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目的评价艾塞那肽对2型糖尿病(T2DM)合并非酒精性脂肪性肝病(NAFLD)患者的疗效,并探讨其作用机制及临床安全性。方法选取张家港市中医院2014年1月-2015年11月收治的T2DM伴发NAFLD患者96例,使用数字法随机分为对照组和治疗组,每组48人。对照组患者口服二甲双胍,起始剂量500 mg/次,2次/d,结合具体病情调整药物剂量;治疗组在对照组基础上加用艾塞那肽注射液,早餐前60 min、晚餐前60 min 5μg皮下注射,均连续用药24周。比较治疗前后两组空腹血糖(FBG)、餐后血糖(PPG)、三酰甘油(TG)、总胆固醇(TC)、丙氨酸氨基转移酶(ALT)和天门冬氨酸氨基转移酶(AST)的变化,临床有效率及不良反应情况;ELISA法检测成纤维细胞生长因子19(FGF19)和FGF21表达的变化。结果两组治疗后FBG、PPG、TG、TC、ALT、AST、BMI、腰围、B超肝内贮脂量均显著减低(P<0.05、0.01),且治疗组均显著低于对照组(P<0.05)。两组治疗后FGF19和FGF21表达均显著升高(P<0.05、0.01),且治疗组FGF19和FGF21表达显著高于对照组(P<0.05)。治疗组的临床治疗有效率为85.4%,显著优于对照组的64.6%(P<0.05);治疗组不良反应率为12.5%,对照组的为10.4%,两组比较无显著性差异(P>0.05)。结论艾塞那肽联合二甲双胍对T2DM伴发NAFLD患者的血糖、血脂以及肝功能具有显著的改善作用,临床使用有效且安全。
Objective To evaluate the efficacy of exenatide in patients with type 2 diabetes mellitus (T2DM) complicated with non-alcoholic fatty liver disease (NAFLD) and its mechanism of action and clinical safety. Methods 96 cases of T2DM with NAFLD admitted from January 2014 to November 2015 in Zhangjiagang Hospital of Traditional Chinese Medicine were randomly divided into control group and treatment group with 48 in each group. Patients in the control group were given metformin orally at the initial dose of 500 mg twice daily for 72 hours. The treatment group was given exenatide injection on the basis of the control group, 60 minutes before breakfast and 60 minutes before dinner min 5μg subcutaneous injection, continuous medication for 24 weeks. The levels of fasting blood glucose (FBG), postprandial blood glucose (PPG), triglyceride (TG), total cholesterol (TC), alanine aminotransferase (ALT) and aspartate aminotransferase ) Changes, clinical efficiency and adverse reactions; ELISA method to detect changes in fibroblast growth factor 19 (FGF19) and FGF21 expression. Results After treatment, FBG, PPG, TG, TC, ALT, AST, BMI, waist circumference and B-liver all significantly decreased in the liver (P <0.05,0.01), and the treatment group were significantly lower than the control group <0.05). The expression of FGF19 and FGF21 in both groups were significantly increased (P <0.05, 0.01), and the expression of FGF19 and FGF21 in the treatment group was significantly higher than that in the control group (P <0.05). The effective rate of clinical treatment in the treatment group was 85.4%, which was significantly better than that in the control group (64.6%, P <0.05). Adverse reaction rate was 12.5% in the treatment group and 10.4% in the control group. There was no significant difference between the two groups > 0.05). Conclusions Exenatide combined with metformin can significantly improve blood glucose, blood lipid and liver function in T2DM patients with NAFLD, and its clinical application is effective and safe.