布地奈德用于维持克罗恩病患者经药物诱导缓解后的缓解状态：四项随机、双盲、安慰剂对照试验的预设汇总分析
Budesonide for maintenance of remission in patients with Crohn's disease in medically induced remission: a predetermined pooled analysis of four randomized, double-blind, placebo-controlled trials.
作者信息
Sandborn William J, Löfberg Robert, Feagan Brian G, Hanauer Stephen B, Campieri Massimo, Greenberg Gordon R
机构信息
Mayo Clinic, Rochester, Minnesota 55905, USA.
出版信息
Am J Gastroenterol. 2005 Aug;100(8):1780-7. doi: 10.1111/j.1572-0241.2005.41992.x.
OBJECTIVES
To evaluate the efficacy and safety of oral budesonide for maintenance of remission in patients with mild to moderately active Crohn's disease (CD) of the ileum and/or ascending colon.
METHODS
Four double-blind, placebo-controlled trials with identical protocols were combined according to a predetermined analysis plan. Three hundred eighty patients with CD in medically induced remission (CD activity index [CDAI]< or =150) were randomized to receive oral budesonide 3 mg, 6 mg, or placebo daily for 12 months. The primary outcome measure was time to relapse (increase in CDAI of 60 points above baseline and >150).
RESULTS
The median time to relapse was 268, 170, and 154 days for budesonide 6 mg, budesonide 3 mg, and placebo groups, respectively (p= 0.0072). The frequency of adverse events and glucocorticosteroid side effects were similar in all groups.
CONCLUSION
Budesonide 6 mg/day is effective for prolonging time to relapse and for significantly reducing rates of relapse at 3 and 6 months but not 12 months in patients with CD in medically induced remission.
目的
评估口服布地奈德对轻度至中度活动性回肠和/或升结肠克罗恩病（CD）患者维持缓解的疗效和安全性。
方法
根据预先确定的分析计划，将四项方案相同的双盲、安慰剂对照试验合并。380例药物诱导缓解（克罗恩病活动指数[CDAI]≤150）的CD患者被随机分为每日口服3毫克、6毫克布地奈德或安慰剂，为期12个月。主要结局指标为复发时间（CDAI较基线增加60分且>150）。
结果
6毫克布地奈德组、3毫克布地奈德组和安慰剂组的中位复发时间分别为268天、170天和154天（p = 0.0072）。所有组的不良事件和糖皮质激素副作用发生率相似。
结论
对于药物诱导缓解的CD患者，每天6毫克布地奈德可有效延长复发时间，并显著降低3个月和6个月而非12个月时的复发率。
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