"Mixing triptans": patient satisfaction

(Headache 2011;51:135‐140) Background.— Although some patients may prefer using an oral triptan other than sumatriptan and injectable sumatriptan to treat an attack of persistent migraine, administration of 2 different triptans within a 24‐hour period currently is contradicted. Objective.— We sought to determine patient satisfaction with an acute migraine treatment regimen wherein patients were permitted to administer an oral triptan other than sumatriptan and injectable sumatriptan within 24 hours of one another Methods.— We evaluated a consecutive series of migraine patients who either had tried and failed oral sumatriptan or were using another oral triptan and were satisfied with it. We advised subjects that they could administer their oral triptan and injectable sumatriptan within a single 24‐hour period (but not within 2 hours of one another); we termed such treatment “mixing triptans.” We asked all subjects to keep detailed written headache diaries for the 6‐month treatment period, and at the 6‐month end‐of‐study visit we asked subjects who had treated at least 3 migraine attacks by mixing triptans to rate their satisfaction with that treatment according to a 5‐point Likert scale. Results.— Of the 200 subjects enrolled, 132 (66%) used an oral triptan other than sumatriptan and injectable sumatriptan within a 24‐hour period on at least 3 occasions. At their final follow‐up visits, 117 (89%) of the 132 reported themselves “very satisfied” or “satisfied” with this specific treatment regimen. No serious adverse events were recorded. Conclusion.— The option of sequentially using an oral triptan other than sumatriptan and injectable sumatriptan to treat a given attack of migraine appears to correlate with a high rate of patient satisfaction. While in our subject population this treatment regimen was well tolerated, our study results do not suffice to establish the safety of “mixing triptans.”     

可注射智能壳聚糖水凝胶的研究进展

本文简要介绍了以壳聚糖或其衍生物为原料制备的可注射智能水凝胶的研究进展、应用以及尚待解决的问题,探讨其作为生物医药高分子材料的前景.     

Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence

Objective The aim of this study was to systematically review all published evidence to determine the efficacy and safety of injectable bulking agents for passive faecal incontinence (FI) in adults. Method Electronic searches were performed for MEDLINE, EMBASE, ISI Web of Knowledge and other relevant databases. Hand searching of relevant conference proceedings was undertaken. Studies were considered if they met the predefined inclusion criteria of more than ten adult patients and receiving an injectable bulking agent for passive FI with a validated means of assessing preoperative and postoperative incontinence. Results Thirteen case series studies and one randomized placebo‐controlled trial (RCT) were included with a total of 420 patients. Two completed RCTs with placebo control were identified but results were unobtainable. Coaptite, Contigen, Durasphere, EVOH and PTQ injections were assessed with 24, 73, 83, 21 and 208 patients respectively. Most studies reported a statistically significant improvement in incontinence scores and quality of life. No statistically significant difference was found between the treatment and placebo arms in the RCT. No serious adverse events were reported. Conclusions Currently there is little evidence for the effectiveness of injectable bulking agents in managing passive FI. The inability to obtain results from two further RCTs concerned the reviewers and hindered their ability to make strong recommendations. The identified injectable bulking agents appear to be safe with only minor complications reported.     

注射型植入剂体外释放方法的考察

目的考察注射型植入剂体外释放方法的可行性。方法建立模型药物诺氟沙星的反相高效液相色谱测定方法,以直接注射法、单向圆筒法、透析袋法及自制圆筒法考察注射型植入剂的体外释药特性,并与大鼠皮下注射的释放结果作比较。结果注射型植入剂体内释药速率明显快于体外,体内持续释药阶段(1~20 d)接近零级释药(r=0.993 5),而体外持续释药阶段以15 d为界分为缓慢释药、快速释药两个阶段。4种体外释放方法中,自制圆筒法的突释阶段较为接近体内释药。结论注射型植入剂的4种体外释放方法均有一定的缺陷,不能完全模拟药物在体内的释放情况,注射型植入剂的体外释放方法有待于进一步探索。     

骨髓间充质干细胞在骨形态发生蛋白2/注射式硫酸钙载体上的成骨

背景：将生长因子复合到支架上构建复合材料可同时具备骨诱导和骨传导作用。 目的：观察骨形态发生蛋白2/注射式硫酸钙复合载体对大鼠骨髓间充质干细胞体外诱导成骨的影响。 方法：取生长状态良好的第2代SD大鼠骨髓间充质干细胞悬液,分3组培养：实验组将细胞悬液滴加到骨形态发生蛋白2/注射式硫酸钙复合材料表面,对照组在细胞悬液中加入骨形态发生蛋白2,空白对照组正常培养。 结果与结论：3组细胞随培养时间延长逐渐增多,实验组细胞数量最多,明显多于对照组及空白对照组(P < 0.05)。实验组培养不同时间点碱性磷酸酶活性高于对照组及空白对照组(P < 0.05)。体外实验显示骨形态发生蛋白2/注射式硫酸钙复合载体可促进骨髓间充质干细胞向成骨细胞分化。     

Organizational Status of Dialysis Facilities and Patient Outcome: Does Higher Injectable Medication Use Mediate Increased Mortality?

