稳心颗粒联合曲美他嗪治疗不稳定型心绞痛疗效和安全性的系统评价及Meta分析

Efficacy and Safety of Wenxin Granules Combined with Trimetazidine on Unstable Angina Pectoris: A Systematic Review and Meta-analysis

目的对稳心颗粒联合曲美他嗪治疗不稳定型心绞痛的疗效和安全性进行系统评价。方法检索中国知网数据库(CNKI)、重庆维普中文科技期刊数据库(VIP)、中国生物医学数据库(CMB)、万方数据库(WANFANG)、PubMed、Cochrane Library等数据库,时间截止至2019年03月31日。由两名评价员根据Cochrane手册分别进行文献筛选、资料提取和质量评价,并运用Revman5.3软件进行Meta分析和相应的描述性分析。结果本系统评价共纳入16项研究,对其中14项研究进行Meta分析,共纳入患者1457例,包括观察组729例,对照组728例。其中8项研究观察组为稳心颗粒联合曲美他嗪+常规治疗,对照组为曲美他嗪+常规治疗;6项研究观察组为稳心颗粒联合曲美他嗪治疗,对照组为单纯使用曲美他嗪治疗。Meta分析结果显示:两类观察组分别与其对照组进行比较,心绞痛临床有效率、心绞痛发作次数及心绞痛发作持续时间的差异均有统计学意义,均优于对照组;不良反应则与对照组差异无统计学意义。结论在研究过程中,不良反应主要表现为不同程度的恶心、呕吐、食欲不振,但所有研究均未报告患者治疗后随访情况,稳心颗粒联合曲美他嗪治疗不稳定型心绞痛的安全性有待进一步研究与明确。依据现有证据,稳心颗粒联合曲美他嗪治疗不稳定型心绞痛具有一定的疗效,但因纳入文献质量不高,样本量少,严重影响结果的可靠性,今后仍需开展高质量、多中心、大样本的临床随机对照试验进行疗效验证。

Objective To systematically evaluate the efficacy and safety of Wenxin Granules combined with trimetazidine in the treatment of unstable angina pectoris.Methods CNKI, VIP, CMB, WANFANG, PubMed, Cochrane Library and other electronic databases were searched since the establishment of the databases to March 31, 2019.According to the evaluation standards in Cochrane Handbook, 2 independent reviewers screened out the literature, extracted the data and assessed the quality of the studies included.RevMan 5.3 software was used for Meta-analysis and corresponding descriptive analysis.Results A total of 16 studies were included in the systematic review, in which 14 were used to perform Meta-analysis.A total of 1457 patients were included, with 729 cases in the observation group and 728 cases in the control group.Among them, the observation groups in 8 studies were treated by Wenxin Granules combined with trimetazidine plus conventional treatment, and the control groups in them were treated by trimetazidine plus conventional treatment;the observation groups in another 6 studies were treated by Wenxin Granules combined with trimetazidine, and their control groups were simplely treated with trimetazidine.Results of the Meta-analysis showed that compared these 2 kinds of observation groups with their control groups respectively, the differences of clinically effective rate in unstable angina pectoris, the number of angina attacks and duration of angina pectoris were statistically significant, and those in the observation groups were better than those in the control groups.In terms of adverse reactions, compared with the control groups, there was no statistically significant difference.Conclusion During the study, the adverse reactions were mainly characterized by various degrees of nausea, vomiting, and loss of appetite.However, all the studies did not report the situation of follow-up after the treatment.The safety of Wenxin Granules combined with trimetazidine in the treatment of unstable angina pectoris needs to be further studied and clarified.According to the available evidence, Wenxin Granules combined with trimetazidine has certain curative effect in unstable angina pectoris.However, due to the low quality of the literature and the small sample size, it seriously affects the reliability of the results.In the future, high-quality, multicenter-based and large-sample clinical randomized controlled trials are needed to perform efficacy validation.