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奥司他韦与神经精神事件风险:一项全国性基于人群的研究。

Oseltamivir and the Risk of Neuropsychiatric Events: A National, Population-based Study.

机构信息

Division of Infectious Diseases, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Artificial Intelligence and Big-Data Convergence Center, Gil Medical Center, Gachon University College of Medicine and Science, Incheon, Korea.

出版信息

Clin Infect Dis. 2020 Dec 3;71(9):e409-e414. doi: 10.1093/cid/ciaa055.

DOI:10.1093/cid/ciaa055
PMID:31996920
Abstract

BACKGROUND

Reports of serious neuropsychiatric events (NPEs), specifically suicide/suicide attempts, following the use of oseltamivir have led to public concerns. Our aim in this study was to determine whether an association exists between oseltamivir use and NPEs.

METHOD

This study was a population-based, retrospective, cohort study on a random sample of 50% of individuals in the Korean National Health Insurance Service (KNIS) database aged ≥8 years who were diagnosed with influenza between 2009 and 2017. The primary exposure was oseltamivir prescription at the time of influenza diagnosis, whereas the primary outcome was a diagnosis of an NPE within 30 days after the influenza diagnosis. Information on oseltamivir prescription, diagnoses of NPEs, demographic characteristics, comorbidities, drugs prescribed within the year before influenza diagnosis, and healthcare utilization were extracted from the KNIS database.

RESULTS

Of 3 352 015 individuals included in the analysis, 1 266 780 (37.8%) were prescribed oseltamivir. The incidence of NPEs was 0.86% and 1.16% in patients who were and were not prescribed oseltamivir, respectively (hazard ratio [HR], 0.74; 95% confidence interval [CI], .73 to .75; P < .001). Oseltamivir use was not associated with a difference in the overall risk of NPEs in the adjusted model (HR, 0.98; 95% CI, .96 to 1.01; P = .16), but the incidence of moderate-to-severe NPEs was significantly lower in those prescribed oseltamivir (HR, 0.92; 95% CI, .88-.96; P < .001).

CONCLUSION

Treating influenza with oseltamivir does not increase the risk of NPEs. Thus, public concern regarding its use is unwarranted.

摘要

背景

使用奥司他韦后出现严重神经精神事件(NPEs),特别是自杀/自杀未遂的报告,引起了公众的关注。我们在这项研究中的目的是确定奥司他韦的使用与 NPEs 是否存在关联。

方法

这是一项基于人群的回顾性队列研究,对韩国国家健康保险服务(KNIS)数据库中 2009 年至 2017 年间诊断为流感的年龄≥8 岁的随机抽取的 50%个体进行了研究。主要暴露因素是流感诊断时开具奥司他韦的处方,主要结果是在流感诊断后 30 天内诊断出 NPE。从 KNIS 数据库中提取了奥司他韦处方、NPE 诊断、人口统计学特征、合并症、流感诊断前一年内开具的药物以及医疗保健利用情况的信息。

结果

在纳入分析的 3352015 人中,有 1266780 人(37.8%)开具了奥司他韦。未开具奥司他韦的患者和开具奥司他韦的患者中 NPE 的发生率分别为 0.86%和 1.16%(风险比[HR],0.74;95%置信区间[CI],0.73 至 0.75;P <.001)。在调整模型中,奥司他韦的使用与 NPE 总体风险无差异(HR,0.98;95%CI,0.96 至 1.01;P =.16),但开具奥司他韦的患者中中重度 NPE 的发生率显著降低(HR,0.92;95%CI,0.88 至 0.96;P <.001)。

结论

用奥司他韦治疗流感不会增加 NPE 的风险。因此,公众对其使用的担忧是没有必要的。

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