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 Objective To observe the clinical efficacy and safety of domestic pioglitazone hydrochloride tablets combined with sulfonylurea in the treatment of type 2 diabetes mellitus. Methods A total of 117 patients with type 2 diabetes mellitus were divided into two groups: the PIO-mono group and the pioglitazone plus sulfonylurea group (PIO-SU) for 12 weeks. The changes of clinical indexes and the levels of Hb A1c, serum insulin and C-peptide, blood lipid and free fatty acid (FFA) were observed before and after treatment. Results After treatment, HbA1c, fasting and postprandial blood glucose levels decreased by 1.6 4%, 2.1 mmol / L and 5.2 mm ol / L, respectively (P <0.01) in PIOmO group, PIO-SU group decreased by 1.06%, 2.3mmol / L and 5.4 mol / L, respectively (P <0.01). There was no significant difference between the two groups. At the same time of decreasing blood glucose level, both fasting and postprandial serum insulin and C - peptide levels decreased slightly, blood triglyceride and free fatty acid levels decreased, and HDL - C increased. Two groups of patients with similar incidence of adverse drug reactions, no observed liver and kidney toxicity. CONCLUSION: The daily administration of pioglitazone in combination with sulfonylureas at 30 mg daily and sulfonylureas in patients with type 2 diabetes can effectively reduce Hb A1 c and fasting and postprandial blood glucose levels, and reduce the load of islet β cells and improve the lipid Metabolic disorders, well tolerated