Fang Sai-Nan, Guo Yu-Bo, Liu Jian-Ping, Liao Xing, Zhang Xiao-Xiao, Mo Mei, Chen Wei
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.
Standards and Guidlinie Developing Office, China Association of Chinese Medicine, Beijing 100029, China.
Zhongguo Zhong Yao Za Zhi. 2018 Dec;43(24):4786-4791. doi: 10.19540/j.cnki.cjcmm.20181009.007.
Chinese patent medicine is widely used in clinical practice, but improper use will not only weaken the efficacy of drugs, but even cause adverse consequences. Evidence-based medicine provides guidance for clinical practice based on the best available evidence, experience of experts and needs of patients. However, considering the situation of "insufficient evidence" or "very low quality" in Chinese medicine research, experts consensus is the main basis for clinical decision-making, but expert opinions on which the consensus depends are susceptible to various subjective biases. Therefore, a reliable and scientific consensus-making process is needed to maximally avoid bias on consensus. Unlike the clinical practice guidelines, there is no unified formulating process for consensus in the world today. This article learns from a set of formulating processes from some international consensus formulating institutions/associations, combined with the characteristics and current situation of traditional Chinese medicine, and draws up a set of standard process that is suitable for the clinical experts consensus on Chinese patent medicine, with the expect of providing evidence and reference for consensus makers, and then bringing evidence-based assistance for the clinical standardized application of Chinese patent medicines.
中成药在临床实践中被广泛应用,但使用不当不仅会削弱药物疗效,甚至会导致不良后果。循证医学基于最佳可得证据、专家经验和患者需求为临床实践提供指导。然而,考虑到中医研究中存在“证据不足”或“质量极低”的情况,专家共识是临床决策的主要依据,但形成共识所依赖的专家意见容易受到各种主观偏差的影响。因此,需要一个可靠且科学的共识形成过程,以最大程度地避免共识中的偏差。与临床实践指南不同,当今世界尚无统一的共识制定流程。本文借鉴了一些国际共识制定机构/协会的一套制定流程,结合中医的特点和现状,拟定了一套适用于中成药临床专家共识的标准流程,以期为共识制定者提供证据和参考,进而为中成药的临床规范应用提供循证支持。