Zhang Yi-Lin, Qiao Li-Jie, Wei Jing-Jing, Zhang Ming-Jie, Lu Jian-Feng, Yu Rui, Zhu Ming-Jun
Henan University of Chinese Medicine Zhengzhou 450000,China Henan Province Engineering Research Center of Safety Evaluation and Risk Management of Traditional Chinese Medicine Zhengzhou 450000,China.
Henan Province Engineering Research Center of Safety Evaluation and Risk Management of Traditional Chinese Medicine Zhengzhou 450000,China the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000,China.
Zhongguo Zhong Yao Za Zhi. 2023 Aug;48(16):4508-4520. doi: 10.19540/j.cnki.cjcmm.20230509.501.
This study reviewed the current status of the use of outcome indicators in randomized controlled trial(RCT) on traditional Chinese medicine(TCM) treatment of microvascular angina(MVA) and analyzed the existing problems and possible solutions, aiming to provide a basis for the design of high-quality RCT and the establishment of core outcome sets for MVA. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries were searched for the RCT on TCM treatment of MVA according to pre-defined criteria. The Cochrane's risk of bias assessment tool was used to evaluate the methodological quality of the included RCT and the use of outcome indicators was summarized. A total of 69 RCTs were included, from which 100 outcome indicators were extracted, with the frequency of 430. The extracted outcome indicators belonged to 8 domains: response rate, symptoms and signs, physical and chemical examinations, TCM efficacy, safety, quality of life, economic evaluation, and long-term prognosis. The indicators of physical and chemical examinations were the most(70 indicators with the frequency of 211), followed by those of response rate(7 indicators with the frequency of 73) and symptoms and signs(7 indicators with the frequency of 54). The outcome indicators with higher frequency were adverse reactions, angina attack frequency, clinical efficacy, endothelin-1, total duration of treadmill exercise, and hypersensitive C-reactive protein. The RCT on TCM treatment of MVA had the following problems: irregular reporting of adverse reactions, diverse indicators with low frequency, lack of attention to the application of endpoint indicators, insufficient use of TCM differentiation and efficacy indicators, non-standard evaluation criteria and failure to reflect the basic characteristics of TCM. A unified MVA syndrome differentiation standard should be established, on the basis of which an MVA treatment efficacy evaluation system and core outcome indicator set that highlights the characteristics of TCM with patient-reported outcomes as the starting point should be established to improve the clinical research and research value.
本研究回顾了中医药治疗微血管性心绞痛（MVA）的随机对照试验（RCT）中结局指标的使用现状，分析了存在的问题及可能的解决方法，旨在为高质量RCT的设计及MVA核心结局集的建立提供依据。按照预先设定的标准，检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆、Web of Science以及2个临床试验注册库中关于中医药治疗MVA的RCT。采用Cochrane偏倚风险评估工具评估纳入RCT的方法学质量，并总结结局指标的使用情况。共纳入69项RCT，从中提取了100个结局指标，出现频次为430次。提取的结局指标分属8个领域：有效率、症状体征、理化检查、中医疗效、安全性、生活质量、经济学评价及远期预后。其中理化检查指标最多（70个，频次211次），其次为有效率指标（7个，频次73次）和症状体征指标（7个，频次54次）。出现频次较高的结局指标有不良反应、心绞痛发作次数、临床疗效、内皮素-1、平板运动总时长及超敏C反应蛋白。中医药治疗MVA的RCT存在以下问题：不良反应报告不规范、指标多样且频次低、对终点指标应用缺乏关注、中医辨证及疗效指标运用不足、评价标准不规范且未体现中医基本特点。应建立统一的MVA辨证标准，在此基础上建立以患者报告结局为出发点、突出中医特色的MVA治疗疗效评价体系及核心结局指标集，以提高临床研究及研究价值。
