马来酸罗格列酮治疗血糖控制未达标的2型糖尿病患者的疗效和安全性  

Efficacy and safety of rosiglitazone maleate in treatment of type 2 diabetes patients with uncontrolled hyperglycemia

作　　者：张冬梅[1] 冯波[1] 

机构地区：[1]同济大学附属东方医院内分泌科,上海200120

出　　处：《上海医学》2009年第5期421-423,共3页Shanghai Medical Journal

摘　　要：目的观察马来酸罗格列酮对血糖控制未达标的伴和不伴代谢综合征的2型糖尿病患者的疗效和安全性。方法63例血糖控制未达标的2型糖尿病患者,按伴和不伴代谢综合征分为A组和B组,两组均予马来酸罗格列酮(商品名为文迪雅)治疗,观察治疗前、后的血糖、胰岛素、糖化血红蛋白(HbA1c)、血脂、血压水平以及药物不良反应,并比较治疗后的血糖达标率。结果A组治疗后3和6个月的空腹血糖(FPG)、餐后2h血糖(2hPG)、空腹胰岛素(FINS)、餐后2h胰岛素(2hINS)、HbA1c、收缩压(SBP)、舒张压(DBP)和三酰甘油(TG)均较治疗前显著下降(P值分别<0.01、0.05),治疗后6个月的体质指数(BMI)较治疗前显著升高(P<0.05);治疗后总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)较治疗前略下降,高密度脂蛋白胆固醇(HDL-C)较治疗前略升高,但差异无统计学意义(P值均>0.05)。B组治疗后3和6个月的FPG、2hPG、HbA1c均较治疗前显著下降(P值均<0.05),治疗后6个月的FINS、2hINS,BMI均较治疗前显著升高(P值均<0.05),治疗前、后TC、TG、HDL-C、LDL-C的差异均无统计学意义(P值均>0.05)。治疗后6个月A组的血糖达标率为81.25%,显著高于B组的61.29%(P<0.05)。治疗前、后两组丙氨酸转氨酶(ALT)均无明显变化(P值均>0.05)。结论马来酸罗格列酮片对伴和不伴代谢综合征的血糖控制未达标的2型糖尿病患者均有降低血糖及HbAc的作用,对伴代谢综合征的2型糖尿病患者的疗效更显著。Objective To evaluate the efficacy and safety of rosiglitazone maleate in treatment of type 2 diabetes mellitus patients with uncontrolled hyperglycemia and with or without metabolic syndrome. Methods Totally 63 patients of type 2 diabetes on response to sulfonylurea, metformin and acarbose were enrolled in the present study and they were divided into type 2 diabetes with metabolic syndrome group （A） and type 2 diabetes without metabolic syndrome group （B）. Patients in both groups received rosiglitazone maleate treatment for 6 months. The changes of blood glucose, insulin, HbA1c, blood lipid, blood pressure, and adverse reactions were observed before and after treatment. The control of blood glucose was compared before and after treatment. Results FPG, 2hFG, HbA1c, SBP and DBP in A group were decreased significantly after 3 and 6 months treatment （ P〈0.01 ）; FINS, 2hlNS and TG were also significantly decreased （ P〈 0.05, P〈 0.01 ） 3 and 6 months after treatment. The BMI was significantly increased 6 months after treatment （P〈0.05）. TC and LDL-C decreased significantly （P〉0. 057 and HDL-C increased significantly （P〉0.05） 6 months after treatment. FPG, 2hPG and HbA1c decreased significantly （P〈0.05） 3 and 6 months after treatment in group B; FINS, 2hINS and BMI increased significantly （P〈0.05） after treatment for 6 months. No changes of TO, TG, HDL-C and LDL-C were observed 6 months after treatment. Glucose-target-rate was significantly higher in A group than in B group 6 months after treatment （P〈0.05）. ALT did not change 3 and 6 months after treatment in group A and B. No severe adverse effects were found in the two groups. Conclusion Rosiglitazone maleate can lower the FPG, 2hPG and HbA1c levels in type 2 diabetes patients either with metabolic syndrome or without metabolic syndrome, especially in patients with metabolic syndrome. （Shanghai Med J, 2009, 32, 421-423）

关 键 词：马来酸罗格列酮 2型糖尿病 代谢综合征 血糖达标率 

分 类 号：R587.1[医药卫生—内分泌]