药物流行病学研究的方案制定清单及案例解读  

Formulation and Examples of Pharmacoepidemiological Study Protocol

作　　者：曹卉娟[1,2] 金雪晶 吴嘉瑞[3] Cao Huijuan;Jin Xuejing;Wu Jiarui(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;Institute for Excellence in Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;School of Chinese Pharmacy,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学循证医学中心,北京100029 [2]北京中医药大学国际循证中医药研究院,北京100029 [3]北京中医药大学中药学院,北京100029

出　　处：《药物流行病学杂志》2021年第10期647-650,678,共5页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金项目(编号:81673829);中国民族医药学会立项项目(编号:2020MZ298-110101)。

摘　　要：2019年中国药学会发布了《中国药物流行病学研究方法学指南》,旨在协助研究者设计、实施并评估药物流行病学的研究。其中研究方案的制定是保障研究"代表性""真实性""可比性"的重要前提,研究者需遵循相关领域的方法学指南、参考方案制定清单来进行设计和报告。本文首先对药物流行病学研究方案的内容逐条进行解析,并提出设计过程中的关键点;继而以两篇已发表的研究方案为例,分别提出试验性研究设计与观察性研究设计在药物流行病学领域开展研究时方案设计的要点;最后强调方案注册的重要性,以及方案撰写与发表的要求。期望本文能为未来该领域研究方案制定的合理性与严谨性提供方法学参考。In 2019, the Chinese Pharmaceutical Association issued the Guide on Methodological Standards in Pharmacoepidemiology, which aims to assist researchers in designing, implementing and evaluating pharmacoepidemiological studies. Among them, the formulation of study protocol is an important premise to ensure the “representative”“authenticity”“comparability” of the research. Researchers need to follow the methodological guidelines and the recognized checklist to design and report the study protocol. We explain the content of the pharmacoepidemiology research protocol item by item in this article, and put forward the key points in the design process;then, taking two published literature as examples to show the contents of protocols when carrying out the pharmacoepidemiology study with the experimental design and the observational design;also, we emphasize the importance of the protocol registration, as well as the reporting standard. It is expected that this paper can provide methodological suggestions for future researchers to improve the rationality and rigor of pharmacoepidemiology studies.

关 键 词：药物流行病学 研究方案 报告清单 案例解读 

分 类 号：R181.35[医药卫生—流行病学]