钠-葡萄糖共转运蛋白 2 抑制剂在射血分数保留的心力衰竭中的应用：荟萃分析方案。
Sodium-glucose cotransporter 2 inhibitors in heart failure with preserved ejection fraction: A protocol for meta-analysis.
机构信息
Core Laboratory, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Department of Medical Innovation, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
出版信息
Medicine (Baltimore). 2021 Dec 23;100(51):e28448. doi: 10.1097/MD.0000000000028448.
BACKGROUND
Nearly half of patients with heart failure (HF) have preserved ejection fraction (EF) and the mortality and morbidity of patients with HF with preserved EF (HFpEF) are high. Patients with HFpEF are often elderly and their primary chronic symptom is severe exercise intolerance that results in a reduced quality of life. Thus, improvement of exercise capacity presents another important clinical outcome in HFpEF patients. Recent randomized controlled trials (RCTs) and meta-analyses of RCTs reported that sodium-glucose cotransporter 2 (SGLT-2) inhibitors improved cardiovascular outcomes in patients with HF with reduced EF. Although the effects of SGLT-2 inhibitors in HFpEF patients have been examined in multiple RCTs, the results are inconsistent due partly to limited power. The purpose of this meta-analysis is to evaluate the efficacy and safety of SGLT-2 inhibitors in HFpEF patients.
METHODS
This meta-analysis will include RCTs examining the effects of SGLT-2 inhibitors on HF severity and health-related quality of life in HFpEF patients. Information of studies will be collected from electronic databases. The primary outcome will be HF severity (plasma B-type natriuretic peptide levels and exercise capacity assessed as 6-minute walk distance). The secondary outcome will be health-related quality of life. The safety outcomes will be all-cause death, HF hospitalization, hypotension, acute renal failure, diabetic ketoacidosis, and urinary tract infection.
DISCUSSION
This meta-analysis will evaluate the efficacy and safety of SGLT-2 inhibitors in HFpEF patients, providing evidence to the clinical use of SGLT-2 inhibitors in these patients.
SYSTEMATIC REVIEW REGISTRATION
INPLASY2021120033.
背景
近半数心力衰竭（HF）患者射血分数保留（EF），HF 伴射血分数保留（HFpEF）患者的死亡率和发病率较高。HFpEF 患者通常为老年人，其主要慢性症状是严重的运动不耐受，导致生活质量降低。因此，运动能力的改善是 HFpEF 患者的另一个重要临床终点。最近的随机对照试验（RCT）和 RCT 荟萃分析报告，钠-葡萄糖共转运蛋白 2（SGLT-2）抑制剂改善了射血分数降低的 HF 患者的心血管结局。尽管在多项 RCT 中已经研究了 SGLT-2 抑制剂在 HFpEF 患者中的作用，但由于部分原因是研究的效力有限，结果并不一致。本荟萃分析的目的是评估 SGLT-2 抑制剂在 HFpEF 患者中的疗效和安全性。
方法
本荟萃分析将包括研究 SGLT-2 抑制剂对 HFpEF 患者 HF 严重程度和与健康相关的生活质量影响的 RCT。将从电子数据库中收集研究信息。主要结局将是 HF 严重程度（血浆 B 型利钠肽水平和 6 分钟步行距离评估的运动能力）。次要结局将是与健康相关的生活质量。安全性结局将是全因死亡、HF 住院、低血压、急性肾衰竭、糖尿病酮症酸中毒和尿路感染。
讨论
本荟萃分析将评估 SGLT-2 抑制剂在 HFpEF 患者中的疗效和安全性，为这些患者使用 SGLT-2 抑制剂提供临床证据。
系统评价注册
INPLASY2021120033。
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