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恩格列净对 2 型糖尿病合并非酒精性脂肪性肝病患者肝脏脂肪的影响:一项随机对照试验(E-LIFT 试验)。

Effect of Empagliflozin on Liver Fat in Patients With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial (E-LIFT Trial).

机构信息

Division of Endocrinology and Diabetes, Medanta-The Medicity Hospital, Gurugram, Haryana, India

Department of Radiology, Medanta-The Medicity Hospital, Gurugram, Haryana, India.

出版信息

Diabetes Care. 2018 Aug;41(8):1801-1808. doi: 10.2337/dc18-0165. Epub 2018 Jun 12.

DOI:10.2337/dc18-0165
PMID:29895557
Abstract

OBJECTIVE

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors have been shown to reduce liver fat in rodent models. Data regarding the effect of SGLT-2 inhibitors on human liver fat are scarce. This study examined the effect of empagliflozin (an SGLT-2 inhibitor) on liver fat in patients with type 2 diabetes and nonalcoholic fatty liver disease (NAFLD) by using MRI-derived proton density fat fraction (MRI-PDFF).

RESEARCH DESIGN AND METHODS

Fifty patients with type 2 diabetes and NAFLD were randomly assigned to either the empagliflozin group (standard treatment for type 2 diabetes plus empagliflozin 10 mg daily) or the control group (standard treatment without empagliflozin) for 20 weeks. Change in liver fat was measured by MRI-PDFF. Secondary outcome measures were change in alanine transaminase (ALT), aspartate transaminase (AST), and γ-glutamyl transferase (GGT) levels.

RESULTS

When included in the standard treatment for type 2 diabetes, empagliflozin was significantly better at reducing liver fat (mean MRI-PDFF difference between the empagliflozin and control groups -4.0%; < 0.0001). Compared with baseline, significant reduction was found in the end-of-treatment MRI-PDFF for the empagliflozin group (16.2% to 11.3%; < 0.0001) and a nonsignificant change was found in the control group (16.4% to 15.5%; = 0.057). The two groups showed a significant difference for change in serum ALT level ( = 0.005) and nonsignificant differences for AST ( = 0.212) and GGT ( = 0.057) levels.

CONCLUSIONS

When included in the standard treatment for type 2 diabetes, empagliflozin reduces liver fat and improves ALT levels in patients with type 2 diabetes and NAFLD.

摘要

目的

钠-葡萄糖共转运蛋白 2(SGLT-2)抑制剂已被证明可减少啮齿动物模型中的肝脂肪。关于 SGLT-2 抑制剂对人类肝脂肪影响的数据很少。本研究通过磁共振成像衍生质子密度脂肪分数(MRI-PDFF)检查 SGLT-2 抑制剂依帕格列净对 2 型糖尿病和非酒精性脂肪性肝病(NAFLD)患者肝脂肪的影响。

研究设计和方法

50 例 2 型糖尿病合并 NAFLD 患者被随机分为依帕格列净组(2 型糖尿病标准治疗加每日依帕格列净 10 毫克)或对照组(无依帕格列净的标准治疗),治疗 20 周。通过 MRI-PDFF 测量肝脂肪的变化。次要终点为丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)和 γ-谷氨酰转移酶(GGT)水平的变化。

结果

当依帕格列净纳入 2 型糖尿病的标准治疗时,降低肝脂肪的效果明显更好(依帕格列净组与对照组之间的 MRI-PDFF 差异平均为 -4.0%;<0.0001)。与基线相比,依帕格列净组治疗结束时 MRI-PDFF 显著降低(从 16.2%降至 11.3%;<0.0001),对照组则无显著变化(从 16.4%降至 15.5%;=0.057)。两组间血清 ALT 水平的变化有显著差异(=0.005),AST(=0.212)和 GGT(=0.057)水平无显著差异。

结论

在 2 型糖尿病的标准治疗中加入依帕格列净可降低 2 型糖尿病合并 NAFLD 患者的肝脂肪并改善 ALT 水平。

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