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机构地区:[1]中国医科大学附属盛京医院内分泌科,辽宁沈阳110004
出 处:《中国新药与临床杂志》2013年第7期572-574,共3页Chinese Journal of New Drugs and Clinical Remedies
摘 要:目的验证沙格列汀联合二甲双胍治疗超重2型糖尿病患者的疗效和安全性。方法按开放性、随机分组的设计将40例超重2型糖尿病患者分为两组,每组20例。二甲双胍组予二甲双胍1 500 mg.d-1,联合用药组予二甲双胍1 500 mg.d-1+沙格列汀5 mg.d-1,均口服,疗程12周。检测治疗前后两组血糖、糖化血红蛋白(HbA1c)及胰岛素水平,观察低血糖事件及其他不良反应。结果治疗12周后,联合用药组糖耐量试验(OGTT)中4个时点血糖及HbA1c均较治疗前下降(P<0.05或P<0.01),OGTT中服糖后胰岛素水平及葡萄糖处置指数(DI)上升(P<0.01)。二甲双胍组各项指标均无显著变化,联合用药组HbA1c及OGTT中30、60、120 min血糖低于二甲双胍组,DI及OGTT中30、60、120 min胰岛素水平高于二甲双胍组,均有非常显著差异(P<0.01)。两组低血糖发生率无差异(P>0.05),均未见严重不良反应。结论沙格列汀联合二甲双胍可协同改善超重2型糖尿病患者的血糖控制及胰岛β细胞功能,且安全。AIM To investigate the efficacy and safety of saxagliptin combined with metformin in overweight patients with type 2 diabetes mellitus (T2DM). METHODS Forty overweight patients with T2DM were chosen into the open-label study and were randomly divided into two groups, with 20 in each. The patients in the metformin group were treated with metformin 1 500 mg·d-~, and the others in the combination group were treated with metformin (1 500 mg .d-t) + saxagliptin (5 mg "d-t) , both for 12 weeks. The glycosylated hemoglobin At~ (HbA^c), plasma glucose and insulin levels in 75 g oral glucose tolerance test (OGTI') were examined before and after the treatment. Hypoglycemia and other adverse reactions were observed. RESULTS After 12 weeks treatment, the levels of HbA1c and 4 time-points plasma glucose in OGTT decreased significantly (P 〈 0.05 or P 〈 0.01 ) in the combination group, while 30, 60, 120 minutes insulin levels and glucose disposition index (DI) significantly increased (P 〈 0.01 ). After 12 weeks treatment, there were no obvious changes in HbA1c, plasma glucose, insulin and DI in the metformin group. Compared with those in the mefformin group, the levels of HbAlc and 30, 60, 120 minutes glucose in OGTT decreased, while DI and 30, 60, 120 minutes insulin increased significantly (P 〈 0.01 ) in the combination group. There were no significant differences in incidence rates of hypoglycemia between the two groups (P 〉 0.05). No serious adverse reactions occurred in both groups. CONCLUSION overweight T2DM patients. Moreover, it Saxagliptin combined with metformin is effective and safe in treating may improve β-cell function.
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