每日一次布地奈德 MMX®缓释肠溶片治疗轻中度溃疡性结肠炎的缓解效果：CORE I 研究结果。

Once-daily budesonide MMX® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study.

机构信息

University of California San Diego, La Jolla, California.

Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, England.

出版信息

Gastroenterology. 2012 Nov;143(5):1218-1226.e2. doi: 10.1053/j.gastro.2012.08.003. Epub 2012 Aug 11.

DOI:10.1053/j.gastro.2012.08.003

PMID:22892337

Abstract

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.

摘要

背景与目的

布地奈德是一种糖皮质激素，由于其在肝脏的首过代谢作用，具有最小的全身糖皮质激素活性。布地奈德 MMX®是一种每日一次的口服布地奈德制剂，通过多基质系统 (MMX) 技术在整个结肠中延长布地奈德的释放。

方法

我们进行了一项随机、双盲、双模拟、安慰剂对照试验，以评估布地奈德 MMX 在 509 例活动期轻度至中度溃疡性结肠炎 (UC) 患者中的诱导缓解疗效。患者被随机分为布地奈德 MMX（9mg 或 6mg）、美沙拉嗪（2.4g，作为参考）或安慰剂组，治疗 8 周。主要终点是第 8 周时的缓解率。

结果

与安慰剂组（7.4%）相比，接受 9mg 或 6mg 布地奈德 MMX 或美沙拉嗪治疗的患者在第 8 周时的缓解率分别为 17.9%、13.2%和 12.1%（P=0.0143，P=0.1393，P=0.2200）。在第 8 周时，接受 9mg 或 6mg 布地奈德 MMX 或美沙拉嗪治疗的患者的临床改善率分别为 33.3%、30.6%和 33.9%，而安慰剂组为 24.8%（P=0.1420，P=0.3146，P=0.1189）。在第 8 周时，接受 9mg 或 6mg 布地奈德 MMX 或美沙拉嗪治疗的患者的内镜改善率分别为 41.5%、35.5%和 33.1%，而安慰剂组为 33.1%。在第 8 周时，接受 9mg 或 6mg 布地奈德 MMX 或美沙拉嗪治疗的患者的症状缓解率分别为 28.5%、28.9%和 25.0%，而安慰剂组为 16.5%（P=0.0258，P=0.0214，P=0.1025）。各组不良反应发生率相似。