单组试验目标值法在中医临床研究中的应用

The Application of Single-arm Clinical Trials with Objective Performance Criteria in Clinical Research of Traditional Chinese Medicine

中医临床研究因其自身的特点,有些时候不适合采用随机对照试验的方法进行研究,单组试验目标值法则可以作为替代的较理想的研究方法。本文介绍了单组试验目标值法的基本原理,及其在中医临床研究过程中的疗效指标选择、目标值的确定、病例标准、样本量估算、统计推断和结果解释等相关问题。该方法具有科学性和可操作性,可以部分解决目前中医临床研究中面临的一些问题,具有较好的应用前景。

Clinical research of Chinese medicine, due to its own features, is not suitable to be studied by randomized controlled trial methods in some cases. The single-arm clinical trials with objective performance crite- ria could be taken as a more ideal alternative method. In this paper the basic principles of single-arm clinical trials with objective performance criteria was introduced. Correlated problems of the selection of therapeutic efficacy in- dex, the target identification, case standards, sample size calculation, statistical inference, and interpretation of results were also addressed. This method was scientific and feasible. It can partially solve some problems in the clinical research of Chinese medicine. It has better application prospect.