二肽基肽酶-4抑制剂治疗2型糖尿病的临床研究

目的 评价二肽基肽酶-4 （DPP-4）抑制剂与二甲双胍联合治疗T2DM的疗效. 方法 受试者随机分为两组,分别在原二甲双胍治疗的基础上加用DPP-4抑制剂或安慰剂,并于治疗前及治疗第12周检测相关指标的变化. 结果 试验中,DPP-4抑制剂组有2例、安慰剂组有1例出现低血糖.与治疗前相比,治疗后DPP-4抑制剂组血糖、HbA1 c均下降FPG：（9.25±1.69）vs（6.79±0.88） mmol/L;HbA1 c：（8.79±1.71）％vs（6.76±2.09）％,P＜0.05],安慰剂组各指标变化的比较,差异均无统计学意义.DPP-4抑制剂组血糖、HbA1c较安慰剂组降低FPG：（6.79±0.88）vs（8.61±1.12） mmol/L;2 hPG：（8.68±0.91）vs（9.98±1.35） mmol/L;HbA1c：（6.76±2.09）％vs（8.33±1.45）％,P＜0.05].无论组内还是组间比较,两组治疗前后体重、血脂及肝肾功能的变化差异比较均无统计学意义（P＞0.05）. 结论 DPP-4抑制剂与二甲双胍联用可有效降低患者血糖及HbA1c水平,未发现体重增加,且不影响患者肝肾功能.

The clinical research on the treatment of type 2 diabetes mellitus by DPP-4 inhibitor

Objective To assess the efficacy of DPP-4 inhibitor plus metformin combination therapy in patients with type 2 diabetes mellitus.Methods All selected patients were randomized into two groups,which used DPP-4 inhibitor or placebo on the basis of metformin.The relevant indicators were tested in patients before and 12 weeks after the trial.Results During the treatment,hypoglycemia was found in 2 cases in the DPP4 inhibitor group and in 1 case in placebo group.The blood glucose level and HbA1c significantly declined after treatment in patients of DPP-4 inhibitor group FPG：（9.25 ± 1.69） vs （6.79±0.88） mmol/L; HbA1c：（8.79± 1.71）％ vs （6.76±2.09）％,P＜0.05],while there were no statistical differences in above indicators in placebo group.The blood glucose and HbA1 c levels were significantly lower in DPP-4 inhibitor group than in placebo group after treatmentFPG：（6.79±0.88） vs （8.61±1.12） mmol/L; 2 hPG：（8.68±0.91） vs （9.98± 1.35） mmol/L; HbA1c：（6.76± 2.09）％ vs （8.33±1.45）％,all P＜0.05].The differences in body weight,blood lipid and hepatorenal function showed no statistical significance either before and after treatment or between the two groups.Conclusion DPP-4 inhibitor plus metformin combination therapy effectively reduced blood glucose and HbA1c levels without the risk of weight gain or hepatorenal dysfunction in T2DM patients.