Bar-Meir S, Chowers Y, Lavy A, Abramovitch D, Sternberg A, Leichtmann G, Reshef R, Odes S, Moshkovitz M, Bruck R, Eliakim R, Maoz E, Mittmann U
Department of Gastroenterology, Chaim Sheba Medical Center, Tel Hashomer 52621, Israel.
Gastroenterology. 1998 Oct;115(4):835-40. doi: 10.1016/s0016-5085(98)70254-9.
BACKGROUND & AIMS: Budesonide (BUD) is a potent steroid that undergoes extensive first-pass metabolism. BUD incorporated in a pH-dependent formulation has been proposed as an alternative treatment for Crohn's disease (CD). The aim of this study was to compare the efficacy and safety of BUD and prednisone (PRED) in the treatment of active CD involving the terminal ileum and/or the colon.
Patients with mild to moderately active CD were included in a randomized, double-blind, double-dummy controlled trial. Patients received either 9 mg BUD once daily for 8 weeks or 40 mg PRED once daily for the first 2 weeks tapered gradually to 5 mg/day by the end of the study. Disease activity, quality of life, and laboratory parameters were recorded.
One hundred patients received BUD, and 101 patients received PRED. By intention-to-treat analysis, treatment efficacy defined as Crohn's Disease Activity Index of <150 at completion was 51% and 52.5% for the BUD and PRED groups, respectively. Twice as many responded to treatment with no side effects in the BUD compared with the PRED group (30% vs. 14%) (P = 0.006). Most of the decrease in CDAI scores occurred during the first 2 weeks.
BUD is as effective as PRED in the treatment of CD involving the terminal ileum and right colon. BUD has significantly fewer steroid-related adverse reactions.
布地奈德（BUD）是一种强效类固醇，会经历广泛的首过代谢。已提出将pH依赖性制剂中的布地奈德作为克罗恩病（CD）的替代治疗方法。本研究的目的是比较布地奈德（BUD）和泼尼松（PRED）治疗累及回肠末端和/或结肠的活动性CD的疗效和安全性。
轻度至中度活动性CD患者纳入一项随机、双盲、双模拟对照试验。患者接受每日一次9mg布地奈德治疗8周，或在研究开始的前2周每日一次40mg泼尼松治疗，到研究结束时逐渐减量至5mg/天。记录疾病活动度、生活质量和实验室参数。
100例患者接受布地奈德治疗，101例患者接受泼尼松治疗。根据意向性分析，以完成治疗时克罗恩病活动指数<150定义的治疗有效率，布地奈德组和泼尼松组分别为51%和52.5%。与泼尼松组相比，布地奈德组治疗后无副作用的患者数量是泼尼松组的两倍（30%对14%）（P = 0.006）。CDAI评分的下降大多发生在最初2周内。
布地奈德在治疗累及回肠末端和右半结肠的CD方面与泼尼松疗效相当。布地奈德与类固醇相关的不良反应明显较少。
