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钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂在 1 型糖尿病中的安全性和疗效:系统评价和荟萃分析。

Safety and efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes: A systematic review and meta-analysis.

机构信息

Eugene Applebaum College of Pharmacy and Health Sciences, Department of Pharmacy Practice, Wayne State University, 259 Mack Avenue, Suite 2134, Detroit, MI 48201, USA.

Wayne State University School of Medicine, Department of Family Medicine and Public Health Sciences, Wayne State University, 6135 Woodward Ave, Rm 1128, Detroit, MI 48202, USA.

出版信息

Diabetes Res Clin Pract. 2018 Mar;137:83-92. doi: 10.1016/j.diabres.2018.01.004. Epub 2018 Jan 6.

Abstract

AIMS

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are currently FDA approved for the management of type 2 diabetes. Our objective was to review the available evidence of the effects of SGLT2 inhibitors on HbA, body weight, and total daily insulin dose, as well as their safety profile in patients with type 1 diabetes.

METHODS

Four randomized controlled trials (RCTs) were identified by conducting a systematic search of PubMed, Embase, Web of Science, Scopus and Cochrane library databases through August 2017. Data on study design, sample size, mean ± standard deviation of HbA, body weight, and total daily insulin dose, as well as reported adverse events were extracted. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were calculated using a random-effects model.

RESULTS

Relative to placebo, therapy with SGLT2 inhibitors led to significant reductions in HbA (WMD 0.39; 95% CI 0.27, 0.51), body weight (WMD 2.76; 95% CI 1.11, 4.40), and total daily insulin dose (WMD 5.03; 95% CI 1.83, 8.23). In addition, there was no significant difference in the rate of adverse events.

CONCLUSIONS

The current study lends supports for the development of SGLT2 inhibitors in combination with insulin as a treatment option for patients with type 1 diabetes.

摘要

目的

钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂目前已获得美国食品药品监督管理局(FDA)批准,用于治疗 2 型糖尿病。我们的目的是综述 SGLT2 抑制剂对 1 型糖尿病患者的血红蛋白 A1c(HbA)、体重和总日胰岛素剂量的影响,以及它们的安全性。

方法

通过对 PubMed、Embase、Web of Science、Scopus 和 Cochrane 图书馆数据库进行系统检索,于 2017 年 8 月前确定了四项随机对照试验(RCT)。提取了研究设计、样本量、HbA、体重和总日胰岛素剂量的均值±标准差以及报告的不良事件数据。使用随机效应模型计算加权均数差(WMD)和 95%置信区间(CI)。

结果

与安慰剂相比,SGLT2 抑制剂治疗可显著降低 HbA(WMD 0.39;95%CI 0.27,0.51)、体重(WMD 2.76;95%CI 1.11,4.40)和总日胰岛素剂量(WMD 5.03;95%CI 1.83,8.23)。此外,不良事件的发生率没有显著差异。

结论

目前的研究支持 SGLT2 抑制剂与胰岛素联合作为 1 型糖尿病患者的治疗选择。

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