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接受奥司他韦治疗或未接受抗病毒治疗的流感患者发生神经精神不良事件的发生率。

Incidence of neuropsychiatric adverse events in influenza patients treated with oseltamivir or no antiviral treatment.

作者信息

Smith J R, Sacks S

机构信息

F. Hoffmann-La Roche Ltd, Basel, Switzerland.

出版信息

Int J Clin Pract. 2009 Apr;63(4):596-605. doi: 10.1111/j.1742-1241.2009.02010.x.

Abstract

AIMS

The association between neuropsychiatric events and antiviral treatments for influenza has been under scrutiny. In this study, the incidence of neuropsychiatric events in influenza patients dispensed oseltamivir or no antiviral was assessed using a large US medical claims database.

METHODS

Propensity score balanced cohorts from a prior study of influenza patients with and without oseltamivir exposure were expanded and reanalysed in this retrospective study. Patients > or = 1 year with an influenza diagnosis [International Classification of Disease, 9th revision (ICD-9) 487.XX] during the study period (1 November 1999 to 30 April 2005) were identified and grouped into two cohorts: those dispensed oseltamivir [n = 60,267, 60,834 incident cases (ICs)] and those dispensed no-antiviral (n = 175,933, 183,786 ICs). Cohorts were stratified by age: < or = 17 years (oseltamivir, n = 20,501 ICs; no-antiviral, n = 84,871 ICs) and > or = 18 years (oseltamivir, n = 40,333 ICs; no-antiviral, n = 98,915 ICs). Medical claims in the 30 days (overall analysis) or 14 days (stratified analysis) after diagnosis were searched for indications of neuropsychiatric events. Claims-based outcome measures included three hierarchical neuropsychiatric categories: one broad, one restrictive (excluding particular disorders/conditions) and one limited to central nervous system (CNS)-specific disorders.

RESULTS

In the overall analysis, no increase in the incidence of claims-based neuropsychiatric events was detected in the patients dispensed oseltamivir vs. those dispensed no antiviral. Claims-based neuropsychiatric events were also reported with a similar frequency in patients < or = 17 years and > or = 18 years who did and did not receive antivirals.

CONCLUSION

In this retrospective cohort study, no increase in claims-based neuropsychiatric events was detected in influenza patients who were and were not exposed to oseltamivir.

摘要

目的

神经精神事件与流感抗病毒治疗之间的关联一直受到密切关注。在本研究中,我们使用一个大型美国医疗理赔数据库评估了接受奥司他韦治疗或未接受抗病毒治疗的流感患者中神经精神事件的发生率。

方法

在这项回顾性研究中,我们对先前一项关于有或无奥司他韦暴露的流感患者的研究中通过倾向得分平衡的队列进行了扩展和重新分析。确定了在研究期间(1999年11月1日至2005年4月30日)诊断为流感[国际疾病分类第九版(ICD - 9)487.XX]且年龄≥1岁的患者,并将其分为两个队列:接受奥司他韦治疗的患者[n = 60,267,60,834例发病病例(ICs)]和未接受抗病毒治疗的患者(n = 175,933,183,786例ICs)。队列按年龄分层:≤17岁(奥司他韦治疗组,n = 20,501例ICs;未接受抗病毒治疗组,n = 84,871例ICs)和≥18岁(奥司他韦治疗组,n = 40,333例ICs;未接受抗病毒治疗组,n = 98,915例ICs)。在诊断后的30天(总体分析)或14天(分层分析)内搜索医疗理赔记录以寻找神经精神事件的迹象。基于理赔的结局指标包括三个层次的神经精神类别:一个宽泛的类别、一个限制性类别(排除特定疾病/病症)和一个仅限于中枢神经系统(CNS)特定疾病的类别。

结果

在总体分析中,未发现接受奥司他韦治疗的患者与未接受抗病毒治疗的患者相比,基于理赔的神经精神事件发生率有所增加。在接受和未接受抗病毒治疗的≤17岁及≥18岁患者中,基于理赔的神经精神事件报告频率也相似。

结论

在这项回顾性队列研究中,未发现暴露于奥司他韦和未暴露于奥司他韦的流感患者中基于理赔的神经精神事件有所增加。

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