Papi C, Luchetti R, Gili L, Montanti S, Koch M, Capurso L
Department of Gastroenterology and Internal Medicine, General Hospital S. Filippo Neri, Rome, Italy.
Aliment Pharmacol Ther. 2000 Nov;14(11):1419-28. doi: 10.1046/j.1365-2036.2000.00867.x.
To perform a meta-analysis to assess the effectiveness and safety of oral budesonide for inducing remission in active Crohn's disease and for preventing relapse in Crohn's disease with medically- or surgically-induced remission.
All randomized, double-blind controlled trials involving oral budesonide therapy in Crohn's disease were retrieved from a Medline search, reviews articles or their bibliographies. Of 83 articles retrieved, 12 met the inclusion criteria. Data extraction was performed by three independent observers and scoring disagreements were resolved by consensus.
Six trials tested budesonide in active disease and six in quiescent disease. Budesonide was less effective than conventional corticosteroids for inducing remission of active Crohn's disease (pooled rate difference, RD -8.5%; 95% CI: -16.4 to -0.7%; P=0.02), but corticosteroid-related adverse events were reduced (RD -22.4%; 95% CI: -32 to -12.8%; P < 0.001). In quiescent Crohn's disease, budesonide was as effective as placebo for preventing relapse in medically induced remission (RD -0.8%; 95% CI: -9.9 to 8.3%; P=0.42) and endoscopic recurrence in surgically induced remission (RD -3.5%; 95% CI: -16.9 to 9.8%; P=0.30). In the long term treatment, budesonide had an occurrence rate of corticosteroid-related adverse effects similar to placebo (RD 5.3%; 95% CI: -3.9 to 14.5%; P=0.30).
Budesonide is significantly less effective than conventional corticosteroids for inducing remission in active Crohn's disease, but the risk of corticosteroid-related adverse effects is significantly reduced. Budesonide is not effective in preventing relapse of Crohn's disease after medically- or surgically-induced remission.
进行一项荟萃分析，以评估口服布地奈德诱导活动期克罗恩病缓解以及预防经药物或手术诱导缓解后的克罗恩病复发的有效性和安全性。
通过检索Medline、综述文章或其参考文献，获取所有涉及口服布地奈德治疗克罗恩病的随机双盲对照试验。在检索到的83篇文章中，12篇符合纳入标准。由三名独立观察者进行数据提取，评分分歧通过协商解决。
六项试验在活动期疾病中测试布地奈德，六项在静止期疾病中测试。布地奈德在诱导活动期克罗恩病缓解方面比传统皮质类固醇效果差（合并率差，RD -8.5%；95%可信区间：-16.4至-0.7%；P=0.02），但与皮质类固醇相关的不良事件减少（RD -22.4%；95%可信区间：-32至-12.8%；P<0.001）。在静止期克罗恩病中，布地奈德在预防药物诱导缓解后的复发方面与安慰剂效果相同（RD -0.8%；95%可信区间：-9.9至8.3%；P=0.42），在预防手术诱导缓解后的内镜复发方面也与安慰剂效果相同（RD -3.5%；95%可信区间：-16.9至9.8%；P=0.30）。在长期治疗中，布地奈德与皮质类固醇相关的不良反应发生率与安慰剂相似（RD 5.3%；95%可信区间：-3.9至14.5%；P=0.30）。
布地奈德在诱导活动期克罗恩病缓解方面明显不如传统皮质类固醇有效，但与皮质类固醇相关的不良反应风险显著降低。布地奈德在预防经药物或手术诱导缓解后的克罗恩病复发方面无效。
Zotero 插件