大株红景天注射液联合常规、西医疗法治疗冠心病合并心力衰竭有效性和安全性的系统评价

背景冠心病是一种常见的心血管疾病，抗冠状动脉硬化、抗心力衰竭是治疗冠心病患者的关键，目前关于大株红景天注射液治疗冠心病合并心力衰竭有效性和安全性的综合评价分析较少。目的系统评价大株红景天注射液联合常规、西医疗法治疗冠心病合并心力衰竭的有效性与安全性。方法检索PubMed、The Cochrane Library、EMBase、中国知网（CNKI）、维普网、中国生物医学文献数据库（SinoMed）、万方数据知识服务平台（Wanfang）等相关文献，检索时限为建库至2020-06-07。筛选出应用大株红景天注射液治疗冠心病心力衰竭的随机对照试验并进行分组，大株红景天注射液联合常规、西医疗法为试验组，常规、西医疗法为对照组。主要结局指标：左心室射血分数（LVEF）、左心室舒张末期内径（LVEDD）、左心房舒张末期内径（LAEDD）、左心室收缩末期内径（LVESD）、血清一氧化碳（CO）、N末端B型利钠肽前体（NT-proBNP）。次要结局指标：内皮素（ET-1）、血清一氧化氮（NO）、临床总有效率、不良反应发生率。采用Cochrane风险偏倚评估工具评价纳入研究质量，运用RevMan 5.3软件进行Meta分析。结果共纳入符合标准的文献8篇，1 075例患者。Meta分析结果显示，试验组在改善心功能指标LVEF〔MD=-8.63，95%CI（-12.33，-4.93），P<0.05〕、LVEDD〔MD=5.71，95%CI（4.82，6.61），P<0.05〕、LAEDD〔MD=6.62，95%CI（5.36，7.88），P<0.05〕、LVESD〔MD=3.15，95%CI（1.84，4.46），P<0.05〕、CO〔MD=-0.44，95%CI（-0.62，-0.25），P<0.05〕效果优于对照组。试验组改善NT-proBNP效果优于对照组〔SMD=2.87，95%CI（1.77，3.97），P<0.05〕。试验组改善内皮功能指标ET-1〔MD=28.32，95%CI（23.95，32.68），P<0.05〕、NO〔MD=-16.74，95%CI（-20.13，-13.35），P<0.05〕效果优于对照组。试验组的临床总有效率优于对照组〔RR=1.25，95%CI（1.18，1.32），P<0.05〕。结论试验组对冠心病合并心力衰竭的临床疗效优于对照组，能改善心功能、心力衰竭标志物、内皮功能指标，且具有良好的安全性。但现有临床研究数量较少，质量偏低，仍需更多高质量的临床研究加以验证。

Efficacy and Safety Combined with Conventional and Western Medicine Treatments on Coronary Heart Disease Complicated with Heart Failure:a Systematic Review

Background Anti-atherosclerotic and anti-heart failure therapies are the key to the treatment of coronary heart disease(CHD),a common cardiovascular disease.At present,there are few comprehensive evaluation and analysis on the efficacy and safety of Sofren Injection(SI)in the treatment of coronary heart disease complicated with heart failure.Objective To systematically evaluate the efficacy and safety of SI combined with conventional and western treatment in the treatment of heart failure in complicated with CHD.Methods PubMed,The Cochrane Library,EMBase,CNKI,CQVIP,SinoMed,Wanfang Data and other databases were searched from inception to June 7,2020.Randomized controlled trials(RCTs)of the application of SI in heart failure with CHD were screened and grouped,SI combined with conventional and western treatment as the experimental group,conventional and western treatment as the control group.Primary outcome indicators included left ventricular ejection fraction(LVEF),left ventricular end-diastolic diameter(LVEDD),left ventricular end-systolic diameter(LVESD),left atrial end-diastolic diameter(LAEDD),serum carbon monoxide(CO),and NT-pro-brain natriuretic peptide(NT-proBNP).Secondary outcome indicators included endothelin-1(ET-1),serum nitric oxide(NO),overall clinical response rate,and incidence of adverse reactions.The Cochrane risk bias assessment tool was used to evaluate the quality of the included studies,and the RevMan 5.3 software was used for meta-analysis.Results Eight documents meeting the criteria and 1075 patients were included.Meta-analysis indicated that the experimental group was superior to the control group in improving heart function index:LVEF(MD=-8.63,95%CI(-12.33,-4.93),P<0.05);LVEDD(MD=5.71,95%CI(4.82,6.61),P<0.05);LAEDD(MD=6.62,95%CI(5.36,7.88),P<0.05);LVESD(MD=3.15,95%CI(1.84,4.46),P<0.05);CO(MD=-0.44,95%CI(-0.62,-0.25),P<0.05).The experimental group also had better effects on improving NT-proBNP(SMD=2.87,95%CI(1.77,3.97),P<0.05).Moreover,the experimental group improved endothelial function index of ET-1(MD=28.32,95%CI(23.95,32.68),P<0.05),and NO(MD=-16.74,95%CI(-20.13,-13.35),P<0.05)more significantly.The total clinical effective rate of the experimental group was better than that of the control group(RR=1.25,95%CI(1.18,1.32),P<0.05).Conclusion The clinical efficacy of the experimental group on coronary heart disease combined with heart failure is better than that of the control group,which can improve heart function,heart failure markers,endothelial function indicators with good safety.However,the number of existing clinical studies is small and the quality is low,and more high-quality clinical studies are still needed for verification.