国内外基于真实世界数据的药品上市后安全性主动监测系统对比分析  

Comparative research on active post-marketing drug safety surveillance systems worldwide based on real-world data

作　　者：孙一鑫 聂晓璐[3] 王晓玲 郭鹏[1,2] SUN Yixin;NIE Xiaolu;WANG Xiaoling;GUO Peng(Clinical Research Center,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045,China;Department of Pharmacy,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045,China;Center for Clinical Epidemiology&Evidencebased Medicine,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045,China)

机构地区：[1]国家儿童医学中心,首都医科大学附属北京儿童医院临床研究中心,北京100045 [2]国家儿童医学中心,首都医科大学附属北京儿童医院药学部,北京100045 [3]国家儿童医学中心,首都医科大学附属北京儿童医院临床流行病学与循证医学中心,北京100045

出　　处：《中国药物警戒》2024年第8期892-899,共8页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82204149);中国药品监督管理研究会课题、国家药监局药品监管科学体系建设重点项目(RS2024G001)。

摘　　要：目的对比分析国内外基于真实世界数据(RWD)构建的药品上市后安全性主动监测系统,以期为我国建立有效可行的全国性系统提供参考。方法检索与梳理全球药品主动监测系统的文献资料,使用框架整合法确定分析框架,编码与标绘有关组织架构、数据特征、运行机制等方面的内容,归纳异同点并总结主动监测模式。结果纳入基于RWD开展主动监测的系统/组织共12个,9个位于欧美国家,1个位于亚洲地区,我国有2个,分别为中国医院药物警戒系统(CHPS)和临床药物不良事件主动监测与智能评估警示系统(ADE-ASAS-Ⅱ)。经过信息整合,从6个维度总结主动监测模式:①组织模式归纳出3类,分别为政府(与学术界、药品生产企业)主导的合作体模式、政府直接管理模式,以及学术联盟协商模式;②数据整合与共享模式包括通用数据模型、通用研究方案与集中式数据库;③数据获取模式可分为2种形式,从数据库自动采集,以及针对目标人群或专项研究进行人工收集;④数据治理模式涉及匿名化、结构化与标准化处理;⑤数据储存与传输模式可分为分布式数据网络与中央数据库存储;⑥数据分析模式包括分布式计算与集中式分析2类。结论目前欧美国家利用RWD开展药品安全性主动监测模式相对成熟,我国在借鉴先进经验的同时,应探索符合本国实际情况的主动监测系统,为患者用药安全保驾护航。Objectives To compare and analyze the active post-marketing safety surveillance practices based on realworld data(RWD)worldwide,in order to provide the reference for establishing an effective and feasible nationwide active surveillance system in China.Methods The literature on active surveillance systems around the world were searched and reviewed.The framework synthesis was used to determine the analytical framework,coding and mapping the information related to organizational structure,data characteristics,and operation mechanism.The similarities and differences of the active surveillance model were summarized.Results A total of 12 systems/organizations that conduct active surveillance based on RWD were included in this study,9 of which are located in Europe and the United States,and in Asia.There are two Chinese systems,the China Hospital Pharmacovigilance System(CHPS)and the Adverse Drug Event Active Surveillance and Assessment System-Ⅱ(ADE-ASAS-Ⅱ).After integrating the information,the active monitoring model was summarized in six dimensions:(i)The organizational model was divided into three categories,including the government(with academia and pharmaceutical companies)led consortium,the direct government management,and the academic alliance consultation;(ii)The data integration and sharing model included the common data model,the common study protocol,and the centralized database;(iii)The data collection model could be divided into two forms:automatic collection from databases,and manual collection for target populations or specialized studies;(iv)The data management model included anonymizing,structuring and standardizing processes;(v)The data storage and transmission model can be categorized into the distributed data networks and the central database storage;(vi)Correspondingly,the data analysis model was divided into two categories:distributed computing and centralized analysis.Conclusion At present,the pattern of active surveillance for drug safety based on RWD are relatively mature in developed count

关 键 词：药品 上市后安全性 主动监测 药物警戒 真实世界数据 

分 类 号：R951[医药卫生—药学] R994.1