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挑战传统观念:静脉注射与口服β-内酰胺类抗生素激发试验

Challenging dogmas: Intravenous versus oral beta-lactam antibiotic provocation tests.

作者信息

Molina-Molina Gustavo-Jorge, Gómez-Duque Manuel, Vidal Guitart Xavier, Agustí Escasany Antònia, Labrador-Horrillo Moisés, Luengo Olga, Sala-Cunill Anna, Galvan-Blasco Paula, Guilarte Mar, Cardona Victoria

机构信息

Allergy Department, Hospital Universitari Bellvitge, Hospitalet de Llobregat, Spain.

Paediatric Allergy Section, Respiratory Paediatric Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

出版信息

World Allergy Organ J. 2024 May 24;17(6):100914. doi: 10.1016/j.waojou.2024.100914. eCollection 2024 Jun.

DOI:10.1016/j.waojou.2024.100914
PMID:38855082
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11153252/
Abstract

BACKGROUND

Drug provocation tests (DPT) are considered the gold standard procedure to ascertain the diagnosis of beta-lactam (BL) allergy. Regarding route of administration, current recommendations prioritize oral challenges, considering them safer, and reserving the intravenous route for drugs for which this is the only formulation.

OBJECTIVE

To compare in terms of tolerance and safety two protocols of BL DPT, using an oral protocol (OR-DPT) and an intravenous protocol (IV-DPT).

METHODS

A descriptive, retrospective study was performed, including adult patients who underwent IV-DPT or OR-DPT for suspected immediate or delayed hypersensitivity to BL antibiotics, over a period of 4 years (between January 2018 and December 2021). Demographical data, index hypersensivity reactions' characteristics and tolerance to DPT were reviewed.

RESULTS

A total of 1036 patients underwent DPT, mean age of 56.8 (standard deviation, SD, 17.8) years, 655 were women (63.2%). Immediate drug hypersensitivity reactions (DHR) had occurred in 564 of patients (54.4%). OR-DPT were performed in 439 (42.4%) and IV-DPT in 597 (57.6%). The frequency of reactions during DPT, regardless of the route used, was low (3.6%): only 16 (3.6%) in OR-DPT and 21 (3.5%) in IV-DPT. From IV-DPT, 16 out 21 DHR during DPT were immediate compared with 4 out of 16 in OR-DPT. Adjusted relative risk of developing a hypersensitivity reaction during IV-DPT versus OR-DPT was 1.13 (95% confidence interval (CI)0.57-2.22).

CONCLUSION

The results suggest that OR-DPT and IV-DPT are both safe procedures when adequately performed. However, IV-DPT protocols showed a higher rate of immediate DHR during DPT probably due to the selection of basal high-risk patients to undergo IV-DPT. In conclusion, IV-DPT may be considered as an option for challenges in drug-allergy studies, entailing a precise administration.

摘要

背景

药物激发试验(DPT)被认为是确定β-内酰胺(BL)过敏诊断的金标准程序。关于给药途径,目前的建议优先考虑口服激发试验,认为其更安全,而静脉途径仅用于该药物唯一可用剂型的情况。

目的

比较使用口服方案(OR-DPT)和静脉方案(IV-DPT)的两种BL DPT方案在耐受性和安全性方面的差异。

方法

进行了一项描述性回顾性研究,纳入在4年期间(2018年1月至2021年12月)因怀疑对BL抗生素有速发型或迟发型超敏反应而接受IV-DPT或OR-DPT的成年患者。回顾了人口统计学数据、首次超敏反应的特征以及对DPT的耐受性。

结果

共有1036例患者接受了DPT,平均年龄56.8岁(标准差,SD,17.8),655例为女性(63.2%)。564例患者(54.4%)发生过速发型药物超敏反应(DHR)。439例(42.4%)接受了OR-DPT,597例(57.6%)接受了IV-DPT。无论使用何种途径,DPT期间的反应频率都很低(3.6%):OR-DPT中仅16例(3.6%),IV-DPT中21例(3.5%)。在IV-DPT中,DPT期间21例DHR中有16例为速发型,而OR-DPT中16例中有4例为速发型。IV-DPT与OR-DPT相比发生超敏反应的调整后相对风险为1.13(95%置信区间(CI)0.57-2.22)。

结论

结果表明,OR-DPT和IV-DPT在操作适当时都是安全的程序。然而,IV-DPT方案在DPT期间速发型DHR的发生率较高,可能是由于选择了基础风险较高的患者进行IV-DPT。总之,IV-DPT可被视为药物过敏研究中激发试验的一种选择,但需要精确给药。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e2c/11153252/a21f1197105b/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e2c/11153252/a21f1197105b/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e2c/11153252/a21f1197105b/gr1.jpg

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本文引用的文献

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JAC Antimicrob Resist. 2022 Nov 19;4(6):dlac116. doi: 10.1093/jacamr/dlac116. eCollection 2022 Dec.
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Drug allergy: A 2022 practice parameter update.药物过敏:2022年实践参数更新
J Allergy Clin Immunol. 2022 Dec;150(6):1333-1393. doi: 10.1016/j.jaci.2022.08.028. Epub 2022 Sep 17.
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Standards for practical intravenous rapid drug desensitization & delabeling: A WAO committee statement.
实用静脉内快速药物脱敏和去标签标准:WAO委员会声明
World Allergy Organ J. 2022 May 31;15(6):100640. doi: 10.1016/j.waojou.2022.100640. eCollection 2022 Jun.
4
Single-step direct drug provocation testing is safe for delabelling selected non-low-risk penicillin allergy labels.一步法直接药物激发试验可安全地用于去除选定的非低风险青霉素过敏标签。
Ann Allergy Asthma Immunol. 2021 Aug;127(2):232-235. doi: 10.1016/j.anai.2021.04.008. Epub 2021 Apr 16.
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Spanish Society of Allergology and Clinical Immunology (SEAIC) Vision of Drug Provocation Tests.西班牙变态反应与临床免疫学会(SEAIC)对药物激发试验的看法。
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β-Lactam Allergy and Cross-Reactivity: A Clinician's Guide to Selecting an Alternative Antibiotic.β-内酰胺类过敏与交叉反应:临床医生选择替代抗生素指南
J Asthma Allergy. 2021 Jan 18;14:31-46. doi: 10.2147/JAA.S242061. eCollection 2021.
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Accuracy of penicillin allergy diagnostic tests: A systematic review and meta-analysis.青霉素过敏诊断测试的准确性:系统评价和荟萃分析。
J Allergy Clin Immunol. 2021 Jan;147(1):296-308. doi: 10.1016/j.jaci.2020.04.058. Epub 2020 May 21.
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Towards a more precise diagnosis of hypersensitivity to beta-lactams - an EAACI position paper.迈向更精准的β-内酰胺类药物超敏反应诊断——欧洲变态反应和临床免疫学会立场文件
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