真实世界数据研究在药品上市后安全性监测评价应用的进展研究  

A Study on the Progress of Real-World Data Studies Used in Post-Marketing Safety Monitoring and Evaluation of Drugs

作　　者：李丽敏 吴文宇 魏芬芳 唐碧雨 吴建茹 LI Li-min;WU Wen-yu;WEI Fen-fang;TANG Bi-yu;WU Jian-ru(Shenzhen Institute of Pharmacovigilance and Risk Management)

机构地区：[1]深圳市药物警戒和风险管理研究院

出　　处：《中国食品药品监管》2024年第10期112-125,共14页China Food & Drug Administration Magazine

基　　金：2023年度基础研究专项(深圳市自然科学基金)面上项目(JCYJ20230807150659006);2023年度广东省基础与应用基础研究基金自然科学基金(2023A1515011495);广东省药品监督管理局2021年科技创新项目(2021ZDB01);广东省药品监督管理局2022年科技创新项目(2022TDB16)。

摘　　要：目的:探讨二十多年来真实世界数据研究在药品上市后安全性监测评价应用中的现状与热点,为开展药品安全性监测评价相关研究提供参考。方法:在中国知网和Web of Science数据库中检索相关关键词,检索时限为2002年1月至2023年8月。利用R语言等多个软件对年度发文量、机构以及关键词的聚类、归类、热点趋势等进行可视化分析。结果:共纳入文献3907篇,二十多年来该领域相关研究的年度发文量波动上涨。目前不良反应和药品安全是国内外共同关注的热点;在分析方法、数据来源、群体、应用等7个研究方向逐渐深入;数据挖掘是该领域未来的主要研究方向。结论:真实世界数据研究在药品上市后安全性监测评价中的应用需通过多学科多机构跨区域合作交流,进一步扩展研究规模与深度,开拓更多真实世界数据的来源,加强真实世界数据的挖掘与利用,形成有效、互通互认、开放、可持续的药品安全性数据。另外,真实世界数据还需发挥对特殊群体用药安全评估和药物再利用等方面的作用。Objective:To explore the current status and hotspots of real-world data(RWD)research in post-marketing drug safety monitoring and evaluation over the past two decades,providing a reference for related research in this area.Methods:Keywords were searched in the China National Knowledge Infrastructure and Web of Science databases spanning from January 2002 to August 2023.Visualization analyses of annual publication volume,institutions,keyword clustering and categorization,hot trends,and other aspects were conducted using R language and other software.Results:A total of 3907 articles were included.The annual publication volume in this field has fluctuated and increased over the past two decades.Adverse drug reactions(ADRs)and drug safety have become common research hotspots both domestically and internationally.Research has gradually deepened in seven research areas,including analytical methods,data sources,populations,and applications.Data mining is expected to be the key research direction in the future.Conclusion:The application of RWD in post-marketing drug safety monitoring and evaluation requires multidisciplinary,multi-institutional,and cross-regional cooperation to expand the research scope and depth.It is necessary to explore more sources of RWD,strengthen data mining and utilization,and form effective,mutually recognized,open,and sustainable drug safety data.Additionally,RWD should play a significant role in assessing medication safety for special populations and drug repositioning.

关 键 词：真实世界数据 上市后 药品安全性监测 药品安全性评价 文献计量 

分 类 号：R95[医药卫生—药学]