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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。
Objectives To evaluate the safety, tolerability and efficacy of glimepiride in the treatment of type 2 diabetes who are not satisfied with simple diets or with metformin and / or acarbose treatment. Methods A multicenter, open, and uncontrolled clinical study was conducted. Patients were enrolled in the study. Glimepiride was administered 1 to 4 mg daily for 16 weeks before breakfast. Blood glucose, glycosylated hemoglobin, blood lipid and liver and kidney function were measured before and after the experiment. Results 129 patients were selected, 122 patients completed the trial, glimepiride fasting 16 weeks and postprandial 2h blood glucose decreased by an average of 1.3 and 1.8 mmol·L -1, HbA1c average decreased 1.8%. After treatment, fasting plasma insulin level did not change, HOMA insulin resistance index decreased significantly, the average body mass index increased 0.3 kg · m ~ (-2). The main adverse events associated with glimepiride therapy were hypoglycemic and gastrointestinal symptoms. Sixteen drug-related hypoglycaemic reactions were mild and resolved spontaneously after eating. No adverse effects on blood lipids and blood pressure. Conclusion Glimepiride can further reduce fasting and 2h postprandial blood glucose and glycosylated hemoglobin (HbAlc) in patients with type 2 diabetes treated with metformin and / or metformin alone, without increasing fasting insulin levels, with fewer side effects, Good sex, the use of more secure.