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米格列醇/维格列汀固定剂量复方制剂在日本 2 型糖尿病患者中控制餐后高血糖的疗效观察。

Tighter control of postprandial hyperglycemia with mitiglinide/voglibose fixed-dose combination in Japanese patients with type 2 diabetes mellitus.

机构信息

Sasazuka Inoue Clinic, 1-15-4 Sasazuka, Shibuya-ku, Tokyo, Japan.

出版信息

Expert Opin Pharmacother. 2012 Nov;13(16):2257-68. doi: 10.1517/14656566.2012.726614. Epub 2012 Sep 21.

Abstract

OBJECTIVE

The objective of this study was to compare the effects of mitiglinide, voglibose and its combination on metabolic responses after a test meal in Japanese patients with type 2 diabetes mellitus (T2DM).

RESEARCH DESIGN AND METHODS

This randomized crossover study consisted of four periods between August and November 2011. In the first period, all patients (n = 12) received water alone (control period). In the next three periods, the patients received 10 mg mitiglinide, 0.2 mg voglibose or a combination in a random order.

MAIN OUTCOME MEASURES

Postprandial metabolite/hormone levels were then measured.

RESULTS

Plasma glucose and serum insulin reached peak levels by 60 - 90 and 90 min, respectively, after the test meal in the control group. The combination reduced postprandial glucose levels compared with mitiglinide or voglibose alone, particularly at 30 - 90 min, which significantly exceeded the effects of mitiglinide (p < 0.05). Mitiglinide and the combination restored early insulin response, whereas the combination provided an insulin-sparing effect compared with mitiglinide alone. The combination improved postprandial lipid profiles, combining the effects of both drugs.

CONCLUSION

This study revealed marked differences in the postprandial metabolic effects of mitiglinide, voglibose and its combination in patients with T2DM. The combination therapy should enable tighter control of postprandial hyperglycemia compared with the individual drugs.

摘要

目的

本研究旨在比较米格列醇、伏格列波糖及其联合用药对日本 2 型糖尿病(T2DM)患者餐后代谢反应的影响。

研究设计和方法

这是一项 2011 年 8 月至 11 月进行的随机交叉研究,共包括四个时期。第一时期,所有患者(n=12)均服用水(对照期)。接下来的三个时期,患者以随机顺序分别服用 10mg 米格列醇、0.2mg 伏格列波糖或联合用药。

主要观察指标

随后测量餐后代谢物/激素水平。

结果

在对照组,餐后 60-90 分钟血糖和 90 分钟时血清胰岛素达到峰值。与米格列醇或伏格列波糖单药治疗相比,联合用药降低了餐后血糖水平,尤其是在 30-90 分钟时,显著优于米格列醇(p<0.05)。米格列醇和联合用药恢复了早期胰岛素反应,而与米格列醇单药治疗相比,联合用药具有胰岛素节省效应。联合用药改善了餐后血脂谱,结合了两种药物的作用。

结论

本研究揭示了米格列醇、伏格列波糖及其联合用药在 T2DM 患者餐后代谢效应方面的显著差异。与单药治疗相比,联合治疗可能更有利于控制餐后高血糖。

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