匹配调整间接比较法在中医药疗效评价中的应用探讨  

Application of Matching-adjusted Indirect Comparison Methods in Efficacy Evaluation of Traditional Chinese Medicine

作　　者：李国栋 胡馨雨 曹卉娟[1] LI Guodong;HU Xinyu;CAO Huijuan(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing,100029;School of Acupuncture-Moxibustion and Tuina,Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学循证医学中心,北京市100029 [2]北京中医药大学针灸推拿学院

出　　处：《中医杂志》2024年第23期2413-2418,共6页Journal of Traditional Chinese Medicine

基　　金：北京中医药大学横向科研发展基金项目(2023-HXFZJJ-021)。

摘　　要：随机对照试验(RCT)被广泛应用于中医药临床疗效评价中,但同时也有成本高、周期长、患者招募和入组困难等局限性。匹配调整间接比较法(MAIC)的提出在一定程度上可以缓解传统RCT的方法学局限性所带来的问题。介绍MAIC的基本原理,分析比较锚定法和非锚定法两种设计方法的异同及优缺点。通过针刺治疗阵发性偏头痛和艾灸治疗腹泻型肠易激综合征两则应用实例分析,详细介绍MAIC在中医药疗效评价中应用的方法学特征,并探讨MAIC在中医药疗效证据评价、中医非药物疗法疗效评价和中药新药研发中的优势、可行性,以及在现有研究、匹配因素和样本量方面的局限性,结合模拟治疗比较法、模拟目标试验和伦理提出了展望,以期为中医药疗效评价提供建议与参考。Randomized controlled trials(RCTs)have been widely used in clinical efficacy evaluation of tradi⁃tional Chinese medicine(TCM),but also having limitations such as high cost,time consuming,and difficulty in patient recruitment and enrollment.The introduction of matching adjusted indirect comparison(MAIC)can alleviate the problem caused by the limitation of traditional RCT methodology to some extent.This paper introduced the basic principles of MAIC,and analyzed the similarities and differences,advantages and disadvantages of the two design methods,that is the anchored and the non-anchored.By analyzing two case studies in the evaluation of TCM efficacy,which are acupuncture for paroxysmal migraine and moxibustion for diarrhea-type irritable bowel syndrome,respec⁃tively,this paper introduced the methodological characteristics of MAIC in the efficacy evaluation of TCM,explored the strengths and feasibility of MAIC in the evaluation of efficacy evidence in TCM,the evaluation of efficacy of nonpharmacological TCM therapy and the development of new Chinese medicine,and discussed the limitations of existing research,matching factors and sample size.Additionally,the paper offered prospects by combining the simulation treatment comparison method and emulated target trials,with the goal of providing recommendations and references for the clinical efficacy evaluation of TCM.

关 键 词：中医药疗效评价 匹配调整 间接比较 随机对照试验 

分 类 号：R24[医药卫生—中医临床基础]