LCZ696对射血分数保留心力衰竭患者疗效及安全性的Meta分析

姚旭贤; 田建伟; 尹巧香; 段景琪; 李玉茜; 于心亚; 曹艳杰

doi:10.12125/j.chj.202104071

LCZ696对射血分数保留心力衰竭患者疗效及安全性的Meta分析

Efficacy and safety of LCZ696 in heart failure with preserved ejection fraction: a meta-analysis

摘要

摘要:
目的系统评价沙库巴曲缬沙坦(LCZ696）治疗射血分数保留心力衰竭（HFpEF）患者的有效性与安全性，为临床提供治疗依据。
方法通过Cochrane图书馆、PubMed、Embase、中国知网、万方数据库、维普和中国生物医学文献服务系统检索有关LCZ696治疗HFpEF的文献，检索时间为自建库至2020年8月，严格按照纳入排除标准进行文献筛选及质量评价，所有结局指标均使用Revman5.3软件进行meta分析。
结果共选入5篇随机对照试验研究，共计5313例患者，合并结局指标结果显示，试验组患者治疗后氨基末端脑钠尿肽前体（NT-pro BNP）SMD = −3.29, 95%CI（−6.40, −0.19），P = 0.04、六分钟步行距离（6MWD）WMD = 84.25, 95%CI（24.95, 143.55），P<0.01、心力衰竭再住院率RR = 0.85, 95%CI（0.78, 0.92），P<0.01、肾损伤 RR = 0.50, 95%CI（0.34, 0.75），P<0.01较对照组显著改善；高血钾发生率 RR = 0.90, 95%CI（0.78, 1.03），P = 0.12、治疗后左室射血分数（LVEF）WMD = 0.43, 95%CI（−0.14, 1.00），P = 0.14、E/e’WMD = −1.71, 95%CI（−4.18, 0.77），P = 0.18及全因病死率 RR = 0.97, 95%CI（0.85, 1.11），P = 0.66与对照组相比，差异均无统计学意义；而试验组症状性低血压发生率 RR = 1.43, 95%CI（1.24, 1.64），P<0.01高于对照组。
结论 LCZ696可以有效改善HFpEF患者的NT-pro BNP、6MWD、再住院率，而不增加肾损伤及高血钾的发生风险。

Abstract:
AIM To systematically evaluate the efficacy and safety of LCZ696 (sacubitril-valsartan) in the treatment of heart failure with preserved ejection fraction (HFpEF), and to provide clinical basis for treatment.
METHODS The Cochrane Library, PubMed, Embase, CNKI, Wanfang database, VIP and China Biomedical Literature Service system were searched for literatures on LCZ696 for HFpEF from the date of the establishment of each database to August 2020. Literature screening and quality evaluation were carried out strictly according to the inclusion and exclusion criteria. All outcome indexes were conducted the meta-analysis by Revman5.3 software.
RESULTS A total of 5 RCTs studies were selected, involving 5313 patients. The results of combined outcome indexes showed that the levels of NT-pro BNP SMD = −3.29, 95%CI(−6.40, −0.19), P = 0.04, 6MWT WMD = 84.25, 95%CI(24.95, 143.55), P<0.01, HF re-hospitalization rate RR = 0.85, 95%CI(0.78, 0.92), P<0.01, and renal injuryRR = 0.50, 95%CI(0.34, 0.75), P<0.01 in trial group were significantly improved. There were no statistical significance in the incidence of hyperkalemiaRR=0.90, 95%CI(0.78, 1.03), P = 0.12, LVEFWMD=0.43, 95%CI(−0.14, 1.00), P = 0.14 and E/e’WMD = −1.71, 95%CI(−4.18, 0.77), P = 0.18 after treatment, and all-cause mortalityRR = 0.97, 95%CI(0.85, 1.11), P = 0.66 between 2 groups. The incidence of symptomatic hypotensionRR = 1.43, 95%CI(1.24, 1.64), P<0.01 in trial group was higher than control group.
CONCLUSIONS LCZ696 effectively improves the level of NT-pro BNP, 6MWT and re-hospitalization rate in the patients of HFpEF, and it does not increase the risk of renal injury and hyperkalemia.

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