《中国药物流行病学研究方法学指南(第2版)》系列解读(3):全球指南的对比  

Interpretation of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)(Ⅲ):comparison of global guidelines

作　　者：颜济南[1,2] 吴昀效 聂晓璐 赵厚宇[4] 詹思延 孙凤[1,2,5,6,7,8] YAN Jinan;WU Yunxiao;NIE Xiaolu;ZHAO Houyu;ZHAN Siyan;SUN Feng(Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,China;Key Laboratory of Epidemiology of Major Diseases(Peking University),Ministry of Education,Beijing 100191,China;Center for Clinical Epidemiology&Evidence-based Medicine,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045,China;Research Center of Clinical Epidemiology,Peking University Third Hospital,Beijing 100191,China;Center of Postmarketing Safety Evaluation PUHSC,Beijing 100191,China;Department of Ophthalmology,Peking University Third Hospital,Beijing 100191,China;School of Traditional Chinese Medicine,Xinjiang Medical University,Urumqi 830017,China;School of Medicine,Shihezi University,Shihezi 832000,Xinjiang Uygur Autonomous Region,China)

机构地区：[1]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [2]重大疾病流行病学教育部重点实验室(北京大学),北京100191 [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与循证医学中心,北京100045 [4]北京大学第三医院临床流行病学研究中心,北京100191 [5]北京大学医学部药品上市后安全性研究中心,北京100191 [6]北京大学第三医院眼科,北京100191 [7]新疆医科大学中医学院,乌鲁木齐830017 [8]新疆石河子大学医学院,新疆石河子832000

出　　处：《药物流行病学杂志》2025年第3期241-259,共19页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金国际(地区)合作与交流项目(72361127500);国家自然科学基金面上项目(72474008);海南省科学技术厅重点研发专项(ZDYF2024LCLH002)。

摘　　要：自2019年中国药学会药物流行病学专业委员会制订《中国药物流行病学研究方法学指南(第1版)》以来,已近5年未更新,亟待修订完善。本研究采用系统综述方法,全面检索全球药物流行病学方法学指南,梳理其制定情况,提取各指南的框架与核心要素进行对比,分析我国指南的不足之处,提出符合我国国情的、务实可行的完善建议,为我国指南的更新提供参考。本研究检索PubMed、Embase、CNKI和WanFang Data等数据库,以及17个国际药物流行病学术组织、欧美日中等国家/地区监管机构的官方网站,根据事先制定的纳入与排除标准进行相关指南或标准的筛选,最终纳入33篇药物流行病学研究方法学指南或标准。采用定性整合方法,通过主题归纳和内容总结,提炼各指南的核心要素,并进行描述性对比分析。结果表明,我国指南第1版在不良反应报告和研究结果发表方面的指导较为完善,但在研究方案的制订、研究实施中的数据分析、研究报告的撰写、具体研究场景等方面还缺乏部分或全部指导。本研究综合借鉴各国最新的药物流行病学研究方法学指南或标准,平衡全面性、实用性与用户友好等各方面,为我国指南的更新提出了修订推荐意见。It has been not been updated for nearly 5 years since the Pharmacoepidemiology Professional Committee of the Chinese Pharmaceutical Association released the Guide on Methodological Standards in Pharmacoepidemiology in China(1st edition)in 2019,and an update is urgently needed.This study adopts a systematic review approach to comprehensively search for global pharmacoepidemiology methodological guidelines and analyze their development status.By extracting the frameworks and key elements of the guidelines,the China’s guide was compared with other included guidelines,its shortcomings were analysed,and pragmatic and feasible suggestions for improvement in line with China's national conditions,were proposed in order to provide references for updating China's guide.A systematic search was conducted by searching PubMed,Embase,CNKI,WanFang Data and 17 official websites of international academic organizations for pharmacoepidemiology and regulatory agencies from countries or regions including Europe,the United States,Japan,and China,etc.,and relevant guidelines or standards were screened based on predefined inclusion and exclusion criteria,resulting in the inclusion of 33 methodological guidelines or standards for pharmacoepidemiological studies.A qualitative synthesis approach was then employed to extract core elements from the guidelines through thematic categorization and content summarization,followed by a descriptive comparative analysis.The results indicate that the 1st edition of the China’s guide provides relatively comprehensive guidance on adverse drug reaction reporting and publication of research findings.However,there are gaps in study protocol development,data analysis during study implementation,study reporting,and specific study scenarios.By integrating and drawing upon the latest international pharmacoepidemiology methodology guidelines while balancing comprehensiveness,practicality,and user-friendliness,this study provides recommendations for updating the China’s guide.

关 键 词：药物流行病学 方法学指南 系统综述 

分 类 号：R181.35[医药卫生—流行病学]