上腺素鼻喷雾改善了口服食物挑战患者的过敏症状,第三阶段试验
Motohiro Ebisawa1, Kyohei Takahashi1, Kento Takahashi1
1Department of Allergy, Clinical Research Center for Allergy and Rheumatology, NHO Sagamihara National Hospital, Kanagawa, Japan.
概括
尼菲 (Neffy) 是一种新的无针的上腺素鼻喷雾,在口服食物挑战期间有效治疗儿童的过敏反应症状. 这种创新的输送方法可能有助于克服注射恐惧,并改善严重过敏反应的治疗坚持.
科学领域:
- 过敏和免疫学 过敏和免疫学
- 儿科急救医学 儿科急救医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 上腺素注射是对过敏反应的标准一线治疗方法.
- 患者和护理人员对注射上腺素的不情愿是一个重大问题.
- 尼菲 (Neffy) 是一种上腺素鼻喷雾剂,为严重的过敏反应提供了无针替代方案.
研究的目的:
- 评估Neffy在治疗儿科患者口服食物挑战 (OFC) 诱导的过敏反应症状中的疗效.
- 评估Neffy作为一种无针的选择,用于管理食物过敏紧急情况.
主要方法:
- 第三阶段的开放性研究,涉及15名患有食物过敏的儿科患者 (6-17岁).
- 在OFC期间出现中度过敏反应症状后,患者接受了Neffy (1 mg或2 mg根据体重) .
- 剂量取决于患者的体重:1毫克15至<30公斤,2毫克≥30公斤.
主要成果:
- 所有15名患者在OFC后都出现了2级过敏反应症状.
- 在所有患者中,Neffy成功地消除了症状,平均解决时间为16分钟.
- 一名患者出现了需要肌内上腺素的双相反应;常见的不良反应包括震和鼻红斑.
结论:
- 尼菲在治疗儿童患者的OFC诱导的过敏反应症状方面表现出有效性.
- 不用注射针的Neffy可以减少对注射上腺素的犹,特别是对于那些有注射恐惧症的人.
- 尼菲代表了治疗严重过敏反应的有希望的替代方案.
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