口服二甲双胍血糖控制不佳的2型糖尿病患者联合西格列汀治疗的有效性和安全性

目的评价口服二甲双胍血糖控制不佳的2型糖尿病患者联合西格列汀治疗的有效性与安全性。方法采用随机、开放、格列美脲平行对照的研究方法。102例口服二甲双胍控制不佳的2型糖尿病患者随机分为早餐前口服西格列汀100 mg（n=52）或早餐前口服格列美脲1~4 mg（n=50）两组,同时继续口服二甲双胍,进行为期24周的观察。结果①基线时两组口服二甲双胍的时间及其他指标相似;②24周时,西格列汀组与格列美脲组的平均HbA1c分别下降了1.41%和1.38%,日平均血糖降幅分别为5.28 mmol/L和4.56 mmol/L;③试验结束时,西格列汀组和格列美脲组分别有3.80%和10.00%的患者发生症状性低血糖（3次和18次）,其中严重低血糖事件,西格列汀组为0次,格列美脲组有4.00%患者（3次）,夜间低血糖西格列汀组为0次,格列美脲组有4.00%患者（2次）,两组间差异有统计学意义（均P〈0.05）;④试验结束时西格列汀组患者平均体重下降1.0 kg,格列美脲组平均增加1.2 kg,两组间差异有统计学意义（P〈0.01）。结论与格列美脲相比,西格列汀联合二甲双胍可使2型糖尿病患者的血糖得到有效控制,且低血糖发生率明显降低,体重下降;因此,作为控制2型糖尿病血糖的二线用药,西格列汀优于格列美脲。

Efficacy and safety of Sitagliptin combined with Biguanide in type 2 diabetic patients with poor glycemic control

Objective To investigate the efficacy and safety of Sitagliptin in type 2 diabetic patients whose blood glucose levels were inadequately controlled by Biguanide.nethods In this open-labeled, randomized,and parallel study,102 patientss were given either once-daily Sitagliptin（n=52） or Glimepiride（n=50） before breakfast, plus Biguanide for 24 weeks.Results Baseline characteristics were similar between the two groups.HbAlc level were decreased in the Sitagliptin and Glargine groups over the study period.The mean daily blood glucose decreased similarly in both groups during the study.Moreover the number of hypoglycemic episodes was significanty lower in patients with Sitagliptin than those with Glimepiride （3.80% vs 10.00%,P〈0.05）,being particularly severe （0 vs 4.00%,P〈0.05） and expressing nocturnal hypoglycemia （0 vs 4.00%,P〈0.05）.The weight was descended in patients with Sitagliptin.But,the weight was added in patients with Glimepiride （P〈0.05）.Conclusion The Sitagliptin provides similar glycemic control with less hypoglycemia compared with Glimepiride.The Sitagliptin yields better results in lowering weight and the incidence of severe and nocturnal hypoglycemia.