century large syringes with a piston made of tin oder brass came into use for enemas and replaced the old baglike devices. THE REINVENTION OF THE EAR SYRINGE AFTER THE PROTOTYPE OF THE ENEMA SYRINGE: Itard, an otologist in France in 1821, was the first to describe irrigating the ear with a syringe to remove hard wax. He recommended using an enema syringe ("seringue à lavement") for the procedure. Soon after his publication special ear syringes of appropriate size were developed and described by Beck in Freiburg, Germany, in 1827; by Fabrizi in Modena, Italy, 1839; and Schmalz in Dresden, Germany, 1846, who also introduced the kidney-shaped bowel for catching the water. Apart from that, small baglike syringes made of rubber were devised especially for use by the patient himself

  17. Low muscle attenuation is a prognostic factor for survival in metastatic breast cancer patients treated with first line palliative chemotherapy.

    PubMed

    Rier, Hánah N; Jager, Agnes; Sleijfer, Stefan; van Rosmalen, Joost; Kock, Marc C J M; Levin, Mark-David

    2017-02-01

    Low muscle mass (LMM) and low muscle attenuation (LMA) reflect low muscle quantity and low muscle quality, respectively. Both are associated with a poor outcome in several types of solid malignancies. This study determined the association of skeletal muscle measures with overall survival (OS) and time to next treatment (TNT). A skeletal muscle index (SMI) in cm 2 /m 2 and muscle attenuation (MA) in Hounsfield units (HU) were measured using abdominal CT-images of 166 patients before start of first-line chemotherapy for metastatic breast cancer. Low muscle mass (SMI <41 cm 2 /m 2 ), sarcopenic obesity (LMM and BMI ≥30 kg/m 2 ) and low muscle attenuation (MA <41 HU and BMI <25 kg/m2 or MA <33 HU and BMI ≥25 kg/m2) were related to OS and TNT. The prevalence of LMM, sarcopenic obesity and LMA were 66.9%, 7.2% and 59.6% respectively. LMM and sarcopenic obesity showed no significant association with OS and TNT, whereas LMA was associated with both lower OS (HR 2.04, 95% CI 1.34-3.12, p = 0.001) and shorter TNT (HR 1.72, 95% CI 1.14-2.62, p = 0.010). Patients with LMA had a median OS and TNT of 15 and 8 months respectively, compared to 23 and 10 months in patients with normal MA. LMA is a prognostic factor for OS and TNT in metastatic breast cancer patients receiving first-line palliative chemotherapy, whereas LMM and sarcopenic obesity are not. Further research is needed to establish what impact LMA should have in daily clinical practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Are major reductions in new HIV infections possible with people who inject drugs? The case for low dead-space syringes in highly affected countries.

    PubMed

    Zule, William A; Cross, Harry E; Stover, John; Pretorius, Carel

    2013-01-01

    Circumstantial evidence from laboratory studies, mathematical models, ecological studies and bio behavioural surveys, suggests that injection-related HIV epidemics may be averted or reversed if people who inject drugs (PWID) switch from using high dead-space to using low dead-space syringes. In laboratory experiments that simulated the injection process and rinsing with water, low dead space syringes retained 1000 times less blood than high dead space syringes. In mathematical models, switching PWID from high dead space to low dead space syringes prevents or reverses injection-related HIV epidemics. No one knows if such an intervention is feasible or what effect it would have on HIV transmission among PWID. Feasibility studies and randomized controlled trials (RCTs) will be needed to answer these questions definitively, but these studies will be very expensive and take years to complete. Rather than waiting for them to be completed, we argue for an approach similar to that used with needle and syringe programs (NSP), which were promoted and implemented before being tested more rigorously. Before implementation, rapid assessments that involve PWID will need to be conducted to ensure buy-in from PWID and other local stakeholders. This commentary summarizes the existing evidence regarding the protective effects of low dead space syringes and estimates potential impacts on HIV transmission; it describes potential barriers to transitioning PWID from high dead space to low dead space needles and syringes; and it presents strategies for overcoming these barriers. Copyright © 2012 Elsevier B.V. All rights reserved.

  19. Cabazitaxel Versus Topotecan in Patients with Small-Cell Lung Cancer with Progressive Disease During or After First-Line Platinum-Based Chemotherapy.

    PubMed

    Evans, Tracey L; Cho, Byoung Chul; Udud, Katalin; Fischer, Juergen R; Shepherd, Frances A; Martinez, Pablo; Ramlau, Rodryg; Syrigos, Konstantinos N; Shen, Liji; Chadjaa, Mustapha; Wolf, Martin

    2015-08-01

    Patients with small-cell lung cancer (SCLC) typically respond well to initial chemotherapy. However, relapse invariably occurs, and topotecan, the only approved second-line treatment option, has limited efficacy. Taxanes have activity in SCLC, and cabazitaxel is a second-generation taxane with potential for enhanced activity in chemorefractory malignancies. Patients with SCLC who relapsed after initial platinum-based chemotherapy were randomly assigned to receive cabazitaxel 25 mg/m every 21 days or topotecan 1.5 mg/m on days 1-5 every 21 days. Two patient subgroups, defined by chemosensitive and chemo-resistant/refractory disease, were assessed in combination and separately. The safety profile of cabazitaxel and topotecan was consistent with previous studies, and despite considerable toxicity in both arms, no new safety concerns were identified. Patients receiving cabazitaxel had inferior progression-free survival compared with topotecan (1.4 versus 3.0 months, respectively; two-sided p < 0.0001; hazard ratio = 2.17, 95% confidence interval = 1.563-3.010), and results were similar in both the chemosensitive and chemorefractory subgroups. No complete responses were observed in either arm, and no partial responses were observed in the cabazitaxel group. The partial response rate in the topotecan arm was 10%. Median overall survival was 5.2 months in the cabazitaxel arm and 6.8 months in the topotecan arm (two-sided p = 0.0125; hazard ratio = 1.57, 95% confidence interval = 1.10-2.25). Cabazitaxel, a next-generation taxane, had inferior efficacy when compared with standard-dose topotecan in the treatment of relapsed SCLC. Topotecan remains a suboptimal therapy, and continued efforts to develop improved second-line treatments are warranted.

  20. The Prison Economy of Needles and Syringes: What Opportunities Exist for Blood Borne Virus Risk Reduction When Prices Are so High?

    PubMed Central

    Treloar, Carla; McCredie, Luke; Lloyd, Andrew R.

    2016-01-01

    Aim A formal Needle and Syringe Program (NSP) is not provided in Australian prisons. Injecting equipment circulates in prisons as part of an informal and illegal economy. This paper examined how this economy generates blood-borne virus (BBV) risk and risk mitigation opportunities for inmates. Method The HITS-p cohort recruited New South Wales inmates who had reported ever injecting drugs and who had a negative HCV serological test within 12 months prior to enrolment. For this study, qualitative interviews were conducted with 30 participants enrolled in HITS-p. Participants included 10 women and were incarcerated in 12 prisons. Results A needle/syringe was nominated as being typically priced in the ‘inside’ prison economy at $100-$150, with a range of $50-$350. Purchase or hire of equipment was paid for in cash (including transactions that occurred outside prison) and in exchange for drugs and other commodities. A range of other resources was required to enable successful needle/syringe economies, especially relationships with visitors and other prisoners, and violence to ensure payment of debts. Strategies to mitigate BBV risk included retaining one needle/syringe for personal use while hiring out others, keeping drug use (and ownership of equipment) “quiet”, stealing used equipment from the prison health clinic, and manufacture of syringes from other items available in the prison. Conclusions The provision of prison NSP would disrupt the inside economies built around contraband needles/syringes, as well as minimise BBV risk. However, any model of prison NSP should be interrogated for any unanticipated markets that could be generated as a result of its regulatory practices. PMID:27611849

  1. Ifosfamide and vinorelbine as first-line chemotherapy for metastatic breast cancer.

    PubMed

    Leone, B A; Vallejo, C T; Romero, A O; Perez, J E; Cuevas, M A; Lacava, J A; Sabatini, C L; Dominguez, M E; Rodriguez, R; Barbieri, M R; Ortiz, E H; Salvadori, M A; Acuña, L A; Acuña, J M; Langhi, M J; Amato, S; Machiavelli, M R

    1996-11-01

    To evaluate the efficacy and toxicity of the combination of ifosfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in metastatic breast cancer (MBC). Between August 1993 and August 1995, 45 patients with untreated MBC received a regimen that consisted of IFX 2 g/m2 by 1-hour intravenous (i.v.) infusion on days 1 to 3, mesna 400 mg/m2 by i.v. bolus at hours 0 and 4 and 800 mg/m2 orally at hour 8 on days 1 to 3, and VNB 35 mg/m2 by 20-minute i.v. infusion on days 1 and 15. Courses were repeated every 28 days. During the first course only, half-dose VNB (17.5 mg/m2) was administered on days 8 and 22. The median age was 53 years and 30 patients (67%) were postmenopausal. Dominant sites of disease were soft tissue in nine patients, bone in seven, and visceral in 29. Objective responses (ORs) were recorded in 25 of 43 assessable patients (58%; 95% confidence interval, 43% to 73%). Complete remissions (CRs) occurred in six patients (14%) and partial remissions (PRs) in 19 (44%). No change (NC) was recorded in 10 patients (23%) and progressive disease (PD) in eight patients (19%). The median time to treatment failure was 12 months and the median survival duration 19 months. Myelosuppression was the limiting toxicity, mainly leukopenia in 32 patients (74%). In contrast, anemia and thrombocytopenia were mild. Other significant toxicities included peripheral neuropathy in nine patients (21%), constipation in 15 (35%), and myalgias in 11 (26%). IFX/VNB is an active combination against MBC with moderate toxicity and deserves further evaluation.

  2. Ifosfamide and mitoxantrone as first-line chemotherapy for metastatic breast cancer.

    PubMed

    Perez, J E; Machiavelli, M; Leone, B A; Romero, A; Rabinovich, M G; Vallejo, C T; Bianco, A; Lacava, J A; Rodriguez, R; Cuevas, M A

    1993-03-01

    A phase II trial was performed to evaluate the efficacy and toxicity of a combination of ifosfamide (IFX) and mitoxantrone (MXN) as first-line chemotherapy for metastatic breast carcinoma. Between January 1990 and August 1991, 48 patients with metastatic breast cancer were entered onto the study. Therapy consisted of IFX 2 g/m2 given as a 1-hour intravenous (IV) infusion on days 1 to 3; mesna 400 mg/m2 as an IV bolus immediately before and 4 hours after IFX administration and 2,000 mg orally 8 hours after IFX administration on days 1 to 3; and MXN 12 mg/m2 as an i.v. bolus on day 3. Cycles were repeated every 21 days until progressive disease (PD) or severe toxicity developed. One patient was considered not assessable for response. Objective regression (OR) was observed in 28 of 47 patients (60%; 95% confidence interval, 46% to 74%). Six patients (13%) had a complete response (CR) and 22 (47%) had a partial response (PR). The median time to treatment failure for the whole group was 9 months (range, 1 to 28); median survival was 19 months (range, 2 to 28). There were no treatment-related deaths. The limiting toxicity was myelosuppression. Leukopenia occurred in 37 patients (77%) and was grade 3 or 4 in 19 patients (40%). Nausea and vomiting were observed in 38 patients (80%), mucositis in 16 patients (33%), and grade 2 hematuria in two patients (4%). Eight patients (16%) developed mild neurotoxicity. The combination of IFX plus MXN is an active regimen against metastatic breast cancer with moderate toxicity that deserves further evaluation.

  3. [Home chemotherapy].

    PubMed

    Ichihara, Toshiaki

    2010-12-01

    We report the case of a male gastric cancer patient who had undergone outpatient chemotherapy with TAXOTAL+TS-1 for adrenal and lung metastases.The disease was in progress.Next, we performed home chemotherapy with TAXOL.However, this chemotherapy also was not effective either.Therefore, the patient was started on Campto with the premedication including NaseaOD, GasterD and Decadron.The 17-course was performed in the period of 12 months.However, his condition did not improve.He experienced delirium and was hospitalized and the chemotherapy was discontinued.Later, his disease was advanced further and he died.Because of our close relationship with the general hospital, this patient had undergone home chemotherapy as long as 13 months, so that if a seamless cooperation was insured, chemotherapy could have been more safely and effectively performed at the patient's home.This study suggests that home chemotherapy is an important treatment modality.

  4. A Novel 3 Dimensional Stromal-based Model for In Vitro Chemotherapy Sensitivity Testing of Leukemia Cells

    PubMed Central

    Aljitawi, Omar S.; Li, Dandan; Xiao, Yinghua; Zhang, Da; Ramachandran, Karthik; Stehno-Bittel, Lisa; Van Veldhuizen, Peter; Lin, Tara L.; Kambhampati, Suman; Garimella, Rama

    2014-01-01

    The disparate responses of leukemia cells to chemotherapy in vivo, compared to in vitro, is partly related to the interactions of leukemic cells and the 3 dimensional (3D) bone marrow stromal microenvironment. We investigated the effects of chemotherapy agents on leukemic cell lines co-cultured with human bone marrow mesenchymal stem cell (hu-BM-MSC) in 3D. Comparison was made to leukemic cells treated in suspension, or grown on a hu-BM-MSC monolayer (2D conditions). We demonstrated that leukemic cells cultured in 3D were more resistant to drug-induced apoptosis compared to cells cultured in 2D or in suspension. We also demonstrated significant differences in leukemic cell response to chemotherapy using different leukemic cell lines cultured in 3D. We suggest that the differential responses to chemotherapy in 3D may be related to the expression of N-cadherin in the co-culture system. This unique model provides an opportunity to study leukemic cell responses to chemotherapy in 3D. PMID:23566162

  5. Second-line chemotherapy with dacarbazine and fotemustine in nitrosourea-pretreated patients with recurrent glioblastoma multiforme.

    PubMed

    Fazeny-Dörner, Barbara; Veitl, Mario; Wenzel, Catharina; Piribauer, Maria; Rössler, Karl; Dieckmann, Karin; Ungersböck, Karl; Marosi, Christine

    2003-07-01

    The aim of this study was to assess the efficacy and toxicity of a combination of dacarbazine (D) and fotemustine (F) administered to a homogenous group of patients with recurrent or progressive glioblastoma multiforme (GBM). Thirty-one patients with computed tomography or magnetic resonance imaging scan evidence of recurrent or progressive GBM after first-line chemotherapy with nitrosoureas as well as radiation therapy were given a combination of D (200 mg/m2) and F (100 mg/m2). At 30 min after termination of D administration, F was given over 60 min. Treatment was performed in an outpatient setting every 21 days. A total of 140 cycles (range 1-12 cycles; median 4 cycles) was administered. One partial response (3%) lasting for 11 weeks was observed. Sixteen (52%) patients reached stable disease lasting between 7 and 94 weeks. Median survival from start of the D/F combination was 45 (range 10-150) weeks. Median time to progression was 17 (3-101) weeks for all patients. Major toxicity was myelosuppression resulting in exclusion from study in seven (23%) patients [due to thrombocytopenia common toxicity criteria (CTC) grade 2 persisting longer than 3 weeks in three patients, due to thrombocytopenia CTC grade >/=3 in three and due to leukopenia CTC grade 3 in one patient]. No other toxicity than alopecia occurred. We conclude that the D/F combination is a well-tolerated second-line regimen and can be administered in a complete outpatient setting. D/F shows efficacy even in nitrosourea-pretreated patients and justifies further investigation.

  6. The Association Between Law Enforcement Encounters and Syringe Sharing Among IDUs on Skid Row: A Mixed Methods Analysis

    PubMed Central

    Simon-Freeman, Rebecca; Bluthenthal, Ricky N.

    2013-01-01

    The legal environment is one factor that influences injection drug users' (IDUs) risk for HIV and other bloodborne pathogens such as hepatitis C virus (HCV). We examined the association between law enforcement encounters (i.e., arrests and citations) and receptive syringe sharing among IDUs in the context of an intensified policing effort. We conducted a mixed methods analysis of 30 qualitative and 187 quantitative interviews with IDUs accessing services at a Los Angeles, CA syringe exchange program from 2008 to 2009. Qualitative findings illustrate concerns related to visibility, drug withdrawal, and previous history of arrest/incarceration. In quantitative analysis, the number of citations received, current homelessness, and perceiving that being arrested would be a “big problem” were independently associated with recent syringe sharing. Findings illustrate some of the unintended public health consequences associated with intensified street-level policing, including risk for HIV and HCV transmission. PMID:23620243

  7. Pharmacy participation in non-prescription syringe sales in Los Angeles and San Francisco counties, 2007.

    PubMed

    Cooper, Erin N; Dodson, Chaka; Stopka, Thomas J; Riley, Elise D; Garfein, Richard S; Bluthenthal, Ricky N

    2010-07-01

    Increasing sterile syringe access for injection drug users (IDUs) is one way to prevent HIV and hepatitis C virus (HCV) transmission in this population. In 2005, California Senate Bill 1159 allowed counties to adopt the Disease Prevention Demonstration Project (DPDP). Where enacted, the DPDP allows pharmacies that register with the county to sell up to ten syringes to adults without a prescription. In the current study, we describe pharmacy participation in nonprescription syringe sales (NPSS) in two counties in California and examine factors associated with NPSS. Telephone and in-person interviews were conducted in Los Angeles (LA) and San Francisco (SF) with 238 pharmacies in 2007 (n = 67 in SF; n = 171 in LA). Quantitative survey items captured pharmacy registration with the county, pharmacy policies/practices, episodes and conditions of NPSS and refusals to sell, potential negative consequences of NPSS, and staff attitudes regarding HIV and HCV prevention for IDUs. Overall, 42% of pharmacies reported NPSS (28% in LA and 81% in SF), although only 34% had registered with the county (17% in LA and 76% in SF). Many pharmacies required proof of a medical condition (80% in LA and 30% in SF) and refused NPSS if the customer was a suspected IDU (74% in LA, 33% in SF). Few negative consequences of NPSS were reported. In multivariate logistic regression analysis, we found that the odds of NPSS were significantly higher among pharmacists who thought syringe access was important for preventing HIV among IDUs [adjusted odds ratio (AOR) = 2.95; 95% confidence interval (CI) = 1.10-7.92], were chain pharmacies (AOR = 12.5; 95% CI = 4.55-33.33), and were located in SF (AOR = 4.88; 95% CI = 1.94-12.28). These results suggest that NPSS were influenced by pharmacists' perception. NPSS might be increased through greater educational efforts directed at pharmacists, particularly those in non-chain pharmacies.

  8. Circulating Tumor Cells and Response to Chemotherapy in Metastatic Breast Cancer: SWOG S0500

    PubMed Central

    Smerage, Jeffrey B.; Barlow, William E.; Hortobagyi, Gabriel N.; Winer, Eric P.; Leyland-Jones, Brian; Srkalovic, Gordan; Tejwani, Sheela; Schott, Anne F.; O'Rourke, Mark A.; Lew, Danika L.; Doyle, Gerald V.; Gralow, Julie R.; Livingston, Robert B.; Hayes, Daniel F.

    2014-01-01

    Purpose Increased circulating tumor cells (CTCs; five or more CTCs per 7.5 mL of whole blood) are associated with poor prognosis in metastatic breast cancer (MBC). A randomized trial of patients with persistent increase in CTCs tested whether changing chemotherapy after one cycle of first-line chemotherapy would improve the primary outcome of overall survival (OS). Patients and Methods Patients with MBC who did not have increased CTCs at baseline remained on initial therapy until progression (arm A). Patients with initially increased CTCs that decreased after 21 days of therapy remained on initial therapy (arm B). Patients with persistently increased CTCs after 21 days of therapy were randomly assigned to continue initial therapy (arm C1) or change to an alternative chemotherapy (arm C2). Results Of 595 eligible and evaluable patients, 276 (46%) did not have increased CTCs (arm A). Of those with initially increased CTCs, 31 (10%) were not retested, 165 were assigned to arm B, and 123 were randomly assigned to arm C1 or C2. No difference in median OS was observed between arm C1 and C2 (10.7 and 12.5 months, respectively; P = .98). CTCs were strongly prognostic. Median OS for arms A, B, and C (C1 and C2 combined) were 35 months, 23 months, and 13 months, respectively (P < .001). Conclusion This study confirms the prognostic significance of CTCs in patients with MBC receiving first-line chemotherapy. For patients with persistently increased CTCs after 21 days of first-line chemotherapy, early switching to an alternate cytotoxic therapy was not effective in prolonging OS. For this population, there is a need for more effective treatment than standard chemotherapy. PMID:24888818

  9. Federal funding for syringe exchange in the US: Explaining a long-term policy failure.

    PubMed

    Showalter, David

    2018-05-01

    The United States prohibited federal funding for syringe exchange programs for people who inject drugs nearly continuously from 1988 to 2015, despite growing scientific evidence, diminishing AIDS-related controversy, and tens of thousands of deaths from injection-related AIDS. This study investigates the political and institutional bases of this long-term failure to support lifesaving public policy. This study draws on national, regional, and local media coverage, archival sources, and semi-structured, in-depth interviews with 6 long-time syringe exchange researchers and activists from California. I use case-oriented process tracing methods to explain the persistence and reform of the federal funding ban. Though previous studies focus on the symbolic clash between conservative morality and empirical science, I find that changing demographic and regional inequalities in the effects of the AIDS epidemic and dynamics produced by the federal structure of US government were more important factors in the creation and persistence of the funding ban. The persistence and eventual repeal of the ban on federal funding for syringe exchange was a product of the changing demographic, geographic, and political effects of the AIDS epidemic within the federal structure of US government, rather than a consequence of intractable morality politics. These contextual dynamics continue to shape AIDS and public health policy at all levels of government. Copyright © 2018. Published by Elsevier B.V.

  10. Comparative evaluation of the amount of debris extruded apically using conventional syringe, passive ultrasonic irrigation and EndoIrrigator Plus system: An in vitro study

    PubMed Central

    Shetty, Vidhi Prabhakar; Naik, Balaram Damodar; Pachlag, Amit Kashinath; Yeli, Mahantesh Mrityunjay

    2017-01-01

    Aim: The aim of this study is to compare the effects of conventional syringe, passive ultrasonic irrigation (PUI), and EndoIrrigator Plus on the amount of apically extruded debris. Materials and Methods: Thirty extracted human mandibular premolars were selected and randomly assigned to three groups (n = 10). The root canals were irrigated with conventional syringe, PUI, and EndoIrrigator Plus. Sodium hypochlorite was used as an irrigant, and debris was collected in a previously described experimental model (Myers and Montgomery 1991). It was then stored in an incubator at 37°C for 10 days to evaporate the irrigant before weighing the dry debris. The mean weight of debris was assessed, one-way analysis of variance was used for comparison of values, and post hoc Tukey's test was used between groups (P = 0.05). Results: The EndoIrrigator Plus group extruded significantly less debris than PUI and conventional syringe groups (P < 0.05). Furthermore, PUI group extruded significantly less debris than conventional syringe irrigation group (P < 0.05). Conclusions: 1. All the three irrigation systems were associated with apical extrusion of debris, 2. EndoIrrigator Plus system extruded significantly less debris than the PUI system and the conventional syringe irrigation system, 3. PUI system extruded significantly less debris than the conventional syringe irrigation system. PMID:29430092

  11. Multicenter phase II study of apatinib treatment for metastatic gastric cancer after failure of second-line chemotherapy.

    PubMed

    Ruan, Hanguang; Dong, Junlin; Zhou, Xueliang; Xiong, Juan; Wang, Hua; Zhong, Xiaoming; Cao, Xiaolong

    2017-11-28

    Apatinib is a tyrosine kinase inhibitor and vascular endothelial growth factor receptor 2 (VEGFR-2) targeted drug. A phase I clinical trial showed that this agent has antitumor activity in Chinese patients with metastatic gastric cancer (mGC). The aim of this study was to investigate the safety and efficacy of apatinib treatment in patients with mGC. This was an open-label, multicenter, single-arm study involving four institutions in China. We enrolled 42 patients from March 2015 to October 2015 who experienced tumor progression after second-line chemotherapy and had no other treatment options that clearly conferred a survival benefit. Oral apatinib (850 mg daily) was administered within 30 min of eating breakfast, lunch, or dinner on days 1 through 28 of each 4-week cycle. The median progression-free survival (PFS) time and median overall survival (OS) time were 4.0 months (95% CI, 2.85-5.15) and 4.50 months (95% CI, 4.03-4.97), respectively. The disease control rate (DCR) and objective response rate (ORR) were, respectively, 78.57% and 9.52% after 2 cycles and 57.14% and 19.05% after 4 cycles. The main adverse events (AEs) were secondary hypertension, elevated aminotransferase, and hand-foot syndrome, with incidences of 35.71%, 45.24%, and 40.48%, respectively. The most common grade 3 to 4 AEs were secondary hypertension and elevated aminotransferase, with incidences of 7.14% each. Apatinib is effective and safe in heavily pretreated patients with mGC who fail to respond to two or more prior chemotherapy regimens. Toxicities were tolerable or could be clinically managed.

  12. First-line nitrosourea-based chemotherapy in symptomatic non-resectable supratentorial pure low-grade astrocytomas.

    PubMed

    Frenay, M P; Fontaine, D; Vandenbos, F; Lebrun, C

    2005-09-01

    At the present time, there are no proven beneficial effects of chemotherapy (CT) for the treatment of pure low-grade astrocytomas. Brain radiotherapy (RT) still remains the standard treatment in order to reduce or delay tumor progression or symptoms, despite possible long-term neurologic complications. We report 10 patients, with histologically proven pure low-grade fibrillary astrocytomas, to which we administered a first-line nitrosourea-based CT. All patients were symptomatic with pharmaco-resistant epilepsy or neurologic symptoms, and had been rejected for neurosurgical resection. All patients with epilepsy had a clinical improvement with reduction in seizure frequency and 60% became seizure-free. CT was well tolerated; all patients developed myelosuppression with 40% of grade III/IV hematotoxicity. Seven were alive at the time of writing with a mean follow-up of 6.5 years (3.5-12) from first recorded symptoms. The three deceased patients died 7.5, 7.5, and 8.5 years from first symptoms. These results demonstrate that some patients with symptomatic non-resectable fibrillary low-grade astrocytomas can be treated with up-front CT to improve their neurologic status. This report suggests that benefits of CT on symptoms, survival, and quality of life should be prospectively compared with RT.

  13. Relationship between race and clinical characteristics, extent of disease, and response to chemotherapy in patients with low-risk gestational trophoblastic neoplasia.

    PubMed

    Maestá, Izildinha; Berkowitz, Ross S; Goldstein, Donald P; Bernstein, Marilyn R; Ramírez, Luz Angela C; Horowitz, Neil S

    2015-07-01

    To evaluate the potential effects of race on clinical characteristics, extent of disease, and response to chemotherapy in women with postmolar low-risk gestational trophoblastic neoplasia (GTN). This non-concurrent cohort study was undertaken including patients with FIGO-defined postmolar low-risk GTN treated with comparable doses and schedules of chemotherapy at the New England Trophoblastic Disease Center (NETDC) between 1973 and 2012. Racial groups investigated included whites, African American and Asians. Information on patient characteristics and response to chemotherapy (need for second line chemotherapy, reason for changing to an alternative chemotherapy, number of cycles/regimens, need for combination chemotherapy, and time to hCG remission) was obtained. Of 316 women, 274 (86.7%) were white, 19 (6%) African American, and 23 (7.3%) Asian. African Americans were significantly younger than white and Asian women (p=0.008). Disease presentation, and extent of disease, including antecedent molar histology, median time to persistence, median hCG level at persistence, rate of D&C at persistence, presence of metastatic disease, and FIGO stage and risk score were similar among races. Need for second line chemotherapy (p=0.023), and median number of regimens (p=0.035) were greater in Asian women than in other races. Low-risk GTN was more aggressive in Asian women, who were significantly more likely to need second line chemotherapy and a higher number of chemotherapy regimens to achieve complete remission than women of African American and Asian descent. Further studies involving racial differences related to clinical, biological and environmental characteristics are needed. Copyright © 2015. Published by Elsevier Inc.

  14. Meta-analysis of first-line therapies with maintenance regimens for advanced non-small-cell lung cancer (NSCLC) in molecularly and clinically selected populations.

    PubMed

    Tan, Pui San; Bilger, Marcel; de Lima Lopes, Gilberto; Acharyya, Sanchalika; Haaland, Benjamin

    2017-08-01

    Evidence has suggested survival benefits of maintenance for advanced NSCLC patients not progressing after first-line chemotherapy. Additionally, particular first-line targeted therapies have shown survival improvements in selected populations. Optimal first-line and maintenance therapies remain unclear. Here, currently available evidence was synthesized to elucidate optimal first-line and maintenance therapy within patient groups. Literature was searched for randomized trials evaluating first-line and maintenance regimens in advanced NSCLC patients. Bayesian network meta-analysis was performed within molecularly and clinically selected groups. The primary outcome was combined clinically meaningful OS and PFS benefits. A total of 87 records on 56 trials evaluating first-line treatments with maintenance were included. Results showed combined clinically meaningful OS and PFS benefits with particular first-line with maintenance treatments, (1) first-line intercalated chemotherapy+erlotinib, maintenance erlotinib in patients with EGFR mutations, (2) first-line afatinib, maintenance afatinib in patients with EGFR deletion 19, (3) first-line chemotherapy + bevacizumab, maintenance bevacizumab in EGFR wild-type patients, (4) chemotherapy+conatumumab, maintenance conatumumab in patients with squamous histology, (5) chemotherapy+cetuximab, maintenance cetuximab or chemotherapy + necitumumab, maintenance necitumumab in EGFR FISH-positive patients with squamous histology, and (6) first-line chemotherapy+bevacizumab, maintenance bevacizumab or first-line sequential chemotherapy+gefitinib, maintenance gefitinib in patients clinically enriched for EGFR mutations with nonsquamous histology. No treatment showed combined clinically meaningful OS and PFS benefits in patients with EGFR L858R or nonsquamous histology. Particular first-line with maintenance treatments show meaningful OS and PFS benefits in patients selected by EGFR mutation or histology. Further research is needed

  15. A clinical comparative study between conventional and camouflaged syringes to evaluate behavior and anxiety in 6-11-year-old children during local anesthesia administration-a novel approach.

    PubMed

    Melwani, Anjana M; Srinivasan, Ila; Setty, Jyothsna V; D R, Murali Krishna; Pamnani, Sunaina S; Lalitya, Dandamudi

    2018-02-01

    The sight of dental injection can bring about severe anxiety in children. Therefore, an alternative method that is convenient, effective, and keeps the needle hidden making it child friendly is necessary. The objective of the study was to compare the efficacy of a camouflaged syringe and conventional syringe on behavior and anxiety in 6-11-year-old children during local anesthesia administration. The study was a randomized, crossover clinical study including 30 children. Children were separated into two groups. Group 1 consisted of 15 children aged 6-8 years while group 2 consisted of 15 children aged 9-11 years. This study involved two sessions wherein all the children were injected using conventional and camouflaged syringes in separate sessions. Their behavior was assessed using the Faces, Legs, Activity, Cry, Consolability (FLACC) behavior pain scale and anxiety was assessed by measuring changes in pulse rate. Patient and operator preferences were compared. The results showed a lower mean change in pulse rate and FLACC scores in the camouflaged group, suggesting a positive behavior and lesser anxiety with camouflaged syringes than with conventional syringes. The use of camouflaged syringes for anesthesia was demonstrated to be effective in improving the behavior of children and decreasing their anxiety, and is therefore recommended as an alternative to the use of conventional syringes for local anesthesia.

  16. Multiple access to sterile syringes for injection drug users: vending machines, needle exchange programs and legal pharmacy sales in Marseille, France.

