Allergy Department, 2nd Paediatric Clinic, University of Athens, Athens, Greece.
Allergy Group, Nutrition & Health Research, Nestlé Research Center, Lausanne, Switzerland.
Allergy. 2016 Nov;71(11):1575-1584. doi: 10.1111/all.12905. Epub 2016 May 13.
A major drawback of oral immunotherapy for food allergy is the possibility of severe side-effects. We assessed both safety and efficacy of a low allergenic hydrolysed egg (HydE) preparation used in a double-blind placebo-controlled randomized study in egg allergic children.
In a pilot multicentre study, 29 egg allergic patients (aged 1-5.5 years) were administered daily for 6 months 9 g HydE or placebo in a blinded, randomized manner. Safety was verified by oral food challenge to assess tolerance towards HydE at the start and efficacy by an open oral food challenge (OFC, primary outcome) at the end. Additionally, changes in basophil activation and specific IgE and IgG4 were assessed.
All egg allergic patients randomized to HydE (n = 15) tolerated the full dose at day 1 and received the maintenance dose from the start at home. No statistically significant difference was observed on the final OFC (36% and 21% had a negative OFC in the treatment and placebo groups, respectively). Specific IgG4 levels increased, while both CD203c+ and CD63+ basophils decreased significantly more over time in the treatment than in the placebo group.
HydE can be regarded as a safe, low allergenic product to use in children allergic to egg. Although not significant, HydE given for 6 months increased numerically the proportion of patients becoming tolerant to egg. HydE induced a modulation of the immune response towards better tolerance. A longer treatment period and/or a higher dose may improve the clinical outcome and should be evaluated.
口服免疫疗法治疗食物过敏的一个主要缺点是可能出现严重的副作用。我们评估了一种低变应原性水解蛋（HydE）制剂的安全性和疗效，该制剂在一项鸡蛋过敏儿童的双盲安慰剂对照随机研究中使用。
在一项试点多中心研究中，29 名鸡蛋过敏患者（年龄 1-5.5 岁）以盲法、随机方式每天接受 9 克 HydE 或安慰剂治疗 6 个月。通过口服食物挑战来评估对 HydE 的耐受性来验证安全性，并在研究结束时通过开放口服食物挑战（OFC，主要结局）来评估疗效。此外，还评估了嗜碱性粒细胞激活和特异性 IgE 和 IgG4 的变化。
所有随机接受 HydE（n=15）的鸡蛋过敏患者在第 1 天均耐受全剂量，并在家中从一开始就接受维持剂量。最终的 OFC 没有观察到统计学上的显著差异（治疗组和安慰剂组分别有 36%和 21%的患者 OFC 为阴性）。特异性 IgG4 水平升高，而治疗组的 CD203c+和 CD63+嗜碱性粒细胞随时间的推移显著减少。
HydE 可被视为一种安全、低变应原的产品，可用于鸡蛋过敏的儿童。尽管不显著，但 6 个月的 HydE 治疗增加了患者对鸡蛋产生耐受性的比例。HydE 诱导了对更好耐受性的免疫反应的调节。更长的治疗时间和/或更高的剂量可能会改善临床结局，应进行评估。
