在棕植物性 pustulosis 的 Janus 激酶抑制剂:混合方法可行性试验 (JAKPPPOT) 协议
David Gleeson1, Sarah Chapman2, Helen McAteer3
1St. John's Institute of Dermatology, Guy's & St. Thomas' NHS Foundation Trust and King's College London, London, UK.
BMJ open
|August 21, 2025
概括
这项研究评估了使用Janus激酶 (JAK) 抑制剂的可行性,如upadacitinib,用于治疗棕植物性 pustulosis (PPP). 这些结果将指导未来对PPP患者的JAK抑制剂疗效和安全性的随机对照试验.
科学领域:
- 皮肤病学
- 免疫学
- 药理学
背景情况:
- Palmoplantar pustulosis (PPP) 是一种使人虚弱的皮肤疾病,导致疼痛的疹.
- 雅努斯酶抑制剂提供潜在的治疗途径,但具有风险,特别是在心血管因素和吸烟史的PPP患者中.
- 在大规模疗效试验之前,评估JAK抑制剂治疗的可行性至关重要.
研究的目的:
- 评估使用JAK抑制剂 (upadacitinib) 治疗手掌植物性 pustulosis 的可行性.
- 在PPP患者中评估JAK抑制剂治疗的招募,坚持和可接受性.
- 为未来PPP中JAK抑制剂的随机对照试验 (RCT) 的设计提供信息.
主要方法:
- 一个开放的,单中心的,混合方法的可行性试验,涉及20名参与者接受了8周的upadacitinib治疗.
- 与参与者,非参与者和医疗保健专业人员进行定性访谈,以探索经验.
- 混合方法分析以评估招聘,坚持和可接受性,其次要目标是招聘策略和影响规模估计.
主要成果:
- 可行性将通过招聘,坚持和可接受性的综合评估来确定.
- 定性数据将为患者和临床医生的观点提供见解.
- 将对疾病严重性的影响大小进行估计,以指导未来的样本大小计算.
结论:
- 这项可行性研究对于未来对JAK抑制剂用于手掌植物性 pustulosis的随机对照试验的规划至关重要.
- 这些发现将决定乌帕达西提尼治疗的可行性,并指导最佳的试验设计.
- 这项研究旨在建立评估JAK抑制剂在PPP中的疗效和安全性的基础.
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