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在中度至重度慢性手湿疹 (DELTA 1和DELTA 2) 的成年人中使用delgocitinib奶油的有效性和安全性:多中心,随机,受控,双盲,第三阶段试验的结果

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  • 1Innovaderm Research, Montreal, QC, Canada.

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与载体奶油相比,德尔戈西提尼布奶油在治疗中度至重度的慢性手湿疹方面表现出更高的疗效. 这种局部泛Janus激酶抑制剂为患有这种衰弱性皮肤疾病的患者提供了一个有前途的新疗法.

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科学领域:

  • 皮肤病学
  • 免疫学
  • 药理学

背景情况:

  • 慢性手湿疹严重影响患者的生活质量和职业能力.
  • 这是一种炎症性,性,通常是疼痛的皮肤疾病,影响手和手腕.

研究的目的:

  • 为了评估delgocitinib奶油 (20 mg/ g) 的有效性和安全性,每天使用两次.
  • 这项研究将delgocitinib奶油与成人中度至重度慢性手湿疹的载体奶油进行了比较.

主要方法:

  • 在多个国际中心进行了3期随机双盲试验 (DELTA 1和DELTA 2).
  • 患有中度至重度慢性手湿疹的成年参与者被分为2:1接受每天两次delgocitinib奶油或载体奶油,持续16周.
  • 主要终点是根据研究人员在第16周对慢性手湿疹的总体评估 (IGA- CHE) 的治疗成功.

主要成果:

  • 在这两项试验中,与载体奶油相比,显著更高比例的患者获得了IGA- CHE治疗成功 (p≤0. 0055).
  • 在delgocitinib和载体组之间,不良事件的比例相似 (45-46% vs 45-51%).
  • 包括COVID-19和鼻炎在内的最常见的不良事件在治疗组中相似.

结论:

  • 在患有中度至重度慢性手湿疹的患者中,delgocitinib奶油显示出较高的疗效,并且在16周内耐受良好.
  • 这些发现支持delgocitinib奶油作为患者的潜在治疗方法,这些患者的疾病无法通过标准治疗得到充分控制.
  • 德尔戈西提尼布乳液是治疗慢性手湿疹的一种有价值的新疗法.