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钠-葡萄糖共转运蛋白 2 抑制剂在伴有中度肾功能损害的 2 型糖尿病患者中的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes and moderate renal function impairment: A systematic review and meta-analysis.

机构信息

Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, PR China

The Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Diabetes Mellitus Prevention and Control Center of Sichuan Province, PR China

出版信息

Diabetes Res Clin Pract. 2018 Jun;140:295-303. doi: 10.1016/j.diabres.2018.03.047. Epub 2018 Apr 9.

Abstract

AIMS

A systematic review and meta-analysis was conducted to evaluate the clinical efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with type 2 diabetes (T2D) and moderate renal function impairment.

METHODS

Embase, Medline, and Cochrane Central were searched, and randomized controlled trials comparing SGLT2 inhibitors to placebos and other drugs for T2D were collected.

RESULTS

Seven RCTs with a total of 3307 participants were included, and the overall bias was low. In the patients with T2D and moderate renal function impairment (30 ml/min/1.73 m ≤ estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m) compared with the placebo, SGLT2 inhibitors improved HbA1c significantly (WMD, -0.23%; 95% CI: -0.38 to -0.08), presented a lower incidence of hypoglycemia (30.1% vs. 34.6%; RR, 0.85; 95% CI: 0.76 to 0.96), led to the reduction of eGFR (WMD, -1.74 ml/min/1.73 m; 95% CI: -3.45 to -0.03), resulted in an obvious reduction in body weight (WMD, -1.45 kg; 95% CI: -2.01 to -0.89), and presented a similar risk of urinary tract infection and genital infection.

CONCLUSIONS

SGLT2 inhibitors are safe, but mildly reduce the HbA1c level. The clinical significance of SGLT2 inhibitors in the target population was limited.

摘要

目的

系统评价和荟萃分析评估了钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂在 2 型糖尿病(T2D)和中度肾功能损害患者中的临床疗效和安全性。

方法

检索 Embase、Medline 和 Cochrane Central,收集比较 SGLT2 抑制剂与安慰剂和其他 T2D 药物的随机对照试验。

结果

纳入 7 项 RCT,共 3307 名参与者,总体偏倚较低。与安慰剂相比,SGLT2 抑制剂可显著改善 T2D 合并中度肾功能损害(30ml/min/1.73m≤估算肾小球滤过率(eGFR)<60ml/min/1.73m)患者的 HbA1c(WMD,-0.23%;95%CI:-0.38 至 -0.08),低血糖发生率较低(30.1%比 34.6%;RR,0.85;95%CI:0.76 至 0.96),导致 eGFR 下降(WMD,-1.74ml/min/1.73m;95%CI:-3.45 至 -0.03),体重明显减轻(WMD,-1.45kg;95%CI:-2.01 至 -0.89),尿路感染和生殖道感染风险相似。

结论

SGLT2 抑制剂安全,但轻度降低 HbA1c 水平。SGLT2 抑制剂在目标人群中的临床意义有限。

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