中医药干预冠心病经皮冠状动脉介入术后心绞痛的随机对照试验现状分析  

Current status of randomized controlled trials of traditional Chinese medicine in treating coronary heart disease with angina pectoris after percutaneous coronary intervention

作　　者：任思霖 葛昭 吴旭东 周宙 李志君[1] 周梦雪 李默涵 王贤良[1] REN Si-lin;CE Zhao;WU Xu-dong;ZHOU Zhou;LI Zhi-jun;ZHOU Meng-xue;LI Mo-han;WANG Xian-liang(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Graduate School of Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

机构地区：[1]天津中医药大学第一附属医院/国家中医针灸临床医学研究中心,天津300381 [2]天津中医药大学研究生院,天津301617

出　　处：《中国中药杂志》2024年第22期6224-6234,共11页China Journal of Chinese Materia Medica

基　　金：国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202203);国家教育部创新团队发展计划项目(IRT_16R54);2023年天津中医药大学研究生科研创新项目(YJSKC-20232002)。

摘　　要：系统梳理中医药干预冠心病经皮冠状动脉介入术(PCI)后心绞痛的随机对照试验(RCT),分析中医药临床试验设计的基本要素(样本量及估算方法、随机化方案、分配隐藏、盲法实施、数据完整性、统计方法、中医证型、干预措施、疗程、随访时间、结局指标),以期为后续开展中医药干预冠心病PCI后心绞痛的RCT设计提供参考,为中医药在PCI后心绞痛中的临床应用提供依据。系统检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane library、EMbase、Web of Science,并查询美国临床试验注册库(ClinicalTrials.gov)和中国临床试验注册中心,纳入符合标准的中医药干预冠心病PCI后心绞痛的RCT,检索时限均为建库至2024年1月31日。共纳入188篇RCTs,其中184篇为临床试验,4篇为临床试验注册方案;样本量15521例,平均样本量83例,最大样本量248例;126篇RCTs报告了中医证型,频次排名前3位的是气虚血瘀证(38.89%)、痰瘀互结证(17.46%)、气滞血瘀证(9.52%);对照组干预措施为指南推荐的最佳药物治疗(GDMT)或GDMT联合安慰剂,试验组均为GDMT联合中医药;治疗疗程以4~8周为主,大部分RCT未设置随访期或随访期不明;共使用160种结局指标,总频次1348次。结局指标按功能整体可分为6个指标域:症状/体征(403次,29.90%)、中医证候/症状(182次,13.50%)、理化检查(468次,34.72%)、生活质量(89次,6.60%)、远期预后(5次,0.37%)、安全性评价(201次,14.91%)。中医药干预冠心病PCI后心绞痛的临床试验设计日趋严谨,方案设计尚需完善,期待未来采用更多设计严谨、兼顾中医药特色优势的临床试验方案,为中医药治疗冠心病PCI后心绞痛的临床实践提供依据。This study systematically reviewed the randomized controlled trial(RCT)of traditional Chinese medicine(TCM)treatment of coronary heart disease patients with angina pectoris after percutaneous coronary intervention(PCI).The basic elements of these RCTs,including sample size and estimation method,randomizing scheme,allocation concealment,blind method implementation,data integrity,statistical method,TCM syndrome,intervention measures,treatment course,follow-up time,and outcome indicators,were analyzed to provide reference for the design of future RCT and the clinical application of TCM in treating angina pectoris after PCI.CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase,Cochrane Library,Web of Science,ClinicalTrials.gov,and Chinese Clinical Trial Registry were searched for the RCT about TCM treatment of coronary heart disease patients with angina pectoris after PCI according to pre-defined criteria,with the time interval from inception to January 31,2024.A total of 188 RCTs were included,of which 184 were clinical research articles and 4 were clinical trial registration schemes.These RCTs involved a total of 15521 patients,with an average sample size of 83 patients and a maximum sample size of 248 patients.Among them,126 RCTs reported TCM syndromes,the top three of which were Qi deficiency and blood stasis(38.89%),phlegm combined with stasis(17.46%),and Qi stagnation and blood stasis(9.52%).The control group received guideline-directed medical therapy(GDMT)or GDMT combined with placebo,and the treatment group received GDMT combined with TCM.The treatment mainly lasted for 4-8 weeks,most of the RCTs did not set the follow-up period or the follow-up period was unknown.A total of 160 outcome indicators were used,with the total frequency of 1348.According to functional attributes,the outcome indicators can be categorized into 6 groups:symptoms/signs(403,29.90%),TCM syndromes/symptoms(182,13.50%),physical and chemical examination(468,34.72%),quality of life(89,6.60%),long-term prognosis(5,0.37%),and safety evaluation(201,14.91%).

关 键 词：中医药 冠心病 经皮冠状动脉介入术后心绞痛 随机对照试验 研究现状 

分 类 号：R259[医药卫生—中西医结合]