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

作　　者：王莉莉 周姿奕 王子文 田文杰 张燕[4] 曾令兵[5] 吴文娟[3] Wang Lili;Zhou Ziyi;Wang Ziwen;Tian Wenjie;Zhang Yan;Zeng Lingbing;Wu Wenjuan(Department of Laboratory Medicine,Zhoushan Women and Children Hospital,Zhoushan 316000,China;Clinical Laboratory Department of Air Force Special Medical Center,Beijing 100142,China;Department of Laboratory Medicine,Shanghai East Hospital,Tongji University School of Medicine,Shanghai 200123,China;Department of Clinical Laboratory,Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing 210008,China;Department of Laboratory Medicine,The First Affiliated Hospital,Jiangxi Medical College,Nanchang 330006,China)

机构地区：[1]舟山市妇女儿童医院检验科,舟山316000 [2]空军特色医学中心临床检验科,北京100142 [3]同济大学附属东方医院南院医学检验科,上海200123 [4]南京大学医学院附属鼓楼医院检验科,南京210008 [5]南昌大学第一附属医院检验科,南昌330006

出　　处：《中华检验医学杂志》2024年第6期639-643,共5页Chinese Journal of Laboratory Medicine

基　　金：国家自然科学基金(81971990,82172326)。

摘　　要：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。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 valuesfor 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.

关 键 词：隐球菌 新型 抗真菌药 流行病学折点 

分 类 号：R519[医药卫生—内科学]