Zhang Li, Zhang Qinglan, Ma Wei, Chu Zhang-Bo, Xu Li, Xing Hongyun, Wang Jishi, Lin Jing, Liu Zhengyin
Department of Infectious Disease, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Department of Hematology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, People's Republic of China.
Infect Drug Resist. 2025 May 13;18:2475-2487. doi: 10.2147/IDR.S494985. eCollection 2025.
This study aimed to explore the efficacy and safety of amphotericin B colloidal dispersion (ABCD) in treating patients with invasive fungal disease (IFD) or febrile neutropenia.
This study retrospectively included patients diagnosed with IFD or febrile neutropenia who received ABCD treatment from 22 hospitals. The efficacy and safety were evaluated at the end of ABCD treatment. The characteristics of patients diagnosed with possible, probable and proven IFD according to the revised EORTC-MSG criteria were then further analyzed to conduct sensitivity analysis.
A total of 503 patients were enrolled in this study. Of these patients, 391 received ABCD treatment for a minimum of seven days, and the overall efficacy of ABCD was determined to be 71.87% (281/391). 183 patients were diagnosed with possible, probable and proven IFD, the ABCD efficacy of whom was 67.76% (124/183). The efficacy of ABCD in patients with hematologic malignancies, AIDS and diabetes was 70.10% (211/301), 88.24% (30/34), and 83.33% (10/12), respectively. In terms of various fungal species, the efficacy of ABCD in patients with and infections was 62.96% (34/54), 80.49% (33/41) and 66.67% (22/33), respectively. For patients in the targeted therapy, diagnostic-driven therapy, and empirical therapy groups, the efficacy of ABCD was 76.92% (60/78), 70.17% (207/295), and 77.78% (14/18), respectively. The most common adverse events (AEs) were infusion reactions (30.22%, 152/503) and hypokalemia (38.97%, 196/503), with the majority of these AEs classified as grade 1-2. This study was registered with ClinicalTrials.gov, NCT05116059.
ABCD has demonstrated satisfactory therapeutic efficacy and safety in the treatment of IFD or febrile neutropenia.
本研究旨在探讨两性霉素B胶体分散体（ABCD）治疗侵袭性真菌病（IFD）或发热性中性粒细胞减少症患者的疗效和安全性。
本研究回顾性纳入了来自22家医院接受ABCD治疗的诊断为IFD或发热性中性粒细胞减少症的患者。在ABCD治疗结束时评估疗效和安全性。然后根据修订的欧洲癌症研究与治疗组织-美国国立医学图书馆（EORTC-MSG）标准，对诊断为可能、很可能和确诊IFD的患者特征进行进一步分析，以进行敏感性分析。
本研究共纳入503例患者。其中，391例接受ABCD治疗至少7天，ABCD的总体疗效确定为71.87%（281/391）。183例患者被诊断为可能、很可能和确诊IFD，其ABCD疗效为67.76%（124/183）。ABCD在血液系统恶性肿瘤、艾滋病和糖尿病患者中的疗效分别为70.10%（211/301）、88.24%（30/34）和83.33%（10/12）。就各种真菌种类而言，ABCD在曲霉属和念珠菌属感染患者中的疗效分别为62.96%（34/54）、80.49%（33/41）和66.67%（22/33）。对于靶向治疗、诊断驱动治疗和经验性治疗组的患者，ABCD的疗效分别为76.92%（60/78）、70.17%（207/295）和77.78%（14/18）。最常见的不良事件（AE）是输液反应（30.22%，152/503）和低钾血症（38.97%，196/503），这些AE大多为1-2级。本研究已在ClinicalTrials.gov注册，注册号为NCT05116059。
ABCD在治疗IFD或发热性中性粒细胞减少症方面已显示出令人满意的治疗疗效和安全性。
