芪参益气滴丸治疗冠心病心绞痛的有效性和安全性:系统评价与Meta分析  

Efficacy and safety of Qishen Yiqi Gutta Pills in treating coronary heart disease-angina pectoris:a systematic review and Meta-analysis

作　　者：卢恩仕 何丽云[1] 雒琳[1] 张迪 王鑫[1] 吴东宁[1] Lu Enshi;He Liyun;Luo Lin;Zhang Di;Wang Xin;Wu Dongning(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;不详)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中国循证心血管医学杂志》2024年第6期667-673,共7页Chinese Journal of Evidence-Based Cardiovascular Medicine

基　　金：首都卫生发展科研专项项目(2022-1-4301);中国中医科学院科技创新工程中医临床基础学科创新团队项目(CI2021B003)。

摘　　要：目的系统评价芪参益气滴丸治疗冠状动脉粥样硬化性心脏病(冠心病)心绞痛的有效性和安全性。方法共检索7个中英文数据库,从中收集芪参益气滴丸治疗冠心病心绞痛的随机对照试验(RCTs),检索时间为建库至2023年1月1日,并采用RevMan 5.4.1软件进行Meta分析。结果共纳入17项研究,涉及1817例受试者。相较于常规西药治疗,芪参益气滴丸能够更好的改善冠心病心绞痛患者的中医证候疗效(OR=6.43,95%CI:4.17~9.90,P<0.00001)、心电图疗效(OR=3.04,95%CI:2.08~4.44,P<0.00001),降低中医症状总积分(MD=-3.49,95%CI:-3.98~-3.00,P<0.00001),改善西雅图心绞痛量表(SAQ)中的PL,AS,AF、TS,DP评分,并能够降低超敏c-反应蛋白(hs-CRP)水平(MD=-1.88,95%CI:-2.81~-0.96,P<0.0001),提高左室射血分数(LVEF)水平(MD=2.53,95%CI:0.76~4.30,P=0.005)。亚组分析显示,当治疗时间为6个月时,芪参益气滴丸在升高LVEF方面具有更好的疗效(MD=2.53,95%CI:0.76~4.30,P=0.005,I^(2)=83%)。两组均未发生严重不良反应,在安全性方面无明显差异。结论芪参益气滴丸联合常规西药治疗对冠心病心绞痛具有更好的临床疗效,且无严重不良反应。但上述结论仍需更多高质量研究进一步验证。Objective To review systematically the efficacy and safety of Qishen Yiqi Gutta Pills in treating coronary heart disease-angina pectoris(CHD-AP).Methods There were totally 7 Chinese and English databases retrieved for collecting randomized controlled trials(RCT)of treating CHD-AP with Qishen Yiqi Gutta Pills from database establishment time to Jan.1,2023.The collected RCT were given a Meta-analysis by using RevMan5.4.1 software.Results There were totally 17 RCT included involved 1817 subjects.Compared with control group(treated with routine Western medicine),in treatment group(treated with Qishen Yiqi Gutta Pills and routine Western medicine),the curative effects on TCM syndromes(OR=6.43,95%CI:4.17~9.90,P<0.00001),electrocardiogram(OR=3.04,95%CI:2.08~4.44,P<0.00001)and the total integrals of TCM symptoms(MD=-3.49,95%CI:-3.98~-3.00,P<0.00001),and scores of PL,AS,AF,TS and DP in Seattle Angina Questionnaire(SAQ)were improved,hs-CRP level(MD=-1.88,95%CI:-2.81~-0.96,P<0.0001)was reduced,and LVEF level was promoted(MD=2.53,95%CI:0.76~4.30,P=0.005).The results of subgroup analysis showed that Qishen Yiqi Gutta Pills had a higher curative effect on LVEF improvement(MD=2.53,95%CI:0.76~4.30,P=0.005,I^(2)=83%)after treatment for 6 months.There were no severe adverse reactions in both 2 groups,and no significant difference in safety between 2 groups.Conclusion Qishen Yiqi Gutta Pills combined with routine Western medicine has a higher clinical efficacy on CHD-AP without severe adverse reactions,but the above conclusion needs to be further verified by more highquality studies.

关 键 词：芪参益气滴丸 冠心病心绞痛 随机对照试验 META分析 

分 类 号：R541.4[医药卫生—心血管疾病]