Hanauer S, Sandborn W J, Persson A, Persson T
University of Chicago Medical Center, Chicago, IL 60637, USA.
Aliment Pharmacol Ther. 2005 Feb 15;21(4):363-71. doi: 10.1111/j.1365-2036.2005.02338.x.
To assess the efficacy and safety of budesonide capsules 6 mg daily for prolongation of time to relapse and maintenance of remission in patients with Crohn's disease (CD) affecting the ileum and/or ascending colon.
In a double-blind, placebo-controlled, multicentre trial, 110 patients with CD, who had previously achieved remission in a placebo-controlled trial of budesonide 9 mg daily, were randomly assigned to receive budesonide 6 mg once daily or placebo for 52 weeks. Primary outcome measure was time to relapse [CD activity index (CDAI) of >150 plus an increase of at least 60 points from study entry or withdrawal due to clinical deterioration].
Median time to relapse was 360 days for budesonide patients; 169 days for placebo patients (P = 0.132). No significant differences were seen between groups in relapse rates at 1 year. Budesonide was safe and well tolerated, with a similar adverse events profile to placebo.
Patients treated with budesonide 6 mg once daily had a trend towards a prolonged time to relapse and lower CDAI scores compared with patients treated with placebo, but relapse rates were not significantly different at the 1-year end point.
评估每日服用6毫克布地奈德胶囊对延长克罗恩病（CD）累及回肠和/或升结肠患者的复发时间及维持缓解状态的疗效和安全性。
在一项双盲、安慰剂对照、多中心试验中，110例曾在每日服用9毫克布地奈德的安慰剂对照试验中实现缓解的CD患者，被随机分配接受每日一次6毫克布地奈德或安慰剂治疗52周。主要结局指标为复发时间[CD活动指数（CDAI）>150，且较研究入组时增加至少60分或因临床病情恶化而退出研究]。
布地奈德组患者的中位复发时间为360天；安慰剂组为169天（P = 0.132）。两组在1年时的复发率无显著差异。布地奈德安全且耐受性良好，不良事件情况与安慰剂相似。
与接受安慰剂治疗的患者相比，每日一次服用6毫克布地奈德治疗的患者复发时间有延长趋势且CDAI评分较低，但在1年终点时复发率无显著差异。
