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对斑块型牛皮的Infliximab单疗法的疗效和安全性:一项随机试验
U Chaudhari1, P Romano, L D Mulcahy
1Clinical Research Center, UMDNJ-Robert Wood Johnson Medical School, 51 French Street, New Brunswick, NJ 08901-0019, USA.
Lancet (London, England)
|June 19, 2001
概括
在临床试验中,Infliximab是一种向瘤亡因子α (TNF-α) 的单克隆抗体,显著改善了中度至重度的牛皮. 与安慰剂相比,接受infliximab的患者表现出快速和大量的皮肤清除.
科学领域:
- 免疫皮肤学 免疫皮肤学
- 类风湿病学 类风湿病学
- 临床药理学 临床药理学
背景情况:
- 目前用于中度至重度牛皮的治疗方法的疗效不完全,或有毒性风险.
- 瘤亡因子α (TNF-α) 参与了牛皮的发病.
研究的目的:
- 评估TNF-α抑制剂infliximab在中度至重度斑块性牛皮患者的临床益处和安全性.
主要方法:
- 这是一项双盲随机试验,涉及33名中度至重度斑块性牛皮的患者.
- 患者在0,2和6周接受了静脉注射安慰剂,5毫克/千克的因弗力西马布或10毫克/千克的因弗力西马布.
- 在第10周使用医生的全球评估 (PGA) 评估的主要终点;治疗意图分析.
主要成果:
- 接受5毫克/公斤因弗利克西马布的82%和接受10毫克/公斤因弗利克西马布的91%的患者反应良好 (PGA评分为好,优秀或清晰),而安慰剂组的18%.
- 在infliximab组和安慰剂组之间观察到响应率的显著差异 (分别p=0.0089和p=0.0019).
- 两剂因弗力西马布的中位反应时间为4周;没有报告严重的不良事件.
结论:
- 与安慰剂相比,Infliximab单疗法在中度至严重的斑块性牛皮中显示出显著的临床益处和快速反应.
- 这些发现支持TNF-alpha在牛皮病原发生过程中的关键作用.
- 在这个患者队列中,infliximab的耐受性很好.
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