【摘要】 药物流行病学是一门运用流行病学的研究方法评估药物在人群中的应用和效果的交叉学科。规范药物流行病学研究方法是保障研究质量、促进学科发展的关键。中国药学会药物流行病学专业委员会在2019年制订了《中国药物流行病学研究方法学指南（第1版）》，但至今已超过5年未更新。国际上，欧美日韩等国家/地区在指南制订与更新方面已取得较多进展。因此，考虑我国药物流行病学领域的快速发展以及与国际接轨的广泛需求，更新指南极为必要。本次指南更新经系统综述、实践调研和多学科协作等过程形成第2版，相比第1版，在研究设计、数据源、具体应用场景等方面有诸多重要变更，并增加了人工智能的应用等全新内容。本文旨在强调指南更新的必要性，并遴选重要变更内容制定解读计划，为相关领域研究人员全面理解与应用新版指南提供参考，以期推动我国药物流行病学研究的规范化发展和质量的提升，促进学科进步。更多还原

【Abstract】 Pharmacoepidemiology is an interdisciplinary discipline that applies epidemiological research methods to evaluate the application and effect of drugs within population.Standardizing pharmacoepidemiological research methods is crucial for ensuring the quality of research and promoting the development of the discipline.The Pharmacoepidemiology Professional Committee of Chinese Pharmaceutical Association developed the Guide on Methodological Standards in Pharmacoepidemiology(1st edition),in 2019,but has not been updated in over five years.Other,countries/regions such as Europe,America,Japan and South Korea have made a lot of progress in developing and updating the guidelines.Therefore,the rapid development of pharmacoepidemiology in our country and the growing need to align with international standards make it essential to update the guidelines.The second edition of the guidelines was developed through a process that included systematic reviews,practical surveys,and multidisciplinary collaboration.Compared with the first edition,the updated version has made many important changes in research design,data sources,specific application scenarios and more,and added new contents such as the application of artificial intelligence.The purpose of this paper is to emphasize the necessity of updating the guidelines,selecting important changes and formulating interpretation plans.It aims to provide references for relevant professionals to comprehensively understand and apply the new guidelines,and to promote the standardized development and quality of pharmacoepidemiologic research in our country,further advancing the field.更多还原