Dignass Axel, Stoynov Simeon, Dorofeyev Andrey E, Grigorieva Galina A, Tomsová Eva, Altorjay István, Tuculanu Daniel, Bunganič Ivan, Pokrotnieks Juris, Kupčinskas Limas, Dilger Karin, Greinwald Roland, Mueller Ralph
Agaplesion Markus Krankenhaus, 1st Dept. of Medicine, Goethe-University, 60431 Frankfurt am Main, Germany.
University General Hospital for Active Treatment "Tzaritza Yoanna", Clinic of Gastroenterology, 1527 Sofia, Bulgaria.
J Crohns Colitis. 2014 Sep;8(9):970-80. doi: 10.1016/j.crohns.2014.01.021. Epub 2014 Feb 15.
Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no precise recommendation for budesonide dosing due to lack of comparative data. A once-daily (OD) 9 mg dose may improve adherence and thereby efficacy.
An eight-week, double-blind, double-dummy randomised trial compared budesonide 9 mg OD versus 3mg three-times daily (TID) in patients with mild-to-moderately active ileocolonic Crohn's disease. Primary endpoint was clinical remission defined as CDAI <150 at week 8 (last observation carried forward).
The final intent-to-treat population comprised 471 patients (238 [9 mg OD], 233 [3 mg TID]). The confirmatory population for the primary endpoint analysis was the interim per protocol population (n=377; 188 [9 mg OD], 189 [3mg TID]), in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID. Clinical remission was achieved in 71.3% versus 75.1%, a difference of -3.9% (95% CI [-14.6%; 6.4%]; p=0.020 for non-inferiority). The mean (SD) time to remission was 21.9 (13.8) days versus 21.4 (14.6) days with budesonide 9 mg OD versus 3 mg TID, respectively. In a subpopulation of 122 patients with baseline SES-CD ulcer score ≥1, complete mucosal healing occurred in 32.8% (21/64) on 9 mg OD and 41.4% (24/58) on 3mg TID; deep remission (mucosal healing and clinical remission) was observed in 26.6% (17/64) and 32.8% (19/58) of patients, respectively. Treatment-emergent suspected adverse drug reactions were reported in 4.6% of 9 mg OD and 4.7% of 3 mg TID patients.
Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn's disease.
口服布地奈德9毫克/天是轻度至中度活动性回结肠克罗恩病的一线治疗方法。然而，由于缺乏比较数据，对于布地奈德的剂量没有确切的推荐。每日一次（OD）9毫克的剂量可能会提高依从性，从而提高疗效。
一项为期八周的双盲、双模拟随机试验，比较了轻度至中度活动性回结肠克罗恩病患者中布地奈德9毫克OD与每日三次（TID）3毫克的疗效。主要终点是临床缓解，定义为第8周时克罗恩病活动指数（CDAI）<150（末次观察结转）。
最终的意向性治疗人群包括471名患者（238名[9毫克OD]，233名[3毫克TID]）。主要终点分析的确证人群是中期符合方案人群（n = 377；188名[9毫克OD]，189名[3毫克TID]），其中布地奈德9毫克OD与3毫克TID相比，主要终点在统计学上非劣效。临床缓解率分别为71.3%和75.1%，差异为-3.9%（95%置信区间[-14.6%；6.4%]；非劣效性检验p = 0.020）。布地奈德9毫克OD与3毫克TID相比，达到缓解的平均（标准差）时间分别为21.9（13.8）天和21.4（14.6）天。在122名基线SES-CD溃疡评分≥1的患者亚组中，9毫克OD组的完全黏膜愈合率为32.8%（21/64），3毫克TID组为41.4%（24/58）；分别有26.6%（17/64）和32.8%（19/58）的患者实现深度缓解（黏膜愈合和临床缓解）。9毫克OD组4.6%的患者和3毫克TID组4.7%的患者报告了治疗中出现的疑似药物不良反应。
在轻度至中度活动性克罗恩病中，与每日三次3毫克给药相比，推荐剂量为9毫克/天的布地奈德采用每日一次给药，疗效和安全性不受影响。
