Adrenaline auto injectors pharmacokinetic/pharmacodynamic studies and potential consequences for clinical practice

IF 4.6 2区医学 Q2 ALLERGY

Clinical and Translational Allergy Pub Date : 2023-12-18 DOI:10.1002/clt2.12323

Margitta Worm, Adam T. Fox, Magnus Wickman, Johannes Ring, Motohiro Ebisawa, Guillaume Pouessel, Pete Smith

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引用次数: 0

Abstract

Background

Anaphylaxis is a sudden multisystem allergic reaction which may result in a fatal outcome if not treated promptly. Guidelines worldwide suggest intramuscular adrenaline as the first-line treatment for anaphylaxis outside a perioperative reaction. Adrenaline autoinjectors (AAIs) are widely used self-administrable devices, especially in community settings. Different commercial AAIs have been authorized to be marketed in Europe. For an AAI to be efficacious, a rapid adrenaline delivery in patients, including those who are overweight or obese, resulting in an optimal cardiovascular (CV) response, is a key feature. AAIs are designed to achieve this requirement, which is reflected in their differing functional properties such as primary container selection, drug delivery mechanism (cartridge-or syringe-based), needle length, needle gauge, and adrenaline dose (150 μg, 300 μg, or 500 μg). However, the differences in functional properties across these devices may play a critical role in achieving these requirements as well as the differences in ergonomics in the handling of these devices.

The purpose of this review

Considering the dynamic pharmacokinetic/pharmacodynamic (PK/PD) profiles of different AAIs marketed in Europe and their effect on adrenaline delivery, the expert panel, also serving as author for this paper have carried out a detailed analysis of the PK/PD profiles of four AAIs, namely, Anapen, Emerade, EpiPen, and Jext, to delineate the adrenaline delivery and their subsequent physiological effects on the backdrop of device characteristics, dose strength, and the skin-to-muscle distances of the participants.

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肾上腺素自动注射器药代动力学/药效学研究及对临床实践的潜在影响

背景过敏性休克是一种突发性多系统过敏反应，如不及时治疗可能会导致死亡。全球指南建议将肾上腺素肌肉注射作为围手术期反应之外的过敏性休克的一线治疗方法。肾上腺素自动注射器（AAI）是一种广泛使用的自行给药装置，尤其是在社区环境中。欧洲已授权销售不同的商用 AAI。自动肾上腺素注射器的一个关键特点是能快速为患者（包括超重或肥胖患者）注射肾上腺素，从而产生最佳的心血管（CV）反应。AAI 就是为实现这一要求而设计的，这反映在其不同的功能特性上，如主容器的选择、给药机制（盒式或注射器式）、针头长度、针头规格和肾上腺素剂量（150 微克、300 微克或 500 微克）。然而，这些设备在功能特性上的差异以及在操作上的人体工学差异可能会对实现这些要求起到至关重要的作用。本综述的目的考虑到在欧洲市场上销售的不同 AAI 的动态药代动力学/药效学（PK/PD）特征及其对肾上腺素给药的影响，同时也是本文作者的专家小组对四种 AAI（即 Anapen、Emerade、EpiPen 和 Jext）的 PK/PD 特征进行了详细分析，以根据设备特征、剂量强度和参与者的皮肤到肌肉的距离来描述肾上腺素的给药及其随后的生理效应。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical and Translational Allergy Immunology and Microbiology-Immunology

CiteScore

7.50

自引率

4.50%

发文量

117

审稿时长

12 weeks

期刊介绍： Clinical and Translational Allergy, one of several journals in the portfolio of the European Academy of Allergy and Clinical Immunology, provides a platform for the dissemination of allergy research and reviews, as well as EAACI position papers, task force reports and guidelines, amongst an international scientific audience. Clinical and Translational Allergy accepts clinical and translational research in the following areas and other related topics: asthma, rhinitis, rhinosinusitis, drug hypersensitivity, allergic conjunctivitis, allergic skin diseases, atopic eczema, urticaria, angioedema, venom hypersensitivity, anaphylaxis, food allergy, immunotherapy, immune modulators and biologics, animal models of allergic disease, immune mechanisms, or any other topic related to allergic disease.