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钠-葡萄糖共转运蛋白 2 抑制剂与 2 型糖尿病患者的长期肾脏结局相关:系统评价和荟萃分析。

Long-term renal outcomes associated with sodium glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: A systematic review and meta-analysis.

机构信息

Department of Endocrinology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

Department of Endocrinology, The First People's Hospital of Nankang District, Ganzhou, China.

出版信息

Diabetes Metab Res Rev. 2020 Jul;36(5):e3303. doi: 10.1002/dmrr.3303. Epub 2020 Mar 5.

DOI:10.1002/dmrr.3303
PMID:32134558
Abstract

AIMS

The long-term impact of sodium glucose cotransporter 2 (SGLT2) inhibitors on renal functions remains undefined. This study was undertaken to investigate the renal outcomes associated with SGLT2 inhibitors in patients with type 2 diabetes (T2DM) in the long term.

METHODS

A systematic literature search of PubMed and ClinicalTrials.gov was conducted. Randomized controlled trials which reported renal outcomes at the study endpoint in patients with T2DM receiving treatments of SGLT2 inhibitors were included. Renal adverse events were determined using prespecified lists from the Medical Dictionary for Regulatory Activities or laboratory values. Odds ratio with 95% confidence interval (CI) was used for assessment of dichotomous data. The mean difference or standardized mean difference with 95% CI was used for assessment of continuous data. Random effects models were adopted to measure the pooled outcomes.

RESULTS

Thirty-nine studies involving 35 trials were identified. Compared with placebo or other anti-diabetic medications, SGLT2 inhibitors were associated with significant lower incidence of composite renal outcome and acute renal failure or injury in patients with T2DM. The risk of progression of albuminuria also appeared to be decreased. No significant changes of estimated glomerular filtration rate levels or urine albumin-creatinine ratios were found in patients receiving SGLT2 inhibitors.

CONCLUSIONS

Overall renal safety and beneficial effects are indicated for SGLT2 inhibitors. Further confirmative data from large trials and real-world studies are needed.

摘要

目的

钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂对肾功能的长期影响尚不清楚。本研究旨在探讨长期应用 SGLT2 抑制剂治疗 2 型糖尿病(T2DM)患者的肾脏结局。

方法

系统检索 PubMed 和 ClinicalTrials.gov 数据库,纳入报告 T2DM 患者 SGLT2 抑制剂治疗终点肾脏结局的随机对照试验。采用监管活动医学词典或实验室值预先指定的列表来确定肾脏不良事件。采用比值比及其 95%置信区间(CI)评估二分类数据,采用均数差值或标准化均数差值及其 95%CI 评估连续性数据。采用随机效应模型来测量汇总结局。

结果

共纳入 39 项研究 35 项试验。与安慰剂或其他降糖药物相比,SGLT2 抑制剂可显著降低 T2DM 患者复合肾脏结局和急性肾损伤或衰竭的发生率,且蛋白尿进展的风险似乎也降低。接受 SGLT2 抑制剂治疗的患者肾小球滤过率水平或尿白蛋白/肌酐比值无显著变化。

结论

SGLT2 抑制剂具有整体肾脏安全性和有益作用。需要来自大型试验和真实世界研究的进一步证实数据。

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