Qiu Rui-Jin, Lei Xiang, Chen Jing, Shang Hong-Cai
Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital,Beijing University of Chinese Medicine Beijing 100700, China.
Tianjin University of Traditional Chinese Medicine Tianjin 300193, China.
Zhongguo Zhong Yao Za Zhi. 2022 Jan;47(1):265-270. doi: 10.19540/j.cnki.cjcmm.20210729.501.
It was pointed out in Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine issued by the State Council in 2019 that 100 varieties of traditional Chinese medicine(TCM) with unique curative effects should be screened out within about three years. Due to the multi-component and multi-target mechanisms of TCM varieties, it is difficult to directly and simply evaluate their multi-dimensional clinical value using methods applicable to chemical or biological agents. The heterogeneity of outcomes for similar TCM makes it difficult to determine the advantages of similar products. The fuzzy comprehensive evaluation method that is developed on the basis of core outcome set and fuzzy mathematics for clinical efficacy evaluation of TCM may solve these problems. This study developed a fuzzy comprehensive evaluation model for the clinical efficacy evaluation of Chinese patent me-dicines for coronary heart disease and angina pectoris, and selected the previous normative studies with complete or incomplete data for verifying the model application. The results showed that original studies with complete data failed to evaluate and compare the comprehensive efficacy of different interventions. The original research only mentioned the advantages and disadvantages of different interventions in different aspects. The comprehensive clinical efficacy of three different interventions obtained through fuzzy comprehensive evaluation was all graded as level Ⅱ. The original research with incomplete data drew the same conclusions as the fuzzy comprehensive evaluation, and the results of fuzzy comprehensive evaluation can provide more comprehensive information. Therefore, the fuzzy comprehensive evaluation shows the products with overall advantages of clinical efficacy, which may become a feasible method for the screening of TCM.
国务院2019年发布的《关于促进中医药传承创新发展的意见》指出，要在三年内左右筛选出100种疗效独特的中药品种。由于中药品种的多成分、多靶点作用机制，难以用适用于化学或生物制剂的方法直接、简单地评估其多维度临床价值。相似中药疗效的异质性使得难以确定相似产品的优势。基于核心结局集和模糊数学开发的模糊综合评价方法用于中药临床疗效评价，可能解决这些问题。本研究建立了冠心病心绞痛中成药临床疗效评价的模糊综合评价模型，并选择既往规范研究中数据完整或不完整的研究对模型应用进行验证。结果显示，数据完整的原始研究未能对不同干预措施的综合疗效进行评价和比较。原始研究仅提及不同干预措施在不同方面的优缺点。通过模糊综合评价得到的三种不同干预措施的综合临床疗效均为Ⅱ级。数据不完整的原始研究与模糊综合评价得出相同结论，且模糊综合评价结果能提供更全面的信息。因此，模糊综合评价能显示出临床疗效具有整体优势的产品，可能成为筛选中药的一种可行方法。
