二甲双胍缓释片治疗2型糖尿病患者的疗效和安全性的临床研究

Efficacy and safety of extended-release metformin in treatment of type 2 diabetes mellitus

目的比较服用二甲双胍缓释片与格华止治疗2型糖尿病的有效性与安全性。方法纳入符合入选条件的2型糖尿病患者150例,随机分为两组:对照组75例,口服格华止,每次500 mg,每日3次;试验组75例,口服二甲双胍缓释片,每次1500 mg,每晚1次。治疗12周后以糖化血红蛋白(HbA1c),空腹血糖(FPG)及餐后2 h 血糖(2hPG),血糖曲线下面积(AUC),评价服用二甲双胍缓释片的有效性;同时通过对不良事件、心电图及实验室检查的分析,评价其安全性。结果 140例完成了试验。药物治疗12周后,两组的空腹血糖水平相似(6.7 mmol/L±1.1 mmol/L vs 7.0 mmol/L±1.3 mmol/L,P=0.07);餐后2 h 血糖用药前后比较格华止组下降(6.9 mmol/L±1.4 mmol/L vs 6.7mmol/L±1.1 mmol/L),组间比较差异有统计学意义(P=0.002);餐后2 h 内 AUC 的变化组间比较差异无统计学意义(P=0.64);HbA1c 两组均有下降,且降低 HbA1c 的作用相似(P=0.73)。主要不良事件以胃肠道反应为主,格华止组发生率为10.8%,二甲双胍缓释片组为4.3%,组间比较差异无统计学意义(P=0.21)。试验过程中无患者因不良事件退出研究,亦无严重不良事件发生。结论国产二甲双胍缓释片和格华止在为期12周的研究中临床疗效可比有相同的降糖作用,且患者依从性好,不良反应轻微。

Objective To study the efficacy and safety of extended-release metformin and Glucophage in treatment of type 2 diabetes mellitus. Methods 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 （HbAlc） were examined before and 12 weeks after treatment. Plasma insulin was detected by radioimmunoassay. Results 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～ 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）. HbA1 c 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 No serious adverse events were found in both groups, and no patient was withdrawn due to adverse events of medication. Conclusion The efficacy and safety of extended-release metformin within 12 week treatment for type 2 diabetes mellitus is comparable to those of Glueophage treatment with good compliance and mild adverse side effects.