Background

Penicillin allergy labels are prevalent, and removal of incorrect labels improves patient outcomes and health economics. Labels may be classified as “low-risk” or “non–low-risk,” of which the symptoms of the latter chiefly suggest immunoglobulin E–mediated etiology. Traditionally, “non–low-risk” allergy labels are evaluated by penicillin skin testing followed by graded multistep penicillin drug provocation testing (DPT).

Objective

To evaluate the safety of assessing “non–low-risk” labels with single-step direct DPT.

Methods

We consecutively enrolled inpatients and outpatients of a teaching hospital in Sydney, Australia, with penicillin allergy labels requiring penicillin for first-line treatment. Patients were classified as “low-risk” or “non–low-risk” based on the allergy labels. All patients proceeded directly to amoxicillin DPT, unless there was a history of anaphylaxis within 10 years of assessment to a beta-lactam (except for cefazolin) or Gell and Coombs type 2, type 3, or severe type 4 reaction. This was followed by a course of amoxicillin.

Results

A total of 149 patients (41 inpatients, 108 outpatients) were enrolled. No patient was excluded from the study. No patient experienced life-threatening reactions to the protocol. There were 85 patients who reported “non–low-risk” allergy labels. One patient developed generalized pruritus and rash that resolved with standard-dose antihistamines, 2 developed delayed benign maculopapular exanthem, and 3 experienced diarrhea during the course of amoxicillin.

Conclusion

In our cohort, direct single-step DPT was safe, with only 6 patients with “non–low-risk” allergy experiencing benign reactions. We hope that further studies can be performed into single-step direct DPT to evaluate “non–low-risk” penicillin allergy labels.

Trial Registration

ClinicalTrials.gov Identifier: LNR/16/HAWKE/452.

中文翻译：

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单步直接药物激发试验对于去除选定的非低风险青霉素过敏标签是安全的

背景

青霉素过敏标签很普遍，去除不正确的标签可以改善患者的治疗效果和健康经济学。标签可分为“低风险”或“非低风险”，后者的症状主要提示免疫球蛋白 E 介导的病因。传统上，“非低风险”过敏标签是通过青霉素皮肤试验和分级多步青霉素药物激发试验 (DPT) 来评估的。

客观的

评估使用单步直接 DPT 评估“非低风险”标签的安全性。

方法

我们连续招募了澳大利亚悉尼一家教学医院的住院病人和门诊病人，这些病人的青霉素过敏标签要求青霉素作为一线治疗。根据过敏标签，患者被分类为“低风险”或“非低风险”。所有患者直接接受阿莫西林 DPT，除非在评估 10 年内对 β-内酰胺（头孢唑林除外）或 Gell and Coombs 2 型、3 型或严重 4 型反应有过敏反应史。随后是一个疗程的阿莫西林。

结果

共招募了 149 名患者（41 名住院患者，108 名门诊患者）。没有患者被排除在研究之外。没有患者对方案产生危及生命的反应。有 85 名患者报告了“非低风险”过敏标签。1 名患者出现全身性瘙痒和皮疹，用标准剂量的抗组胺药消退，2 名患者出现迟发性良性斑丘疹，3 名患者在阿莫西林治疗期间出现腹泻。

结论

在我们的队列中，直接单步 DPT 是安全的，只有 6 名“非低风险”过敏患者出现良性反应。我们希望进一步的研究可以在单步直接 DPT 中进行，以评估“非低风险”青霉素过敏标签。

试用注册

ClinicalTrials.gov 标识符：LNR/16/HAWKE/452。