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贝西格列净对2型糖尿病肾脏结局的影响:一项随机对照试验的系统评价和荟萃分析

Bexagliflozin on Renal Outcomes in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Gobbo Marília, Ura Sudo Renan Y, Milbradt Tanize L, Reinheimer Isabel Cristina, Min Matthew, Poli-de-Figueiredo Carlos E

机构信息

Medical School, Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, BRA.

Medicine, Federal University of Grande Dourados, Dourados, BRA.

出版信息

Cureus. 2025 Apr 17;17(4):e82458. doi: 10.7759/cureus.82458. eCollection 2025 Apr.

Abstract

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are important for treating type 2 diabetes mellitus (T2DM). However, it remains unclear whether the newest SGLT2 inhibitor, bexagliflozin, provides benefits for renal- or urinary-related outcomes. The ClinicalTrials.gov, PubMed, Embase, and Cochrane databases were searched for randomized controlled trials. Using R software version 4.3.1 (R Foundation for Statistical Computing, Vienna, Austria), a random-effects model was employed to compute mean differences (MD) and risk ratios for continuous and binary endpoints. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to rate the certainty of evidence. The International Prospective Register of Systematic Reviews (PROSPERO) identification number is CRD42023478336. Nine studies involving 4,352 patients were included. Over a follow-up that ranged from 12 to 96 weeks, patients taking bexagliflozin showed no changes in serum creatinine levels (MD: 0.05 mg/dL; 95% CI: -0.06 to 0.15; p = 0.35) or estimated glomerular filtration rate (MD: -0.43 mL/min/1.73 m; 95% CI: -6.92 to 6.06; p = 0.89). However, there was a significant reduction in systolic blood pressure in the treatment group (MD: -4.2 mmHg; 95% CI: -5.6 to -2.8; p < 0.01). In large placebo-controlled trials, we observed no beneficial effect of bexagliflozin on kidney function, as described with other SGLT2 inhibitors.

摘要

钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂对2型糖尿病(T2DM)的治疗很重要。然而,最新的SGLT2抑制剂贝西格列净是否能给肾脏或泌尿系统相关结局带来益处仍不清楚。我们检索了ClinicalTrials.gov、PubMed、Embase和Cochrane数据库中的随机对照试验。使用R软件4.3.1版本(奥地利维也纳的R统计计算基金会),采用随机效应模型计算连续和二元终点的平均差(MD)和风险比。采用推荐分级、评估、制定和评价(GRADE)方法对证据的确定性进行评级。国际系统评价前瞻性注册库(PROSPERO)识别号为CRD42023478336。纳入了9项研究,共4352例患者。在12至96周的随访中,服用贝西格列净的患者血清肌酐水平(MD:0.05mg/dL;95%CI:-0.06至0.15;p=0.35)或估算肾小球滤过率(MD:-0.43mL/min/1.73m²;95%CI:-6.92至6.06;p=0.89)无变化。然而,治疗组的收缩压显著降低(MD:-4.2mmHg;95%CI:-5.6至-2.8;p<0.01)。在大型安慰剂对照试验中,我们观察到贝西格列净对肾功能没有像其他SGLT²抑制剂那样的有益作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0503/12085344/7a38ea570f15/cureus-0017-00000082458-i01.jpg

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