维格列汀联合胰岛素治疗2型糖尿病的疗效及安全性研究

Efficacy and safety of vildagliptin combined with insulin in patients with type 2 diabetes mellitus

目的:研究在接受胰岛素治疗的2型糖尿病患者中,联合应用维格列汀治疗的疗效及对胰岛素剂量的影响并进行安全性评价。方法:本实验为前瞻性、开放性、前后自身及空白对照的临床研究。设立试验组和对照组,试验组为110例应用胰岛素治疗的2型糖尿病患者,加用维格列汀50mg,每日2次,治疗12周,对照组为109例应用胰岛素治疗12周的患者,观察两组治疗前后糖化血红蛋白(HbA1c)及血糖变化。结果:治疗12周后,试验组HbA1c由基线的(9.27±1.42)%降至(7.82±1.36)%,下降了(1.45±1.03)%,对照组HbA1c由基线的(8.86±1.06)%降至(8.02±1.32)%,下降了(0.84±1.13)%,两组下降幅度均P<0.05。以HbA1c≤6.5%和HbA1c≤7.0%为目标值,治疗后试验组达标率为16.36%和43.63%,较治疗前增加12.76%和33.63%;试验组胰岛素用量由基线的53.9IU/d降至41.2IU/d,剂量减少23.56%,对照组胰岛素用量由基线的66.7IU/d降至58.3IU/d,剂量减少12.59%,两组胰岛素减少量P<0.05;患者空腹血糖及餐后2h血糖均有明显改善;患者平均每日药品费用较治疗前无明显增加(P>0.05)。治疗期间试验组共14例患者(12.7%)发生一般性低血糖事件(24件·次),无严重低血糖事件发生,与对照组比较,低血糖发生率有统计学差异(P<0.05)。结论:维格列汀联合胰岛素治疗2型糖尿病,可有效降低患者空腹及餐后血糖水平,利于实现HbA1c达标,并减少胰岛素使用剂量,提高治疗的安全性及耐受性。

Objective：To investigate the efficacy and safety of vildagliptin combined with insulin in patients with type 2 diabetes mellitus, and if the insulin dosage induced or not. Methods： Type 2 diabetic patients treated with insulin were enrolled in this prospective open-labeled and self-controlled study. Vildagliptin added to 110 patients for 12 weeks were treatment group, another 109 patients without vildagliptin were control group. Results：HbA1cof the treatment group decreased from 9.27＆#177;1.42%to 7.82＆#177;1.36%（P＆lt;0.05）. HbA1cof the control group decreased from 8.86＆#177;1.06%to 8.02＆#177;1.32%（P＆lt;0.05）. About 12.76% and 33.63% patients of the treatment group obtained the target of HbAIc≤6.5% and HbAIc≤7.0%. Insulin dose of the treatment group decreased from 53.9IU/d to 41.3IU/d （decreased 23.56%）, the other decreased from 66.7IU/d to 58.3IU/d （decreased 12.59%）, P＆lt;0.05. The blood glucose profile was also improved significantly. The daily drug cost was not increased, P＆gt;0.05. During the study period,14 patients （12.7%） of the treatment group experienced with minor hypoglycemia for 24 times, no serious hypoglycemia was reported. The differ was significant compared with control group. Conclusion：Vildagliptin combined with insulin is efficient and safe in type 2 diabetic patients, therefore can decrease insulin dosage and the therapeutic risks of insulin.