利格列汀片联合二甲双胍片治疗初诊2型糖尿病的临床研究

Clinical trial of linagliptin tablets combined with metformin tablets in the treatment of newly diagnosed type 2 diabetes mellitus

目的观察利格列汀片联合二甲双胍片治疗初诊2型糖尿病(T2DM)的临床疗效及安全性。方法将166例初诊T2DM患者随机分为对照组83例和试验组83例。对照组予以二甲双胍片每次0. 5 g,tid,口服;试验组在对照组治疗的基础上,予以利格列汀片每次5 mg,qd,口服。2组患者均治疗3个月。比较2组患者的临床疗效、血糖水平、胰岛素抵抗指数(HOMA-IR)和胰岛β细胞功能指数(HOMA-β),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91. 57%(76例/83例)和72. 29%(60例/83例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的空腹血糖分别为(6. 18±0. 85)和(7. 27±1. 03) mmol·L^(-1),餐后2 h血糖分别为(7. 96±1. 07)和(9. 74±1. 27) mmol·L^(-1),糖化血红蛋白分别为(6. 39±0. 77)%和(7. 15±1. 02)%,HOMA-IR分别为(1. 47±0. 21)和(2. 35±0. 33),HOMA-β分别为(26. 39±3. 75)和(19. 62±2. 71),差异均有统计学意义(均P <0. 05)。2组患者的药物不良反应均以恶心呕吐、腹泻、头晕和乏力为主。试验组和对照组的总药物不良反应发生率分别为14. 46%和10. 83%,差异无统计学意义(P> 0. 05)。结论利格列汀片联合二甲双胍片治疗初诊T2DM的临床疗效确切,其能明显降低患者的血糖水平,改善胰岛β细胞功能,减轻胰岛素抵抗,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of linagliptin tablets combined with metformin tablets in the treatment of newly diagnosed type 2 diabetes mellitus(T2 DM).Methods A total of 166 patients with newly diagnosed T2 DM were randomly divided into control and treatment groups with 83 cases per group.Control group was treated with metformin tablets 0.5 g per time,tid,orally.Treatment group was treated with linagliptin tablets 5 mg per time,qd,orally,on the basis of control group.Two groups were treated for 3 months.The clinical efficacy,blood glucose levels,insulin resistance indexes(HOMA-IR)and isletβ-cell function indexes(HOMA-β),and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 91.57%(76 cases/83 cases)and 72.29%(60 cases/83 cases)with significant difference(P<0.05).After treatment,the main indexes of treatment and controlgroups were compared:the fasting plasma glucose were(6.18±0.85)and(7.27±1.03)mmol·L-1,postprandial2 h blood glucose were(7.96±1.07)and(9.74±1.27)mmol·L-1,the glycosylated hemoglobin were(6.39±0.77)%and(7.15±1.02)%,the HOMA-IR were(1.47±0.21)and(2.35±0.33),the HOMA-βwere(26.39±3.75)and(19.62±2.71),the differences were statistically significant(all P<0.05).The adverse drug reactions of two groups were nausea and vomiting,diarrhea,dizziness and fatigue.The total incidences of adverse drug reactions in the treatment and control groups were 14.46%and 10.83%without significant difference(P>0.05).Conclusion Linagliptin tablets combined with metformin tablets have a definitive clinical efficacy in the treatment of newly diagnosed T2 DM,which can significantly reduce the level of plasma glucose,improve the function of isletβ-cell,reduce insulin resistance,without increasing the incidence of adverse drug reactions.