【摘要】 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。

    【关键词】 2型糖尿病 二甲双胍 格列苯脲 复方 治疗

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

    Sun Min, et al.

    (Department of Endocrinology, The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, 210029 China)

    【Abstract】 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. ......