国产那格列奈和进口瑞格列耐治疗2型糖尿病随机双盲平行对照多中心临床试验  

Randomized controlled multicenter clinical trial of domestic nateglinide and imported repaglinide in the treatment of types 2 diabetes

作　　者：袁戈恒[1] 陈宇[1] 郭晓蕙[1] 高妍[1] 卢纹凯[2] 陈颖丽[2] 洪旭[3] 安良[3] 丘明才[4] 朱铁红[4] 郭剑超[5] 曹风林[5] 

机构地区：[1]北京大学第一医院内分泌科,北京100034 [2]北京大学人民医院,北京100044 [3]北京友谊医院,北京100050 [4]天津医科大学总医院,天津300052 [5]天津医科大学第二医院,天津300211

出　　处：《中国临床药理学杂志》2005年第4期248-251,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的比较国产那格列奈和进口瑞格列耐治疗2型糖尿病的疗效和安全性。方法用双盲双模拟随机平行方法,210例患者经14周治疗,评价组内和组间的糖化血红蛋白、餐后血糖和安全性。结果治疗后,2组糖化血红蛋白和餐后2h血糖均显著降低。糖化血红蛋白:国产那格列奈组为(9.06±1.54)%vs(7.85±1.00)%(P<0.05);进口瑞格列耐组为(8.95±1.56)%vs(7.76±1.04)%(P<0.05)。餐后2h血糖:国产那格列奈组为(14.17±3.44)mmol·L-1vs(10.90±2.97)mmol·L-1(P<0.05);进口瑞格列耐组为(14.14±3.11)mmol·L-1vs(10.89±3.09)mmol·L-1(P<0.05)。治疗后,空腹血糖和胰岛素水平均有不同程度下降,但无统计学差异。药物不良反应主要为轻度低血糖。结论国产那格列奈与进口瑞格列耐均显著降低餐后血糖且无严重药物不良反应。Objective To compare nateglinide the efficiency and safety of domestic imported repaglinide. Methods The study was designed in double blind and double simulation fashion. Two hundreds ten patients with type 2 diabetes were randomized to two groups, one to receive domestic nateglinide （105 cases） and the other imported repaglinide （105 cases）. The study was concluded after 14 weeks. Results After 14 weeks of treatments, mean HbAlc levels of patients in both groups receiving nateglinide and repaglinide were lowered with statistical significance [ nateglinide was （9.06±1.54）% vs （7. 85 ± 1.00）%, P 〈0.05 and repaglinide was （8.95±1.56）% vs （7.76±1.04）%, P〈0.05]. The levels of postprandial plasma glucose were lowered also [ nateglinide was （14.17 ± 3.44） mmol · L^ -1 vs （ 10.90 ±2.97 ）mmol · L^ -1 , P 〈0.05 and repaglinide was （14.14±3.11） mmol· L^-1 vs （10.89±3.09） mmol· L^-1, P〈0.05]. Both fast insulin and plasma glucose levels in the testing groups were lowered as well, but the differences were not statistically significant. Major adverse effect observed was mild hypoglycemia. Conclusion With satisfactory level of safety, the domestic nateglinide and imported repaglinide demonstrated same level of efficiency in the treatment of patients with types 2 diabetes.

关 键 词：那格列奈 瑞格列耐 2型糖尿病 

分 类 号：R587.1[医药卫生—内分泌] R977.15[医药卫生—内科学]