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瑞扎芬净在现实生活中的应用——来自欧洲和美国的真菌观察结果

Rezafungin Utilisation in Real Life-FungiScope Results From Europe and the United States.

作者信息

Reinhold Ilana, Mori Giovanni, Lanzafame Massimiliano, Limongelli Alessandro, Vena Antonio, Götz Julia, Bauernfeind Stilla, Hanses Frank, Tometten Lukas, Mayer Michael, Rieke Ansgar, Soriano-Martin Ana, Valerio Maricela, Vazquez Jose A, Yue Patrick, Rahimli Laman, Azimli Nijat, Sal Ertan, Salmanton-García Jon, Vasenda Natalia, Sprute Rosanne, Stemler Jannik, Wingen-Heimann Sebastian, Cornely Oliver A, Seidel Danila

机构信息

Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Faculty of Medicine, University of Cologne, Cologne, Germany.

Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Faculty of Medicine, University of Cologne, University Hospital Cologne, Cologne, Germany.

出版信息

Mycoses. 2025 Sep;68(9):e70114. doi: 10.1111/myc.70114.

DOI:10.1111/myc.70114
PMID:40958610
Abstract

BACKGROUND

Rezafungin, a novel echinocandin with once-weekly intravenous dosing, offers potential advantages for outpatient parenteral antifungal therapy (OPAT) in invasive candidiasis (IC). While clinical trial data support its efficacy and safety, real-world experience remains limited.

METHODS

A retrospective analysis of patients treated with rezafungin across Germany, Italy, Spain, and the United States between January 2024 and June 2025 was conducted. Data was collected via the FungiScope registry. Clinical characteristics, indications for rezafungin, outcomes, safety, and logistical aspects of administration were evaluated.

RESULTS

Fifteen patients were included, fourteen with IC; one with chronic pulmonary aspergillosis. Regarding patients with IC, the median age was 65.5 years; 43% were female. The most frequently identified pathogens were Candida glabrata (57%) and Candida parapsilosis (21%). Primary indications for rezafungin were intravascular (36%) and osteoarticular infections (36%). Rezafungin was mainly selected to enable OPAT (86%) or due to fluconazole resistance (36%) or drug-drug interactions (14%). The median treatment duration was 9 weeks (range: 1-38 weeks). One mild adverse event occurred (cutaneous photosensitivity), but rezafungin was otherwise well tolerated. Complete clinical or mycological response was observed in 36% at day 30, and partial response in 50% of patients. Access differed substantially across centres due to administrative and reimbursement hurdles, affecting treatment transition to rezafungin in 71% of patients with IC.

CONCLUSIONS

Rezafungin was effective and well tolerated in this cohort, particularly in patients requiring long-term treatment. Administrative and logistical hurdles remain significant barriers to its widespread use. Facilitated access and enhanced awareness may improve patient outcomes by supporting early initiation and continuity of care.

摘要

背景

瑞扎芬净是一种新型棘白菌素,每周静脉给药一次,为侵袭性念珠菌病(IC)的门诊肠外抗真菌治疗(OPAT)提供了潜在优势。虽然临床试验数据支持其疗效和安全性,但真实世界的经验仍然有限。

方法

对2024年1月至2025年6月期间在德国、意大利、西班牙和美国接受瑞扎芬净治疗的患者进行回顾性分析。数据通过FungiScope登记处收集。评估了临床特征、瑞扎芬净的适应症、结局、安全性和给药的后勤方面。

结果

纳入15例患者,14例患有IC;1例患有慢性肺曲霉病。在IC患者中,中位年龄为65.5岁;43%为女性。最常鉴定出的病原体是光滑念珠菌(57%)和近平滑念珠菌(21%)。瑞扎芬净的主要适应症是血管内感染(36%)和骨关节炎感染(36%)。选择瑞扎芬净主要是为了实现OPAT(86%),或由于氟康唑耐药(36%)或药物相互作用(14%)。中位治疗持续时间为9周(范围:1 - 38周)。发生了1例轻度不良事件(皮肤光敏反应),但瑞扎芬净在其他方面耐受性良好。在第30天,36%的患者观察到完全临床或真菌学缓解,50%的患者观察到部分缓解。由于行政和报销障碍,各中心的获取情况差异很大,71%的IC患者的治疗转换为瑞扎芬净受到影响。

结论

瑞扎芬净在该队列中有效且耐受性良好,特别是在需要长期治疗的患者中。行政和后勤障碍仍然是其广泛使用的重大障碍。通过支持早期开始治疗和护理的连续性,便利的获取途径和提高的认识可能会改善患者结局。

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本文引用的文献

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Clin Microbiol Infect. 2025 Jun 7. doi: 10.1016/j.cmi.2025.05.035.
2
Antibiofilm activity of manogepix, ibrexafungerp, amphotericin B, rezafungin, and caspofungin against spp. biofilms of reference and clinical strains.马尼地平、依布雷xafungerp、两性霉素B、瑞扎芬净和卡泊芬净对参考菌株和临床菌株的生物膜的抗生物膜活性。 (注:ibrexafungerp原文拼写有误,可能是ibrexafungin,按照正确的拼写来理解进行翻译)
Antimicrob Agents Chemother. 2025 Jun 4;69(6):e0013725. doi: 10.1128/aac.00137-25. Epub 2025 May 15.
3
Early use of the novel antifungal rezafungin: a case series and literature review.
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J Antimicrob Chemother. 2025 Jul 1;80(7):1885-1892. doi: 10.1093/jac/dkaf143.
4
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J Antimicrob Chemother. 2025 Apr 30;80(6):1482-93. doi: 10.1093/jac/dkaf124.
5
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Open Forum Infect Dis. 2025 Mar 19;12(3):ofaf034. doi: 10.1093/ofid/ofaf034. eCollection 2025 Mar.
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