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目的观察胰岛素联合二肽基肽酶4(DPP-4)抑制剂治疗血糖控制不佳的2型糖尿病(T2DM)患者的疗效及低血糖发生情况。方法入选接受预混胰岛素治疗的T2DM患者100例,研究组(n=50)保持原胰岛素剂量不变,分别联合维格列汀(维格列汀亚组,n=25)和西格列汀(西格列汀亚组,n=25);对照组(n=50)接受预混胰岛素治疗,不联用DPP-4抑制剂,但可根据血糖水平调整胰岛素剂量。随访16周,比较两组糖化血红蛋白(Hb A1c)值、空腹和餐后血糖水平、低血糖发生率、胰岛素用量和体重等指标的变化。结果随访16周,研究组和对照组Hb A1c值均下降,与治疗前比较差异具有统计学意义(P<0.05);然而,Hb A1c值下降程度和Hb A1c值指标达标率、餐后血糖水平及达标率组间差异均无统计学意义(P>0.05)。维格列汀亚组空腹血糖水平达标率明显高于西格列汀亚组和对照组(P<0.05)。研究组低血糖发生率为63%,低于对照组的80%,差异有统计学意义(P<0.05);与研究组比较,对照组胰岛素用量及患者体重显著增加(P<0.05)。结论接受胰岛素治疗但血糖水平未达标的T2DM患者,联合西格列汀或维格列汀可有效改善血糖并减少低血糖的发生,且胰岛素剂量和体重均未增加,其中维格列汀对于改善空腹血糖水平疗效更优。
Objective To observe the efficacy and the incidence of hypoglycemia in patients with type 2 diabetes mellitus (T2DM) with poor glycemic control in combination with DPP-4 inhibitors. Methods One hundred and twenty T2DM patients undergoing premixed insulin therapy were enrolled in this study. The study group (n = 50) maintained the original dose of insulin, and combined with vildagliptin (vildagliptin, n = 25) and sitagliptin (Sitagliptin subgroup, n = 25); control group (n = 50) received premixed insulin without DPP-4 inhibitor but adjusted insulin dose according to blood glucose level. After 16 weeks of follow-up, the changes of Hb A1c, fasting and postprandial blood glucose, the incidence of hypoglycemia, insulin dosage and body weight were compared between the two groups. Results At the 16th week of follow-up, the Hb A1c values of both study group and control group decreased significantly compared with those before treatment (P <0.05); however, the decrease of Hb A1c and the compliance rate of Hb A1c index, postprandial blood glucose level There was no significant difference between the two groups (P> 0.05). The compliance rate of fasting blood glucose in vildagliptin subgroup was significantly higher than that in sitagliptin subgroup and control group (P <0.05). The incidence of hypoglycemia in the study group was 63%, which was lower than 80% of the control group (P <0.05). Compared with the study group, insulin dosage and body weight of the control group increased significantly (P <0.05). Conclusions T2DM patients receiving insulin but not blood glucose levels, combined with sitagliptin or vildagliptin can effectively improve blood glucose and reduce the incidence of hypoglycemia, and insulin dose and weight did not increase, in which vildagliptin for improving Fasting blood glucose level more effective.