用于治疗白风的鲁克索利提尼布奶油:随机对照的第二阶段试验
David Rosmarin1, Amit G Pandya2, Mark Lebwohl3
1Tufts Medical Center, Boston, MA, USA.
Lancet (London, England)
|July 13, 2020
概括
在白风患者中,ruxolitinib奶油在52周内显示出显著的再颜色. 这种局部治疗显示出良好的耐受性,并为治疗这种慢性自身免疫性皮肤疾病提供了一个有希望的新选择.
科学领域:
- 皮肤病学
- 免疫学
- 药理学
背景情况:
- Vitiligo 是一种慢性自身免疫性皮肤疾病,导致皮肤色素脱落,影响生活质量.
- 目前治疗白风的方法缺乏批准,现有的疗法有效性有限.
- 人们急需新有效的治疗方法来治疗白风.
研究的目的:
- 研究ruxolitinib奶油对白风的治疗潜力.
- 评估不同剂量的ruxolitinib奶油的有效性和安全性,长达52周.
- 在双盲研究中比较ruxolitinib奶油与载体对照的有效性.
主要方法:
- 一项多中心,随机,双盲的2期研究涉及157名白风患者.
- 患者被分配给接受ruxolitinib奶油 (0. 15% 1. 5% 每天一次或两次) 或载体对照剂,持续24周.
- 主要终点是在24周实现面部白风区域评分指数 (F- VASI) 的50%或更高的改善.
主要成果:
- 与载体 (3%) 相比,Ruxolitinib奶油每天两次达到F- VASI50的患者数量显著增加 (45%),每天一次达到1. 5% (50%).
- 在所有测试剂量的 ruxolitinib 乳液中观察到重颜色,长达 52 周.
- 与治疗相关的不良反应,主要是应用部位的和,在各组中均为轻度至中度.
结论:
- 卢克索利提尼布奶油治疗与多达52周的白病变重颜色相关.
- 所有经过测试的鲁克索利提尼布奶油剂量都被患者耐受良好.
- 在患有白风的患者中,ruxolitinib奶油具有潜在的有效治疗选择.
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