参芍胶囊治疗冠心病心绞痛的Meta分析与试验序贯分析  

Meta-analysis and trial sequential analysis of Shenshao Capsules in treatment of angina pectoris in coronary heart disease

作　　者：孙恒 邢作英[1] 黄金雨 邱伯雍 王永霞[1] SUN Heng;XING Zuo-ying;HUANG Jin-yu;QIU Bo-yong;WANG Yong-xia(Department of Cardiovascular Diseases,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;First Clinical Medical College,Henan University of Chinese Medicine,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学第一附属医院心脏中心,河南郑州450000 [2]河南中医药大学第一临床医学院,河南郑州450000

出　　处：《中国中药杂志》2024年第12期3385-3395,共11页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(82074229);河南省“双一流”心血管疾病中医药防治科技创新团队项目;河南省中医学“双一流”创建科学研究专项(HSRP-DFCTCM-2023-3-03)。

摘　　要：系统评价参芍胶囊联合常规西药治疗冠心病心绞痛的有效性和安全性。计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、EMbase、PubMed、Cochrane Library等7个数据库,从建库至2023年12月关于参芍胶囊治疗冠心病心绞痛的随机对照试验(RCT)。根据纳入、排除标准,对文献进行筛选、资料提取,采用Cochrane偏倚风险评估工具2.0(RoB 2.0)对纳入文献进行质量评价,RevMan 5.4和Stata/SE 15.1软件进行Meta分析,GRADE系统进行证据质量评价,TSA 0.9.5.10 beta软件进行试验序贯分析(TSA)。共纳入RCTs 12篇,样本量1 128例,其中试验组567例,对照组561例。Meta分析显示,参芍胶囊+常规西药vs常规西药可提高临床疗效(RR=1.20,95%CI[1.15,1.26],P<0.000 01)、心电图疗效(RR=1.16,95%CI [1.04,1.30],P=0.01),减少心绞痛周发作频率(MD=-2.85,95%CI[-5.27,-0.43],P=0.02)、心绞痛日发作频率(MD=-0.30,95%CI[-0.57,-0.03],P=0.03)、心绞痛发作持续时间(RR=-2.28,95%CI[-3.44,-1.12],P=0.000 1)。不良反应发生方面,2组差异无统计学意义(RR=1.33,95%CI[0.71,2.51],P=0.37)。TSA显示,临床疗效累计的研究穿过了传统界值,但未穿过TSA界值,表明结果可能存在假阳性。GRADE系统评价显示,除了临床疗效为低级证据,其余均为极低级。结果表明,参芍胶囊+常规西药在提高临床疗效、心电图疗效,降低心绞痛发作频率、心绞痛发作持续时间可能具有一定优势,但因存在的局限性,尚需设计更为严谨、高质量的RCT加以验证其疗效和安全性。The efficacy and safety of Shenshao Capsules in combination with conventional western medicine for the treatment of angina pectoris in coronary heart disease were systematically evaluated.Computer search of seven databases,including CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase,and Cochrane Library,was conducted to identify randomized controlled trial(RCT)on Shenshao Capsules for the treatment of angina pectoris in coronary heart disease up to December 2023.According to inclusion and exclusion criteria,articles were screened,and data was extracted.Cochrane bias risk assessment tool 2.0(RoB 2.0)was used to evaluate the quality of the included articles.Meta-analysis was performed by RevMan 5.4 and Stata/SE 15.1 software,and evidence quality was rated by the GRADE system.TSA 0.9.5.10 beta software was used for the trial sequential analysis(TSA).Twelve RCTs,with a total of 1128 participants(567 in the experimental group and 561 in the control group),were included.Meta-analysis showed that Shenshao Capsules+conventional western medicine significantly improved clinical efficacy(RR=1.20,95%CI[1.15,1.26],P<0.00001)and electrocardiogram efficacy(RR=1.16,95%CI[1.04,1.30],P=0.01),reduced the frequency of weekly angina pectoris attacks(MD=-2.85,95%CI[-5.27,-0.43],P=0.02),daily angina pectoris attacks(MD=-0.30,95%CI[-0.57,-0.03],P=0.03)and the duration of angina pectoris attacks(RR=-2.28,95%CI[-3.44,-1.12],P=0.0001).There was no statistically significant difference in adverse reactions between the two groups(RR=1.33,95%CI[0.71,2.51],P=0.37).TSA indicated that the cumulative evidence for clinical efficacy exceeded the traditional boundary but did not exceed the TSA boundary,suggesting a potential false positive result.According to GRADE assessment,except for clinical efficacy,which was rated as lowquality evidence,the remaining outcomes were rated as very low-quality evidence.The results indicate that Shenshao Capsules+conventional western medicine may have certain advantages in improving clinical efficacy and electrocardiographic ef

关 键 词：参芍胶囊 冠心病 心绞痛 系统评价 Meta分析 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]