罗格列酮治疗2型糖尿病Ⅱ期临床观察

Phase Ⅱ clinical observation of rosiglitazone in treatment of type 2 diabetes

目的评价盐酸罗格列酮治疗2型糖尿病的有效性及安全性。方法采用多中心随机双盲平行对照方法,共239例2型糖尿病病人(7 mmol·L^(-1)≤空腹血糖<13.0 mmol·L^(-1))入选,随机分为2组。试验组服用盐酸罗格列酮,每日4 mg;对照组服用马来酸罗格列酮,每日4 mg。治疗随访4次,疗程12 wk,观察2组治疗前后血糖、糖化血红蛋白(HbA_(1c))、胰岛素等指标的变化。结果共233例病人完成试验,对照组116例,试验组117例。2组性别、年龄、体重指数、血压等一般资料均无显著差异(P>0.05)。治疗后2组空腹指尖血糖、HbA_(1c)、餐后2 h血糖及胰岛素较前明显下降(P<0.05),且组间无明显差异(P>0.05)。试验组共发生不良反应7例(5.9%),对照组14例(11.7%),2组比较无显著差异(P>0.05)。结论盐酸罗格列酮与马来酸罗格列酮降糖、降HbA_(1c)疗效相当,且安全性均较好。

AIM To evaluate the efficacy and safety of rosiglitazone hydrochloride in the treatment of type 2 diabetes. METHODS A muhicentric, double-blind and randomized controlled method was conducted. Two hundred and thirty-nine patients with type 2 diabetes （7 mmol·L^-1≤ fasting blood glucose 〈 13.0 mmol·L^-1） were selected, and were randomly divided into two groups. The patients in the trial group were treated with rosiglitazone hydrochloride 4 mg daily and those in the control group were treated with rosiglitazone maleate 4 mg daily. With 4 times of follow-up and a course of 12 weeks, blood glucose, hemoglobin A1c （HbA1c） and insulin before and after the treatment were observed and compared. RESULTS Two hundred and thirty-three patients completed the trial, including 116 in the control group and 117 in the trial group. There were no significant difference in sex, age, body mass index, blood pressure, and other general index in both two groups （P 〉 0.05）. The levels of fasting plasma glucose, HbA1c, postprandial glucose and insulin in two groups decreased apparently after the treatment （P 〈 0.05） , with no significant difference （P 〉 0.05）. As regards to adverse reactions, there were 7 patients （5.9%） in the trial group and 14 patients （11.7%） in the control group, also there was no significant difference between the two groups （P 〉 0.05） . CONCLUSION Rosiglitazone hydrochloride and rosiglitazone maleate have equivalent efficacy in lowering blood glucose and HbA1c with similar safety.