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.
出处
《中华内分泌代谢杂志》
CAS
CSCD
北大核心
2009年第4期386-390,共5页
Chinese Journal of Endocrinology and Metabolism
