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SGLT2 抑制剂对 2 型糖尿病患者肾功能的影响:系统评价和随机对照试验的荟萃分析。

Effect of SGLT2 inhibitor on renal function in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Nephrology, Ningbo Urology and Nephrology Hospital, Ningbo, China.

出版信息

Int Urol Nephrol. 2019 Apr;51(4):655-669. doi: 10.1007/s11255-019-02112-6. Epub 2019 Mar 4.

Abstract

OBJECTIVE

This study summarizes the evidence from randomized controlled trials (RCTs) to assess the effects of SGLT2 inhibitors on renal function and albuminuria in patients with type 2 diabetes.

MATERIALS/METHODS: We searched PubMed, Web of Science, Cochrane Library and EMBASE for reports published up to March 2018 and included RCTs reporting estimated glomerular filtration rate (eGFR) and/or urine albumin/creatinine ratio (UACR) changes. Data extraction and assessment of research quality based on Cochrane risk biasing tools. Data were calculated to represent the standardized mean difference (SMD) for each study, and the SMDs with 95% confidence intervals (CIs) were pooled using a random effects model.

RESULTS

Fifty-one studies were included that evaluated eGFR levels, and 17 studies were included that evaluated UACR levels. A meta-analysis showed that SGLT2 inhibitors had no significant effect on eGFR levels (SMD - 0.02, 95% CI - 0.06, 0.03, p = 0.45), and eGFR reduction was observed in the subsets of the duration of the trial 12 < duration ≤ 26 weeks (SMD - 0.08, 95% CI - 0.13, - 0.02, p = 0.005) and mean baseline eGFR < 60 ml/min per 1.73 square meters (SMD - 0.22, 95% CI - 0.37, - 0.07, p = 0.004). We found that SGLT2 inhibitors reduced UACR levels in patients with type 2 diabetes (SMD - 0.11, 95% CI - 0.17, - 0.05, p = 0.0001). Compared with monotherapy, the combination with other hypoglycemic agents can reduce albuminuria levels (SMD - 0.13, 95% CI - 0.19, - 0.06, p < 0.0001).

CONCLUSIONS

The effect of SGLT2 inhibitor on eGFR in patients with T2DM was not statistically significant, but it was effective in reducing albuminuria levels.

摘要

目的

本研究总结了随机对照试验(RCT)的证据,以评估 SGLT2 抑制剂对 2 型糖尿病患者肾功能和蛋白尿的影响。

材料/方法:我们检索了 PubMed、Web of Science、Cochrane 图书馆和 EMBASE 数据库,截至 2018 年 3 月的报告,并纳入了报告估算肾小球滤过率(eGFR)和/或尿白蛋白/肌酐比值(UACR)变化的 RCT。基于 Cochrane 风险偏倚工具提取数据并评估研究质量。使用随机效应模型计算每个研究的标准化均数差(SMD),并汇总 95%置信区间(CI)的 SMD。

结果

共纳入 51 项评估 eGFR 水平的研究,纳入 17 项评估 UACR 水平的研究。荟萃分析显示,SGLT2 抑制剂对 eGFR 水平无显著影响(SMD-0.02,95%CI-0.06,0.03,p=0.45),在试验持续时间 12<持续时间≤26 周的亚组中观察到 eGFR 下降(SMD-0.08,95%CI-0.13,-0.02,p=0.005)和平均基线 eGFR<60ml/min/1.73m2(SMD-0.22,95%CI-0.37,-0.07,p=0.004)。我们发现 SGLT2 抑制剂可降低 2 型糖尿病患者的 UACR 水平(SMD-0.11,95%CI-0.17,-0.05,p=0.0001)。与单药治疗相比,与其他降糖药物联合可降低蛋白尿水平(SMD-0.13,95%CI-0.19,-0.06,p<0.0001)。

结论

SGLT2 抑制剂对 T2DM 患者 eGFR 的影响无统计学意义,但对降低蛋白尿水平有效。

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