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醛固酮拮抗剂对心力衰竭和心肌梗死后患者心脏性猝死预防的影响:一项随机对照试验的系统评价和荟萃分析

Impact of Aldosterone Antagonists on Sudden Cardiac Death Prevention in Heart Failure and Post-Myocardial Infarction Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Le Hai-Ha, El-Khatib Chadia, Mombled Margaux, Guitarian Frédéric, Al-Gobari Muaamar, Fall Mor, Janiaud Perrine, Marchant Ivanny, Cucherat Michel, Bejan-Angoulvant Théodora, Gueyffier François

机构信息

Laboratoire de Biologie et Biométrie Evolutive - Equipe Modélisation des Effets Thérapeutiques, UMR 5558 Université Claude Bernard Lyon1, Lyon, France.

Lausanne University Hospital (CHUV), Institute of social & preventive medicine (IUMSP), Lausanne, Switzerland.

出版信息

PLoS One. 2016 Feb 18;11(2):e0145958. doi: 10.1371/journal.pone.0145958. eCollection 2016.

Abstract

BACKGROUND AND OBJECTIVES

Sudden cardiac death (SCD) is a severe burden of modern medicine. Aldosterone antagonist is publicized as effective in reducing mortality in patients with heart failure (HF) or post myocardial infarction (MI). Our study aimed to assess the efficacy of AAs on mortality including SCD, hospitalization admission and several common adverse effects.

METHODS

We searched Embase, PubMed, Web of Science, Cochrane library and clinicaltrial.gov for randomized controlled trials (RCTs) assigning AAs in patients with HF or post MI through May 2015. The comparator included standard medication or placebo, or both. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Event rates were compared using a random effects model. Prospective RCTs of AAs with durations of at least 8 weeks were selected if they included at least one of the following outcomes: SCD, all-cause/cardiovascular mortality, all-cause/cardiovascular hospitalization and common side effects (hyperkalemia, renal function degradation and gynecomastia).

RESULTS

Data from 19,333 patients enrolled in 25 trials were included. In patients with HF, this treatment significantly reduced the risk of SCD by 19% (RR 0.81; 95% CI, 0.67-0.98; p = 0.03); all-cause mortality by 19% (RR 0.81; 95% CI, 0.74-0.88, p<0.00001) and cardiovascular death by 21% (RR 0.79; 95% CI, 0.70-0.89, p<0.00001). In patients with post-MI, the matching reduced risks were 20% (RR 0.80; 95% CI, 0.66-0.98; p = 0.03), 15% (RR 0.85; 95% CI, 0.76-0.95, p = 0.003) and 17% (RR 0.83; 95% CI, 0.74-0.94, p = 0.003), respectively. Concerning both subgroups, the relative risks respectively decreased by 19% (RR 0.81; 95% CI, 0.71-0.92; p = 0.002) for SCD, 18% (RR 0.82; 95% CI, 0.77-0.88, p < 0.0001) for all-cause mortality and 20% (RR 0.80; 95% CI, 0.74-0.87, p < 0.0001) for cardiovascular mortality in patients treated with AAs. As well, hospitalizations were significantly reduced, while common adverse effects were significantly increased.

CONCLUSION

Aldosterone antagonists appear to be effective in reducing SCD and other mortality events, compared with placebo or standard medication in patients with HF and/or after a MI.

摘要

背景与目的

心源性猝死(SCD)是现代医学面临的一项沉重负担。醛固酮拮抗剂被宣传为可有效降低心力衰竭(HF)患者或心肌梗死(MI)后患者的死亡率。我们的研究旨在评估醛固酮拮抗剂在降低包括心源性猝死在内的死亡率、住院率及几种常见不良反应方面的疗效。

方法

我们检索了Embase、PubMed、科学网、Cochrane图书馆和clinicaltrial.gov,以查找截至2015年5月在HF患者或MI后患者中应用醛固酮拮抗剂的随机对照试验(RCT)。对照包括标准药物或安慰剂,或两者皆有。遵循系统评价和Meta分析的首选报告项目(PRISMA)指南。使用随机效应模型比较事件发生率。如果前瞻性RCT应用醛固酮拮抗剂的持续时间至少为8周,且包含以下至少一项结局:心源性猝死、全因/心血管死亡率、全因/心血管住院率及常见副作用(高钾血症、肾功能恶化和男性乳房发育),则将其纳入研究。

结果

纳入了25项试验中19333例患者的数据。在HF患者中,这种治疗显著降低了19%的心源性猝死风险(风险比[RR]0.81;95%置信区间[CI],0.67 - 0.98;p = 0.03);全因死亡率降低了19%(RR 0.81;95% CI,0.74 - 0.88,p < 0.00001),心血管死亡降低了21%(RR 0.79;95% CI,0.70 - 0.89,p < 0.00001)。在MI后患者中,相应降低的风险分别为20%(RR 0.80;95% CI,0.66 - 0.98;p = 0.03)、15%(RR 0.85;95% CI,0.76 - 0.95,p = 0.003)和17%(RR 0.83;95% CI,0.74 - 0.94,p = 0.003)。对于这两个亚组,应用醛固酮拮抗剂治疗的患者心源性猝死的相对风险分别降低了19%(RR 0.81;95% CI,0.71 - 0.92;p = 0.002),全因死亡率降低了18%(RR 0.82;95% CI,0.77 - 0.88,p < 0.0001),心血管死亡率降低了20%(RR 0.80;95% CI,0.74 - 0.87,p < 0.0001)。此外,住院率显著降低,而常见不良反应显著增加。

结论

与安慰剂或标准药物相比,醛固酮拮抗剂在降低HF患者和/或MI后患者的心源性猝死及其他死亡事件方面似乎是有效的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5fee/4758660/e2b0c4ec509a/pone.0145958.g001.jpg

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