中医证候命名规范化研究在核心指标集构建中的意义及方法

Significance and method for traditional Chinese medicine syndrome name standardization in the development of core outcome sets

构建中医临床研究核心指标集可以减少不同研究中结局指标的异质性,使更多的同类研究可以进行比较或纳入系统评价中进行合并,提高研究价值,减少研究浪费。构建中医临床研究核心指标集无法回避中医证候相关的指标,但目前常用的证候名称不规范,有许多相同实质的证候用不同的名称表达,为构建中医临床研究核心指标集带来困难。因此,笔者提出构建中医临床研究核心指标集首先应规范中医证候命名:采用系统评价、病例回顾、横断面调查等多种途径获得特定疾病的证候名称及分布;进行德尔菲调查和共识会议,对实质相同但命名不同的证候名称达成共识。

The development of core outcome sets（COS） in trials of traditional Chinese medicine（TCM） can resolve reduce the heterogeneity of outcome in clinical trials, so that much more clinical trials can be included in systematic reviews to combine or compare. COS can help to reduce waste and improve the value of trials. TCM syndrome should be considered in the development of COS in clinical trials of TCM. As the TCM syndrome names are unstandardized, it is difficult to compare the same TCM syndrome which expressed with different names in different trials. It is necessary to standardize TCM syndrome in the development of COS. Researchers should conduct systematic review, retrospective study and cross-sectional study to acquire TCM syndrome names for specific disease. Then expert should achieve consensus via Delphi survey and consensus meeting.