单病例随机对照试验的统计分析方法

Statistical approaches for analyzing data from N-of-1 trials

单病例随机对照试验是针对单个患者开展的试验。在开展单病例随机对照试验的过程中,统计分析是一个不可或缺的重要部分。虽然有文献报道了已发表单病例随机对照试验所采用统计分析方法的种类,但是,尚缺乏对这些分析方法进行对比分析的报道。本文主要讨论了单病例随机对照试验中常用统计分析方法的特点以及使用过程中需要注意的问题,旨在为研究者开展高质量的单病例随机对照试验提供统计分析方法参考。

An N-of- 1 trial was conducted in a single patient. Statistical analysis is one of the most important parts of N-of-1 trials. The methods of statistical analysis for N-of-1 trials were reported in some reviews. However, there was still a lack of comparative analysis of these methods. In this study, we introduced the characteristics of statistical methods commonly used as well as some statistical problems which should be paid attention in N-of-1 trials. It is useful to provide some reference for statistical methods in order to high quality N-of-1 trials.