基于真实世界数据的药物利用研究综述  

Review of drug utilization research based on real-world data

作　　者：张元林 宋凯 孙蕊 舒飞 舒丽芯 杨樟卫 ZHANG Yuanlin;SONG Kai;SUN Rui;SHU Fei;SHU Lixin;YANG Zhangwei(No.77570 troops of the PLA,Qamdo 854000,China;Demonstration Center of Military Medical Logistics,School of Pharmacy,Naval Medical University,Shanghai 200433,China;No.32106 troops of the PLA,Ximeng 026300,China;Gansu Armed Police Corps Hospital,Lanzhou 730030,China;Shanghai Fourth People’s Hospital,Shanghai 200433,China)

机构地区：[1]中国人民解放军77570部队,西藏昌都854000 [2]海军军医大学药学系军队药材保障论证中心,上海200433 [3]中国人民解放军32106部队,内蒙古锡盟026300 [4]武警甘肃省总队医院,甘肃兰州730030 [5]上海市第四人民医院,上海200433

出　　处：《药学实践与服务》2024年第6期238-243,共6页Journal of Pharmaceutical Practice and Service

摘　　要：近年来,医学信息技术突飞猛进,基于真实环境分析大规模的诊疗数据并挖掘其中规律,已经成为国内外药械上市评价及监管决策的重要手段。真实世界研究作为药物利用研究领域一种新的药物临床评价方法,为观察性研究在实际疗效或效果方面的评价带来了机遇和挑战。然而,作为药物利用研究领域广大学者关注的热门方法学手段,当前真实世界研究关于人群用药特征分析还存在一些局限和不足,尚未形成系统性的评估研究方法,还不能很好的生成真实世界证据。该研究旨在综述基于真实世界数据的药物利用研究的研究设计、方法路径、评价指标、混杂因素及偏倚处理等进展,以便为药物利用研究深入开展提供参考。In recent years,the rapid development of medical information technology has made it critical to analyze largescale diagnosis and therapeutic data and extract rules based on real medical environment.This has become an essential approach for marketing evaluation and regulatory decision-making of drugs and devices both domestically and internationally.Real world study(RWS),as a novel methodology for clinical evaluation of drugs in the field of drug utilization research(DUR),have presented opportunities and challenges for observational studies in assessing actual efficacy or effectiveness.However,despite being a popular methodological approach among scholars in the field,there are still limitations and deficiencies when analyzing population medication characteristics in RWS.Systematic evaluation research methods have not yet been established,leading to inadequate generation of real-world evidence(RWE).The research design,methodological pathways,evaluation indicators,confounding factors,and bias management involved in DUR based on real-world data(RWD)were reviewed in this artical with the intention of providing guidance for further exploration into DUR.

关 键 词：真实世界研究 药物利用研究 合理用药分析 真实世界证据 真实世界数据 

分 类 号：R95[医药卫生—药学]