Drug-induced Neuropsychiatric Adverse Events Using Post-Marketing Surveillance.

Drug-induced Neuropsychiatric Adverse Events Using Post-Marketing Surveillance.
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DOI:
10.2174/1574884716666210215104540
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发表时间:
2022
影响因子:
1.1
通讯作者:
--
中科院分区:
其他
文献类型:
--
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一些研究报道,在接受包括神经氨酸酶抑制剂(NIs)在内的多种药物治疗的儿科患者中,发现了异常行为。然而,在现实世界中,药物与异常行为相关的信息仍然有限。本研究的目的是利用一个自发报告系统数据库来阐明与异常行为相关的药物。我们使用日本不良药物事件报告数据库进行了回顾性药物警戒歧化分析。对提交给药品和医疗器械管理局的不良事件报告进行分析,并计算95%置信区间的报告优势比。总共发现了1144份异常行为报告。通过4种神经氨酸酶抑制剂(奥司他韦、扎那米韦、拉那米韦和peram- ivir)与异常行为的关联来检测信号。这些信号对于奥司他韦比其他神经氨酸酶抑制剂更强。对乙酰氨基酚和孟鲁司特也能检测到这种信号。我们的结果应该能够提高医生对与异常行为相关的药物的认识,但这些药物的进一步研究是有必要的。
Several studies reported that abnormal behavior was noted in pediatric pa- tients 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 sys- tem database. We performed a retrospective pharmacovigilance disproportionality analysis using the Jap- anese 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. 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 peram- ivir) with the abnormal behaviour. These signals were stronger for oseltamivir than other neuramini- dase inhibitors. The signals were also detected for acetaminophen and montelukast. Our results should be able to raise physicians’ awareness of drugs associated with ab- normal behavior, but further investigation of these medications is warranted.
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