《药物流行病学研究方法学指南（第2版）》系列解读（6）：研究数据源分类与选择

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【关键词】药物流行病学；方法学；数据源；数据【中图分类号】 【文献标识码】A

【Abstract】 Appropriate data sources are the cornerstone of pharmacoepidemiological research. Based on the Guide on Methodological Standards in Pharmacoepidemiology in China （2nd edition），hereinafter referred to as "the Guideline （2nd edition）"，this article provides an in-depth interpretation of the clasification and selection of data sources in pharmacoepidemiological research. It begins with a brief overview of the evolution of data sources in pharmacoepidemiological studies，followed bya detailed analysis ofthe definitions， applicable scopes，conditions of use，and strengthens and limitations of primary and secondary data sources. It further introduces the characteristics ofcommon data sources and relevant clasic domestic and international databases.Subsequently， integrating aspects of the Guideline （2nd edition），including research questions，study design，study population，sample size，exposure or intervention， outcomes，and covariates，the article discusses the criteria and strategies for choosing data sources in pharmacoepidemiological research. Ultimately，a data source selection methodology is established basedon clear clasification，guidedby research questions，tailored to research methods， and supported by data quality， aiming to promote the development of high-quality pharmacoepidemiological research in China.

【Keywords】Pharmacoepidemiology; Methodology; Data sources; Data

药物流行病学作为一门交叉学科，将流行病学方法应用于临床药学领域，研究药物在人群中的使用、获益和风险，为制订临床决策和公共卫生政策提供证据[1-2]。（剩余13963字）