挪威奥斯陆大学医院Håvard Ove Skjerven团队研究了早期食物干预和皮肤润肤剂预防幼儿食物过敏的疗效。该研究于2022年6月25日发表在《柳叶刀》杂志上。

通过早期引入过敏性食物来初步预防食物过敏似乎很有希望。该研究旨在确认在普通人群的婴儿中早期引入食物或使用常规皮肤润肤剂是否可以降低食物过敏的风险。

研究组在挪威奥斯陆的奥斯陆大学医院和奥斯特福德医院信托基金会以及瑞典斯德哥尔摩的卡罗林斯卡大学医院进行了一项2×2析因、群集随机试验。在产前接受常规18周超声检查的妇女的婴儿在出生时被随机分为以下几组：（1）无干预组；（2） 皮肤干预组（皮肤润肤剂；沐浴添加剂和面霜；从2周龄到<9个月龄，每周至少4次）；（3） 食物干预组（从3月龄起早期补充喂养花生、牛奶、小麦和鸡蛋）；或（4）联合干预组（皮肤和食物干预）。参与者被随机分配（1:1:1:1），对进行临床评估的研究人员进行分组。主要结局是36个月大时对任何干预性食物过敏。主要疗效分析通过意向治疗分析进行，包括所有随机分配的参与者，以及3名撤回同意的个体。

研究组招募了2697名共妊娠2701次的女性，其中2397名新生儿于2015年4月14日至2017年4月11日期间出生。在这些婴儿中，597名被随机分配到无干预组，575名被分配到皮肤干预组，642名被分配到食物干预组，583名被分配到联合干预组。无干预组、食物干预组和皮肤干预组各有1名参与者撤回了同意书，因此未纳入任何分析。

44名儿童被诊断为食物过敏；非干预组596名婴儿中有14名（2.3%），皮肤干预组574名婴儿中有17名（3.0%），食物干预组641名婴儿中有6名（0.9%），联合干预组583名婴儿中有7名（1.2%）。32名儿童诊断为花生过敏，12名儿童诊断为鸡蛋过敏，4名儿童诊断为牛奶过敏。没有儿童对小麦过敏。与无食物干预组相比，食物干预组的食物过敏率有所降低（优势比[OR]为0.4），但与皮肤干预组相比（1.3）没有显著的交互作用。每预防一名儿童的食物过敏需要63名儿童早期接触过敏性食物。未观察到严重不良事件。

研究结果表明，对于一般人群，从3月龄开始接触过敏性食物可减少36月龄时的食物过敏率。早期引入常见过敏性食物是预防食物过敏的安全有效策略。

附：英文原文

Title: Early food intervention and skin emollients to prevent food allergy in young children (PreventADALL): a factorial, multicentre, cluster-randomised trial

Author: Hvard Ove Skjerven, Anine Lie, Riyas Vettukattil, Eva Maria Rehbinder, Marissa LeBlanc, Anna Asarnoj, Kai-Hkon Carlsen, shild Wik Despriee, Martin Frdig, Sabina Wrnberg Gerdin, Berit Granum, hrefna Katrín Gudmundsdóttir, Guttorm Haugen, Gunilla Hedlin, Geir Hland, Christine Monceyron Jonassen, Linn Landr, Caroline-Aleksi Olsson Mgi, Inge Christoffer Olsen, Knut Rudi, Carina Madelen Saunders, Marius Kurs Skram, Anne Cathrine Staff, Cilla Sderhll, Sandra G Tedner, Sigve Aadalen, Hilde Aaneland, Bjrn Nordlund, Karin C Ldrup Carlsen

Issue&Volume: 2022/06/25

Abstract:

Background

Primary prevention of food allergy by early introduction of allergenic foods seems promising. We aimed to determine whether early food introduction or the application of regular skin emollients in infants from a general population reduced the risk of food allergy.

Methods

This 2×2 factorial, cluster-randomised trial was done at Oslo University Hospital and stfold Hospital Trust, Oslo, Norway, and Karolinska University Hospital, Stockholm, Sweden. Infants of women recruited antenatally at the routine 18-week ultrasound examination were cluster-randomised at birth to the following groups: (1) no intervention group; (2) the skin intervention group (skin emollients; bath additives and facial cream; from age 2 weeks to <9 months, both at least four times per week); (3) the food intervention group (early complementary feeding of peanut, cow's milk, wheat, and egg from age 3 months); or (4) combined intervention group (skin and food interventions). Participants were randomly assigned (1:1:1:1) using computer-generated randomisation based on clusters of 92 geographical areas and eight 3-month time blocks. Study personnel performing clinical assessments were masked to group allocation. The primary outcome was allergy to any interventional food at 36 months of age. The primary efficacy analysis was done by intention-to-treat analysis, which included all participants who were randomly assigned, apart from three individuals who withdrew their consent. This was a study performed within ORAACLE (the Oslo Research Group of Asthma and Allergy in Childhood; the Lung and Environment). This study is registered as ClinicalTrials.gov, NCT02449850.

Findings

We recruited 2697 women with 2701 pregnancies, from whom 2397 newborn infants were enrolled between April 14, 2015, and April 11, 2017. Of these infants, 597 were randomly assigned to the no intervention group, 575 to the skin intervention group, 642 to the food intervention group, and 583 to the combined intervention group. One participant in each of the no intervention, food intervention, and skin intervention groups withdrew consent and were therefore not included in any analyses. Food allergy was diagnosed in 44 children; 14 (2·3%) of 596 infants in the non-intervention group, 17 (3·0%) of 574 infants in the skin intervention group, six (0·9%) of 641 infants in the food intervention group, and seven (1·2%) of 583 infants in the combined intervention group. Peanut allergy was diagnosed in 32 children, egg allergy in 12 children, and milk allergy in four children. None had allergy to wheat. Prevalence of food allergy was reduced in the food intervention group compared with the no food intervention group (risk difference –1·6% [95% CI –2·7 to –0·5]; odds ratio [OR] 0·4 [95% CI 0·2 to 0·8]), but not compared with the skin intervention group (0·4% [95% CI –0·6 to 1· 5%]; OR 1·3 [0·7 to 2·3]), with no significant interaction effect (p=1·0). Preventing food allergy in one child required early exposure to allergenic foods in 63 children. No serious adverse events were observed.

Interpretation

Exposure to allergenic foods from 3 months of age reduced food allergy at 36 months in a general population. Our results support that early introduction of common allergenic foods is a safe and effective strategy to prevent food allergy.

DOI: 10.1016/S0140-6736(22)00687-0

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00687-0/fulltext