Gross V, Andus T, Caesar I, Bischoff S C, Lochs H, Tromm A, Schulz H J, Bär U, Weber A, Gierend M, Ewe K, Schölmerich J
Department of Internal Medicine, Universities of Regensburg.
Eur J Gastroenterol Hepatol. 1996 Sep;8(9):905-9.
Corticosteroids are effective in acute Crohn's disease (CD). The present study assessed the effectiveness and safety of oral pH-modified release budesonide (BUD) in patients with active CD in comparison with 6-methylprednisolone (MPred).
This was a prospective multicentre, randomized, double-blind, double-dummy study.
A total of 67 patients with active CD (CDAI > 150) were included. Patients were treated with 3 x 3 mg BUD (n = 34) or MPred (n = 33) according to a weekly tapering schedule (48-32-24-20-16-12-8 mg). The primary aim was remission of CD (CDAI < 150 and decrease by at least 60 points from baseline) after eight weeks.
Baseline demographics, disease activity and localization of CD in the small bowel and the colon were similar in both treatment groups. On an intention-to-treat basis 19/34 patients in the BUD group (55.9%) and 24/33 patients in the MPred group (72.7%) were in remission after eight weeks (P = 0.237). Therapy failed in 15/34 patients (44.1%) of the BUD group and in 9/33 patients (27.3%) of the MPred group. The mean CDAI decreased from 262 +/- 50 to 118 +/- 69 in the BUD-group and from 262 +/- 81 to 95 +/- 61 in the Mored group (P = 0.183, final CDAI BUD vs. MPred). Steroid-related side effects appeared in 28.6% of the patients in the BUD group and in 69.7% of the patients in the Mored group (P = 0.0015).
Oral pH-modified release budesonide (3 x 3 mg/day) is almost as effective as a conventional corticosteroid in patients with active CD but causes significantly less corticosteroid-related side effects.
皮质类固醇对急性克罗恩病（CD）有效。本研究评估了口服pH值调节释放型布地奈德（BUD）与6-甲基泼尼松龙（MPred）相比，在活动性CD患者中的有效性和安全性。
这是一项前瞻性多中心、随机、双盲、双模拟研究。
共纳入67例活动性CD患者（CDAI>150）。患者按照每周递减方案（48-32-24-20-16-12-8mg）接受3×3mgBUD（n=34）或MPred（n=33）治疗。主要目标是8周后CD缓解（CDAI<150且较基线至少降低60分）。
两个治疗组在基线人口统计学、疾病活动度以及小肠和结肠CD的定位方面相似。在意向性治疗基础上，BUD组34例患者中有19例（55.9%）、MPred组33例患者中有24例（72.7%）在8周后缓解（P=0.237）。BUD组34例患者中有15例（44.1%）治疗失败，MPred组33例患者中有9例（27.3%）治疗失败。BUD组的平均CDAI从262±50降至118±69，MPred组从262±81降至95±61（P=0.183，最终CDAI BUD与MPred比较）。BUD组28.6%的患者出现类固醇相关副作用，MPred组69.7%的患者出现此类副作用（P=0.0015）。
口服pH值调节释放型布地奈德（3×3mg/天）在活动性CD患者中几乎与传统皮质类固醇一样有效，但引起的类固醇相关副作用明显较少。
