参附注射液联合常规西药治疗冠状动脉粥样硬化性心脏病心力衰竭有效性的Meta分析及GRADE评价

A meta-analysis and GRADE evaluate of Shenfu injection plus conventional western medicine in the treatment of coronary heart disease and heart failure

目的:分析在常规西药基础上加用参附注射液治疗冠状动脉粥样硬化性心脏病(简称冠心病)心力衰竭的疗效和安全性。方法:制定文献的纳排标准及检索策略,计算机检索国内外7个数据库(中国知网、万方、维普、SinoMed、PubMed、Cochrane Library,EMbase)建库至2021年10月24日,收集已发表的关于参附注射液治疗冠心病心力衰竭的随机对照试验。由两位研究人员独立检索、筛选及资料提取,对纳入的研究进行偏倚风险评价,采用RevMan 5.3软件对临床有效率、左室射血分数(Left Ventricular Ejection Fraction,LVEF)、左心室舒张末期内径(Left Ventricular End Diastolic Dimension,LVEDD)、脑钠肽(Brain Natriuretic Peptide,BNP)、N端前脑钠肽(N-terminal Probrain Natriuretic Peptide,NT-proBNP)、C反应蛋白(C-reactive Protein,CRP)、明尼苏达心力衰竭生命质量量表(Minnesota Heart Failure Quality of Life Scale,MLFHQ)进行Meta分析,并对不良反应进行汇总分析。结果:最终纳入研究16篇随机对照试验文献,涉及研究对象1310例,参附组661例,对照组649例。Meta分析结果显示,与单纯常规西药治疗冠心病心力衰竭相比,加用参附注射液后,可进一步提高患者临床有效率[RR=1.72,95%CI(1.42,2.09),P<0.00001],改善LVEF[MD=4.00,95%CI(2.90,5.10),P<0.00001]、LVEDD[MD=-2.39,95%CI(-3.91,-0.87),P=0.002]、BNP[SMD=-2.86,95%CI(-4.76,-0.96),P=0.003]、NT-ProBNP[SMD=-3.05,95%CI(-4.53,-1.56),P<0.0001]、CRP[SMD=-1.39,95%CI(-2.00,-0.79),P<0.00001]和MLFHQ[MD=-10.71,95%CI(-12.41,-9.01),P<0.00001]。安全性方面,不良反应发生较少,安全性较高。亚组分析显示,用药剂量不同可能是各研究间存在异质性的原因。结论:与单纯常规西药治疗相比,加用参附注射液可进一步提高冠心病心力衰竭患者的临床疗效,且安全性较好。但因纳入文献的质量不高,样本量较小,上述结论仍需高质量、大样本量的临床研究进一步验证。

Objective:To analyze the efficacy and safety of the Shenfu injection(参附注射液)on coronary heart disease and heart failure on the basis of conventional western medicine.Methods:The inclusion and arrangement standards and retrieval strategies of the literature were formulated,and 7 domestic and foreign databases(CNKI,Wanfang,VIP,SinoMed,PubMed,Cochrane Library,EMbase)were established until October 24,2021 to be searched by computer,the randomized controlled trial(RCT)of the Shenfu injection on treating heart failure after coronary heart disease were collected.Two researchers independently searched,screened and extracted data,and evaluated the risk of bias in the included studies.RevMan 5.3 software was used to evaluate the clinical effectiveness,LVEF,LVEDD,meta-analysis of BNP,NT-proBNP,CRP,and MLFHQ were performed,and adverse reactions were analyzed.Results:A total of 16 RCT articles were finally included in the study,with a total of 1310 subjects,with 661 cases in the attached group,and 649 cases in the control group.Meta-analysis results:compared with conventional western medicine on treating heart failure after coronary heart disease,the addition of Shenfu injection can further improve the clinical effectiveness of patients[RR=1.72,95%CI(1.42,2.09),P<0.00001],improve LVEF[MD=4.00,95%CI(2.90,5.10),P<0.00001],LVEDD[MD=-2.39,95%CI(-3.91,-0.87),P=0.002],BNP[SMD=-2.86,95%CI(-4.76,-0.96),P=0.003],NT-ProBNP[SMD=-3.05,95%CI(-4.53,-1.56),P<0.0001],CRP[SMD=-1.39,95%CI(-2.00,-0.79),P<0.00001]and MLFHQ[MD=-10.71,95%CI(-12.41,-9.01),P<0.00001].There were fewer adverse reactions and higher safety.Subgroup analysis showed that the different doses of intervention drugs may be the reason for the heterogeneity among the studies.Conclusion:Compared with conventional western medicine treatment alone,the addition of Shenfu injection can further improve the clinical efficacy of patients with heart failure after coronary heart disease,and the safety is better.However,due to the quality of the included literature and the number of patients,the above conclusions still need to be further verified by high-quality clinical studies.