临床纵向数据缺失的多重填补及其敏感性分析

目的：以芪蛭通络胶囊治疗缺血性脑卒中临床试验为例来指导临床纵向数据缺失的多重填补及其敏感性分析，并强调敏感性分析的重要性。方法：应用SAS中的PROC MI过程实现临床纵向数据缺失的多重填补及其敏感性分析。 结果：实例分析中，多重填补后，芪蛭通络组的下肢运动评分改善值优于安慰剂组（P值均小于0.01），而两种非随机缺失机制假定下的敏感性分析结果与随机缺失下的结果一致。结论：多重填补结合使用敏感性分析可以确保多重填补结果的稳健性，建议临床研究者对数据填补后还要进行敏感性分析。

Multiple imputation of missing data in clinical longitudinal studies and its sensitivity analyses

AIM: To guide the multiple imputation of missing data in clinical longitudinal studies and its sensitivity analyses, and highlight the importance of sensitivity analyses by taking the clinical trial of Qizhitongluo Capsule in treating ischemic stroke as an example. METHODS: To implement PROC MI process in SAS to perform multiple imputation and its sensitivity analysis. RESULTS: In the example, after multiple imputation, improvements in lower limb motor scores of the Qizhitongluo group were greater than those of the placebo group (all P<0.01), and the results of two sensitivity analyses under "missing not at random" were consistent with those under "missing at random".CONCLUSION: Multiple imputations combined with sensitivity analyses can ensure a robust result. It is recommended that clinical researchers perform sensitivity analyses after filling missing data.