Thøstesen Lisbeth Marianne, Kjaer Henrik Fomsgaard, Pihl Gitte Thybo, Nissen Thomas Nørrelykke, Birk Nina Marie, Kjaergaard Jesper, Jensen Aksel Karl Georg, Aaby Peter, Olesen Annette Wind, Stensballe Lone Graff, Jeppesen Dorthe Lisbeth, Benn Christine Stabell, Kofoed Poul-Erik
Department of Pediatrics, Kolding Hospital, Kolding, Denmark.
Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark.
Pediatr Allergy Immunol. 2017 Sep;28(6):588-596. doi: 10.1111/pai.12748.
Vaccination with Bacillus Calmette-Guérin (BCG) is used in many countries as protection against tuberculosis. Studies have suggested that BCG may also have non-specific effects, reducing non-tuberculosis mortality, morbidity, and atopic manifestations. In this study, we evaluated the effect of neonatal BCG vaccination on allergic sensitization and suspected food allergy at 13 months of age.
The Danish Calmette Study was conducted from 2012 to 2015 at three Danish hospitals. Within 7 days of birth, the 4262 newborns of 4184 included mothers were randomized 1:1 to BCG or to a no-intervention control group. Exclusion criteria were gestational age <32 weeks, birth weight <1000 g, known immunodeficiency, or no Danish-speaking parent. Follow-up information was collected through telephone interviews at 3 and 13 months of age. Subgroups of participants were offered blood sampling at 13 months of age.
By 13 months of age, the parents and/or general practitioners of 5.6% (117/2089) of the children in the BCG group and 6.1% (126/2061) of the control group suspected food allergy, resulting in a risk ratio comparing BCG-vaccinated children with control children of 0.91 (95% CI 0.71-1.16). Among 1370 blood samples, sensitization (Phadiatop Infant >0.35 kUA/L) was found in 55 of 743 (7.4%) children in the BCG group and 50 of 627 (8.0%) of the control group (risk ratio 0.94 [0.65-1.36]).
In this randomized clinical trial, neonatal BCG had no significant effect on suspected food allergy or on sensitization at 13 months of age.
许多国家使用卡介苗（BCG）接种来预防结核病。研究表明，卡介苗可能还具有非特异性作用，可降低非结核性死亡率、发病率和特应性表现。在本研究中，我们评估了新生儿卡介苗接种对13个月大时过敏性致敏和疑似食物过敏的影响。
丹麦卡介苗研究于2012年至2015年在丹麦的三家医院进行。在出生7天内，4184名纳入研究的母亲所生的4262名新生儿被1:1随机分为卡介苗接种组或无干预对照组。排除标准为孕周<32周、出生体重<1000克、已知免疫缺陷或无会说丹麦语的家长。随访信息通过在3个月和13个月大时的电话访谈收集。部分参与者亚组在13个月大时接受了血液采样。
到13个月大时，卡介苗接种组5.6%（117/2089）的儿童的父母和/或全科医生怀疑有食物过敏，对照组为6.1%（126/2061），卡介苗接种儿童与对照儿童的风险比为0.91（95%CI 0.71 - 1.16）。在1370份血液样本中，卡介苗接种组743名儿童中有55名（7.4%）出现致敏（婴儿Phadiatop>0.35 kUA/L），对照组627名儿童中有50名（8.0%）出现致敏（风险比0.94 [0.65 - 1.36]）。
在这项随机临床试验中，新生儿卡介苗接种对13个月大时的疑似食物过敏或致敏没有显著影响。
