Takahashi Masaya, Taniuchi Shoichiro, Soejima Kazuhiko, Hatano Yasuko, Yamanouchi Sohsaku, Kaneko Kazuanri
Department of Pediatrics, Kansai Medical University, 2-5-1 Shin-machi, Hirakata, Osaka Japan.
Allergy Asthma Clin Immunol. 2016 Aug 26;12(1):44. doi: 10.1186/s13223-016-0150-0. eCollection 2016.
Several studies have reported that oral immunotherapy (OIT) is effective for children with cow's milk (CM) allergy. These studies reported the efficacy of OIT in terms of desensitization, but did not describe sustained unresponsiveness to CM. The aim of this study was to evaluate the efficacy of the OIT protocol using microwave heated cow's milk (MH-CM) in terms of 2-weeks-sustained unresponsiveness (2-weeks-SU) and safety.
Forty-eight children were enrolled in this study. Thirty-one children agreed to receive rush OIT using MH-CM (the OIT group) and another 17 children who did not want to receive rush OIT formed the untreated group. Rates of desensitization and 2-weeks-sustained unresponsiveness were compared between the two groups at 1 year after the start of OIT. We followed up these rates and safety data for another year and for longer in the OIT group.
No children in the untreated group did not pass an open food challenge to CM. Of the 31 children in the OIT group, 14 (P = 0.002) achieved desensitization, and 8 (P = 0.036) achieved 2-weeks-SU to CM at 1 year from the start of OIT. Two years after the start of OIT, both the rate of desensitization and the rate of 2-weeks-SU in the OIT group significantly increased compared with the rates at 1 year (P = 0.025 and P = 0.008 respectively).
The rush OIT protocol using MH-CM was effective at inducing 2-weeks-SU s to CM and had a good safety profile in children with CM allergy. Trial registration Approval number: 324, Registered 3 February 2009.
多项研究报告称,口服免疫疗法(OIT)对牛奶(CM)过敏儿童有效。这些研究报告了OIT在脱敏方面的疗效,但未描述对CM的持续无反应性。本研究的目的是评估使用微波加热牛奶(MH-CM)的OIT方案在2周持续无反应性(2周-SU)和安全性方面的疗效。
48名儿童参与本研究。31名儿童同意接受使用MH-CM的快速OIT(OIT组),另外17名不想接受快速OIT的儿童组成未治疗组。在OIT开始1年后,比较两组的脱敏率和2周持续无反应率。我们对OIT组的这些率和安全性数据进行了另外一年及更长时间的随访。
未治疗组中没有儿童通过CM的开放食物激发试验。在OIT组的31名儿童中,14名(P = 0.002)实现了脱敏,8名(P = 0.036)在OIT开始1年后实现了对CM的2周-SU。OIT开始2年后,OIT组的脱敏率和2周-SU率与1年时相比均显著增加(分别为P = 0.025和P = 0.008)。
使用MH-CM的快速OIT方案在诱导对CM的2周-SU方面有效,并且在CM过敏儿童中具有良好的安全性。试验注册批准号:324,于2009年2月3日注册。