【摘要】 目的 评估二肽基肽酶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、HbA1c均下降[FPG：(9.25±l.69) vs (6.79±0.88) mmol/L;HbAlc：(8.79±l.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、HbAlc较安慰剂组降低[FPG：(6.79±0.88) vs (8.61±1.12) mmmol/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。 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。

　　【关键词】糖尿病，2型;二肽基肽酶4抑制剂;二甲双胍

　　【Abstract】 Objective To assess the efficacy of DPP-4 inhibitor plus metformin combination therapy in patients with type 2 diabetes mellitus. Methods A11 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 DPP-4 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±l.69) vs (6.79±0.88) mmol/L;HbAlc：(8.79±l.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 HbA1c levels were significantly lower in DPP-4 inhibitor group than in placebo group after treatment[FPG：(6.79±0.88) vs (8.61±1.12) mmmol/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.

　　【Key words】 Diabetes mellitus，type 2;DPP-4 inhibitor;Metformin