背景:关于花生舌下免疫疗法(SLIT)疗效的研究有限。SLIT后脱敏的耐久性尚未得到很好的描述。
目的:评价4mg花生SLIT的疗效和安全性以及SLIT停药后脱敏的持久性。
方法:挑战证明的1-11岁花生过敏儿童接受开放标签4mg花生SLIT治疗48个月。花生SLIT后的脱敏通过5000毫克双盲评估,安慰剂对照食物挑战(DBPCFC)。在1-17周之间的新的随机分配的回避期之后是DBPCFC。皮肤点刺试验(SPT),免疫球蛋白,嗜碱性粒细胞活化试验(BAT),纵向测量TH1、TH2和IL-10细胞因子。通过患者报告的家庭日记评估安全性。
结果:54名参与者入组,47名(87%)按照方案完成花生SLIT和48个月DBPCFC。DBPCFC期间的平均成功消耗剂量(SCD)在SLIT后从48mg增加到2723mg花生蛋白(p<0.0001),70%实现临床显著脱敏(SCD>800mg)和36%完全脱敏(SCD=5000mg)。临床上显着脱敏丢失的模拟中位时间为22周。花生SPT;花生特异性IgE,IgG4,IgG4/IgE比率;和花生刺激的BAT,IL-4,IL-5,IL-13,IFN-γ,与基线相比,IL-10发生显着变化,早在6个月时就出现了变化。每剂量的平均反应率为0.5%,短暂性口咽瘙痒最常见,没有需要肾上腺素的给药症状。
结论:在此开放标签中,前瞻性研究,花生SLIT是安全的,大多数儿童在停药后持续超过17周出现了临床显著的脱敏.
Studies on the efficacy of peanut sublingual immunotherapy (SLIT) are limited. The durability of desensitization after SLIT has not been well described.
We sought to evaluate the efficacy and safety of 4-mg peanut SLIT and persistence of desensitization after SLIT discontinuation.
Challenge-proven peanut-allergic 1- to 11-year-old children were treated with open-label 4-mg peanut SLIT for 48 months. Desensitization after peanut SLIT was assessed by a 5000-mg double-blind, placebo-controlled food challenge (DBPCFC). A novel randomly assigned avoidance period of 1 to 17 weeks was followed by the DBPCFC. Skin prick test results immunoglobulin levels, basophil activation test results, TH1, TH2, and IL-10 cytokines were measured longitudinally. Safety was assessed through patient-reported home diaries.
Fifty-four participants were enrolled and 47 (87%) completed peanut SLIT and the 48-month DBPCFC per protocol. The mean successfully consumed dose (SCD) during the DBPCFC increased from 48 to 2723 mg of peanut protein after SLIT (P < .0001), with 70% achieving clinically significant desensitization (SCD > 800 mg) and 36% achieving full desensitization (SCD = 5000 mg). Modeled median time to loss of clinically significant desensitization was 22 weeks. Peanut skin prick test; peanut-specific IgE, IgG4, and IgG4/IgE ratio; and peanut-stimulated basophil activation test, IL-4, IL-5, IL-13, IFN-γ, and IL-10 changed significantly compared with baseline, with changes seen as early as 6 months. Median rate of reaction per dose was 0.5%, with transient oropharyngeal itching being the most common, and there were no dosing symptoms requiring epinephrine.
In this open-label, prospective
study, peanut SLIT was safe and induced clinically significant desensitization in most of the children, lasting more than 17 weeks after discontinuation of therapy.