Prospective Benefit-Risk Monitoring of New Drugs for Rapid Assessment of Net Favorability in Electronic Health Care Data

BackgroundBenefit-risk assessment (BRA) methods can combine measures of benefits and risks into a single value.ObjectivesTo examine BRA metrics for prospective monitoring of new drugs in electronic health care data.MethodsUsing two electronic health care databases, we emulated prospective monitoring of three drugs (rofecoxib vs. nonselective nonsteroidal anti-inflammatory drugs, prasugrel vs. clopidogrel, and denosumab vs. bisphosphonates) using a sequential propensity score–matched cohort design. We applied four BRA metrics: number needed to treat and number needed to harm; incremental net benefit (INB) with maximum acceptable risk; INB with relative-value–adjusted life-years; and INB with quality-adjusted life-years (QALYs). We determined whether and when the bootstrapped 99% confidence interval (CI) for each metric excluded zero, indicating net favorability of one drug over the other.ResultsFor rofecoxib, all four metrics yielded a negative value, suggesting net favorability of nonselective nonsteroidal anti-inflammatory drugs over rofecoxib, and the 99% CI for all but the number needed to treat and number needed to harm excluded the null during follow-up. For prasugrel, only the 99% CI for INB-QALY excluded the null, but trends in values over time were similar across the four metrics, suggesting overall net favorability of prasugrel versus clopidogrel. The 99% CI for INB-relative-value–adjusted life-years and INB-QALY excluded the null in the denosumab example, suggesting net favorability of denosumab over bisphosphonates.ConclusionsProspective benefit-risk monitoring can be used to determine net favorability of a new drug in electronic health care data. In three examples, existing BRA metrics produced qualitatively similar results but differed with respect to alert generation.     

Recent Evidence of Hantavirus Circulation in the American Tropic

Hantaan virus was discovered in Korea during the 1970s while other similar viruses were later reported in Asia and Europe. There was no information about hantavirus human infection in the Americas until 1993 when an outbreak was described in the United States. This event promoted new studies to find hantaviruses in the Americas. At first, many studies were conducted in Brazil, Argentina, Chile, Uruguay and Paraguay, while other Latin American countries began to report the presence of these agents towards the end of the 20th century. More than 30 hantaviruses have been reported in the Western Hemisphere with more frequent cases registered in the southern cone (Argentina, Chile, Uruguay, Paraguay, Bolivia and Brazil). However there was an important outbreak in 2000 in Panama and some rare events have been described in Peru, Venezuela and French Guiana. Since hantaviruses have only recently emerged as a potential threat in the tropical zones of the Americas, this review compiles recent hantavirus reports in Central America, the Caribbean islands and the northern region of South America. These studies have generated the discovery of new hantaviruses and could help to anticipate the presentation of possible future outbreaks in the region.     

3种视网膜新生血管抑制药治疗湿性AMD的临床对比研究

目的:比较3种视网膜新生血管抑制药治疗湿性老年黄斑变性(AMD)的临床疗效,探讨其临床应用价值。方法:按照随机数字法将2013年8月-2016年10月某院收治的114例(114眼)湿性AMD患者分为A、B、C 3组,每组38例。A组患者静脉输注维替泊芬结合光动力疗法,B组与C组患者分别玻璃体内腔注射雷珠单抗与康柏西普,均每月给药1次,治疗3个月,随访3个月。比较治疗前及治疗后1个月、3个月、6个月3组患者的裸眼视力、黄斑中心视网膜厚度、脉络膜新生血管(CNV)渗漏面积以及并发症发生情况。结果:治疗前,3组患者的裸眼视力、黄斑中心视网膜厚度及CNV渗漏面积比较差异无显著性(P>0.05),治疗后,3组患者的裸眼视力均显著提高、黄斑中心视网膜厚度及CNV渗漏面积均显著减小(P<0.05)。A组在治疗后1、3个月的裸眼视力显著低于B与C组、黄斑中心视网膜厚度及CNV渗漏面积显著大于B与C组(P<0.05),C组在治疗后1个月的裸眼视力显著低于B组、黄斑中心视网膜厚度及CNV渗漏面积显著大于B组(P<0.05);治疗后6个月,3组患者的裸眼视力、黄斑中心视网膜厚度及CNV渗漏面积比较差异无显著性(P>0.05);3组患者并发症的发生率差异无显著性(P>0.05)。结论:在湿性AMD的临床治疗中,雷珠单抗的前期效果明显,但3种药物的后期效果相当。     

