阿格列汀联合二甲双胍治疗2型糖尿病合并非酒精性脂肪肝的疗效和安全性分析

Efficacy and safety of alogliptin combined with metformin in the treatment of type 2 diabetes mellitus and nonalcoholic fatty liver disease

目的探讨阿格列汀联合二甲双胍对2型糖尿病(T2DM)合并非酒精性脂肪肝(NAFLD)患者的疗效及安全性。方法 100例2型糖尿病合并NAFLD患者随机分为2组,在生活方式干预治疗的基础上,治疗组给予二甲双胍500 mg,3次/d口服,阿格列汀25 mg,1次/d口服。对照组给予二甲双胍500 mg,3次/d口服。治疗20周后,根据体征、肝脏彩超和各项生化指标判断两组患者的疗效,记录不良事件。结果治疗后,两组患者各项指标明显改善(P<0.05);与对照组比较,治疗组肝酶、糖化血红蛋白、胰岛素抵抗指数、三酰甘油改善更明显(P<0.05)。治疗组患者的脂肪肝治疗有效率高于对照组(80%vs.32%,P<0.01)。两组不良反应比较差异无统计学意义(P>0.05)。结论阿格列汀联合二甲双胍能明显改善脂肪肝及代谢综合征,是一种新型、安全、有效的T2DM合并NAFLD的治疗方案。

Objective To explore the efficacy and safety of alogliptin combined with metformin in the treatment of type 2 diabetes mellitus（T_2DM） and nonalcoholic fatty liver disease（NAFLD）.Methods Totally 100 patients with T_2DM complicated with NAFLD were randomly divided into two groups.Patients in treatment group were treated with metformin（500 mg,three times daily） combined with alogliptin（25 mg,once daily）,and patients in control group received metformin（500 mg,three times daily）,on the basis of lifestyle intervention therapy for both groups.After treatment of 20 weeks,the therapeutic efficacy was analyzed by synthetic judgment according to physical signs,color Doppler ultrasound and the results of liver and biochemical laboratory examination,and the adverse events were recorded.Results After treatment,the indexes of patients in both groups were improved significantly（P〈0.05）;compared with control group,the liver enzyme,glycosylated hemoglobin（HbAlc）,insulin resistance index（HOMA-IR） and triglyceride（TG） in treatment group were better improved than control group（P〈0.05）.The effective rate for fatty liver in treatment group was higher than that of control group,there being significant difference（80%vs.32%,P〈0.01）.No significant difference was found in adverse events between the two groups（P〉0.05）.Conclusion Alogliptin combined with metformin is a new kind of safe and effective treatment for T_2DM complicated with NAFLD,and it can improve the fatty liver disease and the metabolic syndrome significantly.