复方盐酸二甲双胍片治疗2型糖尿病的随机双盲多中心临床研究

目的 通过临床观察评价国产四类新药复方盐酸二甲双胍片治疗2型糖尿病的临床疗效和安全性.方法 采用随机、双盲、双模拟、平行对照、多中心研究设计,用药观察周期为12周.试验组(A)72例服用复方盐酸二甲双胍片加模拟格列苯脲片;对照组(B)72例服用盐酸二甲双胍片加格列苯 脲片.结果 降血糖效果:试验组和对照组治疗2周、4周、8周、12周后各时点空腹血糖都较治疗前有显著降低,但两组间下降率比较在2周、4周、8周无统计学差异,仅在12周时,有统计学差异,对照组下降率比试验组低.在治疗12周后,两组餐后2小时血糖、糖化血红蛋白(HbA1c)、都较用药前显著下降,但组间比较无统计学差异.空腹胰岛素、空腹C肽、餐后2小时胰岛素、餐后2小时C肽仅试验组餐后2小时C肽较用药前明显升高,其余指标两组与用药前比较无统计学意义,组间比较也无差异.两组病人用药后疗效分析,有效率和显效率相近,无统计学差异.安全性观察:两组不良反应共7例,两组不良反应发生率比较无显著性意义.结论 对糖尿病患者而言,复方二甲双胍是一种安全有效的降糖药物,可予临床推广使用.

A Double-blind Randomized Clinical Study on Mutiple Center Observing the Effect of Fixed-Dose Glyburide/Metformin On Type 2Diabetes

Objective To evaluate the effect and safety of fixed-dose glyburide/metformin on type 2 diabetes. Methods A double-blind randomized clinical observation in three centers comparing the blood glucose lowing effect and safety between fixed-dose glyburide/metformin group and glyburide co-administered with metformin group for 12weeks. Results Both groups got a significant reduction in fasting blood glucose, 2 hours-postprandial blood glucose and glycosylated hemoglobin value after 12 weeks therapy. There was no statistical difference between two groups except for the fasting blood glucose reduction at the last follow-up. The rates of side-effect in two groups have no statistical difference. Conclusions Fixed-dose glyburide/metformin has an effective and similar blood glucose lowering effect to glyburide and metformin combination therapy.