阿格列汀联合二甲双胍治疗老年2型糖尿病患者的临床研究OACSTPCD
Clinical trial of alogliptin combined with metformin in the treatment of elderly patients with type 2 diabetes mellitus
目的 观察阿格列汀联合二甲双胍治疗老年2型糖尿病(T2DM)的临床疗效.方法 将二型糖尿病患者按照治疗方案分为对照组和试验组.对照组予以二甲双胍,初始剂量每次0.5 g,qd,根据血糖控制情况和耐受性逐渐增加剂量,最大剂量每天2.0 g;试验组在二甲双胍组的基础上加服阿格列汀,初始剂量每次25 mg,qd,根据耐受性逐渐增加至每天50 mg.2组疗程均为3个月,比较2组患者的血糖水平、血糖波动情况、胰岛β细胞功能指标,并评估药物不良反应发生情况.结果 对照组入组48例,试验组入组42例.试验组、对照组治疗后空腹血糖(FBG)分别为(6.07±0.89)和(6.87±0.82)mmol·L-1,餐后 2 小时血糖(2 h PG)分别为(7.86±1.59)和(8.92±1.65)mmol·L-1,糖化血红蛋白(HbA1c)分别为(6.45±0.53)％、(7.01±0.58)％,血糖波动幅度(MAGE)分别为(2.76±0.83)和(3.37±0.89)mmol·L-1,日间血糖平均绝对值(MODD)分别为(1.51±0.44)和(1.98±0.52)mmol·L-1,血糖标准差(SD)分别为(1.07±0.27)和(1.41±0.33)mmol·L-1,空腹胰岛素(FINS)分别为(14.64±2.47)和(9.40±2.85)μU·L-1,C-肽分别为(1.82±0.45)和(1.41±0.49)μg·L-1,胰岛素抵抗指数(HOMA-IR)分别为2.34±0.52和2.87±0.64;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).试验组治疗期间发生低血糖3例、消化系统反应5例、头晕2例(4.76％)、皮疹2例,对照组发生低血糖2例、消化系统反应4例、头晕1例、皮疹1例,试验组和对照组药物不良反应发生率分别为28.57％和16.67％,2组药物不良反应发生率比较,在统计学上差异无统计学意义(P＞0.05).结论 阿格列汀联合二甲双胍治疗老年T2DM有利于改善胰岛β细胞功能,对于控制血糖、维持血糖稳定具有显著效果.
Objective To observe the clinical efficacy of alogliptin combined with metformin in the treatment of elderly patients with type 2 diabetes mellitus(T2DM).Methods Patients with type 2 diabetes were divided into control group and treatment group according to the treatment plan.The control group was given metformin,the initial dose was 0.5 g each time,qd,and the dose was gradually increased according to blood glucose control and tolerance,the maximum dose was 2.0 g per day.The treatment group was supplemented with alogliptin on the basis of metformin group,the initial dose was 25 mg each time,and the dose was gradually increased to 50 mg per day according to tolerance.The treatment course of the two groups were 3 months.The blood glucose level,blood glucose fluctuation and islet β cell function indexes of the two groups were compared,and the occurrence of adverse drug reactions were evaluated.Results There were 48 cases in the control group and 42 cases in the treatment group.Fasting blood glucose(FBG)in treatment group and control group after treatment were(6.07±0.89)and(6.87±0.82)mmol·L-1;and 2 h postprandial blood glucose(2 h PG)were(7.86±1.59)and(8.92±1.65)mmol·L-1,respectively;hemoglobin A1e(HbA1c)were(6.45±0.53)％,(7.01±0.58)％,respectively;mean amplituse of glycemic excusions(MAGE)were(2.76±0.83)and(3.37±0.89)mmol·L-1,respectively;the mean absolute value of daily blood glucose(MODD)were(1.51±0.44)and(1.98±0.52)mmol·L-1,and the standard deviation(SD)were(1.07±0.27)and(1.41±0.33)mmol·L-1,respectively;fasting insulin(FINS)were(14.64±2.47)and(9.40±2.85)μU·L-1;C-peptide(1.82±0.45)and(1.41±0.49)μg·L-1,respectively;insulin resistance index(HOMA-IR)were 2.34±0.52 and 2.87±0.64,respectively;compared with control group,the above indexes in treatment group had statistical significance(all P＜0.05).During treatment,3 cases of hypoglycemia,5 cases of digestive system reaction,2 cases of dizziness(4.76％),and 2 cases of rash occurred in the test group,while 2 cases of hypoglycemia,4 cases of digestive system reaction,1 case of dizziness,and 1 case of rash occurred in the control group.The incidence of adverse drug reactions in the test group and the control group were 28.57％and 16.67％,respectively.The difference was not statistically significant(P＞0.05).Conclusion Alogliptin combined with metformin in the treatment of elderly T2DM can improve the function of islet βcells,and has a significant effect on controlling and maintaining blood glucose stability.
王海彦;桑丽丽
聊城市人民医院老年医学科,山东聊城 252000
药学
阿格列汀二甲双胍老年2型糖尿病临床疗效胰岛β细胞功能
alogliptinmetforminelderlytype 2 diabetes mellitusclinical efficacypancreatic islet β cell function
《中国临床药理学杂志》 2024 (002)
170-174 / 5
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