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对洗必泰的即刻过敏:法国药物警戒数据库中的一系列儿科病例:对洗必泰的即刻过敏:法国药物警戒数据库中的一系列儿科病例。

Immediate allergies to chlorhexidine: A series of pediatric cases from the French pharmacovigilance database: Immediate allergies to chlorhexidine: series of pediatric cases from the French pharmacovigilance database.

机构信息

Department of Pulmonology and Allergology, University Hospital Centre of Rennes, F-35000, Rennes, France.

Pharmacovigilance, Pharmacoepidemiology and Drug Information Center, Department of Clinical Pharmacology, Nantes University Hospital, 44000, Nantes, France.

出版信息

Arch Pediatr. 2024 Oct;31(7):419-425. doi: 10.1016/j.arcped.2024.06.004. Epub 2024 Sep 27.

Abstract

BACKGROUND

Immediate allergic reactions to chlorhexidine have been clearly identified in numerous countries, generating governmental warnings worldwide.

OBJECTIVES

The aim of our study was to characterize (i) these allergies, which are less reported in pediatric populations, and (ii) the patient-at-risk profile so as to suggest preventive measures.

METHODS

In association with the allergy department and the regional pharmacovigilance center in Rennes University Hospital, France, a multicenter retrospective, descriptive, and observational study was conducted using data from the national pharmacovigilance database for the period of January 1, 2010 to June 30, 2020. Immediate allergies to chlorhexidine cases based on a clinical history compatible with an immunoglobulin E (IgE)-mediated reaction, along with positive allergic testing, were analyzed.

RESULTS

Of the 478 cases identified, 17 pediatric cases of immediate allergic reaction to chlorhexidine (13 cases of grades II-IV anaphylaxis) were retained for the analysis. For 58.8 % of these cases, a history of a previous more moderate reaction to the substance was identified. The reactions occurred most frequently in cases of domestic misuse (88.2 %, n = 15/17) of chlorhexidine to dress a wound. Recurrence was reported for two cases, later leading to severe reactions at each new exposure to the allergen, suggesting an aggravation mechanism.

CONCLUSION

The number of pediatric cases of immediate allergies to chlorhexidine has possibly been underestimated on account of insufficient knowledge of the allergy and in view of its common usage. Information on the method of caring for wounds among children and on the risk of allergic sensitization as well as exploring any unusual reaction to chlorhexidine application could reduce the number of allergic reactions.

摘要

背景

在许多国家已经明确确定了对洗必泰的即刻过敏反应,这在全球范围内引发了政府警告。

目的

我们的研究旨在(i)描述这些在儿科人群中报告较少的过敏反应,以及(ii)具有风险的患者特征,以便提出预防措施。

方法

与法国雷恩大学医院过敏科和区域药物警戒中心合作,我们进行了一项多中心回顾性、描述性和观察性研究,使用了 2010 年 1 月 1 日至 2020 年 6 月 30 日期间全国药物警戒数据库的数据。我们分析了基于与 IgE 介导反应相符的临床病史且过敏检测阳性的即刻对洗必泰过敏的病例。

结果

在确定的 478 例病例中,我们保留了 17 例儿童即时对洗必泰过敏的病例(13 例为 II-IV 级过敏反应)。在这些病例中,58.8%的病例有既往对该物质更中度反应的病史。这些反应最常发生在家用误用(88.2%,n=15/17)的情况下,用于包扎伤口。有两例病例报告了复发,每次新接触过敏原时都导致严重反应,提示存在加重机制。

结论

由于对过敏的认识不足,并且考虑到洗必泰的广泛使用,儿童对洗必泰的即刻过敏反应的病例数量可能被低估了。有关儿童护理伤口的方法的信息,以及对过敏致敏的风险,以及探索对洗必泰应用的任何异常反应,可以减少过敏反应的数量。

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