精制冠心制剂治疗冠心病的快速卫生技术评估  

Rapid Health Technology Assessment of Jingzhi Guanxin Preparations for the Treatment of Coronary Heart Disease

作　　者：康超颖 李朵璐[1] 李卓伦 孔凯 刘楠[1] 杨杰[1] KANG Chao-ying;LI Duo-lu;LI Zhuo-lun;KONG Kai;LIU Nan;YANG Jie(Department of Pharmacy,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Department of Drug and Device,Xunxian Hospital of Traditional Chinese Medicine,Hebi 456250,China;Department of Drug and Device,The Second People's Hospital of Yuchen County,Shangqiu 476300,China)

机构地区：[1]郑州大学第一附属医院药学部,郑州450000 [2]鹤壁市浚县中医院药械科,鹤壁456250 [3]商丘市虞城县第二人民医院药械科,商丘476300

出　　处：《中国合理用药探索》2025年第2期48-55,共8页Chinese Journal of Rational Drug Use

基　　金：中华国际医学交流基金会-中华医学会临床药学分会临床药学科研基金项目(Z-2021-46-2101);河南省医学教育研究项目(WJLX2023015)。

摘　　要：目的:利用快速卫生技术评估(RHTA)方法对精制冠心制剂治疗冠心病的安全性、有效性和经济性进行综合性评价,为临床用药决策提供支持。方法:计算机检索自建库以来至2024年2月1日中国知网(CNKI)、维普网(VIP)、万方(Wanfang)、中国生物医学服务系统(SinoMed)、PubMed、Embase、Cochrane Library及Web of Science。通过文献筛选、质量评价和数据提取整合,对精制冠心制剂进行对比分析。结果:共纳入20篇临床研究,其中随机对照试验17篇,临床对照研究3篇。精制冠心制剂治疗冠心病心绞痛总体安全有效,但总体研究质量偏低,经济学评价欠缺。精制冠心片和冠心Ⅱ号方在治疗冠心病心绞痛方面证据较充分。精制冠心口服液缺乏高质量研究证据。结论:精制冠心制剂治疗冠心病心绞痛有一定的价值,总体安全性良好,但不同制剂间存在明显差别,需要开展更多高质量临床研究及经济学评价。Objective:To evaluate comprehensively the safety,efficacy and economy of Jingzhi Guanxin preparations in the treatment of coronary heart disease by rapid health technology assessment(RHTA),providing support for clinical medication decision-making.Methods:A computer-based search was conducted in databases including CNKI,VIP,Wanfang,SinoMed,PubMed,Embase,Cochrane Library,and Web of Science from their inception to February 1,2024.Through literature screening,quality assessment,and data extraction and integration,a comparative analysis of Jingzhi Guanxin preparations was conducted.Results:A total of 20 clinical studies were included,comprising 17 randomized controlled trials and 3 controlled clinical trials.Jingzhi Guanxin preparations have demonstrated overall safety and efficacy in the treatment of angina pectoris of coronary heart disease.Nevertheless,the overall quality of the studies is relatively low,and there is a lack of economic evaluations.Jingzhi Guanxin Tablets and GuanxinⅡformula have relatively substantial evidence supporting their use in the treatment of angina pectoris of coronary heart disease.There is a lack of high-quality research evidence supporting the use of Jingzhi Guanxin Oral Liquids.Conclusion:Jingzhi Guanxin preparations have demonstrated certain value in the treatment of angina pectoris of coronary heart disease,with an overall favorable safety profile.However,there are significant differences among different preparations,necessitating further high-quality clinical studies and economic evaluations.

关 键 词：精制冠心片 冠心病 快速卫生技术评估 文献分析 心绞痛 

分 类 号：R969[医药卫生—药理学]