目的 观察达格列净联合二甲双胍治疗老年2型糖尿病(T2DM)合并非酒精性脂肪性肝病(NAFLD)患者的临床疗效和安全性.方法 入选老年T2DM合并NAFLD患者的临床资料进行分析,依据队列法分为试验组和对照组.试验组接受达格列净片(10mg,qd)联合二甲双胍(500 mg,tid)口服治疗,对照组接受西格列汀片(100 mg,qd)联合二甲双胍(500mg,tid)口服治疗,连续治疗12周.比较2组临床疗效,治疗前后体质量指数(BMI)、腰臀比(WHR)、内脏脂肪面积、肝脾密度比、肝硬度值(LSM)、糖脂代谢水平及肝功能指标,以及药物不良反应的发生情况.结果 对照组42例,试验组58例.治疗后,试验组和对照组的总有效率分别为84.48％(49例/58例)和66.67％(28例/42例),在统计学上差异有统计学意义(P＜0.05).治疗后,试验组和对照组BMI分别为(24.28±2.52)和(25.73±2.06)kg·m-2,WHR 分别为 0.71±0.13 和 0.80±0.16,内脏脂肪面积分别为(120.57±25.65)和(131.71±21.84)cm2,肝脾密度比分别为0.88±0.20和 0.79±0.18,餐后 2 h 血糖分别为(8.77±1.65)和(11.08±2.19)mmol·L-1,糖化血红蛋白分别为(7.09±1.32)％和(7.68±1.26)％,试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P＜0.05).试验组的药物不良反应主要有胃肠道反应、泌尿生殖道症状,对照组的药物不良反应主要有胃肠道反应、低血糖,试验组和对照组的总药物不良反应发生率分别为31.03％(18例/58例)和11.90％(5例/42例),在统计学上差异有统计学意义(P＜0.05).结论 达格列净联合二甲双胍治疗对老年T2DM合并NAFLD患者,临床疗效显著,能改善患者脂代谢和肝功能.
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.
徐坤;张晓敏;张燕燕;党静;李洁
兰州大学第二医院特需内科、老年病科,甘肃兰州 730030
药学
达格列净;西格列汀;二甲双胍;老年2型糖尿病;非酒精性脂肪性肝病;糖脂代谢;肝功能
dapagliflozin;sitagliptin;metformin;elderly type 2 diabetes mellitus;nonalcoholic fatty liver disease;glucose and lipid metabolism;liver function
《中国临床药理学杂志》 2024 (005)
635-639 / 5
甘肃省卫生健康行业科研基金资助项目(GSWSQN2021-008)
10.13699/j.cnki.1001-6821.2024.05.001
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