真实世界数据在上市后药品安全性监测和评价中的适用范围  

Application Scope of Real-World Data in Post-Marketing Drug Safety Monitoring and Evaluation for Drug Safety

作　　者：乔瑞 刘玉强 卓琳[1] 孟若谷 孙凤[5] 詹思延[1,5] QIAO Rui;LIU Yuqiang;ZHUO Lin;MENG Ruogu;SUN Feng;ZHAN Siyan(Research Center of Clinical Epidemiology,Peking University Third Hospital,Beijing 1001912,China;School of Public Health,Baotou Medical College of Inner Mongolia University of science and technology,Baotou 014040,China;Department of Pharmacy,Changzhi People's Hospital,Changzhi Shanxi 046000,China;National Institute of Health Data Science,Peking University,Beijing 100191,China;School of Public Health,Peking University,Beijing 100191,China)

机构地区：[1]北京大学第三医院临床流行病学研究中心,北京1001912 [2]内蒙古科技大学包头医学院公共卫生学院,内蒙古包头014040 [3]长治市人民医院药学部,山西长治046000 [4]北京大学健康医疗大数据国家研究院,北京100191 [5]北京大学公共卫生学院,北京100191

出　　处：《中国药物警戒》2021年第7期620-623,631,共5页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(72074011、82003536);国家药品监督管理局中国药品监管科学行动计划重点项目(CDRZ20193027)。

摘　　要：目的分析真实世界数据(real-world data,RWD)在上市后药品安全性监测和评价中的应用现状,总结其适用范围。方法检索PubMed、Embase、中国生物医学文献服务系统、中国知网等数据库建库至2020年1月2日中与RWD及上市后药品安全性相关的文献并进行统计分析。结果RWD在上市后药品安全性监测和评价研究中适用范围主要体现在研究设计、药物类别、临床问题3个方面。结论RWD在上市后药品安全性监测和评价中适用范围广,充分合理利用RWD开展真实世界研究(real-world study,RWS),可为药品上市后安全性主动监测与评价开辟新途径。Objective To analyze and summarize the application status of real-world data(RWD)in postmarketing drug safety monitoring and evaluation.Methods The literature related to RWD and post-marketing drug safety were searched and statistical analyzed in PubMed,Embase,SinoMed,CNKI and other databases from the establishment to January 2,2020.Results The scope of application of RWD in post-marketing drug safety monitoring and evaluation research is mainly reflected in 3 aspects,including research design,drug categories and clinical problems.Conclusion RWD has a wide range of applications in post-marketing drug safety monitoring and evaluation.The full and reasonable use of RWD to carry out real-world study(RWS)can open up a new way for the active monitoring and evaluation of drug safety after marketing.

关 键 词：真实世界数据 适用范围 安全性评价 上市后药品监测 

分 类 号：R994.11[医药卫生—毒理学]