British Columbia Children's Hospital Research Institute, Vancouver, BC, Canada; Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.
Division of Allergy and Immunology, Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada; Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, MB, Canada; Meadowood Medical Center, Winnipeg, MB, Canada.
J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2759-2767.e5. doi: 10.1016/j.jaip.2019.04.010. Epub 2019 Apr 17.
In 2017, a clinical trial of 37 subjects demonstrated that preschool peanut oral immunotherapy (P-OIT) was safe, with predominantly mild symptoms reported and only 1 moderate reaction requiring epinephrine.
We sought to examine whether these findings would be applicable in a real-world setting.
As part of a Canada-wide quality improvement project, community and academic allergists administered P-OIT to preschool-age children who had (1) skin prick test wheal diameter greater than or equal to 3 mm or specific IgE level greater than or equal to 0.35 kU/L and history of reaction and/or positive baseline oral food challenge, or (2) no ingestion history and specific IgE level greater than or equal to 5 kU/L. Over 16 to 22 weeks, patients had biweekly clinic visits for updosing, and consumed the dose daily at home between visits. Target maintenance dose was 300 mg peanut protein. Symptoms were classified using a modified World Allergy Organization Subcutaneous Immunotherapy Reaction Grading System (1 mildest, 5 fatal).
Of 270 patients who started P-OIT in the period 2017 to 2018, 243 reached maintenance, and 27 dropped out (10.0%); 67.8% of patients experienced reactions during buildup: 36.3% grade 1, 31.1% grade 2, and 0.40% grade 4. Eleven patients (4.10%) received epinephrine (10 patients received 1 dose, 1 patient received epinephrine on 2 separate days), representing 2.23% of reactions (12 of 538) and 0.029% of doses (12 of 41,020).
We are the first group to describe preschool P-OIT in a real-world multicenter setting. The treatment appears to be safe for the vast majority of patients because symptoms were generally mild and very few reactions received epinephrine; however, life-threatening reactions in a minority of patients (0.4%) can still occur.
2017 年，一项针对 37 名受试者的临床试验表明，学龄前花生口服免疫疗法（P-OIT）是安全的，报告的主要症状较轻，仅有 1 例中度反应需要使用肾上腺素。
我们旨在研究这些发现是否适用于真实环境。
作为加拿大范围内的质量改进项目的一部分，社区和学术过敏专家对有以下情况的学龄前儿童进行 P-OIT 治疗：（1）皮肤点刺试验风团直径大于或等于 3 毫米或特异性 IgE 水平大于或等于 0.35 kU/L 且有过敏反应和/或阳性基线口服食物挑战史，或（2）无摄入史且特异性 IgE 水平大于或等于 5 kU/L。在 16 至 22 周内，患者每两周进行一次诊所就诊以增加剂量，并在就诊之间每天在家中服用剂量。目标维持剂量为 300 mg 花生蛋白。使用改良的世界过敏组织皮下免疫治疗反应分级系统（1 级最轻微，5 级致命）对症状进行分类。
在 2017 年至 2018 年期间开始 P-OIT 的 270 名患者中，有 243 名达到维持剂量，27 名（10.0%）退出；67.8%的患者在建立剂量期间出现反应：36.3%为 1 级，31.1%为 2 级，0.40%为 4 级。有 11 名患者（4.10%）接受了肾上腺素治疗（10 名患者接受了 1 次剂量，1 名患者在 2 天内接受了 2 次剂量），占反应的 2.23%（538 次反应中的 12 次）和剂量的 0.029%（41020 次剂量中的 12 次）。
我们是第一个在真实环境中描述学龄前 P-OIT 的多中心小组。对于绝大多数患者来说，该治疗似乎是安全的，因为症状通常较轻，很少有反应需要使用肾上腺素，但少数患者（0.4%）仍会发生危及生命的反应。
