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埃利亚皮克桑在耐药慢性咳中的有效性和安全性:随机化,安慰剂控制的第2b期PAGANINI研究
Peter V Dicpinigaitis1, Alyn H Morice2, Jaclyn A Smith3
1Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.
帕加尼尼研究发现,埃利亚皮克桑 (eliapixant) 对减少耐药慢性咳 (RCC) 产生了剂量反应. 然而,药物诱导的肝损伤导致了该计划的中止.
科学领域:
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
- 呼吸系统医学 呼吸系统医学
背景情况:
- 耐火性慢性咳 (RCC) 显著影响生活质量.
- P2X3受体对抗剂代表了抑制咳的新疗法标.
研究的目的:
- 评估选择性P2X3抗剂eliapixant在RCC患者中的疗效和安全性.
- 为了确定eliapixant治疗耐火性慢性咳的最佳剂量.
主要方法:
- 进行了一项2b期,随机,双盲,安慰剂控制,剂量确定研究 (PAGANINI).
- 患有RCC的成年人每天服用口服eliapixant (25 mg,75 mg,150 mg) 或安慰剂两次,持续12周.
- 主要终点是从基线24小时咳计数的变化.
主要成果:
- 在减少咳数量方面,观察到埃利亚皮克桑的统计学上显著的剂量反应.
- 最常见的不良事件是发生在剂量相关的方式的异质症.
- 报告的一例中度药物诱导的肝损伤是在最高的eliapixant剂量组.
结论:
- 埃利亚皮克桑在减少耐火性慢性咳方面表现出有效性,具有可接受的味道耐受性.
- 一个药物诱导的肝损伤病例导致加强监测和中止该计划.
- 由于安全问题,埃利亚皮克桑的进一步开发被停止.
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