中成药临床应用专家共识制订有关问题讨论

Discussion on issues related to clinical experts consensus of Chinese patent medicine

国家对于中医药标准化文件的出台促进了中医药行业标准的制订,其中就包括临床实践指南和临床专家共识。但是,目前中医药领域时常面临的"证据不足"或"质量极低"的研究现状,指南的制作面临困难,且这种缺少高质量临床证据的阶段会保持很长一段时间。为了不影响临床决策的有效实施,有必要制订规范的用于指导临床决策的文件,而临床专家共识正适合在临床证据缺乏或质量不高时对临床实践进行指导。然而不同于临床实践指南,国内对临床专家共识的认识尚不足。该文通过对临床专家共识的起源和现状、其与临床实践指南的区别、以及中成药临床应用专家共识制订应遵循的基本原则等方面进行介绍,以期为指导共识文件的规范制订提供依据和参考。

The promulgation of standardized documents on traditional Chinese medicine has promoted the formulation of industrial standards of traditional Chinese medicine,including clinical practice guidelines and clinical expert consensus. In order to adapt to the current research situation of " insufficient evidence" or " very low quality" when developing clinical practice guideline in the field of traditional Chinese medicine,the author has made a retrospective study on the development of guidelines and consensus,and found that the consensus is more suitable for the current research status of Chinese patent medicine,as the stage of lack of high-quality clinical evidence will remain for a long time. However,unlike clinical practice guidelines,domestic scholars and consensus makers have insufficient understanding of the clinical experts consensus. This article will introduce the origin and status of the clinical experts consensus,the differences between clinical experts consensus and the clinical practice guidelines,and the basic principles that should be followed in the formulation of the clinical experts consensus of Chinese patent medicine,expecting to provide theory basis and reference for the normative formulation of clinical experts consensus.