2017—2022年华东地区新型隐球菌抗真菌药物流行病学折点的建立
Establishment of the epidemiological cut-off value for antifungal drugs against Cryptococcus neoformans in East China from 2017 to 2022
目的:通过多中心体外药物敏感性试验,建立我国华东地区新型隐球菌对抗真菌药物的流行病学折点(ECV)。方法:回顾性收集2017年1月1日至2022年12月31日华东地区侵袭性真菌感染监测协作组收集的临床分离新型隐球菌共479株,采用质谱和基因测序进行菌种鉴定;在上海、江西、江苏省3个分中心真菌实验室建立统一的药敏检测体系,并通过一致性评价后,分别独立完成新型隐球菌的药敏检测。依据美国临床实验室标准化委员会M57的原则和流程建立本地区新型隐球菌对氟康唑、伏立康唑、两性霉素B、5-氟胞嘧啶、艾沙康唑、泊沙康唑和伊曲康唑的流行病学折点。结果:通过室间一致性评价,观察到每个中心的所有药物MIC值相差均≤1个稀释梯度,华东地区新型隐球菌ECV为:氟康唑16 mg/L,伏立康唑0.12 mg/L,两性霉素B 1 mg/L,5-氟胞嘧啶8 mg/L,艾沙康唑0.12 mg/L,泊沙康唑0.5 mg/L,伊曲康唑0.5 mg/L。结论:初步揭示了华东地区临床隐球菌的药物敏感性特征,建立了华东地区新型隐球菌抗真菌药物的流行病学折点。
更多Objective:To establish an epidemiological cut-off value (ECV) for antifungal drugs against Cryptococcus neoformans in East China through a multicenter in vitro drug susceptibility test. Methods:A retrospective collection of 479 clinical isolates of Cryptococcus neoformans was conducted by the East China Invasive Fungal Infection Group (ECIFIG) from January 1, 2017 to December 31, 2022. Mass spectrometry and gene sequencing were used for identification. A unified drug susceptibility testing system was established in the fungal laboratories across three sub centers in Shanghai, Jiangxi, and Jiangsu provinces. Drug susceptibility testings of Cryptococcus neoformans were independently completed in each center after passing consistency evaluation. Epidemiological breakpoints were established against fluconazole, voriconazole, amphotericin B, 5-fluorocytosine, isaconazole, posaconazole and itraconazole following the principles and procedures of the Clinical and Laboratory Standards Institute (CLSI) M57. Results:External consistency evaluation revealed that the minimum inhibitory concentration values ??for all drugs in each center did not differ by more than one dilution gradient. A new ECV type of Cryptococcus neoformans in East China was established, including fluconazole 16 mg/L, voriconazole 0.12 mg/L, amphotericin B 1 mg/L, 5-fluorocytosine 8 mg/L, isavuconazole 0.12 mg/L, posaconazole 0.5 mg/L, and itraconazole 0.5 mg/L. Conclusion:This study preliminarily revealed the drug susceptibility characteristics of clinical Cryptococcus neoformans in East China and established the ECVs for antifungal drugs against Cryptococcus neoformans in the region.
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