治疗慢性鼻炎的EDS-FLU疗效:两个随机对照试验 (ReOpen1和ReOpen2)
James N Palmer1, Nithin D Adappa1, Rakesh K Chandra2
1University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pa.
The journal of allergy and clinical immunology. In practice
|January 20, 2024
概括
呼气输送系统与流动 (EDS-FLU) 有效地治疗慢性鼻炎 (CRS) 症状和鼻模糊. 这种新的治疗方法为CRS患者提供了一个非手术的选择,无论多状况如何.
科学领域:
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 肺部病理学 肺部病理学
- 过敏和免疫学 过敏和免疫学
背景情况:
- 慢性鼻炎 (CRS) 是一种常见的炎症状况,影响鼻.
- 目前,没有FDA批准的药物用于没有鼻的CRS.
- 呼气输送系统与流动 (EDS-FLU) 使用新的生物力学来准鼻腔区域,包括鼻腔排水通道.
研究的目的:
- 评估EDS-FLU在治疗慢性鼻炎的疗效,不论鼻多是否存在.
- 评估EDS-FLU对CRS症状,鼻模糊化和疾病恶化的影响.
主要方法:
- 两项复制的随机化,安慰剂对照试验 (ReOpen1和ReOpen2) 在患有CRS的成年人中进行.
- 患者接受EDS-FLU (1-2喷雾/鼻孔) 或EDS-安慰剂每天两次,持续24周.
- 主要终点包括复合症状评分和通过CT扫描的ethmoid/maxillary sinus变暗.
主要成果:
- 与安慰剂相比,EDS-FLU在两个试验中显著降低了复合症状得分 (P <.001在ReOpen1;P = .011到.001在ReOpen2).
- 在EDS-FLU与安慰剂相比,观察到鼻腔暗的显著减少 (P = .045到.018在ReOpen1;P <.001到.009在ReOpen2).
- 与EDS-FLU一起,急性CRS恶化减少了56-66% (P = .001),不良事件与标准鼻内类固醇相比.
结论:
- EDS-FLU是第一个非手术治疗方法,在减少CRS的症状,鼻模糊和恶化方面表现出有效性.
- 这些发现在复制试验中和患有或没有鼻的患者中是一致的.
- 这项研究支持EDS-FLU作为治疗慢性鼻炎的新疗法.
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