评估 Rezafungin 的 CLSI 临时临床折点和流行病学 cutoff 值，该值针对来自全球范围的同期侵袭性真菌分离株进行了测试（2019 年至 2020 年）。
Evaluation of Rezafungin Provisional CLSI Clinical Breakpoints and Epidemiological Cutoff Values Tested against a Worldwide Collection of Contemporaneous Invasive Fungal Isolates (2019 to 2020).
机构信息
JMI Laboratoriesgrid.419652.d, North Liberty, Iowa, USA.
出版信息
J Clin Microbiol. 2022 Apr 20;60(4):e0244921. doi: 10.1128/jcm.02449-21. Epub 2022 Mar 7.
Rezafungin is a new echinocandin under development for the treatment of candidemia and invasive candidiasis. CLSI recently approved provisional susceptible-only breakpoints and epidemiological cutoff values for spp. and rezafungin. The activities of rezafungin and comparators against 2019 to 2020 invasive fungal isolates was evaluated by applying the new CLSI breakpoints. Rezafungin demonstrated potent activity against Candida albicans (MIC/MIC, 0.03/0.06 mg/L; 100.0% susceptible), Candida tropicalis (MIC/MIC, 0.03/0.06 mg/L; 100% susceptible), Candida glabrata (MIC/MIC, 0.06/0.06 mg/L; 98.3% susceptible), Candida krusei (MIC/MIC, 0.03/0.03 mg/L; 100% susceptible), and Candida dubliniensis (MIC/MIC, 0.06/0.12 mg/L; 100% susceptible) when tested by the CLSI broth microdilution method. Rezafungin inhibited 99.6% of Candida parapsilosis isolates (MIC/MIC, 1/2 mg/L) at the susceptible breakpoint of ≤2 mg/L. All C. albicans, C. tropicalis, and C. krusei isolates, as well as most C. glabrata (96.2% to 97.9%) and C. parapsilosis (86.2% to 100%) isolates, were susceptible to comparator echinocandins. Fluconazole resistance was detected among 0.5%, 4.5%, 10.5%, and 1.2% of C. albicans, C. glabrata, C. parapsilosis, and C. tropicalis isolates, respectively. All echinocandins displayed limited activity against Cryptococcus neoformans. Rezafungin and other echinocandins were active against Aspergillus fumigatus (minimum effective concentration for 90% of isolates tested [MEC] range, 0.015 to 0.06 mg/L) and Aspergillus section (MEC range, 0.015 to 0.03 mg/L). All but 16 (8.6%) A. fumigatus isolates were susceptible to voriconazole, and 100% of Aspergillus section isolates were WT to mold-active azoles. When applying the CLSI clinical breakpoints, rezafungin displayed high susceptibility rates (>98.0%) against isolates from invasive fungal infections and showed potent activity against Aspergillus isolates.
雷扎fungin 是一种新的棘白菌素类药物，正在开发用于治疗念珠菌血症和侵袭性念珠菌病。CLSI 最近批准了 spp. 和雷扎fungin 的暂定敏感唯一切点和流行病学截止值。通过应用新的 CLSI 断点，评估了雷扎fungin 和比较剂对 2019 年至 2020 年侵袭性真菌分离株的活性。雷扎fungin 对白色念珠菌（MIC/MIC，0.03/0.06 mg/L；100.0%敏感）、热带念珠菌（MIC/MIC，0.03/0.06 mg/L；100%敏感）、光滑念珠菌（MIC/MIC，0.06/0.06 mg/L；98.3%敏感）、克柔念珠菌（MIC/MIC，0.03/0.03 mg/L；100%敏感）和都柏林念珠菌（MIC/MIC，0.06/0.12 mg/L；100%敏感）表现出强大的活性，当用 CLSI 肉汤微量稀释法进行测试时。雷扎fungin 抑制了 99.6%的近平滑念珠菌分离株（MIC/MIC，1/2 mg/L），在≤2 mg/L 的敏感折点。所有白色念珠菌、热带念珠菌和克柔念珠菌分离株，以及大多数光滑念珠菌（96.2%至 97.9%）和近平滑念珠菌（86.2%至 100%）分离株均对比较棘白菌素敏感。氟康唑耐药性分别在 0.5%、4.5%、10.5%和 1.2%的白色念珠菌、光滑念珠菌、近平滑念珠菌和热带念珠菌分离株中检测到。所有棘白菌素对新型隐球菌的活性有限。雷扎fungin 和其他棘白菌素对烟曲霉（测试的 90%分离株的最小有效浓度[MEC]范围，0.015 至 0.06 mg/L）和曲霉属（MEC 范围，0.015 至 0.03 mg/L）具有活性。除 16 株（8.6%）烟曲霉分离株外，所有烟曲霉分离株均对伏立康唑敏感，且 100%的曲霉属分离株对 mold-active 唑类药物均为 WT。当应用 CLSI 临床折点时，雷扎fungin 对侵袭性真菌感染的 分离株显示出高敏感性（>98.0%），并对曲霉属分离株表现出强大的活性。
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