动态监测评价那格列奈与瑞格列奈联合来得时的降糖疗效

Evaluation of treatment and safety of nateglinide compared with repaglinide plus glargine in newly diagnosed type 2 diabetic patients by continuous glucose monitoring system

目的:应用动态血糖监测系统(CGMS)评价那格列奈和瑞格列奈联合长效胰岛素来得时治疗新诊断的2型糖尿病(T2DM)患者的疗效和安全性。方法:采用随机自身交叉试验设计,选取新诊断的T2DM患者20例,在给予每晚睡前皮下注射基础胰岛素来得时将空腹血糖降至6～8 mmol.L-1基础上,维持剂量不变,按照1∶1比例随机分为两组,分别于3餐前15 min给予那格列奈(120 mg,3次.d-1)或瑞格列奈(1 mg,3次.d-1)治疗3 d,后3 d两药交叉,共计6 d,同时应用CGMS持续进行(154±6)h的血糖监测。结果:(1)那格列奈在控制餐前、餐后平均血糖水平与瑞格列奈比较,差异无统计学意义(P>0.05);(2)使用那格列奈与瑞格列奈的24 h平均血糖水平、血糖极差的差异无统计学意义(P>0.05);(3)使用那格列奈与瑞格列奈的日内血糖漂移最大幅度及平均血糖漂移幅度的差异无统计学意义(P>0.05);(4)使用那格列奈发生低血糖1次,瑞格列奈发生低血糖3次。结论:(1)三餐前口服那格列奈加睡前注射长效胰岛素类似物及三餐前口服瑞格列奈加睡前注射长效胰岛素类似物的两种治疗方案在控制血糖波动方面无明显差异;(2)那格列奈发生低血糖风险小,较瑞格列奈安全性好。

Objective： To study the characteristics of glucose excursions and safety of nateglinide versus repaglinide,combined with insulin glargine in treatment of newly diagnosed patients with type 2 diabetes by continuous glucose monitoring system.Methods： A parallel-group,randomized,and crossover trial was designed,enrolled patients（n=20）with newly diagnosed type 2 diabetes mellitus were randomly（1∶1） divided into two groups（each 10 patients）.Following addition of insulin glargine treatment to achieve a fasting blood glucose target of 6-8 mmol·L-1,one group receiving 120 mg nateglinide three times daily（t.i.d.） while the other receiving 1 mg repaglinide t.i.d.15 min before each meal in the first three days,last three days two drugs change.At the same time all patients were employed from continuous glucose monitoring system for（154±6） hours.Results：（1） There was no statistical difference in the average preprandial and postprandial glycemic levels between nateglinide and repaglinide（P0.05）;（2） There were no significant differences in the 24 hours mean blood glucose and its standard deviation between two groups（P0.05）;（3） There were no statistical differences in individual mean amplitude of glycemic excursion and the lagest amplitude of glycemic excursions（P0.05）;（4） The hypoglycemia event were three times in total in applying repaglinide,however one time in applying nateglinide.Conclusions：（1） Nateglinide and repaglinide combined with insulin glargine were similar in preprandials glucose excursions;（2） Nateglinide has less hypoglycemia event.