Bridi Cavassin Francelise, Magri Marcello Mihailenko Chaves, Borgmann Ariela Victoria, Floriani Isabela Dombeck, Barreto Marina Rachid, Zaleski Tania, de Moraes Costa Carlesse Fabianne Altruda, Breda Giovanni Luís, de Araújo Motta Fábio, Falci Diego Rodrigues, Mendes Ana Verena Almeida, Morales Hugo Paz, Montes Patrícia Silva, Taborda Mariane, Pereira Talita Teles Teixeira, Baú-Carneiro João Luiz, Queiroz-Telles Flávio
Universidade Federal do Paraná (UFPR), 181, General Carneiro Street, Curitiba, PR, Brazil.
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FAMUSP), São Paulo, Brazil.
Infect Dis Ther. 2025 Jan;14(1):133-148. doi: 10.1007/s40121-024-01086-y. Epub 2024 Nov 30.
Amphotericin B lipid complex (ABLC) is an effective antifungal agent for treating invasive fungal infections (IFIs) even though its formulation is associated with potential adverse events, including those related to its infusion. This study aimed to analyze the incidence of acute infusion-related side effects (IRSE) associated with ABLC and their relationship with the profile of patients with oncohematological disease admitted in Brazilian reference tertiary hospitals.
This is an observational retrospective study that included clinical records of patients hospitalized, in a period of 6 years, diagnosed with probable or proved IFI and treated with at least two doses of ABLC.
A total of 229 patients were included, with a male prevalence and an average age of 44 years for adults and 10 years for children. Seventy-nine (34.5%) developed some IRSE, 5.1% of which progressed in severe form to discontinuation of treatment. The most prevalent events in adults were fever (66.7%), tremor/chills (53.3%), and tachycardia (24.4%). In children, the most common were fever (64.7%), tremors/chills (50%), and skin rash/itching (17.6%). Statistical significance was found for premedication use from the first dose of ABLC in relation to the onset of infusion reactions (P = 0.006). Multivariate analysis revealed that ABLC, when compared to liposomal AMB (L-AMB), and neutropenia were associated with a higher risk of developing IRSE (odds ratio [OR] 3.04, P = 0.008; and OR 11.02, P = 0.025, respectively).
The use of premedication was a protective factor against the occurrence of IRSE. Therefore, services providing amphotericin B (AMB) must reinforce protocols or implement new measures that optimize tolerability and safety during the treatment of patients with oncohematological disease, with special attention to patients with neutropenia, prioritizing the liposomal formulation of AMB whenever possible.
两性霉素B脂质复合物（ABLC）是治疗侵袭性真菌感染（IFI）的一种有效抗真菌药物，尽管其制剂存在潜在不良事件，包括与输注相关的不良事件。本研究旨在分析与ABLC相关的急性输注相关副作用（IRSE）的发生率及其与巴西参考三级医院收治的血液肿瘤疾病患者特征的关系。
这是一项观察性回顾性研究，纳入了6年间住院的、被诊断为可能或确诊IFI且接受至少两剂ABLC治疗的患者的临床记录。
共纳入229例患者，其中男性居多，成人平均年龄44岁，儿童平均年龄10岁。79例（34.5%）出现了一些IRSE，其中5.1%进展为严重形式，导致治疗中断。成人中最常见的事件是发热（66.7%）、震颤/寒战（53.3%）和心动过速（24.4%）。儿童中最常见的是发热（64.7%）、震颤/寒战（50%）和皮疹/瘙痒（17.6%）。从第一剂ABLC开始使用预处理与输注反应的发生之间存在统计学意义（P = 0.006）。多因素分析显示，与脂质体两性霉素B（L-AMB）相比，ABLC以及中性粒细胞减少与发生IRSE的风险较高相关（比值比[OR]分别为3.04，P = 0.008；以及OR 11.02，P = 0.025）。
使用预处理是预防IRSE发生的保护因素。因此，提供两性霉素B（AMB）的医疗机构必须加强方案或实施新措施，以优化血液肿瘤疾病患者治疗期间的耐受性和安全性，特别关注中性粒细胞减少的患者，尽可能优先使用AMB的脂质体制剂。
