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Comparative safety of systemic and low‐bioavailability steroids in inflammatory bowel disease: Systematic review and network meta‐analysis

机译:炎症性肠病中系统性和低生物利用度类固醇的比较安全性:系统综述与网络荟萃分析

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Aims Oral systemic corticosteroids have been used to induce remission in patients with active inflammatory bowel disease (IBD) for over 50?years; however, the wide array of adverse events (AEs) associated with these drugs prompted the development of steroid compounds with targeted delivery and low systemic bioavailability. This study assessed corticosteroids' comparative harm using network meta‐analysis. Methods We searched PubMed, Scopus, Embase, the Cochrane Library, clinical trial registries, regulatory authorities' websites and major conference proceedings, through March 2017. Randomized controlled trials that recruited adult IBD patients and compared oral systemic corticosteroids (prednisone/prednisolone) or compounds/formulations with low systemic bioavailability (budesonide, budesonide MMX, and beclomethasone dipropionate) with placebo, or against each other, were considered eligible for inclusion. Two reviewers independently extracted study data and outcomes, and rated each trial's risk‐of‐bias. Results We identified and synthesized evidence from 31 trials including 5689 IBD patients. Budesonide MMX was associated with significantly fewer corticosteroid‐related AEs than oral systemic corticosteroids [odds ratio (OR): 0.25, 95% confidence interval (CI): 0.13–0.49] and beclomethasone (OR: 0.35, 95% CI: 0.13–1.00), but not significantly fewer AEs than budesonide (OR: 0.64, 95% CI: 0.37–1.11); it performed equally good with placebo. By contrast, the occurrence of serious AEs, and treatment discontinuations due to AEs, did not differ between the comparator treatments. Conclusions Budesonide MMX is associated with fewer corticosteroid‐related AEs than its comparator steroid treatments for adult IBD patients. Further high‐quality research is warranted to illuminate the steroid drugs' comparative safety profiles.
机译:目标口腔全身皮质类固醇已被用于诱导有活性炎症肠病(IBD)的患者缓解50多年的患者;然而,与这些药物相关的广泛不良事件(AES)促使与靶向递送和低全身性生物利用度的类固醇化合物的发展。本研究评估了使用网络META分析的皮质类固醇的比较危害。方法采用2017年3月,我们搜查了PubMed,Scopus,Embase,Cochrane图书馆,临床试验登记处,监管机构的网站和主要会议课程。招募成人IBD患者的随机对照试验和对比口腔全身皮质类固醇(泼尼松/泼尼松)或化合物/用安慰剂或互相反馈,具有低系统性生物利用度(预烯胺,美胺,Budersonemmx和Bechlomethasone二水偶联)的制剂被认为是有资格的包含。两位审稿人独立提取研究数据和结果,并评定了每次试验的偏倚风险。结果我们从31项试验中确定和综合证据,包括5689名IBD患者。与口腔系统皮质类固醇的皮质类固醇相关AES显着较少的皮质类固醇蛋白酶蛋白质MMX相关联[赔率比(或):0.25,95%置信区间(CI):0.13-0.49](或:0.35,95%CI:0.13-1.00 ),但不显着较少的AES(或:0.64,95%CI:0.37-1.11);它对安慰剂进行了同样良好的。相比之下,对比较物理处理的严重AES和治疗中断的发生并不不同。结论预升尼蛋白酶MMX与成人IBD患者的比较类固醇治疗较少的皮质类固醇相关AES相关。需要进一步的高质量研究,以照亮类固醇药物的比较安全概况。

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