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Received:November 25, 2017 Published Online:June 21, 2018
Received:November 25, 2017 Published Online:June 21, 2018
中文摘要: 目的 比较维格列汀联合二甲双胍与单用高剂量二甲双胍治疗2型糖尿病的疗效及安全性。方法 收集2015年6月至2016年5月在四川省人民医院门诊就诊的单用二甲双胍治疗血糖控制不佳的2型糖尿病患者33例,分为维格列汀联合二甲双胍组(试验组)27例和二甲双胍单药治疗组(对照组)6例,共治疗24周。试验组在二甲双胍500 mg 2次/d基础上加用维格列汀50 mg,2次/d,对照组在二甲双胍500 mg,2次/d基础上逐渐递增至1 000 mg,2次/d。主要终点为治疗24周后的糖化血红蛋白(HbA1c)；次要终点为治疗24周后空腹血糖(FPG)、餐后2 h血糖(2 hPG)、C肽、体重相比基线水平的变化；安全性分析为评价治疗期间低血糖等不良反应的发生情况。结果 治疗24周后,试验组患者HbA1c为(6.3±0.6)%,对照组患者HbA1c为(7.3±1.5)%,试验组患者的HbA1c显著低于对照组(P=0.004)。试验组和对照组HbA1c相比基线的变化分别为-0.7% (-2.6%,-0.1%)和0.05% (-0.9%，0.8%)，试验组降HbA1c的幅度显著高于对照组(P=0.008)。2 hPG治疗24周后相比基线的变化，试验组降幅显著高于对照组(P=0.005)。而两组FPG、体重及C肽相比基线的变化无统计学差异(P>0.05)。两组均未发生低血糖事件,试验组腹部不适2例(2/27),对照组腹部不适及恶心共2例(2/6),两组比较无统计学差异(P=0.142)。结论 维格列汀联合二甲双胍相比二甲双胍单药治疗血糖控制不佳的2型糖尿病患者具有较好的降糖效果,且两组具有相似的安全性。
Abstract:Objective To compare the efficacy and safety of vildagliptin combined with metformin and higher dose of metformin alone for the treatment of type 2 diabetes mellitus (T2DM). Methods Thirty-three T2DM patients with poor glycemic control by the treatment of metformin alone who visited the Outpatient Department of Sichuan Provincial People′s Hospital between June 2015 and May 2016 were collected. The patients were randomly divided into vildagliptin combined with metformin group (experiment group, n=27) and metformin monotherapy group (control group, n=6). The patients in experiment group received vildagliptin (50 mg bid) plus metformin (500 mg bid). The patients in control group received metformin monotherapy with progressive increase from initial dose of 500 mg bid to high dose of 1 000 mg bid. All patients were treated for 24 weeks. The primary endpoint was the glycated hemoglobin A1c (HbA1c) after 24 weeks of treatment. The secondary endpoints were the changes of fasting blood glucose (FPG), postprandial 2 h blood glucose (2 hPG), C peptide and body weight between 24 weeks after treatment and baseline levels. Safety was assessed by the adverse events during treatment such as hypoglycemia, etc. Results After 24 weeks of treatment, HbA1c level in experiment group was significantly lower than that in control group [(6.3±0.6) % vs (7.3±1.5)%, P=0.004]. Compared with the baseline, the HbA1c changes were -0.7% (-2.6%, -0.1%) and 0.05% (-0.9%, 0.8%) in the experiment group and control group respectively, and the amplitude of HbA1c in the experiment group was significantly higher than that of the control group (P=0.008). At 24 weeks after the treatment, the decrease of 2 hPG in experiment group was significantly higher than that in the control group (P=0.005). However, there was no significant difference in the changes of FPG, body weight and C peptide between the two groups compared with baseline (P>0.05). No hypoglycemic event occurred in both groups. There was abdominal discomfort in 2 cases (7.4%) for experimental group and abdominal discomfort and nausea in 2 cases (34.6%)for control group, and there was no significant difference in them (P=0.142). Conclusion Compared with metformin monotherapy, vildagliptin combined with metformin has better effect of lowering blood glucose and similar security for the treatment of T2DM patients with poor glycemic control.
文章编号： 中图分类号：R 587.1 文献标志码：A
基金项目:四川省卫计委科研课题(110209)
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