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目的 观察国产马来酸罗格列酮片治疗2型糖尿病的临床疗效及安全性。方法:多中心的临床研究,根据给药方案,按双盲、随机、平行、对照的原则进行分组。研究对象为在饮食控制、适当运动及已经使用磺脲类药物治疗1个月基础上,血糖控制不佳的2型糖尿病患者。原治疗方案与用药剂量不变,加用罗格列酮 4mg每日一次为试验组,加用二甲双胍0.25g每日二次为对照组,疗程均为12周。试验前后均进行空腹及餐后2h的血糖和胰岛素、糖化血红蛋白、血生化、血脂等检查。结果:共198例2型糖尿病患者进入疗效统计,其中,试验组102例,对照组96例。罗格列一磺脲类药物联用及二甲双胍一磺脲类药物联用均明显降低(P＜0.01)糖化血红蛋白、空腹及餐后血糖,提高胰岛素敏感性。罗格列酮试验组降低糖化血红蛋白达1.09%,而二甲双胍对照组降低达0.95%。试验组使空腹血糖及餐后2h血糖比基础值分别下降 2.52mmol·L-1(25.0%)和5.63mmol·L-1(35.6%)(P＜0.01),对照组使空腹血糖及餐后2h血糖比基础值分别下降1.76mmol·L-1(17.7%)和 3.73mmol·L-1(23.8%)(P＜0.01)。罗格列酮试验组的总胆固醇、低密度脂蛋白胆固醇及高密度脂蛋白胆固醇的水平均有显著意义的增高,而总胆固醇/高密度脂蛋白比值和低密度脂蛋白/高密度脂蛋白比值无变化。未见肝功能?
Objective To observe the clinical efficacy and safety of domestic-made rosiglitazone maleate in the treatment of type 2 diabetes mellitus. METHODS: A multicenter clinical study was conducted according to the dosing regimen, grouped according to double-blind, randomized, parallel, and controlled principles. Subjects were type 2 diabetic patients with poor glycemic control based on diet control, proper exercise, and one month of treatment with sulfonylureas. The original treatment options and dosage unchanged, plus the use of rosiglitazone 4mg once daily for the experimental group, plus metformin 0.25g twice daily for the control group, the course of treatment were 12 weeks. Before and after the test were fasting and postprandial blood glucose 2h and insulin, glycosylated hemoglobin, blood biochemistry, blood lipids and other tests. Results: A total of 198 patients with type 2 diabetes mellitus were enrolled in the study. Among them, 102 patients in the test group and 96 patients in the control group. Rosiglitazone-sulfonylurea combination and metformin-sulfonylurea combination were significantly lower (P <0.01), HbAlc, fasting and postprandial blood glucose, improve insulin sensitivity. The rosiglitazone test group reduced glycosylated hemoglobin by 1.09%, while the metformin control group reduced by 0.95%. The fasting blood glucose and postprandial 2-hour blood glucose level decreased by 2.52mmol·L-1 (25.0%) and 5.63mmol·L-1 (35.6%) in the experimental group (P <0.01) 2h blood glucose decreased by 1.76mmol·L-1 (17.7%) and 3.73mmol·L-1 (23.8%) respectively (P <0.01). The levels of total cholesterol, low density lipoprotein cholesterol and high density lipoprotein cholesterol in rosiglitazone test group were significantly increased, while the total cholesterol / high density lipoprotein ratio and low density lipoprotein / high density lipoprotein ratio No change. No liver function?