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目的探讨中药新药临床试验中中医证候综合疗效等级指标的非劣效性检验方法。方法选择某个采用非劣效性设计的中药新药临床试验,对其中的中医证候疗效指标(等级形式、有效率形式)分别采用“行平均得分差值法/行平均秩比值法”与频率统计假设检验和可信区间方法进行非劣效性检验,比较检验结果的差异。结果 “行平均得分差值法”与“行平均秩比值法”对中医证候疗效等级指标的非劣效性检验结果不一致,“行平均得分差值法”得到非劣效性结论,而“行平均秩比值法”未能作出非劣效性的判断。“行平均得分差值法”对中医证候疗效等级指标的非劣效性检验结果与频率统计假设检验和可信区间方法对有效率的非劣效性检验结果一致。结论中药新药临床试验中,选择等级指标还是合并转换的二分类有效率指标进行非劣效性检验,需要综合考虑等级分布型、样本含量、非劣效性界值等几个方面的问题。
Objective To explore the non-inferiority test method of traditional Chinese medicine new drug clinical trials comprehensive index of efficacy of TCM syndromes. Methods A clinical trial of a new drug of traditional Chinese medicine with a non-inferiority design was selected. The curative effect index (level form and effective form) And non-inferiority test with frequency statistical hypothesis test and confidence interval method to compare the difference of test results. Results “line average score difference method ” and “line average rank ratio method ” inconsistent with the non-inferiority test results of TCM syndrome efficacy level indicators “line average score difference method ” obtained non-inferior Validity conclusion, and “line average rank ratio method ” failed to make non-inferiority judgments. “Line average score difference method ” on non-inferiority of Chinese medicine syndrome efficacy index test results and frequency statistics hypothesis test and confidence interval method for efficient non-inferiority test results. Conclusion In the clinical trial of new drug of Chinese medicine, the choice of grade index or the conversion efficiency of the two categories of non-inferiority test, the need to consider the grade distribution, sample content, non-inferiority of the value of several aspects of the problem.