Department of Biomedical Sciences for Health, University of Milan, Milan, Italy; Unit of Clinical Epidemiology, IRCCS Galeazzi Orthopedic Institute, Milan, Italy.
Aliment Pharmacol Ther. 2015 Jun;41(11):1055-65. doi: 10.1111/apt.13190. Epub 2015 Apr 13.
Budesonide and mesalazine (mesalamine) are commonly used in the medical management of patients with mild to moderate Crohn's disease.
To assess their comparative efficacy and harm using the methodology of network meta-analysis.
A comprehensive search of Medline, Embase, the Cochrane Library and ClinicalTrials.gov, through October 2014, was performed to identify randomised controlled trials (RCTs) that recruited adult patients with active or quiescent Crohn's disease, and compared budesonide or mesalazine with placebo, or against each other, or different dosing strategies of one drug.
Twenty-five RCTs were combined using Bayesian network meta-analysis. Budesonide 9 mg/day, or at higher doses (15 or 18 mg/day), was shown superior to placebo for induction of remission [odds ratio (OR), 2.93; 95% credible interval (CrI), 1.52-5.39, and OR, 3.28; CrI, 1.46-7.55 respectively] and ranks at the top of the hierarchy of the competing treatments. For maintenance of remission, budesonide 6 mg/day demonstrated superiority over placebo (OR, 1.69; CrI, 1.05-2.75), being also at the best ranking position among all compared treatment strategies. No other comparisons (i.e. different doses of mesalazine vs. placebo or budesonide, for induction or maintenance of remission) reached significance. The occurrence of withdrawals due to adverse events was not shown different between budesonide, mesalazine and placebo, in both the induction and maintenance phases.
Budesonide, at the doses of 9 mg/day, or higher, for induction of remission in active mild or moderate Crohn's disease, and at 6 mg/day for maintenance of remission, appears to be the best treatment choice.
布地奈德和柳氮磺胺吡啶（美沙拉嗪）常用于轻度至中度克罗恩病患者的医学治疗。
使用网络荟萃分析方法评估其疗效和安全性。
对 Medline、Embase、Cochrane 图书馆和 ClinicalTrials.gov 进行全面检索，检索截至 2014 年 10 月，以确定招募活动期或缓解期克罗恩病成年患者的随机对照试验（RCT），并比较布地奈德或柳氮磺胺吡啶与安慰剂或彼此之间的疗效，或不同药物剂量方案。
使用贝叶斯网络荟萃分析合并了 25 项 RCT。布地奈德 9mg/天或更高剂量（15 或 18mg/天）在诱导缓解方面优于安慰剂[比值比（OR）2.93；95%可信区间（CrI）1.52-5.39 和 OR 3.28；CrI 1.46-7.55]，在竞争治疗方案中排名最高。在维持缓解方面，布地奈德 6mg/天优于安慰剂（OR 1.69；CrI 1.05-2.75），在所有比较治疗策略中也处于最佳排名。其他比较（即不同剂量的柳氮磺胺吡啶与安慰剂或布地奈德比较，用于诱导或维持缓解）均未达到统计学意义。诱导和维持缓解期，布地奈德、柳氮磺胺吡啶和安慰剂组因不良反应而停药的发生率无差异。
在活动期轻度至中度克罗恩病患者中，布地奈德 9mg/天或更高剂量诱导缓解，6mg/天维持缓解，似乎是最佳治疗选择。
