在COVID-19肺炎中使用Enpatoran:来自II期随机试验的安全性和有效性结果
John E McKinnon1, Joel Santiaguel2, Claudia Murta de Oliveira3
1Division of Infectious Disease, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
恩帕托兰是一种托尔类受体7/8抑制剂,在住院COVID-19肺炎患者中,其安全性与安慰剂相当. 虽然它没有达到主要的疗效目标,但它在二次结局方面显示出潜在的益处,因此需要进一步调查超炎症状况.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 传染性疾病 传染性疾病
背景情况:
- 严重急性呼吸道综合征冠状病毒2 (SARS-CoV-2) 诱导的促炎途径.
- 托尔类受体7和8 (TLR7/8) 在病毒感染的炎症反应中起作用.
- 恩帕托兰是TLR7/8的选择性抑制剂,研究其调节这些通路的潜力.
研究的目的:
- 评估Enpatoran在COVID-19肺炎住院患者中的安全性和有效性.
- 评估恩帕托兰对恢复时间和临床恶化的影响.
主要方法:
- 进行了一项II期,随机,双盲,安慰剂控制的研究 (NCT04448756).
- 149名患有COVID-19肺炎的住院患者每天两次接受恩帕托兰 (50毫克或100毫克) 或安慰剂,持续14天.
- 主要终点包括安全性和恢复时间 (世卫组织9分级≤3);临床恶化 (世卫组织9分级≥5) 是次要终点.
主要成果:
- 治疗引起的不良事件在所有组中都相似.
- 与安慰剂相比,Enpatoran组的严重不良事件数量较小.
- 主要疗效终点没有达到;恢复的中位时间在各组中相似,安慰剂显示出比预期更快的恢复.
结论:
- 在急性,住院COVID-19肺炎患者中,恩帕托朗耐受性良好.
- 一些次要终点表明了潜在的有益影响,特别是关于临床恶化.
- 支持对超炎性疾病,包括感染或自身免疫性疾病的恩帕托兰进行进一步的研究.
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