冠心宁片治疗冠心病心绞痛的Meta分析及GRADE证据评价

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

系统评价冠心宁片+常规西药治疗冠心病心绞痛的疗效与安全性,为临床用药提供依据。计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、EMbase、Cochrane Library,检索时间从建库至2022年4月,搜索冠心宁片治疗冠心病心绞痛的随机对照试验(RCT)。筛选文献并采用Cochrane 5.1.0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、Stata 14.0软件对结局指标进行Meta分析。共纳入18项RCTs, 2 281例患者。Meta分析结果显示,与单用常规西药相比,冠心宁片+常规西药在提高心绞痛疗效(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)、运动持续时间(MD=59.53,95%CI[39.16,79.90],P<0.000 01),降低心血管事件发生率(MACE)(RR=0.43,95%CI[0.30,0.61],P<0.000 01)、高敏C反应蛋白(hs-CRP)(MD=-2.75,95%CI[-3.71,-1.79],P<0.000 01)、内皮素-1(ET-1)(MD=-9.34,95%CI[-11.36,-7.32],P<0.000 01)水平方面,疗效均更显著。2组间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)。亚组分析表明,冠心宁片治疗心血瘀阻证的短期疗效(小于6个月)可能更好。GRADE分级显示心绞痛疗效、心电图疗效、MACE、ET-1为中级,hs-CRP、不良反应发生率为低级,运动持续时间为极低级。结果表明,冠心宁片+常规西药的疗效优于单用常规西药,且安全性良好,推荐用于心血瘀阻证患者的短期治疗,但部分结局证据质量较低,尚需更多设计严谨的多中心RCT增加证据强度。

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.