Introduction: Oral immunotherapy (OIT) has been reported to be effective but associated with a risk of severe symptoms. Thus, an OIT method with decreased risk is required. Objectives: We aimed to evaluate the efficacy and safety of low- and high-dose OIT regimens in children with severe milk allergy. Methods: Overall, 33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included. The participants were randomly assigned to groups that received either a low (20 mL; n = 19) or high (100 mL; n = 14) maintenance target dose of OIT. The dose was gradually increased to the target dose in the rush escalation phase and was then maintained daily at home. The primary endpoint was the final OFC dose at 6 months of OIT. Adverse events during OIT were evaluated. Results: The final OFC dose after OIT was significantly higher than that before OIT in both groups (low-dose, p = 0.000; high-dose, p = 0.006), but there was no significant difference in the final OFC dose between the 2 groups (p = 0.767). In the maintenance phase, the high-dose group had significantly more severe symptoms than did the low-dose group (0.5%, 11/2,355 total intake events vs. 0.1%, 4/3,230 total intake events; p = 0.018). Conclusions: An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy. The risk of severe symptoms in the maintenance phase was lower in the low-dose group. A low-dose OIT regimen is recommended for severe milk allergy.
Int Arch Allergy Immunol

中文翻译：

---

单中心非劣效性随机试验，关于低剂量和高剂量冲刺口服牛奶免疫疗法对严重牛奶过敏的疗效和安全性。

简介：据报道，口服免疫疗法（OIT）是有效的，但有出现严重症状的风险。因此，需要降低风险的OIT方法。目的：我们旨在评估低剂量和大剂量OIT方案对严重牛奶过敏儿童的疗效和安全性。方法：总共包括33名参与者（中位年龄为9岁；牛奶口服食物攻击的最终剂量中位数为2 mL）。将参与者随机分配到接受低（20 mL; n = 19）或高（100 mL; n= 14）OIT的维持目标剂量。在紧急升级阶段，剂量逐渐增加至目标剂量，然后每天在家中保持剂量。主要终点是OIT 6个月时的最终OFC剂量。对OIT期间的不良事件进行了评估。结果：两组OIT的最终OFC剂量均显着高于OIT之前的剂量（低剂量，P = 0.000；高剂量，P = 0.006），但两组之间的最终OFC剂量之间没有显着差异。组（p = 0.767）。在维持阶段，高剂量组的症状比低剂量组严重得多（0.5％，总摄入量为11 / 2,355，vs.0.1％，总摄入量为4 / 3,230；p = 0.018）。结论：对于严重牛奶过敏的儿童，维持OIT剂量为20和100 mL时，观察到的剂量效应也同样增加。低剂量组维持阶段出现严重症状的风险较低。对于严重的牛奶过敏，建议使用低剂量的OIT方案。
Int Arch过敏免疫