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本文提出新药临床试验中最常用的2周期交叉设计分析法。在病人内比较药物差别;检验药物的周期效应与药物-周期交互作用,前者可分析病人反应是否有与药物无关的自然变迁,后者可分析药物有无后遗效应。
This article proposes the most commonly used 2-cycle crossover design analysis in clinical trials of new drugs. Differences between drugs in patients are tested. Cyclic and drug-cycle interactions between drugs are examined. The former analyzes the patient’s response to any natural change that has nothing to do with the drug, and the latter analyzes whether the drug has a sequelae effect.