7种新型口服抗凝药预防全髋、膝关节置换术后静脉血栓栓塞症的网状Meta分析

目的 采用网状Meta分析法,比较7种新型口服抗凝药预防全髋、膝关节置换术后静脉血栓栓塞症作用的有效性。方法 检索CBM、Cochrane Library、Pubmed等数据库,从中提取随机对照试验,进行质量评价。应用软件Stata12.0,采用mvmeta程序包分析数据。结果 检索相关文献1 091篇,24篇符合标准,共计40 001例患者;按处方药物用量评价预防静脉血栓栓塞症的有效性。直接比较结果：利伐沙班、阿哌沙班优于低分子肝素,结果分别为：RR=0.56,95% CI：0.40~0.78,P<0.05;RR=0.39,95% CI：0.24~0.63,P<0.05。其余5种新型口服抗凝药与低分子肝素比较无显著差别（P>0.05）。间接比较,结果均优于安慰剂。结论 7种新型口服抗凝药预防全髋、膝关节置换术后静脉血栓栓塞症的有效性等级排名：阿哌沙班最佳,其次为利伐沙班、依度沙班、Ym150、TAK-442、达比加群酯、贝曲沙班。     

血凝酶效价测定新方法的方法学研究

目的：本研究提供了一种新的血凝酶效价测定的方法。方法:采用凝血质控血浆为底物,以凝血分析仪进行测定,利用血凝酶可以直接水解血浆中纤维蛋白原为纤维蛋白使血浆凝固,并且在一定血凝酶浓度范围内,血浆的凝固时间与血凝酶效价成反比的原理,测得血凝酶效价。结果:本方法对血凝酶的精密度的相对标准偏差为2.3%,准确度的相对标准偏差在4.1%～4.8%之间,定量线性范围为0.4U.mL-1～2.5 U.mL-1,并具有良好的专属性和耐用性,通过市售3个规格9批次注射用矛头蝮蛇血凝酶效价测定,能够较好的控制产品的效价。结论:本研究避免了检验人对凝固终点判定标准的不同和人-枸缘酸血浆存在的差异,所导致产品之间效价存在的差异,实现血凝酶高效、准确的测定。     

《政府会计制度》与《医院会计制度》会计科目衔接方法研究

为了建立健全政府会计核算体系,实现权责发生制政府综合财务报告制度,国家财政部制定了适用于各级各类行政事业单位统一的会计制度——政府会计制度,此制度适用于各级各类行政单位和事业单位,包括医院及基层医疗卫生机构。文章从《政府会计制度》与《医院会计制度》衔接的前期准备工作、新账科目设置与衔接方法进行了研究。     

新时期公立医院党建工作的实践与思考

随着医药卫生体制改革的不断深入,公立医院党建工作面临许多新情况新问题,如何正确应对和解决这些问题、推动党建工作进一步改进创新,已成为医院改革发展需要面对的重要课题。通过总结思考北京协和医院开展党建工作的经验做法,对新时期加强公立医院党建工作提供了借鉴和启示。     

基于新制度主义视角的药品集中招标采购制度研究

目的：为完善我国药品招标采购政策提供参考。方法：分析相关文献和数据,并基于新制度主义视角,从制度的合法性、路径依赖以及权力与利益的博弈三个方面,分析我国药品招标采购制度运行过程中出现问题的原因。结果与结论：我国药品招标采购制度实施过程中存在招标评价指标不合理,药品质量难以保障;招标采购分离、量价不挂钩;医疗机构回款较慢等问题。建议均衡各个利益集团的利益,完善医疗机构补偿机制,优化综合招标评价体系,落实招标采购合一、带量采购,规范政府在招标采购制度中的现代施政原则。     

Mutations in PLS1, encoding fimbrin,cause autosomal dominant nonsyndromic hearing loss

Nonsyndromic hearing loss (NSHL), a common sensory disorder, is characterized by high clinical and genetic heterogeneity (i.e., approximately 115 genes and 170 loci so far identified). Nevertheless, almost half of patients submitted for genetic testing fail to receive a conclusive molecular diagnosis. We used next‐generation sequencing to identify causal variants in PLS1 (c.805G>A, p.[E269K]; c.713G>T, p.[L238R], and c.383T>C, p.[F128S]) in three unrelated families of European ancestry with autosomal dominant NSHL. PLS1 encodes Plastin 1 (also called fimbrin), one of the most abundant actin‐bundling proteins of the stereocilia. In silico protein modeling suggests that all variants destabilize the structure of the actin‐binding domain 1, likely reducing the protein's ability to bind F actin. The role of PLS1 gene in hearing function is further supported by the recent demonstration that Pls1^?/? mice show a hearing loss phenotype similar to that of our patients. In summary, we report PLS1 as a novel gene for autosomal dominant NSHL, suggesting that this gene is required for normal hearing in humans and mice.