    PubMed

    Moatti, J P; Vlahov, D; Feroni, I; Perrin, V; Obadia, Y

    2001-03-01

    In Marseille, southeastern France, HIV prevention programs for injection drug users (IDUs) simultaneously include access to sterile syringes through needle exchange programs (NEPs), legal pharmacy sales and, since 1996, vending machines that mechanically exchange new syringes for used ones. The purpose of this study was to compare the characteristics of IDUs according to the site where they last obtained new syringes. During 3 days in September 1997, all IDUs who obtained syringes from 32 pharmacies, four NEPs and three vending machines were offered the opportunity to complete a self-administered questionnaire on demographics, drug use characteristics and program utilization. Of 485 individuals approached, the number who completed the questionnaire was 141 in pharmacies, 114 in NEPs and 88 at vending machines (response rate = 70.7%). Compared to NEP users, vending machine users were younger and less likely to be enrolled in a methadone program or to report being HIV infected, but more likely to misuse buprenorphine. They also had lower financial resources and were less likely to be heroin injectors than both pharmacy and NEP users. Our results suggest that vending machines attract a very different group of IDUs than NEPs, and that both programs are useful adjuncts to legal pharmacy sales for covering the needs of IDUs for sterile syringes in a single city. Assessment of the effectiveness and cost-effectiveness of combining such programs for the prevention of HIV and other infectious diseases among IDUs requires further comparative research. Copyright 2001 S. Karger AG, Basel

  17. Third-line therapy in recurrent glioblastoma: is it another chance for bevacizumab?

    PubMed

    Franceschi, Enrico; Lamberti, Giuseppe; Paccapelo, Alexandro; Di Battista, Monica; Genestreti, Giovenzio; Minichillo, Santino; Mura, Antonella; Bartolini, Stefania; Agati, Raffaele; Brandes, Alba A

    2018-04-18

    Standard glioblastoma therapy is long-lasting. Among second-line therapy, choices could be bevacizumab and nitrosoureas depending on National Agencies approval. There is no consensus on 3rd line therapy or clinical trials specifically designed for this setting. We reviewed our institutional database on all consecutive patients who received 3rd line therapy for glioblastoma. Data on 168 out of 1337 (12.6%) glioblastoma patients who underwent 3rd line therapy treatment were collected. Third line treatments were bevacizumab or chemotherapy (nitrosourea, temozolomide or carboplatin plus etoposide). Median progression free survival was 2.9 months and median survival time was 6.6 months from the start of 3rd line therapy. Bevacizumab significantly improved progression-free survival (4.7 vs. 2.6 months, p = .020) and survival from 3rd line start (8.0 vs. 6.0 months, p = .014) in respect to chemotherapy. Toxicity of grade ≥ 3 occurred in 13.7% of patients. In multivariate analysis, survival in 3rd line treatment depends on MGMT methylation (p = .006) and treatment with Bevacizumab (p = .011). Third line therapy in selected glioblastoma patients may be feasible and well tolerated. Bevacizumab improved outcome in 3rd line in respect to chemotherapy.

  18. Correlates of lending needles/syringes among HIV-seropositive injection drug users.

    PubMed

    Metsch, Lisa R; Pereyra, Margaret; Purcell, David W; Latkin, Carl A; Malow, Robert; Gómez, Cynthia A; Latka, Mary H

    2007-11-01

    Among HIV-positive injection drug users (IDUs), we examined the correlates of lending needles/syringes with HIV-negative and unknown status injection partners. HIV-positive IDUs (N=738) from 4 cities in the United States who reported injection drug use with other IDUs in the past 3 months participated in an audio computer-assisted self-administered interview. Eighteen percent of study participants self-reported having lent their needles to HIV-negative or unknown status injection partners. Multivariate analyses showed that 6 variables were significantly associated with this high-risk injecting practice. Older IDUs, high school graduates, and those reporting more supportive peer norms for safer drug use were less likely to lend needles/syringes. Admission to a hospital for drug treatment in the past 6 months, having injected with >1 person in the past 3 months, and having more psychiatric symptoms were all associated with more risk. These findings underscore the need for a continued prevention focus on HIV-positive IDUs that recognizes the combination of drug use, mental health factors, and social factors that might affect this high-risk injecting practice, which could be associated with HIV and hepatitis C transmission.

  19. Adjuvant chemotherapy for endometrial cancer after hysterectomy

    PubMed Central

    Johnson, Nick; Bryant, Andrew; Miles, Tracie; Hogberg, Thomas; Cornes, Paul

    2014-01-01

    Background Endometrial adenocarcinoma (womb cancer) is a malignant growth of the lining (endometrium) of the womb (uterus). It is distinct from sarcomas (tumours of the uterine muscle). Survival depends the risk of microscopic metastases after surgery. Adjuvant (postoperative) chemotherapy improves survival from some other adenocarcinomas, and there is evidence that endometrial cancer is sensitive to cytotoxic therapy. This systematic review examines the effect of chemotherapy on survival after hysterectomy for endometrial cancer. Objectives To assess efficacy of adjuvant (postoperative) chemotherapy for endometrial cancer. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2010, Issue 3), MEDLINE and EMBASE up to August 2010, registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. Selection criteria Randomised controlled trials (RCTs) comparing adjuvant chemotherapy with any other adjuvant treatment or no other treatment. Data collection and analysis We used a random-effects meta-analysis to assess hazard ratios (HR) for overall and progression-free survival and risk ratios (RR) to compare death rates and site of initial relapse. Main results Five RCTs compared no additional treatment with additional chemotherapy after hysterectomy and radiotherapy. Four trials compared platinum based combination chemotherapy directly with radiotherapy. Indiscriminate pooling of survival data from 2197 women shows a significant overall survival advantage from adjuvant chemotherapy (RR (95% CI) = 0.88 (0.79 to 0.99)). Sensitivity analysis focused on trials of modern platinum based chemotherapy regimens and found the relative risk of death to be 0.85 ((0.76 to 0.96); number needed to treat for an additional beneficial outcome (NNT) = 25; absolute risk reduction = 4% (1% to 8%)). The HR for overall survival is 0.74 (0.64 to 0.89), significantly

  20. Client-Level Coverage of Needle and Syringe Program and High-Risk Injection Behaviors: A Case Study of People Who Inject Drugs in Kermanshah, Iran.

    PubMed

    Noroozi, Mehdi; Mirzazadeh, Ali; Noroozi, Alireza; Mehrabi, Yadoallah; Hajebi, Ahmad; Zamani, Saman; Sharifi, Hamid; Higgs, Peter; Soori, Hamid

    2015-01-01

    Needle-syringe programs (NSP) have been running in Iran since 2002. However, the coverage of such program among the NSP clients at the individual level was not studies yet. This study aimed to determine the client coverage of NSP and its correlation with high injection-related risk behaviors. A cross-sectional survey was conducted in Kermanshah province, Iran, in 2014. 230 people who inject drugs (PWID) recruited from two drop-in centers (DICs) from April to September 2014, participated in a face-to-face interview to provide information related individual coverage of NSP, demographic characteristics, and injecting behaviors 30 days prior to the interview. Overall, the average of syringe coverage was 158% [95% confidence interval (CI) = 65.7-205.5], while 56% (95% CI = 40-97) have individual converge less than 100%. Needle/syringe sharing was significantly higher among individual with low NSP coverage [adjusted odds ratio (AOR) = 2.6, 95% CI = 1.3-6.2]. About 85% participants with coverage of less than 100% reported reuse of syringe within the last 30 days (AOR = 3.2, 95% CI = 1.4-7.7). PWID are different regarding their NSP individual-level converges. There are certain clusters of PWID, who do not receive sufficient number of syringes. Given that insufficient individual syringe coverage level is highly associated with injection risk behaviors, reasons for such low converge need to be assessed and addressed carefully.

  1. Client-Level Coverage of Needle and Syringe Program and High-Risk Injection Behaviors: A Case Study of People Who Inject Drugs in Kermanshah, Iran

    PubMed Central

    Noroozi, Mehdi; Mirzazadeh, Ali; Noroozi, Alireza; Mehrabi, Yadoallah; Hajebi, Ahmad; Zamani, Saman; Sharifi, Hamid; Higgs, Peter; Soori, Hamid

    2015-01-01

    Background Needle-syringe programs (NSP) have been running in Iran since 2002. However, the coverage of such program among the NSP clients at the individual level was not studies yet. This study aimed to determine the client coverage of NSP and its correlation with high injection-related risk behaviors. Methods A cross-sectional survey was conducted in Kermanshah province, Iran, in 2014. 230 people who inject drugs (PWID) recruited from two drop-in centers (DICs) from April to September 2014, participated in a face-to-face interview to provide information related individual coverage of NSP, demographic characteristics, and injecting behaviors 30 days prior to the interview. Findings Overall, the average of syringe coverage was 158% [95% confidence interval (CI) = 65.7-205.5], while 56% (95% CI = 40-97) have individual converge less than 100%. Needle/syringe sharing was significantly higher among individual with low NSP coverage [adjusted odds ratio (AOR) = 2.6, 95% CI = 1.3-6.2]. About 85% participants with coverage of less than 100% reported reuse of syringe within the last 30 days (AOR = 3.2, 95% CI = 1.4-7.7). Conclusion PWID are different regarding their NSP individual-level converges. There are certain clusters of PWID, who do not receive sufficient number of syringes. Given that insufficient individual syringe coverage level is highly associated with injection risk behaviors, reasons for such low converge need to be assessed and addressed carefully. PMID:26885353

  2. First- and Second-Line Bevacizumab in Addition to Chemotherapy for Metastatic Colorectal Cancer: A United States–Based Cost-Effectiveness Analysis

    PubMed Central

    Goldstein, Daniel A.; Chen, Qiushi; Ayer, Turgay; Howard, David H.; Lipscomb, Joseph; El-Rayes, Bassel F.; Flowers, Christopher R.

    2015-01-01

    Purpose The addition of bevacizumab to fluorouracil-based chemotherapy is a standard of care for previously untreated metastatic colorectal cancer. Continuation of bevacizumab beyond progression is an accepted standard of care based on a 1.4-month increase in median overall survival observed in a randomized trial. No United States–based cost-effectiveness modeling analyses are currently available addressing the use of bevacizumab in metastatic colorectal cancer. Our objective was to determine the cost effectiveness of bevacizumab in the first-line setting and when continued beyond progression from the perspective of US payers. Methods We developed two Markov models to compare the cost and effectiveness of fluorouracil, leucovorin, and oxaliplatin with or without bevacizumab in the first-line treatment and subsequent fluorouracil, leucovorin, and irinotecan with or without bevacizumab in the second-line treatment of metastatic colorectal cancer. Model robustness was addressed by univariable and probabilistic sensitivity analyses. Health outcomes were measured in life-years and quality-adjusted life-years (QALYs). Results Using bevacizumab in first-line therapy provided an additional 0.10 QALYs (0.14 life-years) at a cost of $59,361. The incremental cost-effectiveness ratio was $571,240 per QALY. Continuing bevacizumab beyond progression provided an additional 0.11 QALYs (0.16 life-years) at a cost of $39,209. The incremental cost-effectiveness ratio was $364,083 per QALY. In univariable sensitivity analyses, the variables with the greatest influence on the incremental cost-effectiveness ratio were bevacizumab cost, overall survival, and utility. Conclusion Bevacizumab provides minimal incremental benefit at high incremental cost per QALY in both the first- and second-line settings of metastatic colorectal cancer treatment. PMID:25691669

  3. Desensitization for Drug Hypersensitivity to Chemotherapy and Monoclonal Antibodies.

    PubMed

    Bonamichi-Santos, Rafael; Castells, Mariana

    2016-01-01

    Chemotherapies drugs and monoclonal antibodies are key components of the treatment of cancer patients and patients with chronic inflammatory conditions to provide increase in life expectancy and quality of life. Their increased use has lead to an increase in drugs hypersensitivity reactions (DHR) worldwide. DHR to those agents prevented their use and promoted the use of second line therapies to protect patients' hypersensitive reactions and anaphylaxis. Second line medications may not fully address the patients' medical condition and it is desirable to keep patients on first line therapy. Drug hypersensitivity symptoms can range from mild cutaneous reactions to life-threatening anaphylaxis. Rapid drug desensitization (RDD) is a novel approach to the management of drug hypersensitivity reactions which are IgE and non-IgE mediated. Through the diferent desensitization protocols patients can receive the full dose of the medications that they have presented a hypersensitive reaction and been protected against anaphylaxis. This review looks at the current literature on hypersensitivity reactions (HSR) to chemotherapy drugs and monoclonal antibodies and the potential use of RDD for their management. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  4. Real-World Effectiveness of Chemotherapy in Elderly Patients With Metastatic Bladder Cancer in the United States.

    PubMed

    Galsky, Matthew D; Pal, Sumanta Kumar; Lin, Shih-Wen; Ogale, Sarika; Zivkovic, Marko; Simpson, Joseph; Derleth, Christina; Schiff, Christina; Sonpavde, Guru

    2018-04-26

    Outcomes for patients with metastatic bladder cancer (mBC) are generally poor and progressively worse following first-line (1L) chemotherapy. To evaluate treatment patterns, survival outcomes, and characteristics of a large, real-world US population of elderly patients with advanced mBC receiving 1L and second-line (2L) treatment retrospectively. We identified patients with advanced mBC (aged ≥66 years)-newly diagnosed between January 1, 2004, and December 31, 2011-in the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program-Medicare linked database and assessed their palliative systemic chemotherapy treatments and survival outcomes. Of 1703 eligible patients, 42% received 1L chemotherapy; 1L-treated patients tended to be younger and healthier than nontreated patients. Only 27% of 1L-treated patients received cisplatin-based chemotherapy, most commonly cisplatin-gemcitabine. Cisplatin-treated patients were younger and had fewer comorbidities than non-cisplatin-treated patients. Thirty-five percent of 1L-treated patients subsequently received 2L chemotherapy. Patients received a variety of 2L agents as combination chemotherapy (52%) or single-agent chemotherapy (39%). Median overall survival durations in 1L-treated and 2L-treated patients were 8.5 and 7.9 months, respectively. Results from this retrospective SEER-Medicare database analysis underscore the historical inadequacies of 1L and 2L treatments in elderly patients with advanced mBC. Few patients were treated with 1L chemotherapy, a minority of whom received 1L cisplatin-based chemotherapy, and even fewer received 2L chemotherapy. These findings highlight the disconnect between 1L treatment in clinical trials and treatment in the real-world setting and the lack of standard approaches to 2L treatment in the United States.

  5. Simple Syringe Filtration Methods for Reliably Examining Dissolved and Colloidal Trace Element Distributions in Remote Field Locations

    NASA Astrophysics Data System (ADS)

    Shiller, A. M.

    2002-12-01

    Methods for obtaining reliable dissolved trace element samples frequently utilize clean labs, portable laminar flow benches, or other equipment not readily transportable to remote locations. In some cases unfiltered samples can be obtained in a remote location and transported back to a lab for filtration. However, this may not always be possible or desirable. Additionally, methods for obtaining information on colloidal composition are likewise frequently too cumbersome for remote locations as well as being time-consuming. For that reason I have examined clean methods for collecting samples filtered through 0.45 and 0.02 micron syringe filters. With this methodology, only small samples are collected (typically 15 mL). However, with the introduction of the latest generation of ICP-MS's and microflow nebulizers, sample requirements for elemental analysis are much lower than just a few years ago. Thus, a determination of a suite of first row transition elements is frequently readily obtainable with samples of less than 1 mL. To examine the "traditional" (<0.45 micron) dissolved phase, 25 mm diameter polypropylene syringe filters and all polyethylene/polypropylene syringes are utilized. Filters are pre-cleaned in the lab using 40 mL of approx. 1 M HCl followed by a clean water rinse. Syringes are pre-cleaned by leaching with hot 1 M HCl followed by a clean water rinse. Sample kits are packed in polyethylene bags for transport to the field. Results are similar to results obtained using 0.4 micron polycarbonate screen filters, though concentrations may differ somewhat depending on the extent of sample pre-rinsing of the filter. Using this method, a multi-year time series of dissolved metals in a remote Rocky Mountain stream has been obtained. To examine the effect of colloidal material on dissolved metal concentrations, 0.02 micron alumina syringe filters have been utilized. Other workers have previously used these filters for examining colloidal Fe distributions in lake

  6. In-Syringe Micro Solid-Phase Extraction Method for the Separation and Preconcentration of Parabens in Environmental Water Samples.

    PubMed

    Mashile, Geaneth Pertunia; Mpupa, Anele; Nomngongo, Philiswa Nosizo

    2018-06-14

    In this study, a simple, rapid and effective in-syringe micro-solid phase extraction (MSPE) method was developed for the separation and preconcetration of parabens (methyl, ethyl, propyl and butyl paraben) in environmental water samples. The parabens were determined and quantified using high performance liquid chromatography and a photo diode array detector (HPLC-PDA). Chitosan-coated activated carbon (CAC) was used as the sorbent in the in-syringe MSPE device. A response surface methodology based on central composite design was used for the optimization of factors (eluent solvent type, eluent volume, number of elution cycles, sample volume, sample pH) affecting the extraction efficiency of the preconcentration procedure. The adsorbent used displayed excellent absorption performance and the adsorption capacity ranged from 227⁻256 mg g −1 . Under the optimal conditions the dynamic linear ranges for the parabens were between 0.04 and 380 µg L −1 . The limits of detection and quantification ranged from 6⁻15 ng L −1 and 20⁻50 ng L −1 , respectively. The intraday (repeatability) and interday (reproducibility) precisions expressed as relative standard deviations (%RSD) were below 5%. Furthermore, the in-syringe MSPE/HPLC procedure was validated using spiked wastewater and tap water samples and the recoveries ranged between from 96.7 to 107%. In conclusion, CAC based in-syringe MSPE method demonstrated great potential for preconcentration of parabens in complex environmental water.

  7. Drug resistance in epithelial ovarian cancer: P-glycoprotein and glutation S-transferase. Can they play an important role in detecting response to platinum-based chemotherapy as a first-line therapy.

    PubMed

    Simşek, T; Ozbilim, G; Gülkesen, H; Kaya, H; Sargin, F; Karaveli, S

    2001-01-01

    Drug resistance is important for the treatment of ovarian cancer. P-glycoprotein and glutation S-transferase as resistance markers play an important role in the effectivity of chemotherapeutical agents. The role of P-glycoprotein and glutation S-transferase in the treatment of epithelial ovarian cancer is not well understood. We investigated the relation between P-glycoprotein and glutation S-transferase level for response to platinum-based chemotherapy in epithelial ovarian cancer. We reviewed 30 cases diagnosed as epithelial ovarian cancer and treated with platinum-based chemotherapy in the Department of Obstetrics and Gynecology, Akdeniz University School of Medicine. The material was attained from initial parafin-embeded blocks stained for P-glycoprotein and glutation S-transferase. The cases that were diagnosed and treated before attending our clinic were not enrolled in the study. Mean age was 58.2 (25-70) and mean gravida 4.1 (0-10). Twenty-four patients (80%) were glutation S-transferase positive. Three cases (10%) out of 30 had positive reaction for P-glycoprotein. No difference was revealed regarding chemotherapy response rate among the cases showing glutation S-transferase positivity and P-glycoprotein negativity. Detection of glutation S-transferase and P-glycoprotein levels in epithelial ovarian cancer tissue is not important for response to platinum-based chemotherapy as a first line.

  8. American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non–Small-Cell Lung Cancer

    PubMed Central

    Azzoli, Christopher G.; Baker, Sherman; Temin, Sarah; Pao, William; Aliff, Timothy; Brahmer, Julie; Johnson, David H.; Laskin, Janessa L.; Masters, Gregory; Milton, Daniel; Nordquist, Luke; Pfister, David G.; Piantadosi, Steven; Schiller, Joan H.; Smith, Reily; Smith, Thomas J.; Strawn, John R.; Trent, David; Giaccone, Giuseppe

    2009-01-01

    The purpose of this article is to provide updated recommendations for the treatment of patients with stage IV non–small-cell lung cancer. A literature search identified relevant randomized trials published since 2002. The scope of the guideline was narrowed to chemotherapy and biologic therapy. An Update Committee reviewed the literature and made updated recommendations. One hundred sixty-two publications met the inclusion criteria. Recommendations were based on treatment strategies that improve overall survival. Treatments that improve only progression-free survival prompted scrutiny of toxicity and quality of life. For first-line therapy in patients with performance status of 0 or 1, a platinum-based two-drug combination of cytotoxic drugs is recommended. Nonplatinum cytotoxic doublets are acceptable for patients with contraindications to platinum therapy. For patients with performance status of 2, a single cytotoxic drug is sufficient. Stop first-line cytotoxic chemotherapy at disease progression or after four cycles in patients who are not responding to treatment. Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy. The first-line use of gefitinib may be recommended for patients with known epidermal growth factor receptor (EGFR) mutation; for negative or unknown EGFR mutation status, cytotoxic chemotherapy is preferred. Bevacizumab is recommended with carboplatin-paclitaxel, except for patients with certain clinical characteristics. Cetuximab is recommended with cisplatin-vinorelbine for patients with EGFR-positive tumors by immunohistochemistry. Docetaxel, erlotinib, gefitinib, or pemetrexed is recommended as second-line therapy. Erlotinib is recommended as third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs. Data are insufficient to recommend routine use of molecular markers to select chemotherapy

  9. Residual Injection Risk Behavior, HIV Infection, and the Evaluation of Syringe Exchange Programs

    ERIC Educational Resources Information Center

    Des Jarlais, Don C.; Braine, Naomi; Yi, Huso; Turner, Charles

    2007-01-01

    This study assessed relationships between residual risk behavior (risk behavior among persons participating in effective HIV prevention programs) and HIV infection. Structured interviews and HIV tests were obtained from participants in six large U.S. syringe exchange programs. Program characteristics were obtained through interviews with the…

  10. Chemotherapy usage patterns in a US-wide cohort of patients with metastatic colorectal cancer.

    PubMed

    Abrams, Thomas A; Meyer, Gary; Schrag, Deborah; Meyerhardt, Jeffrey A; Moloney, Julie; Fuchs, Charles S

    2014-02-01

    Since the introduction of biologic therapies for the treatment of metastatic colorectal cancer (mCRC), few studies have examined patterns of care or predictors of specific treatment approaches. We assessed 4877 mCRC patients who received chemotherapy between January 2004 and March 2011 at academic, private, and community-based oncology practices subscribing to a US-wide chemotherapy order entry (system capturing disease, patient, provider, and treatment data. Multivariable analyses of these prospectively recorded characteristics were used to identify independent predictors of specific therapeutic choices. All statistical tests were two-sided. Throughout the study period, fluoropyrimidine/oxaliplatin combination was the most commonly used first-line chemotherapy regimen, representing 71% of first-line therapy by 2007. First-line bevacizumab use averaged 51%, peaking at 55% in 2006. Of those who received first-line bevacizumab, 34% continued to receive bevacizumab in the second-line. Only 26% of patients in our cohort ever received an anti-EGFR monoclonal antibody (cetuximab = 22%; panitumumab = 6%) at some point in their treatment course. Patients treated at academic centers, with longer duration of first-line therapy, and at sites in the western United States were statistically more likely to receive an anti-EGFR antibody. Anti-EGFR antibody use fell by 18% after the US Food and Drug Administration limited its use to patients with KRAS wild-type tumors in June 2009. Analysis of this US-wide mCRC cohort demonstrates that bevacizumab has been more consistently integrated into treatment regimens than anti-EGFR antibody therapies, particularly in first-line therapy. However, treatment choices vary substantially according to specific patient, practice, and provider characteristics.

  11. Development and evaluation of a decision aid for patients considering first‐line chemotherapy for metastatic breast cancer

    PubMed Central

    Chiew, Kimberly S.; Shepherd, Heather; Vardy, Janette; Tattersall, Martin H.N.; Butow, Phyllis N.; Leighl, Natasha B.

    2007-01-01

    Abstract Objective  Treatment decisions in advanced breast cancer are complex, with enhanced quality of life and survival among important treatment goals. Patients with metastatic breast cancer face the decision of whether or not to have chemotherapy, and many wish to be involved in this decision. We report the development and evaluation of a decision aid (DA) designed to assist patients facing this treatment decision. Design and sample  Women with metastatic breast cancer (n = 17) and medical oncologists in Australia and Canada (n = 7) were invited to evaluate the DA. Intervention  A DA was developed for patients with hormone‐resistant metastatic breast cancer considering chemotherapy. The DA presented options of supportive care, with or without chemotherapy. Potential benefits and side effects of different chemotherapy regimens, and evidence‐based prognostic estimates were described, and a values clarification exercise included. Main outcome measures  Patient questionnaires evaluating information and decision involvement preferences, attitudes toward the DA and oncologist feedback regarding attitudes toward the DA. Results  Seventeen patients participated; fifteen desired as much information about their illness as possible; sixteen wished to be actively involved in the decision‐making process. The majority rated the DA as highly acceptable, clear and informative, and would recommend it to others facing this treatment decision. Conclusion  This is the first DA for patients with advanced metastatic breast cancer considering chemotherapy. A randomized trial is underway to evaluate its role in clinical decision‐making. PMID:18297781

  12. An Improved Syringe Agroinfiltration Protocol to Enhance Transformation Efficiency by Combinative Use of 5-Azacytidine, Ascorbate Acid and Tween-20.

    PubMed

    Zhao, Huimin; Tan, Zilong; Wen, Xuejing; Wang, Yucheng

    2017-02-14

    Syringe infiltration is an important transient transformation method that is widely used in many molecular studies. Owing to the wide use of syringe agroinfiltration, it is important and necessary to improve its transformation efficiency. Here, we studied the factors influencing the transformation efficiency of syringe agroinfiltration. The pCAMBIA1301 was transformed into Nicotiana benthamiana leaves for investigation. The effects of 5-azacytidine (AzaC), Ascorbate acid (ASC) and Tween-20 on transformation were studied. The β-glucuronidase ( GUS ) expression and GUS activity were respectively measured to determine the transformation efficiency. AzaC, ASC and Tween-20 all significantly affected the transformation efficiency of agroinfiltration, and the optimal concentrations of AzaC, ASC and Tween-20 for the transgene expression were identified. Our results showed that 20 μM AzaC, 0.56 mM ASC and 0.03% ( v / v ) Tween-20 is the optimal concentration that could significantly improve the transformation efficiency of agroinfiltration. Furthermore, a combined supplement of 20 μM AzaC, 0.56 mM ASC and 0.03% Tween-20 improves the expression of transgene better than any one factor alone, increasing the transgene expression by more than 6-fold. Thus, an optimized syringe agroinfiltration was developed here, which might be a powerful method in transient transformation analysis.

  13. HIV Risk Behavior among Amphetamine Injectors at U.S. Syringe Exchange Programs

    ERIC Educational Resources Information Center

    Braine, Naomi; Des Jarlais, Don C.; Goldblatt, Cullen; Zadoretzky, Cathy; Turner, Charles

    2005-01-01

    The goal of this study was to compare HIV risk behaviors of amphetamine and non-amphetamine injectors at syringe exchange programs (SEP) in the United States and to identify factors associated with injection risk. This analysis is based on data from a random cross-section of participants at 13 SEPs in different parts of the country. All interviews…

  14. Insulin pen-the "iPod" for insulin delivery (why pen wins over syringe).

    PubMed

    Asamoah, Ernest

    2008-03-01

    Diabetes affects most aspects of everyday life and places considerable responsibility on the patient; therefore, without patient acceptance of what we offer, the therapy is unlikely to be adhered to especially when that therapy happens to be insulin injection. In 2008, almost every physician/health care provider carries new and sleek cell phones (because the newer ones are well designed and function better). Why these same providers continue to prescribe insulin via syringes in 2008 is something that I cannot fathom. Previously, some insurance companies only paid for vials and there was no other choice, but today almost all insurance pay for pens and so the "insurance reason" is no longer tenable. Since Banting and Best discovered insulin in 1921, scientists have continued to improve the types of insulin (making them mimic physiology more closely in order to minimize hypoglycemia and improve glycemic control as seen with the latest analog insulins). In the same manner, the delivery process of insulin has also continued to evolve to make it easier and more acceptable to patients. Studies have shown that patients prefer device use over traditional vials/syringes. Pen devices used to inject insulin lead to better compliance, are quicker to inject, dosing is much more accurate, and, surprisingly, are more cost effective. I challenge my colleagues to take full responsibility for what their patients use. If a provider believes in pen devices, most of his/her patients will use them. The products your patients use is a direct reflection of what you practice. Educating providers to change their beliefs and practices is key to moving American diabetic patients from syringes to pen devices.

  15. Pharmacy Participation in Non-Prescription Syringe Sales in Los Angeles and San Francisco Counties, 2007

    PubMed Central

    Cooper, Erin N.; Dodson, Chaka; Stopka, Thomas J.; Riley, Elise D.; Garfein, Richard S.

    2010-01-01

    Increasing sterile syringe access for injection drug users (IDUs) is one way to prevent HIV and hepatitis C virus (HCV) transmission in this population. In 2005, California Senate Bill 1159 allowed counties to adopt the Disease Prevention Demonstration Project (DPDP). Where enacted, the DPDP allows pharmacies that register with the county to sell up to ten syringes to adults without a prescription. In the current study, we describe pharmacy participation in nonprescription syringe sales (NPSS) in two counties in California and examine factors associated with NPSS. Telephone and in-person interviews were conducted in Los Angeles (LA) and San Francisco (SF) with 238 pharmacies in 2007 (n = 67 in SF; n = 171 in LA). Quantitative survey items captured pharmacy registration with the county, pharmacy policies/practices, episodes and conditions of NPSS and refusals to sell, potential negative consequences of NPSS, and staff attitudes regarding HIV and HCV prevention for IDUs. Overall, 42% of pharmacies reported NPSS (28% in LA and 81% in SF), although only 34% had registered with the county (17% in LA and 76% in SF). Many pharmacies required proof of a medical condition (80% in LA and 30% in SF) and refused NPSS if the customer was a suspected IDU (74% in LA, 33% in SF). Few negative consequences of NPSS were reported. In multivariate logistic regression analysis, we found that the odds of NPSS were significantly higher among pharmacists who thought syringe access was important for preventing HIV among IDUs [adjusted odds ratio (AOR) = 2.95; 95% confidence interval (CI) = 1.10–7.92], were chain pharmacies (AOR = 12.5; 95% CI = 4.55–33.33), and were located in SF (AOR = 4.88; 95% CI = 1.94–12.28). These results suggest that NPSS were influenced by pharmacists’ perception. NPSS might be increased through greater educational efforts directed at pharmacists, particularly those in non-chain pharmacies. PMID:20549568

  16. Rapid discrimination and determination of antibiotics drugs in plastic syringes using near infrared spectroscopy with chemometric analysis: Application to amoxicillin and penicillin.

    PubMed

    Lê, Laetitia Minh Mai; Eveleigh, Luc; Hasnaoui, Ikram; Prognon, Patrice; Baillet-Guffroy, Arlette; Caudron, Eric

    2017-05-10

    The aim of this study was to investigate near infrared spectroscopy (NIRS) combined to chemometric analysis to discriminate and quantify three antibiotics by direct measurement in plastic syringes.Solutions of benzylpenicillin (PENI), amoxicillin (AMOX) and amoxicillin/clavulanic acid (AMOX/CLAV) were analyzed at therapeutic concentrations in glass vials and plastic syringes with NIR spectrometer by direct measurement. Chemometric analysis using partial least squares regression and discriminative analysis was conducted to develop qualitative and quantitative calibration models. Discrimination of the three antibiotics was optimal for concentrated solutions with 100% of accuracy. For quantitative analysis, the three antibiotics furnished a linear response (R²>0.9994) for concentrations ranging from 0.05 to 0.2 g/mL for AMOX, 0.1 to 1.0 MUI/mL for PENI and 0.005 to 0.05 g/mL for AMOX/CLAV with excellent repeatability (maximum 1.3%) and intermediate precision (maximum of 3.2%). Based on proposed models, 94.4% of analyzed AMOX syringes, 80.0% of AMOX/CLAV syringes and 85.7% of PENI syringes were compliant with a relative error including the limit of ± 15%.NIRS as rapid, non-invasive and non-destructive analytical method represents a potentially powerful tool to further develop for securing the drug administration circuit of healthcare institutions to ensure that patients receive the correct product at the right dose. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. A new syringe pump apparatus for the retrieval and temporal analysis of helium in groundwaters and geothermal fluids

    USGS Publications Warehouse

    Barry, P.H.; Hilton, David R.; Tryon, M.D.; Brown, K.M.; Kulongoski, J.T.

