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SGLT2抑制剂在先天性心脏病(ACHD)患者慢性心力衰竭中的安全性和有效性的系统评价与荟萃分析

A Systematic Review and Meta-Analysis of the Safety and Efficacy of SGLT2 Inhibitors in Chronic Heart Failure in ACHD Patients.

作者信息

Das Bibhuti B, Niu Jianli

机构信息

Division of Pediatric Cardiology, University of Mississippi Medical Center, 2500 N State Street, Jackson, MS, 39216, USA.

Office of Human Research, Memorial Healthcare System, Hollywood, FL, 33021, USA.

出版信息

Am J Cardiovasc Drugs. 2025 Mar;25(2):231-240. doi: 10.1007/s40256-024-00697-7. Epub 2024 Dec 2.

Abstract

BACKGROUND

Sodium-glucose cotransporter 2 inhibitors (SGLT2is) have become a first-line therapy for heart failure (HF) in adults. However, data on their use in HF associated with adult congenital heart disease (ACHD) are limited. This systematic review and meta-analysis evaluated the safety, tolerability, and efficacy of SGLT2is in ACHD HF patients, supplementing guideline-directed medical therapy.

METHODS

A comprehensive systematic search and meta-analysis were conducted on studies examining SGLT2i use in ACHD HF patients. The primary endpoint was the change in the New York Heart Association (NYHA) functional class (FC), with secondary endpoints including changes in ventricular function and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels. Additionally, the safety and tolerability of SGLT2is were evaluated.

RESULTS

The meta-analysis included eight studies with 287 patients aged 19-67 years (median age 37.5 years). Adding SGLT2is to combined therapies significantly improved NYHA FC (log odds ratio 1.3, 95% confidence interval [CI] 0.37-2.23, p = 0.01) and reduced NT-proBNP levels (mean difference [MD] -0.43, 95% CI -0.70 to -0.16, p < 0.001). A notable decrease in systolic blood pressure was observed (MD -0.32, 95% CI -0.51 to -0.14, p = 0.00). The adverse effect profile was comparable to that seen in routine HF, with fewer HF hospitalizations post-SGLT2i initiation. Urinary tract infections occurred in 14 patients (5%), with no instances of hypoglycemia or ketoacidosis reported. Medication withdrawal due to adverse effects was noted in 19 patients (7%).

CONCLUSIONS

SGLT2is are well tolerated in ACHD HF patients. Notably, SGLT2is improved NYHA FC and reduced NT-proBNP levels across a diverse ACHD HF patient cohort. However, further prospective, multicenter studies are needed to confirm the safety and efficacy of SGLT2is in this unique patient population.

摘要

背景

钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)已成为成人心力衰竭(HF)的一线治疗方法。然而,关于其在成人先天性心脏病(ACHD)相关心力衰竭中的应用数据有限。本系统评价和荟萃分析评估了SGLT2i在ACHD HF患者中的安全性、耐受性和疗效,作为对指南指导药物治疗的补充。

方法

对研究SGLT2i在ACHD HF患者中应用的研究进行了全面的系统检索和荟萃分析。主要终点是纽约心脏协会(NYHA)心功能分级(FC)的变化,次要终点包括心室功能和N末端B型利钠肽原(NT-proBNP)水平的变化。此外,还评估了SGLT2i的安全性和耐受性。

结果

荟萃分析纳入了8项研究,共287例年龄在19至67岁(中位年龄37.5岁)的患者。在联合治疗中添加SGLT2i可显著改善NYHA FC(对数比值比1.3,95%置信区间[CI]0.37-2.23,p = 0.01)并降低NT-proBNP水平(平均差值[MD]-0.43,95%CI -0.70至-0.16,p < 0.001)。观察到收缩压显著降低(MD -0.32,95%CI -0.51至-0.14,p = 0.00)。不良反应情况与常规HF中所见相当,SGLT2i开始使用后HF住院次数减少。14例患者(5%)发生尿路感染,未报告低血糖或酮症酸中毒病例。19例患者(7%)因不良反应停药。

结论

SGLT2i在ACHD HF患者中耐受性良好。值得注意的是,SGLT2i在不同的ACHD HF患者队列中改善了NYHA FC并降低了NT-proBNP水平。然而,需要进一步的前瞻性、多中心研究来证实SGLT2i在这一独特患者群体中的安全性和疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea44/11811263/773d80acd550/40256_2024_697_Fig1_HTML.jpg

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