真实世界证据在上市后药品安全性监测与评价中的应用价值  

Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety

作　　者：孟若谷 卓琳[2] 乔瑞 刘玉强 孙凤[5] 詹思延[2,5] MENG Ruogu;ZHUO Lin;QIAO Rui;LIU Yuqiang;SUN Feng;ZHAN Siyan(National Institute of Health Data Science,Peking University,Beijing 100191,China;Research Center of Clinical Epidemiology,Peking University Third Hospital,Beijing 100191,China;Department of Social Medicine and Health Management,Baotou Medical College,Baotou 014040,China;Department of Pharmacy,Changzhi People's Hospital,Changzhi 046000,China;School of Public Health,Peking University,Beijing 100191,China)

机构地区：[1]北京大学健康医疗大数据国家研究院,北京100191 [2]北京大学第三医院临床流行病学研究中心,北京100191 [3]内蒙古科技大学包头医学院社会医学与卫生事业管理教研室,内蒙古包头014040 [4]山西省长治市人民医院药剂科,山西长治046000 [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624-627,共4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：目的了解真实世界证据(real world evidence,RWE)在上市后药品安全性监测与评价中的应用价值。方法检索PubMed、Embase、Web of Science、Scopus、中国生物医学文献服务系统、中国知网、维普网、万方数据建库至2020年1月2日中与RWE及上市后药品安全性相关的文献,归纳RWE应用价值。结果及结论经课题组讨论和专家咨询将RWE在上市后药品安全性监测与评价中的应用价值,归纳为补充药品安全性证据、辅助药品上市后管理、支持临床决策及卫生政策、技术方法开发优化4个方面,并提供参考案例。Objective To understand the application values of real-world evidence(RWE)in post-marketing surveillance and evaluation for drug safety.Methods Literatures related to RWE in post-marketing surveillance for drug safety were searched in PubMed,Embase,Web of Science,Scopus,SinoMed,CNKI,VIP,Wanfang Data from the establishment to January 2,2020.Results and conclusion After research team and expert consultation,application values of RWE in post-marketing surveillance and evaluation for drug safety was summarized into four aspects,including supplementing drug safety evidence,auxiliary drug post-marketing management,supporting clinical decision-making and health policies,as well as technical methods development and optimization.And for each aspect reference cases were provided.

关 键 词：真实世界证据 上市后药品监测与评价 药品安全 

分 类 号：R994.11[医药卫生—毒理学]