中医药治疗冠状动脉血运重建术后心绞痛的随机对照试验结局指标分析  

Analysis of outcome indicators of randomized controlled trial of traditional Chinese medicine in treating angina pectoris after coronary revascularization

作　　者：任高灿 刘锦 高风 张宏伟 马晓昌[1] REN Gaocan;LIU Jin;GAO Feng;ZHANG Hongwei;MA Xiaochang(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;‘The First Affiliated Hospital of Henan University of CM,Zhengzhou 450046,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]河南中医药大学第一附属医院,郑州450046

出　　处：《中华中医药杂志》2024年第9期4884-4893,共10页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家重点研发计划(No.2018YFC1707404)。

摘　　要：目的:分析近10年中医药治疗冠状动脉血运重建术后心绞痛的随机对照试验(RCT)结局指标的选择现状,为后续相关研究提供依据和基础。方法:通过系统检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(SinoMed)、PubMed、EMbase、Cochrane Library、Web of Science,搜集中医药治疗冠状动脉血运重建术后心绞痛的RCT。检索时限为2012年1月1日至2022年6月30日,筛选文献后提取资料,利用Cochrane偏倚风险评估工具对纳入研究进行质量评价,描述性分析结局指标的使用情况。结果:初步检索出1416篇文献,最终纳入55篇文献,包括3篇英文文献。涉及的84种结局指标主要分为9大类:生化指标(45.15%,205/454)、心绞痛疗效指标(13.88%,63/454)、安全性指标(8.15%,37/454)、临床有效率指标(7.93%,36/454)、中医证候疗效指标(7.49%,34/454)、生活质量量表(5.51%,25/454)、心电图指标(5.29%,24/454)、心功能指标(4.41%,20/454)、其他指标(2.20%,10/454)。结论:中医药治疗冠状动脉血运重建术后心绞痛的RCT结局指标遴选存在较多问题,应构建中医药治疗冠状动脉血运重建术后心绞痛的核心结局指标集,提高RCT质量。Objective:To analyze the current situation of the outcome indicators of randomized controlled trial(RCT)in the treatment of angina pectoris after coronary revascularization with traditional Chinese medicine(TCM)in recent ten years,so as to provide basis and foundation for the follow-up related research.Methods:The databases of CNKI,Wanfang.VIP,SinoMed,PubMed,EMbase,Cochrane Library,and Web of Science were systematically searched to collect RCT of TCM in the treatment of angina pectoris after coronary revascularization.The search time limit was from January 1,2012 to June 30,2022.The data were extracted after screening the literature,and the quality of the included studies was evaluated using Cochrane bias risk assessment tool,and the use of outcome indicators was analyzed descriptively.Results:A total of 1416 articles were initially retrieved,and 55 articles were finally included,including 3 English articles.The 84 outcome indicators involved are mainly divided into 9 categories:biochemical indicators(45.15%,205/454),angina pectoris efficacy indicators(13.88%,63/454),safety indicators(8.15%,37/454),clinical efficiency indicators(7.93%,36/454),TCM syndrome efficacy indicators(7.49%,34/454),quality of life scale(5.51%,25/454),ECG indicators(5.29%,24/454),cardiac function indicators(4.41%,20/454),other indicators(2.20%,10/454).Conclusion:There are many problems in the selection of RCT outcome indicators for the treatment of angina pectoris after coronary revascularization with TCM.The core outcome indicator set for the treatment of angina pectoris after coronary revascularization with TCM should be constructed to improve the quality of RCT.

关 键 词：中医药 冠状动脉血运重建术后心绞痛 随机对照试验 结局指标 试验设计 研究现状 

分 类 号：R256.22[医药卫生—中医内科学]