吡格列酮治疗2型糖尿病的双盲、随机、平行对照多中心临床研究  

Multicenter,randomized,double-blind, placebo-controlled clinical trial of pioglitazone for type 2 diabetes mellitus

作　　者：汪启迪[1] 荣蓉[1] 毕宇芳[1] 赵咏桔[1] 罗邦尧[1] 刘超 狄福松[2] 王德全[3] 陈丽[3] 苏炳华[4] 何清波[4] 宁光[1] 

机构地区：[1]上海第二医科大学附属瑞金医院内分泌科,上海200025 [2]南京医科大学附属医院,江苏南京210029 [3]山东大学附属齐鲁医院,山东济南250012 [4]上海第二医科大学统计学教研室,上海200025

出　　处：《中国新药与临床杂志》2003年第9期529-533,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :观察吡格列酮对 2型糖尿病病人血糖控制的疗效和安全性。方法 :多中心、随机双盲、安慰剂平行对照的为期 12wk试验。吡格列酮组12 0例 ,安慰剂组 12 0例。结果 :吡格列酮组空腹和餐后 2h血糖治疗后较前皆明显下降 :(1.5±s1.8)mmol·L- 1和 (2 .2± 2 .8)mmol·L- 1(P <0 .0 1) ,糖化血红蛋白从 (7.5± 1.2 ) %下降至 (6 .7± 1.3) %。而安慰剂组则从 (7.3± 1.4 ) %上升至(7.6± 1.2 ) % ,2组间存在非常显著差异 (P <0 .0 1)。但 2组治疗前后的空腹及餐后 2h胰岛素变化无显著差异 (P >0 .0 5 )。吡格列酮组的HDL明显高于安慰剂组 (P <0 .0 5 ) ,而TG/HDL比值则无显著差异 (P >0 .0 5 )。吡格列酮组和安慰剂组的不良反应发生率分别为 6 .0 %和 4 .4 % ,2组间无显著差异 (P >0 .0 5 )。结论 :吡格列酮有良好的降糖作用 ,还可改善脂代谢 。AIM: To observe the effect and safety of pioglitazone in type 2 diabetes mellitus. METHODS: Multicenter, randomized, double blind, placebo controlled clinical trial for 12 wk. One hundred and twenty patients were randomly divided into pioglitazone group, and one hundred and twenty patients into placebo group. RESULTS: The fasting and 2 h postprandial glucose levels were decreased significantly from baseline at wk 12 in pioglitazone group:(1.5± s 1.8)mmol·L -1 and (2.2±2.8)mmol·L -1 ( P <0.01), and the HbA1c was decreased to (6.7±1.3) % from (7.5±1.2) %( P <0.01).And the HbA1c was increased to ( 7.6± 1.2) % from (7.3±1.4) %( P <0.01) in placebo group, there was remarkable difference in pioglitazone group and placebo group( P <0.01). However, there wasn't remarkable difference observed in the fasting and 2 h postprandial insulin level before and after treatment in pioglitazone group and placebo group( P >0.05).The HDL level was significantly higher in pioglitazone group than that in placebo group after 12 wk treatment( P <0.05), but the ratio of TG/HDL had no remarkable change( P > 0.05 ). The rate of adverse reaction was 6.0 % in pioglitazone group and 4.4 % in placebo group( P > 0.05). CONCLUSION:Pioglitazone has good effect on decreasing blood glucose and improving fat metabolize, and it's adverse reaction is low.

关 键 词：吡格列酮 2型糖尿病 降糖作用 不良反应 

分 类 号：R977.15[医药卫生—药品] R587.1[医药卫生—药学]