通心络胶囊联合西医常规治疗不稳定型心绞痛疗效与安全性的Meta分析

Meta-analysis of efficacy and safety of Tongxinluo Capsule combined with conventional western medicine in treatment of unstable angina pectoris

目的系统评价通心络胶囊联合西医常规治疗不稳定型心绞痛的有效性及安全性,为临床研究提供循证依据。方法以中国学术期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang Data)、维普中文期刊全文数据库(VIP)、中国临床试验注册中心网站(Chinese Clinical Trial Registry)、中国生物医学文献数据库(CBM)、荷兰医学文摘数据库(Embase)、循证医学图书馆(The Cochrane library)、美国生物医学期刊文献数据库(PubMed)为主要检索来源,检索时间为建库始至2020年7月31日。采用偏倚风险评估工具评价纳入研究的方法学质量。采用RevMan 5.3软件对结局指标进行Meta分析。结果最终共纳入30个随机对照试验(RCTs),共计2295例不稳定型心绞痛患者,其中观察组1188例,对照组1107例。Meta分析结果显示,试验组比对照组可显著降低心血管事件发生率[RR=0.28,95%CI=(0.18,0.45),P<0.00001]、提高心绞痛疗效[OR=2.46,95%CI=(1.96,3.10),P<0.00001],减少心绞痛发作次数[SMD=-1.00,95%CI=(-1.58,-0.42),P=0.0007]、心绞痛持续时间[SMD=-2.25,95%CI=(-3.31,-1.19),P<0.0001]及硝酸甘油用量[SMD=-1.47,95%CI=(-2.14,-0.79),P<0.0001],提高心电图疗效[OR=2.25,95%CI=(1.64,3.09),P<0.00001],降低超敏C反应蛋白水平[SMD=-2.78,95%CI=(-3.95,-1.62),P<0.00001];在不良反应发生率方面,两组比较差异无统计学意义[RR=0.87,95%CI=(0.48,1.55),P=0.63]。结论在西医常规治疗基础上加用通心络胶囊对不稳定型心绞痛的疗效确切,能显著降低心血管事件发生率、提高心绞痛疗效,减少心绞痛发作次数、心绞痛持续时间及硝酸甘油用量,提高心电图疗效,降低超敏C反应蛋白水平,且无明显不良反应。但研究的质量较低,尚需更多设计严谨的多中心随机对照试验以增加证据强度。

Objective To systematically evaluate the efficacy and safety of Tongxinluo Capsule combined with conventional western medicine in the treatment of unstable angina pectoris(UAP),and to provide evidence-based basis for clinical research.Methods CNKI,WanFang Data,VIP,Chinese Clinical Trial Registry,CBM,Embase,The Cochrane library and PubMed were used as the main search sources.The search time was limited to July 31,2020.The bias risk assessment tool was used to evaluate the methodological quality of the included studies.Meta-analysis was performed using RevMan 5.3 software.Results A total of 30 RCTs were included,2295 patients with unstable angina pectoris,including 1188 cases in the observation group and 1107 cases in the control group.The results of meta-analysis showed that compared with the control group,the experimental group could significantly reduce the incidence of cardiovascular events[RR=0.28,95%CI=(0.18,0.45).P<0.00001],improve the efficacy of angina pectoris[OR=2.46,95%CI=(1.96,3.10),P<0.00001],reduce the number of angina attacks[SMD=-1.00,95%CI=(-1.58,-0.42),P=0.0007],duration of angina pectoris[SMD=-2.25,95%CI=(-3.31,-1.19),P<0.0001],the dosage of nitroglycerin[SMD=-1.47,95%CI=(-2.14,-0.79),P<0.0001],improve The efficacy of ECG[OR=2.25,95%CI=(1.64,3.09),P<0.00001]and decrease the level of hs-CRP[SMD=-2.78,95%CI=(-3.95,-1.62),P<0.00001].In the incidence of adverse reactions,there was no significant difference between the two groups[RR=0.87,95%CI=(0.48,1.55),P=0.63].Conclusion Tongxinluo Capsule is effective in the treatment of unstable angina pectoris on the basis of conventional western medicine treatment.It can significantly reduce the incidence of cardiovascular events,improve the curative effect of angina pectoris,reduce the number of angina attacks,angina duration and nitroglycerin dosage,improve the curative effect of ECG,reduce the level of high sensitivity C reactive protein,and have no obvious adverse reactions.However,the quality of the study is low,and more rigorously designed multicenter randomized controlled trials are needed to increase the intensity of evidence.