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依美格鲁明对2型糖尿病合并代谢功能障碍相关脂肪性肝病患者的疗效:一项多中心研究。

Efficacy of imeglimin in patients with type 2 diabetes mellitus complicated by metabolic dysfunction-associated steatotic liver disease: A multicentre study.

作者信息

Fukunaga Kensaku, Morishita Asahiro, Imachi Hitomi, Oura Kyoko, Sato Seisuke, Kobayashi Toshihiro, Saheki Takanobu, Yoshimura Takafumi, Komori Kurumi, Nakahara Mai, Tadokoro Tomoko, Fujita Koji, Tani Joji, Kobara Hideki, Murao Koji

机构信息

Department of Endocrinology and Metabolism, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa, Japan.

Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Miki-cho, Kagawa, Japan.

出版信息

Diabetes Obes Metab. 2025 Mar;27(3):1498-1506. doi: 10.1111/dom.16157. Epub 2024 Dec 26.

Abstract

AIMS

This study aimed to evaluate the effectiveness of imeglimin in improving liver function and fibrosis in patients with type 2 diabetes (T2D) complicated by metabolic dysfunction-associated steatotic liver disease (MASLD).

MATERIALS AND METHODS

We conducted a multicentre study involving 80 patients with T2D and MASLD who were treated with or without imeglimin for 24 weeks. We assessed the changes in diabetes-related parameters, including HbA1c, fasting blood glucose, glycoalbumin and C-peptide index. Liver function was monitored using AST, ALT, γ-GTP and liver fibrosis indicators such as Fib-4 index and FibroScan-AST (FAST) score. Liver fat content and stiffness were measured using controlled attenuation parameter and vibration-controlled transient elastography, which were measured using FibroScan.

RESULTS

Compared with the control group, imeglimin treatment led to a significant reduction in HbA1c levels, fasting blood glucose and liver-related parameters, including AST, ALT and γ-GTP. Additionally, the Fib-4 index and FAST score, which reflect liver fibrosis and inflammation, were significantly lower in the imeglimin group. Liver fat content and stiffness remained unchanged during the study period.

CONCLUSIONS

Imeglimin efficaciously improved liver inflammation and fibrosis in patients with T2D and MASLD, with no significant changes in liver fat content or stiffness. These findings suggest that imeglimin is a promising therapeutic drug for the management of MASLD in the context of T2D, warranting further research on its long-term efficacy and mechanisms of action.

摘要

目的

本研究旨在评估依美格列明对改善2型糖尿病(T2D)合并代谢功能障碍相关脂肪性肝病(MASLD)患者肝功能及肝纤维化的有效性。

材料与方法

我们开展了一项多中心研究,纳入80例T2D合并MASLD患者,对其进行为期24周的依美格列明治疗或不治疗。我们评估了糖尿病相关参数的变化,包括糖化血红蛋白(HbA1c)、空腹血糖、糖化白蛋白和C肽指数。使用谷草转氨酶(AST)、谷丙转氨酶(ALT)、γ-谷氨酰转肽酶(γ-GTP)监测肝功能,并使用Fib-4指数和FibroScan-AST(FAST)评分等肝纤维化指标。使用受控衰减参数和振动控制瞬时弹性成像测量肝脏脂肪含量和硬度,这两项测量均通过FibroScan进行。

结果

与对照组相比,依美格列明治疗使HbA1c水平、空腹血糖以及包括AST、ALT和γ-GTP在内的肝脏相关参数显著降低。此外,反映肝纤维化和炎症的Fib-4指数和FAST评分在依美格列明组显著更低。在研究期间,肝脏脂肪含量和硬度保持不变。

结论

依美格列明有效改善了T2D合并MASLD患者的肝脏炎症和纤维化,肝脏脂肪含量和硬度无显著变化。这些发现表明,依美格列明是治疗T2D背景下MASLD的一种有前景的治疗药物,值得对其长期疗效和作用机制进行进一步研究。

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