Department of Clinical Science and Education, Södersjukhuset, Centre for Allergy Research, Karolinska Institutet, Stockholm, Sweden.
PLoS One. 2013;8(1):e53465. doi: 10.1371/journal.pone.0053465. Epub 2013 Jan 9.
Double-blind placebo-controlled food challenge, DBPCFC, the gold standard for diagnosing food allergy, is time-consuming and potentially dangerous. A basophil allergen threshold sensitivity test, CD-sens, has shown promising results as a diagnostic tool in food allergy.
To evaluate the reproducibility of oral peanut challenge and compare the outcome to CD-sens in peanut-sensitized children.
Twenty-seven children (4-19 years) underwent a DBPCFC followed by a single-blind oral food-challenge. The peanut challenges (1 mg to 5 g) were evaluated by severity scoring. Blood samples were drawn for CD-sens before the two first challenges.
Thirteen children (48%) did not react at any of the challenges. Fourteen reacted at both peanut challenges but not to placebo. Only two of these children reacted at the same threshold dose and with the same severity score. All other children scored differently or reacted at different doses. For children with a positive challenge the geometric mean of the ratio of the doses was 1.834 (p = 0.307) and the arithmetic mean of the difference between the severity scores was 0.143 (p = 0.952). No association was obtained between the two peanut challenges regarding severity score (r(s) = 0.11, p = 0.71) or threshold dose (r(s) = 0.35, p = 0.22). Among the children positive in peanut challenge, 12 were positive in CD-sens. Two were low-responders and could not be evaluated. Geometric mean of the ratio of CD-sens values in children with a positive challenge was 1.035 (p = 0.505) but unlike for the severity score and the threshold dose the association between the two CD-sens values was strong (r(s) = 0.94, P<0.001).
For a positive/negative test the reproducibility is 100% for both peanut challenge and CD-sens. However, a comparison of the degree of allergen threshold sensitivity between the two tests is not possible since the threshold dose and severity scoring is not reproducible.
双盲安慰剂对照食物挑战(DBPCFC)是诊断食物过敏的金标准,但耗时且具有潜在危险。嗜碱性粒细胞过敏原阈值敏感测试(CD-sens)作为食物过敏的诊断工具已显示出良好的效果。
评估花生口服挑战的可重复性,并比较其与花生致敏儿童 CD-sens 的结果。
27 名儿童(4-19 岁)接受 DBPCFC 后进行单次盲法口服食物挑战。通过严重程度评分评估花生挑战(1mg 至 5g)。在两次首次挑战前抽取血液样本进行 CD-sens。
13 名儿童(48%)在任何挑战中均未反应。14 名儿童在两次花生挑战中均有反应,但对安慰剂无反应。其中只有 2 名儿童在相同的阈值剂量和相同的严重程度评分下有反应。其他所有儿童的评分不同或在不同剂量下有反应。对于阳性挑战的儿童,剂量比的几何平均值为 1.834(p=0.307),严重程度评分差异的算术平均值为 0.143(p=0.952)。两次花生挑战之间在严重程度评分(r(s)=0.11,p=0.71)或阈值剂量(r(s)=0.35,p=0.22)方面均无关联。在花生挑战阳性的儿童中,12 名儿童 CD-sens 阳性。2 名是低反应者,无法进行评估。阳性挑战儿童的 CD-sens 值比的几何平均值为 1.035(p=0.505),但与严重程度评分和阈值剂量不同,两个 CD-sens 值之间的关联很强(r(s)=0.94,P<0.001)。
对于阳性/阴性测试,花生挑战和 CD-sens 的可重复性均为 100%。然而,由于无法复制阈值剂量和严重程度评分,因此无法比较两种测试之间的过敏原阈值敏感性程度。