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目的 :观察国产罗格列酮片治疗2型糖尿病的临床疗效及安全性。方法 :按双盲、随机及安慰剂对照的方法进行Ⅱ期临床试验 ,试验组给予罗格列酮4mg(n=27) ,对照组给予安慰剂(n=27) ,每日1次 ,疗程均为8wk。结果与结论 :试验组空腹血糖及餐后2h血糖比基础值分别下降27 1 %和55 7 % ,对照组分别下降10 6 %和19 8 % ,试验组空腹及餐后2h血糖下降明显大于对照组(P均<0 01)。罗格列酮不良反应发生率与对照组接近 ,未见肝功能损害等严重不良反应
Objective: To observe the clinical efficacy and safety of domestic rosiglitazone tablets in the treatment of type 2 diabetes mellitus. METHODS: A phase II clinical trial was conducted in a double-blind, randomized, and placebo-controlled trial with rosiglitazone 4 mg (n = 27) and placebo (n = 27) All 8wk. RESULTS AND CONCLUSION: The fasting blood glucose and 2-hour postprandial blood glucose in the experimental group decreased by 27 1% and 55 7% respectively, while the control group decreased by 10 6% and 19 8% respectively. The fasting blood glucose and postprandial blood glucose drop in the experimental group were significantly greater than those in the control group Group (all P <0.01). The incidence of adverse reactions of rosiglitazone was similar to that of the control group, with no serious adverse reactions such as liver dysfunction