卡博平临床应用研究

STUDY OF THE CLINICAL APPLICATION OF ACARBOSE

[目的]观察国产阿卡波糖片剂(卡博平)和进口阿卡波糖片剂(拜唐苹)对2型糖尿病的血糖、血脂控制的疗效和安全性及其对胰岛素水平、体重及血脂的影响。[方法]采用随机对照试验方法,对147例2型糖尿病患者,随机分为卡博平组(73例)和拜唐苹组(74例)进行治疗和比较。[结果]共有135例完成了试验(卡博平组67例,拜唐苹组68例)。与用药前相比,第4周卡博平、拜唐苹组的空腹血糖分别下降2.06和2.54mmol/L,餐后血糖分别下降5.19和4.54mmol/L;第8周时空腹血糖分别下降2.56和2.34mmol/L,餐后血糖分别下降5.35和5.45mmol/L;HbA1c值分别下降1.25%和1.45%,卡博平、拜唐苹组,下降幅度差异无统计学意义(P>0.01)。两组第4周及8周TG水平,以及体重和BMI均一定程度下降。与用药前相比,国产和进口阿卡波糖组的空腹及餐后血糖、HbA1c值均明显降低(P<0.01);两组血脂及体重指数也有一定程度的下降。胃肠道等不良反应随服药时间的延长有缓解趋势。[结论]国产阿卡波糖片剂在血糖控制的疗效以及安全性和耐受性与拜唐苹接近。

[Objective] To observe the efficacy and safety of domestic Acarbose tablet （Kaboping） compared with Giu, cobay in patients with type 2 diabetes. [Methods] 147 Chinese type 2 diabetic patients were recruited. The patients were ran, domly divided into the Kaboping group and the Glucobay group, then treated and compared. [ Results ] 135 patients finished the trial （67 in Kaboping group and 68 in Glucobay group）. After 4 weeks of treatment, the mean of fasting blood glucose （FBG） in Kaboping and Glucobay group reduced 2.06 and 2.54mml/L respectively, and the mean of postprandial blood glucose （PBG） in Kaboping and Glucobay group reduced 5.19 and 4.54mmol/L respectively. After 8 weeks of treatment, the mean of fasting blood glucose （FBG） in Kaboping and Glucobay group reduced 2.56 and 2.34mmol/L respectively, and the mean of postprandial blood glucose （PBG） in Kaboping and Glucobay group reduced 5.35 and 5.54mmol/L respectively, and the mean of HbAlc lowered 1.25% and 1.45% respectively in Kaboping and Glucobay group. The differences in reduction of FBG, PBG and HbAlc between Kaboping and Glucobay group were not statistic significances. The serum triglyceride levels and BMI de. creased in both Kaboping and Glucobay groups. The side effects like flatulence had a catabatic trend with the prolongation Of taking medicine. [ Conclusion ] In this study, domestic Acarbose tablet is an effective, safe and generally well-tolerated therapy as similar as Glucobay in type 2 diabetic patients.