《药物流行病学研究方法学指南（第2版）》及其系列解读（8）：统计分析策略的制定与注意事项

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【关键词】药物流行病学；方法学；指南；统计分析策略；偏倚控制【中图分类号】 【文献标识码】A

Guide on Methodological Standards in Pharmacoepidemiology （2nd edition） and their series interpretation （8）： development of statistical analysis strategies and key considerations

WANG Qing1， FENG Xinyan1，WANG Dandan1，Gu Zenan1， MAO Guangyun1，WANG Yi1.2

1.DepartmentofEpidemiologyand Biostatistics，SchoolofPublicHealth，WenzhouMedical University，

Wenzhou325035，ZhejiangProvince，China

2. ZhejiangLab for RegenerativeMedicine，Visionand BrainHealth （OujiangLaboratory），Wenzhou

325000，ZhejiangProvince， China

Correspondingauthor：WANGYi， Email： wang.yi@wmu.edu.cn

【Abstract】The establishment of standardized statistical analysis strategies is of great significance to ensuring scientific value and promoting high-quality development in pharmacoepidemiology research. Based on the Guide on Methodological Standards in Pharmacoepidemiology （2nd edition），this article interprets the statistical analysis content within it section of the Guidelines.The first part outlines the importance and specific content of statistical analysis strategies in pharmacoepidemiology studies， introduces the variable definitions and sample size estimation and elaborates on data preprocessing and statistical methods. It also briefly discusses bias control and sensitivity analysis. The second part focuses on considerations for developing statistical analysis strategies，with further clarification on subgroup analysis，interim analysis，and the preparation of the statistical analysis reports.

【Keywords】Pharmacoepidemiology; Methodology; Guildelines; Statistical analysis strategies; jias control

统计分析作为药物流行病学研究的关键环节，其规范性与结果可靠性直接影响对药物有效性与安全性的评估。（剩余23721字）