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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 observe the curative effect and safety of domestic acarbose and imported acarbose tablets (Baitangping) on blood sugar and blood lipid control in type 2 diabetes mellitus by randomized controlled trial. Methods A total of 177 patients with type 2 diabetes mellitus were enrolled from 4 clinical centers and were randomly divided into domestic acarbose tablet (group A, 87 cases) and beitang pang (group B, 90 cases) for treatment and comparison. Before treatment, Week balance period, treatment for 8 weeks. Results A total of 165 patients completed the trial (group A 81 cases, group B 84 cases). Compared with pre-treatment, the fasting blood glucose in groups A and B decreased by 1.6 1 and 2.08 mmol / L at week 4, and decreased by 5.06 and 5.90 mmol / Blood glucose decreased 1.95 and 2.62mmol / L, postprandial blood glucose decreased 4.88 and 5.98mmol / L; HbA1c values decreased by 1.13% and 1.2 0%, A group decreased slightly lower than the B group, but no Statistical differences. The levels of TG in groups A and B at 4 weeks and 8 weeks, as well as body weight and BMI decreased to a certain extent. A group of 3 patients with recent alcohol consumption ALT had a transient increase. The most common adverse reactions in groups A and B both showed increased flatulence and anal exhaust. Conclusion The efficacy and safety and tolerability of domestic acarbose tablet in glycemic control are close to that of Baitangping.