Yang Jinkui, Di Fusong, He Ronghua, Zhu Xuesu, Wang Dequan, Yang Minggong, Wang Yangang, Yuan Shenyuan, Chen Jiawei
Department of Endocrinology, Tongren Hospital, Capital University of Medical Sciences, Beijing 100730, China.
Chin Med J (Engl). 2003 May;116(5):785-7.
We designed a multi-center, double-blind, randomized, parallel, with metformin controlled clinical trial to evaluate the efficacy and safety of low dose rosiglitazone combined with sulphonylurea therapy in type 2 diabetic patients who were inadequately controlled with sulphonylurea alone.
Patients were treated with 4 mg rosiglitazone once daily plus sulphonylurea (test group) or 0.5 g metformin twice daily plus sulphonylurea (control group) for 12 weeks. The mean levels of HbA(1c), fasting and postprandial plasma glucose were recorded and compared between the two groups.
The mean levels of HbA(1c) decreased by 1.09% and 0.95% in the test group (n = 102) and control group (n = 96) respectively. Fasting and postprandial plasma glucose levels in the test group decreased by 25.0% and 35.6%, and in the control group, decreased by 17.7% and 23.8% as compared with the baseline (both P < 0.01). No liver damage was found.
Combination treatment of rosiglitazone and sulphonylurea can effectively improve glycemic control in type 2 diabetic patients inadequately controlled with sulphonylurea alone.
我们设计了一项多中心、双盲、随机、平行、以二甲双胍为对照的临床试验，以评估低剂量罗格列酮联合磺脲类药物治疗对仅用磺脲类药物治疗血糖控制不佳的2型糖尿病患者的疗效和安全性。
患者分别接受每日一次4毫克罗格列酮加磺脲类药物治疗（试验组）或每日两次0.5克二甲双胍加磺脲类药物治疗（对照组），为期12周。记录并比较两组患者糖化血红蛋白（HbA1c）、空腹及餐后血糖的平均水平。
试验组（n = 102）和对照组（n = 96）的糖化血红蛋白平均水平分别下降了1.09%和0.95%。试验组空腹及餐后血糖水平较基线分别下降了25.0%和35.6%，对照组分别下降了17.7%和23.8%（均P < 0.01）。未发现肝损伤。
罗格列酮与磺脲类药物联合治疗可有效改善仅用磺脲类药物治疗血糖控制不佳的2型糖尿病患者的血糖控制情况。