Objective

Examine the mediating effect of injectable drugs in the relationship between dialysis facility organizational status and patient mortality.

Study Setting

Medicare dialysis population.

Study Design

Data from the U.S. Renal Data System (USRDS) were used to identify 3,884 freestanding dialysis facilities and 37,942 Medicare patients incident to end-stage renal disease (ESRD) in 2006. The role of injectable medications was evaluated during a 2-year follow-up period by mediational analyses using mixed-effect regression models.

Data Collection

USRDS data were matched with Dialysis Facility Report data from Centers for Medicare and Medicaid Services (CMS) and census data.

Principal Findings

There was a strong association found between organizational status and use of injectable drugs. Large for-profit chains used significantly higher injectable medications compared with nonprofit chains and independent facilities. However, the relationship between facility organizational status and patient mortality was not found to be mediated through the higher use of injectable drugs.

Conclusions

Large for-profit chain facilities administered higher IV epoetin, iron, and vitamin D dosages, but this did not result in improved survival. Given the associated costs and lack of a survival benefit, the overuse of injectable medications among the U.S. dialysis patients will likely end under the recent bundling of injectable medications without jeopardizing patient outcomes.     

目前有关避孕药安全性的争议问题

该文阐述了目前避孕药安全性有争议的4个问题,包括避孕药是否增加静脉血栓,子宫肌瘤,子宫颈癌和骨密度降低等不良反应的相关风险。表明对有恰当的适应证,使用中能有较好观察的育龄妇女,使用避孕药仍然是可供选择的有价值的避孕措施。     

FDA对注射药品包装类型术语的新要求

美国食品药品管理局（FDA）于2015年12月发布了“多剂量、单剂量和单一患者用容器包装的人用注射药品的合适包装类型术语的选择和标识建议行业指导原则（草案）”,该指导原则明确了人用注射药品的包装类型术语的定义,并对药品说明书和包装标签上如何进行标识提供了相应建议,以保证使用者很容易识别包装类型,进而保障用药安全。我国目前尚无这类指导原则,介绍该指导原则的主要内容,以期对我国制药企业严谨而合理使用注射药品的包装类型术语和药品监管部门加强这方面的管理有所帮助。     

Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil

Aripiprazole monohydrate (AM) and aripiprazole lauroxil (AL) are two different long-acting injectable formulations of aripiprazole. AM 400 mg administered once monthly demonstrated efficacy in an acute, double-blind, placebo-controlled, randomized clinical trial, as well as in a double-blind, placebo-controlled, randomized-withdrawal maintenance study, and in two non-inferiority maintenance studies. AL is a prodrug of aripiprazole and available in 441 mg, 662 mg or 882 mg strengths. AL 441 mg and 882 mg administered once monthly demonstrated efficacy in an acute, double-blind, placebo-controlled, randomized clinical trial. The pharmacokinetic profile of AL also led to approval of dosing intervals of every 6 weeks for the 882 mg dose. The overall tolerability profiles of both products are consistent with what is known about oral aripiprazole.     

Treatment of menopausal symptoms with three low-dose continuous sequential 17β-estradiol/progesterone parenteral monthly formulations using novel non-polymeric microsphere technology

Abstract

Objective: To analyze the short-term efficacy and safety over menopausal symptoms of three low-dose continuous sequential 17β-estradiol (E)/progesterone (P) parental monthly formulations using novel non-polymeric microspheres.

Methods: This was a multicenter, randomized, single blinded study in which peri- and postmenopausal women were assigned to receive a monthly intramuscular injection of 0.5?mg E?+?15?mg?P (Group A, n?=?34), 1?mg E?+?20?mg?P (Group B, n?=?24) or 1?mg E?+?30?mg?P (Group C, n?=?26) for 6 months. Primary efficacy endpoints included mean change in the frequency and severity of hot flushes and the effect over urogenital atrophy symptoms at 3 and 6 months. Safety variables included changes in the rate of amenorrhea, endometrial thickness and histopathology, and local and systemic adverse events.

Results: Compared to baseline at month 6, the three treatment schemes significantly decreased the rate of urogenital atrophy symptoms and the frequency (mean number per day) and severity (mean number graded as moderate and severe per month) of hot flushes. No differences in studied efficacy parameters were observed between studied groups at baseline or at the end of the study. For all groups the most frequent adverse event was pain at the injection site; however they were all rated as mild. At the end of the study peri- and postmenopausal women displayed no significant changes in endometrial thickness or histopathology in all treated groups. The rate of amenorrhea at the end of the study decreased for all studied groups yet was less evident among postmenopausal women as compared to perimenopausal ones.

Conclusions: The three low-dose continuous sequential intramuscular monthly treatments of E/P using novel microsphere technology were effective at reducing menopausal symptoms at short-term with a low rate of adverse events. More long-term and comparative research is warranted to support our positive findings.