Ueda Natsumi, Umetsu Ryogo, Abe Junko, Kato Yamato, Nakayama Yoko, Kato Zenichiro, Kinosada Yasutomi, Nakamura Mitsuhiro
Laboratory of Drug Informatics, Gifu Pharmaceutical University.
Biol Pharm Bull. 2015;38(10):1638-44. doi: 10.1248/bpb.b15-00253.
There have been concerns that oseltamivir causes neuropsychiatric adverse events (NPAEs). We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model. NPAE data were obtained from the U.S. Food and Drug Administration Adverse Event Reporting System (2004 to 2013). The lower limit of the reporting odds ratio (ROR) 95% confidence interval (CI) of "abnormal behavior" in Japan, Singapore, and Taiwan was ≥1. The effects of the interaction terms for oseltamivir in male patients aged 10-19 years were statistically significant. The adjusted ROR of "abnormal behavior" was 96.4 (95% CI, 77.5-119.9) in male patients aged 10-19 years treated with osletamivir. In female patients, the results of the likelihood ratio test for "abnormal behavior" were not statistically significant. The adjusted NPAE RORs were increased in male and female patients under the age of 20 years. Oseltamivir use could be associated with "abnormal behavior" in males aged 10-19 years. After considering the causality restraints of the current analysis, further epidemiological studies are recommended.
有人担心奥司他韦会引起神经精神不良事件（NPAEs）。我们使用逻辑回归模型分析了奥司他韦治疗患者中年龄和性别与NPAEs的关联。NPAE数据来自美国食品药品监督管理局不良事件报告系统（2004年至2013年）。日本、新加坡和台湾地区“异常行为”的报告比值比（ROR）95%置信区间（CI）下限≥1。10至19岁男性患者中奥司他韦交互项的影响具有统计学意义。在接受奥司他韦治疗的10至19岁男性患者中，“异常行为”的校正ROR为96.4（95%CI，77.5 - 119.9）。在女性患者中，“异常行为”似然比检验结果无统计学意义。20岁以下男性和女性患者的校正NPAE ROR均升高。使用奥司他韦可能与10至19岁男性的“异常行为”有关。在考虑当前分析的因果关系限制后，建议进行进一步的流行病学研究。
