Kuenzig M Ellen, Rezaie Ali, Kaplan Gilaad G, Otley Anthony R, Steinhart A Hillary, Griffiths Anne Marie, Benchimol Eric I, Seow Cynthia H
CHEO Inflammatory Bowel Disease Centre, Division of Gastroenterology Hepatology & Nutrition, Children's Hospital of Eastern Ontario, Ontario, Ottawa, Canada.
Department of Medicine, Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
J Can Assoc Gastroenterol. 2018 Dec;1(4):159-173. doi: 10.1093/jcag/gwy018. Epub 2018 May 24.
Budesonide is an oral glucocorticoid designed for the treatment of inflammatory bowel disease (IBD) that may reduce systemic adverse events (AEs). This review examined the efficacy and safety of budesonide for the induction and maintenance of clinical remission in Crohn's disease (CD).
MEDLINE, EMBASE, other electronic databases, reference lists and conference proceedings were searched to November 2017 to identify randomized controlled trials of budesonide. Outcomes were the induction and maintenance of remission at eight weeks and one year, respectively, as well as corticosteroid-related AEs and abnormal adrenocorticotropic hormone (ACTH) tests. Pooled relative risks (RRs) and 95% confidence intervals (CIs) were estimated using random effects models.
Thirteen induction and 10 maintenance trials were included. Budesonide 9 mg/day was more effective than placebo (RR 1.93; 95% CI, 1.37-2.73; GRADE: moderate) but less effective than conventional steroids (RR 0.85; 95% CI, 0.75-0.97; GRADE: moderate) to induce remission. Corticosteroid-related AEs occurred less often with induction doses of budesonide than steroids (RR 0.64; 95% CI, 0.54-0.76; GRADE: moderate); budesonide did not increase AEs relative to placebo (RR 0.97; 95% CI, 0.76-1.23; GRADE: moderate). Budesonide 6 mg/day was not different from placebo for maintaining remission (RR 1.13; 95% CI, 0.94-1.35; GRADE: moderate). Both induction (GRADE: low for 3 mg/day, moderate for 9 mg/day) and maintenance budesonide treatment (GRADE: very low for 3 mg/day, low for 6 mg/day) increased the risk of an abnormal ACTH test compared with placebo, but less than conventional steroids (GRADE: very low for both induction and maintenance).
For induction of clinical remission, budesonide was more effective than placebo, but less effective than conventional steroids. Budesonide was not effective for the maintenance of remission. Budesonide was safer than conventional steroids, but the long-term effects on the adrenal axis and bone health remain unknown.
布地奈德是一种用于治疗炎症性肠病（IBD）的口服糖皮质激素，可能会减少全身性不良事件（AE）。本综述研究了布地奈德在诱导和维持克罗恩病（CD）临床缓解方面的疗效和安全性。
检索MEDLINE、EMBASE、其他电子数据库、参考文献列表和会议论文集至2017年11月，以识别布地奈德的随机对照试验。结局分别为8周和1年时缓解的诱导和维持，以及与皮质类固醇相关的AE和促肾上腺皮质激素（ACTH）试验异常。使用随机效应模型估计合并相对风险（RR）和95%置信区间（CI）。
纳入了13项诱导试验和10项维持试验。布地奈德9毫克/天在诱导缓解方面比安慰剂更有效（RR 1.93；95% CI，1.37 - 2.73；证据质量等级：中等），但比传统类固醇效果差（RR 0.85；95% CI，0.75 - 0.97；证据质量等级：中等）。与类固醇相比，布地奈德诱导剂量时与皮质类固醇相关的AE发生频率更低（RR 0.64；95% CI，0.54 - 0.76；证据质量等级：中等）；与安慰剂相比，布地奈德未增加AE（RR 0.97；95% CI，0.76 - 1.23；证据质量等级：中等）。布地奈德6毫克/天在维持缓解方面与安慰剂无差异（RR 1.13；95% CI，0.94 - 1.35；证据质量等级：中等）。与安慰剂相比，诱导（3毫克/天证据质量等级：低，9毫克/天证据质量等级：中等）和维持布地奈德治疗（3毫克/天证据质量等级：极低，6毫克/天证据质量等级：低）均增加了ACTH试验异常的风险，但低于传统类固醇（诱导和维持证据质量等级均为极低）。
对于诱导临床缓解，布地奈德比安慰剂更有效，但比传统类固醇效果差。布地奈德对维持缓解无效。布地奈德比传统类固醇更安全，但其对肾上腺轴和骨骼健康的长期影响仍未知。
