那格列奈片治疗2型糖尿病安全性和有效性的临床观察

目的评价那格列奈片治疗2型糖尿病的有效性和安全性。方法 2型糖尿病患者未使用促胰岛素分泌剂以及胰岛素的患者,已经使用二甲双胍和葡萄糖苷酶抑制剂者剂量不变。采用5个中心、随机、双盲、瑞格列奈片对照研究,计划入选240例患者(1:1随机,每组120例),完成研究的2型糖尿病患者231例,那格列奈组115例,对照药物瑞格列奈116例。观察时间12周,治疗前后观察指标包括标准餐(0、60、120分)取血测定血糖和血清胰岛素水平、HbAlc和安全性指标(肝肾功能、血尿常规)。结果与瑞格列奈片相比,那格列奈片治疗2型糖尿病患者 HbAlc下降水平相似,治疗前后HbAlc的变化那格列奈片为(-0．95±1．32)％,瑞格列奈片为(-1．22±1．23)％, 两组之间没有统计学差异,但是每组治疗前后相比均具有统计学差异。标准餐后1h和2h血糖两组较治疗前相比均有统计学意义的下降,餐后2h血糖那格列奈组治疗前后分别为12．72±3．84mmol／L和10．93±3．59mmol／L(P <0．05),瑞格列奈组治疗前后分别为13．28±2．80mmol／L和11．09±3．24mmol／L(P<0．05),但两组之间比较没有统计学差异。使用那格列奈治疗12周后标准餐1h血清胰岛素水平显著升高,治疗前后的水平分别为21．89± 14．01μIU／mL和22．41±13．93μIU／mL(P<0．05),瑞格列奈组治疗前后分别为22．77±17．14μIU／mL和23.06± 17．29μIU／mL(P<0．05),两组之间比较和0分及2h治疗前后均没有差别。两组安全性方面没有差别。结论那格列奈和瑞格列奈一样是安全有效的降血糖药物。

Clinical evaluation of efficacy and safety of nateglinide in the treatment of type 2 diabetes

Objective To evaluate the efficacy and safety of new antidiabetic agent nateglinide in the treatment of type 2 diabetes. Methods Five center 231 type 2 diabetic patients without using insulintropic drugs or insulin randomly assigned in ratio 1 : 1 to nateglinide group or repaglinide group in double blind way. The whole observation lasted for 12 weeks. Before and after 12 weeks treatment all subjects were performed stand meal test to measure the blood glucose and serum insulin, HbAlc and safety markers include liver and renal function, regular test for blood and urine. Results Similar decreases in fasting blood glucose, 2h postprandial blood glucose and HbAlc were found in both nateglinide and repaglinide groups. 2h postprandial after standard meal in Nateglinide group before treatment was 12.72 ±3.84mmol/L decreased to 10.93 ± 3.59mmol/L( P <0.05) after 12 weeks treatment was comparable with that in repaglinide group before 13.28 ± 2.80mmol/L decreased to 11.09 ± 3.24mmol/L(P< 0.05) after 12 treatment . After treatment HbAlc changed from baseline in nateglinide group was(-0. 95 ±1. 32) % , and that in repaglinide group was ( - 1.22 ± 1.23) %. There was no difference between the two groups. Both nateglinide and repaglinide treatment can increase serum insulin levels at 1h after standard meal 21.89 ± 14.01μIU/mL and 22.41 ± 13.93μIU/mL( P <0.05) ;22.77 ±17. 14μIU/mL and 23.06 ± 17.29μIU/mL P <0. 05) , respectively. There was no safety concern of the two drugs. The hypoglycemia event reports not increased in nateglinide group. Conclusion nateglinide is efficacy and safety drug in treatment of type 2 diabetes mellitus.