Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02120, USA.
Section of General Internal Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.
BMJ. 2022 Oct 4;379:e069931. doi: 10.1136/bmj-2021-069931.
To evaluate the association between initiation of fluoroquinolones and hospital admission or emergency department visit for suicidality.
Population based cohort study.
IBM MarketScan database, USA.
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.
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.
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.
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.
评估氟喹诺酮类药物的使用与自杀意念或自杀行为所致住院或急诊就诊之间的关联。
基于人群的队列研究。
美国 IBM MarketScan 数据库。
2756268 名成年人（≥18 岁），他们接受了口服氟喹诺酮类药物（环丙沙星、左氧氟沙星、莫西沙星、加替沙星、氧氟沙星、吉米沙星、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）治疗，且至少有 6 个月的连续健康计划参保，并在用药起始日期前 3 天或更短时间内被诊断为肺炎或尿路感染（UTI）。在肺炎队列中，对照抗生素为阿奇霉素；在 UTI 队列中，对照抗生素为复方磺胺甲噁唑。每个队列中，通过多变量逻辑回归模型计算出的倾向评分，对参与者进行了 1:1 匹配，该模型纳入了 57 个基线协变量。
主要结局为治疗起始后 60 天内自杀意念或自伤所致住院或急诊就诊。采用 Cox 比例风险模型来估计风险比和 95%置信区间。
肺炎队列纳入了 551042 名参与者，UTI 队列纳入了 2205526 名参与者。在 60 天随访期间，肺炎队列中观察到 181 例事件，UTI 队列中观察到 966 例事件。在肺炎队列中，氟喹诺酮类药物与阿奇霉素相比，风险比为 1.01（95%置信区间 0.76 至 1.36）；在 UTI 队列中，氟喹诺酮类药物与复方磺胺甲噁唑相比，风险比为 1.03（0.91 至 1.17）。敏感性分析和性别、年龄或精神疾病史亚组分析的结果一致。
与阿奇霉素或复方磺胺甲噁唑相比，氟喹诺酮类药物的使用与自杀意念或自杀行为所致住院或急诊就诊的风险增加没有显著关联。
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