    2009-01-01

    [1] We present details of a newly designed syringe pump apparatus for the retrieval and temporal analysis of helium (SPARTAH). The device is composed of a commercially available syringe pump connected to coils of Cu tubing, which interface the syringe and the groundwater or geothermal wellhead. Through test deployments at geothermal wells in Iceland and California, we show that well fluids are drawn smoothly, accurately, and continuously into the Cu tubing and can be time-stamped through user-determined operating parameters. In the laboratory, the tubing is sectioned to reveal helium (He) characteristics of the fluids at times and for durations of interest. The device is capable of prolonged deployments, up to 6 months or more, with minimal maintenance. It can be used to produce detailed time series records of He, or any other geochemical parameter, in groundwaters and geothermal fluids. SPARTAH has application in monitoring projects assessing the relationship between external transient events (e.g., earthquakes) and geochemical signals in aqueous fluids. ?? 2009 by the American Geophysical Union.

  18. Trend Analyses of Users of a Syringe Exchange Program in Philadelphia, Pennsylvania: 1999-2014.

    PubMed

    Maurer, Laurie A; Bass, Sarah Bauerle; Ye, Du; Benitez, José; Mazzella, Silvana; Krafty, Robert

    2016-12-01

    This study examines trends of injection drug users' (IDUs) use of a Philadelphia, Pennsylvania, syringe exchange program (SEP) from 1999 to 2014, including changes in demographics, drug use, substance abuse treatment, geographic indicators, and SEP use. Prevention Point Philadelphia's SEP registration data were analyzed using linear regression, Pearson's Chi square, and t-tests. Over time new SEP registrants have become younger, more racially diverse, and geographically more concentrated in specific areas of the city, corresponding to urban demographic shifts. The number of new registrants per year has decreased, however syringes exchanged have increased. Gentrification, cultural norms, and changes in risk perception are believed to have contributed to the changes in SEP registration. Demographic changes indicate outreach strategies for IDUs may need adjusting to address unique barriers for younger, more racially diverse users. Implications for SEPs are discussed, including policy and continued ability to address current public health threats.

  19. Disintegration of chemotherapy tablets for oral administration in patients with swallowing difficulties.

    PubMed

    Siden, Rivka; Wolf, Matthew

    2013-06-01

    The administration of oral chemotherapeutic drugs can be problematic in patients with swallowing difficulties. Inability to swallow solid dosage forms can compromise compliance and may lead to poor clinical outcome. The current technique of tablet crushing to aid in administration is considered an unsafe practice. By developing a technique to disintegrate tablets in an oral syringe, the risk associated with tablet crushing can be avoided. The purpose of this study was to determine the feasibility of using disintegration in an oral syringe for the administration of oral chemotherapeutic tablets. Eight commonly used oral chemotherapeutic drugs were tested. Tablets were placed in an oral syringe and allowed to disintegrate in tap water. Various volumes and temperatures were tested to identify which combination allows for complete disintegration of the tablet in the shortest amount of time. The oral syringe disintegration method was considered feasible if disintegration occurred in ≤15 min and in ≤20 mL of water and the dispersion passed through an oral syringe tip. The following tablets were shown to disintegrate within 15 min and in <20 mL of water: busulfan, cyclophosphamide 50 mg, dasatinib, imatinib, methotrexate, and thioguanine. For these drugs, drug-specific information pamphlets can be prepared for patient or caregiver use. Mercaptopurine, cyclophosphamide 25 mg, and mitotane tablets did not pass the disintegration test. Disintegrating oral chemotherapeutic tablets in a syringe provides a closed system to administer hazardous drugs and allows for the safe administration of oral chemotherapeutic drugs in a tablet form to patients with swallowing difficulties.

  20. Implementation study of patient-ready syringes containing 25 mg/mL methotrexate solution for use in treating ectopic pregnancy.

    PubMed

    Respaud, R; Gaudy, A S; Arlicot, C; Tournamille, J F; Viaud-Massuard, M C; Elfakir, C; Antier, D

    2014-01-01

    Ectopic pregnancy (EP) is a significant cause of morbidity and mortality during the first trimester of pregnancy. Small unruptured tubal pregnancies can be treated medically with a single dose of methotrexate (MTX). The aim of this study was to evaluate the stability of a 25 mg/mL solution of MTX to devise a secure delivery circuit for the preparation and use of this medication in the management of EP. MTX solutions were packaged in polypropylene syringes, stored over an 84-day period, and protected from light either at +2 to +8°C or at 23°C. We assessed the physical and chemical stability of the solutions at various time points over the storage period. A pharmaceutical delivery circuit was implemented that involved the batch preparation of MTX syringes. We show that 25 mg/mL MTX solutions remain stable over an 84-day period under the storage conditions tested. Standard doses were prepared, ranging from 50 mg to 100 mg. The results of this study suggest that MTX syringes can be prepared in advance by the pharmacy, ready to be dispensed at any time that a diagnosis of EP is made. The high stability of a 25 mg/mL MTX solution in polypropylene syringes makes it possible to implement a flexible and cost-effective delivery circuit for ready-to-use preparations of this drug, providing 24-hour access and preventing treatment delays.

  1. First-line intra-arterial versus intravenous chemotherapy in unilateral sporadic group D retinoblastoma: evidence of better visual outcomes, ocular survival and shorter time to success with intra-arterial delivery from retrospective review of 20 years of treatment.

    PubMed

    Munier, Francis L; Mosimann, Pascal; Puccinelli, Francesco; Gaillard, Marie-Claire; Stathopoulos, Christina; Houghton, Susan; Bergin, Ciara; Beck-Popovic, Maja

    2017-08-01

    The introduction of intra-arterial chemotherapy (IAC) as salvage treatment has improved the prognosis for eye conservation in group D retinoblastoma. The aim of this study was to compare the outcomes of consecutive patients with advanced unilateral disease treated with either first-line intravenous chemotherapy (IVC) or first-line IAC. This is a retrospective mono-centric comparative review of consecutive patients. Sporadic unilateral retinoblastoma group D cases treated conservatively at Jules-Gonin Eye Hospital and CHUV between 1997 and 2014. From January 1997 to August 2008, IVC, combined with focal treatments, was the primary treatment approach. From September 2008 to October 2014, IAC replaced IVC as first-line therapy. 48 patients met the inclusion criteria, receiving only either IAC or IVC as primary treatment modality. Outcomes of 23 patients treated by IVC were compared with those of 25 treated by IAC; mean follow-up was 105.3 months (range 29.2-218.6) and 41.7 months (range 19.6-89.5), respectively. Treatment duration was significantly shorter in the IAC group (p<0.001). Ten eyes in the IVC group underwent enucleation. Recordable visual acuity of the salvaged eyes was significantly better in the IAC group (0.9 vs 1.4 logarithm of the minimum angle of resolution, p<0.01). No extraocular disease, metastases or long-term systemic complications were observed in either group. The difference in the time frame between treatment groups had an impact on the availability of intravitreal chemotherapy treatment. Despite this, the results reported here imply that eyes treated with first-line IAC will have shorter treatment period, better ocular survival and visual acuity than first-line IVC. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  2. A simple pore water hydrogen diffusion syringe sampler

    USGS Publications Warehouse

    Vroblesky, D.A.; Chapelle, F.H.; Bradley, P.M.

    2007-01-01

    Molecular hydrogen (H2) is an important intermediate product and electron donor in microbial metabolism. Concentrations of dissolved H 2 are often diagnostic of the predominant terminal electron-accepting processes in ground water systems or aquatic sediments. H2 concentrations are routinely measured in ground water monitoring wells but are rarely measured in saturated aquatic sediments due to a lack of simple and practical sampling methods. This report describes the design and development (including laboratory and field testing) of a simple, syringe-based H 2 sampler in (1) saturated, riparian sediments, (2) surface water bed sediments, and (3) packed intervals of a fractured bedrock borehole that are inaccessible by standard pumped methods. ?? 2007 National Ground Water Association.

  3. Cost Effectiveness of Pembrolizumab vs. Standard-of-Care Chemotherapy as First-Line Treatment for Metastatic NSCLC that Expresses High Levels of PD-L1 in the United States.

    PubMed

    Huang, Min; Lou, Yanyan; Pellissier, James; Burke, Thomas; Liu, Frank Xiaoqing; Xu, Ruifeng; Velcheti, Vamsidhar

    2017-08-01

    Our objectives were to evaluate the cost effectiveness of pembrolizumab compared with standard-of-care (SoC) platinum-based chemotherapy as first-line treatment in patients with metastatic non-small-cell lung cancer (NSCLC) that expresses high levels of programmed death ligand-1 (PD-L1) [tumour proportion score (TPS) ≥50%], from a US third-party public healthcare payer perspective. We conducted a partitioned-survival model with a cycle length of 1 week and a base-case time horizon of 20 years. Parametric models were fitted to Kaplan-Meier estimates of time on treatment, progression-free survival and overall survival from the KEYNOTE-024 randomized clinical trial (patients aged ≥18 years with stage IV NSCLC, TPS ≥50%, without epidermal growth factor receptor (EGFR)-activating mutations or anaplastic lymphoma kinase (ALK) translocations who received no prior systemic chemotherapy) and validated with long-term registry data. Quality-adjusted life-years (QALYs) were calculated based on EuroQoL-5 Dimensions (EQ-5D) utility data collected in the trial. Costs ($US, year 2016 values) for drug acquisition/administration, adverse events and clinical management were included. Costs and outcomes were discounted at 3% per year. A series of deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results. In the base-case scenario, pembrolizumab resulted in an expected gain of 1.31 life-years (LYs) and 1.05 QALYs and an incremental cost of $US102,439 compared with SoC. The incremental cost per QALY gain was $US97,621/QALY and the incremental cost per LY gain was $US78,344/LY. Pembrolizumab is projected to be a cost-effective option compared with SoC platinum-based chemotherapy as first-line treatment in adults with metastatic NSCLC expressing high levels of PD-L1.

  4. Glioma-derived mutations in isocitrate dehydrogenase 2 beneficial to traditional chemotherapy

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

    Fu, Yuejun, E-mail: yjfu@sxu.edu.cn; Huang, Rui; Zheng, Yali

    2011-07-01

    Highlights: {yields} IDH1 and IDH2 mutations are not detected in the rat C6 glioma cell line model. {yields} IDH2 mutations are not required for the tumorigenesis of glioma. {yields} IDH2{sup R172G} can sensitize glioma sensitivity to chemotherapy through NADPH levels. {yields} IDH2{sup R172G} can give a benefit to traditional chemotherapy of glioma. {yields} This finding serves as an important complement to existing research on this topic. -- Abstract: Heterozygous mutations in either the R132 residue of isocitrate dehydrogenase I (IDH1) or the R172 residue of IDH2 in human gliomas were recently highlighted. In the present study, we report that mutationsmore » of IDH1 and IDH2 are not detected in the rat C6 glioma cell line model, which suggests that these mutations are not required for the development of glioblastoma induced by N,N'-nitroso-methylurea. The effects of IDH2 and IDH2{sup R172G} on C6 cells proliferation and sensitivity to chemotherapy and the possible mechanism are analyzed at the cellular level. IDH1 and IDH2 mutations lead to simultaneous loss and gain of activities in the production of {alpha}-ketoglutarate ({alpha}-KG) and 2-hydroxyglutarate (2HG), respectively, and result in lowering NADPH levels even further. The low NADPH levels can sensitize tumors to chemotherapy, and account for the prolonged survival of patients harboring the mutations. Our data extrapolate potential importance of the in vitro rat C6 glioma cell model, show that the IDH2{sup R172G} mutation in gliomas may give a benefit to traditional chemotherapy of this cancer and serve as an important complement to existing research on this topic.« less

  5. The impact of harm reduction programs and police interventions on the number of syringes collected from public spaces. A time series analysis in Barcelona, 2004-2014.

    PubMed

    Espelt, A; Villalbí, J R; Bosque-Prous, M; Parés-Badell, O; Mari-Dell'Olmo, M; Brugal, M T

    2017-12-01

    To estimate the effect of opening two services for people who use drugs and three police interventions on the number of discarded syringes collected from public spaces in Barcelona between 2004 and 2014. We conducted an interrupted time-series analysis of the monthly number of syringes collected from public spaces during this period. The dependent variable was the number of syringes collected per month. The main independent variables were month and five dummy variables (the opening of two facilities with safe consumption rooms, and three police interventions). To examine which interventions affected the number of syringes collected, we performed an interrupted time-series analysis using a quasi-Poisson regression model, obtaining relative risks (RR) and 95% confidence intervals (CIs). The number of syringes collected per month in Barcelona decreased from 13,800 in 2004 to 1655 in 2014 after several interventions. For example, following the closure of an open drug scene in District A of the city, we observed a decreasing trend in the number of syringes collected [RR=0.88 (95% CI: 0.82-0.95)], but an increasing trend in the remaining districts [RR=1.11 (95% CI: 1.05-1.17) and 1.08 (95% CI: 0.99-1.18) for districts B and C, respectively]. Following the opening of a harm reduction facility in District C, we observed an initial increase in the number collected in this district [RR=2.72 (95% CI: 1.57-4.71)] and stabilization of the trend thereafter [RR=0.97 (95% CI: 0.91-1.03)]. The overall number of discarded syringes collected from public spaces has decreased consistently in parallel with a combination of police interventions and the opening of harm reduction facilities. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Time from prior chemotherapy enhances prognostic risk grouping in the second-line setting of advanced urothelial carcinoma: a retrospective analysis of pooled, prospective phase 2 trials.

    PubMed

    Sonpavde, Guru; Pond, Gregory R; Fougeray, Ronan; Choueiri, Toni K; Qu, Angela Q; Vaughn, David J; Niegisch, Guenter; Albers, Peter; James, Nicholas D; Wong, Yu-Ning; Ko, Yoo-Joung; Sridhar, Srikala S; Galsky, Matthew D; Petrylak, Daniel P; Vaishampayan, Ulka N; Khan, Awais; Vogelzang, Nicholas J; Beer, Tomasz M; Stadler, Walter M; O'Donnell, Peter H; Sternberg, Cora N; Rosenberg, Jonathan E; Bellmunt, Joaquim

    2013-04-01

    Outcomes for patients in the second-line setting of advanced urothelial carcinoma (UC) are dismal. The recognized prognostic factors in this context are Eastern Cooperative Oncology Group (ECOG) performance status (PS) >0, hemoglobin level (Hb) <10 g/dl, and liver metastasis (LM). The purpose of this retrospective study of prospective trials was to investigate the prognostic value of time from prior chemotherapy (TFPC) independent of known prognostic factors. Data from patients from seven prospective trials with available baseline TFPC, Hb, PS, and LM values were used for retrospective analysis (n=570). External validation was conducted in a second-line phase 3 trial comparing best supportive care (BSC) versus vinflunine plus BSC (n=352). Cox proportional hazards regression was used to evaluate the association of factors, with overall survival (OS) and progression-free survival (PFS) being the respective primary and secondary outcome measures. ECOG-PS >0, LM, Hb <10 g/dl, and shorter TFPC were significant prognostic factors for OS and PFS on multivariable analysis. Patients with zero, one, two, and three to four factors demonstrated median OS of 12.2, 6.7, 5.1, and 3.0 mo, respectively (concordance statistic=0.638). Setting of prior chemotherapy (metastatic disease vs perioperative) and prior platinum agent (cisplatin or carboplatin) were not prognostic factors. External validation demonstrated a significant association of TFPC with PFS on univariable and most multivariable analyses, and with OS on univariable analyses. Limitations of retrospective analyses are applicable. Shorter TFPC enhances prognostic classification independent of ECOG-PS >0, Hb <10 g/dl, and LM in the setting of second-line therapy for advanced UC. These data may facilitate drug development and interpretation of trials. Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  7. Time from Prior Chemotherapy Enhances Prognostic Risk Grouping in the Second-line Setting of Advanced Urothelial Carcinoma: A Retrospective Analysis of Pooled, Prospective Phase 2 Trials

    PubMed Central

    Sonpavde, Guru; Pond, Gregory R.; Fougeray, Ronan; Choueiri, Toni K.; Qu, Angela Q.; Vaughn, David J.; Niegisch, Guenter; Albers, Peter; James, Nicholas D.; Wong, Yu-Ning; Ko, Yoo-Joung; Sridhar, Srikala S.; Galsky, Matthew D.; Petrylak, Daniel P.; Vaishampayan, Ulka N.; Khan, Awais; Vogelzang, Nicholas J.; Beer, Tomasz M.; Stadler, Walter M.; O’Donnell, Peter H.; Sternberg, Cora N.; Rosenberg, Jonathan E.; Bellmunt, Joaquim

    2014-01-01

    Background Outcomes for patients in the second-line setting of advanced urothelial carcinoma (UC) are dismal. The recognized prognostic factors in this context are Eastern Cooperative Oncology Group (ECOG) performance status (PS) >0, hemoglobin level (Hb) <10 g/dl, and liver metastasis (LM). Objectives The purpose of this retrospective study of prospective trials was to investigate the prognostic value of time from prior chemotherapy (TFPC) independent of known prognostic factors. Design, setting, and participants: Data from patients from seven prospective trials with available baseline TFPC, Hb, PS, and LM values were used for retrospective analysis (n = 570). External validation was conducted in a second-line phase 3 trial comparing best supportive care (BSC) versus vinflunine plus BSC (n = 352). Outcome measurements and statistical analysis Cox proportional hazards regression was used to evaluate the association of factors, with overall survival (OS) and progression-free survival (PFS) being the respective primary and secondary outcome measures. Results and limitations ECOG-PS >0, LM, Hb <10 g/dl, and shorter TFPC were significant prognostic factors for OS and PFS on multivariable analysis. Patients with zero, one, two, and three to four factors demonstrated median OS of 12.2, 6.7, 5.1, and 3.0 mo, respectively (concordance statistic = 0.638). Setting of prior chemotherapy (metastatic disease vs perioperative) and prior platinum agent (cisplatin or carboplatin) were not prognostic factors. External validation demonstrated a significant association of TFPC with PFS on univariable and most multivariable analyses, and with OS on univariable analyses. Limitations of retrospective analyses are applicable. Conclusions Shorter TFPC enhances prognostic classification independent of ECOG-PS>0, Hb<10 g/ dl, and LM in the setting of second-line therapy for advanced UC. These data may facilitate drug development and interpretation of trials. PMID:23206856

  8. Safety and efficacy of first-line bevacizumab with chemotherapy in Asian patients with advanced nonsquamous NSCLC: results from the phase IV MO19390 (SAiL) study.

    PubMed

    Tsai, Chun-Ming; Au, Joseph Siu-kie; Chang, Gee-Chen; Cheng, Ashley Chi-kin; Zhou, Caicun; Wu, Yi-long

    2011-06-01

    First-line treatment with bevacizumab combined with chemotherapy has been shown to improve outcomes in patients with advanced, nonsquamous non-small cell lung cancer (NSNSCLC) in phase III clinical trials. SAiL (MO19390), an open-label, multicenter, single-arm study, evaluated the safety and efficacy of first-line bevacizumab-based treatment in clinical practice. This report presents the results of a preplanned subanalysis of Asian patients enrolled in SAiL. Patients with untreated, locally advanced, metastatic or recurrent NSNSCLC received bevacizumab 7.5 or 15 mg/kg every 3 weeks plus chemotherapy for up to six cycles, followed by single-agent bevacizumab until disease progression. Eligibility criteria for SAiL permitted enrolment of a broad patient population. The primary end point was safety; secondary end points included time to disease progression and overall survival. The Asian intent-to-treat population comprised 314 of the 2212 patients enrolled in the SAiL trial. In the Asian subanalysis, patients received a median of nine cycles of bevacizumab, and the median follow-up was 16.4 months. The incidence of clinically significant adverse events (grade ≥3) of special interest was relatively low in this population (15.6% overall); proteinuria (7.6%), hypertension (4.8%), and bleeding (2.5%) were the most common. A total of five adverse events related to bevacizumab were reported as grade 5. Disease control rate was 94.1%, median time to disease progression was 8.3 months, and median overall survival was 18.9 months. The safety and efficacy of first-line bevacizumab-based treatment in Asian patients with advanced NSNSCLC is consistent with that demonstrated in phase III studies and in the overall SAiL population. There were no new safety signals.

  9. Keratin 5 overexpression is associated with serous ovarian cancer recurrence and chemotherapy resistance.

    PubMed

    Ricciardelli, Carmela; Lokman, Noor A; Pyragius, Carmen E; Ween, Miranda P; Macpherson, Anne M; Ruszkiewicz, Andrew; Hoffmann, Peter; Oehler, Martin K

    2017-03-14

    This study investigated the clinical significance of keratin 5 and 6 expression in serous ovarian cancer progression and chemotherapy resistance. KRT5 and KRT6 (KRT6A, KRT6B & KRT6C) gene expression was assessed in publically available serous ovarian cancer data sets, ovarian cancer cell lines and primary serous ovarian cancer cells. Monoclonal antibodies which detect both K5/6 or only K5 were used to assess protein expression in ovarian cancer cell lines and a cohort of high grade serous ovarian carcinomas at surgery (n = 117) and after neoadjuvant chemotherapy (n = 21). Survival analyses showed that high KRT5 mRNA in stage III/IV serous ovarian cancers was significantly associated with reduced progression-free (HR 1.38, P < 0.0001) and overall survival (HR 1.28, P = 0.013) whilst high KRT6 mRNA was only associated with reduced progression-free survival (HR 1.2, P = 0.031). Both high K5/6 (≥ 10%, HR 1.78 95% CI; 1.03-2.65, P = 0.017) and high K5 (≥ 10%, HR 1.90, 95% CI; 1.12-3.19, P = 0.017) were associated with an increased risk of disease recurrence. KRT5 but not KRT6C mRNA expression was increased in chemotherapy resistant primary serous ovarian cancer cells compared to chemotherapy sensitive cells. The proportion of serous ovarian carcinomas with high K5/6 or high K5 immunostaining was significantly increased following neoadjuvant chemotherapy. K5 can be used to predict serous ovarian cancer prognosis and identify cancer cells that are resistant to chemotherapy. Developing strategies to target K5 may therefore improve serous ovarian cancer survival.

  10. Vorinostat in combination with capecitabine plus cisplatin as a first-line chemotherapy for patients with metastatic or unresectable gastric cancer: phase II study and biomarker analysis

    PubMed Central

    Yoo, Changhoon; Ryu, Min-Hee; Na, Young-Soon; Ryoo, Baek-Yeol; Lee, Chae-Won; Kang, Yoon-Koo

    2016-01-01

    Background: Vorinostat, a histone deacetylase (HDAC) inhibitor, was investigated in combination with capecitabine plus cisplatin (XP) as a first-line chemotherapy for patients with unresectable or metastatic gastric cancer (GC). Methods: Eligible patients received 400 mg vorinostat once daily on days 1–14, 1000 mg m−2 capecitabine twice daily on days 1–14, and 60 mg m−2 cisplatin on day 1 every 3 weeks. Plasma levels of acetyl-H3, HDAC2, and p21 were measured for correlative analysis. The primary end point was the 6-month progression-free survival (PFS) rate. Secondary end points included the response rate, PFS, overall survival (OS), and safety profile. Results: A total of 45 patients with HER2-negative GC were included in this study. The objective response rate was 42%. The median PFS was 5.9 months, and the 6-month PFS rate was 44.4%. The median OS was 12.7 months. Most common grade 3–4 toxicities were neutropenia (41%), fatigue (34%), anorexia (32%), thromboembolism (27%), stomatitis (14%), and thrombocytopenia (11%). High plasma acetyl-H3 and p21 levels were significantly associated with a poor OS (P=0.02 and P=0.03, respectively). Conclusions: Vorinostat-XP is a feasible first-line chemotherapy for patients with advanced GC. However, this trial did not meet its primary end point, and more adverse events were observed in comparison with the historical data of flouropyrimidine–platinium doublet regimens. PMID:27172248

  11. Vorinostat in combination with capecitabine plus cisplatin as a first-line chemotherapy for patients with metastatic or unresectable gastric cancer: phase II study and biomarker analysis.

    PubMed

    Yoo, Changhoon; Ryu, Min-Hee; Na, Young-Soon; Ryoo, Baek-Yeol; Lee, Chae-Won; Kang, Yoon-Koo

    2016-05-24

    Vorinostat, a histone deacetylase (HDAC) inhibitor, was investigated in combination with capecitabine plus cisplatin (XP) as a first-line chemotherapy for patients with unresectable or metastatic gastric cancer (GC). Eligible patients received 400 mg vorinostat once daily on days 1-14, 1000 mg m(-2) capecitabine twice daily on days 1-14, and 60 mg m(-2) cisplatin on day 1 every 3 weeks. Plasma levels of acetyl-H3, HDAC2, and p21 were measured for correlative analysis. The primary end point was the 6-month progression-free survival (PFS) rate. Secondary end points included the response rate, PFS, overall survival (OS), and safety profile. A total of 45 patients with HER2-negative GC were included in this study. The objective response rate was 42%. The median PFS was 5.9 months, and the 6-month PFS rate was 44.4%. The median OS was 12.7 months. Most common grade 3-4 toxicities were neutropenia (41%), fatigue (34%), anorexia (32%), thromboembolism (27%), stomatitis (14%), and thrombocytopenia (11%). High plasma acetyl-H3 and p21 levels were significantly associated with a poor OS (P=0.02 and P=0.03, respectively). Vorinostat-XP is a feasible first-line chemotherapy for patients with advanced GC. However, this trial did not meet its primary end point, and more adverse events were observed in comparison with the historical data of flouropyrimidine-platinium doublet regimens.

  12. Chemotherapy Toxicity Risk Score for Treatment Decisions in Older Adults with Advanced Solid Tumors.

    PubMed

    Nishijima, Tomohiro F; Deal, Allison M; Williams, Grant R; Sanoff, Hanna K; Nyrop, Kirsten A; Muss, Hyman B

    2018-05-01

    The decision whether to treat older adults with advanced cancer with standard therapy (ST) or reduced therapy (RT) is complicated by heterogeneity in aging. We assessed the potential utility of the chemotherapy toxicity risk score (CTRS) [J Clin Oncol 2011;29:3457-3465] for treatment decisions in older adults. This was a prospective observational study of patients aged ≥65 years receiving first-line chemotherapy for advanced cancer for which combination chemotherapy is the standard of care. Patients were categorized as high risk (CTRS ≥10), for whom RT (dose-reduced combination or single-agent chemotherapy) is deemed appropriate, or nonhigh risk (CTRS <10), for whom ST is deemed appropriate for toxicity. The primary objective was to estimate the agreement in chemotherapy choice (ST vs. RT) between the treating physician and the CTRS using a κ statistic. Fifty-eight patients (median age, 71 years) were enrolled. Thirty-eight patients received ST (21 had CTRS <10, and 17 had CTRS ≥10), and 20 patients received RT (12 had CTRS ≥10, and 8 had CTRS <10), with minimal agreement in chemotherapy choice (κ = 0.14; 95% CI, -0.10 to 0.38). Grade 3-4 toxicity and hospitalization occurred in 60% and 27% of 55 patients with follow-up data, respectively. Among patients receiving ST, patients with CTRS ≥10 had a higher incidence of toxicity (88% vs. 40%, p  = .006) and hospitalization (50% vs. 15%, p  = .03) than those with CTRS <10. Older patients with cancer with a high CTRS who receive combination chemotherapy have an exceedingly high rate of severe toxicity and hospitalization. The potential utility of the chemotherapy toxicity risk score (CTRS) in old adults with advanced solid tumors receiving first-line chemotherapy was assessed. Little agreement was found between chemotherapy treatment decisions based on the clinical impression versus what was recommended based on the CTRS. Among patients treated with standard-dose combination chemotherapy, patients

  13. Use of metronomic chemotherapy in oncology: results from a national Italian survey.

    PubMed

    Collovà, Elena; Sebastiani, Federica; De Matteis, Elisabetta; Generali, Daniele; Aurilio, Gaetano; Boccardo, Francesco; Crispino, Sergio; Cruciani, Giorgio

    2011-01-01

    Metronomic chemotherapy refers to the administration of low doses of cytotoxic agents over a prolonged period of time with no or only short drug-free intervals. It is designed to overcome acquired tumor resistance to chemotherapy and reduce neo-angiogenesis despite a lower toxicity than with standard chemotherapy. The role of metronomic chemotherapy remains controversial, and its optimal therapeutic use has not yet been defined. The present survey was designed as a short questionnaire and was sent to the medical oncologists registered with Medikey, a national database listing all the Italian oncology specialists linked with the Italian Council of Medical Oncology Hospital Consultants (Collegio Italiano Primari Oncologi Medici Ospedalieri, CIPOMO) and the Italian Association of Medical Oncology (Associazione Italiana di Oncologia Medica, AIOM). The questionnaire was completed on a voluntary basis and it was totally anonymous. The questionnaire was sent to 3,289 oncologists, and 191 (5.8%) actively participated in the survey. Seventy-two percent of responders declared that they had administered a regimen of metronomic chemotherapy at least once. Metronomic chemotherapy is commonly used in advanced breast cancer patients, and in most cases it was prescribed after failure of at least two lines of treatment. Oral agents such as cyclophosphamide, capecitabine, methotrexate and vinorelbine were the most commonly prescribed drugs. Nearly 60% of responders was believed to have significantly less toxicity with metronomic chemotherapy than with standard chemotherapy. The sample of oncologists who participated in the survey is small but it appears to be representative of the Italian medical oncology community. The answers to the questionnaire indicate a significant interest in metronomic chemotherapy, which is apparently widely prescribed. This is the first large national survey on the use of metronomic chemotherapy. Considering the results, larger research on metronomic

  14. AutoSyP: A Low-Cost, Low-Power Syringe Pump for Use in Low-Resource Settings.

    PubMed

    Juarez, Alexa; Maynard, Kelley; Skerrett, Erica; Molyneux, Elizabeth; Richards-Kortum, Rebecca; Dube, Queen; Oden, Z Maria

    2016-10-05

    This article describes the design and evaluation of AutoSyP, a low-cost, low-power syringe pump intended to deliver intravenous (IV) infusions in low-resource hospitals. A constant-force spring within the device provides mechanical energy to depress the syringe plunger. As a result, the device can run on rechargeable battery power for 66 hours, a critical feature for low-resource settings where the power grid may be unreliable. The device is designed to be used with 5- to 60-mL syringes and can deliver fluids at flow rates ranging from 3 to 60 mL/hour. The cost of goods to build one AutoSyP device is approximately $500. AutoSyP was tested in a laboratory setting and in a pilot clinical study. Laboratory accuracy was within 4% of the programmed flow rate. The device was used to deliver fluid to 10 healthy adult volunteers and 30 infants requiring IV fluid therapy at Queen Elizabeth Central Hospital in Blantyre, Malawi. The device delivered fluid with an average mean flow rate error of -2.3% ± 1.9% for flow rates ranging from 3 to 60 mL/hour. AutoSyP has the potential to improve the accuracy and safety of IV fluid delivery in low-resource settings. © The American Society of Tropical Medicine and Hygiene.

  15. Addition of rapamycin and hydroxychloroquine to metronomic chemotherapy as a second line treatment results in high salvage rates for refractory metastatic solid tumors: a pilot safety and effectiveness analysis in a small patient cohort.

    PubMed

    Chi, Kwan-Hwa; Ko, Hui-Ling; Yang, Kai-Lin; Lee, Cheng-Yen; Chi, Mau-Shin; Kao, Shang-Jyh

    2015-06-30

    Autophagy is an important oncotarget that can be modulated during anti-cancer therapy. Enhancing autophagy using chemotherapy and rapamycin (Rapa) treatment and then inhibiting it using hydroxychloroquine (HCQ) could synergistically improve therapy outcome in cancer patients. It is still unclear whether addition of Rapa and HCQ to chemotherapy could be used for reversing drug resistance. Twenty-five stage IV cancer patients were identified. They had no clinical response to first-line metronomic chemotherapy; the patients were salvaged by adding an autophagy inducer (Rapa, 2 mg/day) and an autophagosome inhibitor (HCQ, 400 mg/day) to their current metronomic chemotherapy for at least 3 months. Patients included 4 prostate, 4 bladder, 4 lung, 4 breast, 2 colon, and 3 head and neck cancer patients as well as 4 sarcoma patients. Chemotherapy was administered for a total of 137 months. The median duration of chemotherapy cycles per patient was 4 months (95% confidence interval, 3-7 months). The overall response rate to this treatment was of 40%, with an 84% disease control rate. The most frequent and clinically significant toxicities were myelotoxicities. Grade ≥3 leucopenia occurred in 6 patients (24%), grade ≥3 thrombocytopenia in 8 (32%), and anemia in 3 (12%). None of them developed febrile neutropenia. Non-hematologic toxicities were fatigue (total 32%, with 1 patient developing grade 3 fatigue), diarrhea (total 20%, 1 patient developed grade 3 fatigue), reversible grade 3 cardiotoxicity (1 patient), and grade V liver toxicity from hepatitis B reactivation (1 patient). Our results of Rapa, HCQ and chemotherapy triplet combination suggest autophagy is a promising oncotarget and warrants further investigation in phase II studies.

