瑞格列奈治疗老年2型糖尿病患者的临床研究

Clinical trial of repaglinide in the treatment of elderly patients with type 2 diabetes mellitus

目的观察瑞格列奈对老年2型糖尿病(T2DM)患者糖脂代谢、血糖波动及氧化应激的影响。方法将老年T2DM患者随机分为试验组和对照组。对照组给予盐酸二甲双胍500 mg,每天2次,口服;试验组在对照组的基础上给予瑞格列奈1 mg,每天2次,口服。2组患者均连续治疗12周。比较2组治疗后血糖、血脂和体质量变化,比较治疗前后血糖波动指标、游离脂肪酸(FFA)及脂质过氧化损伤指标水平,记录治疗期间药物不良反应发生情况。结果试验组48例,对照组50例。治疗后12周,试验组的糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后2 h血糖(2 h PBG)变化值分别为(-1.48±0.42)%、(-1.76±0.51)mmol·L^(-1)和(-2.75±0.83)mmol·L^(-1),对照组分别为(-1.21±0.38)%、(-1.54±0.46)mmol·L^(-1)和(-1.91±0.62)mmol·L^(-1),差异均有统计学意义(均P<0.05)。治疗后12周,试验组的平均血糖波动幅度(MAGE)、平均血糖(MBG)、平均血糖标准差(SDBG)和最大血糖波动幅度(LAGE)分别为(3.49±0.75)、(8.27±1.17)、(1.93±0.54)和(6.76±2.03)mmol·L^(-1),对照组分别为(4.01±0.82)、(8.85±1.23)、(2.24±0.58)和(8.38±2.29)mmol·L^(-1),差异均有统计学意义(均P<0.05)。治疗后12周,试验组和对照组的超氧化物歧化酶(SOD)水平分别为(97.61±4.49)和(84.05±4.25)U·L^(-1),谷胱甘肽过氧化物酶(GSH-Px)水平分别为(105.63±5.84)和(90.26±7.63)pg·mL^(-1),8-异前列腺素2a(8-iso-PGF2a)水平分别为(10.83±1.67)和(13.94±1.85)pg·mL^(-1),差异均有统计学意义(均P<0.05)。治疗期间,2组患者药物不良反应以胃肠道反应、低血糖为主,试验组和对照组的药物不良反应总发生率分别为18.75%和12.00%,差异无统计学意义(P>0.05)。结论瑞格列奈治疗老年T2DM患者可有效改善患者血糖水平,降低血糖波动幅度,缓解氧化应激反应,在临床应用中的安全性和耐受性良好。

Objective To investigate the effect of repaglinide on glucose and lipid metabolism,blood glucose fluctuation and oxidative stress in elderly patients with type 2 diabetes mellitus(T2DM).Methods Patients with T2DM were randomly divided into treatment group and control group.The control group was treated with metformin hydrochloride 500 mg,orally,twice a day.On this basis,the treatment group was treated with repaglinide 1 mg,orally,twice a day.All patients were treated for 12 weeks.The changes in blood glucose,blood lipids and weight,and the levels of blood glucose fluctuation indicators,free fatty acids(FFA)and lipid peroxidation injury indicators before and after treatment in two groups were compared.The incidence of adverse drug reactions during treatment was recorded in two groups.Results There were 48 cases in treatment group and 50 cases in control group.At 12 weeks after treatment,the variations of glycosylated hemoglobin(Hb A1c)in treatment group and control group were(-1.48±0.42)%and(-1.21±0.38)%;the variations of fasting plasma glucose(FPG)were(-1.76±0.51)and(-1.54±0.46)mmol·L^(-1);the variations of postprandial 2-hour blood glucose(2 h PBG)were(-2.75±0.83)and(-1.91±0.62)mmol·L^(-1);mean amplitude of glycemic excursions(MAGE)were(3.49±0.75)and(4.01±0.82)mmol·L^(-1);mean blood glucose(MBG)were(8.27±1.17)and(8.85±1.23)mmol·L^(-1);standard deviation of blood glucose(SDBG)were(1.93±0.54)and(2.24±0.58)mmol·L^(-1);largest amplitude of glycemic excursions(LAGE)were(6.76±2.03)and(8.38±2.29)mmol·L^(-1).The above indexes were significantly different between control group and treatment group(all P<0.05).At 12 weeks after treatment,superoxide dismutase(SOD)levels in treatment group and control group were(97.61±4.49)and(84.05±4.25)U·L^(-1);glutathione peroxidase(GSH-Px)levels were(105.63±5.84)and(90.26±7.63)pg·m L^(-1);8-isoprostaglandin F2α(8-iso-PGF2a)levels were(10.83±1.67)and(13.94±1.85)pg·m L^(-1).The above indexes were significantly different between control group and treatment group(all P<0.05).The total incidence rates of adverse drug reactions in treatment group and control group were 18.75%and 12.00%,without statistically significant differences(P>0.05).Conclusion Repaglinide in the treatment of elderly T2DM patients can effectively improve the blood glucose level,reduce the amplitude of blood glucose fluctuation,relieve the oxidative stress response,and has a good safety and tolerance in clinical application.