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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
Objective To observe the curative effect and safety of the domestic two kinds of new drugs nateglinide tablets in the treatment of type 2 diabetes mellitus. Methods A double-blind, double-dummy, randomized, double-blind, double-dummy, nateglinide and repaglinide (1: 1) parallel control was designed. There were 233 patients in 4 centers who entered the trial, 117 in the experimental group (A group) and 116 in the control group (B group). Results Hypoglycemic effect: HbA1c, postprandial blood glucose (2hPBG) and fasting blood glucose (FBG) decreased significantly in both control and experimental groups after 12 weeks of treatment, with a significant difference between before and after treatment (P <0.05) There was no significant difference between the two groups (P> 0.05). Changes of lipid metabolism index: The triglyceride (TG) and total cholesterol (TC) in the control group and the experimental group decreased compared with those before treatment at 12 weeks of treatment, but there was significant difference between before and after treatment in TG group only (P <0 0 1), no significant difference between the two groups before and after comparison. In the 12 weeks of treatment, only one patient in the control group was treated with PLT and then decreased. A total of 4 cases occurred adverse reactions, including 2 cases in the control group, respectively, decreased dizziness and platelet (PLT); experimental group 2 cases, respectively, for the hand shake and hypoglycemia responses; 3 cases were mild, does not affect the treatment. The incidence of adverse reactions was no significant significance. Prompt 12 weeks of repaglinide and nateglinide treatment of good security, patients with good tolerance to the test. Conclusion The effect of nateglinide and repaglinide in treating diabetes is similar with less adverse reactions, which is a safe and effective hypoglycemic drug