摘要
通过证据图对中成药治疗急性心肌梗死后心力衰竭的临床研究进行全面梳理,了解该领域的证据分布。通过检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library、EMbase数据库,纳入近20年中成药治疗急性心肌梗死后心力衰竭的随机对照试验(randomized controlled trial,RCT)、系统评价/Meta分析、指南/共识,以文字、图表、气泡图、柱状图相结合的形式对证据进行分析展示,分别采用RoB 1.0、AMSTAR2、AGREEⅡ对RCT、系统评价/Meta分析、指南/共识进行质量评价。共纳入163篇RCTs,4篇系统评价/Meta分析,1篇网状Meta分析,2篇观察性研究,5篇指南/共识。近年来,中成药治疗急性心肌梗死后心力衰竭发文量整体呈上升趋势,中成药种类较多,其中参附注射液的关注度最高。临床RCT和系统评价/Meta分析的文献质量普遍不高,RCT多为小样本、单中心、短周期;结局指标方面主要包括心功能指标、心肌损伤标志物、总有效率、血流动力学指标、安全性指标,中医特色疗效指标关注较少;部分指南/共识制定流程缺乏规范,导致其权威性和科学性有所降低。结果表明,中成药治疗急性心肌梗死后心力衰竭既有优势,但也存在问题,仍需更多高质量循证证据提供支撑,未来应开展更多大样本、多中心的临床试验,同时规范相关系统评价/Meta分析、指南/共识制定流程并提升其证据质量,以便进一步挖掘中成药治疗急性心肌梗死后心力衰竭的有效性和安全性。
An evidence map was established to comprehensively sort out the clinical research in the treatment of post⁃acute myocar⁃dial infarction heart failure(P⁃AMI⁃HF)with Chinese patent medicines,so as to reveal the distribution of evidence in this field.CNKI,Wanfang,VIP,SinoMed,PubMed,Cochrane Library,and EMbase were searched for the randomized controlled trial(RCT),systematic reviews/Meta⁃analysis,and guidelines/consensus in this field.The evidence was analyzed and displayed in the form of a combination of text,charts,bubble charts,and bar charts,and the quality of RCT,systematic reviews/Meta⁃analysis,and guidelines/consensus were evaluated by RoB 1.0,AMSTAR2,and AGREEⅡ,respectively.A total of 163 RCTs,4 systematic reviews/Meta⁃analysis,1 network Meta⁃analysis,2 observational studies,and 5 guidelines/consensus were included.In recent years,the total num⁃ber of publications in this field has shown an upward trend.There were a variety of Chinese patent medicines in the treatment of P⁃AMI⁃HF,among which Shenfu Injection received the most attention.The clinical RCT and systematic reviews/Meta⁃analysis general⁃ly had poor quality,and the RCT mostly had a small size,a single center,and a short cycle.The outcome indicators mainly included cardiac function indicators,myocardial injury markers,total response rate,hemodynamic indicators,and safety indicators,while the characteristic efficacy indicators of TCM received insufficient attention.The development processes of some guidelines/consensus lack standardization,which compromised their authority and rationality.Chinese patent medicines have advantages in the treatment of P⁃AMI⁃HF,while there are also problems,which remain to be solved by more high⁃quality evidence.That is,more large⁃sample and multi⁃center clinical studies should be carried out in the future,and the formulation process of relevant systematic reviews/Meta⁃analy⁃sis and guideline/consensus should be standardized and the quality of evidence should be improved.In this way,the effectiveness and safety of Chinese patent medicines in the treatment of P⁃AMI⁃HF can be explored.
作者
张赤道
黄金雨
王永霞
朱明军
邢作英
邱伯雍
ZHANG Chi-dao;HUANG Jin-yu;WANG Yong-xia;ZHU Ming-jun;XING Zuo-ying;QIU Bo-yong(Henan University of Chinese Medicine,Zhengzhou 450000,China;Department of Cardiovascular Diseases,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第6期1673-1682,共10页
China Journal of Chinese Materia Medica
基金
第五批全国中医临床优秀人才研修项目(国中医药人教函[2022]1号)
国家自然科学基金项目(82074229)
河南省卫生健康委国家中医临床研究基地科研专项(2022JDZX117)。
关键词
中成药
心肌梗死
心力衰竭
随机对照试验
证据图
系统评价
Chinese patent medicine
myocardial infarction
heart failure
randomized controlled trial
evidence map
systematic review
