中医药临床研究两组疗效对比数据不同处理方法解读

The strategy of statistic analysis in clinical efficacy comparison between two treatments

[目的]解析中医药临床研究中两组疗效对比数据的不同处理方法。[方法]以四联疗法治疗肾虚血瘀型膝关节骨性关节病(KOA)的数据分析为例,将采集到的两组62例肾虚血瘀型KOA患者5个时间点数据,分别进行了基线分析、纵向计量指标的疗效分析及等级分类指标的疗效分析,比较采取不同处理方法可能产生的不同效果。[结果]采取不同的统计方法,统计结果不尽相同。[结论]根据研究设计及数据结构与特征,并结合中医临床研究的专业性需求,选择适宜的统计分析策略,以期为中医临床研究提供最佳技术支持,也是中医临床研究和统计学共同发展的需要。

[Objective] To discuss the strategy of statistic analysis in clinical efficacy comparison between two treatments in clinical research of traditional Chinese medicine. [Methods] For KOA with renal weak and silky blood cases, the data include 62 patients who are divided into two groups in random and were observed at five time points. To explore and compare different statistic procedures and results, the data was analyzed in baseline and efficacy in different ways. [Results] Different statistic strategy of statistic analysis would lead to different results. [Conclusion] To support in clinical research of traditional Chinese medicine, try to process data in different ways according to dif- ferent designs, different data types, different features and professional requires, which is needed by the developments of Chinese medicine and statistics.