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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。
Objective To evaluate the efficacy and safety of rosiglitazone hydrochloride in the treatment of type 2 diabetes. Methods A total of 239 patients with type 2 diabetes mellitus (7 mmol·L -1 ≤ fasting glucose <13.0 mmol·L -1) were enrolled in this study. They were randomly divided into two groups. The trial group took rosiglitazone hydrochloride 4 mg daily, while the control group took rosiglitazone maleate 4 mg daily. The treatment was followed up for 4 times and the course of treatment was 12 weeks. The changes of blood glucose, HbA 1c and insulin before and after treatment were observed. Results A total of 233 patients completed the trial, 116 cases in the control group and 117 cases in the experimental group. There was no significant difference in general information such as sex, age, body mass index, blood pressure between the two groups (P> 0.05). Fasting fingertip blood glucose, HbA_ (1c), postprandial blood glucose and insulin at 2 h after treatment were significantly decreased (P <0.05), and there was no significant difference between the two groups (P> 0.05). There were 7 adverse reactions (5.9%) in the experimental group and 14 (11.7%) in the control group. There was no significant difference between the two groups (P> 0.05). Conclusion Rosiglitazone hydrochloride and rosiglitazone maleate hypoglycemic, HbA_ (1c) reduction in efficacy, and safety are better.