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冠心宁片治疗冠心病心绞痛的Meta分析及GRADE评价

[Meta-analysis and GRADE evaluation of Guanxinning Tablets in treatment of angina pectoris of coronary heart disease].

作者信息

Li Xiao-Ying, Sun Dong-Xia, Xu Ya-Ni, Gao Xiao-Han, Fan Kai-Fang

机构信息

Shanxi University of Chinese Medicine Jinzhong 030619, China.

Zhejiang Chinese Medical University Hangzhou 310000, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2023 Jan;48(1):247-255. doi: 10.19540/j.cnki.cjcmm.20221015.501.

Abstract

This study aims to evaluate the efficacy and safety of Guanxinning Tablets+conventional western medicine in the treatment of angina pectoris of coronary heart disease, and provide evidence-based references for clinical medication. Retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, randomized controlled trial(RCT) about Guanxinning Tablets for the treatment of angina pectoris of coronary heart disease from the inception to April 2022 were collected. After literature screening and data extraction, the bias risk assessment tool recommended by the Cochrane evaluation manual handbook 5.1.0 was used to evaluate the quality of the included literature, and RevMan 5.3 and Stata 14.0 were used for Meta-analysis. Eighteen RCTs were finally included, involving 2 281 patients. Meta-analysis showed that, compared with conventional western medicine treatment alone, Guanxinning Tablets+conventional western medicine significantly improved angina pectoris efficacy(RR=1.33, 95%CI[1.13, 1.57], P=0.000 8), electrocardiogram efficacy(RR=1.32, 95%CI[1.02, 1.71], P=0.03), and exercise duration(MD=59.53, 95%CI[39.16, 79.90], P<0.000 01) and reduced the incidence of cardiovascular events(MACE)(RR=0.43, 95%CI[0.30, 0.61], P<0.000 01), high sensitivity C-reactive protein(hs-CRP)(MD=-2.75, 95%CI[-3.71,-1.79], P<0.000 01), and endothelin-1(ET-1) levels(MD=-9.34, 95%CI[-11.36,-7.32], P<0.000 01). There was no statistically significant difference in the incidence of adverse reactions between two groups(RR=0.91, 95%CI[0.68, 1.22], P=0.52). Subgroup analysis showed that Guanxinning Tablets may have better short-term efficacy(less than 6 months) in the treatment of heart-blood stasis syndrome. GRADE grading showed that angina pectoris efficacy, electrocardiogram efficacy, MACE, and ET-1 were in the medium grade, hs-CRP and adverse reactions were in the low grade, and exercise duration was in the extremely low grade. In conclusion, the efficacy of Guanxinning Tablets+conventional western medicine is better than conventional western medicine treatment alone, with good safety. Therefore, it is recommended for the short-term treatment of patients with heart-blood stasis syndrome. However, the evidence quality of some results is low, and more rigo-rous RCT is still needed to enhance the reliability of evidence.

摘要

本研究旨在评价冠心宁片联合常规西药治疗冠心病心绞痛的有效性和安全性,为临床用药提供循证参考。通过检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane图书馆,收集自建库至2022年4月关于冠心宁片治疗冠心病心绞痛的随机对照试验(RCT)。经文献筛选和数据提取后,采用Cochrane评价手册5.1.0推荐的偏倚风险评估工具对纳入文献质量进行评价,并用RevMan 5.3和Stata 14.0软件进行Meta分析。最终纳入18项RCT,涉及2 281例患者。Meta分析结果显示,与单纯常规西药治疗相比,冠心宁片联合常规西药能显著提高心绞痛疗效(RR=1.33,95%CI[1.13,1.57],P=0.000 8)、心电图疗效(RR=1.32,95%CI[1.02,1.71],P=0.03)及运动持续时间(MD=59.53,95%CI[39.16,79.90],P<0.000 01),并降低心血管事件(MACE)发生率(RR=0.43,95%CI[0.30,0.61],P<0.000 01)、高敏C反应蛋白(hs-CRP)水平(MD=-(此处原文有误,应为2.75),95%CI[-3.71,-1.79],P<0.000 01)和内皮素-1(ET-1)水平(MD=-9.34,95%CI[-11.36,-7.32],P<0.000 01)。两组不良反应发生率差异无统计学意义(RR=0.91,95%CI[0.68,1.22],P=0.52)。亚组分析显示,冠心宁片治疗心血瘀阻证可能具有较好的短期(小于6个月)疗效。GRADE分级显示,心绞痛疗效、心电图疗效、MACE及ET-1为中级,hs-CRP及不良反应为低级,运动持续时间为极低级别。综上所述,冠心宁片联合常规西药的疗效优于单纯常规西药治疗,安全性良好。因此,推荐用于心血瘀阻证患者的短期治疗。然而,部分结果的证据质量较低,仍需要更严格的RCT以提高证据的可靠性。

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