Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville.
Faculty of Pharmacy, Ho Chi Minh City University of Technology (HUTECH), Ho Chi Minh City, Vietnam.
JAMA Intern Med. 2021 Jun 1;181(6):808-816. doi: 10.1001/jamainternmed.2021.1154.
In May 2016, due to concerns of the risks outweighing the benefits, the US Food and Drug Administration (FDA) removed systemic quinolones' indications for acute, uncomplicated urinary tract infection (uUTI), acute sinusitis (AS), and acute exacerbation of chronic obstructive pulmonary disease (AE-COPD). How the change influenced oral quinolone use is unknown.
To assess the association of oral quinolone safety warnings and indication restrictions with use.
DESIGN, SETTING, AND PARTICIPANTS: This interrupted time series (January 2015-November 2018) analysis of the monthly prevalence of oral quinolone-treated infection episodes used a national sample of privately insured patients in outpatient care from the IBM MarketScan Database and included adults with antibiotic treatment of new uUTI, AS, or AE-COPD episodes, excluding patients with conditions that complicate infections, previous hospitalization, or other infections.
Time before and after May 2016 when the FDA mandated label changes.
Monthly oral quinolone use prevalence by each condition before and after the label changes, overall and stratified by prescriber specialty.
In January 2015, quinolone prevalence among antibiotic-treated uUTI episodes (n = 652 235) was 41.6% (95% CI, 40.6%-42.5%); AS (n = 1 742 248) was 8.3% (95% CI, 7.9%-8.6%), and AE-COPD (n = 22 817) was 31.9% (95% CI, 30.3%-33.4%). Before the label changes, trends in monthly quinolone prevalence were nearly flat. The month of the label changes we noted an immediate reduction for uUTI (-7.2%; 95% CI, -8.6% to -5.8%); and to a lesser extent for AS (-1.2%; 95% CI, -1.5% to -0.9%) and AE-COPD (-2.6%; 95% CI, -4.1% to -1.1%), and continued monthly declines thereafter. Falsification tests confirmed an immediate decrease after the label change of quinolone use for uUTI but more obscured effects for AS and AE-COPD. Treatment shifted mostly to first-line (eg, nitrofurantoin in uUTI, amoxicillin in AS, macrolides in AE-COPD) and other second-line agents but use of not recommended antibiotics also increased (eg, tetracyclines in AE-COPD). Prescribing preferences varied, but significant reductions were seen across all prescriber specialties. At the end of the study period, quinolone was used for 19.2% of treated uUTIs, 2.9% of treated AS, and 14.6% of treated AE-COPD episodes.
Label changes and their announcements was associated with an immediate reduction in oral quinolone use for uUTI and to a lesser extent for AS and AE-COPD. Quinolones continued to contribute a considerable proportion of treatments for uUTI and AE-COPD episodes at the end of the study period, pointing to opportunities for further improvement.
2016 年 5 月，由于担心风险大于收益，美国食品和药物管理局 (FDA) 取消了全身喹诺酮类药物治疗急性、非复杂性尿路感染 (uUTI)、急性鼻窦炎 (AS) 和慢性阻塞性肺疾病急性加重 (AE-COPD) 的适应证。这一变化如何影响口服喹诺酮类药物的使用情况尚不清楚。
评估口服喹诺酮类药物安全性警告和适应证限制与使用之间的关系。
设计、地点和参与者：这项使用 IBM MarketScan 数据库中全国性的私人保险患者门诊护理样本的每月口服喹诺酮类药物治疗感染发作流行率的中断时间序列 (2015 年 1 月至 2018 年 11 月) 分析包括新 uUTI、AS 或 AE-COPD 感染发作的接受抗生素治疗的成年人，排除了伴有感染并发症、住院或其他感染的患者。
在 FDA 要求更改标签之前和之后的时间。
在标签更改前后，每种情况下每月口服喹诺酮类药物的使用流行率，总体情况以及按处方医生专业分类。
在 2015 年 1 月，接受抗生素治疗的 uUTI 发作 (n=652235) 中，喹诺酮类药物的流行率为 41.6%(95%CI，40.6%-42.5%)；AS(n=1742248)为 8.3%(95%CI，7.9%-8.6%)，AE-COPD(n=22817)为 31.9%(95%CI，30.3%-33.4%)。在标签更改之前，每月喹诺酮类药物流行率的趋势几乎持平。在标签更改的那个月，我们注意到 uUTI 的使用率立即下降了 7.2%(95%CI，8.6%至 5.8%)；而 AS(-1.2%；95%CI，1.5%至 0.9%)和 AE-COPD(-2.6%；95%CI，4.1%至 1.1%)的下降幅度较小，此后每月持续下降。伪造检验证实，uUTI 后标签更改后喹诺酮类药物的使用立即减少，但 AS 和 AE-COPD 的影响更为模糊。治疗主要转向一线治疗(如 uUTI 中的呋喃妥因、AS 中的阿莫西林、AE-COPD 中的大环内酯类药物)和其他二线药物，但不推荐使用的抗生素的使用也有所增加(如 AE-COPD 中的四环素)。处方偏好有所不同，但所有处方医生专业都有显著减少。在研究期末，喹诺酮类药物用于 19.2%的治疗 uUTI、2.9%的治疗 AS 和 14.6%的治疗 AE-COPD 发作。
标签更改及其公告与 uUTI 口服喹诺酮类药物的使用率立即降低以及 AS 和 AE-COPD 的使用率降低有关。在研究期末，喹诺酮类药物仍然在相当一部分 uUTI 和 AE-COPD 发作的治疗中发挥作用，这表明有进一步改进的机会。
