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首页> 外文期刊>Allergy >Placebo reactions in double-blind, placebo-controlled food challenges in children.
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Placebo reactions in double-blind, placebo-controlled food challenges in children.

机译：儿童双盲，安慰剂对照食物挑战中的安慰剂反应。

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BACKGROUND: A cardinal feature of the double-blind, placebo-controlled food challenge (DBPCFC) is that placebo administration is included as a control. To date, the occurrence and diagnostic significance of placebo events have not extensively been documented. OBJECTIVE: To analyse the occurrence and features of placebo events in DBPCFCs and to assess their contribution to the diagnostic accuracy of the DBPCFC in children. METHODS: The study population consisted of 132 challenges in 105 sensitized children (age range 0.7-16.6 years, median 5.3 years), who underwent DBPCFCs with cow's milk, egg, peanut, hazelnut and soy. Placebo and active food challenges were performed on different days. RESULTS: A total number of 17 (12.9%) positive placebo events occurred, which could be classified as immediate (9/17), late-onset (8/17), objective (11/17) or subjective (6/17). Four of 74 (5.4%) positive active food challenges were revealed to be false positive by administration of a placebo challenge. This is 3% (4/132) of all challenges. When computed by a statistical model, the false positive rate was 0.129 (12.9% of all challenges). CONCLUSION: Placebo events with diverse clinical characteristics occur in DBPCFCs in a significant number of children. The diagnostic significance of the administration of a placebo challenge is first, to identify false positive diagnoses in DBPCFCs by refuting false positive tests in individual patients. Secondly, to allow for blinding of the active food challenge. Thirdly, applying a statistical model demonstrates that some positive challenges may be false positive and that the test may need to be repeated in selected cases.
机译：背景：双盲，安慰剂对照食物挑战（DBPCFC）的主要特征是安慰剂的给药被作为对照。迄今为止，尚未广泛记录安慰剂事件的发生和诊断意义。目的：分析DBPCFC中安慰剂事件的发生和特征，并评估其对儿童DBPCFC诊断准确性的贡献。方法：本研究人群由105位致敏儿童（年龄范围0.7-16.6岁，中位数5.3岁）中的132个挑战组成，他们接受了DBPCFCs的牛奶，鸡蛋，花生，榛子和大豆。安慰剂和积极饮食挑战在不同的日子进行。结果：总共发生了17例（12.9％）阳性安慰剂事件，可分为即刻（9/17），迟发（8/17），客观（11/17）或主观（6/17） 。通过服用安慰剂激发，发现74例积极食物激发阳性（5.4％）中有4例为假阳性。这是所有挑战的3％（4/132）。通过统计模型计算时，假阳性率为0.129（占所有挑战的12.9％）。结论：大量儿童的DBPCFC中发生了具有多种临床特征的安慰剂事件。首先，通过驳斥单个患者的假阳性试验来确定安慰剂激发的诊断意义，从而确定DBPCFC中的假阳性诊断。第二，考虑到积极的食物挑战。第三，应用统计模型表明，一些积极的挑战可能是假阳性，并且在某些情况下可能需要重复测试。

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