利拉鲁肽治疗2型糖尿病合并非酒精性脂肪性肝病的临床研究

Clinical trial of liraglutide in the treatment of patients with type 2 diabetes mellitus and non-alcoholic fatty liver

目的观察利拉鲁肽治疗2型糖尿病(T2DM)合并非酒精性脂肪性肝病(NAFLD)的临床效果。方法将116例T2DM合并NAFLD患者随机分为试验组58例和对照组58例。对照组口服二甲双胍,每次0.25 g,每天3次,皮下注射胰岛素0.4 U·kg^-1·d^-1;试验组在对照组的基础上皮下注射利拉鲁肽,初始适应剂量为0.6 mg,1周后提高为1.2 mg,每天1次,2组均治疗持续24周。比较2组患者治疗前后的肝功能、体重指数(BMI)、糖化血红蛋白(Hb A1c)、成纤维细胞生长因子21(FGF-21)、肝脂肪含量和脂联素水平,并分析肝脂肪含量与其他指标相关性。结果治疗后,试验组和对照组谷丙转氨酶(GPT)分别为(22.46±11.04),(38.93±12.46)U·L-1,谷氨酰转肽酶(GGT)分别为(38.03±18.02),(52.25±18.77)U·L-1,脂联素分别为(9.11±3.24),(6.36±2.22)U·L^-1,FGF-21分别为(142.35±30.33),(274.25±40.01)pg·m L^-1,差异均有统计学意义(均P<0.05)。肝脂肪含量与BMI、Hb A1c、GPT、谷草转氨酶(GOT)和FGF-21呈正相关(P<0.05)。试验组出现恶心呕吐4例,腹泻3例,药物不良反应发生率为12.07%;对照组出现恶心呕吐5例,腹泻4例,药物不良反应发生率为15.52%。2组药物不良反应发生率差异无统计学意义(P>0.05)。结论利拉鲁肽治疗T2DM合并NAFLD患者,能有效降低血糖水平及患者体重,抑制肝脂肪沉积,减少肝损伤。

Objective To explore the clinical effect of liraglutide in the treatment of patients with type 2 diabetes mellitus(T2 DM)and non-alcoholic fatty liver disease(NAFLD).Methods A total of 116 T2 DM patients with NAFLD were randomly divided into treatment group(58 cases)and control group(58 cases).Control group was treated with metformin 0.25 g·time^-1,tid orally+insulin 0.4 U·kg^-1·d^-1,subcutaneous injection.Treatment group was treated with lilalutide(qd,the initial adaptation dose was 0.6 mg,increased to 1.2 mg after 1 week,subcutaneous injection)on the basis of control group.Both groups were treated for 24 weeks.The liver function,body mass index(BMI),levels of glycosylated hemoglobin(Hb A1 c),fibroblast growth factor 21(FGF-21),hepatic fat content and adiponectin were compared between the two groups,and the correlation between liver fat content and otherindexes were analyzed.Results After treatment,the glutamic-pyruvic transaminase(GPT)of treatment group and control group were(22.46±11.04),(38.93±12.46)U·L^-1,glutamyl transpeptidase(GGT)were(38.03±18.02),(52.25±18.77)U·L^-1,adiponectin were(9.11±3.24),(6.36±2.22)U·L^-1,FGF21 were(142.35±30.33),(274.25±40.01)pg·mL^-1,all with significant difference(all P<0.05).Liver fat content was positively correlated with BMI,Hb A1 c,GPT,glutamic-oxaloacetic transaminase(GOT)and FGF-21,and the correlation was statistical(P<0.05).There were 4 cases of nausea and vomiting and 3 cases of diarrhea in treatment group,with the incidence of 12.07%;there were 5 cases of nausea and vomiting,4 cases of diarrhea in control group,with the incidence of 15.52%.There was no significant difference in the incidence of adverse drug reactions between the two groups(P>0.05).Conclusion Liraglutide in the treatment of T2 DM combined with NAFLD can effectively reduce the level of blood sugar and body weight,inhibit liver fat deposition,reduce liver injury.