维格列汀联合胰岛素治疗2型糖尿病的临床研究

Vildagliptin Combined with Insulin in Patients with Type 2 Diabetes: a Prospective, Randomized, Open-label Study

目的:评价维格列汀联合胰岛素治疗方案在2型糖尿病治疗中的疗效和安全性。方法:选取2015~2016年我院内分泌科新诊断的2型糖尿病(type 2 diabetes mellitus,T2DM)住院患者70名,随机对照分为两组,其中对照组35例,给予常规预混胰岛素方案治疗;试验组35例,在常规预混胰岛素治疗方案基础上给予维格列汀50m g,早晚各1次。治疗12周后,比较两组患者治疗前后及组间治疗后相关指标的改善情况:空腹血糖(fasting plasma glucose,FPG)、餐后2h血糖(2-hour postprandial blood glucose,2h PG)、糖化血红蛋白(hemoglobin A1c,Hb A1c)、果糖胺(fructosamin,FRA);总胆固醇(total cholesterol,TC)、甘油三酯(triglyceride,TG)、低密度脂蛋白胆固醇(low density lipoprotein-cholesterol,LDL-C)、高密度脂蛋白胆固醇(high density lipoprotein-cholesterol,HDL-C);空腹C肽(C-peptide,CP)、餐后2h C肽(2-hour postprandial C-peptide,2h CP)、空腹胰岛素(insulin,INS)、餐后2h胰岛素(2h postprandial insulin,2h INS)、胰岛素抵抗指数(insulin resistance index,HOMA-IR);体质指数(body mass index,BMI)、胰岛素用量、低血糖发生、血糖达标率及血糖达标中位时间等。结果:治疗12周后,两组治疗前后患者血糖水平均有显著改善(P<0.01),但相对于对照组,试验组FPG、HOMA-IR、HDL-C、CP、2h CP、INS等指标改善更为明显(P<0.05),两组血糖达标率与达标中位时间均存在显著性差异。结论:维格列汀联合胰岛素治疗新诊断的T2DM患者,降糖疗效显著,且安全性高,同时还可以明显改善胰岛素抵抗,保护胰岛β细胞,降低胰岛素用量和低血糖风险等,是一种安全有效的治疗方案。

Objective To evaluate the efficacy and safety profile of vildagliptin combined with insulin in patients with type 2 diabetes. Methods： 70 newly diagnosed T2DM patients enrolled from 2015 to 2016 in the department of endocrinology in our hospital, were randomly divided into two groups. In control group, 35 subjects were given routine pre-mixed insulin therapy; In experimental group, 35 subjects were administrated vildagliptin 50mg in the morning and night respectively, combined with conventional premixed insulin therapy. After 12 weeks of treatment, following indexes were examined of the two groups： fasting blood glucose （FPG）, 2h postprandial blood glucose （2hPG）, glycosylated hemoglobin （HbA1c）, fructosamine （FRA）, total cholesterol （TC）, triglyceride （TG）, low density lipoprotein-cholesterol （LDL-C）, high density lipoprotein-cholesterol （HDL-C）, fasting C peptide （CP）, 2h postprandial C peptide （2hCP）, fasting insulin （INS）, 2h postprandial insulin （2h INS）, insulin resistance index （HOMA-IR）, body mass index （BMI）, insulin dosage, and incidence of hypoglycemia, etc. Results： After 12 weeks of treatment, the glycemic control in patients of both groups was significantly improved （P〈0.01）. Moreover, compared with the control group, the indexes of the experimental group, including FPG, HOMA-IR, HDL-C, CP, 2hCP, INS and other indicators, were improved significantly （P〈0.05）. Conclusions： Vildagliptin combined with insulin regimens in newly diagnosed patietns with type 2 diabetes could improve glycemic control with good safety profile, protect the function of beta cell efficiently, improve insulin resistance, and reduce the dosage of insulin and occurrence of hypoglycemia. It is an efficient and safe combination therapy for T2DM patients.