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对于性结肠炎的症状缓解,Etrasimod:来自ELEVATEUC临床计划的后期分析
María Chaparro1, Remo Panaccione2, Bruce E Sands3
1Department of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Community of Madrid, Spain.
在一项III期试验中,埃特拉西莫德显著改善了性结肠炎的症状,如便频率和直肠出血. 这些症状的改善很快被观察到,并持续了长达52周.
科学领域:
- 胃肠病学
- 免疫学
- 药理学
背景情况:
- 性结肠炎 (UC) 严重影响患者的生活质量,因为症状令人烦.
- 缓解症状是UC治疗的主要目标.
- 埃特拉西莫德是一种口服的选择性酸盐受体调节剂.
研究的目的:
- 评估埃特拉西莫德在中度至重度UC患者的症状缓解方面的有效性.
- 评估与便频率,直肠出血,腹痛和肠急性相关的结果.
主要方法:
- 成年患者中度至重度UC被纳入第三期ELEVATEUC临床计划.
- 参与者被随机分配 (2:1) 接受每天一次的乙胺2 mg或安慰剂.
- 在不同的时间点评估了症状缓解,反应,完全症状缓解,便频率,直肠出血,肠急性和腹痛.
主要成果:
- 与安慰剂相比,在第12周和第52周,埃特拉西莫德在症状缓解和反应方面表现出显著的改善 (p< 0. 001).
- 从第2/4周开始,对直肠出血和便频率进行显著改善.
- 更多的患者获得了完全的症状缓解,以及肠道急迫性和腹痛的临床上有意义的改善 (p< 0. 05).
结论:
- 埃特拉西莫德在迅速改善UC症状方面是有效的,并且在第二周就观察到好处.
- 随着埃特拉西莫德的使用,症状的改善持续到第52周.
- 对于中度至重度活跃的性结肠炎,Etrasimod是一种有前途的口服治疗方案.
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