摘要
交叉试验是新药临床试验中常用的一种实验设计方法,一般用于比较两种或多种药物或处理的效应是否相同。本文探讨了交叉试验设计资料的两种等效性检验方法,即双单侧t检验和可信区间法。对2×2的交叉试验,以及m×m交叉试验(m>2)中单纯比较两种处理时,双单侧t检验与可信区间法是等价的;对复杂的对比情形只能用可信区间法。交叉试验的等效性检验是基于交叉试验方差分析中的误差均方计算的。
Cross-over design is often used in clinical trials to compare the efficacy of two or more treatmentc. Two one-side test and confidence interval method can be used to test the equivalence. For 2 × 2 cross-over design,both methods can be used,the same as comparison between two treatments of m × m cross-over. In complicated occasion , just confidence interval method can be used. Equivalence test of cross-over design is based on mean square of ANOVA.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2001年第4期294-297,共4页
The Chinese Journal of Clinical Pharmacology