INTRODUCTION Outcomes and safety of budesonide maintenance therapy in microscopic colitis (MC) are not well known. METHODS Adult residents of Olmsted County, Minnesota, diagnosed with MC (2002-2019) and treated with budesonide were identified using the Rochester Epidemiology Project. Response was assessed at 12 ± 4 weeks after initiation of therapy and defined as complete (resolution of diarrhea), partial (≥50% improvement in the number of bowel movements), nonresponse (<50% improvement), and intolerance (discontinued because of side effects). For safety outcomes, cases (budesonide maintenance) and MC controls (no budesonide therapy) were matched by sex and age at diagnosis (±2 years). RESULTS A total of 450 patients were identified, of whom 162 (36.0%) were treated with budesonide for induction of clinical remission (median age 67 [23-91] years and 126 women [77.8%] ). Clinical outcomes for induction were as follows: 130 (80.2%) complete response, 22 (13.6%) partial response, 8 (4.9%) no response, and 2 (1.2%) intolerance. After induction, 96 (63.2%) had recurrence after discontinuation, of whom 27 (28.1%) required further budesonide induction treatment without maintenance, 56 (58.3%) required long-term budesonide maintenance, and 13 (13.5%) were treated with other therapies. Of those receiving budesonide maintenance, all responded (55 [98.2%] complete and 1 [1.8%] partial). No patient stopped maintenance from adverse events. The median duration of follow-up was 5.6 years (0.3-18.9). There was no significant difference between cases and controls in the incidence of osteopenia/osteoporosis, diabetes mellitus, hypertension, glaucoma, or cataracts. DISCUSSION The long-term use of budesonide in MC seems to be effective and generally well tolerated with limited adverse effects.

中文翻译：

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布地奈德维持治疗显微镜下结肠炎：基于人群的研究的临床结果和安全性概况。

引言 布地奈德维持治疗治疗微小结肠炎 (MC) 的结果和安全性尚不清楚。方法 使用罗切斯特流行病学项目对明尼苏达州奥姆斯特德县诊断为 MC（2002-2019 年）并接受布地奈德治疗的成年居民进行识别。治疗开始后 12 ± 4 周评估疗效，定义为完全（腹泻消退）、部分（排便次数改善≥50%）、无反应（改善<50%）和不耐受（因以下原因中止）副作用）。对于安全结果，病例（布地奈德维持治疗）和 MC 对照（无布地奈德治疗）按诊断时的性别和年龄（±2 岁）进行匹配。结果 总共确定了 450 名患者，其中 162 名 (36.0%) 接受布地奈德治疗以诱导临床缓解（中位年龄 67 [23-91] 岁，其中 126 名女性 [77.8%]）。诱导的临床结果如下：130 例（80.2%）完全缓解，22 例（13.6%）部分缓解，8 例（4.9%）无缓解，2 例（1.2%）不耐受。诱导后，96例（63.2%）停药后复发，其中27例（28.1%）需要进一步布地奈德诱导治疗而不维持，56例（58.3%）需要长期布地奈德维持治疗，13例（13.5%）接受其他治疗疗法。在接受布地奈德维持治疗的患者中，全部有反应（55 例 [98.2%] 完全缓解，1 例 [1.8%] 部分缓解）。没有患者因不良事件而停止维持治疗。中位随访时间为 5.6 年 (0.3-18.9)。病例和对照之间骨质减少/骨质疏松症、糖尿病、高血压、青光眼或白内障的发生率没有显着差异。讨论 长期使用布地奈德治疗 MC 似乎是有效的，并且通常耐受性良好，不良反应有限。