2型糖尿病患者维格列汀与阿卡波糖单药治疗的比较研究——24周多中心、随机、双盲、双模拟、阳性对照试验  

Comparison of vildagliptin and acarbose monotherapy in patients with type 2 diabetes： a 24-week, multi-center, double-blind, double-dummy, active-controlled, randomized trial

作　　者：潘长玉[1] 姬秋和[2] 杨文英[3] 冯凭[4] 刘超[5] 阎胜利[6] 高妍[7] 翁建平[8] 高鑫[9] 宁光[10] 刘志民[11] 田浩明[12] 贾伟平 严励[14] 薛耀明 汪寅章[1] 郭晓蕙[7] 

机构地区：[1]中国人民解放军总医院内分泌科,北京100853 [2]中国人民解放军第四军医大学西京医院内分泌科,西安 [3]卫生部中日友好医院内分泌科,北京 [4]天津医科大学总医院代谢科 [5]南京大学附属第一医院内分泌科 [6]青岛大学医学院第一附属医院内分泌科 [7]北京大学第一医院内分泌科 [8]中山大学附属第一医院内分泌科,广州 [9]复旦大学附属中山医院内分泌科,上海 [10]上海交通大学医学院附属瑞金医院内分泌代谢病科 [11]中国人民解放军第二军医大学附属长征医院内分泌科 ,上海 [12]四川大学华西医院内分科 ,成都 [13]上海交通大学附属上海市第六人民医院内分泌科 [14]中山大学第二附属医院内分泌科 ,广州 [15]南方医院内分泌代谢科 ,广州

出　　处：《中华内分泌代谢杂志》2009年第4期386-390,共5页Chinese Journal of Endocrinology and Metabolism

摘　　要：目的比较2型糖尿病患者应用维格列汀或阿卡波糖进行单药治疗的有效性和耐受性。方法多中心、随机、双盲、双模拟、阳性对照试验。未经降糖药物治疗的2型糖尿病患者随机接受维格列汀（100mg／d，50mg bid，n=399）或阿卡波糖（根据耐受性调整，最大剂量300mg／d，100mg tid，n=202）治疗24周。结果维格列汀与阿卡波糖单药治疗24周后，与基线相比，校正后的HbA1c平均降幅分别为（-1．44±0．07）％和（-1．36±0．10）％，非劣效性检验成立（组间差异95％CI的上限≤0．4％），治疗有效率在两组间的差别无统计学意义（P〉0．05）。次要疗效指标空腹血糖在两组均有一定程度下降，维格列汀组下降（-1．25±0．11）mmoL／L，阿卡波糖组下降（-1．52±0．16）mmol／L，非劣效假设未得到证实（组间差异95％CI的上限〉0．6mmoL／L）。治疗后，维格列汀组体重略有下降[（-0．5±0．1）kg]，阿卡波糖组体重较基线降低[（-1．8±0．2）kg，P〈0．01]。维格列汀组和阿卡波糖组的总不良事件发生率分别为33．6％和50．0％；阿卡波糖组的胃肠道不良事件明显多于维格列汀组，分别为24．8％和11．3％（P〈0．01）。两组患者均未发生低血糖事件。结论对于未经降糖药物治疗的中国2型糖尿病患者，维格列汀降低HbA1c的作用与阿卡波糖相似，且胃肠道不良反应更少。Objective To compare the efficacy and tolerability of monotherapy with vildagliptin and acarbose in patients with type 2 diabetes （T2DM）. Methods Drug-narve T2DM patients were treated by vildagliptin（100 mg daily, given as two equally-divided doses, n=399）or acarbose （up to 300 mg daily, given as three equally-divided doses, n=202） for 24 weeks in this multi-center, randomized, double-blind, double-dummy, parallel-arm and active-controlled study. Results Vildagliptin and acarbose decreased HbA1c to a similar extent during 24-week treatment. The adjusted mean change from baseline to endpoint in HbA1c was -1. 44%in patients receiving vildagliptin and -1.36% in those receiving acarbose, meeting the statistical criterion for non-inferiority （upper limit of 95% confidence interval for between-treatment difference ≤ 0.4%）. There was no significant difference in responder rates between groups（P〉0.05）. Fasting plasma glucose（FPG） tended to decrease more with acarbose （-1.52 mmol/L）than with vildagliptin（-1.25 mmol/L）, not meeting the statistical criterion for non-ilfferiority （upper limit of 95% confidence interval for betweentreatment difference 〉0.6 mmol/L）. Body weight did not change in vildagliptin-treated patients（-0.5 kg）butdecreased in acarbose-treated patients （-1.8 kg, P〈0.01 ）. The proportion of patients experiencing any adverse event was 33. 6% vs 50. 0% in patients receiving vildagliptin or acarbose, respectively. Adverse gastrointestinal events were significantly more frequent with aearbose（24.8% ）than with vildagliptin （11.3%, P〈0.01 ）. No hypoglycemia was reported in either treatment group. Conclusion Vildagliptin is effective and well tolerated in patients with T2DM, demonstrating similar HbAlc reduction as aearbose, but with less adverse gastrointestinal event.

关 键 词：二肽基肽酶Ⅳ HbA1c 胰升糖素样肽1 肠促胰岛素 

分 类 号：R686[医药卫生—骨科学]