消化在线: CORE I研究结果
来源：
目的：布地奈德是一种糖皮质激素，因其首先在肝脏代谢，具有最小的全身糖皮质激素活性。布地奈德MMX是一种一日一次的布地奈德口服剂型，结肠内释放布地奈德采用多矩阵系统（MMX）技术。
方法：我们进行了一项随机、双盲、双模拟、安慰剂对照试验，来评估布地奈德MMX ?诱导509名轻中度活动期溃疡性结肠炎患者缓解的效果。患者被随机分成组，服用布地奈德MMX （9mg或6mg）、美沙拉秦（2.4g，作为参照）或安慰剂8周。主要终点是在第八周达到缓解。
结果：服用9mg或6mg布地奈德MMX 或美沙拉秦的对象中，第8周的缓解率分别为17.9%、13.2%和12.1%，服用安慰剂的缓解率为7.4%(P= .0143、P= .1393、P= .2200)。服用9mg或6mg布地奈德MMX 或美沙拉秦的患者中，第8周临床改善率分别为33.3%、30.6%和33.9%，服用安慰剂的则为24.8%(P= .1420、P= .3146和P= .1189)。服用9mg或6mg布地奈德MMX 或美沙拉秦的患者中，第8周的内窥镜改善率分别为41.5%、35.5%和33.1%，服用安慰剂的则为33.1%。服用9mg或6mg布地奈德MMX?或美沙拉秦的患者中，第8周的症状改善率分别为28.5%、28.9%和25.0%，服用安慰剂的则为16.5%(P= .0258、P= .0214和P= .1025)。各组中，不良反应的频率相似。
结论：在诱导缓解轻中度活动期溃疡性结肠炎方面，布地奈德MMX （9mg）是安全的，且比安慰剂更有效。
Once-daily budesonide MMX extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study.
BACKGROUND AIMS: Budesonide is a corticosteroid with minimal systemic corticosteroid activity due to first-pass hepatic metabolism. Budesonide MMX? is a once-daily oral formulation of budesonide that extends budesonide release throughout the colon using multi-matrix system (MMX) technology.
METHODS: We performed a randomized, double-blind, double-dummy, placebo-controlled trial to evaluate the efficacy of budesonide MMX for induction of remission in 509 patients with active, mild to moderate ulcerative colitis (UC). Patients were randomly assigned to groups that were given budesonide MMX (9 mg or 6 mg), mesalamine (2.4 g, as reference), or placebo for 8 weeks. The primary end point was remission at week 8.
RESULTS: The rates of remission at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 17.9%, 13.2%, and 12.1%, respectively, compared with 7.4% for placebo (P = .0143, P = .1393, and P = .2200). The rates of clinical improvement at week 8 among patients given 9 mg or 6 mg budesonide MMX or mesalamine were 33.3%, 30.6%, and 33.9%, respectively, compared with 24.8% for placebo (P = .1420, P = .3146, and P = .1189). The rates of endoscopic improvement at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 41.5%, 35.5%, and 33.1%, respectively, compared with 33.1% for placebo. The rates of symptom resolution at week 8 among subjects given 9 mg or 6 mg budesonide MMX or mesalamine were 28.5%, 28.9%, and 25.0%, respectively, compared with 16.5% for placebo (P = .0258, P = .0214, and P = .1025). Adverse events occurred at similar frequencies among groups.
CONCLUSIONS: Budesonide MMX (9 mg) was safe and more effective than placebo in inducing remission in patients with active, mild to moderate UC.
Ref: Sandborn WJ, Travis S, Moro L, et al. Gastroenterology. 2012 Nov;143(5):1218-26.e1-2. doi: 10.1053/j.gastro.2012.08.003. Epub 2012 Aug 11.