NIHR Southampton Respiratory Biomedical Research Unit, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
NIHR Southampton Respiratory Biomedical Research Unit, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Clinical and Experimental Sciences Academic Unit, University of Southampton Faculty of Medicine, Southampton, United Kingdom; David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Isle of Wight, United Kingdom.
J Allergy Clin Immunol. 2015 Dec;136(6):1541-1547.e11. doi: 10.1016/j.jaci.2015.04.045. Epub 2015 Jun 12.
Children born to atopic parents are at increased risk of sensitization to environmental allergens.
We sought to demonstrate proof of concept for oral immunotherapy to high-dose house dust mite (HDM) allergen in infancy in the prevention of allergen sensitization and allergic diseases.
This was a prospective, randomized, double-blind, placebo-controlled, proof-of-concept study involving 111 infants less than 1 year of age at high risk of atopy (≥ 2 first-degree relatives with allergic disease) but with negative skin prick test responses to common allergens at randomization. HDM extract (active) and appropriate placebo solution were administered orally twice daily for 12 months, and children were assessed every 3 months. Coprimary outcomes were cumulative sensitization to HDM and sensitization to any common allergen during treatment, whereas development of eczema, wheeze, and food allergy were secondary outcomes. All adverse events were recorded.
There was a significant (P = .03) reduction in sensitization to any common allergen (16.0%; 95% CI, 1.7% to 30.4%) in the active (5 [9.4%]) compared with placebo (13 [25.5%]) treatment groups. There was no treatment effect on the coprimary outcome of HDM sensitization and the secondary outcomes of eczema, wheeze, and food allergy. The intervention was well tolerated, with no differences between active and placebo treatments in numbers or nature of adverse events.
Prophylactic HDM oral immunotherapy is well tolerated in children at high heredity risk. The results met the trial's prespecified criteria for proof of concept in reducing sensitization to any allergen; however, no significant preventive effect was observed on HDM sensitization or allergy-related symptoms.
有特应性父母的儿童对环境过敏原致敏的风险增加。
我们旨在证明在婴儿期接受高剂量屋尘螨（HDM）过敏原口服免疫治疗可预防过敏原致敏和过敏性疾病的概念验证。
这是一项前瞻性、随机、双盲、安慰剂对照的概念验证研究，纳入了 111 名年龄小于 1 岁、特应性高风险（≥ 2 位一级亲属患有过敏性疾病）但在随机分组时对常见过敏原的皮肤点刺试验反应为阴性的婴儿。HDM 提取物（活性）和适当的安慰剂溶液每日口服 2 次，持续 12 个月，每 3 个月评估一次。主要结局是治疗期间 HDM 累计致敏和任何常见过敏原致敏，次要结局为湿疹、喘息和食物过敏的发展。记录所有不良事件。
与安慰剂组（13 [25.5%]）相比，活性（5 [9.4%]）治疗组中任何常见过敏原致敏率显著降低（P =.03；16.0%；95%CI，1.7%至 30.4%）。该干预措施对 HDM 致敏的主要结局和次要结局（湿疹、喘息和食物过敏）没有治疗效果。该干预措施耐受性良好，活性和安慰剂治疗组之间不良事件的数量和性质没有差异。
在高遗传风险的儿童中，预防性 HDM 口服免疫治疗耐受良好。结果符合试验预先规定的减少任何过敏原致敏的概念验证标准；然而，对 HDM 致敏或过敏相关症状未观察到显著的预防作用。
