Kobayashi Taku, Moriya Kei, Fujii Toshimitsu, Bamba Shigeki, Shinzaki Shinichiro, Yamada Akihiro, Hisabe Takashi, Sagami Shintaro, Hibiya Shuji, Amano Takahiro, Takatsu Noritaka, Inagaki Katsutoshi, Iwayama Ken-Ichi, Hibi Toshifumi
Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Department of Gastroenterology, Nara Medical University, Kashihara, Japan.
Intest Res. 2025 Apr;23(2):157-169. doi: 10.5217/ir.2024.00005. Epub 2024 Jul 15.
BACKGROUND/AIMS: Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%-71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%-76.4%). One adverse event not related to budesonide rectal foam occurred.
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
背景/目的：排便急迫感是决定溃疡性结肠炎（UC）患者生活质量的重要症状。很少有临床研究将排便急迫感作为疗效终点。布地奈德泡沫灌肠剂已显示出对轻至中度UC的临床和内镜改善效果。我们评估了每日两次使用布地奈德泡沫灌肠剂对UC患者临床症状（排便急迫感）的改善情况、安全性及其对生活质量的影响。
这项开放标签、多中心、前瞻性观察性研究包括一个为期4周的观察期，评估每日两次使用布地奈德泡沫灌肠剂的有效性和安全性。纳入有排便急迫感的轻至中度UC患者。患者通过电子患者报告结局系统或日志每日收集数据。主要终点是4周观察期结束时排便急迫感缓解率。还评估了大便失禁率。
共纳入61例患者。在进行最终评估的患者中，排便急迫感缓解率为58.5%（31/53；95%置信区间，44.1%-71.9%）。排便急迫感随时间下降，第7天与第0天相比有显著差异。大便失禁从第5天开始呈下降趋势，第12天与第0天相比差异得到确认。临床缓解率为64.4%（38/59；95%置信区间，50.9%-76.4%）。发生了1例与布地奈德直肠泡沫无关的不良事件。
研究结果表明，每日两次使用布地奈德泡沫灌肠剂可早期改善排便急迫感。未观察到新的安全信号。
