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钠-葡萄糖协同转运蛋白2抑制剂在东亚2型糖尿病患者中的疗效与安全性:一项系统评价与荟萃分析

Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitors in East Asians with Type 2 Diabetes: A Systematic Review and Meta-Analysis.

作者信息

Yang Lidan, Zhang Lin, He He, Zhang Mei, An Zhenmei

机构信息

Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.

The Third Affiliated Hospital of Chengdu, University of Traditional Chinese Medicine, Diabetes Mellitus Prevention and Control Center of Sichuan Province, Chengdu, 610075, Sichuan, China.

出版信息

Diabetes Ther. 2019 Oct;10(5):1921-1934. doi: 10.1007/s13300-019-0674-7. Epub 2019 Aug 2.

Abstract

INTRODUCTION

The aim of this study was to assess the efficacy and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors in East Asians with type 2 diabetes mellitus (T2DM).

METHODS

A literature search that focused primarily on the PubMed, Embase, and Cochrane library databases was performed. All randomized controlled trials (RCTs) which satisfied the inclusion and exculsion criteria were eligible to be included in the meta-analysis. Risk ratios (RRs) and weighted mean differences (WMDs) were used as statistical indicators for the analysis of dichotomous data and continuous outcomes, respectively. Pooled estimates were obtained using random-effects models in RevMan version 5.3.5.

RESULTS

Thirty-three RCTs (8496 randomized patients) fulfilled the eligibility criteria for inclusion in the meta-analysis. The meta-analysis showed that, compared with the control group, the use of SGLT2 inhibitors improved both glycated hemoglobin (HbA1c) in patients (WMD - 0.73%; 95% confidence interval [CI] - 0.84, - 0.61) and the percentage of patients with HbA1c  < 7% (RR 2.33; 95% CI 1.74, 3.12); lowered both fasting plasma glucose (WMD - 28.47 mg/dl; 95% CI - 32.86, - 24.08) and postprandial glucose (WMD - 52.32 mg/dl; 95% CI - 67.67, - 39.96); reduced body weight (WMD - 1.73 kg; 95% CI - 2.28, - 1.17); and did not increase the risk of hypoglycemia (RR 1.27; 95% CI 0.89, 1.82) and urinary tract infections (RR 0.93; 95% CI 0.68, 1.27). However, SGLT2 inhibitors did increase the risk of genital tract infections (GTIs) (RR 1.73; 95% CI 1.02, 2.96). The stratified analysis showed that patients with higher HbA1c levels at baseline may achieve a greater improvement in HbA1c after taking SGLT2 inhibitors, while those with higher body weight or a longer history of diabetes may have an increased risk of developing GTIs.

CONCLUSION

Current research suggests that SGLT2 inhibitors have favorable efficacy and safety in East Asian patients with T2DM.

摘要

引言

本研究旨在评估钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂在东亚2型糖尿病(T2DM)患者中的疗效和安全性。

方法

主要针对PubMed、Embase和Cochrane图书馆数据库进行文献检索。所有符合纳入和排除标准的随机对照试验(RCT)均有资格纳入荟萃分析。风险比(RRs)和加权平均差(WMDs)分别用作二分数据和连续结果分析的统计指标。使用RevMan 5.3.5版本中的随机效应模型获得合并估计值。

结果

33项RCT(8496例随机分组患者)符合纳入荟萃分析的资格标准。荟萃分析表明,与对照组相比,使用SGLT2抑制剂可改善患者的糖化血红蛋白(HbA1c)水平(WMD -0.73%;95%置信区间[CI] -0.84,-0.61)以及HbA1c<7%的患者百分比(RR 2.33;95% CI 1.74,3.12);降低空腹血糖(WMD -28.47 mg/dl;95% CI -32.86,-24.08)和餐后血糖(WMD -52.32 mg/dl;95% CI -67.67,-39.96);减轻体重(WMD -1.73 kg;95% CI -2.28,-1.17);并且不会增加低血糖风险(RR 1.27;95% CI 0.89,1.82)和尿路感染风险(RR 0.93;95% CI 0.68,1.27)。然而,SGLT2抑制剂确实会增加生殖道感染(GTIs)的风险(RR 1.73;95% CI 1.02,2.96)。分层分析表明,基线HbA1c水平较高的患者在服用SGLT2抑制剂后HbA1c改善可能更大,而体重较高或糖尿病病程较长的患者发生GTIs的风险可能增加。

结论

目前的研究表明,SGLT2抑制剂在东亚T2DM患者中具有良好的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5392/6778578/c975350ea791/13300_2019_674_Fig1_HTML.jpg

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