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目的 以瑞格列奈为对照,评价那格列奈治疗2型糖尿病的疗效和安全性。方法 用多中心随机双盲双模拟平行对照的试验设计,观察了228例2型糖尿病病人,其中那格列奈组111例,瑞格列奈组117例。结果 与基础值比较,治疗12周后那格列奈组空腹血糖(FBG)、餐后2h血糖(PBG)及糖化血红蛋白(HbA1c)分别下降(1.25±1.79) mmol.L-1,(4.03±2.82) mmol.L-1和(0.56±1.07)%;瑞格列奈组病人FBG、PBG及HbA1c分别下降(1.54±1.49)mmol.L-1,(3.79±3.44) mmol.L-1和(0.53±0.97)%;2组下降各指标比较均有显著性差异,而2组间比较无显著性差异。2组药物不良反应发生率比较无统计学差异。结论 那格列奈是治疗2型糖尿病有效和安全的药物。
The purpose of repaglinide as a control to evaluate the efficacy and safety of nateglinide in the treatment of type 2 diabetes. Methods A total of 228 patients with type 2 diabetes mellitus were observed in a multicenter, randomized, double-blind, double-dummy, parallel-controlled trial. Of these, 111 were nateglinide and 117 were repaglinide. Results Compared with the baseline, fasting blood glucose (FBG), postprandial blood glucose (PBG) and HbA1c in nateglinide group decreased by 1.25 ± 1.79 mmol.L-1 and 4.03 ± (1.54 ± 1.49) mmol.L-1, (3.79 ± 3.44) mmol.L-1 and (3.79 ± 3.44) mmol.L-1 and (0.56 ± 1.07)% respectively in the repaglinide group and (0.53 ± 0.97)% respectively. There were significant differences between the two groups in all indexes, but there was no significant difference between the two groups. Two groups of adverse drug reactions incidence no significant difference. Conclusion Nateglinide is an effective and safe drug for the treatment of type 2 diabetes.