那格列奈治疗II型糖尿病的疗效和安全性研究  

A Study of Efficacy and Safety of Nateglinide as Pharmacologic Treatment for Patients with Type II Diabetes Mellitus

作　　者：刘汾[1] 李新芳[1] 李菊相[1] 温秀琴[1] 

机构地区：[1]中国人民解放军白求恩国际和平医院国家药品临床研究基地,河北石家庄050082

出　　处：《解放军药学学报》2005年第4期286-288,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的评价那格列奈的降糖效应与安全性。方法50例II型糖尿病患者随机分为2组,每组25例,分别服用那格列奈或瑞格列奈,共12周。开始剂量那格列奈30mg,tid;瑞格列奈0.5mg,tid。根据血糖水平,在2、4、8周调整药物剂量。最大服药剂量:那格列奈每日360mg,瑞格列奈每日6mg。结果与基础值比较,12周时那格列奈组糖化血红蛋白(HbAlc)下降1.09%,空腹血糖(FBG)下降1.11mmol·L-1,餐后2h血糖(PBG)下降4.78mmol·L-1;瑞格列奈对照组HbAlc下降1.27%,FBG2.06mmol·L-1,PBG下降4.43mmol·L-1。2组不良反应轻微,发生率分别为16%和4%(P>0.05)。结论那格列奈可使HbAlc、FPG、FPG显著下降,是治疗II型糖尿病的一个安全有效的药物。Aim To evaluate the efficacy and safety of domestic nateglinide in the clinical treatment for patients with type Ⅱ diabetes mellitus. Methods Fifty volunteer patient with type II diabetes mellitus were selected and randomly double-blind divided into nateglinide and repaglinide groups. Each of them, respectively, received an oral dose of nateglinide Tab one（30mg） and repaglinide dummy Tab or repaglinide Tab one （0.5mg） and nateglinide dummy Tab, tid, for 12 weeks. The dose of medication was titrated during the 2rd, 4th and 8th week, if fasting glucose（FPG） exceeded 7.8mmol·L^-1. Results In patients who were administrated nateglinide for 12 weeks, HbAlc decreased by 1.09% from the baseline, FPG by 1.11 mmol·L^-1 and postprandial 2h glucose（PBG） by 4.78mmol·L^-1 while in patients who were administrated Repaglinide, HbA1c by 1.27% from baseline, FBG decreased 2.06 mmol·L^-1, PBG by 4.43mmo1·L^-1. The adverse drug reactions of both groups were mild with the rates of 16.0% and 4.0% respectively （ P 〉 0.05）. Conclusion Nateglinide significantly decreased HbAlc, FBG and PBG and is an safe and effective drug for patients with type Ⅱ diabetes mellitus.

关 键 词：那格列奈 瑞格列奈 Ⅱ型糖尿病 随机双盲平行研究 

分 类 号：R969[医药卫生—药理学]