Abstract: Objective To evaluate outcome interpretation of family open oral food challenge(OFC) utilized in infants who could not be confirmed by CMP-specific IgE and skin prick tests,in order to improve the accuracy of parent-reported symptoms. Methods A prospective study was conducted to enroll infants who took open OFCs from November 2018 to June 2019. The diagnosis efficiency and the accuracy of parent-reported symptoms were analyzed. Results A total of 162 infants received OFC for diagnosis,with an average age of(5.85±3.03)months old.While OFCs were conducted in 142 infants [(8.10±3.08) months old] for the judgment of oral tolerance.No episodes of anaphylaxis occurred in the process of challenge.Cutaneous and gastrointestinal symptoms were commonly reported on the first day of the test(77.78%) and the first week(79.58%).Kappa coefficient was 0.868(P＜0.001),suggesting good consistency of judgments between parents and specialists.The diagnosis accuracy of family open OFC tesx was 93.43%.The false-positive rate,false-negative rate,positive predictive value,negative predictive value was 9.15%,4.32%,90.85% and 95.68%,respectively.Vomiting was the most frequent reactions reported in false-positive cases.The amount of stimulation formula and the observation time were the important factors accounting for the false-negative results. Conclusions Family open OFC is an accurate and safe tool for assessing oral tolerance status in CMPA infants.The detailed instruction for parents and identification of the reproducibility could increase the safety and reliability of open OFC performing at home.

Key words: open oral food challenge, cow's milk protein allergy, non-IgE mediated, infants

摘要： 目的 研究家庭开放性口服激发试验(OFC)在非IgE介导牛奶蛋白过敏婴儿中应用时的结果判读,从而提高家长症状报告的准确性。方法 前瞻性纳入2018年11月—2019年6月接受家庭开放性OFC的婴儿,分析其诊断效能及家长症状报告的准确性。结果 162例婴儿[(5.85±3.03)月龄]接受OFC进行确诊,142例婴儿[(8.10±3.08)月龄]接受OFC进行口服耐受的判断。在激发过程中没有严重过敏反应发生,142例报告出现不同程度症状。皮肤和胃肠道反应多分别出现在激发试验的第1天(77.78%)和第1周(79.58%)。家长报告与医生判断结果一致性Kappa指数0.868(P<0.001);家庭开放性OFC准确性为93.42%,假阳性率9.15%,假阴性率4.32%,阳性预测值90.85%,阴性预测值95.68%。呕吐是最常见的假阳性报告症状;激发量及观察时间是导致假阴性的主要因素。结论 家庭开放性激发试验用于非IgE介导的牛奶蛋白过敏婴儿是安全且准确率较高的诊断手段。通过家长教育以及对于症状可重复性的识别,能够提高其准确性。

关键词: 口服激发试验, 牛奶蛋白过敏, 非IgE介导, 婴儿