中医临床疗效评价中核心结局指标集理论初探

近年中医药治疗疾病的随机对照试验及在此基础上的系统评价逐年增加以证明中药疗效的优越性,其中一些被考克兰图书馆收录.但由于潜在的结局指标选择性报告偏倚和发表偏倚而致较少的试验可以纳入meta分析,进而导致中药治疗某些疾病的证据不足,且结局指标报告的差异降低了干预措施之间比较的效果.近年来,结局指标问题正逐步受到学界的重视并研究解决办法.通过形成并应用必须报告的、统一的、标准化的最小结局指标集合,即核心结局指标集可有效解决相关问题.针对以上问题,本文进行核心结局指标集形成与进展的梳理.

Explosion on the core outcome set (COS) in the clinical evaluation in the TCM clinical studies

Recently, more systemic reviews and randomized controlled trials were published to prove the effectiveness of TCM,and some of those were included by Cochrane Library. But due to the potential selective reporting bias and publication bias, few trials were included in the meta analysis, which failed to prove the evidence for the TCM treatment. The difference of reported outcomes comes to the big problem of the comparison between interventions. Such problem of difference was gradually brought to the attention. Therefore, Core Outcome Sets(COS), which stands for that the minimum standardized outcome set that must be repoted, may be the solusion to that problem. In this research we've introduced the formation and development of core outcome sets in TCM.