弹力袜在围术期静脉血栓栓塞症防治中的最佳证据总结

目的 检索并整合弹力袜在围术期静脉血栓栓塞症防治中的最佳证据,为临床实践提供依据。方法 根据“6 S”证据模型,系统检索国内外中英文数据库及指南网,对符合纳入标准的文献由2名研究者分别进行质量评价,并结合专业判断完成证据的提取及汇总。结果 共纳入9篇文献,包括2篇指南,1篇专家共识,4篇推荐实践,1篇证据总结,1篇系统评价。通过对证据的汇总,最终分别从适应证、禁忌证、压力选择、长度选择、尺寸测量、穿着时机、评估与观察7个方面形成了24条最佳证据。结论 总结了弹力袜在围术期静脉血栓栓塞症防治中的最佳证据,为医护人员的临床决策提供了依据,实践过程中应结合患者意愿、临床实际有针对性的进行证据选择。     

葛根素注射剂不良反应的循证医学研究

目的系统分析葛根素注射液不良反应发生现状,为临床用药提供参考依据。方法计算机检索中国期刊全文数据库、中文科技期刊数据库和中国生物医学文献数据库公开发表的有关葛根素注射液临床随机对照试验及不良反应病例报告等文献,应用描述性评价方法进行分析。结果共有221篇文献纳入研究。葛根素注射液不良反应发生涉及多个系统,不良反应发生率为2.5%;部分重症病例是在出现不适反应后继续用药,导致了严重不良反应后果,甚至死亡。结论葛根素注射液不良反应发生率较低,但用药过程需严密监视患者反应,如出现不适症状继续用药可导致严重后果,甚至危及患者生命。     

真实世界证据与随机对照试验：RCT DUPLICATE项目概述

摘 要近年来,利用真实世界数据（real world data, RWD）通过恰当的设计和分析产生真实世界证据（real world evidence, RWE）,已经成为学术界、工业界和监管机构共同关注的话题。但RWE能否代替来自严格受控的随机对照试验（RCT）产生的证据仍不确定。为此,2018年美国启动了RCT DUPLICATE项目,旨在利用真实世界证据,通过非随机的观察性研究来重复RCT的结果。本文回顾了RCT DUPLICATE产生的背景,重点介绍了该项目的研究团队、研究目的、研究内容及项目意义,以期促进国内学者更好地理解RWE的适用范围和应用价值。     

贵州水族22个STR基因座遗传多态性调查

目的 调查22个STR基因座在贵州水族人群中的群体遗传学数据,研究其在法医学中的应用价值.方法 应用PowerPlex(R) Fusion系统对124名贵州水族无关个体血样DNA进行PCR扩增,用ABI 3500型遗传分析仪进行毛细管电泳,GeneMapper ID-X软件进行基因分型,Modified-Powerstates进行统计分析.结果 获得22个STR基因座等位基因的频率分布与相关法医学参数,其中:各基因座H值介于0.573～0.884,DP值介于0.763～0.974,PE值介于0.260～0.763,PIC值介于0.52～0.87,累计个人识别率为1-33682×10-25,累计非父排除概率为0.999999994.结论 D3S1358等22个STR基因座在贵州水族人群中具有良好的遗传多态性和法医学应用价值.     

用于支持药械注册的现实世界研究统计学思考

目的 探讨现实世界研究(RWS)获得现实世界证据(RWE)的统计学问题.方法 对现实世界数据(RWD),RWS的因果推断方法及RWE的评价方式进行总结,分析现存问题.结果 获得可靠的RWE用于支持药械监管是RWS的重要目标,适当的RWD通用标准是进行数据质量评价的前提,规范化的数据治理和完善的数据质量评价体系是规范开展...     

