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
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篇名: 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
TITLE: Efficacy and Safety of Sacubitril-valsartan in the Treatment of Heart Failure without Reduced Ejection Fraction : A Meta-analysis
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Stata14.0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。
ABSTRACT: OBJECTIVE:To systematically evaluate the efficacy and saf ety 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- angio- tensin converting enzyme inhibitors/angiotensin Ⅱ receptor 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 5 502 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-HFrEFpatients,improve the heart function but the risk of hypotension is high. The results should be interpreted carefully.
期刊: 2020年第31卷第18期
作者: 熊波,钱俊,容顺康,姚沅清,黄晶
AUTHORS: XIONG Bo,QIAN Jun,RONG Shunkang ,YAO Yuanqing ,HUANG Jing
关键字: 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
KEYWORDS: Sacubitril-valsartan; Heart failture without
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