沙库巴曲缬沙坦钠对比血管紧张素转换酶抑制剂/血管紧张素Ⅱ受体拮抗剂治疗心力衰竭的安全性和有效性的荟萃分析

Safety and efficacy of sacubatril valsartan sodium versus angiotensin converting enzyme inhibitor/angiotensinⅡreceptor blocker in the treatment of heart failure:a meta-analysis

目的系统评价心力衰竭患者使用沙库巴曲缬沙坦钠的有效性和安全性。方法系统检索Embase、PubMed、Medline、Cochrane、Google学术、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)及万方数据库。搜集有关心力衰竭患者应用沙库巴曲缬沙坦钠(试验组)与应用血管紧张素转换酶抑制剂/血管紧张素Ⅱ受体拮抗剂(ACEI/ARB)类药物(对照组)治疗的疗效和安全性比较的随机对照试验(RCT)。提取相关资料并按照Cochrane系统评价手册5.2.2推荐的偏倚风险评估工具评价纳入文献质量后,采用RevMan 5.3软件进行荟萃分析。结果纳入10项RCT研究共6839例患者。荟萃分析结果显示,试验组的N末端B型利钠肽原[均数差(MD)=-170.14,95%CI:-243.15^-97.12,P<0.05]、左室射血分数(MD=2.92,95%CI:0.63~5.20,P<0.05)、左室收缩末期容积(MD=-5.32,95%CI:-10.25^-0.21,P<0.05)、6 min步行距离(MD=58.4,95%CI:40.37~56.42,P<0.05)改善程度均优于对照组,差异有统计学意义。两组心力衰竭治疗有效率[比值比(OR)=1.57,95%CI:0.96~2.57,P>0.05]、左室舒张末期内径改善程度(MD=-1.27,95%CI:-2.62~0.08,P>0.05)、左室舒张末期容积改善程度(MD=-1.36,95%CI:-10.72~8.00,P>0.05)和总不良反应发生率(OR=0.95,95%CI:0.73~1.23,P<0.05;I 2=68%)比较差异均无统计学意义。结论心力衰竭患者使用沙库巴曲缬沙坦钠可显著改善临床症状,提高左室射血分数和6 min步行距离、降低左室收缩末期容积,但应注意低血压、高血钾等不良反应的发生。

Objective To systematically evaluate the efficacy and safety of sacubatril valsartan sodium on the treatment of heart failure.Methods Literatures were searched from Embase,PubMed,Medline,Cochrane,Google Scholar,CNKI,CBM and Wanfang database.Randomized controlled trials(RCTs)about Sacubitril/Valsartan(experimental group)versus angiotensin-converting enzyme inhibitors/angiotensinⅡreceptor blockers(ACEI/ARB)(control group)in the treatment of heart failure were enrolled.Literatures quality was evaluated with bias risk evaluation tool recommended by Cochrane systematic evaluator manual 5.2.2.Meta-analysis was performed by using Rev Man 5.3 software.Results A total of 6839 patients from 10 RCTs were included.Meta-analysis results showed that N-terminal pro-brain natriuretic peptide(MD=-170.14,95%CI:-243.15 to-97.12,P<0.05),left ventricular ejection fraction improved(MD=2.92,95%CI:0.63 to 5.20,P<0.05),left ventricular end systolic volume improvement(MD=-5.32,95%CI:-10.25 to-0.21,P<0.05),6-min walking distance improvement(MD=58.4,95%CI:40.37 to 56.42,P<0.05)in experimental group were significantly improved than those in control group.Heart failure treatment effective rate(OR=1.57,95%CI:0.96 to 2.57,P>0.05),left ventricular end diastolic diameter improved(MD=-1.27,95%CI:-2.62 to 0.08,P>0.05),left ventricular end diastolic volume improved(MD=-1.36,95%CI:-10.72 to 8.00,P>0.05)and the incidence of total adverse reactions(OR=0.95,95%CI:0.73 to 1.23,P<0.05;I 2=68%)did not show significantly difference.Conclusions The use of sacubatril valsartan sodium therapy for patients with heart failure can significantly improve clinical symptoms,increase left ventricular ejection fraction and 6-min walking distance,and reduce left ventricular end systolic volume,but attention should be paid to the occurrence of adverse reactions such as hypotension and hyperkalemia.