瑞格列奈与胰岛素联合二甲双胍对初发2型糖尿病的疗效与安全性研究

Comparison of Effectivity,Security of Repaglinde and Insulin Combined with Metformin of New Diagnostic T2DM

目的比较瑞格列奈与胰岛素联合二甲双胍治疗新诊断糖化血红蛋白(HbA1 c)>8.5%的2型糖尿病患者的疗效及安全性。方法符合条件的2型糖尿病患者75名,随机分为两组,口服降糖药组(A组)40例,给予瑞格列奈;胰岛素组(B组)35例,两组均联合二甲双胍治疗。观察两组治疗8周及16周后的HbA1 c达标率、空腹及餐后2h血糖、低血糖发生率、依从性、生活质量的变化。结果 A组8周及16周时HbA1 c分别降低(3.41±1.00)%、(4.26±1.28)%;B组降低(3.61±1.63)%、(4.16±1.55)%。16周时空腹血糖A组降低(4.80±2.05)mmol/L;B组降低(4.89±2.98)mmol/L。16周时餐后血糖A组降低(8.36±4.46)mmol/L;B组降低(9.21±4.60)mmol/L。分别对照AACE(HbA1 c<6.5%)及ADA/EASD(HbA1 c<7.0%)标准,8周时A组达标率为25.0%及47.5%,B组为22.9%及51.4%;16周时A组为60.0%及87.5%,B组为45.7%及74.3%。A组患者依从性佳者比例为37/40,B组为15/35。低血糖发生次数A组20人次,轻中重次数分别为13、7及0;B组60人次,轻中重次数分别为20、40及0,B组总低血糖发生率高于A组。16周总治疗费用A组为(1835.10±759.03)元,B组为(2293.30±727.12)元。生活质量评分比较,治疗前A组(104.64±13.68)分,B组(103.80±10.93)分,16周后A组(128.74±18.10)分,B组(119.63±16.23)分,两组评分较治疗前升高,且口服药物组的生活质量较胰岛素组高。结论新诊断HbA1 c>8.5%的2型糖尿病患者,瑞格列奈联合二甲双胍与胰岛素联合二甲双胍治疗相比,两组降糖效果相当,口服药物组低血糖的发生率低,总治疗花费少,依从性好,生活质量较高。

Objective To compare the effectiveness,security of therapy with repaglinide and insulin combined with metformin of new diagnostic,HbA1c8.5% T2DM.Methods 75 patients were choosed.40 patients were given repaglinide（group A）,and the other 35 patients were given insulin（group B） combined with metformin.After 8 and 16 weeks,we observe the change of HbA1c,fasting blood glucose,postprandial blood glucose,successful control of HbA1c,incidence of hypoglycemia,score of life quality conspicuously.Results The HbA1c of group A reduced（3.41±1.00）% for 8 weeks,（4.26±1.28）% for 16 weeks;and that of group B reduced（3.61±1.63）% for 8 weeks,（4.16±1.55）% for 16 weeks.FPG of group A reduced（4.80±2.05）mmol/L,group B reduced（4.89±2.98）mmol/L for 16weeks.PPG reduced（8.36±4.46）mmol/L in group A,group B reduced（9.21±4.60）mmol/L for 16weeks.The percentage of the patients up to the standard of HbA1c6.5% and 7.0% of the group A was 25.0%,47.5% and group B 22.9%,51.4% for 8 weeks,group A 60.0%,87.5% and group B 45.7%,74.3% for 16 weeks,respectively.In group A,the rate of well compliance was 37/40.Group B was 15/35.The incidence of hypoglycemia of the group A was lower than group B.The total cost of group A was（1835.10±759.03）yuan,and（2293.30±727.12）yuan in group B.After 16 weeks,the score of life quality of the group A was better than the group B.Conclusion For the patients of new diagnostic T2DM with HbA1c above 8.5%,the effectiveness of repaglinide and insulin together with metformin was equivalency.For the group A,the incidence rate of hypoglycemia was lower,the total cost was lower,the compliance and the quality of life was better.