国产阿卡波糖(胶囊剂)降糖疗效的多中心随机对照临床试验

目的 评价国产阿卡波糖(胶囊剂)对2 型糖尿病患者的降糖疗效和安全性.方法 以德国拜耳公司生产的阿卡波糖片剂(拜唐苹)为对照, 进行多中心随机对照临床观察.将179例2型糖尿病患者随机分为试验组(国产阿卡波糖胶囊剂,A组)89例、对照组(进口阿卡波糖片剂,拜唐苹,B组)90例.每例受试者在治疗前均有2～4周的平衡期,疗程8周.分别于受试后的4 周和8 周随访.结果 完成试验165例(A组81例,B组84 例),脱落14例(A组8例,B组6例,均因患者不合作).治疗4周时, A、B组的空腹血糖下降值分别为(1.81±2.75) mmol/L和(2.08±2.65) mmol/L,餐后血糖下降值分别为(5.43±4.34) mmol/L和(5.09±4.59) mmol/L.第8周时A、B两组的空腹血糖分别下降(2.35±2.64) mmol/L和(2.62±2.65) mmol/L,餐后血糖分别下降(5.93±4.61) mmol/L和5.98 mmol/L;HbA1c值分别下降1.07%和1.20%,下降百分率分别为11.39%和11.50%.在4周和8周时两组间血糖及HbA1c下降值和下降百分率接近,差异无统计学意义.不良反应主要为消化道症状,最常见的不良反应为肠胀气、肛门排气增加,其发生率在A、B两组分别为32.53%和48.81%.结论 国产阿卡波糖(胶囊剂)的疗效与拜唐苹相近, 值得临床推广应用.

A Multicenter Randomized Controlled Clinical Trial on Blood Glucose Lowering Effects of Domestic Acarbose (Capsule) in Type 2 Diabetic Patients

Objective To assess the efficacy, tolerability, and safety of the domestic Acarbose capsule (DAC, produced by Luzhou Baoguang Pharmaceutical Co.LTD) in treating patients with type 2 diabetes mellitus. Methods One hundred and seventy nine type 2 diabetic patients were randomly divided into DAC (group A, 89 patients) and Glucoby (group B, 90 patients) treatment groups. The trial consisted of a 2-4 weeks equilibrated period followed by an 8 week course of treatments. All of the patients were followed up at the 4th week and 8th week after the commencement of the treatments. One hundred and sixty five patients completed the trial, with 81 in group A and 84 in group B. Results At the 4th week of the treatments, an average reduction of 1.81 and 2.08 mmol/L of fasting blood glucose (FBG) was found in group A and group B, respectively (P>0.05); and an average reduction of 5.43 and 5.09 mmol/ L of postprandial blood glucose (PBG) was found in group A and group B, respectively (P>0.05). At the 8th week, an average reduction of 2.35 and 2.62 mmol/L FBG was found in group A and group B, respectively (P>0.05); and an average of reduction of 5.93 and 5.98 mmol/L of PBG was found in group A and group B, respectively (P>0.05); The mean HbA1c was lowered by 1.07% and 1.20% by DAC and Glucoby respectively (P>0.05). The incidence rate of side effects in group A was 32.53%, less than that in group B (48.81%). Flatulence was the most common side effect. The clinical effects of both Glucoby and DAC were more significant at the 8th week than at the 4th week. Conclusion DAC is as effective and safe as Glucobay for treating type 2 diabetic patients.