氟康唑和念珠菌的野生型 MIC 分布、流行病学折点值和种特异性临床断点：CLSI 和 EUCAST 肉汤微量稀释方法协调的时机。
Wild-type MIC distributions, epidemiological cutoff values and species-specific clinical breakpoints for fluconazole and Candida: time for harmonization of CLSI and EUCAST broth microdilution methods.
机构信息
University of Iowa, Iowa City, IA, USA.
出版信息
Drug Resist Updat. 2010 Dec;13(6):180-95. doi: 10.1016/j.drup.2010.09.002. Epub 2010 Nov 2.
BACKGROUND
Both the Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST) have MIC clinical breakpoints (CBPs) for fluconazole (FLU) and Candida. EUCAST CBPs are species-specific, and apply only to C. albicans, C. tropicalis and C. parapsilosis, while CLSI CBPs apply to all species. We reassessed the CLSI CBPs for FLU and Candida in light of recent data.
METHODS
We examined (1) molecular mechanisms of resistance and cross-resistance profiles, (2) wild-type (WT) MICs and epidemiological cutoff values (ECVs) for FLU and major Candida species by both CLSI and EUCAST methods, (3) determination of essential (EA) and categorical agreement (CA) between CLSI and EUCAST methods, (4) correlation of MICs with outcomes from previously published data using CLSI and EUCAST methods, and (5) pharmacokinetic and pharmacodynamic considerations. We applied these findings to propose new species-specific CLSI CBPs for FLU and Candida.
RESULTS
WT distributions from large collections of Candida revealed similar ECVs by both CLSI and EUCAST methods (0.5-1 mcg/ml for C. albicans, 2 mcg/ml for C. parapsilosis and C. tropicalis, 32 mcg/ml for C. glabrata, and 64-128 for C. krusei). Comparison of CLSI and EUCAST MICs reveal EA and CA of 95% and 96%, respectively. Datasets correlating CLSI and EUCAST FLU MICs with outcomes revealed decreased response rates when MICs were > 4 mcg/ml for C. albicans, C. tropicalis and C. parapsilosis, and > 16 mcg/ml for C. glabrata.
CONCLUSIONS
Adjusted CLSI CBPs for FLU and C. albicans, C. parapsilosis, C. tropicalis (S, ≤ 2 mcg/ml; SDD, 4 mcg/ml; R, ≥ 8 mcg/ml), and C. glabrata (SDD, ≤ 32 mcg/ml; R, ≥ 64 mcg/ml) should be more sensitive for detecting emerging resistance among common Candida species and provide consistency with EUCAST CBPs.
背景
临床和实验室标准协会（CLSI）和抗菌药物敏感性试验欧洲委员会（EUCAST）都为氟康唑（FLU）和念珠菌制定了 MIC 临床折点（CBPs）。EUCAST CBPs 是种特异性的，仅适用于白念珠菌、热带念珠菌和近平滑念珠菌，而 CLSI CBPs 适用于所有念珠菌。我们根据最近的数据重新评估了 CLSI 对氟康唑和念珠菌的 CBPs。
方法
我们检查了（1）耐药性的分子机制和交叉耐药谱，（2）CLSI 和 EUCAST 方法测定的氟康唑和主要念珠菌种的野生型（WT）MIC 和流行病学截断值（ECVs），（3）CLSI 和 EUCAST 方法之间的基本（EA）和分类学一致（CA）的确定，（4）使用 CLSI 和 EUCAST 方法对先前发表的数据中的 MIC 与结果进行相关性分析，以及（5）药代动力学和药效学考虑。我们将这些发现应用于提出新的种特异性 CLSI CBPs 用于氟康唑和念珠菌。
结果
从大量念珠菌收集物中获得的 WT 分布表明，CLSI 和 EUCAST 方法的 ECVs 相似（白念珠菌为 0.5-1 mcg/ml，近平滑念珠菌和热带念珠菌为 2 mcg/ml，光滑念珠菌为 32 mcg/ml，克柔念珠菌为 64-128 mcg/ml）。CLSI 和 EUCAST MICs 的比较显示 EA 和 CA 分别为 95%和 96%。将 CLSI 和 EUCAST 氟康唑 MIC 与结果进行关联的数据集表明，当 MIC 对白念珠菌、热带念珠菌和近平滑念珠菌为>4 mcg/ml，对光滑念珠菌为>16 mcg/ml 时，反应率降低。
结论
调整后的氟康唑和白念珠菌、近平滑念珠菌、热带念珠菌（S，≤2 mcg/ml；SDD，4 mcg/ml；R，≥8 mcg/ml）和光滑念珠菌（SDD，≤32 mcg/ml；R，≥64 mcg/ml）的 CLSI CBPs 应该更敏感地检测常见念珠菌种中出现的耐药性，并与 EUCAST CBPs 保持一致。
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