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钠-葡萄糖共转运蛋白 2 抑制剂治疗 2 型糖尿病:系统评价和荟萃分析。

Sodium-glucose cotransporter 2 inhibitors for type 2 diabetes: a systematic review and meta-analysis.

出版信息

Ann Intern Med. 2013 Aug 20;159(4):262-74. doi: 10.7326/0003-4819-159-4-201308200-00007.

DOI:10.7326/0003-4819-159-4-201308200-00007
PMID:24026259
Abstract

BACKGROUND

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of antidiabetic drugs.

PURPOSE

To assess the efficacy and safety of SGLT2 inhibitors in adults with type 2 diabetes.

DATA SOURCES

MEDLINE, EMBASE, and the Cochrane Library from inception through April 2013 without language restrictions; regulatory authorities' reports; and gray literature.

STUDY SELECTION

Randomized trials comparing SGLT2 inhibitors with placebo or other medication for type 2 diabetes.

DATA EXTRACTION

Three reviewers extracted or checked data for study characteristics, outcomes of interest, and risk of bias, and 3 reviewers summarized strength of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach.

DATA SYNTHESIS

Sodium-glucose cotransporter 2 inhibitors were compared with placebo in 45 studies (n = 11 232) and with active comparators in 13 studies (n = 5175). They had a favorable effect on hemoglobin A1c level (mean difference vs. placebo, -0.66% [95% CI, -0.73% to -0.58%]; mean difference vs. active comparators, -0.06% [CI, -0.18% to 0.05%]). Sensitivity analyses incorporating unpublished data showed similar effect estimates. Compared with other agents, SGLT2 inhibitors reduced body weight (mean difference, -1.80 kg [CI, -3.50 to -0.11 kg]) and systolic blood pressure (mean difference, -4.45 mm Hg [CI, -5.73 to -3.18 mm Hg]). Urinary and genital tract infections were more common with SGLT2 inhibitors (odds ratios, 1.42 [CI, 1.06 to 1.90] and 5.06 [CI, 3.44 to 7.45], respectively). Hypoglycemic risk was similar to that of other agents. Results for cardiovascular outcomes and death were inconclusive. An imbalance in incidence of bladder and breast cancer was noted with dapagliflozin compared with control.

LIMITATION

Most trials were rated as high risk of bias because of missing data and last-observation-carried-forward methods.

CONCLUSION

Sodium-glucose cotransporter 2 inhibitors may improve short-term outcomes in adults with type 2 diabetes, but effects on long-term outcomes and safety are unclear.

PRIMARY FUNDING SOURCE

None.

摘要

背景

钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂是一类新型的抗糖尿病药物。

目的

评估 SGLT2 抑制剂在成人 2 型糖尿病患者中的疗效和安全性。

资料来源

从创建到 2013 年 4 月,无语言限制地检索了 MEDLINE、EMBASE 和 Cochrane 图书馆;监管机构的报告;以及灰色文献。

研究选择

比较 SGLT2 抑制剂与安慰剂或其他药物治疗 2 型糖尿病的随机试验。

数据提取

3 位评审员提取或核对了研究特征、感兴趣的结局和偏倚风险的数据,3 位评审员使用 Grading of Recommendations Assessment, Development and Evaluation 方法总结证据强度。

数据综合

SGLT2 抑制剂与安慰剂相比,在 45 项研究(n=11232)中具有有利的效果,与活性对照相比,在 13 项研究(n=5175)中具有有利的效果。它们对糖化血红蛋白水平有有利影响(与安慰剂相比的平均差异,-0.66%[95%CI,-0.73%至-0.58%];与活性对照相比的平均差异,-0.06%[CI,-0.18%至 0.05%])。纳入未发表数据的敏感性分析显示出相似的效果估计值。与其他药物相比,SGLT2 抑制剂减轻体重(平均差异,-1.80kg[CI,-3.50 至-0.11kg])和收缩压(平均差异,-4.45mmHg[CI,-5.73 至-3.18mmHg])。SGLT2 抑制剂更常见的是泌尿系统和生殖系统感染(比值比,1.42[CI,1.06 至 1.90]和 5.06[CI,3.44 至 7.45])。低血糖风险与其他药物相似。心血管结局和死亡的结果不确定。与对照组相比,达格列净的膀胱癌和乳腺癌发病率不平衡。

局限性

由于数据缺失和最后观察值延续方法,大多数试验被评为高偏倚风险。

结论

SGLT2 抑制剂可能改善成人 2 型糖尿病患者的短期结局,但对长期结局和安全性的影响尚不清楚。

主要资金来源

无。

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