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口服司美格鲁肽对代谢相关脂肪性肝病合并 2 型糖尿病患者的疗效:一项前瞻性、多中心、观察性研究。

Beneficial effect of oral semaglutide for type 2 diabetes mellitus in patients with metabolic dysfunction-associated steatotic liver disease: A prospective, multicentre, observational study.

机构信息

Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.

Core Research Facilities for Basic Science, Research Center for Medical Sciences, The Jikei University School of Medicine, Tokyo, Japan.

出版信息

Diabetes Obes Metab. 2024 Nov;26(11):4958-4965. doi: 10.1111/dom.15898. Epub 2024 Sep 2.

Abstract

AIMS

To evaluate the efficacy and safety of oral semaglutide for type 2 diabetes mellitus (T2DM) in patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

MATERIALS AND METHODS

This was a single-arm, multicentre, prospective study. Among 80 consecutive patients with MASLD and T2DM who newly received oral semaglutide, 70 completed 48-week oral semaglutide treatment as scheduled and were included in an efficacy analysis. Dose adjustments of oral semaglutide were determined by each physician while monitoring efficacy and adverse events.

RESULTS

Significant improvements in body weight, liver enzymes, lipid profile, and glycaemic control were found at 48 weeks compared with baseline values (all p < 0.01). Controlled attenuation parameter values significantly decreased from baseline to 48 weeks (p < 0.01). Changes in alanine aminotransferase concentrations (r = 0.37, p < 0.01) and controlled attenuation parameter values (r = 0.44, p < 0.01) were significantly correlated with changes in body weight. Liver fibrosis markers, such as type IV collagen 7S, Wisteria floribunda agglutinin-positive Mac-2-binding protein, fibrosis-4 index, and liver stiffness measurement, significantly decreased from baseline to 48 weeks (all p < 0.01). The most common adverse events were Grades 1-2 transient gastrointestinal symptoms, such as nausea (23 patients, 28.8%), dyspepsia (12, 15.0%) and appetite loss (4, 5.0%).

CONCLUSIONS

Oral semaglutide treatment for T2DM in patients with MASLD leads to an improvement in liver steatosis and injury, surrogate markers of fibrosis, diabetic status, and lipid profile, and reduces body weight.

摘要

目的

评估口服司美格鲁肽治疗代谢相关脂肪性肝病(MASLD)合并 2 型糖尿病(T2DM)患者的疗效和安全性。

材料和方法

这是一项单臂、多中心、前瞻性研究。在 80 例新接受口服司美格鲁肽治疗的 MASLD 合并 T2DM 患者中,70 例按计划完成了 48 周的口服司美格鲁肽治疗,并纳入疗效分析。口服司美格鲁肽的剂量调整由每位医生根据疗效和不良反应监测情况决定。

结果

与基线值相比,治疗 48 周后患者的体重、肝酶、血脂谱和血糖控制均显著改善(均 P < 0.01)。受控衰减参数值从基线到 48 周显著降低(P < 0.01)。丙氨酸氨基转移酶浓度的变化(r = 0.37,P < 0.01)和受控衰减参数值的变化(r = 0.44,P < 0.01)与体重变化显著相关。肝纤维化标志物,如Ⅳ型胶原 7S、Wisteria floribunda 凝集素阳性 Mac-2 结合蛋白、纤维化 4 指数和肝硬度测量值,从基线到 48 周均显著降低(均 P < 0.01)。最常见的不良事件是 1-2 级短暂的胃肠道症状,如恶心(23 例,28.8%)、消化不良(12 例,15.0%)和食欲减退(4 例,5.0%)。

结论

口服司美格鲁肽治疗 MASLD 合并 T2DM 可改善肝脂肪变性和损伤、纤维化的替代标志物、糖尿病状态和血脂谱,并减轻体重。

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