Department of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
School of Pharmacy, College of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
Antimicrob Agents Chemother. 2021 May 18;65(6). doi: 10.1128/AAC.00074-21.
The Clinical and Laboratory Standards Institute (CLSI) revised the fluoroquinolone MIC breakpoints for in 2019, based on pharmacokinetic/pharmacodynamic analyses. However, clinical evidence supporting these breakpoint revisions is limited. A retrospective study was conducted at 3 hospitals in Taiwan between January 2017 and March 2019. Patients treated with levofloxacin for bacteremia caused by members of the with high MICs (1 or 2 μg/ml; levofloxacin susceptible by pre-2019 CLSI breakpoints) were compared with those with low-MIC bacteremia (≤0.5 μg/ml; levofloxacin susceptible by 2019 CLSI breakpoints) to assess therapeutic effectiveness by multivariable logistic regression. The primary outcome was 30-day mortality, and the secondary outcome was the emergence of levofloxacin-resistant isolates within 90 days after levofloxacin initiation. A total of 308 patients were eligible for the study. Kaplan-Meier analysis showed that patients infected with high-MIC isolates ( = 63) had a significantly lower survival rate than those infected with low-MIC isolates ( = 245) ( = 0.001). Multivariable logistic regression revealed that high levofloxacin MIC was a predictor of 30-day mortality (odds ratio [OR], 6.05; 95% confidence interval [CI], 1.51 to 24.18; = 0.011). We consistently found similar results in a propensity score-matched cohort (OR, 5.38; 95% CI, 1.06 to 27.39; = 0.043). The emergence of levofloxacin-resistant isolates was more common in the high-MIC group than the low-MIC group (25.0% versus 7.5%; = 0.065). An estimated area under the concentration-time curve/MIC ratio of ≥87 was significantly associated with better survival ( = 0.002). In conclusion, patients infected with isolates with levofloxacin MICs within the pre-2019 CLSI susceptible range of 1 or 2 μg/ml exhibited higher mortality than those infected with isolates with MICs of ≤0.5 μg/ml.
临床和实验室标准协会（CLSI）于 2019 年基于药代动力学/药效学分析修订了 的氟喹诺酮 MIC 折点。然而，支持这些折点修订的临床证据有限。一项回顾性研究在台湾的 3 家医院进行，时间为 2017 年 1 月至 2019 年 3 月。比较了接受左氧氟沙星治疗血培养阳性且 MIC 值较高（1 或 2μg/ml；按 2019 年 CLSI 折点判断为左氧氟沙星敏感）的患者与 MIC 值较低（≤0.5μg/ml；按 2019 年 CLSI 折点判断为左氧氟沙星敏感）的患者的治疗效果，采用多变量逻辑回归分析。主要结局是 30 天死亡率，次要结局是左氧氟沙星治疗开始后 90 天内出现左氧氟沙星耐药分离株。共纳入 308 例患者。Kaplan-Meier 分析显示，感染高 MIC 分离株（n=63）的患者生存率显著低于感染低 MIC 分离株（n=245）（=0.001）。多变量逻辑回归显示，左氧氟沙星 MIC 值较高是 30 天死亡率的预测因素（比值比 [OR]，6.05；95%置信区间 [CI]，1.51 至 24.18；=0.011）。在倾向评分匹配队列中，我们也得到了类似的结果（OR，5.38；95%CI，1.06 至 27.39；=0.043）。高 MIC 组中左氧氟沙星耐药分离株的出现更为常见（25.0%比 7.5%；=0.065）。估计浓度-时间曲线下面积/ MIC 比值≥87 与生存改善显著相关（=0.002）。总之，感染左氧氟沙星 MIC 值在 2019 年 CLSI 敏感范围 1 或 2μg/ml 的患者死亡率高于 MIC 值≤0.5μg/ml 的患者。