  16. Types of chemotherapy

    MedlinePlus

    ... or on cancer cells. How Doctors Choose Your Chemotherapy The type and dose of chemotherapy your doctor gives you ... drugs. Below are the seven main types of chemotherapy, the types of cancer they treat, and examples. The caution ...

  17. Biodegradation of Lignin Monomers Vanillic, p-Coumaric, and Syringic Acid by the Bacterial Strain, Sphingobacterium sp. HY-H.

    PubMed

    Wang, Jinxing; Liang, Jidong; Gao, Sha

    2018-05-10

    Many bacterial strains have been demonstrated to biodegrade lignin for contaminant removal or resource regeneration. The goal of this study was to investigate the biodegradation amount and associated pathways of three lignin monomers, vanillic, p-coumaric, and syringic acid by strain Sphingobacterium sp. HY-H. Vanillic, p-coumaric, and syringic acid degradation with strain HY-H was estimated as 88.71, 76.67, and 72.78%, respectively, after 96 h. Correspondingly, the same three monomers were associated with a COD removal efficiency of 87.30, 55.17, and 67.23%, and a TOC removal efficiency of 82.14, 61.03, and 43.86%. The results of GC-MS, HPLC, FTIR, and enzyme activities show that guaiacol and o-dihydroxybenzene are key intermediate metabolites of the vanillic acid and syringic acid degradation. p-Hydroxybenzoic acid is an important intermediate metabolite for p-coumaric and syringic acid degradation. LiP and MnP play an important role in the degradation of lignin monomers and their intermediate metabolites. One possible pathway is that strain HY-H degrades lignin monomers into guaiacol (through decarboxylic and demethoxy reaction) or p-hydroxybenzoic acid (through side-chain oxidation); then guaiacol demethylates to o-dihydroxybenzene. The p-hydroxybenzoic acid and o-dihydroxybenzene are futher through ring cleavage reaction to form small molecule acids (butyric, valproic, oxalic acid, and propionic acid) and alcohols (ethanol and ethanediol), then these acids and alcohols are finally decomposed into CO 2 and H 2 O through the tricarboxylic acid cycle. If properly optimized and controlled, the strain HY-H may play a role in breaking down lignin-related compounds for biofuel and chemical production.

  18. [History of cancer and chemotherapy before chemotherapy].

    PubMed

    Bonnichon, Philippe; Berger, J P; Bonni, N; Fontaine, M; Pion-Graff, J

    2014-01-01

    Chemotherapy stands today for cancer. In 1909, Paul Ehrlich (1854-1915) advocates the use of arsphenamine by infusion. So, he is considered as the father of chemotherapy. In fact, the first to have thought through chemotherapy was Sir Christopher Wren (1632-1723). In 1676, ideas and experiments on animals had sufficiently progressed to allow Michel Ettmuller (1644-1683) to publish the first edition of his book and several others were printed until 1753. In this book, he describes the first intravenous treatment, it sets the first indications, dosages and different products which can be used. However this method has been forgotten until the late 19th century.

  19. Smiths Medical Medfusion 3010a syringe pump may overinfuse if software is outdated.

    PubMed

    2010-04-01

    Smiths Medical Medfusion 3010a syringe pumps that aren't equipped with the latest software version (2.0.6) could overinfuse if the "recall last settings" function is used following an infusion in volume/time mode. If your facility has pumps equipped with software versions older than 2.0.6, contact Smiths Medical to obtain an upgrade.

  20. [Preference for etanercept pen versus syringe in patients with chronic arthritis. Nurse education workshop].

    PubMed

    Garcia-Diaz, Silvia; Girabent-Farrés, Montserrat; Roig-Vilaseca, Daniel; Reina, Delia; Cerdà, Dacia; González, Marina; Torrente-Segarra, Vicenç; Fíguls, Ramon; Corominas, Hèctor

    2013-01-01

    The aims of this study are to evaluate the level of fear of post-injection pain prior to the administration, the difficulty in handling the device, and the level of satisfaction of patients using a pre-filled syringe versus an etanercept pen, as well as to evaluate the usefulness of the training given by nursing staff prior to starting with the pen, and the preferences of patients after using both devices. A prospective study was designed to follow-up a cohort of patients during a 6 months period. The data was collected using questionnaires and analyzed with SPSS 18.00. Rank and McNemar tests were performed. Statistical significance was pre-set at an α level of 0.05. A total of 29 patients were included, of whom 69% female, and with a mean age 52.5±10.9 years. Of these, 48% had rheumatoid arthritis, 28% psoriatic arthritis, 21% ankylosing spondylitis, and 3% undifferentiated spondyloarthropathy. There were no statistically significant differences either with the fear or pain or handling of the device between the syringe and the pen (P=.469; P=.812; P=.169 respectively). At 6 months, 59% of patients referred to being satisfied or very satisfied with the pen. Almost all (93%) found useful or very useful the training given by nursing staff prior to using the pen, and 55% preferred the pen over the pre-filled syringe. The etanercept pen is another subcutaneous device option for patients with chronic arthritis. According to the present study, nursing educational workshops before starting this therapy are recommended. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  1. Insulin Pen—The “iPod” for Insulin Delivery (Why Pen Wins over Syringe)

    PubMed Central

    Asamoah, Ernest

    2008-01-01

    Diabetes affects most aspects of everyday life and places considerable responsibility on the patient; therefore, without patient acceptance of what we offer, the therapy is unlikely to be adhered to especially when that therapy happens to be insulin injection. In 2008, almost every physician/health care provider carries new and sleek cell phones (because the newer ones are well designed and function better). Why these same providers continue to prescribe insulin via syringes in 2008 is something that I cannot fathom. Previously, some insurance companies only paid for vials and there was no other choice, but today almost all insurance pay for pens and so the “insurance reason” is no longer tenable. Since Banting and Best discovered insulin in 1921, scientists have continued to improve the types of insulin (making them mimic physiology more closely in order to minimize hypoglycemia and improve glycemic control as seen with the latest analog insulins). In the same manner, the delivery process of insulin has also continued to evolve to make it easier and more acceptable to patients. Studies have shown that patients prefer device use over traditional vials/syringes. Pen devices used to inject insulin lead to better compliance, are quicker to inject, dosing is much more accurate, and, surprisingly, are more cost effective. I challenge my colleagues to take full responsibility for what their patients use. If a provider believes in pen devices, most of his/her patients will use them. The products your patients use is a direct reflection of what you practice. Educating providers to change their beliefs and practices is key to moving American diabetic patients from syringes to pen devices. PMID:19885358

  2. The Impact of a Shortage of Pharmacy-Prepared Ephedrine Syringes on Intraoperative Medication Use.

    PubMed

    Ladha, Karim S; Nanji, Karen C; Pierce, Eric; Poon, K Trudy; Hyder, Joseph A

    2015-08-01

    Anesthesia-related medication shortages have become increasingly common in the United States. We tested whether a local shortage of pharmacy-prepared ephedrine syringes, replaced by provider-prepared ephedrine, was associated with provider-level changes in ephedrine and phenylephrine use and patient-level changes in intraoperative hemodynamics. Consecutive patients undergoing general and orthopedic surgery at a tertiary care center were included 1 month before and 1 month after the start of the pharmacy-prepared ephedrine syringe shortage. Lowest mean arterial blood pressure and slowest heart rate were obtained as measures of hemodynamics. Adjusted associations were tested using mixed-effects regression with repeated measures. Three hundred four patients before the shortage and 298 patients after the shortage began were included. The administration of at least 1 bolus of ephedrine was significantly more common before versus during the shortage (148/304 [48.7]% vs 117/298 [39.3]%; P = 0.0199). After adjusting for age, sex, ASA physical status, surgery type, anesthesia provider, and operative duration, patients were significantly less likely to receive ephedrine during the shortage (relative risk [RR] = 0.78 [95% confidence interval {CI}, 0.61-0.96]; P = 0.0198) and more likely to receive a phenylephrine bolus (RR = 1.27 [95% CI, 1.02-1.51]; P = 0.0357). Patient hemodynamics assessed by slowest heart rate or lowest mean arterial blood pressure did not differ significantly during the shortage. There was an alteration in medication administration patterns during a shortage of pharmacy-prepared syringes. Changes in ephedrine and phenylephrine use were noted; however, patient hemodynamics remained comparable. Provider use patterns were sensitive even to a relative and not absolute medication shortage as observed in this study.

  3. Evaluation of the Amount of Debris extruded apically by using Conv-entional Syringe, Endovac and Ultrasonic Irrigation Technique: An In Vitro Study

    PubMed Central

    Tambe, Varsha H; Nagmode, Pradnya S; Vishwas, Jayshree R; P, Saujanya K; Angadi, Prabakar; Ali, Fareedi Mukram

    2013-01-01

    Background: To compare the amount of debris extruded apically by using conventional syringe, Endovac & Ultrasonic irrigation. Materials & Methods: Thirty freshly extracted mandibular premolars were selected, working length was determined and mounted in a debris and collection apparatus. The canals were prepared. After each instrument change, 1 ml. of 3% sodium hypochlorite was used as irrigation. Debris extruded apically by using conventional syringe, endovac& ultrasonic irrigation tech, was measured using the electronic balance to determine its weight and statistical analysis was performed. The mean difference between the groups was determined using statistical analysis within the groups &between the groups for equal variances. Results: Among all the groups, significantly less debris were found apically in the Endovac group (0.96) compared to conventional and ultrasonic group (1.23) syringe. Conclusion: The present study showed that endovac system extrudes less amount of debris apically as compared to ultrasonic followed by conventional so incidence of flare up can be reduce by using endovac irrigation system. How to cite this article: Tambe V H, Nagmode P S, Vishwas J R, Saujanya K P, Angadi P, Ali F M. Evaluation of the Amount of Debris extruded apically by using Conventional Syringe, Endovac and Ultrasonic Irrigation Technique: An In Vitro Study. J Int Oral Health 2013; 5(3):63-66. PMID:24155604

  4. Improving chemotherapy for patients with advanced non-small cell lung cancer.

    PubMed

    von Plessen, Christian

    2011-01-01

    Lung cancer is the third most common mortal disease in industrialised countries and the prognosis has been slow to improve. The largest subgroup has locally advanced or metastatic non-small cell lung cancer (NSCLC). Unfortunately, these patients can usually not be cured and the main treatment option is palliative chemotherapy. Given the palliative intention of the chemotherapy, it is clinically highly relevant to establish the optimal treatment duration. While chemotherapy prolongs survival and improves quality of life (QoL), it also has side effects and only a minority of patients achieve an objective treatment response. Clinicians need guidance on treatment duration from controlled trials to balance these aspects. Improvements of the conditions under which chemotherapy is given can increase patient and staff satisfaction and increase system performance. This is especially relevant to incurable patients who spend a lot of their limited time at oncology outpatient clinics. Staffing, infrastructure and organisation of these units are often suboptimal to serve patients with palliative needs and reports of improvement projects can inspire and guide clinicians in improving their microsystems of care. Clinicians, health care administrators and the public need knowledge about the outcomes of palliative chemotherapy in unselected patient populations. The efficacy of palliative chemotherapy for advanced NSCLC has been amply documented in controlled clinical trials. Meanwhile, the elderly and patients with higher performance status have usually been under-represented in these trials and population studies of the effectiveness of chemotherapy are needed. (i) To establish the optimal duration of platinum-based first line chemotherapy for advanced NSCLC; (ii) To improve the care processes at an oncology outpatient clinical microsystem; (iii) To describe the use of chemotherapy in a national population and investigate associations between chemotherapy use and survival; and (iv

  5. Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer.

    PubMed

    Bishop, J F; Dewar, J; Toner, G C; Smith, J; Tattersall, M H; Olver, I N; Ackland, S; Kennedy, I; Goldstein, D; Gurney, H; Walpole, E; Levi, J; Stephenson, J; Canetta, R

    1999-08-01

    To determine the place of single-agent paclitaxel compared with nonanthracycline combination chemotherapy as front-line therapy in metastatic breast cancer. Patients with previously untreated metastatic breast cancer were randomized to receive either paclitaxel 200 mg/m(2) intravenously (IV) over 3 hours for eight cycles (24 weeks) or standard cyclophosphamide 100 mg/m(2)/d orally on days 1 to 14, methotrexate 40 mg/m(2) IV on days 1 and 8, fluorouracil 600 mg/m(2) IV on days 1 and 8, and prednisone 40 mg/m(2)/d orally on days 1 to 14 (CMFP) for six cycles (24 weeks) with epirubicin recommended as second-line therapy. A total of 209 eligible patients were randomized with a median survival duration of 17.3 months for paclitaxel and 13.9 months for CMFP. Multivariate analysis showed that patients who received paclitaxel survived significantly longer than those who received CMFP (P =.025). Paclitaxel produced significantly less severe leukopenia, thrombocytopenia, mucositis, documented infections (all P <.001), nausea or vomiting (P =.003), and fever without documented infection (P =.007), and less hospitalization for febrile neutropenia than did CMFP (P =.001). Alopecia, peripheral neuropathy, and myalgia or arthralgia were more severe with paclitaxel (all P <.0001). Overall, quality of life was similar for both treatments (P > = .07). Initial paclitaxel was associated with significantly less myelosuppression and fewer infections, with longer survival and similar quality of life and control of metastatic breast cancer compared with CMFP.

  6. Economic Analysis of First-Line Treatment with Erlotinib in an EGFR-Mutated Population with Advanced NSCLC.

    PubMed

    Vergnenegre, Alain; Massuti, Bartomeu; de Marinis, Filippo; Carcereny, Enric; Felip, Enriqueta; Do, Pascal; Sanchez, Jose Miguel; Paz-Arez, Luis; Chouaid, Christos; Rosell, Rafael

    2016-06-01

    The cost-effectiveness of first-line tyrosine kinase inhibitor therapy in epidermal growth factor receptor gene (EGFR)-mutated advanced-stage non-small cell lung cancer (NSCLC) is poorly documented. We therefore conducted a cost-effectiveness analysis of first-line treatment with erlotinib versus standard chemotherapy in European patients with advanced-stage EGFR-mutated NSCLC who were enrolled in the European Erlotinib versus Chemotherapy trial. The European Erlotinib versus Chemotherapy study was a multicenter, open-label, randomized phase III trial performed mainly in Spain, France, and Italy. We based our economic analysis on clinical data and data on resource consumption (drugs, drug administration, adverse events, and second-line treatments) collected during this trial. Utility values were derived from the literature. Incremental cost-effectiveness ratios were calculated for the first-line treatment phase and for the overall strategy from the perspective of the three participating countries. Sensitivity analyses were performed by selecting the main cost drivers. Compared with standard first-line chemotherapy, the first-line treatment with erlotinib was cost saving (€7807, €17,311, and €19,364 for Spain, Italy and France, respectively) and yielded a gain of 0.117 quality-adjusted life-years. A probabilistic sensitivity analysis indicated that, given a willingness to pay at least €90,000 for 1 quality-adjusted life-year, the probability that a strategy of first-line erlotinib would be cost-effective was 100% in France, 100% in Italy, and 99.8% in Spain. This economic analysis shows that first-line treatment with erlotinib, versus standard chemotherapy, is a dominant strategy for EGFR-mutated advanced-stage NSCLC in three European countries. Copyright © 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

  7. Identifying clinically relevant drug resistance genes in drug-induced resistant cancer cell lines and post-chemotherapy tissues.

    PubMed

    Tong, Mengsha; Zheng, Weicheng; Lu, Xingrong; Ao, Lu; Li, Xiangyu; Guan, Qingzhou; Cai, Hao; Li, Mengyao; Yan, Haidan; Guo, You; Chi, Pan; Guo, Zheng

    2015-12-01

    Until recently, few molecular signatures of drug resistance identified in drug-induced resistant cancer cell models can be translated into clinical practice. Here, we defined differentially expressed genes (DEGs) between pre-chemotherapy colorectal cancer (CRC) tissue samples of non-responders and responders for 5-fluorouracil and oxaliplatin-based therapy as clinically relevant drug resistance genes (CRG5-FU/L-OHP). Taking CRG5-FU/L-OHP as reference, we evaluated the clinical relevance of several types of genes derived from HCT116 CRC cells with resistance to 5-fluorouracil and oxaliplatin, respectively. The results revealed that DEGs between parental and resistant cells, when both were treated with the corresponding drug for a certain time, were significantly consistent with the CRG5-FU/L-OHP as well as the DEGs between the post-chemotherapy CRC specimens of responders and non-responders. This study suggests a novel strategy to extract clinically relevant drug resistance genes from both drug-induced resistant cell models and post-chemotherapy cancer tissue specimens.

  8. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer.

    PubMed

    Vrdoljak, E; Marschner, N; Zielinski, C; Gligorov, J; Cortes, J; Puglisi, F; Aapro, M; Fallowfield, L; Fontana, A; Inbar, M; Kahan, Z; Welt, A; Lévy, C; Brain, E; Pivot, X; Putzu, C; González Martín, A; de Ducla, S; Easton, V; von Minckwitz, G

    2016-11-01

    The randomised phase III TANIA trial demonstrated that continuing bevacizumab with second-line chemotherapy for locally recurrent/metastatic breast cancer (LR/mBC) after progression on first-line bevacizumab-containing therapy significantly improved progression-free survival (PFS) compared with chemotherapy alone [hazard ratio (HR) = 0.75, 95% confidence interval (CI) 0.61-0.93]. We report final results from the TANIA trial, including overall survival (OS) and health-related quality of life (HRQoL). Patients with HER2-negative LR/mBC that had progressed on or after first-line bevacizumab plus chemotherapy were randomised to receive standard second-line chemotherapy either alone or with bevacizumab. At second progression, patients initially randomised to bevacizumab continued bevacizumab with their third-line chemotherapy, but those randomised to chemotherapy alone were not allowed to cross over to receive third-line bevacizumab. The primary end point was second-line PFS; secondary end points included third-line PFS, combined second- and third-line PFS, OS, HRQoL and safety. Of the 494 patients randomised, 483 received second-line therapy; 234 patients (47% of the randomised population) continued to third-line study treatment. The median duration of follow-up at the final analysis was 32.1 months in the chemotherapy-alone arm and 30.9 months in the bevacizumab plus chemotherapy arm. There was no statistically significant difference between treatment arms in third-line PFS (HR = 0.79, 95% CI 0.59-1.06), combined second- and third-line PFS (HR = 0.85, 95% CI 0.68-1.05) or OS (HR = 0.96, 95% CI 0.76-1.21). Third-line safety results showed increased incidences of proteinuria and hypertension with bevacizumab, consistent with safety results for the second-line treatment phase. No differences in HRQoL were detected. In this trial, continuing bevacizumab beyond first and second progression of LR/mBC improved second-line PFS, but no improvement in longer term efficacy was

  9. Ex vivo biomechanical characterization of syringe-needle ejections for intracerebral cell delivery.

    PubMed

    Wahlberg, Brendon; Ghuman, Harmanvir; Liu, Jessie R; Modo, Michel

    2018-06-15

    Intracerebral implantation of cell suspensions is finding its clinical translation with encouraging results in patients with stroke. However, the survival of cells in the brain remains poor. Although the biological potential of neural stem cells (NSCs) is widely documented, the biomechanical effects of delivering cells through a syringe-needle remain poorly understood. We here detailed the biomechanical forces (pressure, shear stress) that cells are exposed to during ejection through different sized needles (20G, 26G, 32G) and syringes (10, 50, 250 µL) at relevant flow rates (1, 5, 10 µL/min). A comparison of 3 vehicles, Phosphate Buffered Saline (PBS), Hypothermosol (HTS), and Pluronic, indicated that less viscous vehicles are favorable for suspension with a high cell volume fraction to minimize sedimentation. Higher suspension viscosity was associated with greater shear stress. Higher flow rates with viscous vehicle, such as HTS reduced viability by ~10% and also produced more apoptotic cells (28%). At 5 µL/min ejection using a 26G needle increased neuronal differentiation for PBS and HTS suspensions. These results reveal the biological impact of biomechanical forces in the cell delivery process. Appropriate engineering strategies can be considered to mitigate these effects to ensure the efficacious translation of this promising therapy.

  10. Surgical outcomes in patients with primary mediastinal non-seminomatous germ cell tumours and elevated post-chemotherapy serum tumour markers.

    PubMed

    De Latour, Bertrand; Fadel, Elie; Mercier, Olaf; Mussot, Sacha; Fabre, Dominique; Fizazi, Karim; Dartevelle, Philippe

    2012-07-01

    Platinum-based chemotherapy followed by surgical resection of residual masses has become the standard treatment of patients with primary mediastinal non-seminomatous germ cell tumours (NSGCTs). Persistent serum tumour marker (STM) elevation after chemotherapy usually indicates a poor prognosis. We retrospectively assessed surgical outcomes in patients with high STM levels after chemotherapy for primary mediastinal NSGCT. Between 1983 and 2010, residual tumour excision was performed in 21 patients, 20 men and one woman with a median age of 30 years (range: 19-49 years), with primary mediastinal NSGCTs and high STM levels after platinum-based chemotherapy, followed by second-line chemotherapy in 11 patients. Alpha-fetoprotein was elevated in all 21 patients and β-human chorionic gonadotropin in three patients. Permanent histology demonstrated viable germ cell tumour (n=13), teratoma (n=3) or necrosis (n=5). After surgery, the STM levels returned to normal in 11 patients. Eight patients are alive with a median follow-up of 98 months. The 5-year survival rate was 36% and was not significantly affected by the use of preoperative second-line chemotherapy. At univariate analysis, only postoperative STM elevation and residual viable tumour, indicating incomplete resection, were significantly associated with lower survival (P=0.018 and P=0.04, respectively). In patients with primary mediastinal NSGCTs and elevated post-chemotherapy STMs, surgery is warranted when complete resection is deemed feasible. In specialized oncology centres, this aggressive approach can provide a cure in some patients.

  11. Cancer Chemotherapy

    MedlinePlus

    ... controlled way. Cancer cells keep growing without control. Chemotherapy is drug therapy for cancer. It works by killing the cancer ... It depends on the type and amount of chemotherapy you get and how your body reacts. Some ...

  12. Analysis of Hypodermic Needles and Syringes for the Presence of Blood and Polydimethylsiloxane (Silicone) Utilizing Microchemical Tests and Infrared Spectroscopy.

    PubMed

    Crowe, John B; Lanzarotta, Adam; Witkowski, Mark R; Andria, Sara E

    2015-07-01

    Suspect hypodermic needles and syringes were seized from an unlicensed individual who was allegedly injecting patients with silicone (polydimethylsiloxane [PDMS]) for cosmetic enhancement. Since control syringe barrels and needles often contain an interfering PDMS lubricant, a risk for false positives of foreign PDMS exists. The focus of this report was to minimize this risk and determine a quick and reliable test for the presence of blood in PDMS matrices. Using ATR-FT-IR spectroscopy, the risk for false-positive identification of foreign PDMS was reduced by (i) overfilling the sampling aperture to prevent spectral distortions and (ii) sampling a region of the suspect syringe/needle assembly where manufacturer-applied PDMS is not typically located. Analysis for blood indicated that the Teichman microchemical test was effective for detecting blood in the presence of PDMS. Overall, detecting PDMS established intent and detecting blood established that the needle containing the PDMS had been used for injection. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

  13. Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging.

    PubMed

    Shieu, Wendy; Stauch, Oliver B; Maa, Yuh-Fun

    2015-01-01

    Syringe filling of high-concentration/viscosity monoclonal antibody formulations is a complex process that is not fully understood. This study, which builds on a previous investigation that used a bench-top syringe filling unit to examine formulation drying at the filling nozzle tip and subsequent nozzle clogging, further explores the impact of formulation-nozzle material interactions on formulation drying and nozzle clogging. Syringe-filling nozzles made of glass, stainless steel, or plastic (polypropylene, silicone, and Teflon®), which represent a full range of materials with hydrophilic and hydrophobic properties as quantified by contact angle measurements, were used to fill liquids of different viscosity, including a high-concentration monoclonal antibody formulation. Compared with hydrophilic nozzles, hydrophobic nozzles offered two unique features that discouraged formulation drying and nozzle clogging: (1) the liquid formulation is more likely to be withdrawn into the hydrophobic nozzle under the same suck-back conditions, and (2) the residual liquid film left on the nozzle wall when using high suck-back settings settles to form a liquid plug away from the hydrophobic nozzle tip. Making the tip of the nozzle hydrophobic (silicone-coating on glass and Teflon-coating stainless steel) could achieve the same suck-back performance as plastic nozzles. This study demonstrated that using hydrophobic nozzles are most effective in reducing the risk of nozzle clogging by drying of high-concentration monoclonal antibody formulation during extended nozzle idle time in a large-scale filling facility and environment. Syringe filling is a well-established manufacturing process and has been implemented by numerous contract manufacturing organizations and biopharmaceutical companies. However, its technical details and associated critical process parameters are rarely published. Information on high-concentration/viscosity formulation filling is particularly lacking. This

  14. Pharmacy staff characteristics associated with support for pharmacy-based HIV-testing in pharmacies participating in the New York State Expanded Access Syringe Exchange Program

    PubMed Central

    Amesty, Silvia; Blaney, Shannon; Crawford, Natalie D.; Rivera, Alexis V.; Fuller, Crystal

    2013-01-01

    Objective To determine support of in-pharmacy HIV-testing among pharmacy staff and the individual-level characteristics associated with in-pharmacy HIV testing support. Design Descriptive, nonexperimental, cross-sectional study. Setting New York City (NYC) during January 2008 to March 2009. Intervention 131 pharmacies registered in the Expanded Syringe Access Program (ESAP) completed a survey. Participants 480 pharmacy staff, including pharmacists, owners/managers, and technicians/clerks. Main outcome measures Support of in-pharmacy HIV testing. Results Support of in-pharmacy HIV testing is high among pharmacy staff (79.4%). Pharmacy staff that supported in-pharmacy vaccinations were significantly more likely to support in-pharmacy HIV testing. Pharmacy staff that think that selling syringes to IDUs causes the community to be littered with dirty syringes were significantly less likely to support in-pharmacy HIV testing. Conclusion Support for in-pharmacy HIV testing is high among our sample of ESAP pharmacy staff actively involved in non-prescription syringe sales. These findings suggest that active ESAP pharmacy staff may be amenable to providing HIV counseling and testing to injection drug users and warrants further investigation. PMID:22825227

  15. Meta-analysis Exploring the Effectiveness of S-1-Based Chemotherapy for Advanced Non-Small Cell Lung Cancer.

    PubMed

    Sun, Xin; Sun, Li; Zhang, Shu-Ling; Xiong, Zhi-Cheng; Ma, Jie-Tao; Han, Cheng-Bo

    2017-01-01

    S-1 is a new oral fluoropyrimidine formulation that comprises tegafur, 5-chloro-2,4-dihydroxypyridine, and potassium oxonate. S-1 is designed to enhance antitumor activity and to reduce gastrointestinal toxicity. Several studies have demonstrated that both S-1 monotherapy and S-1 combination regimens showed encouraging efficacies and mild toxicities in the treatment of lung squamous cell carcinoma and adenocarcinoma. However, it is unclear whether S-1 can be used as standard care in advanced non-small cell lung cancer (NSCLC). The purpose of this meta-analysis was to assess the efficacy and safety of S-1-based chemotherapy, compared with standard chemotherapy, in patients with locally advanced or metastatic NSCLC. Thirteen randomized controlled trials (RCTs) involving 2,134 patients with a similar ratio of different pathological types were included. In first-line or second-line chemotherapy, compared with standard chemotherapy, S-1-based chemotherapy showed similar efficacy in terms of median overall survival (mOS), median progression free survival (mPFS), and objective response rate (ORR) (all P > 0.1), and significantly reduced the incidence of grade ≥ 3 hematological toxicities. In patients with locally advanced NSCLC receiving concurrent chemoradiotherapy, compared with standard chemoradiotherapy, significantly improved survival in the S-1-based chemotherapy was noted in terms of mOS and mPFS (risk radio [RR] = 1.289, P = 0.009; RR = 1.289, P = 0.000, respectively) with lower incidence of grade ≥ 3 neutropenia (RR = 0.453, P = 0.000). The present meta-analysis demonstrates that S-1-based chemotherapy shows similar benefits in advanced NSCLC and improves survival in locally advanced NSCLC, compared with standard treatment.

  16. Implementation Study of Patient-Ready Syringes Containing 25 mg/mL Methotrexate Solution for Use in Treating Ectopic Pregnancy

    PubMed Central

    Respaud, R.; Gaudy, A. S.; Arlicot, C.; Tournamille, J. F.; Viaud-Massuard, M. C.; Elfakir, C.; Antier, D.

    2014-01-01

    Background. Ectopic pregnancy (EP) is a significant cause of morbidity and mortality during the first trimester of pregnancy. Small unruptured tubal pregnancies can be treated medically with a single dose of methotrexate (MTX). Objective. The aim of this study was to evaluate the stability of a 25 mg/mL solution of MTX to devise a secure delivery circuit for the preparation and use of this medication in the management of EP. Method. MTX solutions were packaged in polypropylene syringes, stored over an 84-day period, and protected from light either at +2 to +8°C or at 23°C. We assessed the physical and chemical stability of the solutions at various time points over the storage period. A pharmaceutical delivery circuit was implemented that involved the batch preparation of MTX syringes. Results. We show that 25 mg/mL MTX solutions remain stable over an 84-day period under the storage conditions tested. Standard doses were prepared, ranging from 50 mg to 100 mg. The results of this study suggest that MTX syringes can be prepared in advance by the pharmacy, ready to be dispensed at any time that a diagnosis of EP is made. Conclusion. The high stability of a 25 mg/mL MTX solution in polypropylene syringes makes it possible to implement a flexible and cost-effective delivery circuit for ready-to-use preparations of this drug, providing 24-hour access and preventing treatment delays. PMID:24900977

  17. Physical stability of 20% lipid injectable emulsions via simulated syringe infusion: effects of glass vs plastic product packaging.

    PubMed

    Driscoll, David F; Ling, Pei-Ra; Bistrian, Bruce R

    2007-01-01

    The United States Pharmacopeia (USP) has proposed large-globule-size limits to ensure the physical stability of lipid injectable emulsions, expressed as the percent fat >5 microm, or PFAT(5), not exceeding 0.05%. Visibly obvious phase separation as free oil has been shown to occur in some samples if PFAT(5) is >0.4%. We recently found that lipids, newly packaged in plastic (P), exceed the proposed USP limits and seem to produce less stable total nutrient admixtures compared with those made from conventional glass (G), which do meet proposed USP standards. We tested the possible stability differences between 20% lipid injectable emulsions in either P or G in a simulated neonatal syringe infusion study. Eighteen individual syringes were prepared from each 20% lipid injectable emulsion product (n = 36) and attached to a syringe pump set at an infusion rate of 0.5 mL/hour. The starting PFAT(5) levels were measured at time 0 and after 24 hours of infusion, using a laser-based light obscuration technique as described by the USP Chapter <729>. The data were assessed by a 2-way analysis of variance (ANOVA) with Container (G vs P) and Time as the independent variables and PFAT as the dependent variable. At time 0, the starting PFAT(5) level for lipids packaged in G was 0.006% +/- 0.001% vs 0.162% +/- 0.026% for P, whereas at the end of the infusion they were 0.013% +/- 0.003% and 0.328% +/- 0.046%, respectively. Significant differences were noted overall between groups for Container, Time, and Container-Time interaction (all p < .001). Bonferroni tests showed significant differences in PFAT(5) levels between Containers at time 0 (T-0; p < .001) and T-0 vs T-24 for P-based lipids (p < .001), whereas no such differences were noted for Time for the G-based lipids. Similar results were noted for PFAT(10) levels. We confirm that presently available lipid injectable emulsions packaged in newly introduced plastic containers exceed the proposed USP <729> PFAT(5) limits and

  18. Aggregation and Particle Formation of Therapeutic Proteins in Contact With a Novel Fluoropolymer Surface Versus Siliconized Surfaces: Effects of Agitation in Vials and in Prefilled Syringes.

