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钠-葡萄糖共转运蛋白 2(SGLT-2)抑制剂与 2 型糖尿病患者的微血管结局:系统评价和荟萃分析。

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors and microvascular outcomes in patients with type 2 diabetes: systematic review and meta-analysis.

机构信息

Endocrinology Division, Department of Internal Medicine, University Hospital "Dr. José E. González", Universidad Autonoma de Nuevo Leon, 64460, Monterrey, Mexico.

Plataforma INVEST Medicina UANL-KER Unit Mayo Clinic (KER Unit México), Universidad Autonoma de Nuevo Leon, 64460, Monterrey, Mexico.

出版信息

J Endocrinol Invest. 2020 Mar;43(3):289-304. doi: 10.1007/s40618-019-01103-9. Epub 2019 Sep 5.

DOI:10.1007/s40618-019-01103-9
PMID:31489568
Abstract

PURPOSE

The effect of the sodium-glucose 2 (SGLT-2) inhibitors on microvascular complications remains uncertain. We performed a systematic review to determine the efficacy of the SGLT-2 inhibitors on microvascular outcomes in patients with type 2 diabetes.

METHODS

A comprehensive search was performed using Ovid, MEDLINE, EMBASE, Web of Science, and Scopus from inception to May 2019. Randomized trials comparing SGLT-2 inhibitors with placebo or other medication for type 2 diabetes for ≥ 4 weeks were included. Diabetes-related microvascular complications such as nephropathy, retinopathy, neuropathy, and peripheral vascular disease were evaluated. A random-effect model using mean differences for continuous outcomes and risk ratio for dichotomous outcomes was used to synthesize data. PROSPERO (CRD 42017076460).

RESULTS

A total of 40 RCTs with overall moderate quality of evidence were included. SGLT-2 inhibitors reduced the risk of renal-replacement therapy (0.65; 95% CI 0.54-0.79), renal death (0.57; 95% CI 0.49-0.65), and progression of albuminuria (0.69; 95% CI 0.66-0.73). Conversely, they appeared ineffective in maintaining eGFR (0.33; 95% CI - 0.74 to 1.41) or reducing serum creatinine (- 0.07; 95% CI - 0.26 to 0.11), whereas urine albumin-creatinine ratio (- 23.4; 95% CI - 44.6 to - 2.2) was reduced. Risk of amputation was non-significant (1.30; 95% CI 0.93-1.83). No available data were found regarding neuropathy and retinopathy to perform a quantitative analysis.

CONCLUSION

SGLT-2 inhibitors may reduce the risk of renal patient-important outcomes but fail to improve surrogate outcomes. Apparently, no increased risk of amputations was observed with these medications. No data were available regarding other microvascular complications.

摘要

目的

SGLT-2 抑制剂对微血管并发症的影响仍不确定。我们进行了一项系统评价,以确定 SGLT-2 抑制剂在 2 型糖尿病患者微血管结局方面的疗效。

方法

从建库到 2019 年 5 月,使用 Ovid、MEDLINE、EMBASE、Web of Science 和 Scopus 进行全面检索。纳入比较 SGLT-2 抑制剂与安慰剂或其他药物治疗 2 型糖尿病超过 4 周的随机试验。评估了糖尿病相关的微血管并发症,如肾病、视网膜病变、神经病变和外周血管疾病。使用连续结局的均数差和二分类结局的风险比的随机效应模型来综合数据。PROSPERO(CRD42017076460)。

结果

共纳入 40 项 RCT,整体证据质量为中。SGLT-2 抑制剂降低了肾脏替代治疗的风险(0.65;95%CI0.54-0.79)、肾脏死亡的风险(0.57;95%CI0.49-0.65)和蛋白尿进展的风险(0.69;95%CI0.66-0.73)。相反,它们在维持 eGFR(0.33;95%CI-0.74 至 1.41)或降低血清肌酐(-0.07;95%CI-0.26 至 0.11)方面似乎无效,而尿白蛋白/肌酐比值(-23.4;95%CI-44.6 至-2.2)则降低。截肢风险无统计学意义(1.30;95%CI0.93-1.83)。没有关于神经病变和视网膜病变的可用数据进行定量分析。

结论

SGLT-2 抑制剂可能降低肾脏患者重要结局的风险,但不能改善替代结局。这些药物显然没有增加截肢的风险。没有关于其他微血管并发症的可用数据。

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