中国临床药理学杂志2011，Vol.27Issue(1)：15-18,4.
牛蒡子苷治疗糖尿病肾病的随机双盲安慰剂多中心Ⅲ期临床试验
Double-blind,randomized,placebo-controlled multi-centre phase Ⅲ clinical trial of Arctiin granule in the treatment of diabetic nephropathy
摘要
Abstract
Objective To evaluate the safety and efficacy of Arctiin granule in the treatment of patients suffering from diabetic nephropathy.Methods The clinical trials were designed multicentered, doubleblind, double -dummy, randomized and parallel placebo controlled. Eligible patients were coequal to receive the Arctiin granule and placebo.All patients received diabetes fundamental drugs. Meanwhile, those assigned to the test team were administrated one pack of Arctiin granule three times daily with lukewarm water after every meal, those assigned to the control group were received one pack of placebo three times daily with lukewarm water after every meal. The treatment lasted 8 weeks. The 24 - hours urine albumin excretion ( UAE, mg · 24 h - 1 ) and 24 - hours urine protein quantitative (UPQ, mg · 24 h-1) were used as the assessment index of therapeutic effect. Four hundreds thirty - one patients participated in the trials, excluding 20 cases; the per - protocol set was 411. Results The clinical control rates were 64. 82％, 19. 61％ in Arctiin granule group and placebo control, respectively. And the clinical control rates were significantly differences observed among the two groups (P ＜ 0. 05 ). After treatment the 24 -hours urine albumin excretion ( UAE, mg/24 h) and 24 - hours urine protein quantitative ( UPQ, mg ·24 h- 1 )in Arctiin granule group all significantly lower than placebo control (P ＜ 0. 05). Conclusion The results show that Arctiin granule has a definite effect on patients suffering from diabetic nephropathy with good clinatiale effect and safety.关键词
牛蒡子苷/糖尿病肾病分类
医药卫生引用本文复制引用
马松涛,刘冬恋,牛锐,刘睿斌,吉勤,詹继红,史伟,张磊..牛蒡子苷治疗糖尿病肾病的随机双盲安慰剂多中心Ⅲ期临床试验[J].中国临床药理学杂志,2011,27(1):15-18,4.基金项目
国家"十一五""重大新药创制科技重大专项"课胚基金资助项目(2008ZX09101-Z-019) （2008ZX09101-Z-019）
