Mendoza-Palomar Natalia, Soler-Palacín Pere
Paediatric Infectious Diseases and Immunodeficiencies Unit, Children's Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Paediatric Infectious Diseases and Immunodeficiencies Unit, Children's Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Rev Iberoam Micol. 2025 Jan-Mar;42(1):32-36. doi: 10.1016/j.riam.2025.04.002. Epub 2025 May 12.
Invasive fungal infections (IFI) present significant challenges in newborn, children and adolescents, particularly in immunocompromised patients, such as those with some primary immunodeficiencies or hematologic malignancies, and those who undergo hematopoietic stem cell transplantation. Isavuconazole (ISA), a broad-spectrum triazole antifungal, has emerged as an effective alternative for treating IFI in adults, especially those caused by Aspergillus and Mucorales. Recent approvals by the Food and Drug Administration (2023) and the European Medicines Agency (2024) have extended the use of ISA to paediatric populations, offering an important addition to the current treatment options. Two clinical trials have assessed ISA in paediatric patients, showing it is generally well tolerated, with an acceptable safety profile. While adverse events are primarily gastrointestinal and hepatic, they are less frequent than those associated with voriconazole or liposomal amphotericin B. According to pharmacokinetic studies, drug clearance is faster in children, particularly in those under 35kg; thus, doses require careful modification. ISA may represent a crucial advancement in the treatment of paediatric IFIs, but therapeutic drug monitoring remains essential due to variability in drug concentrations.
侵袭性真菌感染(IFI)在新生儿、儿童和青少年中构成重大挑战,尤其是在免疫功能低下的患者中,例如患有某些原发性免疫缺陷或血液系统恶性肿瘤的患者,以及接受造血干细胞移植的患者。艾沙康唑(ISA)是一种广谱三唑类抗真菌药物,已成为治疗成人IFI的有效替代药物,尤其是由曲霉菌和毛霉目引起的感染。美国食品药品监督管理局(2023年)和欧洲药品管理局(2024年)最近的批准将ISA的使用范围扩大到了儿科人群,为当前的治疗选择增添了重要补充。两项临床试验评估了ISA在儿科患者中的应用,结果表明其耐受性总体良好,安全性可接受。虽然不良事件主要是胃肠道和肝脏方面的,但比伏立康唑或脂质体两性霉素B相关的不良事件频率更低。根据药代动力学研究,儿童尤其是体重低于35kg的儿童药物清除更快;因此,剂量需要仔细调整。ISA可能代表了儿科IFI治疗的一项关键进展,但由于药物浓度存在变异性,治疗药物监测仍然至关重要。