    PubMed

    Teska, Brandon M; Brake, Jeffrey M; Tronto, Gregory S; Carpenter, John F

    2016-07-01

    We examined the effects of an accelerated agitation protocol on 2 protein therapeutics, intravenous immunoglobulin (IVIG) and Avastin (bevacizumab), in contact with a novel fluoropolymer surface and more typical siliconized surfaces. The fluoropolymer surface provides "solid-phase" lubrication for the syringe plunger-obviating the need for silicone oil lubrication in prefilled syringes. We tested the 2 surfaces in a vial system and in prefilled glass syringes. We also examined the effects of 2 buffers, phosphate-buffered saline (PBS) and 0.2-M glycine, with and without the addition of polysorbate 20, on agitation-induced aggregation of IVIG. Aggregation was monitored by measuring subvisible particle formation and soluble protein loss. In both vials and syringes, protein particle formation was much lower during agitation with the fluoropolymer surface than with the siliconized surface. Also, particle formation was greater in PBS than in glycine buffer, an effect attributed to lower colloidal stability of IVIG in PBS. Polysorbate 20 in the formulation greatly inhibited protein particle formation. Overall, the fluoropolymer plunger surface in an unsiliconized glass barrel was demonstrated to be a viable solution for eliminating silicone oil droplets from prefilled syringe formulations and providing a consistent system for rationale formulation development and simplified particle analysis. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  19. Identifying clinically relevant drug resistance genes in drug-induced resistant cancer cell lines and post- chemotherapy tissues

    PubMed Central

    Tong, Mengsha; Zheng, Weicheng; Lu, Xingrong; Ao, Lu; Li, Xiangyu; Guan, Qingzhou; Cai, Hao; Li, Mengyao; Yan, Haidan; Guo, You; Chi, Pan; Guo, Zheng

    2015-01-01

    Until recently, few molecular signatures of drug resistance identified in drug-induced resistant cancer cell models can be translated into clinical practice. Here, we defined differentially expressed genes (DEGs) between pre-chemotherapy colorectal cancer (CRC) tissue samples of non-responders and responders for 5-fluorouracil and oxaliplatin-based therapy as clinically relevant drug resistance genes (CRG5-FU/L-OHP). Taking CRG5-FU/L-OHP as reference, we evaluated the clinical relevance of several types of genes derived from HCT116 CRC cells with resistance to 5-fluorouracil and oxaliplatin, respectively. The results revealed that DEGs between parental and resistant cells, when both were treated with the corresponding drug for a certain time, were significantly consistent with the CRG5-FU/L-OHP as well as the DEGs between the post-chemotherapy CRC specimens of responders and non-responders. This study suggests a novel strategy to extract clinically relevant drug resistance genes from both drug-induced resistant cell models and post-chemotherapy cancer tissue specimens. PMID:26515599

  20. Comparison of utilization, cost, adherence, and hypoglycemia in patients with type 2 diabetes initiating rapid-acting insulin analog with prefilled pen versus vial/syringe.

    PubMed

    Lee, Lauren J; Li, Qian; Reynolds, Matthew W; Pawaskar, Manjiri D; Corrigan, Sheila M

    2011-01-01

    Studies examining outcomes of different insulin delivery systems are limited. The objective of this study was to compare healthcare utilization, costs, adherence, and hypoglycemia rates in patients with type 2 diabetes mellitus (T2DM) initiating rapid-acting insulin analog (RAIA) using prefilled pen versus vial/syringe. A retrospective analysis was conducted using a US claims database (1/1/2007 to 12/31/2008). Inclusion criteria were: ≥18 years old, with T2DM, ≥12 months of continuous eligibility, and new to RAIA. Difference-in-difference analyses after propensity score matching were conducted to compare changes in outcomes from 6 months prior to and 6 months after initiating RAIA with a prefilled pen versus vial/syringe (Wilcoxon rank-sum test for costs and t-test for other outcomes). Categories of utilization and costs (2009 USD) included total and diabetes-related inpatient, outpatient, and emergency room. Adherence was measured by proportion of days covered (PDC). Hypoglycemia was identified using ICD-9-CM codes. Baseline characteristics were similar between the prefilled pen (n = 239) and vial/syringe (n = 590) cohorts after matching. Adherence to RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (PDC: 54.6 vs. 45.2%, p < 0.001). While the increase in diabetes-related pharmacy costs from before to after initiating RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (+$900 vs. +$607, p < 0.001), the prefilled pen cohort was associated with greater reductions in the total diabetes-related costs (-$235 vs. +$61, p = 0.006) and the utilization of oral anti-hyperglycemic agents (-1.3 vs. -0.7, p = 0.016). There were no significant differences in other outcomes. Claims databases do not provide optimal measures for adherence or T2DM severity, and only capture hypoglycemia events requiring clinical intervention. Initiating RAIA with a prefilled pen was associated with better adherence and

  1. Simultaneous extraction and determination of albendazole and triclabendazole by a novel syringe to syringe dispersive liquid phase microextraction-solidified floating organic drop combined with high performance liquid chromatography.

    PubMed

    Asadi, Mohammad; Dadfarnia, Shayessteh; Haji Shabani, Ali Mohammad

    2016-08-17

    A syringe to syringe dispersive liquid phase microextraction-solidified floating organic drop was introduced and used for the simultaneous extraction of trace amounts of albendazole and triclabendazole from different matrices. The extracted analytes were determined by high performance liquid chromatography along with fluorescence detection. The analytical parameters affecting the microextraction efficiency including the nature and volume of the extraction solvent, sample volume, sample pH, ionic strength and the cycles of extraction were optimized. The calibration curves were linear in the range of 0.1-30.0 μg L(-1) and 0.2-30.0 μg L(-1) with determination coefficients of 0.9999 and 0.9998 for albendazole and triclabendazole respectively. The detection limits defined as three folds of the signal to noise ratio were found to be 0.02 μg L(-1) for albendazole and 0.06 μg L(-1) for triclabendazole. The inter-day and intra-day precision (RSD%) for both analytes at three concentration levels (0.5, 2.0 and 10.0 μg L(-1)) were in the range of 6.3-10.1% and 5.0-7.5% respectively. The developed method was successfully applied to determine albendazole and triclabendazole in water, cow milk, honey, and urine samples. Copyright © 2016. Published by Elsevier B.V.

  2. Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper.

    PubMed

    Kiminami, Hideaki; Takeuchi, Katsuyuki; Nakamura, Koji; Abe, Yoshihiko; Lauwers, Philippe; Dierick, William; Yoshino, Keisuke; Suzuki, Shigeru

    2015-01-01

    A 36 month leachable study on water for injection in direct contact within a polymer-based prefillable syringe consisting of a cyclo olefin polymer barrel, a chlorinated isoprene isobutene rubber plunger stopper, a polymer label attached on the barrel, and a secondary packaging was conducted at 25 ± 2 °C and 60 ± 5% relative humidity. Through the various comparison studies, no difference in the leachable amounts was observed between this polymer-based prefilled syringe and a glass bottle as a blank sample reference by 36 months. No influence on the leachables study outcome was noted from the printed label and/or label adhesive or from the secondary packaging. In an additional study, no acrylic acid used as the label adhesive leachable was detected by an extended storage for 45 months at 25 ± 2 °C and 60 ± 5% relative humidity as a worst case. To obtain more details, a comparison extractable study was conducted between a cyclo olefin polymer barrel and a glass barrel. In addition, chlorinated isoprene isobutene rubber and bromo isoprene isobutene rubber were compared. As a result, no remarkable difference was found in the organic extractables for syringe barrels. On the other hand, in the case of element extractable analysis, the values for the cyclo olefin polymer barrel were lower than that for the glass barrel. For the plunger stoppers, the chlorinated isoprene isobutene rubber applied in this study was showing a lower extractable profile as compared to the bromo isoprene isobutene rubber, both for organic and element extractables. In conclusion, the proposed polymer-based prefillable syringe system has great potential and represents a novel alternative that can achieve very low level extractable profiles and can bring additional value to the highly sensitive biotech drug market. A 36 month leachable study on water for injection in direct contact within a cyclo olefin polymer barrel and chlorinated isoprene isobutene rubber plunger stopper that has a

  3. Prospective effects of traumatic event re-exposure and post-traumatic stress disorder in syringe exchange participants.

    PubMed

    Peirce, Jessica M; Brooner, Robert K; Kolodner, Ken; Schacht, Rebecca L; Kidorf, Michael S

    2013-01-01

    Determine the effect of traumatic event re-exposure and post-traumatic stress disorder (PTSD) symptom severity on proximal drug use and drug abuse treatment-seeking in syringe exchange participants. Prospective longitudinal 16-month cohort study of new syringe exchange registrants enrolled in a parent study of methods to improve treatment engagement. Data were collected in a research van next to mobile syringe exchange distribution sites in Baltimore, Maryland. Male and female (n = 162) injecting drug users (IDUs) registered for syringe exchange. Traumatic event re-exposure was identified each month with the Traumatic Life Events Questionnaire. PTSD symptoms were measured with the Modified PTSD Symptom Scale-Revised, given every 4 months. Outcome measures collected monthly were days of drug use (heroin, cocaine) and drug abuse treatment-seeking behavior (interest, calls to obtain treatment, treatment participation). Each traumatic event re-exposure was associated with about 1 more day of cocaine use after accounting for the previous month's cocaine use [same month adjusted B, standard error = 1.16 (0.34); 1 month later: 0.99 (0.34)], while PTSD symptoms had no effect. Traumatic event re-exposure increased interest in drug abuse treatment [same month adjusted odds ratios with 95% confidence intervals = 1.34 (1.11-1.63)] and calling to obtain treatment [same month 1.58 (1.24-2.01); 1 month later 1.34 (1.03-1.75)]. Each 10% increase in PTSD symptom severity was associated with persistent increased interest in treatment [same month 1.25 (1.10-1.42); 1 month later 1.16 (1.02-1.32); 2 months later 1.16 (1.02-1.32)] and calling to obtain treatment [same month 1.16 (1.02-1.32)]. Neither traumatic events nor PTSD symptoms were associated with participants receiving treatment. Becoming exposed again to traumatic events among injecting drug users is associated with an increase in cocaine use up to 1 month later, but drug use is not related to post-traumatic stress disorder

  4. Combination Chemotherapy with S-1 and Oxaliplatin (SOX) as First-Line Treatment in Elderly Patients with Advanced Gastric Cancer.

    PubMed

    Zhong, Dong-ta; Wu, Ri-ping; Wang, Xin-li; Huang, Xiao-bing; Lin, Meng-xin; Lan, Yan-qin; Chen, Qiang

    2015-09-01

    This study is a retrospective analysis evaluating the efficacy and toxicity of combination chemotherapy with S-1 and oxaliplatin (SOX) as first-line treatment in elderly patients with advanced gastric cancer. One hundred and twenty-nine patients with recurrent or metastatic gastric adenocarcinoma were treated with SOX; S-1 (40-60 mg depending on patient's body surface area) was given orally, twice daily on days 1 to 14 followed by a 7-day rest period, 130 mg/m(2) oxaliplatin was given as an intravenous infusion over 2-hours on day one. The cycle was repeated every three weeks. All of the patients were older than 65 years. Among 129 patients enrolled, nine patients could not be evaluated for responses because of the absence of any measurable lesions or early discontinuation of therapy. Assessment of the response of 120 patients was made. The overall objective response rate was 54.2 % (95 %CI, 45.3-63.1 %), with three complete responses and 62 partial responses. The disease control rate was 80.8 % (95 %CI, 73.8-87.8 %). The median follow-up period was 23 months (range, 5-42 months). The median time to progression was 6.9 months (95 %CI, 5.5-8.3 months) and the median overall survival was 12.8 months (95 %CI, 11.4-14.2 months). The one-year survival rate was 57.5 % (95 %CI, 48.7-66.3 %). In 129 patients assessed safety, grade 3 and 4 toxicities included leucopenia (20.9 %), neutropenia (24.0 %), anemia (10.9 %), thrombocytopenia (10.1 %), anorexia (3.1 %), peripheral neurotoxicity (15.5 %), and fatigue (12.4 %). No treatment-related deaths occurred. Combination chemotherapy with SOX offers an effective, safe and well-tolerated regimen for elderly patients with advanced gastric cancer.

  5. Use of health-care services during chemotherapy for breast cancer.

    PubMed

    Baena-Cañada, José M; Estalella-Mendoza, Sara; Rosado-Varela, Petra; Expósito-Álvarez, Inmaculada; González-Guerrero, Macarena; Díaz-Blanco, María C; Cortés-Carmona, Cristina; Ramírez-Daffós, Patricia; Arriola-Arellano, Esperanza; Rueda-Ramos, Antonio; Solana-Grimaldi, Lourdes; Benítez-Rodríguez, Encarnación

    2012-12-01

    The authors analyse the effect of chemotherapy on the use of additional health-care resources and report the clinical and demographic factors associated with such use. In women with breast cancer, eligible to receive first-line (neo)-adjuvant or palliative chemotherapy, consultations with health-care practitioners (general practitioners [GPs] and specialists) and admissions to emergency department and to hospital were prospectively recorded. Differences were studied according to these clinical and demographic variables: age, tumour stage, performance status, weight, height, body mass index, surgery type, chemotherapy type, number of courses, comorbidity, marital status, educational level, social status and occupational status. Among 268 patients, 124 (42.2%) required one or more non-protocol health-care encounters. 180 visits were generated (GP 23.3%, specialist 35.5%, emergency department admission 21.1%, hospital admission 8.3%, others 3.3% and more than one resource 8.3%). Of total consultations 150 (83.3%) were chemotherapy-related. The number of visits was higher in the first courses. Fever and infection were the most frequent reasons for consultation in all resources. The dependent variable: 'need for non-protocol health-care encounter in any course' was statistically associated with age (p=0.002) and marital status (p=0.021); no association was found with other variables. In multivariate analysis, age (p=0.001) and marital status (p=0.009) remained statistically significant. Younger and married patients consumed less extra health resources. Many patients receiving chemotherapy consume health-care resources in addition to their routine visits, usually treatment-related. Patients consult less in the later courses. Older and unmarried women in particular need extra care during chemotherapy. Copyright © 2012 Elsevier Ltd. All rights reserved.

  6. Lab-In-Syringe automation of stirring-assisted room-temperature headspace extraction coupled online to gas chromatography with flame ionization detection for determination of benzene, toluene, ethylbenzene, and xylenes in surface waters.

    PubMed

    Horstkotte, Burkhard; Lopez de Los Mozos Atochero, Natalia; Solich, Petr

    2018-06-22

    Online coupling of Lab-In-Syringe automated headspace extraction to gas chromatography has been studied. The developed methodology was successfully applied to surface water analysis using benzene, toluene, ethylbenzene, and xylenes as model analytes. The extraction system consisted of an automatic syringe pump with a 5 mL syringe into which all solutions and air for headspace formation were aspirated. The syringe piston featured a longitudinal channel, which allowed connecting the syringe void directly to a gas chromatograph with flame ionization detector via a transfer capillary. Gas injection was achieved via opening a computer-controlled pinch valve and compressing the headspace, upon which separation was initialized. Extractions were performed at room temperature; yet sensitivity comparable to previous work was obtained by high headspace to sample ratio V HS /V Sample of 1.6:1 and injection of about 77% of the headspace. Assistance by in-syringe magnetic stirring yielded an about threefold increase in extraction efficiency. Interferences were compensated by using chlorobenzene as an internal standard. Syringe cleaning and extraction lasting over 10 min was carried out in parallel to the chromatographic run enabling a time of analysis of <19 min. Excellent peak area repeatabilities with RSD of <4% when omitting and <2% RSD when using internal standard corrections on 100 μg L -1 level were achieved. An average recovery of 97.7% and limit of detection of 1-2 μg L -1 were obtained in analyses of surface water. Copyright © 2018 Elsevier B.V. All rights reserved.

  7. 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.

  8. Bevacizumab plus chemotherapy for patients with advanced pulmonary adenocarcinoma harboring EGFR mutations.

    PubMed

    Chen, R-L; Chen, H-J; Jiang, B-Y; Zhang, X-C; Zhou, Q; Tu, H-Y; Zhong, W-Z; Wu, Y-L; Yang, J-J

    2018-02-01

    Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and bevacizumab plus chemotherapy were effective for EGFR-mutant patients. However, the appropriated treatment orders remained controvertible. We investigated the efficacy of treatment orders between bevacizumab plus chemotherapy and EGFR-TKIs for EGFR-mutant patients with advanced pulmonary adenocarcinoma. This study involved 40 EGFR-mutant patients with advanced pulmonary adenocarcinoma who were treated with bevacizumab plus carboplatin and paclitaxel (Bev + CP) and EGFR-TKIs in different treatment orders or gemcitabine plus cisplatin (GP) in first-line setting. Seventeen patients were treated with Bev + CP and 10 cases with GP in first-line treatment. Thirteen patients received EGFR-TKIs after first-line Bev + CP regimen, while 13 patients were treated with first-line EGFR-TKIs. Progression-free survival (PFS), the response rate (ORR) and overall survival (OS) were evaluated. Median PFS of Bev + CP treatment was significantly longer in first-line than non-first-line settings (11.7 vs. 5.6 months, P = 0.003). Median OS was 37.8 months for EGFR-mutant patients with first-line Bev + CP followed by second-line EGFR-TKIs and 31.0 months for those with first-line EGFR-TKIs and non-first-line Bev + CP, respectively (P = 0.509). Median PFS was 11.7 (95% CI 10.6-12.8) months for Bev + CP group and 4.7 (95% CI 4.4-5.0) months for GP group with the hazard ratio of 0.17 (P = 0.001). ORR was 70.6 and 50.0% in the two groups, respectively (P = 0.415). However, there was no significant difference in median OS (33.7 vs 27.8 months, P = 0.293). First-line Bev + CP followed by EGFR-TKIs might possibly provide favorable prognosis for EGFR-mutant patients. Bev + CP regimen significantly prolonged PFS in first-line than non-first-line settings. These findings warrant further investigations.

  9. Preconditioning of mesenchymal stromal cells toward nucleus pulposus-like cells by microcryogels-based 3D cell culture and syringe-based pressure loading system.

    PubMed

    Zeng, Yang; Feng, Siyu; Liu, Wei; Fu, Qinyouen; Li, Yaqian; Li, Xiaokang; Chen, Chun; Huang, Chenyu; Ge, Zigang; Du, Yanan

    2017-04-01

    To precondition mesenchymal stromal/stem cells (MSCs) with mechanical stimulation may enhance cell survival and functions following implantation in load bearing environment such as nucleus pulposus (NP) in intervertebral disc (IVD). In this study, preconditioning of MSCs toward NP-like cells was achieved in previously developed poly (ethylene glycol) diacrylate (PEGDA) microcryogels (PMs) within a syringe-based three-dimensional (3D) culture system which provided a facile and cost-effective pressure loading approach. PMs loaded with alginate and MSCs could be incubated in a sealable syringe which could be air-compressed to apply pressure loading through a programmable syringe pump. Expression levels of chondrogenic marker genes SOX9, COL II, and ACAN were significantly upregulated in MSCs when pressure loading of 0.2 MPa or 0.8 MPa was implemented. Expression levels of COL I and COL X were downregulated when pressure loading was applied. In a nude mouse model, MSCs loaded in PMs mechanically stimulated for three days were subcutaneously injected using the same culture syringe. Three weeks postinjection, more proteoglycans (PGs) were deposited and more SOX9 and COL II but less COL I and COL X were stained in 0.2 MPa group. Furthermore, injectable MSCs-loaded PMs were utilized in an ex vivo rabbit IVD organ culture model that demonstrated the leak-proof function and enhanced cell retention of PMs assisted cell delivery to a load bearing environment for potential NP regeneration. This microcryogels-based 3D cell culture and syringe-based pressure loading system represents a novel method for 3D cell culture with mechanical stimulation for better function. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 507-520, 2017. © 2015 Wiley Periodicals, Inc.

  10. Optimal chemotherapy treatment for women with recurrent ovarian cancer

    PubMed Central

    Fung-Kee-Fung, M.; Oliver, T.; Elit, L.; Oza, A.; Hirte, H.W.; Bryson, P.

    2007-01-01

    what is actually a continuum, “platinum sensitivity” refers to disease recurrence 6 months or more after prior platinum-containing chemotherapy, and “platinum resistance” refers to a response to platinum-based chemotherapy followed by relapse less than 6 months after chemotherapy is stopped. “Platinum-refractory disease” refers to a lack of response or to progression while on platinum-based chemotherapy. Recommendations Although the body of evidence that informs the clinical recommendations is based on randomized trial data, those data are incomplete. Based on the available data and expert consensus opinion, the Gynecology Cancer dsg makes these recommendations: Systemic therapy for recurrent ovarian cancer is not curative. It is therefore recognized that each patient must be individually assessed to determine optimal therapy in terms of recurrence, sensitivity to platinum, toxicity, ease of administration, and patient preference. All suitable patients should be offered the opportunity to participate in randomized trials, if available. In the absence of contraindications, combination platinum-based chemotherapy should be considered for patients with prior sensitivity to platinum-containing chemotherapy. As compared with carboplatin alone, the combination of carboplatin and paclitaxel significantly improved both progression-free and overall survival. If combination platinum-based chemotherapy is not indicated, then a single platinum agent should be considered. Carboplatin has demonstrated efficacy across trials and has a manageable toxicity profile. If a single platinum agent is not being considered, then monotherapy with paclitaxel, topotecan, or pegylated liposomal doxorubicin are seen as reasonable treatment options. Some patients may be repeatedly sensitive to treatment and may benefit from multiple lines of chemotherapy. For patients with platinum-refractory or platinum-resistant disease, the goals of treatment should be to improve quality of life by

  11. Sensitizing basal-like breast cancer to chemotherapy using nanoparticles conjugated with interference peptide

    NASA Astrophysics Data System (ADS)

    Sorolla, A.; Ho, D.; Wang, E.; Evans, C. W.; Ormonde, C. F. G.; Rashwan, R.; Singh, R.; Iyer, K. Swaminathan; Blancafort, P.

    2016-04-01

    Basal-like breast cancers are highly aggressive malignancies associated with very poor prognosis. Although these cancers may initially respond to first-line treatment, they become highly resistant to standard chemotherapy in the metastatic setting. Chemotherapy resistance in basal-like breast cancers is associated with highly selective overexpression of the homeobox transcription factor Engrailed 1 (EN1). Herein, we propose a novel therapeutic strategy using poly(glycidyl methacrylate) nanoparticles decorated with poly(acrylic acid) that enable dual delivery of docetaxel and interference peptides designed to block or inhibit EN1 (EN1-iPep). We demonstrate that EN1-iPep is highly selective in inducing apoptotic cell death in basal-like cancer cells with negligible effects in a non-neoplastic human mammary epithelial cell line. Furthermore, we show that treatment with EN1-iPep results in a highly synergistic pharmacological interaction with docetaxel in inhibiting cancer cell growth. The incorporation of these two agents in a single nanoformulation results in greater anticancer efficacy than current nanoparticle-based treatments used in the clinical setting.Basal-like breast cancers are highly aggressive malignancies associated with very poor prognosis. Although these cancers may initially respond to first-line treatment, they become highly resistant to standard chemotherapy in the metastatic setting. Chemotherapy resistance in basal-like breast cancers is associated with highly selective overexpression of the homeobox transcription factor Engrailed 1 (EN1). Herein, we propose a novel therapeutic strategy using poly(glycidyl methacrylate) nanoparticles decorated with poly(acrylic acid) that enable dual delivery of docetaxel and interference peptides designed to block or inhibit EN1 (EN1-iPep). We demonstrate that EN1-iPep is highly selective in inducing apoptotic cell death in basal-like cancer cells with negligible effects in a non-neoplastic human mammary

  12. Palliative chemotherapy and targeted therapies for esophageal and gastroesophageal junction cancer.

    PubMed

    Janmaat, Vincent T; Steyerberg, Ewout W; van der Gaast, Ate; Mathijssen, Ron Hj; Bruno, Marco J; Peppelenbosch, Maikel P; Kuipers, Ernst J; Spaander, Manon Cw

    2017-11-28

    survival time was one month. Five studies in 750 participants contributed data to the comparison of palliative therapy versus best supportive care. We found a benefit in overall survival in favor of the group receiving palliative chemotherapy and/or targeted therapy compared to best supportive care (HR 0.81, 95% CI 0.71 to 0.92, high-quality evidence). Subcomparisons including only people receiving second-line therapies, chemotherapies, targeted therapies, adenocarcinomas, and squamous cell carcinomas all showed a similar benefit. The only individual agent that more than one study found to improve both overall survival and progression-free survival was ramucirumab. Palliative chemotherapy and/or targeted therapy increased the frequency of grade 3 or higher treatment-related toxicity. However, treatment-related deaths did not occur more frequently. Quality of life often improved in the arm with an additional agent. People who receive more chemotherapeutic or targeted therapeutic agents have an increased overall survival compared to people who receive less. These agents, administered as both first-line or second-line treatments, also led to better overall survival than best supportive care. With the exception of ramucirumab, it remains unclear which other individual agents cause the survival benefit. Although treatment-associated toxicities of grade 3 or more occurred more frequently in arms with an additional chemotherapy or targeted therapy agent, there is no evidence that palliative chemotherapy and/or targeted therapy decrease quality of life. Based on this meta-analysis, palliative chemotherapy and/or targeted therapy can be considered standard care for esophageal and gastroesophageal junction carcinoma.

  13. Quality of life, compliance, safety and effectiveness in fit older metastatic colorectal patients with cancer treated in first-line with chemotherapy plus cetuximab: A restrospective analysis from the ObservEr study.

    PubMed

    Rosati, Gerardo; Pinto, Carmine; Di Fabio, Francesca; Chiara, Silvana; Lolli, Ivan R; Ruggeri, Enzo M; Ciuffreda, Libero; Ferrara, Raimondo; Antonuzzo, Lorenzo; Adua, Daniela; Racca, Patrizia; Bilancia, Domenico; Benincasa, Elena; Stroppolo, Maria Elena; Di Costanzo, Francesco

    2018-05-01

    The influence of age (<70 years and ≥70 years) was retrospectively studied on the quality of life (QoL), incidence of side effects (including skin reactions) and efficacy of chemotherapy plus cetuximab in patients with KRAS wild type (WT) metastatic colorectal cancer (mCRC). 225 patients of the Observed study (PS 0-1) were retrieved based on age (< 70 and ≥70 years) and evaluated through EORTC QLQ-C30 and DLQI questionnaires. The two patient groups (141 < 70 and 84 ≥ 70 years, respectively) were balanced with no differences in any of the clinical and pathological characteristics considered. Both groups underwent similar type of first-line chemotherapy plus cetuximab, treatment duration and compliance. Cetuximab therapy caused similar incidence of side effects and impact on QoL in older and younger patients. No difference was observed in progression free survival (PFS) and in disease control rates between the two patient populations. Median overall survival (OS) was higher in patients <70 (27 months, 95% CI: 22.7-31.27) than in patients ≥70 (19 months, 95% CI: 14.65-23.35) (p = 0.002), which is likely due to higher proportions of metastatic resection (27.0% vs 8.3%; p = 0.001) and utilization of second-line therapy in younger group (58.9% vs 42.9%; p = 0.028). The current data suggest that fit older patients with mCRC can be safely treated with a cetuximab-based therapy, as QoL and safety profile do not seem to be affected by age. In addition, age did not impact the choice of chemotherapy to be associated to cetuximab and treatment compliance. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. Color-coded prefilled medication syringes decrease time to delivery and dosing errors in simulated prehospital pediatric resuscitations: A randomized crossover trial.

    PubMed

    Stevens, Allen D; Hernandez, Caleb; Jones, Seth; Moreira, Maria E; Blumen, Jason R; Hopkins, Emily; Sande, Margaret; Bakes, Katherine; Haukoos, Jason S

    2015-11-01

    Medication dosing errors remain commonplace and may result in potentially life-threatening outcomes, particularly for pediatric patients where dosing often requires weight-based calculations. Novel medication delivery systems that may reduce dosing errors resonate with national healthcare priorities. Our goal was to evaluate novel, prefilled medication syringes labeled with color-coded volumes corresponding to the weight-based dosing of the Broselow Tape, compared to conventional medication administration, in simulated prehospital pediatric resuscitation scenarios. We performed a prospective, block-randomized, cross-over study, where 10 full-time paramedics each managed two simulated pediatric arrests in situ using either prefilled, color-coded syringes (intervention) or their own medication kits stocked with conventional ampoules (control). Each paramedic was paired with two emergency medical technicians to provide ventilations and compressions as directed. The ambulance patient compartment and the intravenous medication port were video recorded. Data were extracted from video review by blinded, independent reviewers. Median time to delivery of all doses for the intervention and control groups was 34 (95% CI: 28-39) seconds and 42 (95% CI: 36-51) seconds, respectively (difference=9 [95% CI: 4-14] seconds). Using the conventional method, 62 doses were administered with 24 (39%) critical dosing errors; using the prefilled, color-coded syringe method, 59 doses were administered with 0 (0%) critical dosing errors (difference=39%, 95% CI: 13-61%). A novel color-coded, prefilled syringe decreased time to medication administration and significantly reduced critical dosing errors by paramedics during simulated prehospital pediatric resuscitations. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Social marketing of low dead space syringes in Vietnam: findings from a 1-year pilot program in Hanoi, Thai Nguyen, and Ho Chi Minh City.

    PubMed

    Huong, Ngo Thi Thanh; Mundy, Gary; Neukom, Josselyn; Zule, William; Tuan, Nguyen Minh; Tam, Nguyen Minh

    2015-05-30

    Although a growing body of evidence suggests that low dead space syringes may reduce the risk of human immunodeficiency virus (HIV) and Hepatitis C virus infection associated with sharing syringes among people who inject drugs, there is little evidence of effective approaches to motivate people who inject drugs (PWID) to shift from high to low dead space syringes. Using a mix of consumer and trade marketing approaches, informed by rapid assessments of both the syringe market and PWID preferences, practices, and behaviors in Hanoi and Ho Chi Minh City, Population Services International (PSI) Vietnam piloted an intervention to increase the use of low dead space syringes (LDSS) in the three provinces of Hanoi, Ho Chi Minh City, and Thai Nguyen, where an estimated 31% of PWID are HIV positive and 58% are living with hepatitis C virus (HCV). This paper provides a summary of the social marketing activities implemented and results achieved by PSI Vietnam during an initial 1-year pilot period from December 2012 to December 2013 in these three provinces to explore their effectiveness in motivating PWID to use low dead space syringes. We found major increases in sales of LDSS accompanied by increases in reported use and consistent use of LDSS among PWID in the three provinces included in the pilot program and a positive and independent association (odds ratio (OR) 21.08; 95% confidence interval (CI) 10.6-27.3) between LDSS use and exposure to social marketing activities. We also found that LDSS use had a stronger association with perceptions of LDSS product quality than with perceptions regarding LDSS potential to reduce HIV transmission risk and use. We conclude that social marketing interventions have an important role to play in widening access to and the use of LDSS for PWID, as they address the need for PWID to find LDSS when and where they need them and also promote the benefits of LDSS use to PWID. High coverage of these activities among PWID appears to be the key in

  16. Preliminary results of multicenter phase II trial of docetaxel (Taxotere) in combination with doxorubicin as first line chemotherapy in Indonesian patients with advanced or metastatic breast cancer.