A “leap in the dark?” Lessons for the United Kingdom from past extensions of bar opening hours

The Licensing Act of 2003 for England and Wales paves the way for 24-hour opening of licensed premises. Senior members of the United Kingdom Government have claimed that the pressure of rigid closing times contributes to the rising problem of binge-drinking and associated harm in the UK. Removing set opening times it is hoped will reduce these problems. These plans have been widely criticised. Moreover, international evidence suggests this may not be the case. Studies from Europe, Iceland, Australia and North America have indicated that extending trading hours may not only fail to reduce alcohol-related problems but might increase them. Evidence exists of licensing liberalisation being followed by rises in alcohol consumption, violent crime, traffic accidents, illicit drug use as well as extra public health and tourism costs.     

基于D-S证据理论的电厂工业控制系统信息安全风险评估

针对工业控制系统日益严峻的信息安全问题,结合工业控制系统信息安全的特点,提出了一种结合D S证据理论和层次分析法的工业控制系统信息安全风险评估方法。首先建立风险评估层次结构,并量化专家的语言评价;然后采用D S证据理论对评估结果进行合成来降低主观因素的影响;最后利用各安全威胁概率的置信区间进行重要性排序,并提出了相关信息安全防护对策。对火电厂工业控制系统的应用结果表明,该方法能够量化各安全威胁的影响,能有效处理工业控制系统信息安全风险评估过程中的不确定性问题。     

Replication of Randomized,Controlled Trials Using Real-World Data: What Could Go Wrong?

With the growing interest in using real-world evidence (RWE) for regulatory purposes, researchers and policy makers are considering how best to assess the credibility of RWE. Because the randomized controlled trial (RCT) has long been regarded as the gold standard for high-quality research, one approach being pursued is to see to what extent findings from RCTs can be replicated based on analyses of nonrandomized real-world data (RWD). If findings are congruent, the reasoning goes, this would bolster confidence in the underlying RWD sources and validity of the RWE generated. But it is well known that medical interventions perform differently in experimental clinical trials versus real-world clinical practice, reflecting a phenomenon known as the “efficacy-effectiveness gap.” So even with the highest-quality RWD sources and strongest analytic methods, we can and should expect to observe discrepancies in findings between RCTs and RWE. This calls into question the objectives of RCT replication efforts and makes clear that impugning RWD sources and analytic methods for failing to align with RCT findings is inappropriate and, worse, potentially harmful to the growing acceptance of RWE in stakeholder decision making.     

Effectiveness of the recombinant zoster vaccine among Kaiser Permanente Hawaii enrollees aged 50 and older: A retrospective cohort study

BackgroundThe incidence of herpes zoster (HZ) has been on the rise for decades in the United States. Clinical trials for the recombinant zoster vaccine (RZV) demonstrated vaccine efficacy of over 90% in preventing herpes zoster. However, there is limited information on its effectiveness outside of a clinical trial setting, as well as its effectiveness against herpes zoster ophthalmicus (HZO).MethodsA de-identified electronic health records database from Kaiser Permanente Hawaii (KPH) was used to conduct this retrospective cohort study to assess the effectiveness of the recombinant zoster vaccine against HZ and HZO in immunocompetent, vaccine age-eligible individuals without a prior history of HZ, who were continuously enrolled in KPH for ≥365 days prior to becoming age-eligible for RZV between January 1, 2018, through December 31, 2019.ResultsA total of 78 356 adults were included in this study, with 11 864 (15.1%) adults receiving two valid doses of the recombinant zoster vaccine. The incidence rate of HZ was 325.6 (95% CI: 217.7 to 464.4) cases per 100 000 person-years in vaccinated persons compared to 1063.3 cases per 100 000 person-years (95% CI: 1006.0 to 1122.8) in the unvaccinated group. The incidence rate of HZO was 11.9 (95% CI: 0.7 to 52.3) cases per 100 000 person-years in the vaccinated group compared to 72.1 (95% CI: 58.0 to 88.3) in the unvaccinated group. RZV was 83.5% (95% CI: 74.9% to 89.2%) effective against HZ and 93.3% (95% CI: 48.7% to 99.1%) effective against HZO.ConclusionsRZV has demonstrated high effectiveness against both HZ and HZO outside of a clinical trial setting in the United States. Vaccine coverage is low, emphasizing the need for public health efforts to increase vaccination to reduce morbidity from HZ and HZO.