先前的研究在早期引入牛奶蛋白对牛奶过敏(CMA)的预防作用方面产生了相互矛盾的证据。
通过一项随机对照试验,我们试图确定早期引入牛奶配方(CMF)是否可以作为普通人群CMA一级预防的有效策略.
我们从冲绳的4家医院招募了新生儿,日本。参与者被随机分配到1至2月龄之间每天摄入至少10mL的CMF(摄入组)或避免CMF(回避组)。在避免组中,母乳喂养根据需要补充大豆配方。在6月龄时进行口服食物激发以评估CMA发育。两组均建议连续母乳喂养至6月龄。
我们确定了504名婴儿随机分为两组。总之,12名参与者的父母拒绝接受干预,研究样本包括491名参与者(摄入组242名,回避组249名),用于改良的意向治疗分析.摄入组242名成员中有2例CMA(0.8%),回避组249名参与者中有17例CMA(6.8%)(风险比=0.12;95%CI=0.01-0.50;P<.001)。风险差异为6.0%(95%CI=2.7-9.3)。两组中大约70%的参与者在6个月大时仍在母乳喂养。
在1至2月龄之间每日摄入CMF可防止CMA发展。这种策略不与母乳喂养竞争。
Previous research has produced conflicting evidence on the preventive effects of early introduction of cow\'s milk protein on cow\'s milk allergy (CMA).
Through a randomized controlled trial, we sought to determine whether the early introduction of cow\'s milk formula (CMF) could serve as an effective strategy in the primary prevention of CMA in a general population.
We recruited newborns from 4 hospitals in Okinawa, Japan. Participants were randomly allocated to ingest at least10 mL of CMF daily (ingestion group) or avoid CMF (avoidance group) between 1 and 2 months of age. In the avoidance group breast-feeding was supplemented with soy formula as needed. Oral food challenge was performed at 6 months of age to assess CMA development. Continuous breast-feeding was recommended for both groups until 6 months of age.
We identified 504 infants for randomization into the 2 groups. In all, the parents of 12 participants declined to receive the intervention, and the study sample comprised 491 participants (242 in the ingestion group and 249 in the avoidance group) for a modified intention-to-treat analysis. There were 2 CMA cases (0.8%) among the 242 members of the ingestion group and 17 CMA cases (6.8%) among the 249 participants in the avoidance group (risk ratio = 0.12; 95% CI = 0.01-0.50; P < .001). The risk difference was 6.0% (95% CI = 2.7-9.3). Approximately 70% of the participants in both groups were still being breast-fed at 6 months of age.
Daily ingestion of CMF between 1 and 2 months of age prevents CMA development. This strategy does not compete with breast-feeding.