    PubMed

    Muthalib, A; Darwis, I; Prayogo, N; Sutjipto

    2000-05-01

    Docetaxel and doxorubicin have produced a high degree of activity in previously untreated/treated patients with metastatic breast cancer (MBC). The efficacy of Taxotere (T) single agent as 2nd line chemotherapy is well established in large randomized phase III studies. The objective of this study is to confirm the efficacy and safety of a combination of Taxotere with doxorubicin as 1st line chemotherapy in Indonesian MBC patients. TREATMENT AND METHOD: Eighteen patients age < or = 70 years with advanced or metastatic breast cancer (MBC) with no prior taxane chemotherapy or prior cumulative doxorubicin (D) of no more than 250 mg/m2 and no heart disease were enrolled in this phase II study of D (50 mg/m2) IV bolus followed one hour later by Taxotere (T) 60 mg/m2 IV infusion over 1 hour every 3 weeks for 6 cycles treatments. A 3-day oral corticosteroid premedication was administered starting one day before the infusion of each cycle. Left ventricular ejection fraction (LVEF) was evaluated at baseline and after cycle 6. 18 patients (pts) have been treated with 108 cycles administered. Median age was 46 years (31-58), WHO PS 0 = 50%, 1 = 50% and number of organs involved were: 2 (72%), 3 (22%) and 4 (6%). After 3 cycles, partial (PR) and no change (NC) responses occurred in 15 pts (83.3%) and 3 pts (16.7%). The best overall response after 6 cycles, including complete (CR) and partial (PR) responses, occurred in 13 pts (72.2%) including 3 CRs and 10 PRs. Two patients with extensive liver metastases at the baseline had a complete disappearance after 6 cycles. No patients developed congestive heart failure (CHF). Grade 3/4 hematological toxicities included leukopenia in 18 pts (100%), febrile neutropenia in 6 pts (33%), leukopenia with infection in 2 pts (11%), leukopenia with fever in 1 pt (5.5%), and anemia in 6 pts (33.3%). Nonhematological toxicities grade 3/4 included alopecia (61%), asthenia (4.6%), nausea/vomiting (2.7%), pain (2.7%), stomatitis (2.7%), and

  17. Randomized, Community-Based Pharmacy Intervention to Expand Services Beyond Sale of Sterile Syringes to Injection Drug Users in Pharmacies in New York City

    PubMed Central

    Amesty, Silvia; Rivera, Alexis V.; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M.

    2013-01-01

    Structural interventions may help reduce racial/ethnic disparities in HIV. In 2009 to 2011, we randomized pharmacies participating in a nonprescription syringe access program in minority communities to intervention (pharmacy enrolled and delivered HIV risk reduction information to injection drug users [IDUs]), primary control (pharmacy only enrolled IDUs), and secondary control (pharmacy did not engage IDUs). Intervention pharmacy staff reported more support for syringe sales than did control staff. An expanded pharmacy role in HIV risk reduction may be helpful. PMID:23865644

  18. Randomized, community-based pharmacy intervention to expand services beyond sale of sterile syringes to injection drug users in pharmacies in New York City.

    PubMed

    Crawford, Natalie D; Amesty, Silvia; Rivera, Alexis V; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M

    2013-09-01

    Structural interventions may help reduce racial/ethnic disparities in HIV. In 2009 to 2011, we randomized pharmacies participating in a nonprescription syringe access program in minority communities to intervention (pharmacy enrolled and delivered HIV risk reduction information to injection drug users [IDUs]), primary control (pharmacy only enrolled IDUs), and secondary control (pharmacy did not engage IDUs). Intervention pharmacy staff reported more support for syringe sales than did control staff. An expanded pharmacy role in HIV risk reduction may be helpful.

  19. Needle and syringe sharing practices of injecting drug users participating in an outreach HIV prevention program in Tehran, Iran: A cross-sectional study

    PubMed Central

    Vazirian, Mohsen; Nassirimanesh, Bijan; Zamani, Saman; Ono-Kihara, Masako; Kihara, Masahiro; Mortazavi Ravari, Shahrzad; Gouya, Mohammad Mehdi

    2005-01-01

    HIV infection rates have reached epidemic proportions amongst injecting drug users (IDUs) in Iran. Although a number of community-based interventions have being implemented in the country, there is little information on the risk behaviors of IDU participants in these programs. This cross-sectional report aimed to compare the risk behaviors of injecting drug users with differential exposure rates to an HIV outreach program in Tehran, Iran. Results indicated that shared use of needle/syringe in the past month was significantly lower among IDUs who received estimated ≥ 7 syringes per week than those who did not [adjusted odds ratio (OR) = 14.36, 95% confidence interval (CI) 2.30–89.56]. While the effectiveness of this outreach program needs further evaluation through a longitudinal investigation, our preliminary findings suggest that the outreach program in Tehran may have been beneficial in reducing direct sharing among those who received more than several needles/syringes from the program. PMID:16212655

  20. Role of Chemotherapy and Targeted Therapy in Early-Stage Non-Small Cell Lung Cancer.

    PubMed

    Gadgeel, Shirish M

    2017-01-01

    On the basis of several randomized trials and meta-analyses, adjuvant chemotherapy is the accepted standard of care for certain patients with early-stage non-small cell lung cancer (NSCLC). Patients with stage II, IIIA, or large (≥ 4 cm) IB tumors are candidates for adjuvant chemotherapy. The survival improvement with adjuvant chemotherapy is approximately 5% at 5 years, though certain trials have suggested that it can be 8% to 10%. Neoadjuvant chemotherapy also has shown a survival advantage, though the volume of data with this approach is far less than that of adjuvant chemotherapy. The combination of cisplatin and vinorelbine is the most well-studied regimen, but current consensus is to use four cycles of any of the platinum-based chemotherapy regimens commonly used as front-line therapy for patients with advanced-stage NSCLC. Trials to define biomarkers that can predict benefit from adjuvant chemotherapy have not been successful, but results of other such trials are still awaited. On the basis of the benefit observed with targeted agents in patients with advanced-stage disease and driver genetic alterations in their tumors, ongoing trials are evaluating the utility of these targeted agents as adjuvant therapy. Similarly, clinical benefit observed with checkpoint inhibitors has prompted assessment of these drugs in patients with early-stage NSCLC. It is very likely, in the future, that factors other than the anatomy of the tumor will be used to select patients with early-stage NSCLC for systemic therapy and that the choice of systemic therapy will extend beyond platinum-based chemotherapy.

  1. Metronomic chemotherapy.

    PubMed

    Mutsaers, Anthony J

    2009-08-01

    Chemotherapy drugs are usually administered at doses that are high enough to result in an obligatory break period to allow for the observation of potential side effects and institution of supportive care, if required. In recent years, efforts to administer chemotherapy on a more continuous basis, with a much shorter break period, or none at all, have received increased interest, and the practice has come to be known as metronomic chemotherapy. The basis for success with this currently investigational approach may be rooted in continuous drug exposure to susceptible cancer cells, inhibition of tumor blood vessel growth-a process known as tumor angiogenesis, and/or alterations in tumor immunology. Increased benefit also appears to occur when metronomic chemotherapy is used in combination with newer, targeted antiangiogenic agents, and therefore represents a promising approach to combination therapy, particularly as targeted oncology drugs make their way into veterinary oncology applications. There is still much to be learned in this field, especially with regard to optimization of the proper drugs, dose, schedule, and tumor applications. However, the low cost, ease of administration, and acceptable toxicity profiles potentially associated with this therapeutic strategy make metronomic chemotherapy protocols attractive and suitable to veterinary applications. Preliminary clinical trial results have now been reported in both human and veterinary medicine, including adjuvant treatment of canine splenic hemangiosarcoma and incompletely resected soft tissue sarcoma, and, further, more powerful studies are currently ongoing.

  2. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer.

    PubMed

    Gandhi, Leena; Rodríguez-Abreu, Delvys; Gadgeel, Shirish; Esteban, Emilio; Felip, Enriqueta; De Angelis, Flávia; Domine, Manuel; Clingan, Philip; Hochmair, Maximilian J; Powell, Steven F; Cheng, Susanna Y-S; Bischoff, Helge G; Peled, Nir; Grossi, Francesco; Jennens, Ross R; Reck, Martin; Hui, Rina; Garon, Edward B; Boyer, Michael; Rubio-Viqueira, Belén; Novello, Silvia; Kurata, Takayasu; Gray, Jhanelle E; Vida, John; Wei, Ziwen; Yang, Jing; Raftopoulos, Harry; Pietanza, M Catherine; Garassino, Marina C

    2018-04-16

    Background First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial. Methods In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. Crossover to pembrolizumab monotherapy was permitted among the patients in the placebo-combination group who had verified disease progression. The primary end points were overall survival and progression-free survival, as assessed by blinded, independent central radiologic review. Results After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab-combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebo-combination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P<0.001). Improvement in overall survival was seen across all PD-L1 categories that were evaluated. Median progression-free survival was 8.8 months (95% CI, 7.6 to 9.2) in the pembrolizumab-combination group and 4.9 months (95% CI, 4.7 to 5.5) in the placebo-combination group (hazard ratio for disease progression or death, 0.52; 95% CI, 0.43 to 0.64; P<0.001). Adverse events of grade 3 or higher occurred in 67.2% of the

  3. Knowledge of tuberculosis among drug users. Relationship to return rates for tuberculosis screening at a syringe exchange.

    PubMed

    Salomon, N; Perlman, D C; Friedmann, P; Perkins, M P; Ziluck, V; Jarlais, D C; Paone, D

    1999-04-01

    Tuberculosis is an important health issue among drug users. We sought to evaluate active drug users' (DUs) knowledge of tuberculosis (TB) and to assess the relationship between TB knowledge and attitudes and tuberculin skin test (TST) return rates at a syringe exchange program. DUs were recruited at a syringe exchange program in New York City, were interviewed and offered TSTs, and received $15.00 upon returning for TST reading. The questionnaire evaluated knowledge of TB transmission, prevention, and treatment. From March 13, 1995 to January 31, 1996, 610 of 650 (94%) of DUs approached agreed to participate. Of these, 80% had previous TSTs within the past 2 years and 20% were known to be HIV infected. Almost all knew that TB is contagious and more than two thirds knew that TB is treatable and that TB preventive therapy existed. However, fewer than half knew that HIV-related TB could be treated, 30% thought TB could be treated without a medical doctor, and the majority (70%) thought a reactive TST implied infectivity. The rate of return for TST reading was 93%. In multivariate analysis, those who knew that HIV-related TB was curable were more likely to return for TST reading (odds ratio 2.0; 95% confidence interval 1.04 to 3.95; p = .03). The high acceptance and return rates suggest that TB services can be incorporated into syringe exchange programs. However, several important gaps in TB knowledge existed in this population at high risk of TB, which may impact on adherence and which support the need for TB education for drug users.

  4. Syringeless power injector versus dual-syringe power injector: economic evaluation of user performance, the impact on contrast enhanced computed tomography (CECT) workflow exams, and hospital costs.

    PubMed

    Colombo, Giorgio L; Andreis, Ivo A Bergamo; Di Matteo, Sergio; Bruno, Giacomo M; Mondellini, Claudio

    2013-01-01

    The utilization of diagnostic imaging has substantially increased over the past decade in Europe and North America and continues to grow worldwide. The purpose of this study was to develop an economic evaluation of a syringeless power injector (PI) versus a dual-syringe PI for contrast enhanced computed tomography (CECT) in a hospital setting. Patients (n=2379) were enrolled at the Legnano Hospital between November 2012 and January 2013. They had been referred to the hospital for a CECT analysis and were randomized into two groups. The first group was examined with a 256-MDCT (MultiDetector Computed Tomography) scanner using a syringeless power injector, while the other group was examined with a 64-MDCT scanner using a dual-syringe. Data on the operators' time required in the patient analysis steps as well as on the quantity of consumable materials used were collected. The radiologic technologists' satisfaction with the use of the PIs was rated on a 10-point scale. A budget impact analysis and sensitivity analysis were performed under the base-case scenario. A total of 1,040 patients were examined using the syringeless system, and 1,339 with the dual-syringe system; the CECT examination quality was comparable for both PI systems. Equipment preparation time and releasing time per examination for syringeless PIs versus dual-syringe PIs were 100±30 versus 180±30 seconds and 90±30 and 140±20 seconds, respectively. On average, 10±3 mL of contrast media (CM) wastage per examination was observed with the dual-syringe PI and 0±1 mL with the syringeless PI. Technologists had higher satisfaction with the syringeless PI than with the dual-syringe system (8.8 versus 8.0). The syringeless PI allows a saving of about €6.18 per patient, both due to the lower cost of the devices and to the better performance of the syringeless system. The univariate sensitivity analysis carried out on the base-case results within the standard deviation range confirmed the saving generated

  5. Color-coded prefilled medication syringes decrease time to delivery and dosing errors in simulated prehospital pediatric resuscitations: A randomized crossover trial☆, ☆

    PubMed Central

    Stevens, Allen D.; Hernandez, Caleb; Jones, Seth; Moreira, Maria E.; Blumen, Jason R.; Hopkins, Emily; Sande, Margaret; Bakes, Katherine; Haukoos, Jason S.

    2016-01-01

    Background Medication dosing errors remain commonplace and may result in potentially life-threatening outcomes, particularly for pediatric patients where dosing often requires weight-based calculations. Novel medication delivery systems that may reduce dosing errors resonate with national healthcare priorities. Our goal was to evaluate novel, prefilled medication syringes labeled with color-coded volumes corresponding to the weight-based dosing of the Broselow Tape, compared to conventional medication administration, in simulated prehospital pediatric resuscitation scenarios. Methods We performed a prospective, block-randomized, cross-over study, where 10 full-time paramedics each managed two simulated pediatric arrests in situ using either prefilled, color-coded-syringes (intervention) or their own medication kits stocked with conventional ampoules (control). Each paramedic was paired with two emergency medical technicians to provide ventilations and compressions as directed. The ambulance patient compartment and the intravenous medication port were video recorded. Data were extracted from video review by blinded, independent reviewers. Results Median time to delivery of all doses for the intervention and control groups was 34 (95% CI: 28–39) seconds and 42 (95% CI: 36–51) seconds, respectively (difference = 9 [95% CI: 4–14] seconds). Using the conventional method, 62 doses were administered with 24 (39%) critical dosing errors; using the prefilled, color-coded syringe method, 59 doses were administered with 0 (0%) critical dosing errors (difference = 39%, 95% CI: 13–61%). Conclusions A novel color-coded, prefilled syringe decreased time to medication administration and significantly reduced critical dosing errors by paramedics during simulated prehospital pediatric resuscitations. PMID:26247145

  6. Synergistic Effects of Targeted PI3K Signaling Inhibition and Chemotherapy in Liposarcoma

    PubMed Central

    Guo, Shang; Lopez-Marquez, Hector; Fan, Kenneth C.; Choy, Edwin; Cote, Gregory; Harmon, David; Nielsen, G. Petur; Yang, Cao; Zhang, Changqing; Mankin, Henry; Hornicek, Francis J.; Borger, Darrell R.; Duan, Zhenfeng

    2014-01-01

    While liposarcoma is the second most common soft tissue malignant tumor, the molecular pathogenesis in this malignancy is poorly understood. Our goal was therefore to expand the understanding of molecular mechanisms that drive liposarcoma and identify therapeutically-susceptible genetic alterations. We studied a cohort of high-grade liposarcomas and benign lipomas across multiple disease sites, as well as two liposarcoma cell lines, using multiplexed mutational analysis. Nucleic acids extracted from diagnostic patient tissue were simultaneously interrogated for 150 common mutations across 15 essential cancer genes using a clinically-validated platform for cancer genotyping. Western blot analysis was implemented to detect activation of downstream pathways. Liposarcoma cell lines were used to determine the effects of PI3K targeted drug treatment with or without chemotherapy. We identified mutations in the PIK3CA gene in 4 of 18 human liposarcoma patients (22%). No PIK3CA mutations were identified in benign lipomas. Western blot analysis confirmed downstream activation of AKT in both PIK3CA mutant and non-mutant liposarcoma samples. PI-103, a dual PI3K/mTOR inhibitor, effectively inhibited the activation of the PI3K/AKT in liposarcoma cell lines and induced apoptosis. Importantly, combination with PI-103 treatment strongly synergized the growth-inhibitory effects of the chemotherapy drugs doxorubicin and cisplatin in liposarcoma cells. Taken together, these findings suggest that activation of the PI3K/AKT pathway is an important cancer mechanism in liposarcoma. Targeting the PI3K/AKT/pathway with small molecule inhibitors in combination with chemotherapy could be exploited as a novel strategy in the treatment of liposarcoma. PMID:24695632

  7. Tuberculosis knowledge among injecting drug users visiting syringe exchange programme in Tallinn, Estonia.

    PubMed

    Rüütel, Kristi; Parker, R David; Sobolev, Igor; Loit, Helle-Mai

    2012-12-01

    The purpose of the current study was to describe tuberculosis (TB) knowledge, beliefs, and experience with TB services among injecting drug users. Participants for this anonymous, cross-sectional study were recruited from a community based syringe exchange programme in Tallinn, Estonia. A structured questionnaire was completed and included information on socio-demographics, health history, drug use, and knowledge about TB and HIV. The study included 407 people (79% male, mean age 27.9 years, mean injection drug use 9.4 years). 32.9% of participants reported HIV infection and 1.7% lifetime history of TB. 26.4% participants (n=106) reported symptoms suggestive of TB. 93% of participants recognized correctly that TB is air-borne infection and 91% that HIV is a risk factor for TB. Only 40% of the participants knew that TB diagnostics and treatment in Estonia are free of charge for everybody and 58% reported they knew where to get health care services in case they suspected that they had TB. TB transmission and treatment adherence knowledge was better among those in contact with either health care or harm reduction services, e.g the community based syringe exchange programme. Similar to HIV services, TB prevention and education should be integrated into harm reduction and drug treatment programmes to facilitate early diagnosis and treatment of TB among injecting drug users.

  8. Electrospinning-based synthesis of highly ordered mesoporous silica fiber for lab-in-syringe enrichment of plasma peptides.

    PubMed

    Zhu, Gang-Tian; Li, Xiao-Shui; Fu, Xiao-Meng; Wu, Jian-Yuan; Yuan, Bi-Feng; Feng, Yu-Qi

    2012-10-14

    Silica fiber with highly ordered mesoporous structure and continuously long fibrous property was synthesized on a large-scale for the first time. It can be applied to the rapid (less than 3 min) and effective enrichment of endogenous peptides with a novel lab-in-syringe approach.

  9. Effects of back massage on chemotherapy-related fatigue and anxiety: supportive care and therapeutic touch in cancer nursing.

    PubMed

    Karagozoglu, Serife; Kahve, Emine

    2013-11-01

    This quasi-experimental and cross-sectional study was carried out to determine the efficacy of back massage, a nursing intervention, on the process of acute fatigue developing due to chemotherapy and on the anxiety level emerging in cancer patients receiving chemotherapy during this process. The study was conducted on 40 patients. To collect the data, the Personal Information Form, the State Anxiety part of Spielberger State-Trait Anxiety Inventory and the Brief Fatigue Inventory were used. In our study, it was determined that mean anxiety scores decreased in the intervention group patients after chemotherapy. The level of fatigue in the intervention group decreased statistically significantly on the next day after chemotherapy (p=.020; effect size=0.84). At the same time, the mean anxiety scores of the patients in the intervention group decreased right after the massage provided during chemotherapy (p=.109; effect size=0.37) and after chemotherapy. In line with our study findings, it can be said that back massage given during chemotherapy affects anxiety and fatigue suffered during the chemotherapy process and that it significantly reduces state anxiety and acute fatigue. Therefore, the effective use of back massage in the process of chemotherapy by oncology nurses who have a key role in cancer treatment and care can make it more modulated. © 2013.

  10. Enrofloxacin enhances the effects of chemotherapy in canine osteosarcoma cells with mutant and wild-type p53

    PubMed Central

    York, D.; Withers, S. S.; Watson, K. D.; Seo, K. W.; Rebhun, R. B.

    2016-01-01

    Adjuvant chemotherapy improves survival time in dogs receiving adequate local control for appendicular osteosarcoma, but most dogs ultimately succumb to metastatic disease. The fluoroquinolone antibiotic enrofloxacin has been shown to inhibit survival and proliferation of canine osteosarcoma cells in vitro. Others have reported that fluoroquinolones may modulate cellular responses to DNA damaging agents and that these effects may be differentially mediated by p53 activity. We therefore determined p53 status and activity in three canine osteosarcoma cell lines and examined the effects of enrofloxacin when used alone or in combination with doxorubicin or carboplatin chemotherapy. Moresco and Abrams canine osteosarcoma cell lines contained mutations in p53, while no mutations were identified in the D17 cells or in a normal canine osteoblast cell line. The addition of enrofloxacin to either doxorubicin or carboplatin resulted in further reductions in osteosarcoma cell viability; this effect was apparent regardless of p53 mutational status or downstream activity. PMID:27333821

  11. Enrofloxacin enhances the effects of chemotherapy in canine osteosarcoma cells with mutant and wild-type p53.

    PubMed

    York, D; Withers, S S; Watson, K D; Seo, K W; Rebhun, R B

    2017-09-01

    Adjuvant chemotherapy improves survival time in dogs receiving adequate local control for appendicular osteosarcoma, but most dogs ultimately succumb to metastatic disease. The fluoroquinolone antibiotic enrofloxacin has been shown to inhibit survival and proliferation of canine osteosarcoma cells in vitro. Others have reported that fluoroquinolones may modulate cellular responses to DNA damaging agents and that these effects may be differentially mediated by p53 activity. We therefore determined p53 status and activity in three canine osteosarcoma cell lines and examined the effects of enrofloxacin when used alone or in combination with doxorubicin or carboplatin chemotherapy. Moresco and Abrams canine osteosarcoma cell lines contained mutations in p53, while no mutations were identified in the D17 cells or in a normal canine osteoblast cell line. The addition of enrofloxacin to either doxorubicin or carboplatin resulted in further reductions in osteosarcoma cell viability; this effect was apparent regardless of p53 mutational status or downstream activity. © 2016 John Wiley & Sons Ltd.

  12. Syringe-Injectable Electronics with a Plug-and-Play Input/Output Interface.

    PubMed

    Schuhmann, Thomas G; Yao, Jun; Hong, Guosong; Fu, Tian-Ming; Lieber, Charles M

    2017-09-13

    Syringe-injectable mesh electronics represent a new paradigm for brain science and neural prosthetics by virtue of the stable seamless integration of the electronics with neural tissues, a consequence of the macroporous mesh electronics structure with all size features similar to or less than individual neurons and tissue-like flexibility. These same properties, however, make input/output (I/O) connection to measurement electronics challenging, and work to-date has required methods that could be difficult to implement by the life sciences community. Here we present a new syringe-injectable mesh electronics design with plug-and-play I/O interfacing that is rapid, scalable, and user-friendly to nonexperts. The basic design tapers the ultraflexible mesh electronics to a narrow stem that routes all of the device/electrode interconnects to I/O pads that are inserted into a standard zero insertion force (ZIF) connector. Studies show that the entire plug-and-play mesh electronics can be delivered through capillary needles with precise targeting using microliter-scale injection volumes similar to the standard mesh electronics design. Electrical characterization of mesh electronics containing platinum (Pt) electrodes and silicon (Si) nanowire field-effect transistors (NW-FETs) demonstrates the ability to interface arbitrary devices with a contact resistance of only 3 Ω. Finally, in vivo injection into mice required only minutes for I/O connection and yielded expected local field potential (LFP) recordings from a compact head-stage compatible with chronic studies. Our results substantially lower barriers for use by new investigators and open the door for increasingly sophisticated and multifunctional mesh electronics designs for both basic and translational studies.

  13. Stability of Hydromorphone-Ketamine Solutions in Glass Bottles, Plastic Syringes, and IV Bags for Pediatric Use.

    PubMed

    Ensom, Mary H H; Decarie, Diane; Leung, Karen; Montgomery, Carolyne

    2009-03-01

    To evaluate the stability of mixtures of hydromorphone and ketamine in 0.9% sodium chloride (normal saline [NS]) after storage for up to 7 days at room temperature (25°C). The stability of 3 standard mixtures of hydromorphone and ketamine (hydromorphone 0.2 mg/mL + ketamine 0.2 mg/mL, hydromorphone 0.2 mg/mL + ketamine 0.6 mg/mL, and hydromorphone 0.2 mg/mL + ketamine 1.0 mg/mL) in NS was studied. Portions of each mixture were transferred to 3 brown glass bottles (100 mL), 3 plastic syringes (50 mL), and 3 IV bags (50 mL), which were then stored at room temperature (25°C). Physical characteristics, including pH, colour, and precipitation, were evaluated daily. Three 1.5-mL samples were collected from each bottle, syringe, and IV bag at baseline, at 24, 48, and 72 hours, and on day 7. Samples were analyzed in triplicate by a stability-indicating high-performance liquid chromatography method. Solutions were considered stable if they maintained 90% of the initial concentration of each drug. Samples from syringes and IV bags were subjected to standard sterility testing by incubation for 5 days in an enriched culture media. No notable changes in pH or colour were observed, and no precipitation occurred in any of the solutions. All formulations maintained more than 90% of the initial concentration of each drug on day 7. No bacterial growth was observed in any of the samples tested. Mixtures of hydromorphone and ketamine were stable for up 7 days at 25°C, and the sterility of the preparations was maintained. Because stability alone does not guarantee efficacy, it is recommended that clinical studies be conducted to evaluate the pharmacokinetics and pharmacodynamics of these formulations.

  14. Development of a syringe pump assisted dynamic headspace sampling technique for needle trap device.

    PubMed

    Eom, In-Yong; Niri, Vadoud H; Pawliszyn, Janusz

    2008-07-04

    This paper describes a new approach that combines needle trap devices (NTDs) with a dynamic headspace sampling technique (purge and trap) using a bidirectional syringe pump. The needle trap device is a 22-G stainless steel needle 3.5-in. long packed with divinylbenzene sorbent particles. The same sized needle, without packing, was used for purging purposes. We chose an aqueous mixture of benzene, toluene, ethylbenzene, and p-xylene (BTEX) and developed a sequential purge and trap (SPNT) method, in which sampling (trapping) and purging cycles were performed sequentially by the use of syringe pump with different distribution channels. In this technique, a certain volume (1 mL) of headspace was sequentially sampled using the needle trap; afterwards, the same volume of air was purged into the solution at a high flow rate. The proposed technique showed an effective extraction compared to the continuous purge and trap technique, with a minimal dilution effect. Method evaluation was also performed by obtaining the calibration graphs for aqueous BTEX solutions in the concentration range of 1-250 ng/mL. The developed technique was compared to the headspace solid-phase microextraction method for the analysis of aqueous BTEX samples. Detection limits as low as 1 ng/mL were obtained for BTEX by NTD-SPNT.

  15. Ifosfamide and vinorelbine as first-line chemotherapy for advanced non-small cell lung carcinoma.

    PubMed

    Vallejo, C; Romero, A; Perez, J; Cuevas, M; Lacava, J; Sabatini, C; Dominguez, M; Rodriguez, R; Barbieri, M; Romero Acuña, L; Romero Acuña, J; Langhi, M; Amato, S; Salvadori, M; Ortiz, E; Machiavelli, M; Leone, B

    1996-12-01

    We evaluated the efficacy and toxicity of the novel combination of ifosfamide (IFX) and vinorelbine (VNB) as first-line chemotherapy in patients with stage IIIB and IV non-small cell lung cancer (NSCLC). Between March 1993 and November 1994, 44 patients (17 stage IIIB; 27 stage IV) received a regimen consisting of IFX, 2 g/m2 in a 1-h infusion, days 1-3; mesna, 400 mg/m2 in an i.v. bolus at hours 0 and 4 and 800 mg orally at hour 8, days 1-3; and VNB, 35 mg/ m2 in a 20-min infusion, days 1 and 15. During the first course only, a half dose of VNB (17.5 mg/m2) was administered on days 8 and 22. Courses were repeated every 28 days. Forty patients were fully evaluable for response, and 44 were assessable for toxicity. Objective regression was recorded in 13 of 40 patients (33%). No patient achieved a complete response. Thirteen patients presented a partial response (33%); 17 (42%) had no change; and progressive disease was observed in 10 (25%). The median duration of response was 10 months, and the median time to treatment failure for the whole group was 4 months. Median survival was 11 months. The dose-limiting toxic effect was myelosuppression. Leukopenia occurred in 25 patients (57%) and was grade 3 or 4 in 8 patients (18%). Twelve patients (27%) developed peripheral neurotoxicity, while five had mild IFX-induced CNS toxicity. Phlebitis was observed in 15 of 30 patients (50%) who did not have central implantable venous systems. The IFX-VNB combination exhibited an activity against NSCLC that was among the highest reported for non-cisplatin-containing regimens, with a toxicity profile that was easily managed.

  16. Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

    PubMed

    Simonetti, Andrea; Amari, Filippo

    2015-01-01

    In reaction to the limitations of the traditional sterility test methods, in 2008, the U.S. Food and Drug Administration issued the guidance "Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products" encouraging sterile drug manufacturers to use properly validated physical methods, apart from conventional microbial challenge testing, to confirm container closure integrity as part of the stability protocol. The case study presented in this article investigated the capability of four container closure integrity testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, Novartis Vaccines, Siena, Italy). Vacuum decay, pharmacopoeial dye ingress test, Novartis specific dye ingress test, and high-voltage leak detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference prefilled syringes, classified, respectively, as examples of conforming to closure integrity requirements (negative controls) and as defective (positive controls). Positive controls were, in turn, split in six groups, three of with holes laser-drilled through the prefilled syringe glass barrel, while the other three with capillary tubes embedded in the prefilled syringe plunger. These reference populations were then investigated by means of validated equipment used for container closure integrity testing of prefilled syringe commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that the vacuum decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical

  17. The iron chelator deferasirox synergizes with chemotherapy to treat triple negative breast cancers.

    PubMed

    Tury, Sandrine; Assayag, Franck; Bonin, Florian; Chateau-Joubert, Sophie; Servely, Jean-Luc; Vacher, Sophie; Becette, Véronique; Caly, Martial; Rapinat, Audrey; Gentien, David; de la Grange, Pierre; Schnitzler, Anne; Lallemand, François; Marangoni, Elisabetta; Bièche, Ivan; Callens, Céline

    2018-06-07

    To ensure their high proliferation rate, tumor cells display an iron metabolic disorder with increased iron needs, making them more susceptible to iron deprivation. This vulnerability could be a therapeutic target. In breast cancers, the development of new therapeutic approaches is urgently needed for patients with triple negative tumors which frequently relapse after chemotherapy and suffer from a lack of targeted therapies. In this work, we demonstrated that deferasirox (DFX) synergizes with standard chemotherapeutic agents such as with doxorubicin, cisplatin and carboplatin to inhibit cell proliferation and induce apoptosis and autophagy in triple-negative breast cancer (TNBC) cell lines. Moreover, the combination of DFX with doxorubicin and cyclophosphamide delayed recurrences in breast cancer patient-derived xenografts without increasing the side-effects of chemotherapies alone or altering global iron storage of mice. Antitumor synergy of DFX and doxorubicin seems to involve down-regulation of the PI3K and NF-κB pathways. Iron deprivation in combination with chemotherapy could thus help to improve the effectiveness of chemotherapy in TNBC patients without increasing toxicities. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  18. Chemotherapy induced Takotsubo cardiomyopathy

    PubMed Central

    Goel, Sunny; Sharma, Abhishek; Garg, Aakash; Chandra, Abhinav; Shetty, Vijay

    2014-01-01

    Chemotherapy has been linked with Takotsubo cardiomyopathy. Most of the literature on chemotherapy associated Takotsubo cardiomyopathy is on the drug 5-fluorouracil. In this report, we describe the case of a 55-year-old Asian male who developed Takotsubo cardiomyopathy while receiving dual chemotherapy with cytarabine and daunorubicin for acute myeloid leukemia. To our knowledge, it is the first case of Takotsubo cardiomyopathy associated with daunorubicin and/or cytarabine. PMID:25325068

  19. Chemotherapy induced Takotsubo cardiomyopathy.

    PubMed

    Goel, Sunny; Sharma, Abhishek; Garg, Aakash; Chandra, Abhinav; Shetty, Vijay

    2014-10-16

    Chemotherapy has been linked with Takotsubo cardiomyopathy. Most of the literature on chemotherapy associated Takotsubo cardiomyopathy is on the drug 5-fluorouracil. In this report, we describe the case of a 55-year-old Asian male who developed Takotsubo cardiomyopathy while receiving dual chemotherapy with cytarabine and daunorubicin for acute myeloid leukemia. To our knowledge, it is the first case of Takotsubo cardiomyopathy associated with daunorubicin and/or cytarabine.

