那格列奈与瑞格列奈治疗2型糖尿病的随机双盲多中心临床研究

目的　观察国产 2类新药那格列奈片剂的治疗 2型糖尿病的疗效和安全性。方法　采用随机双盲双模拟、那格列奈片剂与瑞格列奈片剂 ( 1∶1)平行对照、多中心研究设计 ,整个试验过程历时 14周 ,药物观察期 12周。 4个中心 2 3 3例患者进入本试验 ,其中试验组 (A组 ) 117例 ,对照组 (B组 ) 116例。结果　降血糖效果 :对照组与试验组糖化血红蛋白 (HbA1c)、餐后血糖 ( 2hPBG)、空腹血糖 (FBG)治疗 12周后均明显下降 ,前后对照有统计学意义 (P <0 0 5 ) ,但下降率 2组比较无统计学差异 ( P >0 0 5 )。脂代谢指标的变化 :治疗 12周时对照组和试验组甘油三酯 (TG)和总胆固醇 (TC)均较治疗前有下降 ,但仅试验组TG治疗前后比较有显著性差异 (P <0 0 1) ,2组间前后比较均无显著性差异。治疗 12周中仅对照组 1例PLT用药后降低。发生不良反应共 4例次 ,其中对照组 2例 ,分别为头昏和血小板 (PLT)下降 ;试验组 2例 ,分别为手抖和低血糖反应 ;对照组 1例因头昏停药 ,其余 3例均为轻度 ,不影响治疗。不良反应发生率比较无显著性意义。提示瑞格列奈与那格列奈 12周的治疗安全性较好 ,患者能良好耐受试验。结论　那格列奈与瑞格列奈治疗糖尿病的疗效相似 ,不良反应少 ,是一种安全有效的降糖药物

A double-blind randomized clinical study in multiple-center comparing the effect of natelginide on type 2 diabetes with repaglinide

Objective: To evaluate the effect and safety of nateglinide on type 2 diabetes. Methods: A double、blind randomized clinical study in the multiple、center comparison with the effects of nateglinide on type 2 diabetes and repaglinide in 2 groups for 14 weeks of experiement and 12 weeks of observntion. Rusults: After 12 weeks, nateglinide significantly reduced the hemoglobin A(1c) (HbA1c), Fasting blood glucose (FBG) and 2h postprandial blood glucose(2hPBG)as well as repaglinide(P<0.05). Nateglinide and repaglinide tended to decrease the total cholesterol (TC) and triglyceride (TG), but only nateglinide can reduce triglyceride (TG) significantly (P<0.05). Theratesofsidereactionsfornateglinideandrepaglinidewere1.74%and 1.75% respectively (P>0.05). Conclutions: Nateglinide appeared to be effective and safe in the treatment of type 2 diabetes, which is similar to repaglinide.