In this open-label, phase 2, single-arm clinical trial, children aged 6-18 years with a positive history of peanut allergy and positive peanut skin prick test ≥ 8 mm and/or peanut-specific IgE ≥ 15 kU/L at screening underwent OIT involving sequential up-dosing with 12-hour boiled peanut for 12 weeks, 2-hour boiled peanut for 20 weeks and roasted peanut for 20 weeks, to a target maintenance dose of 12 roasted peanuts daily.
proportion of children passing open-label oral food challenge involving cumulative administration of 12 roasted peanuts (12 g peanuts; approximately 3000 mg peanut protein) 6-8 weeks after reaching the target maintenance dose. Secondary outcomes included treatment-related adverse events and use of medications for treating allergy symptoms.
Between 1 July 2017 and 22 June 2018, 70 participants were enrolled and commenced OIT. Desensitization was successfully induced in 56 of 70 (80%) participants. Withdrawal due to treatment-related adverse events was infrequent (n = 3). Treatment-related adverse events were reported in 43 (61%) participants, corresponding to a rate of 6.58 per 1000 OIT doses. Medication use associated with treatment-related adverse events was infrequent, with rescue epinephrine use reported by three (4%) participants (0.05 per 1000 doses).
Oral immunotherapy using boiled followed by roasted peanuts represents a pragmatic approach that appears effective in inducing desensitization and is associated with a favourable safety profile.
方法:在此开放标签中,第二阶段,单臂临床试验,6-18岁有花生过敏史阳性,花生皮肤点刺试验阳性≥8mm和/或花生特异性IgE≥15kU/L的儿童在筛查时接受了OIT,包括连续加药12小时煮花生12周,2小时煮花生20周,烤花生20周,每天12份烤花生的目标维持剂量。
方法:在达到目标维持剂量后6-8周,通过开放标签口服食物挑战的儿童的比例涉及12个烤花生(12克花生;约3000毫克花生蛋白)的累积给药。次要结果包括治疗相关的不良事件和使用药物治疗过敏症状。
结果:在2017年7月1日至2018年6月22日期间,70名参与者被登记并开始OIT。70名参与者中有56名(80%)成功诱导脱敏。由于治疗相关的不良事件而停药的情况很少见(n=3)。43名(61%)参与者报告了与治疗相关的不良事件,对应于每1000个OIT剂量6.58的比率。与治疗相关的不良事件相关的药物使用很少,3名(4%)参与者报告使用了急救肾上腺素(0.05/1000剂量).
结论:使用煮沸后烤花生的口服免疫疗法代表了一种实用的方法,该方法似乎可有效诱导脱敏,并具有良好的安全性。