沙库巴曲缬沙坦治疗非射血分数降低心力衰竭疗效和安全性的Meta分析  

Efficacy and Safety of Sacubitril-valsartan in the Treatment of Heart Failure without Reduced Ejection Fraction:A Meta-analysis

作　　者：熊波[1] 钱俊[1] 容顺康[1] 姚沅清[1] 黄晶[1] XIONG Bo;QIAN Jun;RONG Shunkang;YAO Yuanqing;HUANG Jing(Dept.of Cardiology,the Second Affiliated Hospital of Chongqing Medical University,Chongqing 400010,China)

机构地区：[1]重庆医科大学附属第二医院心血管内科,重庆400010

出　　处：《中国药房》2020年第18期2263-2268,共6页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81900361)。

摘　　要：目的:系统评价沙库巴曲缬沙坦治疗非射血分数降低心力衰竭(non-HFrEF)的有效性和安全性,为临床治疗提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国知网、维普和万方数据等,检索时限均为建库起至2020年2月29日。收集沙库巴曲缬沙坦(试验组)对比肾素-血管紧张素转化酶抑制剂/血管紧张素Ⅱ受体拮抗药(对照组)等常规药物用于治疗non-HFrEF的随机对照试验(RCT)。筛选文献、提取资料后,采用Cochrane偏倚风险评估工具5.3.0对纳入文献质量进行评价,采用Stata 14.0软件进行Meta分析,并行发表偏倚和敏感性分析。结果:共纳入6项RCT,共计5502例患者。Meta分析结果显示,试验组患者心力衰竭再住院率[RR=0.84,95%CI(0.77,0.91),P<0.001]、血肌酐升高发生率[RR=0.78,95%CI(0.67,0.91),P=0.001]均显著低于对照组,纽约心脏病协会心功能分级改善率[RR=1.25,95%CI(1.10,1.43),P=0.001]、低血压发生率[RR=1.43,95%CI(1.24,1.65),P<0.001]均显著高于对照组;两组患者心血管相关死亡率[RR=0.94,95%CI(0.79,1.12),P=0.481]、全因死亡率[RR=0.95,95%CI(0.83,1.08),P=0.417]、治疗后氨基末端脑钠肽前体水平[WMD=-301.16,95%CI(-602.77,0.44),P=0.050]、左心室射血分数水平[WMD=1.49,95%CI(-1.33,4.32),P=0.300]、高钾血症发生率[RR=0.88,95%CI(0.77,1.01),P=0.070]比较,差异均无统计学意义。发表偏倚和敏感性分析结果均显示,存在发表偏倚的可能性较大,且部分指标结果不稳定。结论:沙库巴曲缬沙坦可能会有效降低non-HFrEF患者的心力衰竭再住院率及血肌酐升高发生风险,改善其心功能,但低血压发生风险较高。上述结果需谨慎解读。OBJECTIVE:To systematically evaluate the efficacy and safety of sacubitril-valsartan in the treatment of heart failure without reduced ejection fraction(non-HFrEF)patients,and to provide evidence-based reference for its clinical treatment.METHODS:Retrieved from Cochrane Library,PubMed,Embase,CNKI,VIP and Wanfang data,during the inception to Feb.29th,2020,randomized controlled trials(RCTs)about sacubitril-valsartan(trial group)versus routine medicine as renin-angiotensin converting enzyme inhibitors/angiotensinⅡreceptor antagonists(control group)in the treatment of non-HFrEF were collected.After literature screening and data extraction,the quality of included literatures were evaluated with Cochrane bias risk evaluation tool 5.3.0.Meta-analysis was conducted with Stata 14.0 software,and the publication bias analysis and sensitivity analysis were performed.RESULTS:Totally 6 RCTs were included,involving 5502 patients.Results of Meta-analysis showed that the HF re-hospitalization rate[RR=0.84,95%CI(0.77,0.91),P<0.001]and the serum creatinine elevation rate[RR=0.78,95%CI(0.67,0.91),P=0.001]in trial group were significantly lower than control group.NYHA classification improvement rate[RR=1.25,95%CI(1.10,1.43),P=0.001]and the hypotension rate[RR=1.43,95%CI(1.24,1.65),P<0.001]were significantly higher than control group.There was no statistical significance in the cardiovascular mortality[RR=0.94,95%CI(0.79,1.12),P=0.481],all-cause mortality[RR=0.95,95%CI(0.83,1.08),P=0.417],the levels of NT-proBNP[WMD=-301.16,95%CI(-602.77,0.44),P=0.050]and LVEF[WMD=1.49,95%CI(-1.33,4.32),P=0.300]after treatment,and the hyperkalaemia rate[RR=0.88,95%CI(0.77,1.01),P=0.070]between 2 groups.The results of publication bias analysis and sensitivity analysis showed there was a high possibility of publication bias,and the results of several indexes were not stable.CONCLUSIONS:Sacubitril-valsartan may effectively reduce HF re-hospitalization rate and the risk of elevated serum creatinine in non-HFrEF patients,improve the heart function but th

关 键 词：沙库巴曲缬沙坦 非射血分数降低心力衰竭 有效性 安全性 META分析 

分 类 号：R541[医药卫生—心血管疾病]