罗格列酮治疗2型糖尿病的临床观察

The safety and efficacy of rosiglitazone maleate in the treatment of patients with type 2 diabetes mellitus in China

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 。

Objective To assess the clinical safety and efficacy of rosiglitazone maleate in the treatment of patients with type 2 diabetes mellitus. Methods A multi center, open label and 12 week duration study comprising of three cohorts, rosiglitazone maleate mono therapy, rosiglitazone maleate plus metformin(Met) or sulphonylurea(SU) was carried out. Results A total of 2 308 patients enrolled in the study; but 2 134 completed and 174 withdrew from it. The percentages of patients reporting on therapy adverse events were similar in the three cohorts. The most frequent adverse experiences were hyperlipidaemia (9.77%), upper respiratory tract infection (6.11%) and oedema (5.32%). There were totally 11 patients with serious, on therapy adverse experiences. All serious adverse events(SAE) were considered by the investigator being not related to study medication except one case of SAE which was considered to be possibly related to the study medication. The mean levels of ALT in the three treatment cohorts were all reduced from baseline (25.5 IU/L) after treatment of 12 weeks (22.8 IU/L). Minor decreases in haemoglobin and haematocrit were observed in all treatment cohorts. Slight increases in total cholesterol, low density lipoprotein cholesterol and triglyceride were observed following 12 weeks of treatment, whereas high density lipoprotein cholesterol remained stable. In the efficacy evaluable population, the fasting plasma glucose reduction following 12 weeks of treatment was 1.70 mmol/L in the rosiglitazone maleate mono therapy cohort, 1.47 mmol/L in the rosiglitazone maleate plus SU cohort and 1.36 mmol/L in the rosiglitazone maleate plus Met cohort, respectively.Conclusions In this 12 week phase Ⅳ study, rosiglitazone maleate was found to be safe and well tolerated in all the three cohorts receiving rosiglitazone maleate as monotherapy or in combination with SU or MET for a large sample of population of patients with type 2 diabetes. Statistically significant reduction in fasting plasma glucose was observed in all the treated cohorts.