《中国药物流行病学研究方法学指南(第2版)》的制订/修订过程  

Revision process of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)

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] 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;Clinical Epidemiology Research Center,Peking University Third Hospital,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]北京大学第三医院眼科,北京100191 [6]新疆医科大学中医学院,乌鲁木齐830017 [7]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2期121-135,共15页Chinese Journal of Pharmacoepidemiology

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

摘　　要：药物流行病学是运用流行病学原理和方法,研究人群中药品的利用及其效应的科学,对于促进合理用药和提升人群健康水平具有重要意义。高质量的药物流行病学研究离不开规范的方法学支撑。2024年,中国药学会正式启动了《中国药物流行病学研究方法学指南(第2版)》的制订/修订工作。本次指南的制订/修订依托于中国药学会药物流行病学专业委员会,由北京大学公共卫生学院流行病与卫生统计学系牵头并提供方法学指导,联合全国多学科专家共同参与。基于指南第1版的制订经验,工作组通过定性系统综述,汇总全球药物流行病学研究相关指南的关键信息,初步形成指南第2版的制订/修订意见;随后通过两轮德尔菲法专家咨询和定性访谈,结合工作组的充分讨论,完善并形成指南修订稿,最后通过名义小组法专家共识会达成共识,完成定稿,形成一套兼具国际视野与本土适用性的药物流行病学研究方法学指南。指南第2版共包含41个条目,其中8个一级条目、20个二级条目、13个三级条目,全面覆盖研究方案的制定、研究实施、不良事件报告、研究报告撰写、研究结果发表等核心环节,同时涵盖具体应用场景、特定应用主题,以及人工智能的应用、真实世界研究等专题内容。Pharmacoepidemiology is a scientific discipline that applies epidemiological principles and methods to study the utilization and effects of pharmaceuticals in populations.It plays a crucial role in promoting rational drug use and improving public health outcomes.High-quality pharmacoepidemiological research relies on rigorous methodological frameworks.Chinese Pharmaceutical Association(CPA)has officially initiated the development/revision of the of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)in 2024.This revision project was supported by the Pharmacoepidemiology Committee of CPA,and was led by the Department of Epidemiology and Biostatistics at Peking University School of Public Health,which provided methodological guidance,in collaboration with multidisciplinary experts from across the country.Building on the experience of the 1st edition’s development,the working group conducted a qualitative systematic review,to extract key information from global pharmacoepidemiology-related guidelines,laying the foundation for the development/revision proposals of the 2nd edition.Subsequently,through two rounds of Delphi method expert consultations and qualitative interviews,alongside extensive discussions within the working group,the draft revision of the guideline was created.Finally,through an expert consensus meeting using the Nominal Group Technique(NGT),a consensus was reached,resulting in a methodological guideline that integrates international perspectives with local applicability for pharmacoepidemiological research in China.The 2nd edition consists of 41 entries,including 8 primary entries,20 secondary entries,and 13 tertiary entries.It comprehensively covers key aspects such as study protocol development,study implementation,adverse event reporting,research report writing,and dissemination of study findings.Additionally,it addresses specific application scenarios and topics,as well as the application of artificial intelligence and real-world studies.

关 键 词：药物流行病学研究 方法学 指南 专家咨询 共识 

分 类 号：R181.35[医药卫生—流行病学]