在诱导过敏性鼻炎期间,在重复注射neffy (上腺素鼻喷剂) 和肌肉内注射后的药理动力学和药理动力学
John Oppenheimer1, Thomas B Casale2, Jonathan M Spergel3
1Department of Internal Medicine, UMDNJ Rutgers University School of Medicine, Newark, NJ, USA.
The journal of allergy and clinical immunology. In practice
|February 13, 2026
概括
尼菲 (Neffy) 是一种无针的上腺素鼻喷雾剂,即使在过敏性鼻炎期间,它也提供了与肌内上腺素相比的可比或更好的药理动力学和药理动力学. 这项研究支持其作为严重过敏反应的耐受性良好替代品的使用.
科学领域:
- 药理学和药物输送 药理学和药物输送
- 过敏和免疫学 过敏和免疫学
背景情况:
- 尼菲是第一个无针的上腺素鼻喷雾剂,用于严重的过敏反应.
- 过敏性鼻炎对鼻上腺素吸收的影响以前尚不清楚.
研究的目的:
- 为了比较Neffy重复剂量的药理动力学 (PK) 和药理动力学 (PD) 与肌内注射 (IM) 上腺素.
- 为了评估Neffy在正常鼻子条件下以及在鼻子过敏原挑战 (NAC) 引起的过敏性鼻炎期间的性能.
- 评估重复剂量横向性对内菲的PK/PD概况的影响.
主要方法:
- 第1期,开放标签,随机化,交叉研究,对43名患有季节性过敏性鼻炎 (SAR) 的成年人进行.
- 在正常条件下,Neffy (2.0 mg + 2.0 mg) 和IM上腺素 (0.3 mg + 0.3 mg) 的比较.
- 对同一个 (R/R) 或相反的 (R/L) 鼻孔注射的Neffy和NAC后的IM上腺素的评估.
- 在剂后240分钟内测量上腺素度,血压和心率.
主要成果:
- 在这两种情况中,Neffy表现出更高或可比的Cmax,更大的早期AUC和更快的Tmax与IM上腺素相比.
- 在NAC下,Neffy R/R提供了最高的持续上腺素暴露和PD反应.
- 尼菲的R/L剂量通常与IM上腺素相当,所有不良事件都是轻微的.
结论:
- 重复服用Neffy,包括在过敏性鼻炎期间,产生与IM上腺素相比或优于PK/PD的特征.
- 这项研究支持Neffy的相同鼻孔重复剂量.
- 尼菲为需要第二剂上腺素的患者提供了一个耐受良好,无针的选择.
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