单病例随机对照试验的设计和评价方法

Design and Data Analysis Methods of N-of-1 Trials

本文重点介绍了单病例随机对照试验(N-of-1)的设计、优缺点及其应用范围,并介绍了N-of-1常用的评价方法,包括非参数检验和参数检验方法(t检验、配对t检验、方差分析)、混合效应模型、Meta分析方法。N-of-1符合个体化治疗的需要,希望其可以在现代医学及中医药学研究中得到广泛使用。

This paper mainly introduces the design,advantages,disadvantages and its application of single case of randomized controlled trials（N-of-1 trials）,and also introduces the commonly used data analysis methods of N-of-1 trials including nonparametric test and parameter test methods（t-test,paired t-test,analysis of variance）,mixed-effects model,and meta-analysis.N-of-1 trials are suitable for individualized treatment,and could be expected to be widely used in the research of modern medicine and traditional Chinese medicine.