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目的 评价马来酸罗格列酮治疗 2型糖尿病的安全性和有效性。方法 多中心开放、马来酸罗格列酮单一或与二甲双胍或磺酰脲类合用治疗 2型糖尿病 12周。结果 2 30 8例患者入选 ,2 134例完成 ,174例退出。各治疗组不良事件的发生率相似 ,主要为血脂紊乱 ( 9 77% )、上呼吸道感染 ( 6 11% )和水肿 ( 5 32 % )。严重不良事件的发生率极低 ,其中除 1例不排除与试验药物相关的可能性外 ,其余 10例均与试验药物无关。 12周治疗后 ,ALT平均值 ( 2 2 8IU/L)较基线值 ( 2 5 5IU/L)轻度下降 ;血红蛋白、血细胞压积轻度下降 ;总胆固醇、甘油三酯、低密度脂蛋白有轻微升高 ,高密度脂蛋白保持不变。空腹血浆血糖 :马来酸罗格列酮单一治疗组下降 1 70mmol/L ,合用磺酰脲类药物组下降 1 4 7mmol/L ,合用二甲双胍组下降 1 36mmol/L。结论 大样本的患者单一服用及在磺酰脲类药物或二甲双胍的基础上服用罗格列酮是安全的 ,可良好耐受 ,并可有效降低患者空腹血糖的水平
Objective To evaluate the safety and efficacy of rosiglitazone maleate in the treatment of type 2 diabetes. Methods Multi-center open, rosiglitazone maleate alone or in combination with metformin or sulfonylurea for type 2 diabetes for 12 weeks. Results 2,308 patients were enrolled, 2,134 completed and 174 exited. The incidence of adverse events in each treatment group was similar, with dyslipidemia (9,7%), upper respiratory tract infection (6,11%) and edema (5,32%). The incidence of serious adverse events was extremely low, except for 1 case that did not rule out the possibility associated with the test drug, the other 10 cases were not related to the test drug. After 12 weeks of treatment, the mean ALT (2 28 IU / L) was slightly lower than the baseline (25 5 IU / L); hemoglobin and hematocrit decreased slightly; total cholesterol, triglycerides and low density lipoprotein Slightly elevated, high-density lipoprotein remained unchanged. Fasting plasma glucose: rosiglitazone maleate monotherapy a decrease of 1 70mmol / L, sulfonylurea combination group decreased 147mmol / L, combination metformin group decreased 136mmol / L. Conclusions Large samples of patients taking rosiglitazone alone or in combination with sulfonylureas or metformin are safe, well-tolerated and effective in reducing fasting plasma glucose