基于真实世界数据的药物利用研究综述
投稿时间:2023-12-05  修订日期:2024-03-21  点此下载全文
引用本文:张元林,宋凯,孙蕊,舒飞,舒丽芯,杨樟卫.基于真实世界数据的药物利用研究综述[J].药学实践杂志,2024,42(6):238~243
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作者单位E-mail
张元林 中国人民解放军 77570部队, 西藏 昌都 854000
海军军医大学药学系军队药材保障论证中心, 上海 200433 
 
宋凯 海军军医大学药学系军队药材保障论证中心, 上海 200433
中国人民解放军 32106部队, 内蒙古 锡盟 026300 
 
孙蕊 海军军医大学药学系军队药材保障论证中心, 上海 200433
武警甘肃省总队医院, 甘肃 兰州 730030 
 
舒飞 海军军医大学药学系军队药材保障论证中心, 上海 200433  
舒丽芯 海军军医大学药学系军队药材保障论证中心, 上海 200433 shulixin@smmu.edu.cn 
杨樟卫 上海市第四人民医院, 上海 200433  
中文摘要: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。
中文关键词: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
 
Review of drug utilization research based on real-world data
Abstract:In recent years, the rapid development of medical information technology has made it critical to analyze large-scale 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.
keywords:real-world research  drug utilization research  rational drug use analysis  real-world evidence  real-world data
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