Despite the recent introduction of a new class of anti-Aspergillus agents, no standard regimen for the prevention of invasive fungal disease (IFD) following allogeneic hematopoietic stem cell transplantation has been shown to be superior to fluconazole. The present prospective, single-arm study investigated the feasibility of voriconazole (VOR) administration as primary prophylaxis in 52 recipients of umbilical cord blood transplantation (CBT) with fludarabine-based conditioning, who had no previous IFD episodes. Proven or probable IFD was determined using the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group, and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria were considered as breakthrough infections. VOR was administered as prophylaxis for a total of 6884 patient-days following CBT. The mean duration of VOR administration after transplantation was 132 days (range, 1-769); 44 patients (85 %) had advanced disease, 15 (29 %) had a history of allogeneic HSCT, and 29 (56 %) received systemic corticosteroid therapy for allogeneic immune-mediated complications. Under the prophylaxis with VOR, one patient developed probable invasive aspergillosis on day 71, and the cumulative incidence of IFD was 4.5 % at day 180. None of the patients developed breakthrough candida or zygomycetes infections. Under the extensive therapeutic dose monitoring, VOR was safely administered with a calcineurin inhibitor and was well tolerated. These results suggest that VOR represents a feasible primary prophylactic agent for IFD after CBT with fludarabine-based conditioning.

译文

尽管最近引入了一种新型的抗曲霉菌药,但尚无用于预防异基因造血干细胞移植后侵袭性真菌病 (IFD) 的标准方案优于氟康唑。目前的前瞻性单臂研究调查了在52名以前没有IFD发作的基于氟达拉滨的脐带血移植 (CBT) 接受者中使用伏立康唑 (VOR) 作为主要预防的可行性。使用欧洲癌症/侵袭性真菌感染研究与治疗组织合作小组确定了已证实或可能的IFD,而美国国家过敏和传染病研究所Mycoses研究小组 (EORTC/MSG) 标准被认为是突破性感染。在CBT后总共6884个患者日给予VOR作为预防。移植后VOR给药的平均持续时间为132天 (范围,1-769天); 44例患者 (85% 例) 患有晚期疾病,15例 (29% 例) 有同种异体HSCT病史,29例 (56% 例) 因同种异体免疫介导的并发症接受全身性皮质类固醇治疗。在VOR的预防下,一名患者在第71天发生了可能的侵袭性曲霉病,并且在第180天4.5% 了IFD的累积发生率。没有患者出现突破性的念珠菌或接合菌感染。在广泛的治疗剂量监测下,VOR与钙调神经磷酸酶抑制剂一起安全给药,并且耐受性良好。这些结果表明,在使用基于氟达拉滨的CBT调理后,VOR代表了IFD的可行的主要预防剂。

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