Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Department of Neurology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Pharmacoepidemiol Drug Saf. 2021 Jun;30(6):797-805. doi: 10.1002/pds.5219. Epub 2021 Mar 23.
Fluoroquinolones, one of the most commonly prescribed antibiotic classes, have been implicated in cases of central nervous system (CNS) and peripheral nervous system (PNS) adverse events, which highlights the need for epidemiologic studies of the neurological safety of fluoroquinolones.
To evaluate the safety of fluoroquinolones with regard to risk of diagnosed neurological dysfunction.
We conducted a propensity score-matched inception cohort study using claims data from a commercially insured population. Our study included adults prescribed an oral fluoroquinolone or comparator antibiotic between January 2000 and September 2015 for acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, uncomplicated urinary tract infection, or acute bronchitis. Our outcomes were CNS dysfunction, and four separate but complementary PNS dysfunction outcomes. Cox proportional hazards models were estimated after matching on propensity scores fitted using the variables age, sex, epilepsy, hereditary peripheral neuropathy, renal dysfunction, diabetes, gabapentinoid use, statin use, isoniazid use, and chemotherapy use.
Our cohort contained 976 568 individuals exposed to a fluoroquinolone antibiotic matched 1:1 with a comparator. Matching produced balance (standardized mean difference <0.1) on all variables included in the propensity score. The hazard ratio associated with fluoroquinolone exposure was 1.08 (95% confidence interval 1.05-1.11) for CNS dysfunction, and 1.09 (95% CI 1.07-1.11) for the most commonly occurring PNS dysfunction outcome.
Fluoroquinolone antibiotic use was associated with the development of neurological dysfunction versus comparator antibiotic use in the adult population.
氟喹诺酮类药物是最常用的抗生素类别之一，已被牵连到中枢神经系统（CNS）和周围神经系统（PNS）不良事件中，这凸显了需要进行氟喹诺酮类药物神经安全性的流行病学研究。
评估氟喹诺酮类药物在诊断为神经功能障碍方面的安全性。
我们使用来自商业保险人群的索赔数据，开展了一项倾向评分匹配的起始队列研究。我们的研究包括 2000 年 1 月至 2015 年 9 月期间因急性细菌性鼻窦炎、慢性支气管炎急性加重、单纯性尿路感染或急性支气管炎而接受口服氟喹诺酮类药物或对照抗生素治疗的成年人。我们的结局是中枢神经系统功能障碍和四个单独但互补的周围神经系统功能障碍结局。在使用年龄、性别、癫痫、遗传性周围神经病、肾功能障碍、糖尿病、加巴喷丁类药物、他汀类药物、异烟肼和化疗使用等变量拟合的倾向评分进行匹配后，估计了 Cox 比例风险模型。
我们的队列包含 976568 名接受氟喹诺酮类抗生素暴露的个体，与对照抗生素 1:1 匹配。匹配在倾向评分中包含的所有变量上产生了平衡（标准化均差<0.1）。氟喹诺酮类药物暴露与中枢神经系统功能障碍相关的风险比为 1.08（95%置信区间 1.05-1.11），与最常见的周围神经系统功能障碍结局相关的风险比为 1.09（95%置信区间 1.07-1.11）。
与对照抗生素相比，氟喹诺酮类抗生素的使用与成年人群中神经功能障碍的发展相关。
