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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。
Objective To evaluate the efficacy and safety of nateglinide in the treatment of type 2 diabetes mellitus. Methods Patients with type 2 diabetes who did not use insulin-secretagogues and insulin, and those already on metformin and glucosidase inhibitors, did not. In a randomized, double-blind, repaglinide-controlled study, 240 patients (1: 1 randomized, 120 in each group) were enrolled in the study. Two hundred and one patients with type 2 diabetes who completed the study, nateglinide 115 cases, the control drug repaglinide 116 cases. The observation time was 12 weeks. The indexes before and after treatment included standard meal (0, 60, 120), blood glucose and serum insulin, HbAlc and safety index (liver and kidney function and hematuria routine). Results Compared with repaglinide, nateglinide treated patients with type 2 diabetes had similar reduction in HbAlc. The change in HbAlc before and after treatment with nateglinide was (-0.95 ± 1.32)%, (-1.22 ± 1.23)%, there was no significant difference between the two groups, but there was significant difference between before and after treatment in each group. The standard 1h and 2h postprandial blood glucose decreased significantly compared with those before treatment, before and after 2h postprandial blood glucose nateglinide treatment before and after treatment were 12.72 ± 3.84mmol / L and 10.93 ± 3 .59mmol / L (P <0.05). The levels of repaglinide before and after treatment were 13.28 ± 2.80mmol / L and 11.09 ± 3.24mmol / L respectively (P <0.05) There was no statistical difference between groups. Serum insulin levels were significantly increased at 1 h after nateglinide treatment for 12 weeks, with levels of 21.89 ± 14.01 μIU / mL and 22.41 ± 13.93 μIU / mL before and after treatment (P <0.05 ) And 22.77 ± 17.14μIU / mL and 23.06 ± 17.29μIU / mL before and after repaglinide treatment (P <0.05). There was no difference between the two groups before and after 0 and 2h treatment difference. There is no difference in safety between the two groups. Conclusion Nateglinide and repaglinide are safe and effective hypoglycemic drugs.