沙库巴曲缬沙坦治疗难治性心力衰竭患者疗效及安全性的Meta分析

The efficacy and safety of Sacubitril/Valsartan in patients with refractory heart failure:A meta analysis

目的比较沙库巴曲缬沙坦(LCZ696)与血管紧张素转换酶抑制剂(ACEI)或血管紧张素Ⅱ受体拮抗剂(ARB)治疗难治性心力衰竭(RHF)患者的疗效和安全性,为临床提供参考依据。方法通过检索Pubmed,Embase,Web of science,Cochrane,CBM,知网等数据库中已发表的中英文随机对照研究(RCTs),筛选文献并提取数据后,采用Cochrane偏倚风险评估工具对纳入的RCTs质量进行评价,采用Stata15.1和Revman 5.4进行Meta分析。结果共纳入13篇文献,总计1338例患者。Meta分析结果显示,研究组N末端B型利钠肽原[加权均数差](WMD)=-294.79,95%CI-422.28~-167.31,P=0.000、高敏感性心肌肌钙蛋白T(WMD=-0.09,95%CI-0.11~-0.08,P=0.000)、左心室舒张末期内径(WMD=-4.00,95%CI-5.34~-2.67,P=0.000)、左心室收缩末期内径(WMD=-4.94,95%CI-7.05~-2.82,P=0.000)低于对照组;左心室射血分数(WMD=5.88,95%CI 4.38~7.38,P=0.000)、6 min步行距离和有效率(RR=1.81,95%CI 1.11~1.26,P=0.000)明显高于对照组。两组细胞间黏附分子、血肌酐、醛固酮水平、低血压、头晕、恶心/呕吐、粒细胞减少、高钙血症与对照组相比,差异无统计学意义。结论LCZ696疗效好,能显著提高RHF患者心功能,改善心室重塑,减轻心肌组织损伤,无明显不良反应。

Objective To compare the efficacy and safety of sacubitril/valsartan(LCZ696)and ACEI/ARB in treatment of refractory heart failure(RHF).Methods Pubmed,Embase,Web of Sience,Cochrane Library,CBM and CNKI databases for the related randomized controlled trials were searched.Selected literatures and extracted data the risk of bias of the included studies were assessed by Cochrane bias risk evaluation tool.The meta analysis was performen by Revman 5.4 and Stata 15.1 softwares.Results A total of 13 articles were included,involving1338 patients.Meta analysis showed that the N-terminal prohormone of brain natriuretic peptide NT-proBNP(WMD=-294.79,95%CI-422.28~-167.31,P=0.000),high-sensitivity cardiac troponin T(hs-cTnT)(WMD=-0.09,95%CI-0.11~-0.08,P=0.000),left ventricular end-diastolic dimension(LVEDD)(WMD=-4.00,95%CI-5.34~-2.67,P=0.000)and left ventricular end-systolic diameter(LVESD)(WMD=-4.94,95%CI-7.05~-2.82,P=0.000)in the group of sacubitril/valsartan were significantly lower than that of the control group,but the left ventricular ejection fraction(LVEF)(WMD=5.88,95%CI 4.38~7.38,P=0.000),6 min walking distance(6 MWD)and the effective rate(RR=1.81,95%CI 1.11~1.26,P=0.000)of the sacubitril/valsartan group were higher than that of the control group.There was no difference between the scubitril/valsartan group and the control group in the intercellular adhesion molecule 1(ICAM-1),creatinine(CREA),aldosterone(ALD),hypotension,dizziness,nausea,granulopenia and hypercalcemia.Conclusion In comparison of angiotensin-converting enzyme inhibitor(ACEI)/angiotensin receptor blocke(ARB),LCZ696 is more effective in the treatment of RHF,which may reduce the myocardial tissue injury and remodeling,ameliorate the function of heart and have no significant adverse reactions.