Gross V, Andus T, Ecker K W, Raedler A, Loeschke K, Plauth M, Rasenack J, Weber A, Gierend M, Ewe K, Schölmerich J
Department of Internal Medicine I, University of Regensburg, Germany.
Gut. 1998 Apr;42(4):493-6. doi: 10.1136/gut.42.4.493.
The relapse rate after steroid induced remission in Crohn's disease is high.
To test whether oral pH modified release budesonide (3 x 1 mg/day) reduces the relapse rate and to identify patient subgroups with an increased risk of relapse.
In a multicentre, randomised, double blind study, 179 patients with steroid induced remission of Crohn's disease received either 3 x 1 mg budesonide (n = 84) or placebo (n = 95) for one year. The primary study aim was the maintenance of remission of Crohn's disease for one year.
Patient characteristics at study entry were similar for both groups. The relapse rate was 67% (56/84) in the budesonide group and 65% (62/95) in the placebo group. The relapse curves in both groups were similar. The mean time to relapse was 93.5 days in the budesonide group and 67.0 days in the placebo group. No prognostic factors allowing prediction of an increased risk for relapse or definition of patient subgroups who derived benefit from low dose budesonide were found. Drug related side effects were mild and no different between the budesonide and the placebo group.
Oral pH modified release budesonide at a dose of 3 x 1 mg/day is not effective for maintaining steroid induced remission in Crohn's disease.
克罗恩病患者在类固醇诱导缓解后复发率很高。
测试口服pH值修饰释放的布地奈德（3×1毫克/天）是否能降低复发率，并识别复发风险增加的患者亚组。
在一项多中心、随机、双盲研究中，179例类固醇诱导缓解的克罗恩病患者接受3×1毫克布地奈德（n = 84）或安慰剂（n = 95）治疗一年。主要研究目的是维持克罗恩病缓解一年。
两组患者入组时的特征相似。布地奈德组的复发率为67%（56/84），安慰剂组为65%（62/95）。两组的复发曲线相似。布地奈德组的平均复发时间为93.5天，安慰剂组为67.0天。未发现可预测复发风险增加的预后因素，也未发现能从低剂量布地奈德中获益的患者亚组的定义。药物相关副作用较轻，布地奈德组和安慰剂组之间无差异。
剂量为3×1毫克/天的口服pH值修饰释放布地奈德对维持克罗恩病类固醇诱导的缓解无效。
