摘要
目的系统评价注射用益气复脉(冻干)联合化学药治疗冠心病心绞痛的有效性和安全性。方法计算机检索中国学术期刊全文数据库(CNKI)、万方数据知识服务平台(Wangfang Data)、维普中文期刊全文数据库(VIP)、中国生物医学文献数据库(CBM)、美国生物医学期刊文献数据库(PubMed)、荷兰医学文摘数据库(Embase)、循证医学图书馆(The Cochrane Library)、美国引文数据库(Web of Science)等,检索时间从建库至2021年8月31日,全面收集注射用益气复脉(冻干)联合化学药治疗与单纯化学药治疗冠心病心绞痛的随机对照试验(RCT)和半随机对照试验(CCT)的文献,采用RevMan 5.3软件进行Meta分析。结果共纳入9个RCTs和1个CCT,总样本量为1207例,其中试验组607例、对照组600例。Meta分析结果显示,与化学药常规治疗相比,注射用益气复脉(冻干)联合化学药常规治疗能降低心血管事件发生率[RR=0.14,95%CI(0.06,0.32),P<0.00001],提高临床有效率[RR=1.26,95%CI(1.17,1.35),P<0.00001],减少心绞痛发生次数[SMD=−2.38,95%CI(−2.64,−2.11),P<0.00001]、心绞痛持续时间[SMD=−3.40,95%CI(−4.10,−2.70),P<0.00001],提升西雅图心绞痛评分量表评分[MD=14.15,95%CI(11.69,16.60),P<0.00001],提高心电图改善率[RR=1.20,95%CI(1.05,1.38),P=0.009],降低全血黏度[MD=−2.23,95%CI(−3.28,−1.18),P<0.0001];两组不良反应发生率比较差异无统计学意义[OR=0.58,95%CI(0.21,1.59),P=0.29]。结论与单纯化学药常规治疗相比,注射用益气复脉(冻干)联合化学药常规治疗在降低心血管事件发生率、提高临床有效率,减少心绞痛发作次数和心绞痛持续时间,提高心电图疗效和西雅图评分和改善血液流变学作用方面疗效更优,且无明显不良反应。但上述研究结果仍需多中心、大样本RCT试验进一步验证。
Objective To systematically evaluate the efficacy and safety of Yiqi Fumai Lyophilized Injection(YQFM)combined with western medicine in the treatment of angina pectoris of coronary heart disease.Methods CNKI,Wanfang Data,VIP,CBM,PubMed,EMbase,the Cochrane library,and Web of science were searched from the date of establishment of the databases to August 31,2021.The studies of randomized controlled trial(RCT)and controlled clinical trial(CCT)of YQFM combined with chemical drug and chemical drug alone in the treatment of angina pectoris were comprehensively collected.evaluated studies by the Cochrane risk assessment form.Meta-analysis of the included studies was performed using RevMan 5.3 software.Results A total of nine RCTs and one CCT were included,with a total sample size of 1207 cases,including 607 cases in the experimental group and 600 cases in the control group.Meta-analysis showed that compared with WM alone,YQFM combined with chemical drug could reduce the incidence of cardiovascular events[RR=0.14,95%CI(0.06,0.32),P<0.00001],increase clinical efficiency[RR=1.26,95%CI(1.17,1.35),P<0.00001],reduce the number of angina attacks[SMD=−2.38,95%CI(−2.64,−2.11),P<0.00001],duration of angina pectoris[SMD=−3.40,95%CI(−4.10,−2.70),P<0.00001],increase SAQ scores[MD=14.15,95%CI(11.69,16.60),P<0.00001],improve the efficacy of ECG[RR=1.20,95%CI(1.05,1.38),P=0.009],reduce whole blood viscosity level[MD=−2.23,95%CI(−3.28,−1.18),P<0.0001].In the incidence of adverse reactions,there was no significant difference between the two groups[OR=0.58,95%CI(0.21,1.59),P=0.29].Conclusion Compared with chemical drug alone,the combination of YQFM and chemical drug can reduce the incidence of cardiovascular events,improve the clinical effective rate,reduce the number of angina attacks and angina duration,improve the curative effect of ECG,SAQ scores,and hemorheology and has no obvious adverse reactions.The above research results still need to be verified bymoremulticenter randomized controlled trials.
作者
苏小琴
张磊
鞠爱春
李德坤
SU Xiaoqin;ZHANG Lei;JU Aichun;LI Dekun(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections,Tianjin 300410,China)
出处
《药物评价研究》
CAS
2021年第11期2518-2526,共9页
Drug Evaluation Research
关键词
注射用益气复脉(冻干)
冠心病心绞痛
Meta分析
心血管事件
Yiqi Fumai Lyophilized Injection
angina pectoris of coronary heart disease
Meta-analysis
cardiovascular events
