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使用 FDA 不良事件报告系统和在线患者评论评估与抗流感神经氨酸酶抑制剂相关的不良事件。

Assessment of adverse events related to anti-influenza neuraminidase inhibitors using the FDA adverse event reporting system and online patient reviews.

机构信息

College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea.

出版信息

Sci Rep. 2020 Feb 20;10(1):3116. doi: 10.1038/s41598-020-60068-5.

DOI:10.1038/s41598-020-60068-5
PMID:32080337
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7033147/
Abstract

The recommended antiviral drugs available for the treatment and prevention of influenza are neuraminidase inhibitors (NAIs). The aim of this study was to evaluate age-related clinical manifestations of adverse events (AEs) related to NAIs. FAERS and WebMD data were downloaded. The available NAIs selected for the analysis were oseltamivir, peramivir, zanamivir, and laninamivir. Disproportionality was analyzed using the proportional reporting ratio (PRR), the reporting odds ratio (ROR), and the information component (IC) methods. In total, 16729 AEs from 4598 patients and 575 AEs from 440 patients in the FAERS and WebMD, respectively, were included in the analysis. In the FAERS, AEs were more common among those who were younger (<19 years) for zanamivir, while for those who were older (>65 years) for peramivir. A disproportionality analysis showed that signals for vomiting and hallucinations were detected in younger patients given oseltamivir, while an abnormal hepatic function, cardiac failure, shock, and cardio-respiratory arrest were detected in older patients given peramivir. Psychiatric disorders were most common in younger and older patients, while gastrointestinal disorders were most common in adult given oseltamivir in the WebMD. Adverse symptoms related to NAIs varied and depended on the drugs used and the age of the patient.

摘要

用于治疗和预防流感的推荐抗病毒药物是神经氨酸酶抑制剂(NAIs)。本研究旨在评估与 NAI 相关的不良事件(AE)的年龄相关临床表现。下载了 FAERS 和 WebMD 数据。分析中选择了奥司他韦、帕拉米韦、扎那米韦和拉尼米韦这几种可用的 NAI。使用比例报告比(PRR)、报告比值比(ROR)和信息成分(IC)方法分析了比例失调。总共纳入了 FAERS 中 4598 例患者的 16729 例 AE 和 WebMD 中 440 例患者的 575 例 AE。在 FAERS 中,扎那米韦的年轻患者(<19 岁)中 AE 更为常见,而年长患者(>65 岁)中则是帕拉米韦更为常见。不平衡分析表明,给予奥司他韦的年轻患者出现呕吐和幻觉的信号,而给予年长患者(>65 岁)的帕拉米韦则出现肝功能异常、心力衰竭、休克和心肺骤停。在 FAERS 中,年轻和年长患者中最常见的是精神障碍,而在 WebMD 中,成年患者最常见的是给予奥司他韦后的胃肠道疾病。与 NAI 相关的不良反应各不相同,取决于所用药物和患者年龄。