Department of Urology, New York-Presbyterian Hospital, Weill Cornell Medical College, New York, NY, USA.
Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
J Gen Intern Med. 2024 Jun;39(8):1414-1422. doi: 10.1007/s11606-023-08559-9. Epub 2023 Dec 26.
The FDA issued a "black box" warning regarding risks of fluoroquinolones in 2008 with updates in 2011, 2013, and 2016.
To examine antimicrobial use in hospital-treated UTIs from 2000 to 2020.
Cross-sectional study with interrupted time series analysis.
Patient encounters with a diagnosis of UTI from January 2000 to March 2020, excluding diagnoses of renal abscess, chronic cystitis, and infection of the gastrointestinal tract, lungs, or prostate.
Monthly use of fluoroquinolone and non-fluoroquinolone antibiotics were assessed. Fluoroquinolone resistance was assessed in available cultures. Interrupted time series analysis examined level and trend changes of antimicrobial use with each FDA label change.
A total of 9,950,790 patient encounters were included. From July 2008 to March 2020, fluoroquinolone use declined from 61.7% to 11.7%, with similar negative trends observed in inpatients and outpatients, age ≥ 60 and < 60 years, males and females, patients with and without pyelonephritis, and across physician specialties. Ceftriaxone use increased from 26.4% encounters in July 2008 to 63.6% of encounters in March 2020. Among encounters with available culture data, fluoroquinolone resistance declined by 28.9% from 2009 to 2020. On interrupted time series analysis, the July 2008 FDA warning was associated with a trend change (-0.32%, < 0.001) and level change (-5.02%, p < 0.001) in monthly fluoroquinolone use.
During this era of "black box" warnings, there was a decline in fluoroquinolone use for hospital-treated UTI with a concomitant decline in fluoroquinolone resistance and rise in ceftriaxone use. Efforts to restrict use of a medication class may lead to compensatory increases in use of a single alternative agent with changes in antimicrobial resistance profiles.
FDA 于 2008 年发布了关于氟喹诺酮类药物风险的“黑框警告”，并在 2011 年、2013 年和 2016 年进行了更新。
研究 2000 年至 2020 年医院治疗的尿路感染中抗菌药物的使用情况。
横断面研究，采用中断时间序列分析。
2000 年 1 月至 2020 年 3 月期间，排除肾脓肿、慢性膀胱炎以及胃肠道、肺部或前列腺感染诊断的，诊断为尿路感染的患者。
评估每月氟喹诺酮类和非氟喹诺酮类抗生素的使用情况。评估了可获得的培养物中的氟喹诺酮耐药性。中断时间序列分析检查了每次 FDA 标签更改时抗菌药物使用的水平和趋势变化。
共纳入 9950790 例患者。从 2008 年 7 月至 2020 年 3 月，氟喹诺酮类药物的使用率从 61.7%降至 11.7%，住院患者和门诊患者、年龄≥60 岁和<60 岁、男性和女性、有和无肾盂肾炎的患者以及各科室医生的使用率均呈类似的负向趋势。头孢曲松的使用率从 2008 年 7 月的 26.4%增加到 2020 年 3 月的 63.6%。在有可获得培养物数据的患者中，氟喹诺酮类耐药率从 2009 年至 2020 年下降了 28.9%。在中断时间序列分析中，2008 年 7 月 FDA 的警告与每月氟喹诺酮类药物使用的趋势变化（-0.32%，<0.001）和水平变化（-5.02%，p<0.001）有关。
在“黑框警告”时代，医院治疗的尿路感染中氟喹诺酮类药物的使用减少，同时氟喹诺酮类耐药率下降，头孢曲松的使用增加。限制一类药物使用的努力可能导致单一替代药物的使用增加，并改变抗菌药物耐药谱。
