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疑似青霉素过敏儿童未经预先皮肤试验的药物激发试验评估及与PEN-FAST的相关性:一项单中心研究

Evaluation of drug provocation tests without prior skin testing in children with suspected penicillin allergy and correlation with PEN-FAST: A single-center study.

作者信息

Yağmur Halime, Atay Özge, Bakır Damla Baysal, Kabadayı Gizem, Boyacıoğlu Özge Kangallı, Asi̇lsoy Suna, Uzuner Nevin

机构信息

Department of Pediatric Immunology and Allergy, Dokuz Eylul University, İzmir, Türkiye.

Department of Pediatric Immunology and Allergy, Çiğli Training and Research Hospital, Bakırçay University, İzmir, Türkiye.

出版信息

Eur J Pediatr. 2025 Jul 17;184(8):488. doi: 10.1007/s00431-025-06301-7.

DOI:10.1007/s00431-025-06301-7
PMID:40676330
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12271276/
Abstract

PURPOSE

To evaluate patients with suspected penicillin allergy in whom skin testing was omitted during immediate and delayed reactions before drug provocation test (DPT).

METHODS

This retrospective study analyzed patients aged 0-18 years with suspected penicillin allergy between 2020 and 2023. Data on hypersensitivity reaction history, laboratory tests, PEN-FAST scores, and DPT records were collected.

RESULTS

We evaluated 75 patients (male: 61.3%; median age at index reaction: 4 [range: 1-15] years) with suspected penicillin allergy. Nearly all reactions occurred at home (98.7%) following oral administration, with antihistamines being the most common treatment (56%). Urticaria was the most frequent manifestation in immediate reactions (30.7%), whereas maculopapular exanthema was predominant in delayed reactions (33.7%). Amoxicillin-clavulanic acid was the most frequently implicated drug (85.3%). The median PEN-FAST score was 3 (range: 0-5). Immediate reactions were significantly more common in females (p < 0.05). In total, 78 DPTs were performed, and four patients tested positive, all experiencing mild cutaneous reactions. No life-threatening reactions were observed. At the 3-month follow-up, 90.7% of patients tolerated beta-lactam antibiotics, though 4% chose to avoid them despite negative DPT results.

CONCLUSION

In our study, we successfully performed DPT without major complications by omitting skin testing in both immediate and delayed reactions. Our findings suggest that in delayed reactions, direct DPT can safely replace skin testing. Notably, we also propose that after in vitro tests, DPT may be safely used in immediate reactions without additional in vivo testing. Also, this is the first study to evaluate PEN-FAST in children with suspected penicillin allergy in our country, offering practical value for clinicians and patients.

WHAT IS KNOWN

• The label of drug allergy in children is assigned far more frequently than the actual diagnosis of true allergic reactions. • Due to unverified drug allergy diagnoses, patients face challenges such as inadequate treatment and the development of antibiotic resistance.

WHAT IS NEW

• In cases with immediate reactions, including anaphylaxis, direct drug provocation test (DPT) performed without prior skin testing can be conducted without severe reactions. • The PEN-FAST score has been observed to be highly effective in ruling out beta-lactam allergy in pediatric patients with low scores.

摘要

目的

评估在药物激发试验(DPT)前的速发和迟发反应期间未进行皮肤试验的疑似青霉素过敏患者。

方法

这项回顾性研究分析了2020年至2023年间0至18岁疑似青霉素过敏的患者。收集了过敏反应史、实验室检查、PEN-FAST评分和DPT记录的数据。

结果

我们评估了75例疑似青霉素过敏的患者(男性:61.3%;首次反应的中位年龄:4岁[范围:1至15岁])。几乎所有反应都发生在家中(98.7%),口服给药后发生,抗组胺药是最常用的治疗药物(56%)。荨麻疹是速发反应中最常见的表现(30.7%),而斑丘疹在迟发反应中占主导地位(33.7%)。阿莫西林-克拉维酸是最常涉及的药物(85.3%)。PEN-FAST评分的中位数为3(范围:0至5)。速发反应在女性中明显更常见(p<0.05)。总共进行了78次DPT,4例患者检测呈阳性,均出现轻度皮肤反应。未观察到危及生命的反应。在3个月的随访中,90.7%的患者耐受β-内酰胺抗生素,尽管4%的患者尽管DPT结果为阴性仍选择避免使用。

结论

在我们的研究中,我们通过在速发和迟发反应中均省略皮肤试验成功进行了DPT,且无重大并发症。我们的研究结果表明,在迟发反应中,直接DPT可以安全地替代皮肤试验。值得注意的是,我们还提出,在体外试验后,DPT可以安全地用于速发反应,而无需额外的体内试验。此外,这是我国第一项评估疑似青霉素过敏儿童PEN-FAST的研究,为临床医生和患者提供了实用价值。

已知信息

•儿童药物过敏标签的分配频率远高于真正过敏反应的实际诊断频率。•由于药物过敏诊断未经证实,患者面临治疗不足和抗生素耐药性发展等挑战。

新发现

•在包括过敏反应在内的速发反应病例中,无需事先进行皮肤试验即可进行直接药物激发试验(DPT),且不会出现严重反应。•观察到PEN-FAST评分在排除低分儿科患者的β-内酰胺过敏方面非常有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57cb/12271276/a57068e3eafe/431_2025_6301_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57cb/12271276/be070463334e/431_2025_6301_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57cb/12271276/a57068e3eafe/431_2025_6301_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57cb/12271276/be070463334e/431_2025_6301_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57cb/12271276/a57068e3eafe/431_2025_6301_Fig2_HTML.jpg

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本文引用的文献

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Resensitization-Should Repeat Testing Be Performed in Patients Undergoing Penicillin Allergy Evaluations? A Pro-Con Debate.重新致敏——对正在接受青霉素过敏评估的患者应进行重复检测吗?一场正反方辩论。
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Are skin tests useful after benign immediate reactions to beta-lactams in children?
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Pediatr Allergy Immunol. 2023 May;34(5):e13957. doi: 10.1111/pai.13957.
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