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二甲双胍缓释片每日一次给药对2型糖尿病患者的代谢影响:一项多中心研究。

The metabolic effects of once daily extended-release metformin in patients with type 2 diabetes: a multicentre study.

作者信息

Gao H, Xiao W, Wang C, Zhang J, Yang Y, Yang J, Yang W, Hong T

机构信息

Department of Endocrinology, Peking University Third Hospital, Beijing, China.

出版信息

Int J Clin Pract. 2008 May;62(5):695-700. doi: 10.1111/j.1742-1241.2008.01733.x.

DOI:10.1111/j.1742-1241.2008.01733.x
PMID:18412932
Abstract

AIM

To investigate the effects of extended-release metformin (MXR) compared with immediate-release metformin (MIR) on post-prandial glycaemic excursion, chronic glycaemia, lipid profiles, insulin resistance and islet function in type 2 diabetes.

METHODS

A randomised, open-labelled, positive-controlled multicentre study was conducted on 150 Chinese patients with type 2 diabetes. After 2 weeks of run-in period with MIR, 150 subjects were randomised into MXR group and MIR group. The patients in MXR group were assigned to take MXR 1500 mg once daily after dinner, while the patients in MIR group were assigned to continue MIR 500 mg thrice daily after meals for 12 weeks. Standard meal tests were carried out at baseline and at the end of this study. Plasma glucose, serum insulin, HbA1c and lipid profiles were measured. Homeostasis model assessment (HOMA) was used to evaluate insulin resistance index (HOMA-IR) and islet beta-cell function index (HOMA-B).

RESULTS

Either MIR or MXR modestly, but significantly decreased HbA1c levels and body mass index (BMI) after 12 weeks of treatment. However, there were no significant differences between two groups. The post-prandial glycaemia at 120 min after a standard meal in MXR group was higher than in MIR group (11.02 +/- 3.08 mmol/l vs. 9.74 +/- 2.61 mmol/l, p < 0.05). Moreover, no differences in the areas under curve of insulin release response, HOMA-B, HOMA-IR and lipid profiles were found within or between groups after 12 weeks of treatment.

CONCLUSION

The effects of once daily MXR on chronic glycaemia, BMI, lipid profiles, insulin resistance and islet function are comparable with that of thrice daily MIR in oriental population.

摘要

目的

研究缓释二甲双胍(MXR)与速释二甲双胍(MIR)相比,对2型糖尿病患者餐后血糖波动、慢性血糖、血脂谱、胰岛素抵抗及胰岛功能的影响。

方法

对150例中国2型糖尿病患者进行了一项随机、开放标签、阳性对照的多中心研究。在使用MIR进行2周的导入期后,将150名受试者随机分为MXR组和MIR组。MXR组患者被指定在晚餐后每日服用一次1500 mg MXR,而MIR组患者被指定继续每日三次、每次500 mg餐中服用MIR,共12周。在基线和研究结束时进行标准餐试验。测量血浆葡萄糖、血清胰岛素、糖化血红蛋白(HbA1c)和血脂谱。采用稳态模型评估(HOMA)来评估胰岛素抵抗指数(HOMA-IR)和胰岛β细胞功能指数(HOMA-B)。

结果

治疗12周后,MIR和MXR均适度但显著降低了HbA1c水平和体重指数(BMI)。然而,两组之间无显著差异。MXR组标准餐后120分钟的餐后血糖高于MIR组(11.02±3.08 mmol/L对9.74±2.61 mmol/L,p<0.05)。此外,治疗12周后,组内或组间胰岛素释放反应曲线下面积、HOMA-B、HOMA-IR和血脂谱均无差异。

结论

在东方人群中,每日一次MXR对慢性血糖、BMI、血脂谱、胰岛素抵抗和胰岛功能的影响与每日三次MIR相当。

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