乌斯特基努马布治疗性结肠炎的有效性和安全性:一项巴西多中心观察性研究
Rogério Serafim Parra1, Júlio Maria Fonseca Chebli2, Matheus Freitas Cardoso de Azevedo3
1Department of Surgery and Anatomy, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.
在巴西性结肠炎 (UC) 患者实践中使用乌斯特基努马布 (UST) 显示出显著的临床和内镜改善. 该疗法表现出良好的安全性,为难以治疗的病例提供了可行的选择.
科学领域:
- 胃肠病学 胃肠病学
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
背景情况:
- 在拉丁美洲的性结肠炎 (UC) 患者中,关于乌斯提纽马布 (UST) 疗效和安全性的现实数据有限.
- 本研究通过评估巴西UC队列中的UST来解决当地数据的需求.
研究的目的:
- 描述ustekinumab (UST) 在现实世界中的有效性和安全性,多中心队列的巴西患者中度至重度的性结肠炎 (UC).
主要方法:
- 进行了一项多中心回顾性观察性队列研究.
- 包括接受UST的中度至重度UC患者,其共同主要终点是1年后临床和内镜缓解.
- 二级终点包括临床和内镜反应,无类固醇缓解和安全性评估.
主要成果:
- 在50名患者中,50.0%的患者在1年内实现了临床缓解,36.0%的患者在1年内实现了内镜缓解.
- 12-16周的临床反应为56.0%,其中68.0%在1年内显示内镜反应.
- 24个月治疗持续率为73.7%,其中18.0%因缺乏有效性而停止治疗,报告了16起严重不良事件.
结论:
- 乌斯特基努马布 (UST) 在巴西难以治疗的UC患者群体中改善了临床,生化和内镜结局的有效性.
- 在这个队列中,UST的安全性概况是有利的,并且与现有数据一致.
- 在现实环境中,UST代表了管理性结肠炎的有价值的治疗选择.
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