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

XIONG Bo; QIAN Jun; RONG Shunkang; YAO Yuanqing; HUANG Jing

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

更新时间：2022-06-21

- Efficacy and Safety of Sacubitril-valsartan in the Treatment of Heart Failure without Reduced Ejection Fraction ： A Meta-analysis
- China Pharmacy Vol. 31, Issue 18, (2020)
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- Published：2020，
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XIONG Bo, QIAN Jun, RONG Shunkang, et al. Efficacy and Safety of Sacubitril-valsartan in the Treatment of Heart Failure without Reduced Ejection Fraction ： A Meta-analysis. [J]. China Pharmacy 31(18).(2020)
DOI：

XIONG Bo, QIAN Jun, RONG Shunkang, et al. Efficacy and Safety of Sacubitril-valsartan in the Treatment of Heart Failure without Reduced Ejection Fraction ： A Meta-analysis. [J]. China Pharmacy 31(18).(2020) DOI：

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.

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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

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