国产盐酸吡格列酮对2型糖尿病的疗效及安全性研究

The efficacy and safety of pioglitazone hydrochloride in combination with sulpho nylureas and metformin in the treatment of type 2 diabetes mellitus-a 12 weeks randomized double-blind placebo-controlled study

目的 :评价国产盐酸吡格列酮对 2型糖尿病 (DM)患者合用磺脲类及双胍类药物时的降糖疗效及安全性。方法 :采用随机、双盲、安慰剂平行对照的临床研究方法 ,将 4 8例应用磺脲类及双胍类治疗而空腹血糖 (FPG)控制不佳 (7.5mmol·L-1≤FPG <12 .0mmol·L-1)的 2型DM患者随机分为吡格列酮组 (30mg·d-1)与安慰剂组治疗 ,共 12周。结果 :于 12周时 ,吡格列酮组与安慰剂组FPG较基线值分别下降 1.1mmol·L-1和 0 .2 3mmol·L-1(P <0 .0 5 ) ;PPG分别下降 1.7mmol·L-1和 0 .2 3mmol·L-1(P >0 .0 5 ) ;HbAlc分别下降 0 .5 2 %和 0 .0 5 % (P >0 .0 5 )。结论 :12周的临床观察显示 ,对 2型DM患者饮食、运动和应用磺脲类及双胍类治疗而血糖控制不佳者联合应用盐酸吡格列酮 (30mg·d-1) ,改善糖代谢紊乱 ,且安全性和依从性好。

OBJECTIVE To evaluate the efficacy and safety of p ioglitazone hydrochloride 30 mg·d -1 with sulphonylureas and metformin in the treatment of type 2 diabetes mellitus. METHODS There were 48 patients treated with sulphonylureas and metformin randomized in double-blind placebo-controlled clinical trial.Patie nts who had 7.5 mmol·L -1≤fasting plasma glucose(FPG)< 12.0 mmol· L -1 were randomized to receive pioglitazone 30 mg or placebo once daily fo r 12 weeks. RESULTS The patients who had been treated with pioglitazone sh owed significant decrease on average from baseline in FPG ( 1.1 mmol·L - 1 versus 0.23 mmol·L -1 P< 0.05).postprandial plasma glucose( PPG, 1.7 mmol·L -1 versus 0.23 mmol·L -1 (P> 0.05), a nd glycosylated hemoglobin(HbA1c, 0.52% versus 0.05%,P> 0.05). CONCLUSION Pioglitazone 30 mg·d -1 for 12 weeks might imp rove the insulin sensitivity and the glucose metabolic disorder in poorly contro lled type 2 diabetes with previous administration of sulphonylureas and metformi n. It provides a safety and tolerance profile for type 2 diabetes mellitus in th is trial.