  20. Building a city wide service for exchanging needles and syringes.

    PubMed Central

    Gruer, L; Cameron, J; Elliott, L

    1993-01-01

    How best can injecting drug misusers obtain clean injecting equipment in a city where drug injecting is widespread? An exchange service for needles and syringes throughout Glasgow has been established in health centres and clinics in the evening. Over the past four years seven new exchanges have been opened and over 2700 injecting drug misusers have attended. Attendances rose from under 1000 in 1988 to 28,000 in 1992. The exchanges also provide a wide range of other health and social services. Public hostility to the exchanges has abated. During the same period equipment sharing in the city diminished and the observed prevalence of HIV among injecting drug misusers stabilised at around 1%. Images FIG 1 FIG 2 FIG 3 PMID:8518609

  1. Preventing medication errors in cancer chemotherapy.

    PubMed

    Cohen, M R; Anderson, R W; Attilio, R M; Green, L; Muller, R J; Pruemer, J M

    1996-04-01

    Recommendations for preventing medication errors in cancer chemotherapy are made. Before a health care provider is granted privileges to prescribe, dispense, or administer antineoplastic agents, he or she should undergo a tailored educational program and possibly testing or certification. Appropriate reference materials should be developed. Each institution should develop a dose-verification process with as many independent checks as possible. A detailed checklist covering prescribing, transcribing, dispensing, and administration should be used. Oral orders are not acceptable. All doses should be calculated independently by the physician, the pharmacist, and the nurse. Dosage limits should be established and a review process set up for doses that exceed the limits. These limits should be entered into pharmacy computer systems, listed on preprinted order forms, stated on the product packaging, placed in strategic locations in the institution, and communicated to employees. The prescribing vocabulary must be standardized. Acronyms, abbreviations, and brand names must be avoided and steps taken to avoid other sources of confusion in the written orders, such as trailing zeros. Preprinted antineoplastic drug order forms containing checklists can help avoid errors. Manufacturers should be encouraged to avoid or eliminate ambiguities in drug names and dosing information. Patients must be educated about all aspects of their cancer chemotherapy, as patients represent a last line of defense against errors. An interdisciplinary team at each practice site should review every medication error reported. Pharmacists should be involved at all sites where antineoplastic agents are dispensed. Although it may not be possible to eliminate all medication errors in cancer chemotherapy, the risk can be minimized through specific steps. Because of their training and experience, pharmacists should take the lead in this effort.

  2. Front-line intraperitoneal versus intravenous chemotherapy in stage III-IV epithelial ovarian, tubal, and peritoneal cancer with minimal residual disease: a competing risk analysis.

    PubMed

    Chang, Yen-Hou; Li, Wai-Hou; Chang, Yi; Peng, Chia-Wen; Cheng, Ching-Hsuan; Chang, Wei-Pin; Chuang, Chi-Mu

    2016-03-17

    In the analysis of survival data for cancer patients, the problem of competing risks is often ignored. Competing risks have been recognized as a special case of time-to-event analysis. The conventional techniques for time-to-event analysis applied in the presence of competing risks often give biased or uninterpretable results. Using a prospectively collected administrative health care database in a single institution, we identified patients diagnosed with stage III or IV primary epithelial ovarian, tubal, and peritoneal cancers with minimal residual disease after primary cytoreductive surgery between 1995 and 2012. Here, we sought to evaluate whether intraperitoneal chemotherapy outperforms intravenous chemotherapy in the presence of competing risks. Unadjusted and multivariable subdistribution hazards models were applied to this database with two types of competing risks (cancer-specific mortality and other-cause mortality) coded to measure the relative effects of intraperitoneal chemotherapy. A total of 1263 patients were recruited as the initial cohort. After propensity score matching, 381 patients in each arm entered into final competing risk analysis. Cumulative incidence estimates for cancer-specific mortality were statistically significantly lower (p = 0.017, Gray test) in patients receiving intraperitoneal chemotherapy (5-year estimates, 34.5%; 95% confidence interval [CI], 29.5-39.6%, and 10-year estimates, 60.7%; 95% CI, 52.2-68.0%) versus intravenous chemotherapy (5-year estimates, 41.3%; 95% CI, 36.2-46.3%, and 10-year estimates, 67.5%, 95% CI, 61.6-72.7%). In subdistribution hazards analysis, for cancer-specific mortality, intraperitoneal chemotherapy outperforms intravenous chemotherapy (Subdistribution hazard ratio, 0.82; 95% CI, 0.70-0.96) after correcting other covariates. In conclusion, results from this comparative effectiveness study provide supportive evidence for previous published randomized trials that intraperitoneal chemotherapy

  3. Chemotherapy in metastatic retinoblastoma.

    PubMed

    Kingston, J E; Hungerford, J L; Plowman, P N

    1987-03-01

    Eleven children with metastatic retinoblastoma diagnosed during the period 1970-1984 were treated with chemotherapy. Short-term complete responses were observed in three children treated with a four-drug combination which included cisplatinum, and in one child treated with vincristine and cyclophosphamide. The median duration of survival of the 11 children receiving chemotherapy was nine months, whilst the median survival of 13 children with metastatic retinoblastoma who were not given chemotherapy was only 2.3 months (p = 0.06). This suggests that retinoblastoma is a chemosensitive tumour and therefore adjuvant chemotherapy may have a role in children with retinoblastoma who at diagnosis are thought to be at high risk of developing metastatic disease.

  4. Using Simulated Microgravity to Enhance the Effectiveness of Nanodrug Chemotherapy in Breast Cancer

    DTIC Science & Technology

    2010-03-01

    Frangos ) Award Number: W81XWH-09-1-0179 & W81XWH-09-1-0178 Title: "Using Simulated Microgravity to Enhance the Effectiveness of Nanodrug Chemotherapy in...an expert in mouse breast cancer cell lines. Task 2: Establishment of the simulated microgravity model Mr. Barkho was trained by Dr John Frangos

  5. Intensified chemotherapy with stem-cell rescue in germ-cell tumors.

    PubMed

    Simonelli, M; Rosti, G; Banna, G L; Pedrazzoli, P

    2012-04-01

    Based on the high chemosensitivity of germ-cell tumors (GCTs), the concept of high-dose chemotherapy (HDCT) has been developed worldwide and investigated through many clinical trials. It has been carried out in different clinical settings, ranging from resistant or absolute refractory disease to chemosensitive relapse. HDCT with stem-cell support has been also explored as a part of first-line strategy for poor-prognosis patients. Our review summarized results from clinical trials evaluating the role of HDCT in patients with advanced GCTs. So far available data were obtained through a Medline search of English-language literature. Several phase II trials and retrospective series have shown a possible benefit for GCT patients with recurrent disease as well as in first-line setting. Despite these results, data derived from randomized phase III studies failed to demonstrate any survival advantage for HDCT over conventional chemotherapy. The role of HDCT in GCTs remains controversial. We need new prospective studies based on prognostic factors with multiple transplants of carboplatin and etoposide as the preferred high dose regimen. At present, based mainly on retrospective and phase II studies, HDCT may represent a therapeutic option for patients with primary refractory disease or for those with a second or further relapse.

  6. Apatinib treatment combined with chemotherapy for advanced epithelial ovarian cancer: a case report.

    PubMed

    Deng, Linghui; Wang, Yue; Lu, Wenbin; Liu, Qian; Wu, Jie; Jin, Jianhua

    2017-01-01

    Apatinib is a novel oral tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2, which has been proved by clinical trials to be effective and safe for patients with chemotherapy-refractory gastric cancer. To date, there is no study or case report on apatinib treatment for patients with ovarian cancer. Here, we present the case of a 50-year-old Chinese woman with advanced ovarian cancer, who received apatinib at a daily dose of 500 mg for 28 days per cycle after failure of fourth-line chemotherapy. Favorable oncologic outcome was achieved in this case after treatment with apatinib. The patient's progression-free survival is now 11.3 months, and she is taking apatinib and capecitabine as maintenance treatment. The common side effect of apatinib was fatigue; however, the toxicity of apatinib was controllable and tolerable. Thus, apatinib may be an option for chemotherapy-refractory advanced epithelial ovarian cancer, but this still warrants further investigation.

  7. Evaluation of the use of a needle-free injection syringe as a cause of non-specific reactions in the intradermal tuberculin test used for the diagnosis of bovine tuberculosis.

    PubMed

    Díez-Guerrier, A; Roy, A; de la Cruz, M L; Sáez, J L; Sanz, C; Boschiroli, M L; Romero, B; de Juan, L; Domínguez, L; Bezos, J

    2018-05-24

    The objective of the study was to elucidate whether the use of the needle-free Dermojet syringe, which is based on a high pressure inoculation and is used to inject tuberculin in cattle in several countries, may, in itself, cause skin reactions that can be interpreted as positive reactions to the intradermal tests that are not, in fact, related to the real infection status of the animals. Forty-four cattle from an officially tuberculosis-free (OTF) herd were selected, and four single intradermal tuberculin (SIT) tests were performed on each animal, two on each side of the neck. Three different Dermojet (D1, D2 and D3) and one McLintock (M4) syringes were used to carry out sterile phosphate buffer saline (PBS) with 10% of glycerol and bovine PPD injections. No positive reactions to the SIT test were observed when using the D1-D3 syringes in the case of either bovine PPD or PBS. With regard to M4 (PBS), all the tests were negative when using a standard interpretation but three were positive in the case of the severe interpretation. Significant differences (p < 0.05) in the skin fold thickness measured were found only between certain Dermojet and McLintock syringes at certain inoculation sites. The results showed that the needle-free Dermojet syringe used for PPD intradermal testing in cattle did not cause significant reactions that could be misunderstood as positives. Copyright © 2018 Elsevier Ltd. All rights reserved.

  8. Vorinostat, a histone deacetylase (HDAC) inhibitor, promotes cell cycle arrest and re-sensitizes rituximab- and chemo-resistant lymphoma cells to chemotherapy agents.

    PubMed

    Xue, Kai; Gu, Juan J; Zhang, Qunling; Mavis, Cory; Hernandez-Ilizaliturri, Francisco J; Czuczman, Myron S; Guo, Ye

    2016-02-01

    Preclinical models of chemotherapy resistance and clinical observations derived from the prospective multicenter phase III collaborative trial in relapsed aggressive lymphoma (CORAL) study demonstrated that primary refractory/relapsed B cell diffuse large B cell lymphoma has a poor clinical outcome with current available second-line treatments. Preclinically, we found that rituximab resistance is associated with a deregulation on the mitochondrial potential rendering lymphoma cells resistant to chemotherapy-induced apoptotic stimuli. There is a dire need to develop agents capable to execute alternative pathways of cell death in an attempt to overcome chemotherapy resistance. Posttranscriptional histone modification plays an important role in regulating gene transcription and is altered by histone acetyltransferases (HATs) and histone deacetylases (HDACs). HDACs regulate several key cellular functions, including cell proliferation, cell cycle, apoptosis, angiogenesis, migration, antigen presentation, and/or immune regulation. Given their influence in multiple regulatory pathways, HDAC inhibition is an attractive strategy to evaluate its anti-proliferation activity in cancer cells. To this end, we studied the anti-proliferation activity and mechanisms of action of suberoylanilide hydroxamic acid (SAHA, vorinostat) in rituximab-chemotherapy-resistant preclinical models. A panel of rituximab-chemotherapy-sensitive (RSCL) and rituximab-chemotherapy-resistant cell lines (RRCL) and primary tumor cells isolated from relapsed/refractory B cell lymphoma patients were exposed to escalating doses of vorinostat. Changes in mitochondrial potential, ATP synthesis, and cell cycle distribution were determined by Alamar blue reduction, Titer-Glo luminescent assays, and flow cytometric, respectively. Protein lysates were isolated from vorinostat-exposed cells, and changes in members of Bcl-2 family, cell cycle regulatory proteins, and the acetylation status of histone H3 were

  9. Gemcitabine-Based Chemotherapy in Adrenocortical Carcinoma: A Multicenter Study of Efficacy and Predictive Factors.

    PubMed

    Henning, Judith E K; Deutschbein, Timo; Altieri, Barbara; Steinhauer, Sonja; Kircher, Stefan; Sbiera, Silviu; Wild, Vanessa; Schlötelburg, Wiebke; Kroiss, Matthias; Perotti, Paola; Rosenwald, Andreas; Berruti, Alfredo; Fassnacht, Martin; Ronchi, Cristina L

    2017-11-01

    Adrenocortical carcinoma (ACC) is rare and confers an unfavorable prognosis in advanced stages. Other than combination chemotherapy with cisplatin, etoposide, doxorubicin, and mitotane, the second- and third-line regimens are not well-established. Gemcitabine (GEM)-based chemotherapy was suggested in a phase 2 clinical trial with 28 patients. In other solid tumors, human equilibrative nucleoside transporter type 1 (hENT1) and/or ribonucleotide reductase catalytic subunit M1 (RRM1) expression have been associated with resistance to GEM. To assess the efficacy of GEM-based chemotherapy in ACC in a real-world setting and the predictive role of molecular parameters. Retrospective multicenter study. Referral centers of university hospitals. A total of 145 patients with advanced ACC were treated with GEM-based chemotherapy (132 with concomitant capecitabine). Formalin-fixed paraffin-embedded tumor material was available for 70 patients for immunohistochemistry. The main outcome measures were progression-free survival (PFS) and an objective response to GEM-based chemotherapy. The secondary objective was the predictive role of hENT1 and RRM1. The median PFS for the patient population was 12 weeks (range, 1 to 94). A partial response or stable disease was achieved in 4.9% and 25.0% of cases, with a median duration of 26.8 weeks. Treatment was generally well tolerated, with adverse events of grade 3 or 4 occurring in 11.0% of cases. No substantial effect of hENT1 and/or RRM1 expression was observed in response to GEM-based chemotherapy. GEM-based chemotherapy is a well-tolerated, but modestly active, regimen against advanced ACC. No reliable molecular predictive factors could be identified. Owing to the scarce alternative therapeutic options, GEM-based chemotherapy remains an important option for salvage treatment for advanced ACC. Copyright © 2017 Endocrine Society

  10. [Pharmacogenomics of the first-line treatment for gastric cancer: advances in the identification of genomic biomarkers for clinical response to chemotherapy].

    PubMed

    Castro-Rojas, Carlos; Ortiz-Lópezj, Rocío; Rojas-Martínez, Augusto

    2014-06-01

    Gastric cancer (GC) is often diagnosed at later stages due to the lack of specificity of symptoms associated with the neoplasm, causing high mortality rates worldwide. The first line of adjuvant and neoadjuvant treatment includes cytotoxic fluoropyrimidines and platin-containing compounds which cause the formation of DNA adducts. The clinical outcome with these antineoplastic agents depends mainly on tumor sensitivity, which is conditioned by the expression level of the drug targets and the DNA-repair system enzymes. In addition, some germ line polymorphisms, in genes linked to drug metabolism and response to chemotherapy, have been associated with poor responses and the development of adverse effects, even with fatal outcomes in GC patients. The identification of genomic biomarkers, such as individual gene polymorphisms or differential expression patterns of specific genes, in a patient-by-patient context with potential clinical application is the main focus of current pharmacogenomic research, which aims at developing a rational and personalized therapy (i.e., a therapy that ensures maximum efficacy with no predictable side effects). However, because of the future application of genomic technologies in the clinical setting, it is necessary to establish the prognostic value of these genomic biomarkers with genotype-phenotype association studies and to evaluate their prevalence in the population under treatment. These issues are important for their cost-effectiveness evaluation, which determines the feasibility of using these medical genomic research products for GC treatment in the clinical setting.

  11. Metronomic chemotherapy and nanocarrier platforms.

    PubMed

    Abu Lila, Amr S; Ishida, Tatsuhiro

    2017-08-01

    The therapeutic concept of administering chemotherapeutic agents continuously at lower doses, relative to the maximum tolerated dose (MTD) without drug-free breaks over extended periods -known as "metronomic chemotherapy"- is a promising approach for anti-angiogenic cancer therapy. In comparison with MTD chemotherapy regimens, metronomic chemotherapy has demonstrated reduced toxicity. However, as a monotherapy, metronomic chemotherapy has failed to provide convincing results in clinical trials. Therapeutic approaches including combining the anti-angiogenic "metronomic" therapy with conventional radio-/chemo-therapy and/or targeted delivery of chemotherapeutic agents to tumor tissues via their encapsulation with nanocarrier-based platforms have proven to potentiate the overall therapeutic outcomes. In this review, therefore, we focused on the mutual contribution made by nanoscale drug delivery platforms to the therapeutic efficacy of metronomic-based chemotherapy. In addition, the influence that the dosing schedule has on the overall therapeutic efficacy of metronomic chemotherapy is discussed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  12. Hepatic artery infusion therapy is effective for chemotherapy-resistant liver metastatic colorectal cancer.

    PubMed

    Goi, Takanori; Naruse, Takayuki; Kimura, Youhei; Fujimoto, Daisuke; Morikawa, Mitsuhiro; Koneri, Kenji; Yamaguchi, Akio

    2015-10-09

    Systemic FOLFOX (folinic acid (leucovorin (LV)), 5-fluorouracil (5-FU), and oxaliplatin), FOLFIRI (LV, 5-FU, and irinotecan), or FOLFOXIRI (5-FU, leucovorin, oxaliplatin, and irinotecan) chemotherapy regimens and additional molecular-target treatments, including anti-vascular endothelial growth factor, anti-epidermal growth factor receptor, and anti-multi-kinase antibodies, have been recommended for unresectable recurrent colorectal cancers. However, no effective treatments are currently available for cases refractory to these therapies. Therefore, the development of alternative therapies is desired. In the present study, we administered and observed the effectiveness of hepatic artery infusion therapy (HAIC) in patients with unresectable liver metastatic colorectal cancers refractory to systemic chemotherapy. In addition, we observed that in an experimental system with anticancer drug-resistant colorectal cancer lines, apoptosis and cell death could be induced by increasing anticancer drug concentrations. The subjects had liver metastatic colorectal cancers that were unresponsive to systemic chemotherapy (FOLFOX/FOLFIRI) or to additional molecular-target therapies for progressive disease. Hepatic infusion tube placement was conducted according to the Seldinger method to insert a catheter with a side hole via the right femoral artery. A coiling procedure was performed to prevent drug influx into the gastroduodenal artery. Ten subjects were selected, and the results were evaluated after HAIC (5-FU and LV administered once weekly). Moreover, anticancer drug-resistant colorectal cancer lines were subsequently prepared to investigate whether increased anticancer drug concentrations could induce apoptosis or cell death. Of the 10 subjects, 3 (30 %) showed partial response and 4 (40 %) showed no change according to computed tomography imaging findings obtained after hepatic artery infusion. The disease control rate was 70 %. Eight subjects had improved quality of life

  13. Exercise and chemotherapy-induced amenorrhea.

    PubMed

    Mathis, Katlynn M; Sturgeon, Kathleen M; Winkels, Renate M; Wiskemann, Joachim; Williams, Nancy I; Schmitz, Kathryn

    2018-07-01

    Chemotherapy-induced amenorrhea (CIA) is the temporary or permanent loss of menses experienced by premenopausal women undergoing chemotherapy treatment for cancer. Two possible mechanisms through which chemotherapy induces CIA have been identified: systemic endothelial dysfunction, resulting in decreased blood flow to the ovaries, and increased oxidative stress within the ovaries, both of which are proposed to lead to apoptosis of follicles. Endothelial dysfunction in ovarian arteries in women undergoing or who have undergone chemotherapy treatment is characterized by prothrombotic changes and thickening of the vascular wall. These changes result in occlusion of the blood vessels. Oxidative stress is increased and antioxidants decreased in the ovaries secondary to chemotherapy drugs, specifically cyclophosphamide. It is hypothesized that low to moderate intensity aerobic exercise during chemotherapy may prevent these changes and lessen the risk for developing CIA in premenopausal women. Low to moderate intensity aerobic exercise has been shown to improve endothelial function and blood flow in patients with cardiovascular disease-a disease state characterized by endothelial dysfunction and for which patients who have undergone chemotherapy are at increased risk. In mice, moderate intensity aerobic exercise has been shown to decrease the amount of oxidative stress within the ovaries, and in humans, chronic aerobic exercise has been shown to increase antioxidant production systemically. This hypothesis should be tested in both a mouse model, using sedentary and exercising mice treated with chemotherapy drugs that commonly result in CIA, as well as a human model to determine the effects of low to moderate intensity aerobic exercise on ovarian function in premenopausal women undergoing chemotherapy. Copyright © 2018 Elsevier Ltd. All rights reserved.

  14. Laws prohibiting over-the-counter syringe sales to injection drug users: relations to population density, HIV prevalence, and HIV incidence.

    PubMed

    Friedman, S R; Perlis, T; Des Jarlais, D C

    2001-05-01

    This study sought to assess relations of laws prohibiting over-the-counter syringe sales (anti-OTC laws) to population prevalence of injection drug users and HIV prevalence or incidence among 96 US metropolitan areas. A cross-sectional analysis was used. Metropolitan areas with anti-OTC laws had a higher mean HIV prevalence (13.8% vs 6.7%) than other metropolitan areas (pseudo-P < .001). In 83 metropolitan areas with HIV prevalence of less than 20%, anti-OTC laws were associated with HIV incidence rates of 1% or greater (pseudo-P < .001). Population proportions of injection drug users did not vary by presence of anti-OTC laws. Anti-OTC laws are not associated with lower population proportions of injection drug users. Laws restricting syringe access are associated with HIV transmission and should be repealed.

  15. Targeted release of transcription factors for cell reprogramming by a natural micro-syringe.

    PubMed

    Berthoin, Lionel; Toussaint, Bertrand; Garban, Frédéric; Le Gouellec, Audrey; Caulier, Benjamin; Polack, Benoît; Laurin, David

    2016-11-20

    Ectopic expression of defined transcription factors (TFs) for cell fate handling has proven high potential interest in reprogramming differentiated cells, in particular for regenerative medicine, ontogenesis study and cell based modelling. Pluripotency or transdifferentiation induction as TF mediated differentiation is commonly produced by transfer of genetic information with safety concerns. The direct delivery of proteins could represent a safer alternative but still needs significant advances to be efficient. We have successfully developed the direct delivery of proteins by an attenuated bacterium with a type 3 secretion system that does not require challenging and laborious steps for production and purification of recombinant molecules. Here we show that this natural micro-syringe is able to inject TFs to primary human fibroblasts and cord blood CD34 + hematopoietic stem cells. The signal sequence for vectorization of the TF Oct4 has no effect on DNA binding to its nucleic target. As soon as one hour after injection, vectorized TFs are detectable in the nucleus. The injection process is not associated with toxicity and the bacteria can be completely removed from cell cultures. A three days targeted release of Oct4 or Sox2 embryonic TFs results in the induction of the core pluripotency genes expression in fibroblasts and CD34 + hematopoietic stem cells. This micro-syringe vectorization represents a new strategy for TF delivery and has potential applications for cell fate reprogramming. Copyright © 2016 Elsevier B.V. All rights reserved.

  16. Syringe test screening of microbial gas production activity: Cases denitrification and biogas formation.

    PubMed

    Østgaard, Kjetill; Kowarz, Viktoria; Shuai, Wang; Henry, Ingrid A; Sposob, Michal; Haugen, Hildegunn Hegna; Bakke, Rune

    2017-01-01

    Mass produced plastic syringes may be applied as vessels for cheap, simple and large scale batch culture testing. As illustrated for the cases of denitrification and of biogas formation, metabolic activity was monitored by direct reading of the piston movement due to the gas volume formed. Pressure buildup due to friction was shown to be moderate. A piston pull and slide back routine can be applied before recording gas volume to minimize experimental errors due to friction. Inoculum handling and activity may be conveniently standardized as illustrated by applying biofilm carriers. A robust set of positive as well as negative controls ("blanks") should be included to ensure quality of the actual testing. The denitrification test showed saturation response at increasing amounts of inoculum in the form of adapted moving bed biofilm reactor (MBBR) carriers, with well correlated nitrate consumption vs. gas volume formed. As shown, the denitrification test efficiently screened different inocula at standardized substrates. Also, different substrates were successfully screened and compared at standardized inocula. The biogas potential test showed efficient screening of different substrates with effects of relative amounts of carbohydrate, protein, fat. A second case with CO 2 capture reclaimer waste as substrate demonstrated successful use of co-feeding to support waste treatment and how temperature effects on kinetics and stoichiometry can be observed. In total, syringe test screening of microbial gas production seems highly efficient at a low cost when properly applied. Copyright © 2016 Elsevier B.V. All rights reserved.

  17. A Quantitative Chemotherapy Genetic Interaction Map Reveals Factors Associated with PARP Inhibitor Resistance.

    PubMed

    Hu, Hsien-Ming; Zhao, Xin; Kaushik, Swati; Robillard, Lilliane; Barthelet, Antoine; Lin, Kevin K; Shah, Khyati N; Simmons, Andy D; Raponi, Mitch; Harding, Thomas C; Bandyopadhyay, Sourav

    2018-04-17

    Chemotherapy is used to treat most cancer patients, yet our understanding of factors that dictate response and resistance to such drugs remains limited. We report the generation of a quantitative chemical-genetic interaction map in human mammary epithelial cells charting the impact of the knockdown of 625 genes related to cancer and DNA repair on sensitivity to 29 drugs, covering all classes of chemotherapy. This quantitative map is predictive of interactions maintained in other cell lines, identifies DNA-repair factors, predicts cancer cell line responses to therapy, and prioritizes synergistic drug combinations. We identify that ARID1A loss confers resistance to PARP inhibitors in cells and ovarian cancer patients and that loss of GPBP1 causes resistance to cisplatin and PARP inhibitors through the regulation of genes involved in homologous recombination. This map helps navigate patient genomic data and optimize chemotherapeutic regimens by delineating factors involved in the response to specific types of DNA damage. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  18. A protocol and ethical framework for the distribution of rationed chemotherapy.

    PubMed

    Hantel, Andrew

    2014-01-01

    Shortages of generic, injectable chemotherapeutics have been increasing in prevalence since 2006. Due to the lack of access to first-line, lifesaving treatments, physicians have been forced to ration chemotherapy between patients. Although the scarcity has been managed with good intentions, it has been done in an ad hoc manner, without the benefit of an ethically grounded and standardized schema. Using an approach based on the "accountability for reasonableness" method by Daniel and Sabin, I establish a framework and protocol for rationing that is specific to chemotherapy. Prior to the state of true shortage, I present guidelines for the use of an adequate supply of chemotherapy with knowledge of upcoming scarcity. Within the rationing framework itself, I first prioritize emergency use of chemotherapeutics and those already receiving treatment at the time of shortage. I advocate for stratifying patients based on the prognostic indicators of their cancer type, using a combination of clinical-trial-based initial response and longer term survival, followed by the patients' line of treatment. All patients who are not able to receive their "best" treatment must receive a sequent, next-best treatment, and their treatment team must have the ability to appeal to a rationing committee in special circumstances. I reject the ideas of stratification based on the intention of the treatment, perceived quality of life, pre-existing condition not impacting performance status, the classical "sickest first" argument, and giving preference to pediatric cases. Lastly, I advocate for any system of rationing to be transparent to those it affects and acknowledge the difficulties it presents to patients and physicians alike. Copyright 2014 The Journal of Clinical Ethics. All rights reserved.

  19. Real-World Analysis of Medical Costs and Healthcare Resource Utilization in Elderly Women with HR+/HER2- Metastatic Breast Cancer Receiving Everolimus-Based Therapy or Chemotherapy.

    PubMed

    Hao, Yanni; Li, Nanxin; Fang, Anna P; Koo, Valerie; Peeples, Miranda; Kageleiry, Andrew; Wu, Eric Q; Guérin, Annie

    2016-06-01

    The objective of this study was to analyze medical costs and healthcare resource utilization (HRU) associated with everolimus-based therapy or chemotherapy among elderly women with hormone-receptor-positive, human-epidermal-growth-factor-receptor-2-negative (HR+/HER2-) metastatic breast cancer (mBC). Elderly women (≥65 years) with HR+/HER2- mBC who failed a non-steroidal-aromatase-inhibitor and subsequently began a new line of treatment with everolimus-based therapy or chemotherapy for mBC (index therapy) during July 20, 2012 to March 31, 2014 were identified from two large commercial claims databases. All-cause, BC-, and adverse event (AE)-related medical costs (2014 USD), and all-cause and AE-related HRU per patient per month (PPPM) were compared between patients treated with everolimus-based therapy and chemotherapy across their first four lines of therapy for mBC. Adjusted costs and HRU differences were estimated by pooling all lines and using multivariable models adjusted for differences in patient characteristics. In total, 925 elderly patients (mean age approximately 73 years) with HR+/HER2- mBC met the inclusion criteria; 230 received everolimus-based therapy (240 lines) and 737 received chemotherapy (939 lines). Compared with chemotherapy, everolimus-based therapy was associated with significantly lower total all-cause PPPM medical services costs (adjusted mean difference: $4007), driven by lower inpatient ($1994) and outpatient ($1402) costs; lower BC-related medical services costs ($3129), driven by both BC-related inpatient ($1883) and outpatient costs ($913); and lower AE-related medical services costs ($1873; all P < 0.01). Additionally, compared to patients treated with chemotherapy, patients treated with everolimus-based therapy had fewer all-cause outpatient visits (adjusted incidence rate ratio = 0.69), BC-related outpatient visits (0.66), other-medical-service visits (0.65), and AE-related HRU (0.59), which was driven by significantly

  20. [Long term results of exclusive chemotherapy for glottic squamous cell carcinoma complete clinical responders after induction chemotherapy].

    PubMed

    Vachin, F; Hans, S; Atlan, D; Brasnu, D; Menard, M; Laccourreye, O

    2004-06-01

    To evaluate the long-term results of exclusive chemotherapy for T1-T3N0M0 glottic squamous cell carcinoma complete clinical responders after induction chemotherapy. Between 1985 and 2000, 69 patients with glottic squamous cell carcinoma complete clinical responders after induction chemotherapy were managed with exclusive chemotherapy at our department. Chemotherapy associated platinum and fluorouracil. This retrospective analysis evaluated actuarial survival, treatment morbidity, oncologic events and laryngeal preservation. Various independent factors were tested for potential correlation with survival and local recurrence. The 5-year Kaplan-Meier actuarial survival, local control, lymph node control estimate were 83,6%, 64,8%, 98,6% respectively. Chemotherapy never resulted in death. The 10-year actuarial metachronous second primary tumors estimate was 32%. The overall laryngeal preservation rate was 98,6%. Altogether our data and the review of the literature suggest that in patients achieving a complete clinical response after and induction based chemotherapy regimen, the completion of an exclusive chemotherapy regimen appears to be a valid alternative to the conventional use of radiotherapy or chemo-radiation protocols.

  1. Protective Effect of a Mitochondria-Targeted Peptide against the Development of Chemotherapy-Induced Peripheral Neuropathy in Mice.

    PubMed

    Toyama, Satoshi; Shimoyama, Naohito; Szeto, Hazel H; Schiller, Peter W; Shimoyama, Megumi

    2018-04-18

    Several chemotherapeutic agents used for cancer treatment induce dose-limiting peripheral neuropathy that compromises patients' quality of life and limits cancer treatment. Recently, mitochondrial dysfunction has been shown to be involved in the mechanism of chemotherapy-induced peripheral neuropathy. SS-20 is a mitochondria-targeted peptide that promotes mitochondrial respiration and restores mitochondrial bioenergetics. In the present study, we examined the protective effect of SS-20 against the development of chemotherapy-induced peripheral neuropathy utilizing a murine model of peripheral neuropathy induced by oxaliplatin, a first-line chemotherapy agent for colon cancer. Weekly administrations of oxaliplatin induced peripheral neuropathy as demonstrated by the development of neuropathic pain and loss of intraepidermal nerve fibers in the hind paw. Continuous administration of SS-20 protected against the development of oxaliplatin-induced neuropathic pain and mitigated the loss of intraepidermal nerve fibers to normal levels. Our findings suggest that SS-20 may be a drug candidate for the prevention of chemotherapy-induced peripheral neuropathy.

