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目的观察国产那格列奈治疗2型糖尿病的有效性和安全性。方法随机入组2型糖尿病患者240例,试验组(那格列奈组)和对照组(瑞格列奈组)各120例。采用随机、双盲、那格列奈与瑞格列奈平行对照的研究方法,进行为期12周的临床研究。结果与(基础值0周)比较,12周试验组HbA1c下降1.53%,空腹血糖下降1.39mmol/L,餐后2h血糖下降3.92mmol/L;对照组糖化血红蛋白(HbA1c)下降1.48%,空腹血糖下降1.68mmol/L,餐后2h血糖下降3.51mmol/L。治疗12周中,生命体征、实验室检查指标均未见有临床意义的变化。结论国产那格列奈可使2型糖尿病人HbA1c、空腹血糖、餐后2h血糖显著下降,且安全性和耐受性较好,其临床作用不次于瑞格列奈。
Objective To observe the efficacy and safety of domestic nateglinide in the treatment of type 2 diabetes. Methods A total of 240 patients with type 2 diabetes mellitus (T2DM) were randomly enrolled. The patients in trial group (nateglinide group) and control group (n = 120) A 12-week clinical study was conducted using a randomized, double-blind, parallel-controlled study of nateglinide and repaglinide. The results showed that HbA1c decreased by 1.53%, fasting blood glucose decreased by 1.39mmol / L and decreased by 3.92mmol / L at 2h postprandial compared with baseline (week 0). HbA1c decreased by 1.48% and fasting blood glucose Decreased 1.68mmol / L, 2h postprandial blood glucose decreased 3.51mmol / L. During the 12 weeks of treatment, no clinical changes were found in vital signs and laboratory tests. Conclusion Domestic nateglinide can significantly reduce HbA1c, fasting blood glucose and postprandial 2h blood glucose in type 2 diabetic patients with good safety and tolerability. Its clinical effect is not inferior to that of repaglinide.