Objective To evaluate the association between initiation of fluoroquinolones and hospital admission or emergency department visit for suicidality. Design Population based cohort study. Setting IBM MarketScan database, USA. Participants 2 756 268 adults (≥18 years) who initiated an oral fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin, gemifloxacin, ofloxacin, gatifloxacin, norfloxacin, lomefloxacin, besifloxacin) or comparator antibiotic (January 2003 to September 2015) and had at least six months of continuous health plan enrollment and a diagnosis of pneumonia or urinary tract infection (UTI) three days or less before the drug initiation date. Comparator antibiotics were azithromycin in the pneumonia cohort and trimethoprim-sulfamethoxazole in the UTI cohort. Participants were matched 1:1 within each cohort on a propensity score, calculated from a multivariable logistic regression model that included 57 baseline covariates. Main outcomes measure Primary outcome was hospital admission or emergency department visit for suicidal ideation or self-harm within 60 days after treatment initiation. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals. Results The pneumonia cohort included 551 042 individuals, and the UTI cohort included 2 205 526 individuals. During the 60 day follow-up, 181 events were observed in the pneumonia cohort and 966 in the UTI cohort. The adjusted hazard ratios for fluoroquinolones were 1.01 (95% confidence interval 0.76 to 1.36) versus azithromycin in the pneumonia cohort and 1.03 (0.91 to 1.17) versus trimethoprim-sulfamethoxazole in the UTI cohort. Results were consistent across sensitivity analyses and subgroups of sex, age, or history of mental illnesses. Conclusion Initiation of fluoroquinolones was not associated with a substantially increased risk of admission to hospital or emergency department visits for suicidality compared with azithromycin or trimethoprim-sulfamethoxazole. No patient level data are available. The study protocol was registered with the centralized research tracking of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital (#2011P002580-201). Study protocol is available from the corresponding author upon request.

中文翻译：

---

开始使用氟喹诺酮类药物与因自杀而入院或急诊就诊之间的关联：基于人群的队列研究

目的 评估开始使用氟喹诺酮类药物与因自杀入院或急诊就诊之间的关联。设计基于人群的队列研究。设置 IBM MarketScan 数据库，美国。参与者 2 756 268 名成人（≥18 岁），他们开始口服氟喹诺酮类药物（环丙沙星、左氧氟沙星、莫西沙星、吉米沙星、氧氟沙星、加替沙星、诺氟沙星、洛美沙星、贝西沙星）或对照抗生素（2003 年 1 月至 2015 年 9 月），并且至少服用六个月连续健康计划登记和肺炎或尿路感染 (UTI) 的诊断在药物开始日期前三天或更短时间。比较抗生素是肺炎队列中的阿奇霉素和 UTI 队列中的甲氧苄氨嘧啶-磺胺甲恶唑。参与者在每个队列中根据倾向得分进行 1:1 匹配，从包含 57 个基线协变量的多变量逻辑回归模型计算得出。主要结果测量 主要结果是治疗开始后 60 天内因自杀意念或自残入院或急诊就诊。Cox 比例风险模型用于估计风险比和 95% 置信区间。结果 肺炎队列包括 551 042 人，UTI 队列包括 2 205 526 人。在 60 天的随访期间，在肺炎队列中观察到 181 起事件，在 UTI 队列中观察到 966 起事件。氟喹诺酮类药物在肺炎队列中与阿奇霉素相比的调整后风险比为 1.01（95% 置信区间 0.76 至 1.36），在 UTI 队列中与甲氧苄氨嘧啶-磺胺甲恶唑相比为 1.03（0.91 至 1.17）。结果在敏感性分析和性别、年龄或精神疾病史的亚组中是一致的。结论 与阿奇霉素或甲氧苄氨嘧啶-磺胺甲恶唑相比，开始使用氟喹诺酮类药物与因自杀入院或急诊就诊的风险显着增加无关。没有可用的患者水平数据。该研究方案已在布里格姆妇女医院药物流行病学和药物经济学部的集中研究跟踪中心注册 (#2011P002580-201)。研究协议可根据要求从相应的作者处获得。结论 与阿奇霉素或甲氧苄氨嘧啶-磺胺甲恶唑相比，开始使用氟喹诺酮类药物与因自杀入院或急诊就诊的风险显着增加无关。没有可用的患者水平数据。该研究方案已在布里格姆妇女医院药物流行病学和药物经济学部的集中研究跟踪中心注册 (#2011P002580-201)。研究协议可根据要求从相应的作者处获得。结论 与阿奇霉素或甲氧苄氨嘧啶-磺胺甲恶唑相比，开始使用氟喹诺酮类药物与因自杀入院或急诊就诊的风险显着增加无关。没有可用的患者水平数据。该研究方案已在布里格姆妇女医院药物流行病学和药物经济学部的集中研究跟踪中心注册 (#2011P002580-201)。研究协议可根据要求从相应的作者处获得。