西格列汀联合二甲双胍治疗2型糖尿病的疗效及对胰岛功能的影响

Effects of sitagliptin and metformin as combination therapy on blood glucose control and β cell function in type 2 diabetes mellitus

目的 探讨西格列汀和二甲双胍单药及联合治疗对2型糖尿病（T2DM）的疗效及对胰岛功能的影响.方法 将2011年1月至2012年12月收治的60例初治T2DM患者,按随机数字表法分为3组,西格列汀治疗组（S组,西格列汀100 mg每天1次）、二甲双胍治疗组（M组,二甲双胍500 mg每天3次）及西格列汀、二甲双胍联合治疗组（SM组,西格列汀100 mg每天1次＋二甲双胍500 mg每天3次）,每组20例.治疗12周后,比较三组治疗前后空腹血糖（FBG）、餐后2h血糖（2 hPG）、糖化血红蛋白（HbA1c）、血压、血脂及稳态模型β细胞功能指数（HOMA-β）、稳态模型胰岛素抵抗指数（HOMA-IR）等指标的变化,并观察体质指数（BMI）、药物不良反应发生况.治疗前后比较采用配对t检验,组间比较采用方差分析.结果 治疗后,三组血糖、HbA1c、血甘油三酯（TG）、总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、血压及HOMA-IR均较治疗前明显下降,而HOMA-β均明显升高,差异均有统计学意义（均P ＜0.05）.治疗后,S组与M组各项指标差异均无统计学意义（均P＜0.05）.SM组HbA1c（6.1％±0.5％）相较于S组（6.6％±0.5％）及M组（6.5％±0.6％）下降更为显著（F=4.964,P＜0.05）,血糖、TG、TC、LDL-C及血压亦显著下降（均P＜0.05）.与S组（65±18）及M组（63±23）相比,SM组HOMA-β（83±27）显著升高（F=4.349,P＜0.05）.治疗后三组HOMA-IR差异无统计学意义（F=0.149,P＞0.05）.S组治疗前后BMI无显著变化,M组及SM组治疗后BMI较前显著下降（均P＜0.05）,与S组比较差异均有统计学意义（均P＜0.05）.三组均未出现严重低血糖事件.结论 西格列汀起始单药治疗2型糖尿病对血糖的控制及胰岛β细胞功能的改善与二甲双胍相似,而两者联合用药效果更佳,且耐受性良好.

Objective To assess the effects of monotherapy and combination therapy with sitagliptin and metformin on blood glucose control and β-cell function in type 2 diabetes mellitus （T2DM）.Methods Sixty drug-na（i）ve T2DM patients treated from January 2011 to December 2012 were randomized to receive sitagliptin monotherapy（S group：100 mg q.d）,metformin monotherapy（M group：500 mg t.i.d） and combination therapy of sitagliptin and metformin （SM group：sitagliptin 100 mg q.d ＋ metformin 500 mg t.i.d） for 12 weeks according to random number table.Fasting plasma glucose（FBG）,2-hour postprandial blood glucose （2hPG）,glycated hemoglobin A 1 c （HbA1 c）,body mass index （BMI）,triglyceride （TG）,total cholesterol （TC）,low density lipoprotein-cholesterol （LDL-C）,blood pressure （BP）,homeostatic model assessment of the insulin secretion index （HOMA-β） and insulin resistance index （HOMA-IR） were measured before and after the treatment.The incidence of hypoglycemia and drug adverse reaction was also observed during the treatment.The Student＆#39;s t test and analysis of variance was used when data was compared before and after treatment and among groups.Results After intervention,FPG,2hPG,HbA1c,TG,TC,LDL-C,blood pressure and HOMA-IR decreased significantly,while HOMA-β increased significantly in all three groups（all P 〈 0.05）.Significant difference of glucose profile and β-cell function was not observed between M group and S group.The HbA1c decreased further in SM group （6.1% ± 0.5%） when compared with S group （6.6% ± 0.5%） and M group （6.5% ± 0.6%） （F =4.964,P =0.01）.The HOMA-β in SM group（83 ±27） was significant higher than those in S group （65 ± 18） and M group （63 ± 23） after treatment （F =4.349,P =0.017）.In addition,TG,TC,LDL-C and blood pressure also decreased further in SM group,while HOMA-IR didn＆#39;t compared with S group or M group（F =0.149,P 〉 0.05）.BMI in M group and SM group decreased significantly after treatment but there was no significant change in S group.No severe hypoglycemic events occurred in all groups.Conclusion Sitagliptin has similar effect on glycemic control as metformin.Better glucose profile is observed when patients receiving combination therapy.