Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study.

IF 3.4 Q2 GASTROENTEROLOGY & HEPATOLOGY
Taku Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-Ichi Iwayama, Toshifumi Hibi
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引用次数: 0

Abstract

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.

Methods: 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.

Results: 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.

Conclusions: The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

一项多中心前瞻性观察研究:布地奈德泡沫灌肠剂早期缓解肠道紧迫感,改善溃疡性结肠炎患者的生活质量。
背景/目的:肠紧迫感是决定溃疡性结肠炎(UC)患者生活质量的一个重要症状。很少有临床研究将肠促作为疗效终点。布地奈德泡沫灌肠剂对轻度至中度溃疡性结肠炎的临床和内镜改善有一定疗效。我们评估了每日两次布地奈德泡沫灌肠对 UC 患者临床症状(肠紧迫感)的改善、安全性以及治疗对生活质量的影响:这项开放标签、多中心、前瞻性观察研究包括为期4周的观察期,评估每日两次布地奈德泡沫灌肠的有效性和安全性。研究纳入了有肠道紧迫感的轻度至中度 UC 患者。患者每天通过患者报告结果电子系统或日志收集数据。主要终点是4周观察期结束时肠紧迫症状的缓解率。此外,还对大便失禁率进行了评估:共有 61 名患者入选。在接受最终评估的患者中,肠促症状缓解率为 58.5%(31/53;95% 置信区间,44.1%-71.9%)。随着时间的推移,肠促症状有所减轻,第 7 天与第 0 天相比差异显著。大便失禁从第 5 天开始呈下降趋势,第 12 天与第 0 天相比有显著差异。临床缓解率为 64.4%(38/59;95% 置信区间,50.9%-76.4%)。发生了一起与布地奈德直肠泡沫无关的不良事件:结论:研究结果表明,每天两次布地奈德泡沫灌肠可及早改善肠道紧迫感。没有观察到新的安全信号。
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来源期刊
Intestinal Research
Intestinal Research GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
7.40
自引率
10.20%
发文量
69
审稿时长
38 weeks
期刊介绍: Intestinal Research (Intest Res) is the joint official publication of the Asian Organization for Crohn''s and Colitis (AOCC), Chinese Society of IBD (CSIBD), Japanese Society for IBD (JSIBD), Korean Association for the Study of Intestinal Diseases (KASID), Taiwan Society of IBD (TSIBD) and Colitis Crohn''s Foundation (India) (CCF, india). The aim of the Journal is to provide broad and in-depth analysis of intestinal diseases, especially inflammatory bowel disease, which shows increasing tendency and significance. As a Journal specialized in clinical and translational research in gastroenterology, it encompasses multiple aspects of diseases originated from the small and large intestines. The Journal also seeks to propagate and exchange useful innovations, both in ideas and in practice, within the research community. As a mode of scholarly communication, it encourages scientific investigation through the rigorous peer-review system and constitutes a qualified and continual platform for sharing studies of researchers and practitioners. Specifically, the Journal presents up-to-date coverage of medical researches on the physiology, epidemiology, pathophysiology, clinical presentations, and therapeutic interventions of the intestinal diseases. General topics of interest include inflammatory bowel disease, colon and small intestine cancer or polyp, endoscopy, irritable bowel syndrome and other motility disorders, infectious enterocolitis, intestinal tuberculosis, and so forth. The Journal publishes diverse types of academic materials such as editorials, clinical and basic reviews, original articles, case reports, letters to the editor, brief communications, perspective, statement or commentary, and images that are useful to clinicians and researchers.
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