儿童蛋过敏的口服免疫治疗。
Oral immunotherapy for treatment of egg allergy in children.
机构信息
Department of Pediatrics, Duke University Medical Center, Durham, NC 27599-7220, USA.
出版信息
N Engl J Med. 2012 Jul 19;367(3):233-43. doi: 10.1056/NEJMoa1200435.
BACKGROUND
For egg allergy, dietary avoidance is the only currently approved treatment. We evaluated oral immunotherapy using egg-white powder for the treatment of children with egg allergy.
METHODS
In this double-blind, randomized, placebo-controlled study, 55 children, 5 to 11 years of age, with egg allergy received oral immunotherapy (40 children) or placebo (15). Initial dose-escalation, build-up, and maintenance phases were followed by an oral food challenge with egg-white powder at 10 months and at 22 months. Children who successfully passed the challenge at 22 months discontinued oral immunotherapy and avoided all egg consumption for 4 to 6 weeks. At 24 months, these children underwent an oral food challenge with egg-white powder and a cooked egg to test for sustained unresponsiveness. Children who passed this challenge at 24 months were placed on a diet with ad libitum egg consumption and were evaluated for continuation of sustained unresponsiveness at 30 months and 36 months.
RESULTS
After 10 months of therapy, none of the children who received placebo and 55% of those who received oral immunotherapy passed the oral food challenge and were considered to be desensitized; after 22 months, 75% of children in the oral-immunotherapy group were desensitized. In the oral-immunotherapy group, 28% (11 of 40 children) passed the oral food challenge at 24 months and were considered to have sustained unresponsiveness. At 30 months and 36 months, all children who had passed the oral food challenge at 24 months were consuming egg. Of the immune markers measured, small wheal diameters on skin-prick testing and increases in egg-specific IgG4 antibody levels were associated with passing the oral food challenge at 24 months.
CONCLUSIONS
These results show that oral immunotherapy can desensitize a high proportion of children with egg allergy and induce sustained unresponsiveness in a clinically significant subset. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00461097.).
背景
对于鸡蛋过敏，饮食回避是目前唯一批准的治疗方法。我们评估了使用蛋清粉进行口服免疫治疗来治疗鸡蛋过敏的儿童。
方法
在这项双盲、随机、安慰剂对照研究中，55 名 5 至 11 岁的鸡蛋过敏儿童接受了口服免疫治疗（40 名儿童）或安慰剂（15 名）。在 10 个月和 22 个月时，进行蛋清粉口服食物挑战，随后进行初始剂量递增、递增和维持阶段。在 22 个月时成功通过挑战的儿童停止口服免疫治疗，并避免食用所有鸡蛋 4 至 6 周。在 24 个月时，这些儿童接受蛋清粉和煮鸡蛋的口服食物挑战，以测试持续无反应。在 24 个月时通过该挑战的儿童可以自由食用鸡蛋，并在 30 个月和 36 个月时评估持续无反应的情况。
结果
在 10 个月的治疗后，接受安慰剂的儿童中没有一人通过口服食物挑战，被认为脱敏；在 22 个月时，接受口服免疫治疗的儿童中有 75%脱敏。在口服免疫治疗组中，28%（40 名儿童中的 11 名）在 24 个月时通过口服食物挑战，被认为具有持续无反应性。在 30 个月和 36 个月时，所有在 24 个月时通过口服食物挑战的儿童都在食用鸡蛋。在测量的免疫标志物中，皮肤点刺试验的小硬结直径和鸡蛋特异性 IgG4 抗体水平的增加与 24 个月时通过口服食物挑战相关。
结论
这些结果表明，口服免疫治疗可以使很大一部分鸡蛋过敏儿童脱敏，并在临床上显著的亚组中诱导持续无反应。（由美国国立卫生研究院资助；临床试验.gov 编号，NCT00461097。）
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