Association between Medications and Road Traffic Accidents: An Exploratory Study Based on the FDA Adverse Event Reporting System (FAERS) Database

目的：减少道路交通事故(RTAs)是维护公共卫生的重大挑战。在众多风险因素中，药物的影响逐渐引起公众关注，但该领域研究仍显不足。本研究利用美国食品药品监督管理局(FDA)不良事件报告系统(FDA Adverse Event Reporting System, FAERS)中与RTAs相关的报告，评估各类药物与RTAs的关联性及特征。方法：研究提取了FAERS数据库中2004年第一季度至2023年第三季度由医疗专业人员提交的报告，并将药物判定为导致RTAs的主要嫌疑因素。通过描述性分析总结人群临床特征，采用报告比值比(ROR)评估关联性，运用Weibull形状参数检验评价潜伏时间特征，并基于性别进行亚组分析。结果：纳入研究的报告中，女性比例高于男性。前30种药物的报告量范围为56至517例，ROR值介于0.48至13.26之间。25种药物符合ROR显著性标准，且潜伏时间特征呈现差异。研究还发现，男性与女性显著药物列表的ROR前三位药物相同，但有4种药物在两者列表中均不显著。结论：本研究基于FAERS数据库提供了与RTAs最常关联的药物清单，为道路交通、药品监管机构及医疗专业人员提供参考依据。Objective: Reducing road traffic accidents (RTAs) is a significant challenge in maintaining public health. Among numerous risk factors, the impact of medications has gradually garnered public attention; however, research in this area remains insufficient. This study evaluated the association and characteristics of various medications with RTAs using reports related to RTAs in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. Methods: This study extracted reports submitted by medical professionals from FAERS database from Q1 2004 to Q3 2023, and identified medications as the primary suspects leading to RTAs. It summarized the clinical characteristics of the population through descriptive analysis and assessed associations using the reporting odds ratio (ROR). The time-to-onset characteristics were evaluated using the Weibull shape parameter test, and a subgroup analysis based on sex was also conducted. Results: Among the reports included in the study, a higher proportion were females than males. For the top 30 medications, the number of reports ranged from 56 to 517, with ROR values ranging from 0.48 to 13.26. Twenty-five medications met the significance criteria according to the ROR and exhibited variations in time-to-onset characteristics. The study also found that the top three medications by ROR value were the same in both the male and female lists of significant medications, with four medications being non-significant in both lists. Conclusions: This study provides a list of medications most commonly associated with RTAs based on the FAERS database, offering a reference for road traffic and pharmaceutical regulatory authorities and medical professionals.