  2. Chemotherapy to Treat Cancer

    Cancer.gov

    Chemotherapy is a type of cancer treatment that uses drugs to kill cancer cells. Learn how chemotherapy works against cancer, why it causes side effects, and how it is used with other cancer treatments.

  3. A new solid phase microextraction method using organic ligand in micropipette tip syringe system packed with modified carbon cloth for preconcentration of cadmium in drinking water and blood samples of kidney failure patients.

    PubMed

    Panhwar, Abdul Haleem; Kazi, Tasneem Gul; Afridi, Hassan Imran; Arain, Salma Aslam; Naeemullah; Brahman, Kapil Dev; Arain, Mariam Shahzadi

    2015-03-05

    A simple and efficient miniaturized solid phase microextraction (M-SPμE) in a syringe system was developed for preconcentration of cadmium (Cd) in environmental and biological samples, followed by flame atomic absorption technique. The syringe system contains the micropipette tip packed with activated carbon cloth, coated with modified magnetic nanoparticles of iron oxide Triton X114 (ACC-NPs). Scanning electron microscopy and energy dispersive spectroscopy used for characterization of the size, morphology and elemental composition of ACC-NPs. The sample solution treated with a complexing reagent 8-hydroxyqunilone (8-HQ), and drawn into the syringe, filled with ACC-MNPs and dispensed manually for 2-10 drawing/discharging cycles. The analyte retained on ACC-NPs in micropipette tip-syringe system were then eluted with different volume of 1.5molL(-1) HCl by 1-5 drawing/discharging cycles. The syringe system directly couple with FAAS for analysis. The influence of different variables on the extraction efficiency of Cd, including adsorbent dosage, pH, sample volume, eluent volume and drawing/discharging cycles of syringe system were optimized. At optimized extraction conditions, the method showed good linearity in the range of 5-250μgL(-1), with a limit of detection 0.15μgL(-1). Repeatability of the extraction (%RSD) was <5%, n=5. The validity and accuracy of the method was checked by the certified reference materials. The proposed method was successfully applied for the determination of Cd in different drinking water and biological samples of kidney failure patients and healthy controls. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. A new solid phase microextraction method using organic ligand in micropipette tip syringe system packed with modified carbon cloth for preconcentration of cadmium in drinking water and blood samples of kidney failure patients

    NASA Astrophysics Data System (ADS)

    Panhwar, Abdul Haleem; Kazi, Tasneem Gul; Afridi, Hassan Imran; Arain, Salma Aslam; Naeemullah; Brahman, Kapil Dev; Arain, Mariam Shahzadi

    2015-03-01

    A simple and efficient miniaturized solid phase microextraction (M-SPμE) in a syringe system was developed for preconcentration of cadmium (Cd) in environmental and biological samples, followed by flame atomic absorption technique. The syringe system contains the micropipette tip packed with activated carbon cloth, coated with modified magnetic nanoparticles of iron oxide Triton X114 (ACC-NPs). Scanning electron microscopy and energy dispersive spectroscopy used for characterization of the size, morphology and elemental composition of ACC-NPs. The sample solution treated with a complexing reagent 8-hydroxyqunilone (8-HQ), and drawn into the syringe, filled with ACC-MNPs and dispensed manually for 2-10 drawing/discharging cycles. The analyte retained on ACC-NPs in micropipette tip-syringe system were then eluted with different volume of 1.5 mol L-1 HCl by 1-5 drawing/discharging cycles. The syringe system directly couple with FAAS for analysis. The influence of different variables on the extraction efficiency of Cd, including adsorbent dosage, pH, sample volume, eluent volume and drawing/discharging cycles of syringe system were optimized. At optimized extraction conditions, the method showed good linearity in the range of 5-250 μg L-1, with a limit of detection 0.15 μg L-1. Repeatability of the extraction (%RSD) was <5%, n = 5. The validity and accuracy of the method was checked by the certified reference materials. The proposed method was successfully applied for the determination of Cd in different drinking water and biological samples of kidney failure patients and healthy controls.

  5. Salmonella Immunotherapy Improves the Outcome of CHOP Chemotherapy in Non-Hodgkin Lymphoma-Bearing Mice

    PubMed Central

    Bascuas, Thais; Moreno, María; Grille, Sofía; Chabalgoity, José A.

    2018-01-01

    We have previously shown that Salmonella immunotherapy is effective to treat B-cell non-Hodgkin lymphoma (B-NHL) in mice. However, this model involves animals with high tumor burden, whereas in the clinics B-NHL patients are usually treated with chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) as first-line therapy prior to immunotherapy. Recently, we have described a NHL-B preclinical model using CHOP chemotherapy to achieve MRD in immunocompetent animals that closely resemble patients’ conditions. In this work, we assessed the efficacy of Salmonella immunotherapy in B-NHL-bearing mice undergoing chemotherapy. Salmonella administration significantly delayed tumor growth and prolonged survival of chemotherapy-treated NHL-bearing animals. Mice receiving the CHOP–Salmonella combined therapy showed increased numbers of tumor-infiltrating leukocytes and a different profile of cytokines and chemokines expressed in the tumor microenvironment. Further, Salmonella immunotherapy in CHOP-treated animals also enhanced NK cells cytotoxic activity as well as induced systemic lymphoma-specific humoral and cellular responses. Chemotherapy treatment profoundly impacted on the general health status of recipient animals, but those receiving Salmonella showed significantly better overall body condition. Altogether, the results clearly demonstrated that Salmonella immunotherapy could be safely used in individuals under CHOP treatment, resulting in a better prognosis. These results give strong support to consider Salmonella as a neoadjuvant therapy in a clinical setting. PMID:29410666

  6. Neutrophil-lymphocyte ratio predicts survival in patients with advanced cholangiocarcinoma on chemotherapy.

    PubMed

    Lee, Ban Seok; Lee, Sang Hyub; Son, Jun Hyuk; Jang, Dong Kee; Chung, Kwang Hyun; Lee, Yoon Suk; Paik, Woo Hyun; Ryu, Ji Kon; Kim, Yong-Tae

    2016-02-01

    The blood neutrophil-to-lymphocyte ratio (NLR) is reported to be a prognostic marker in several cancers. However, the prognostic role of NLR in patients with advanced cholangiocarcinoma on chemotherapy is unknown. A total of 221 patients with pathologically confirmed locally advanced or metastatic cholangiocarcinoma receiving first-line palliative chemotherapy were enrolled. Associations between baseline clinical and laboratory variables including NLR and survival were investigated. Patients were classified into two groups according to the NLR level (≤ 5 vs. >5). Median overall survival (OS) and time to progression (TTP) in patients with NLR ≤ 5 were 10.9 and 6.7 months, respectively, and 6.8 and 4.1 months in patients with NLR > 5 (P < 0.001, P = 0.002, respectively). In multivariate analysis, number of cycles of chemotherapy was a significant predictor of longer OS (HR 0.86, P < 0.001), whereas adverse prognostic factors for OS were CA 19-9 > 300 (HR 1.43, P = 0.025), CEA > 5 (HR 1.44, P = 0.029), higher stage (HR 1.69, P = 0.004), and NLR > 5 (HR 1.87, P < 0.001). NLR > 5 was also associated with reduced TTP (HR 1.66, P = 0.007). Among 50 patients with initial NLR > 5, 33 patients had NLR ≤ 5 after two cycles of chemotherapy and they had significantly better survival than the others (HR 0.48, P = 0.015). NLR independently predicts survival in patients with advanced cholangiocarcinoma undergoing chemotherapy. Considering cost-effectiveness and easy availability, NLR may be a useful biomarker for prognosis prediction.

  7. A practical guide for nurses in diluent selection for subcutaneous infusion using a syringe driver.

    PubMed

    McLeod, Fiona; Flowers, Charne

    2006-12-01

    Appropriate diluent selection in continuous subcutaneous infusion optimises symptom management and client well-being. The responsibility of diluent selection is commonly one of the attending nurse. This paper was developed with the intention of providing nurses with practical instruction for diluent selection when preparing medications for administration subcutaneously using a syringe driver. A literature review was undertaken of published journal databases and published guidelines sites. Recommendations regarding diluent choice were reviewed in two iterations by an expert panel of palliative care nurse clinicians. The principles for diluent selection are presented. They are based primarily on expert opinion level of evidence given a lack of primary research evidence in the area of diluent selection. There is a pressing need for manufacturers' guidance on diluent selection and independent research to establish the impact of diluents on drug and drug combinations when using syringe drivers. Until such time that this evidence is available to guide practice, clinicians need to be trained to inspect solutions and assess the effectiveness of the medication in controlling symptoms. The capacity of this paper to provide practical instruction has been limited by the lack of rigorous evidence available, and indeed, the process of developing this guide identified perhaps more questions than answers available at the present time.

  8. Color-Coded Prefilled Medication Syringes Decrease Time to Delivery and Dosing Error in Simulated Emergency Department Pediatric Resuscitations.

    PubMed

    Moreira, Maria E; Hernandez, Caleb; Stevens, Allen D; Jones, Seth; Sande, Margaret; Blumen, Jason R; Hopkins, Emily; Bakes, Katherine; Haukoos, Jason S

    2015-08-01

    The Institute of Medicine has called on the US health care system to identify and reduce medical errors. Unfortunately, medication dosing errors remain commonplace and may result in potentially life-threatening outcomes, particularly for pediatric patients when dosing requires weight-based calculations. Novel medication delivery systems that may reduce dosing errors resonate with national health care priorities. Our goal was to evaluate novel, prefilled medication syringes labeled with color-coded volumes corresponding to the weight-based dosing of the Broselow Tape, compared with conventional medication administration, in simulated pediatric emergency department (ED) resuscitation scenarios. We performed a prospective, block-randomized, crossover study in which 10 emergency physician and nurse teams managed 2 simulated pediatric arrest scenarios in situ, using either prefilled, color-coded syringes (intervention) or conventional drug administration methods (control). The ED resuscitation room and the intravenous medication port were video recorded during the simulations. Data were extracted from video review by blinded, independent reviewers. Median time to delivery of all doses for the conventional and color-coded delivery groups was 47 seconds (95% confidence interval [CI] 40 to 53 seconds) and 19 seconds (95% CI 18 to 20 seconds), respectively (difference=27 seconds; 95% CI 21 to 33 seconds). With the conventional method, 118 doses were administered, with 20 critical dosing errors (17%); with the color-coded method, 123 doses were administered, with 0 critical dosing errors (difference=17%; 95% CI 4% to 30%). A novel color-coded, prefilled syringe decreased time to medication administration and significantly reduced critical dosing errors by emergency physician and nurse teams during simulated pediatric ED resuscitations. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  9. Impact of chemotherapy on telomere-length in sporadic and familial breast cancer patients

    PubMed Central

    Benitez-Buelga, C.; Sanchez-Barroso, L.; Gallardo, M.; Apellániz-Ruiz, María; Inglada-Pérez, L.; Yanowski, K.; Carrillo, J.; Garcia-Estevez, L.; Calvo, I.; Perona, R.; Urioste, M.; Osorio, A.; Blasco, MA.; Rodriguez-Antona, C.; Benitez, J.

    2015-01-01

    Purpose Recently, we observed that telomeres of BRCA1/2 mutation carriers were shorter than those of controls or sporadic breast cancer patients, suggesting that mutations in these genes might be responsible for this event. Given the contradictory results reported in the literature, we tested whether other parameters, such as chemotherapy, could be modifying telomere-length. Methods We performed a cross-sectional study measuring leukocyte telomere-length of 266 sporadic breasts cancer patients treated with first-line chemotherapy, with a median follow up of 240 days. Additionally, we performed both cross-sectional and longitudinal studies in a series of 236 familial breast cancer patients that included affected and non-affected BRCA1/2 mutation carriers. We have measured in leukocytes from peripheral blood: The telomere-length, percentage of short telomeres (<3Kb), telomerase activity levels and the annual telomere shortening speed. Results In sporadic cases we found that chemotherapy exerts a transient telomere shortening effect (around 2 years) that varies depending on the drug combination. In familial cases, only patients receiving treatment were associated with telomere shortening but they recovered normal telomere-length after a period of two years. Conclusion Chemotherapy affects telomere-length and should be considered in the studies that correlate telomere-length with disease susceptibility. PMID:25528024

  10. [Efficacy and Survival Analysis of Apatinib in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer after Failure of First-line Treatment].

    PubMed

    Wang, Xuemin; Zhang, Weihong; Du, Weijiao; Zhang, Xinwei; Ren, Xiubao; Cao, Shui

    2017-11-20

    The efficacy of second or third-line chemotherapy in advanced non-small cell lung cancer (NSCLC) patients is low. The use of targeted drugs brings survival benefit for some patients. Apatinib, as a novel small molecule antiangiogenic drug, has demonstrated satisfactory anticancer activity across a broad range of malignancies. The aim of this study is to evaluate the efficacy and safety of apatinib in patients with advanced NSCLC after first-line treatment failure. A retrospective study of 128 patients was conducted to evaluate the safety, short-term efficacy and survival status with different regimens. Kaplan-Meier method and Cox regression model were used for analysis. Compared with chemotherapy alone, the median progression free survival (PFS) in apatinib monotherapy, chemotherapy alone and apatinib combined with chemotherapy were 3.0 (P=0.381), 3.7 and 6.0 months (P<0.001), respectively. The median overall survival (OS) were 6.0 (P=0.494), 6.5 and 9.0 months (P=0.001), respectively. The incidence of adverse events in grades 3-4 were 18.5%, 15.8% and 16.0%, respectively (P=0.947). Different treatment regimens (P=0.018) and performance status (PS)(P<0.001) were the independent factors of PFS. The smoking history (P=0.014), treatment regimens (P=0.002) and PS (P<0.001) were independent influencing factors of OS. Apatinib has a good security. After first-line treatment failure of lung cancer, chemotherapy combined with apatinib in second or third-line is beneficial in PFS and OS when compared with chemotherapy alone. But when making comparison between apatinib monotherapy and chemotherapy alone, there is no significant difference in PFS and OS. Patients who never smoke or has a better PS or use combination therapy have longer survival time.
.

  11. Improvement of selective lignin degradation in fungal pretreatment of sweet sorghum bagasse using synergistic CuSO4-syringic acid supplements.

    PubMed

    Mishra, Vartika; Jana, Asim K; Jana, Mithu Maiti; Gupta, Antriksh

    2017-05-15

    Sweet sorghum bagasse (SSB) generated in large quantities could be hydrolyzed to sugar and then fermented to green fuels. The hydrolysis of SSB polysaccharides interlocked in recalcitrant lignin network is the major problem. Pretreatment of SSB in SSF by using Coriolus versicolor with CuSO 4 -syringic acid supplements for effects on production of ligninocellulolytic enzymes, lignin degradation and selectivity values (SV) were studied. C. versicolor was selected based on high ligninolytic and low cellulolytic abilily. Individually, CuSO 4 increased the activities of laccase (4.9 folds) and PPO (1.9 folds); syringic acid increased LiP (13 folds), AAO (2.8 folds) and laccase (5.6 folds) resulting in increased lignin degradation and SVs. Combined syringic acid (4.4 μmol g -1 SSB) and CuSO 4 (4.4 μmol g -1 SSB) increased the activities of laccase, LiP, MnP, PPO and AAO by 11.2, 17.6, 2.8, 2.4 and 2.3 folds respectively due to synergistic effect, resulting in maximum lignin degradation 35.9 ± 1.3% (w w -1 ) (1.86 fold) and highest SV 3.07 (4.7 fold). Enzymatic hydrolysis of pretreated SSB yielded higher (∼2.2 times) fermentable sugar. Pretreated SSB was characterized by XRD, SEM, FTIR and TGA/DTG analysis to confirm results. It is possible to improve fungal pretreatment of agricultural waste by combination of supplements. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. EGFR molecular profiling in advanced NSCLC: a prospective phase II study in molecularly/clinically selected patients pretreated with chemotherapy.

    PubMed

    Milella, Michele; Nuzzo, Carmen; Bria, Emilio; Sperduti, Isabella; Visca, Paolo; Buttitta, Fiamma; Antoniani, Barbara; Merola, Roberta; Gelibter, Alain; Cuppone, Federica; D'Alicandro, Valerio; Ceribelli, Anna; Rinaldi, Massimo; Cianciulli, Anna; Felicioni, Lara; Malatesta, Sara; Marchetti, Antonio; Mottolese, Marcella; Cognetti, Francesco

    2012-04-01

    The optimal use of epidermal growth factor receptor (EGFR)-related molecular markers to prospectively identify tyrosine kinase inhibitor (TKI)-sensitive patients, particularly after a previous chemotherapy treatment, is currently under debate. We designed a prospective phase II study to evaluate the activity of EGFR-TKI in four different patient groups, according to the combination of molecular (EGFR gene mutations, EGFR gene copy number and protein expression, and phosphorylated AKT expression, pAKT) and clinicopathological (histology and smoking habits) factors. Correlations between molecular alterations and clinical outcome were also explored retrospectively for first-line chemotherapy and EGFR-TKI treatment. Patients who had progressed during or after first-line chemotherapy were prospectively assigned to EGFR-TKI treatment as follows: (G1) EGFR mutation (n = 12); (G2) highly polysomic/amplified EGFR (n = 18); (G3) EGFR and/or pAKT positive (n = 41); (G4) adenocarcinoma/bronchoalveolar carcinoma and no smoking history (n = 15). G1 and G4 had the best and second-best overall response rate (25% and 20%, respectively), whereas the worst outcome was observed in G2 (ORR, 6%; p = 0.05). Disease control was highest in G1 and G4 (>50%) and lowest in G3 (<20%) (p = 0.02). Patients selected by EGFR mutation or clinical parameters (G1 and G4) also had significantly better progression-free survival and overall survival (p = 0.02 and p = 0.01, respectively). Multivariate analysis confirmed the impact of sex, smoking history, EGFR/KRAS mutation, and pAKT on outcomes and allowed us to derive an efficient predictive model. Histology, EGFR mutations, and pAKT were independent predictors of response to first-line chemotherapy at retrospective analysis, whereas pAKT and human epidermal growth factor receptor 2 expression were the only independent predictors of progression-free survival and overall survival. Selection of patients based on either EGFR mutation or clinical

  13. Progress in the second year of patients with quiescent pulmonary tuberculosis after a year of domiciliary chemotherapy, and influence of further chemotherapy on the relapse rate*

    PubMed Central

    Velu, S.; Andrews, R. H.; Angel, J. H.; Devadatta, S.; Fox, Wallace; Gangadharam, P. R. J.; Narayana, A. S. L.; Ramakrishnan, C. V.; Selkon, J. B.; Somasundaram, P. R.

    1961-01-01

    This study from the Tuberculosis Chemotherapy Centre, Madras, summarizes the progress during the second year of those patients in a 1-year comparison of four domiciliary chemotherapeutic regimens (isoniazid plus PAS and three regimens of isoniazid alone) whose pulmonary tuberculosis had attained bacteriological quiescence at the end of the year of chemotherapy. During the second year, about half of the patients received further chemotherapy, with isoniazid alone, and the remainder received a placebo, calcium gluconate. The main objects of the study were to determine the influence on the progress during the second year of (a) a second year of chemotherapy with isoniazid alone, (b) residual cavitation at the end of the first year, and (c) the chemotherapeutic regimen received during the first year, and to compare the results with those obtained in an earlier study by the Centre of the progress during the second year of patients with quiescent pulmonary tuberculosis after a year's chemotherapy with isoniazid plus PAS at home or in sanatorium. The results of the present study, which was planned on the same lines as the earlier one, showed that relapse in the second year was unrelated to the chemotherapeutic regimen received in the first year, and it was therefore permissible to amalgamate the findings in the two studies. The amalgamated results showed that the relapse rate in the second year was low (5.9%) and that a second year of treatment with isoniazid alone was of definite value for the patients with no residual cavitation at the end of the first year, but had no effect on the relapse rate of those with residual cavitation. The combined data from the two studies have thus clarified the position with regard to the effectiveness of isoniazid in preventing bacteriological relapse in patients without residual cavitation, slight evidence of which was apparent in the earlier study. PMID:13925282

  14. The use of anthracycline at first-line compared to alkylating agents or nucleoside analogs improves the outcome of salvage treatments after relapse in follicular lymphoma The REFOLL study by the Fondazione Italiana Linfomi.

    PubMed

    Rossi, Giuseppe; Marcheselli, Luigi; Dondi, Alessandra; Bottelli, Chiara; Tucci, Alessandra; Luminari, Stefano; Arcaini, Luca; Merli, Michele; Pulsoni, Alessandro; Boccomini, Carola; Puccini, Benedetta; Micheletti, Moira; Martinelli, Giovanni; Rossi, Andrea; Zilioli, Vittorio Ruggero; Bozzoli, Valentina; Balzarotti, Monica; Bolis, Silvia; Cabras, Maria Giuseppina; Federico, Massimo

    2015-01-01

    Follicular lymphoma (FL) patients experience multiple remissions and relapses and commonly receive multiple treatment lines. A crucial question is whether anthracyclines should be used at first-line or whether they would be better "reserved" for relapse and whether FL outcome can be optimized by definite sequences of treatments. Randomized trials can be hardly designed to address this question. In this retrospective multi-institutional study, time-to-next-treatment after first relapse was analyzed in 510 patients who had received either alkylating agents- or anthracycline- or nucleoside analogs-based chemotherapy with/without rituximab at first-line and different second-line therapies. After a median of 42 months, median time-to-next-treatment after relapse was 41 months (CI95%:34-47 months). After adjustment for covariates, first-line anthracycline-based chemotherapy with/without rituximab was associated with better time-to-next-treatment after any salvage than alkylating agents-based chemotherapy with/without rituximab or nucleoside analogs-based chemotherapy with/without rituximab (HR:0.74, P = 0.027). The addition of rituximab to first-line chemotherapy had no significant impact (HR:1.22, P = 0.140). Autologs stem cell transplantation performed better than any other salvage treatment (HR:0.53, P < 0.001). First-line anthracycline-based chemotherapy significantly improved time-to-next-treatment even in patients receiving salvage autologs stem cell transplantation (P = 0.041). This study supports the concept that in FL previous treatments significantly impact on the outcome of subsequent therapies. The outcome of second-line treatments, either with salvage chemoimmunotherapy or with autologs stem cell transplantation, was better when an anthracycline-containing regimen was used at first-line. © 2014 Wiley Periodicals, Inc.

  15. [Comparison of transverse short-axis classic and oblique long-axis "Syringe-Free" approaches for internal jugular venous catheterization under ultrasound guidance].

    PubMed

    Ince, Ilker; Arı, Muhammet Ali; Sulak, Muhammet Mustafa; Aksoy, Mehmet

    There are different ultrasound probe positions used for internal jugular venous catheter placement. Also, in-plane or out of plane needle approach may be used for catheterization. Transverse short-axis classic approach is the most popular performed approach in literature. "Syringe-Free" is a new described technique that is performed with oblique long-axis approach. We aimed to compare performance of these two approaches. This study was conducted as a prospective and randomized study. 80 patients were included the study and divided into two groups that were named Group C (transverse short-axis classic approach) and Group SF (oblique long-axis syringe-free approach) by a computer-generated randomization. The primary outcome was mean time that guidewire is seen in the internal jugular vein (performing time). The secondary outcomes were to compare number of needle pass, number of skin puncture and complications between two groups. Demographic and hemodynamic data were not significantly different. The mean performing time was 54.9±19.1s in Group C and 43.9±15.8s in Group SF. Significant differences were found between the groups (p=0.006). Mean number of needle pass was 3.2(±2.1) in Group C and 2.1(±1.6) in Group SF. There were statistically significant differences between two groups (p=0.002). The number of skin puncture was 1.6(±0.8) and 1.2(±0.5) in Group C and SF, respectively (p=0.027). "Syringe-Free" technique has lower performing time, number of needle pass and skin puncture. Also, it allows to follow progress of guide-wire under continuous ultrasound visualization and the procedure does not need assistance during catheter insertion. Namely, "Syringe-Free" is effective, safe and fast technique that may be used to place internal jugular venous catheter. Copyright © 2017 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  16. Impact of Neoadjuvant Chemotherapy on Breast Reconstruction

    PubMed Central

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

    2011-01-01

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

  17. CHOP plus etoposide and gemcitabine (CHOP-EG) as front-line chemotherapy for patients with peripheral T cell lymphomas.

    PubMed

    Kim, Jong Gwang; Sohn, Sang Kyun; Chae, Yee Soo; Kim, Dong Hwan; Baek, Jin Ho; Lee, Kyu Bo; Lee, Je-Jung; Chung, Ik-Joo; Kim, Hyeoung-Joon; Yang, Deok-Hwan; Lee, Won-Sik; Joo, Young-Don; Sohn, Chang-Hak

    2006-07-01

    The present study evaluated the feasibility of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) plus etoposide and gemcitabine (CHOP-EG) as front-line chemotherapy in patients with peripheral T cell lymphomas (PTCLs). Twenty-six patients with newly diagnosed PTCLs were enrolled into the pilot study. Treatment consisted of classical CHOP plus etoposide 100 mg/m(2) intravenously (i.v.) on day 1 and gemcitabine 600 mg/m(2) i.v. on day 1 in a 3 week interval. Fifteen complete responses (CR, 57.7%) or one unconfirmed complete response (uCR, 3.8%) and four partial responses (PR, 15.4%) were confirmed, giving an overall response rate of 76.9% (95% CI, 58.3-96.3%). Median survival has not yet been reached, while median event free survival was 215 days at a median follow-up duration of 383 days. Estimated overall survival at 1 year was 69.6%. The most severe haematological adverse event was neutropaenia, which occurred with a grade 4 intensity in 14 patients (53.8%). Additionally, febrile neutropaenia was observed in four patients (15.4%). However, there was no treatment-related death. The CHOP-EG regimen was found to be feasible in patients with PTCLs. For further investigation on the role of gemcitabine in the treatment of PTCLs, a more large scale phase II or phase III study is warranted.

  18. Haematological toxicity of Valproic acid compared to Levetiracetam in patients with glioblastoma multiforme undergoing concomitant radio-chemotherapy: a retrospective cohort study.

    PubMed

    Tinchon, Alexander; Oberndorfer, Stefan; Marosi, Christine; Gleiss, Andreas; Geroldinger, Angelika; Sax, Cornelia; Sherif, Camillo; Moser, Walter; Grisold, Wolfgang

    2015-01-01

    Patients with glioblastoma multiforme (GBM) and symptomatic seizures are in need of a sufficient antiepileptic treatment. Haematological toxicity is a limiting side effect of both, first line radio-chemotherapy with temozolomide (TMZ) and co-medication with antiepileptic drugs. Valproic acid (VPA) and levetiracetam (LEV) are considered favourable agents in brain tumor patients with seizures, but are commonly reported to induce haematological side effects on their own. We hypothesized, that antiepileptic treatment with these agents has no increased impact on haematological side effects during radio-chemotherapy in the first line setting. We included 104 patients from two neuro-oncologic centres with GBM and standard radio-chemotherapy in a retrospective cohort study. Patients were divided according to their antiepileptic treatment with either VPA, LEV or without antiepileptic drug therapy (control group). Declines in haemoglobin levels and absolute blood cell counts for neutrophil granulocytes, lymphocytes and thrombocytes were analyzed twice during concomitant and once during adjuvant phase. A comparison between the examined groups was performed, using a linear mixed model. Neutrophil granulocytes, lymphocytes and thrombocytes significantly decreased over time in all three groups (all p < 0.012), but there was no significant difference between the compared groups. A significant decline in haemoglobin was observed in the LEV treated group (p = 0.044), but did not differ between the compared groups. As a novel finding, this study demonstrates that co-medication either with VPA or LEV in GBM patients undergoing first line radio-chemotherapy with TMZ has no additional impact on medium-term haematological toxicity.

  19. Adenosine triphosphate-based chemotherapy response assay-guided chemotherapy in unresectable colorectal liver metastasis

    PubMed Central

    Hur, H; Kim, N K; Kim, H G; Min, B S; Lee, K Y; Shin, S J; Cheon, J H; Choi, S H

    2012-01-01

    Background: This study aims to evaluate the effectiveness of adenosine triphosphate-based chemotherapy response assay (ATP-CRA)-guided neoadjuvant chemotherapy for increasing resectability in patients with unresectable colorectal liver metastasis. Patients and methods: Patients were randomised into two groups: Group A was treated by conventional chemotherapy regimen and Group B was treated by chemotherapy regimen according to the ATP-CRA. Three chemotherapeutic agents (5-fluorouracil, oxaliplatin and irinotecan) were tested by ATP-CRA and more sensitive agents were selected. Either FOLFOX or FOLFIRI was administered. Between Group A and B, treatment response and resectability were compared. Results: Between November 2008 and October 2010, a total 63 patients were randomised to Group A (N=32) or Group B (N=31). FOLFOX was more preferred in Group A than in Group B (26 out of 32 (81.3%) vs 20 out of 31 (64.5%)). Group B showed better treatment response than Group A (48.4% vs 21.9%, P=0.027). The resectability of hepatic lesion was higher in Group B (35.5% vs 12.5%, P=0.032). Mean duration from chemotherapy onset to the time of liver resection was 11 cycles (range 4–12) in Group A and 8 cycles (range 8–16) in Group B. Conclusion: This study showed that tailored-chemotherapy based on ATP-CRA could improve the treatment response and resectability in initially unresectable colorectal liver metastasis. PMID:22068817

  20. Polymerase ε (POLE) ultra-mutation in uterine tumors correlates with T lymphocyte infiltration and increased resistance to platinum-based chemotherapy in vitro

    PubMed Central

    Bellone, Stefania; Eliana, Bignotti; Lonardi, Silvia; Ferrari, Francesca; Centritto, Floriana; Masserdotti, Alice; Pettinella, Francesca; Black, Jonathan; Menderes, Gulden; Altwerger, Gary; Hui, Pei; Lopez, Salvatore; de Haydu, Christopher; Bonazzoli, Elena; Predolini, Federica; Zammataro, Luca; Cocco, Emiliano; Ferrari, Federico; Ravaggi, Antonella; Romani, Chiara; Facchettie, Fabio; Sartori, Enrico; Odicino, Franco E.; Silasi, Dan-Arin; Litkouhi, Babak; Ratner, Elena; Azodi, Masoud; Schwartz, Peter E.; Santin, Alessandro D.

    2016-01-01

    Objective Up to 12 % of all endometrial-carcinomas (EC) harbor DNA-polymerase-ε-(POLE) mutations. It is currently unknown whether the favorable prognosis of POLE-mutated EC is derived from their low metastatic capability, extraordinary number of somatic mutations thus imparting immunogenicity, or a high sensitivity to chemotherapy. Methods Polymerase-chain-reaction-amplification and Sanger-sequencing were used to test for POLE exonuclease-domain-mutations (exons 9–14) 131 EC. Infiltration of CD4+ and CD8+ T-lymphocytes (TIL) and PD-1-expression in POLE-mutated vs POLE wild-type EC was studied by immunohistochemistry (IHC) and the correlations between survival and molecular features were investigated. Finally, primary POLE-mutated and POLE-wild-type EC cell lines were established and compared in-vitro for their sensitivity to chemotherapy. Results Eleven POLE-mutated EC (8.5%) were identified. POLE-mutated tumors were associated with improved progression-free-survival (P<0.05) and displayed increased numbers of CD4+ (44.5 vs 21.8; P = .001) and CD8+ (32.8 vs 13.5; P < .001) TILs when compared to wild-type POLE EC. PD-1 receptor was overexpressed in TILs from POLE-mutated vs wild-type-tumors (81% vs 28%; P < .001). Primary POLE tumor cell lines were significantly more resistant to platinum-chemotherapy in-vitro when compared to POLE-wild-type tumors (P < 0.004). Conclusions POLE ultra-mutated EC are heavily infiltrated with CD4+/CD8+ TIL, overexpress PD-1 immune-check-point (i.e., features consistent with chronic antigen-exposure), and have a better prognosis when compared to other molecular subtypes of EC patients. POLE-mutated tumor-cell lines are resistant to platinum-chemotherapy in-vitro suggesting that the better prognosis of POLE-patients is not secondary to a higher sensitivity to chemotherapy but likely linked to enhanced immunogenicity. PMID:27894751