Duke Center for Antimicrobial Stewardship and Infection Prevention, Durham, North Carolina.
Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.
Infect Control Hosp Epidemiol. 2019 Nov;40(11):1297-1300. doi: 10.1017/ice.2019.247. Epub 2019 Sep 2.
We analyzed antibiotic use data from 29 southeastern US hospitals over a 5-year period to determine changes in antibiotic use after the fluoroquinolone US Food and Drug Administration (FDA) advisory update in 2016. Fluoroquinolone use declined both before and after the FDA announcement, and the use of select, alternative antibiotics increased after the announcement.Fluoroquinolones are among the 4 most commonly prescribed antibiotic classes.1,2 Postmarketing reports of serious adverse events linked to fluoroquinolones include tendonitis, neuropathy, hypoglycemia, psychiatric side effects, and possible aortic vessel rupture, leading to safety label changes in July 2008 and August 2013.3 In July 2016, the US Food and Drug Administration (FDA) strengthened the "black box" warning following an initial safety announcement in May 2016, recommending avoidance of fluoroquinolones for uncomplicated infections such as acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, and acute bacterial sinusitis.4 Concerns over safety and the association with Clostridiodes difficile infection have led inpatient antimicrobial stewardship programs (ASPs) to develop initiatives to promote avoidance of quinolones. The objective of this study was to quantify the effect of the 2016 FDA "black box" update on inpatient antibiotic use among a cohort of southeastern US hospitals.
我们分析了 29 家美国东南部医院在五年期间的抗生素使用数据，以确定在 2016 年氟喹诺酮类药物美国食品和药物管理局（FDA）咨询更新后抗生素使用的变化。在 FDA 宣布之前和之后，氟喹诺酮类药物的使用都有所下降，并且在宣布之后，一些替代抗生素的使用有所增加。氟喹诺酮类药物是最常开的 4 种抗生素类别之一。1,2 与氟喹诺酮类药物相关的上市后严重不良事件报告包括肌腱炎、神经病、低血糖、精神副作用和可能的主动脉血管破裂，导致 2008 年 7 月和 2013 年 8 月安全标签发生变化。3 2016 年 7 月，美国食品和药物管理局（FDA）在 2016 年 5 月首次发布安全公告后，加强了“黑框”警告，建议避免将氟喹诺酮类药物用于慢性支气管炎急性加重、单纯性尿路感染和急性细菌性鼻窦炎等简单感染。4 对安全性的担忧以及与艰难梭菌感染的关联，导致住院抗菌药物管理计划（ASPs）制定了各种举措，以促进避免使用喹诺酮类药物。本研究的目的是量化 2016 年 FDA“黑框”更新对美国东南部医院住院患者抗生素使用的影响。
