使用FAERS数据比较丙型肝炎药物的不良反应

Jing Huang, Xinyuan Zhang, Jiayi Tong, Jingcheng Du, R. Duan, Liu Yang, J. Moore, Y. Chen, Cui Tao
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引用次数: 0

摘要

丙型肝炎是一种慢性感染,影响着世界上1亿多人。在美国,丙型肝炎是肝癌的头号病因,也是肝移植最常见的适应症。丙型肝炎研究的最新进展已经开发出新的治疗丙型肝炎的药物。然而,这些新的丙型肝炎药物的安全性也引起了人们的关注。在这项研究中,我们使用美国食品和药物管理局不良事件报告系统的数据,提出了一种统计程序来比较多种丙型肝炎药物不良事件的差异。我们报告了不同丙型肝炎药物使用者不良事件发生率的差异,并估计了不同年龄和性别分布在不同吸毒者群体中的差异。此外,所提出的程序是一个通用的管道,可用于测试和可视化多种药物之间不良事件的差异,以支持监管决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparing adverse effects of Hepatitis C drugs using FAERS data
Hepatitis C is a chronic infection that affects more than 100 million people in the world. In the United States, hepatitis C is the number one cause of liver cancer and the most common indication for liver transplantation. Recent advance in hepatitis C research have developed new drugs as a cure for hepatitis C. However, concerns have also been raised over safety of these new hepatitis C drugs. In this study, we presented a statistical procedure to compare the difference in adverse events among multiple hepatitis C drugs using data from the US Food and Drug Administration Adverse Event Reporting System. We reported the identified difference in adverse event rates among users of different hepatitis C drugs and estimated the difference attributable to different distributions in age and gender across groups of drug users. Moreover, the proposed procedure is a general pipeline that can be used to test and visualize difference of adverse events among multiple drugs to support regulatory decision-makings.
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