Seth Shrey, Lukose Lipin, Sud Kamal, Goh Jing Xin, Tesfaye Wubshet, Small Fatima, Sridhar Sathvik B, Castelino Ronald L
Sydney School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India.
Intern Med J. 2025 Mar;55(3):353-368. doi: 10.1111/imj.16605. Epub 2024 Dec 24.
Excipients have been identified as 'inert' substances that often enhance the non-pharmacological aspects of a medication. However, recent clinical evidence elucidates their potential in inducing anaphylaxis and indicates that they are often overlooked as potential allergens in routine clinical practice. The aim of the study was to assimilate published evidence on excipient-induced allergies associated with the use of oral medications and to underline their potential as potent allergens. A systematic literature search of MEDLINE, EMBASE and International Pharmaceutical Abstracts databases was performed for case reports published from inception to June 2024. Studies were excluded if they were animal and laboratory studies or not published in English, full-text articles were unavailable, and they lacked essential information. This systematic review was conducted in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Polyethylene glycol was the most prevalent allergenic excipient, followed by colouring agents. Clinical manifestations exhibited wide variability ranging from mild to life-threatening reactions, and the most common presentations were urticaria and angioedema. Most patients recovered spontaneously after withdrawal of the offending agent with less than half necessitating additional drug interventions and only a single instance of reported fatality, which cannot be attributed to the excipient alone. Despite being labelled as inert, excipients pose a significant threat for the development of allergic reactions. Simple measures such as increased awareness among patients and healthcare professionals, comprehensive history taking, reviewing medication compositions and improved patient awareness regarding potentially allergenic excipients can aid in avoiding these readily preventable reactions.
辅料已被认定为“惰性”物质，它们常常能增强药物的非药理学特性。然而，最近的临床证据揭示了它们在引发过敏反应方面的潜在可能性，并表明在常规临床实践中，它们常常被忽视，未被视作潜在的过敏原。本研究的目的是收集已发表的关于与口服药物使用相关的辅料诱发过敏反应的证据，并强调它们作为强效过敏原的潜在可能性。对MEDLINE、EMBASE和国际药学文摘数据库进行了系统的文献检索，以查找从数据库建立到2024年6月发表的病例报告。如果研究是动物和实验室研究、非英文发表、没有全文文章以及缺乏关键信息，则将其排除。本系统评价是按照系统评价和Meta分析的首选报告项目（PRISMA）指南进行的。聚乙二醇是最常见的致敏辅料，其次是着色剂。临床表现从轻度到危及生命的反应呈现出广泛的变异性，最常见的表现是荨麻疹和血管性水肿。大多数患者在停用致病药物后自发康复，不到一半的患者需要额外的药物干预措施，仅有一例报告的死亡病例，且不能仅归因于辅料。尽管被标记为惰性物质，但辅料对过敏反应的发生构成了重大威胁。诸如提高患者和医护人员的认识、全面采集病史、查看药物成分以及提高患者对潜在致敏辅料的认识等简单措施，有助于避免这些易于预防的反应。
