Zhang Jin-ping, Yang Wen-ying, Hong Tian-pei, Yang Jin-kui, Xiao Wen-hua, Gao Hong-wei, Yang Yi
Department of Endocrionology, China-Japan Friendship Hospital, Beijing 100029, China.
Zhonghua Yi Xue Za Zhi. 2007 May 15;87(18):1238-40.
To study the efficacy and safety of extended-release metformin and Glucophage in treatment of type 2 diabetes mellitus.
150 out-patients with type 2 diabetes mellitus visiting 3 hospitals in Beijing were randomly divided into two equal groups: study group treated with extended-release metformin 1500 mg qd for 12 weeks, and control group treated with Glucophage (tablet of metformin, 500 mg, tid) and in for 12 weeks. The levels of fasting plasma glucose (FPG), plasma glucose 2 h after meal (2 hPG), and glycated hemoglobin (HbA1c) were examined before and 12 weeks after treatment. Plasma insulin was detected by radioimmunoassay.
Completed study had been obtained in 140 patients, 71 in the control group and 69 in the study group. 12 weeks after treatment there was no significant difference in the FPG level between these two groups (P = 0.07), the postprandial plasma glucose level decreased by 0.4 (-1.4 approximately 1.7) mmol/L in the control group and increased slightly in the study group (P = 0.002), however, the levels plasma glucose area under curve 2 hours after meal in these 2 groups did not changed significantly (P = 0.64). HbA1c decreased in both groups and there was not significant difference between these two groups (P = 0.73). The adverse event rates of the study and control groups were 10.8% and 4.3% respectively (P = 0.21), and the main adverse events were gastrointestinal side effects. No serious adverse events were found in both groups, and no patient was withdrawn due to adverse events of medication.
The efficacy and safety of extended-release metformin within 12 week treatment for type 2 diabetes mellitus is comparable to those of Glucophage treatment with good compliance and mild adverse side effects.
研究缓释二甲双胍与格华止治疗2型糖尿病的疗效和安全性。
将在北京3家医院就诊的150例2型糖尿病门诊患者随机分为两组，每组75例。研究组服用缓释二甲双胍1500 mg，每日1次，共12周；对照组服用格华止（二甲双胍片，500 mg，每日3次），共12周。治疗前及治疗12周后检测空腹血糖（FPG）、餐后2小时血糖（2hPG）和糖化血红蛋白（HbA1c）水平。采用放射免疫法检测血浆胰岛素。
140例患者完成研究，其中对照组71例，研究组69例。治疗12周后，两组FPG水平差异无统计学意义（P = 0.07）；对照组餐后血糖水平下降0.4（-1.4～1.7）mmol/L，研究组略有升高（P = 0.002），但两组餐后2小时血糖曲线下面积差异无统计学意义（P = 0.64）。两组HbA1c均下降，组间差异无统计学意义（P = 0.73）。研究组和对照组的不良事件发生率分别为10.8%和4.3%（P = 0.21），主要不良事件为胃肠道副作用。两组均未发现严重不良事件，无患者因药物不良事件退出研究。
缓释二甲双胍治疗2型糖尿病12周的疗效和安全性与格华止相当，依从性好，不良反应轻微。
