Department of Pediatrics, Kolding Hospital, and the Institute of Regional Health Research, University of Southern Denmark, Kolding, Denmark.
Department of Paediatrics and Adolescent Medicine, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
J Allergy Clin Immunol. 2017 Dec;140(6):1616-1621.e3. doi: 10.1016/j.jaci.2016.12.990. Epub 2017 Mar 25.
Recurrent wheeze (RW) is frequent in childhood. Studies have suggested that BCG vaccination can have nonspecific effects, reducing general nontuberculosis morbidity, including respiratory tract infections and atopic diseases. The mechanisms behind these nonspecific effects of BCG are not fully understood, but a shift from a T2 to a T1 response has been suggested as a possible explanation.
We hypothesized that BCG at birth would reduce the cumulative incidence of RW during the first year of life.
The Danish Calmette Study is a multicenter randomized trial conducted from 2012-2015 at 3 Danish hospitals. The 4262 newborns of 4184 included mothers were randomized 1:1 to BCG (SSI strain 1331) or to a no-intervention control group within 7 days of birth; siblings were randomized together as one randomization unit. Exclusion criteria were gestational age of less than 32 weeks, birth weight of less than 1000 g, known immunodeficiency, or no Danish-speaking parent. Information was collected through telephone interviews and clinical examinations at 3 and 13 months of age; data collectors were blind to randomization group. RW was defined in several ways, with the main definition being physician-diagnosed and medically treated RW up to 13 months of age.
By 13 months, 211 (10.0%) of 2100 children in the BCG group and 195 (9.4%) of 2071 children in the control group had received a diagnosis of RW from a medical doctor and received antiasthma treatment (relative risk, 1.07; 95% CI, 0.89-1.28). Supplementary analyses were made, including an analysis of baseline risk factors for development of RW.
Neonatal BCG had no effect on the development of RW before 13 months of age.
反复喘息（RW）在儿童中很常见。研究表明，卡介苗（BCG）接种具有非特异性效应，可以降低非结核发病率，包括呼吸道感染和特应性疾病。BCG 这些非特异性效应的机制尚未完全阐明，但有人提出，从 T2 反应向 T1 反应的转变可能是一种解释。
我们假设出生时接种卡介苗（BCG）可降低儿童生命最初一年 RW 的累积发生率。
丹麦卡介苗研究（Danish Calmette Study）是一项多中心随机试验，于 2012 年至 2015 年在丹麦的 3 家医院进行。纳入的 4184 名产妇所生的 4262 名新生儿被 1:1 随机分配至 BCG（SSI 株 1331）组或无干预对照组，出生后 7 天内进行；兄弟姐妹作为一个随机单位一起随机分组。排除标准为胎龄<32 周、出生体重<1000g、已知免疫缺陷或无讲丹麦语的父母。通过电话访谈和 3 个月和 13 个月时的临床检查收集信息；数据收集人员对随机分组情况不知情。RW 通过多种方式定义，主要定义为医生诊断和治疗的 RW，直至 13 个月龄。
在 13 个月时，BCG 组 2100 名儿童中有 211 名（10.0%）和对照组 2071 名儿童中有 195 名（9.4%）儿童被医生诊断为 RW，并接受了哮喘治疗（相对风险，1.07；95%CI，0.89-1.28）。进行了补充分析，包括对 RW 发生的基线危险因素的分析。
新生儿接种卡介苗对 13 个月前 RW 的发生没有影响。
