Naganuma Makoto, Aoyama Nobuo, Suzuki Yasuo, Nishino Haruo, Kobayashi Kiyonori, Hirai Fumihito, Watanabe Kenji, Hibi Toshifumi
Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan
Gastrointestinal Endoscopy and Inflammatory Bowel Disease Center, Aoyama Medical Clinic, Hyogo, Japan.
J Crohns Colitis. 2016 Jul;10(7):828-36. doi: 10.1093/ecco-jcc/jjv208. Epub 2015 Nov 16.
Mucosal healing is an important therapeutic goal for ulcerative colitis. Once-daily administration of budesonide 2-mg foam is widely used for inducing clinical remission. No study has assessed the usefulness of twice-daily budesonide 2mg foam on mucosal healing in ulcerative colitis patients. We explored the efficacy for mucosal healing of once- or twice-daily budesonide foam in distal ulcerative colitis patients.
This study was a multicentre, randomised, double-blind, placebo-controlled trial. In all, 165 patients with active, mild to moderate distal ulcerative colitis were randomised to three groups: once- or twice-daily budesonide 2mg/25ml foam, or placebo foam, for 6 weeks. Complete mucosal healing [endoscopic subscore = 0] and the safety profile were assessed at Week 6. Prespecified and post hoc analyses were used.
The percentages of complete mucosal healing in the twice-daily budesonide foam group were 46.4% compared with 23.6% in the once-daily group [p = 0.0097], or 5.6% in the placebo group [p < 0.0001]. The percentages of clinical remission and the percentages of endoscopic subscore ≤ 1 in the twice-daily budesonide foam group were 48.2% and 76.8%, compared with 50.9% and 69.1% in the once-daily group [no difference], or 20.4% and 46.3% in the placebo group [p = 0.0029 and p = 0.0007], respectively. In the subgroup of patients with previous use of a 5-aminosalicylic acid suppository or enema, there was a greater percentage of complete mucosal healing in the twice-daily budesonide foam group [32.0%] compared with that in the once-daily [8.7%, p = 0.0774] or placebo groups [4.8%, p = 0.0763], though there was no significant difference. No serious adverse event occurred.
A significantly greater percentage of patients receiving twice-daily administration of budesonide foam compared with once-daily administration/placebo achieved complete mucosal healing. This is the first study to evaluate the endoscopic efficacy of twice-daily administration of 6-week budesonide foam treatment for ulcerative colitis.
黏膜愈合是溃疡性结肠炎的重要治疗目标。每日一次给予2毫克布地奈德泡沫剂被广泛用于诱导临床缓解。尚无研究评估每日两次给予2毫克布地奈德泡沫剂对溃疡性结肠炎患者黏膜愈合的有效性。我们探讨了每日一次或两次给予布地奈德泡沫剂对远端溃疡性结肠炎患者黏膜愈合的疗效。
本研究为一项多中心、随机、双盲、安慰剂对照试验。总共165例活动期轻度至中度远端溃疡性结肠炎患者被随机分为三组：每日一次或两次给予2毫克/25毫升布地奈德泡沫剂，或安慰剂泡沫剂，为期6周。在第6周评估完全黏膜愈合[内镜亚评分=0]和安全性。采用预设分析和事后分析。
每日两次布地奈德泡沫剂组的完全黏膜愈合百分比为46.4%，而每日一次组为23.6%[p = 0.0097]，安慰剂组为5.6%[p < 0.0001]。每日两次布地奈德泡沫剂组的临床缓解百分比和内镜亚评分≤1的百分比分别为48.2%和76.8%，而每日一次组为50.9%和69.1%[无差异]，安慰剂组为20.4%和46.3%[p = 0.0029和p = 0.0007]。在既往使用过5-氨基水杨酸栓剂或灌肠剂的患者亚组中，每日两次布地奈德泡沫剂组的完全黏膜愈合百分比[32.0%]高于每日一次组[8.7%，p = 0.0774]或安慰剂组[4.8%，p = 0.0763]，尽管无显著差异。未发生严重不良事件。
与每日一次给药/安慰剂相比，接受每日两次布地奈德泡沫剂给药的患者实现完全黏膜愈合的百分比显著更高。这是第一项评估每日两次给予布地奈德泡沫剂6周治疗溃疡性结肠炎的内镜疗效的研究。
