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与安慰剂相比,钠-葡萄糖协同转运蛋白2抑制剂在心力衰竭患者中的疗效和安全性:一项系统评价和荟萃分析。

Effects and safety of SGLT2 inhibitors compared to placebo in patients with heart failure: A systematic review and meta-analysis.

作者信息

Chambergo-Michilot Diego, Tauma-Arrué Astrid, Loli-Guevara Silvana

机构信息

Research Working Group, Facultad de Ciencias de la Salud, Carrera de Medicina Humana, Universidad Científica del Sur, Lima, Peru.

Department de of Cardiology Research, Torres de Salud National Research Center, Lima, Peru.

出版信息

Int J Cardiol Heart Vasc. 2020 Dec 11;32:100690. doi: 10.1016/j.ijcha.2020.100690. eCollection 2021 Feb.

DOI:10.1016/j.ijcha.2020.100690
PMID:33335975
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7734238/
Abstract

BACKGROUND

Heart failure (HF) prognosis without therapy is poor, however introduction of a range of drugs has improved it. We aimed to perform a systematic review on the effects and safety of sodium-glucose transporter 2 inhibitors (SGLT2i) in HF patients.

METHODS

We carried out a systematic review of randomized controlled trials (RCTs) on SGLT2i compared to placebo for HF patients. We searched in PubMed, Scopus, Web of Science and EMBASE, with no language restriction, from inception to 31 August 2020. We included nine RCTs comprising three arms (empagliflozin, dapagliflozin and placebo). Effects sizes for continuous variables were expressed as mean differences (MDs) and 95% confidence intervals (CIs). Effects sizes for dichotomous variables were expresses as risk ratio (RR) and 95% CIs. We used random-effect models with the inverse variance method. We performed subgroup meta-analyses by intervention drug and follow-up period.

RESULTS

SGLT2i significantly reduced all-cause mortality (RR: 0.88, 95%CI 0.79-0.98, I2 = 0%), cardiovascular mortality (RR: 0.87, 95%CI 0.77-0.99, I2 = 0%), HF hospitalization (RR: 0.73, 95%CI 0.66-0.81, I2 = 0%) and emergency room visits due to HF (RR: 0.40, 95%CI 0.21-0.76, I2 = 0%), as well as composite outcomes including the previous ones. Besides, it significantly improved the score of the Kansas City Cardiomyopathy Questionnaire (KCCQ, MD: 1.70, 95%CI 1.67-1.73, I2 = 54%). SGLT2i reduced any serious adverse events, blood pressure and weight. However, it increased hematocrit and creatinine. The meta-analysis of RCTs of > 12 weeks of follow-up showed that SGTL2i significantly reduced NT-proBNP.

CONCLUSIONS

SGLT2i showed to improve critical outcomes in HF patients, and it is apparently safe.

摘要

背景

未经治疗的心力衰竭(HF)预后较差,然而一系列药物的引入改善了这一情况。我们旨在对钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)在HF患者中的疗效和安全性进行系统评价。

方法

我们对比较SGLT2i与安慰剂用于HF患者的随机对照试验(RCT)进行了系统评价。我们在PubMed、Scopus、科学网和EMBASE中进行检索,检索时间从数据库建立至2020年8月31日,无语言限制。我们纳入了9项RCT,包括三个组(恩格列净、达格列净和安慰剂)。连续变量的效应量以均值差(MDs)和95%置信区间(CIs)表示。二分变量的效应量以风险比(RR)和95% CIs表示。我们采用随机效应模型和逆方差法。我们按干预药物和随访时间进行亚组Meta分析。

结果

SGLT2i显著降低全因死亡率(RR:0.88,95%CI 0.79 - 0.98,I2 = 0%)、心血管死亡率(RR:0.87,95%CI 0.77 - 0.99,I2 = 0%)、HF住院率(RR:0.73,95%CI 0.66 - 0.81,I2 = 0%)以及因HF导致的急诊就诊率(RR:0.40,95%CI 0.21 - 0.76,I2 = 0%),以及包括上述指标的复合结局。此外,它显著改善了堪萨斯城心肌病问卷(KCCQ)评分(MD:1.70,95%CI 1.67 - 1.73,I2 = 54%)。SGLT2i降低了任何严重不良事件、血压和体重。然而,它增加了血细胞比容和肌酐。随访时间>12周的RCT的Meta分析表明,SGTL2i显著降低了NT - proBNP。

结论

SGLT2i显示可改善HF患者的关键结局,且显然是安全的。

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