Clinical trial of dapagliflozin in the treatment of elderly patients with type 2 diabetes mellitus complicated with nonalcoholic fatty liver disease
Objective To observe the clinical effects and safety of dapagliflozin combined with metformin in the treatment of elderly patients with type 2 diabetes mellitus(T2DM)complicated with nonalcoholic fatty liver disease(NAFLD).Methods The clinical data of enrolled elderly patients with T2DM and NAFLD were analyzed.They were divided into the treatment group and the control group according to cohort method.The treatment group was treated with oral dapagliflozin tablets(10 mg,qd)combined with metformin(500 mg,tid).The control group was treated with oral sitagliptin tablets(100 mg,qd)combined with metformin(500 mg,tid).All patients underwent 12 weeks of treatment.The two groups were compared on clinical efficacy,body mass index(BMI),waist hip ratio(WHR),visceral fat area,liver spleen density ratio,liver stiffness measurement(LSM),glucose and lipid metabolism,liver function indicators,and the occurrence of adverse drug reactions.Results There were 42 cases in control group,58 case in treatment group.After treatment,the total effective rates in the treatment group and the control group were 84.48％(49 cases/58 cases)and 66.67％(28 cases/42 cases);BMI were(24.28±2.52)and(25.73±2.06)kg·m-2;WHR were 0.71±0.13 and 0.80±0.16;visceral fat areas were(120.57±25.65)and(131.71±21.84)cm2;liver spleen density ratios were 0.88±0.20 and 0.79±0.18;2-hour postprandial blood glucose(2 h PG)levels were(8.77±1.65)and(11.08±2.19)mmol·L glycosylated hemoglobin(HbAlc)levels were(7.09±1.32)％and(7.68±1.26)％.The above indexes were significantly different between the treatment group and the control group(all P＜0.05).The total incidence rates of adverse reactions in the treatment group and the control group were 31.03％(18 cases/58 cases)and 11.90％(5 cases/42 cases),with statistically significant difference between the two groups(P＜0.05).Conclusion The treatment of dapagliflozin combined with metformin in elderly patients with T2DM and NAFLD has a significant clinical effect,which can improve lipid metabolism and liver function.
dapagliflozinsitagliptinmetforminelderly type 2 diabetes mellitusnonalcoholic fatty liver diseaseglucose and lipid metabolismliver function
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