药物引起的神经精神不良事件的上市后监测。
Drug-induced Neuropsychiatric Adverse Events Using Post-Marketing Surveillance.
机构信息
Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences, Takatsuki, Osaka, Japan.
出版信息
Curr Rev Clin Exp Pharmacol. 2022;17(2):144-148. doi: 10.2174/1574884716666210215104540.
BACKGROUND
Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs, including neuraminidase inhibitors (NIs). However, the information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify the drugs associated with abnormal behavior using a spontaneous reporting system database.
METHODS
We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed, and the reporting odds ratio at 95% confidence interval were calculated.
RESULTS
A total of 1,144 reports of abnormal behavior were identified. The signals were detected through the association of 4 neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with the abnormal behaviour. These signals were stronger for oseltamivir than other neuraminidase inhibitors. The signals were also detected for acetaminophen and montelukast.
CONCLUSION
Our results should be able to raise physicians' awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.
背景
多项研究报告指出，儿科患者在使用包括神经氨酸酶抑制剂（NIs）在内的多种药物后出现了异常行为。然而，关于真实环境中与异常行为相关的药物的信息仍然有限。本研究旨在利用自发报告系统数据库阐明与异常行为相关的药物。
方法
我们使用日本药物不良反应报告数据库进行了回顾性药物警戒不比例性分析。对向药品和医疗器械管理局提交的不良事件报告进行了分析，并计算了报告比值比及其 95%置信区间。
结果
共确定了 1144 份异常行为报告。通过将 4 种神经氨酸酶抑制剂（奥司他韦、扎那米韦、拉尼米韦和帕拉米韦）与异常行为相关联，发现了这些信号。奥司他韦与其他神经氨酸酶抑制剂相比，这种关联更为显著。对乙酰氨基酚和孟鲁司特也出现了信号。
结论
我们的研究结果应该能够提高医生对与异常行为相关药物的认识，但有必要对这些药物进行进一步的调查。
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