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西班牙异基因造血干细胞移植中伊曲康唑的真实世界经验。

Real-World Experience with Isavuconazole in Allogeneic Stem Cell Transplantation in Spain.

机构信息

Department of Hematology, Hospital General Universitario Gregorio Marañon, Madrid, Spain; Department of Hematology, Instituto de Investigación Sanitaria Gregorio Marañon, Madrid, Spain.

Department of Hematology, Hospital General Universitario Gregorio Marañon, Madrid, Spain; Department of Hematology, Instituto de Investigación Sanitaria Gregorio Marañon, Madrid, Spain.

出版信息

Transplant Cell Ther. 2024 Oct;30(10):1033.e1-1033.e8. doi: 10.1016/j.jtct.2024.06.009. Epub 2024 Jun 12.

Abstract

Invasive fungal infections (IFI) pose a significant complication after hematopoietic stem cell transplantation (HSCT). Isavuconazole (ISV) is a new generation azole with a favourable adverse effect and interaction profile approved for the treatment of invasive aspergillosis and mucormycosis. We analyzed the indications, effectiveness, adverse event profile and drug interaction management of ISV in the real-world setting in adults who received allogeneic-HSCT (allo-HSCT) within the Spanish Group of HSCT and Cell Therapy (GETH-TC). We conducted a multicenter retrospective study of all consecutive adult allo-HSCT recipients (≥18 years) who received ISV either for IFI treatment or prophylaxis, from December 2017 to August 2021, in 20 centers within the Spanish Group of Hematopoietic Stem Cell Transplantation and Cell Therapy (GETH-TC). A total of 166 adult allografted patients who received ISV from 2017 to 2021 were included. Median age was 48 years with 43% females. In 81 (49%) patients, ISV was used for treatment of IFI, and in 85 (51%) for prophylaxis. Median duration of ISV administration for IFI treatment was 57 days (range 31-126) and 86 days (range 33-196) for prophylaxis. Most frequent indication for treatment was invasive aspergillosis (78%), followed by mucormycosis (6%). Therapeutic success (45%) was the most frequent reason for ISV withdrawal. In the prophylaxis group, the resolution of IFI risk factors was the most frequent reason for withdrawal (62%). Six (7%) breakthrough IFI were reported. The majority of patients (80%) presented pharmacologic interactions. Twenty-one patients (13%) reported adverse events related to ISV, mainly liver biochemistry abnormalities, which led to ISV withdrawal in 7 patients (4%). ISV was effective and well tolerated for IFI treatment and prophylaxis, with a manageable interaction profile.

摘要

侵袭性真菌病(IFI)是造血干细胞移植(HSCT)后严重的并发症。伊曲康唑(ISV)是一种新一代唑类药物,具有良好的不良反应和相互作用谱,已被批准用于侵袭性曲霉病和毛霉病的治疗。我们分析了在西班牙造血干细胞移植和细胞治疗小组(GETH-TC)中接受异基因 HSCT(allo-HSCT)的成年人中,ISV 在真实环境中的适应症、有效性、不良事件谱和药物相互作用管理。我们对 2017 年 12 月至 2021 年 8 月期间在西班牙造血干细胞移植和细胞治疗小组(GETH-TC)的 20 个中心接受 ISV 治疗 IFI 或预防 IFI 的所有连续成年 allo-HSCT 受者(≥18 岁)进行了一项多中心回顾性研究。共纳入 166 例 2017 年至 2021 年接受 ISV 的成年 allo 移植患者。中位年龄为 48 岁,女性占 43%。81 例(49%)患者使用 ISV 治疗 IFI,85 例(51%)患者使用 ISV 预防 IFI。IFI 治疗中 ISV 治疗的中位持续时间为 57 天(范围 31-126 天),预防的中位持续时间为 86 天(范围 33-196 天)。治疗的最常见适应症是侵袭性曲霉病(78%),其次是毛霉病(6%)。ISV 停药的最常见原因是治疗的疗效(45%)。在预防组中,IFI 危险因素的解决是停药的最常见原因(62%)。报告了 6 例(7%)突破性 IFI。大多数患者(80%)存在药物相互作用。21 例(13%)患者报告与 ISV 相关的不良反应,主要为肝生化异常,导致 7 例(4%)患者停用 ISV。ISV 对 IFI 的治疗和预防有效且耐受良好,具有可管理的相互作用谱。

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