杭州浙大迪迅生物基因工程有限公司Allergy 挑战验证的过敏原标签强制性阈值：对最敏感的患者来说是多少？
发布日期：2023-10-30
——浙大迪迅 译
背景：在欧盟，食品必须标明14种主要过敏原。合理的过敏原标签需要了解来自基于人群食物挑战的阈值。本研究的目的是评估临床验证的食物过敏患者中强制性标签过敏原的阈值分布。
方法：包括在丹麦欧登塞大学医院过敏中心进行开放性口服食物挑战和双盲安慰剂对照食物挑战（DBPCFC）（2000-2022）的所有阳性数据。对于每个纳入的挑战，获得累积阈值（LOAEL）并估计NOAEL。数据被建模为区间截尾对数正态分布。
结果：总体而言，1229例患者(717例男性，986例儿童)的2612例挑战中有38例(1.5%)对<5 mg蛋白质有反应。大多数最敏感的患者反应的Sampson严重程度评分为2-3。使用间隔剔除对数正态模型，只有5组(鸡蛋、鱼、花生、牛奶、坚果)在摄入0.5 mg蛋白质后引起反应，并且在人群中频率较低。鸡蛋是最强效的过敏原，0.24%[0.13-0.44%]的鸡蛋过敏患者对<0.5 mg蛋白质的反应性，而对大多数其他过敏原产生0.5 mg蛋白质诱导剂量的过敏患者的估计比例低于0.04%。
结论：研究表明，大多数食物过敏患者都能像预期的那样耐受微量过敏性食物，而不会出现严重的过敏症状和体征。鸡蛋似乎是最容易在极低剂量下引起最敏感个体反应的食物。
原始出处
Allergy
DOI: 10.1111/all.15870
Abstract:
Background:It is mandatory to label food products with the 14 main allergens in the EU. Reasonable allergen labeling requires knowledge of population-based thresholds derived from food challenges. The aim of this study was to evaluate the threshold-distribution in clinically verified food allergic patients for allergens mandatory for labeling.
Methods:All positive open oral food challenges and double-blind placebo-controlled food challenges (DBPCFC) performed at the Allergy Center, Odense University Hospital, Denmark (2000–2022) were included. For each included challenge, the cumulative threshold (LOAEL) was obtained and NOAEL estimated. Data were modelled as an interval censored log-normal distribution.
Results:Overall, 38 of all 2612 challenges (1.5%) in 1229 patients (717 male, 986 children) reacted to <5 mg protein. The majority of the most sensitive patients reacted with a Sampson severity score of 2–3. Using interval censored log-normal models only five groups (hens´ egg, fish, peanut, milk, tree-nuts) elicited reactions after ingestion of 0.5 mg protein and in low frequencies of the population. Hen's egg was the most potent allergen, with reactivity to <0.5 mg protein in 0.24% [0.13–0.44%] of egg allergic patients while the estimated fraction of allergic patients reacting to a eliciting dose on 0.5 mg protein for most other allergens were below 0.04%.
Conclusion:Our data demonstrates that the majority of food allergic patients as expected tolerating traces of allergenic foods without developing severe allergic symptoms and signs. Hen's egg appears to be the food most likely to elicit reactions in the most sensitive individuals at very low doses.
First Author:
Charlotte G
Corresponding author:
Charlotte G
Correspondence: Mortz, Department of Dermatology and Allergy Centre, ORCA (Odense Research Center for Anaphylaxis), Odense University Hospital, Kløvervænget 15, DK-5000 Odense C, Denmark.
Email: charlotte.moertz@rsyd.dk
Allergy
[IF: 14.71]
Challenge-verified thresholds for allergens mandatory for labeling: How little is too much for the most sensitive patient?DOI: 10.1111/all.15870
Abstract:
Background:It is mandatory to label food products with the 14 main allergens in the EU. Reasonable allergen labeling requires knowledge of population-based thresholds derived from food challenges. The aim of this study was to evaluate the threshold-distribution in clinically verified food allergic patients for allergens mandatory for labeling.
Methods:All positive open oral food challenges and double-blind placebo-controlled food challenges (DBPCFC) performed at the Allergy Center, Odense University Hospital, Denmark (2000–2022) were included. For each included challenge, the cumulative threshold (LOAEL) was obtained and NOAEL estimated. Data were modelled as an interval censored log-normal distribution.
Results:Overall, 38 of all 2612 challenges (1.5%) in 1229 patients (717 male, 986 children) reacted to <5 mg protein. The majority of the most sensitive patients reacted with a Sampson severity score of 2–3. Using interval censored log-normal models only five groups (hens´ egg, fish, peanut, milk, tree-nuts) elicited reactions after ingestion of 0.5 mg protein and in low frequencies of the population. Hen's egg was the most potent allergen, with reactivity to <0.5 mg protein in 0.24% [0.13–0.44%] of egg allergic patients while the estimated fraction of allergic patients reacting to a eliciting dose on 0.5 mg protein for most other allergens were below 0.04%.
Conclusion:Our data demonstrates that the majority of food allergic patients as expected tolerating traces of allergenic foods without developing severe allergic symptoms and signs. Hen's egg appears to be the food most likely to elicit reactions in the most sensitive individuals at very low doses.
First Author:
Charlotte G
Corresponding author:
Charlotte G
Correspondence: Mortz, Department of Dermatology and Allergy Centre, ORCA (Odense Research Center for Anaphylaxis), Odense University Hospital, Kløvervænget 15, DK-5000 Odense C, Denmark.
Email: charlotte.moertz@rsyd.dk
