Wu Lisha, Li Shougang, Gao Weixi, Zhu Xiaojian, Luo Pan, Xu Dong, Liu Dong, He Yan
Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.
Department of Pharmacy, Huangjiahu Hospital, Hubei University of Traditional Chinese Medicine, Wuhan 430065, China.
Microorganisms. 2023 Sep 4;11(9):2229. doi: 10.3390/microorganisms11092229.
The incidence of invasive fungal disease (IFD) has increased significantly, and IFD is a major cause of mortality among those with hematological malignancies. As a novel second-generation triazole antifungal drug offering both efficacy and safety, isavuconazole (ISA) is recommended by various guidelines internationally for the first-line treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) infecting adults. Given that it was only approved in China at the end of 2021, there is currently a lack of statistical data regarding its usage in the Chinese population. The primary objective of this report is to describe early experiences with ISA for the treatment of IFD.
This was a real-world, multicenter, observational case series study conducted in China. It included patients from three centers who received ISA treatment from January 2022 to April 2023. A retrospective assessment on patient characteristics, variables related to ISA administration, the treatment response of IFD to ISA, and potential adverse events attributed to ISA was conducted.
A total of 40 patients met the inclusion criteria. Among them, 12 (30%) were diagnosed with aspergillosis, 2 (5%) were diagnosed with candidiasis, 12 (30%) were diagnosed with mucormycosis, and 14 cases did not present mycological evidence. The predominant site of infection was the lungs (36), followed by the blood stream (8), sinuses (4), and respiratory tract (2). The overall response rate was 75% (30 patients), with male patients having a higher clinical response than female patients (24/24 versus 6/16, = 0.000) and autologous stem cell transplant patients having a higher clinical response than allogeneic stem cell transplant patients (6/6 versus 4/10, = 0.027). During the observation period, four patients experienced adverse effects associated with ISA, but none of them discontinued the treatment.
Our findings suggest that ISA, a novel first-line treatment for IA and IM, is associated with a high clinical response rate, low incidence, and a low grade of adverse effects. Given the short time that ISA has been available in China, further research is needed to identify its efficacy and safety in the real world.
侵袭性真菌病（IFD）的发病率显著上升，是血液系统恶性肿瘤患者死亡的主要原因。作为一种兼具疗效和安全性的新型第二代三唑类抗真菌药物，艾沙康唑（ISA）在国际上被各种指南推荐用于侵袭性曲霉病（IA）和侵袭性毛霉病（IM）感染成人的一线治疗。鉴于其于2021年底才在中国获批，目前缺乏其在中国人群中使用情况的统计数据。本报告的主要目的是描述艾沙康唑治疗IFD的早期经验。
这是一项在中国进行的真实世界、多中心、观察性病例系列研究。纳入了2022年1月至2023年4月期间在三个中心接受艾沙康唑治疗的患者。对患者特征、与艾沙康唑给药相关的变量、IFD对艾沙康唑的治疗反应以及归因于艾沙康唑的潜在不良事件进行了回顾性评估。
共有40例患者符合纳入标准。其中，12例（30%）被诊断为曲霉病，2例（5%）被诊断为念珠菌病，12例（30%）被诊断为毛霉病，14例未提供真菌学证据。主要感染部位为肺部（36例），其次是血流（8例）、鼻窦（4例）和呼吸道（2例）。总体缓解率为75%（30例患者），男性患者的临床缓解率高于女性患者（24/24对6/16，P = 0.000），自体干细胞移植患者的临床缓解率高于异基因干细胞移植患者（6/6对4/10，P = 0.027）。在观察期内，4例患者出现了与艾沙康唑相关的不良反应，但均未停药。
我们的研究结果表明，艾沙康唑作为IA和IM的新型一线治疗药物，临床缓解率高、发病率低且不良反应程度低。鉴于艾沙康唑在中国上市时间较短，需要进一步研究以确定其在现实世界中的疗效和安全性。
