国产匹格列酮片单用及与磺脲类药物合用治疗2型糖尿病的临床疗效

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

Pioglitazone Hydrochloride Monotherapy or in Combination with Sulfonylurea Therapy Improves Glycemia Control in Patients with Type 2 Diabetes

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) 7.8-15.0 mmol/L; postprandial blood glucose (PBG) >11.1 mmol/L)). The patients received once daily pioglitazone 30 mg 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 beta-cell function with beneficial effects on serum triglyceride and HDL-C levels.