【摘要】 目的　观察国产盐酸匹格列酮片单用及与磺脲类药物合用治疗 2型糖尿病患者的临床疗效及安全性。方法　 117例 2型糖尿病患者分为单用匹格列酮组 (PIO- mono)和匹格列酮加磺脲类药物组 (PIO- SU) ,进行为期 12周的自身前后对照临床研究。观察治疗前后临床指标及血糖、糖化白红蛋白 (Hb A1 c)、血清胰岛素及 C肽、血脂、游离脂肪酸 (FFA)水平的变化。结果　治疗后 PIO- m ono组 Hb A1 c、空腹及餐后血糖水平较治疗前分别下降了1.6 4 %、 2 .1mmol/ L、 5 .2 mm ol/ L (P<0 .0 1) ,PIO- SU组分别下降了 1.0 6 %、 2 .3mmol/ L、 5 .4 m mol/ L (P<0 .0 1) ,上述指标两组间差别无统计学意义。在血糖水平下降的同时 ,两组空腹及餐后血清胰岛素及 C肽水平均有轻度下降 ,血甘油三酯及游离脂肪酸水平降低 ,HDL - C升高。两组患者药物不良反应发生率相似 ,未观察到肝肾毒性反应。结论　国产匹格列酮片每日 30 mg单用及与磺脲类药物合用治疗 2型糖尿病患者均可有效降低 Hb A1 c和空腹及餐后血糖水平 ,并能减轻胰岛β细胞负荷和改善脂代谢紊乱 ,耐受性良好更多还原

【Abstract】 Objective To evaluate the clinical efficacy and tolerability of pioglitazone monotherapy or in combination with sulfonylurea therapy in the treatment of chinese patients with type 2 diabetes. Methods This 12 week study involved 117 patients with type 2 diabetes whose blood glucose was uncontrolled on a stable regimen of diet or oral sulfonylureas for at least 3 months 〔fasting blood glucose (FBG)7.8 15.0mmol/L; postprandial blood glucose (PBG)>11.1mmol/L)〕. The patients received once daily pioglitazone 30mg plus diet (Group PIO mono) or sulfonylurea (Group PIO SU). The fasting and postprandial plasma glucose, serum insulin, C peptid, lipid profile, free fatty acids (FFAs) levels were measured at baseline and every 4 weeks after treatment. Results All patients showed significant improvement in glycemic control over baseline. There were 1.64%, 2.1 mmol/L, 5.2 mmol/L decrease from baseline HbA1c, FBG and PBG levels in the Group PIO mono and 1.06%, 2.3 mmol/L, 5.4 mmol/L decrease in the Group PIO SU after 12 weeks treatment, respectivley. Both groups experienced slight decreases in C peptide and insulin concentrations during 12 weeks period. Both groups showed mean percent decreases in triglyceride and FFA levels(21.8% and 20.7% for PIO mono, 22.2% and 14.5 for PIO SU) and increases in HDL C( 21.4% for PIO mono and 30.8% for PIO SU), compared with baseline. pioglitazone was well tolerated. Conclusion In patients with type 2 diabetes, pioglitazone monotherapy or in combination with sulfonylurea therapy significantly improves HbA1c , FBG and PBG levels and reserves the β cell function with beneficial effects on serum triglyceride and HDL C levels.更多还原