Department of Medicine and Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.
Aliment Pharmacol Ther. 2016 Nov;44(10):1018-1029. doi: 10.1111/apt.13803. Epub 2016 Sep 21.
Oral corticosteroids are the mainstay treatment for induction of ulcerative colitis remission in patients failing or intolerant to aminosalicylate therapy, but the poor tolerability profile of these drugs limits their usefulness. Second-generation, gut-selective corticosteroids may offer a safe alternative to systemic agents.
To review the efficacy and safety of systemic and second-generation oral corticosteroids for the induction of remission in ulcerative colitis.
The PubMed database was searched for randomised, controlled, and open-label trials of orally administered corticosteroids published between January 1950 and September 2015. Additional trials were identified from review of citation lists. Trials that compared oral corticosteroids with non-oral agents or in combination with agents other than aminosalicylates were excluded.
Of the 240 studies identified, 21 were eligible for inclusion. Few trials directly compared oral systemic and second-generation corticosteroids (n = 4). Some second-generation corticosteroids had questionable efficacy vs. placebo or mesalazine (mesalamine), but beclomethasone dipropionate and budesonide MMX demonstrated a comparative benefit. Only beclomethasone dipropionate was similar to conventional corticosteroids for induction of remission and other clinical endpoints. Direct comparative trials for budesonide MMX were unavailable. Second-generation corticosteroids had an overall favourable safety profile, with minimal adverse effects on cardiovascular and metabolic parameters and a low incidence of adverse events.
Beclomethasone dipropionate and budesonide MMX provide greater induction of remission in ulcerative colitis than placebo or mesalazine but additional active-comparator trials are needed to firmly establish the efficacy profile vs. systemic corticosteroids. Second-generation corticosteroids have a more favourable safety and tolerability profile than systemic corticosteroids.
口服皮质类固醇是氨基水杨酸类药物治疗失败或不耐受的溃疡性结肠炎患者诱导缓解的主要治疗方法，但这些药物的耐受性差限制了其应用。第二代肠道选择性皮质类固醇可能为全身皮质类固醇提供一种安全的替代方法。
回顾用于诱导溃疡性结肠炎缓解的全身皮质类固醇和第二代口服皮质类固醇的疗效和安全性。
检索了 1950 年 1 月至 2015 年 9 月发表的口服皮质类固醇治疗溃疡性结肠炎的随机对照和开放标签试验的 PubMed 数据库。通过对参考文献的审查确定了其他试验。排除了比较口服皮质类固醇与非口服药物或与除氨基水杨酸以外的药物联合使用的试验。
在确定的 240 项研究中，有 21 项符合纳入标准。很少有试验直接比较口服全身皮质类固醇和第二代皮质类固醇（n = 4）。一些第二代皮质类固醇与安慰剂或美沙拉嗪（美沙拉嗪）相比疗效可疑，但二丙酸倍氯米松和布地奈德 MMX 显示出相当的益处。只有二丙酸倍氯米松在诱导缓解和其他临床终点方面与传统皮质类固醇相似。布地奈德 MMX 的直接比较试验不可用。第二代皮质类固醇具有总体良好的安全性，对心血管和代谢参数的不良影响最小，不良事件发生率低。
二丙酸倍氯米松和布地奈德 MMX 比安慰剂或美沙拉嗪更能诱导溃疡性结肠炎缓解，但需要更多的活性对照试验来确定与全身皮质类固醇相比的疗效特征。第二代皮质类固醇的安全性和耐受性优于全身皮质类固醇。
