格列美脲治疗2型糖尿病安全性和有效性的多中心临床研究

目的 评价格列美脲对单纯饮食或用二甲双胍和/或阿卡波糖治疗控制不满意的2型糖尿病治疗的安全性、耐受性和有效性。方法 用多中心、开放性、非对照性临床研究,入选患者给予格列美脲1～4 mg,每日早餐前顿服,疗程16周。试验前后测定血糖、糖化血红蛋白、血脂和肝肾功能。结果129例患者人选,122例患者完成试验,格列美脲治疗16周空腹和餐后2h血糖平均分别下降1.3和1.8 mmol·L~(-1),糖化血红蛋白平均下降1.8％。治疗后空腹血浆胰岛素水平无变化,HOMA胰岛素抵抗指数明显下降,患者体重指数平均增加0.3 kg·m~(-2)。与格列美脲治疗有关的主要不良事件为低血糖反应和消化道症状,16例次与药物有关的低血糖反应均为轻度,进食后可自行缓解。对血脂和血压无不良影响。结论 格列美脲可以进一步降低单纯饮食控制或应用二甲双胍和/或阿卡波糖治疗的2型糖尿病患者的空腹和餐后2h时血糖以及糖化血红蛋白,且不增加空腹胰岛素水平,副作用小,耐受性好,使用较安全。

Multi-center study of safety and efficacy evalution of glimepiride in type 2 diabetic patients

Objective To assess the tolerance, safety and efficacy profile of glimepiride. Method One hundred twenty-nine type 2 diabetes patients who were treated with non-pharmacotherapy treatment or treated with metaformin and/or a -glucosidase inhibitor in a stable dosage more than one month were enrolled this multicenter non-comparative single group open assessment study. Patients received 16 weeks course of glimepiride 1~4 mg q.d according to the study plan. Results One hundred twenty-two patients fulfilled the trial. After 16 weeks glimepiride treatment, median fasting blood glucose (FBG), fasting plasma glucose (FPG), 2-hours postprandial blood glucose (2-hBG) were decreased 1.4,1.3 and 1.8 mmol.L-1, respectively. Glycosalated hemoglobin (GHbAIC) were decreased 1.8% (from 9.6% to 7.8%). Median body mass index (MBI) was increased 0.3 kg.m-2. There was no difference of fasting plasma insulin level between baseline and endpoint and had no adverse effects on blood pressure and blood lipid metabolism. The common treatment-related adverse events were hypoglycemic symptoms and digestive system disturbance. All hypoglycemic symptoms could be improved by taking foods themselves. Conclusion The results of this multicenter non-comparative single group open study indicated that glimepirid is a safe effective oral agent for lowing plasma glucose and GHbAIC in type 2 diabetic patients.