盐酸吡格列酮治疗2型糖尿病的多中心临床研究  

Multicenter clinical trial of pioglitazone in the treatment of 2 type diabetes

作　　者：姚军[1] 陈颖丽[2] 胡虹莺[3] 郑宝忠[4] 于桂娜[5] 张俊清[1] 陈静[2] 袁申元[3] 高志红[4] 高燕燕[5] 郭晓蕙[1] 高蕾莉[2] 冯凭[4] 李茵茵[5] 卢纹凯[2] 陈凌[5] 高妍[1] 

机构地区：[1]北京大学第一医院内分泌科,北京100034 [2]北京大学人民医院,北京100044 [3]北京同仁医院,北京100730 [4]天津医科大学总医院,天津300052 [5]山东省立医院,济南250012

出　　处：《中国临床药理学杂志》2005年第2期95-99,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的　评价盐酸吡格列酮治疗2型糖尿病的有效性及安全性。方法　用多中心随机双盲平行对照方法,将已合用磺脲类和双胍类药物的2型糖尿病患者随机分为2组:试验组口服吡格列酮,每日30mg;对照组服用安慰剂。各118例,疗程12周。结果　试验组空腹血糖、餐后2h血糖有明显下降(P<0. 01);糖化血红蛋白2组均有下降,试验组为-1. 06%,对照组为-0. 51%,均P<0. 01。2组胰岛素水平均无明显变化。治疗后,试验组高密度脂蛋白胆固醇升高了0. 11mmol·L-1 (P<0. 01),低密度脂蛋白胆固醇下降了0. 21mmol·L-1(P<0. 01),血压下降有统计学意义(P<0. 01),体重指数升高了0. 36 (P<0. 01)。试验组中,仅1例因中度肝功能异常退出试验,水肿较常见,程度轻。其他不良事件发生率2组相近。结论　口服降糖药后血糖控制不佳的2型糖尿病患者,加用盐酸吡格列酮30mg,可显著降低血糖,提高胰岛素敏感性,改善高血压状态,病人耐受性较好。Objective To evaluate the efficacy and safety of pioglitazone in the treatment of type 2 diabetes. Methods Two hundreds and thirty six patients with type 2 diabetes who have received metformin and sulfonylureas treatment were included in this 12-week, multicenter, double-blind study. They were divided randomly into trial group (pioglitazone 30 mg one time a day) and contro group (placebo). Results Fasting and post prandial plasma glucose levels of the trial group decreased significantly (P< 0.01 ). The mean levels of glycosylated hemoglobin levels decreased by 1.06 % (P<0.01) in the trial group and by 0.51% (P<0.01) in the control group. Meanwile, fasting and postprandial plasma insulin levels of the two groups unchanged significantly. High-density lipoprotein cholesterol increased by 0.11 mmol·L -1 (P<0.01) and low-density lipoprotein cholesterol decreased by 0.21 mmol·L -1 (P<0.01) in the trial group at week 12 vs baseline. Blood pressure of the trial group decreased significantly (P<0.01). Body mass index increased (0.36, P<0.01) in the trial group. One case in the trial group dropped off because of moderate liver damage, mild edema occurred frequently.The proportion of patients reporting other adverse experiences was comparable between two groups. Conclusion Treatment with pioglitazone 30 mg qd in patients plus previous metformin-sulfonylureas can improve glycemic control, improve insulin sensitivity and have possibility to improve lipid metabolism and hypertention. Pioglitazone 30 mg qd is generally all tolerated.

关 键 词：吡格列酮 2型糖尿病 血糖 胰岛素 

分 类 号：R587.1[医药卫生—内分泌] R977.15[医药卫生—内科学]