Greenberg G R, Feagan B G, Martin F, Sutherland L R, Thomson A B, Williams C N, Nilsson L G, Persson T
Department of Medicine, University of Toronto, Ontario, Canada.
Gastroenterology. 1996 Jan;110(1):45-51. doi: 10.1053/gast.1996.v110.pm8536887.
BACKGROUND & AIMS: Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism. The efficacy and safety of an oral controlled-release preparation of budesonide for maintenance of remission was evaluated in patients with ileal or ileocecal Crohn's disease.
In a double-blind, multicenter trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg daily for 1 year. The primary outcome measure was relapse defined by a Crohn's Disease Activity Index score of > 150 and a minimum increase of 60 points.
Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 mg of budesonide and 39 days in those receiving placebo. However, at 1 year, the rate of relapse in the group receiving 6 mg of budesonide was similar to the rates in the 3-mg and placebo groups. Basal plasma cortisol levels and incidence of corticosteroid-associated effects were similar in the three groups.
Oral controlled-release budesonide (6 mg/day) was well tolerated and prolonged remission in Crohn's disease of the ileum and proximal colon, but this effect was not sustained at 1-year follow-up.
布地奈德是一种皮质类固醇，因其快速的肝脏代谢而具有高局部抗炎活性和低全身活性。对布地奈德口服控释制剂用于维持回肠或回盲部克罗恩病缓解的疗效和安全性进行了评估。
在一项双盲、多中心试验中，105例患者被随机分配接受安慰剂或每日剂量为3或6毫克的布地奈德，为期1年。主要结局指标是由克罗恩病活动指数评分>150且至少增加60分定义的复发。
接受6毫克布地奈德的患者复发或停止治疗的中位时间为178天，接受3毫克布地奈德的患者为124天，接受安慰剂的患者为39天。然而，在1年时，接受6毫克布地奈德组的复发率与3毫克组和安慰剂组相似。三组的基础血浆皮质醇水平和皮质类固醇相关效应的发生率相似。
口服控释布地奈德（6毫克/天）耐受性良好，可延长回肠和近端结肠克罗恩病的缓解期，但在1年随访时这种效果未持续。
