在患有慢性炎的患者中用维多利祖马布治疗粘膜:EARNEST,一个随机,双盲,安慰剂控制的试验
Vipul Jairath1, Brian G Feagan2, Mark S Silverberg3
1Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Alimentiv, London, Ontario, Canada.
维多利祖马布治疗显著改善了慢性炎患者的内镜结局. 14周内粘膜愈合与34周内更好的临床缓解有关.
科学领域:
- 胃肠病学 胃肠病学
- 炎症性肠道疾病研究研究
- 临床试验分析
背景情况:
- 慢性口腔炎是一种使人衰弱的疾病,影响了科乐切除术后的患者.
- 维多利祖马布是治疗包括克罗恩病在内的炎症性肠道疾病的既定治疗方法.
- 维多利祖马布在诱导慢性囊炎的粘膜愈合的疗效需要进一步研究.
研究的目的:
- 评估vedolizumab是否诱导慢性囊炎患者的粘膜愈合 (MH).
- 为了确定是否实现的MH与改善的临床结果有关.
主要方法:
- EARNEST研究:一个随机,双盲,安慰剂控制的试验.
- 在基线,第14周和第34周内镜和组织学评估.
- 普炎疾病活动指数和炎性肠病问卷缓解按MH状态的比较.
主要成果:
- 与安慰剂相比,vedolizumab显著减少了的数量和的表面积.
- 在vedolizumab组观察到更高的粘膜愈合率 (MH) (16.7%与W14的2.5%相比).
- 在第14周达到MH的患者在第14周和34周显著更高的临床缓解率.
结论:
- 维多利祖马布诱导慢性囊炎的内镜改善.
- 用维多利祖马布实现的粘膜愈合与改善的临床结果有关.
- 早期的粘膜愈合预测慢性囊炎治疗的长期临床成功.
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