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一种针对交叉研究的替代分析方法,该方法考虑了药物反应中的组间差异。

An alternative analysis for crossover studies that accounts for between-group disparities in drug response.

作者信息

Cleophas T J

机构信息

Department of Medicine, Merwede Hospital Dordrecht, Sliedrecht, The Netherlands.

出版信息

Eur J Clin Chem Clin Biochem. 1997 Oct;35(10):775-9.

PMID:9368796
Abstract

BACKGROUND

In crossover clinical trials comparing completely different treatments, patients tend to fall into different populations: those who respond better to treatment 1 and those who respond better to treatment 2. The correlation between treatment response in such trials is negative. The current ANCOVA analysis for crossover studies does not allow for correlations being negative, and is therefore not adequate for testing in this kind of trials.

OBJECTIVE OF STUDY

To study whether matrix algebra provides a more appropriate approach for this purpose.

RESULTS AND CONCLUSIONS

Using a mathematical model as well as hypothesized examples, it is demonstrated that matrix algebra of 2 pairs of cells of the same order not only allows for negative correlations in a crossover design but also provides enough power to test both the treatment and carryover effect.

摘要

背景

在比较完全不同治疗方法的交叉临床试验中,患者往往会分为不同的群体:对治疗1反应较好的群体和对治疗2反应较好的群体。此类试验中治疗反应之间的相关性为负。当前用于交叉研究的协方差分析不允许相关性为负,因此不适用于此类试验的检验。

研究目的

研究矩阵代数是否为此目的提供了一种更合适的方法。

结果与结论

通过数学模型和假设示例表明,同阶的两对单元格的矩阵代数不仅允许交叉设计中存在负相关性,而且还提供了足够的检验效能来检验治疗效果和延滞效应。

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