那格列奈和瑞格列奈治疗2型糖尿病有效性和安全性的临床研究

Efficiency and safety of Nateglinide and Repaglinide in treatment of type 2 diabetes mellitus-a multi-centre,double-blind,randomized and controlled clinical trial

目的:评价那格列奈治疗2型糖尿病的疗效和安全性。方法:采用多中心、随机、双盲、双模拟平行对照研究,观察那格列奈(A组,119例,120 mg 3/d)和瑞格列奈(B组,120例1.0 mg 3/d)治疗12周前后糖化血红蛋白(HbA1c)、血糖、胰岛素水平、体重及安全性指标的变化。结果:那格列奈和瑞格列奈均能有效降低HbA1c(P均<0.01)、空腹血糖(FPG,P分别<0.01和0.05)、餐后1 h、2 h血糖(PPG1、PPG2,P均<0.01),提升餐后1 h、2 h胰岛素(INS1,P均<0.01;INS2,P分别<0.01和0.05)水平。其中对HbA1c和FPG的疗效,那格列奈优于瑞格列奈(P分别<0.05和0.01),但前者低血糖反应也多于后者。两组的体重较治疗前均略有增加;两药安全性及顺应性较好。结论:那格列奈和瑞格列奈都是治疗2型糖尿病有效和安全的药物,那格列奈120 mg 3/d降低HbA1c和空腹血糖的效果强于瑞格列奈1.0 mg 3/d。

Objective：To evaluate the efficiency and safety of Nateglinide in the treatment of type 2 diabetes mellitus. Methods ：A muhi-centre, double-blind, controled trial was conducted on 239 patients with type 2 diabetes mellitus, 119 of whom （ group A） received Nateglinide 120mg tid for 12 weeks. The other 120 patients （ group B） were given Repaglinide 1.0 mg tid as controls. Parameters of therapeutic effects （HbAlc, blood glucose, insulin and body weight） were compared with that before the treatment. Results：The patients who had been treated with either Nateglinide or Repaglinide showed significant decrease on average from baseline in HbA1c （ P 〈 0.01 ）, fasting plasma glucose （ FPG, P 〈 0.01 and 0.05, respectively）, and postprandial plasma glucose at 1 and 2 hour （ PPG1, PPG2, P 〈 0.01 ）. Nateglinide had stronger effect on reducing HbA1c and FPG than Repaglinide（P 〈0.05 and 0.01, respectively）but more hypoglycemia in the former. The postprandial insulin levels at 1 and 2 hour （INS1, INS2） increased significantly in both groups（P 〈 0.01 ）and so was the body weight. Conclusion：Nateglinide and Repaglinide are both efficient, safe and well-tolerated drugs in the management of type 2 diabetes mellitus with better effect on reducing HbA1c and FPG.