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·循证药学·

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 Δ

＊
熊 波 ，钱 俊，容顺康，姚沅清，黄 晶（重庆医科大学附属第二医院心血管内科，重庆 400010）
#
中图分类号 R541 文献标志码 A 文章编号 1001-0408（2020）18-2263-06
DOI 10.6039/j.issn.1001-0408.2020.18.16

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5 502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。
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

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（Dept. of Cardiology，the Second
Affiliated Hospital of Chongqing Medical University，Chongqing 400010，China）

ABSTRACT 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-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
Δ 基金项目：国家自然科学基金资助项目（No.81900361）
rate and the risk of elevated serum creatinine in non-HFrEF
＊主治医师，博士。 研究方向：心力衰竭的基础与临床。电话：
patients，improve the heart function but the risk of hypoten-
023-63693702。E-mail：xiongbo@hospital.cqmu.edu.cn
# 通信作者：主任医师，教授，博士生导师，硕士。研究方向：自主 sion is high. The results should be interpreted carefully.
神经调节与心血管疾病。电话：023-63693702。E-mail：huangjingc- KEYWORDS Sacubitril-valsartan； Heart failture without
qmu@126.com reduced ejection fraction；Efficacy；Safety；Meta-analysis

中国药房 2020年第31卷第18期 China Pharmacy 2020 Vol. 31 No. 18 ·2263 ·