比较国产阿卡波糖片剂与拜唐苹治疗2型糖尿病的疗效和安全性——随机对照试验

Comparison of efficacy and safety of the domestic acarbose tablet with glucoby in type 2 diabetic patients——randomized controlled trial

目的 用随机对照方法观察国产阿卡波糖片剂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。方法 从 4个临床中心征集 177例 2型糖尿病患者 ,随机分为国产阿卡波糖片剂 (A组 87例 )和拜唐苹 (B组 90例 )进行治疗和比较 ,治疗前 2～ 4周平衡期 ,疗程为 8周。结果 共有 16 5例完成了试验 (A组 81例 ,B组84例 )。与用药前相比 ,第 4周A、B组的空腹血糖分别下降 1.6 1和 2 .0 8mmol/L ,餐后血糖分别下降 5 .0 6和 5 .0 9mmol/L ;第 8周时空腹血糖分别下降 1.95和 2 .6 2mmol/L ,餐后血糖分别下降 4 .88和 5 .98mmol/L ;HbA1c值分别下降 1.13%和 1.2 0 % ,A组下降幅度略低于B组 ,但无统计学差异。A、B两组第 4周及 8周TG水平 ,以及体重和BMI均一定程度下降。A组有 3例近期饮酒的患者出现ALT一过性升高。A、B两组最常见的不良反应均表现为肠胀气和肛门排气增加。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 demonstrate the efficacy, tolerability, and safety of domestic Acarbose tablet compared with Glucobay(Acarbose tablet produced by Bayer company) in patients with type 2 diabetic patients. Methods A multicenter randomized controlled parallel-group comparison study was conducted. 177 Chinese type 2 diabetic patients were recruited from 4 clinical centers. The patients were divided randomly into domestic Acarbose tablet (A group) or Glucoby(B group) treatment group. The trial consisted of a 2～4 weeks equilibrated period followed by an 8 week course of treatment. Results 165 patients have finished the trial (81 in A group and 84 in B group). After 4 weeks of treatment, the mean of fasting blood glucose (FBG) in A and B group were reduced 1.61 and 2.08 mmol/L respectively, and mean of postprandial blood glucose (PBG) lowered 5.06 and 5.09mmol/L respectively. After 8 weeks of treatment, the mean of FBG were reduced 1.95 and2.62mmol/L respectively, and mean of PBG lowered 4.88 and 5.98 mmol/L, respectively, and mean of HbA1c were lowered 1.13% and 1.20% respectively in A and B group. The differences in reduction of FBG, PBG, and HbA1c between A and B group were no statistic significance. The serum triglyceride levels and BMI were decreased significantly in both A,B groups. 3 patients who drinking wine during trial on A group had asymptomatic elevations in serum transaminases that normalized in 2 weeks after stopped drinking and Acarbose withdrawal. Flatulence was the most common side effect. Conclusion In this multicenter study, domestic Acarbose tablet 50 mg t.i.d. was an effective, safe, and generally well-tolerated therapy as similar as Glucobay in type 2 diabetic patients.