Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.
Inflamm Bowel Dis. 2017 Oct;23(10):1689-1701. doi: 10.1097/MIB.0000000000001261.
The risk of corticosteroid-associated adverse events can limit the use of systemic corticosteroids. Oral, topically acting, second-generation corticosteroids that deliver drug to the site of inflammation, and biologic therapies, are effective treatment alternatives. The aim of this review was to evaluate the safety and tolerability of topically acting corticosteroids and biologic therapies versus oral systemic corticosteroids for ulcerative colitis (UC).
The PubMed database was searched for clinical and observational trials, systematic reviews, and case reports/series published between January 1950 and September 30, 2016. Search terms used included "corticosteroids," "beclomethasone dipropionate," "budesonide," "infliximab," "adalimumab," "golimumab," and "vedolizumab" in combination with "ulcerative colitis" or "inflammatory bowel disease."
A total of 582 studies were identified from PubMed searches. Only 1 direct comparative trial for oral topically acting corticosteroids and systemic corticosteroids was available, and no comparative trials versus biologic therapies were identified. In patients with mild-to-moderate UC, short-term (4-8 wk) oral beclomethasone dipropionate or oral budesonide multimatrix system demonstrated safety profiles comparable with placebo with few corticosteroid-related adverse events reported. Based on long-term data in patients with moderate-to-severe UC, biologics have a generally tolerable adverse event profile, although infections, infusion reactions, and autoimmune disorders were frequently reported.
Second-generation corticosteroids, beclomethasone dipropionate and budesonide multimatrix system, exhibited a favorable safety profile in patients with mild-to-moderate UC. For biologics, which are only indicated in moderate-to-severe UC, additional studies are needed to further ascertain the benefit to risk profile of these agents in patients with mild-to-moderate disease (see Video Abstract, Supplemental Digital Content, http://links.lww.com/IBD/B653).
皮质类固醇相关不良反应的风险会限制全身皮质类固醇的使用。局部作用的口服、第二代皮质类固醇可将药物递送至炎症部位，以及生物疗法，是有效的替代治疗方法。本综述的目的是评估局部作用皮质类固醇和生物疗法与口服全身皮质类固醇治疗溃疡性结肠炎（UC）的安全性和耐受性。
检索了 1950 年 1 月至 2016 年 9 月 30 日期间发表的临床和观察性试验、系统评价和病例报告/系列的 PubMed 数据库。使用的搜索词包括“皮质类固醇”、“二丙酸倍氯米松”、“布地奈德”、“英夫利昔单抗”、“阿达木单抗”、“戈利木单抗”和“vedolizumab”，与“溃疡性结肠炎”或“炎症性肠病”组合。
从 PubMed 搜索中确定了 582 项研究。仅找到了 1 项关于口服局部作用皮质类固醇和全身皮质类固醇的直接比较试验，也未发现与生物疗法的比较试验。在轻度至中度 UC 患者中，短期（4-8 周）口服二丙酸倍氯米松或口服布地奈德多基质系统显示出与安慰剂相当的安全性，很少有报道与皮质类固醇相关的不良反应。基于中度至重度 UC 患者的长期数据，生物制剂具有通常可耐受的不良事件谱，尽管经常报告感染、输注反应和自身免疫性疾病。
在轻度至中度 UC 患者中，第二代皮质类固醇，二丙酸倍氯米松和布地奈德多基质系统，表现出良好的安全性。对于仅在中度至重度 UC 中指征的生物制剂，需要进一步研究以进一步确定这些药物在轻度至中度疾病患者中的获益与风险谱（参见视频摘要，补充数字内容，http://links.lww.com/IBD/B653）。
