有临床相关的高血症风险与局部clascoterone治疗吗?
James Del Rosso1, Linda Stein Gold2, Nicholas Squittieri3
1Dr. Del Rosso is with Touro University Nevada in Henderson, Nevada.
The Journal of clinical and aesthetic dermatology
|June 26, 2023
概括
克拉斯科特 1% 奶油用于治疗,显示血清的风险很小,没有严重的不良事件. 即使在年轻的患者中,也不需要监测,尽管在12岁以下的患者中观察到更高的风险.
科学领域:
- 皮肤病学 皮肤病学
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 克拉斯科特 1% 奶油是一种FDA批准的局部安德روج因受体抑制剂,用于.
- 治疗需要仔细考虑潜在的副作用,包括电解质失衡.
研究的目的:
- 为了评估高血症的发病率和临床意义,在接受 1% 克拉斯科特龙奶油治疗的患者中治疗.
- 为了评估clascoterone暴露和高卡利米亚的发展之间的相关性.
主要方法:
- 从I,II和III期临床研究中对治疗1%的克拉斯科特奶油的综合数据的分析.
- 评估报告的高血病病例,其严重程度,与治疗和患者人口统计的关系.
主要成果:
- 大约5%的克拉斯科特治疗患者和4%的车载治疗患者报告过高热血症.
- 没有报告过过高胆固醇血量病例作为不良事件,导致停药,或引起不良临床后果.
- 在clascoterone血度和高血症之间没有发现相关性.
- 较高频率的水平变化发生在12岁以下的患者中,这是未经批准的年龄组.
结论:
- 克拉斯科特 1% 奶油与高卡莱米亚的发病率较低有关,这通常不是临床显著的.
- 在经批准的患者群体中,对克拉斯科特 1% 奶油治疗时,不需要对水平进行实验室监测.
- 风险与益处的概况支持在12岁及以上的患者中使用克拉斯科特 1% 的奶油.
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