Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS.
Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS.
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DOI：
10.1186/1756-9966-30-93
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发表时间：
2011-10-05
期刊：
影响因子：
--
通讯作者：
Okuno Y
中科院分区：
文献类型：
--
作者：
Kadoyama K;Kuwahara A;Yamamori M;Brown JB;Sakaeda T;Okuno Y
此前，提交给美国食品和药物管理局(FDA)数据库的不良事件报告(AER)进行了审查，以确认铂类药物相关的过敏反应。本研究旨在确认该数据库是否可以提示抗癌药物紫杉醇、多西紫杉醇、原卡巴肼、天冬酰胺酶、替尼平和依托泊苷引起的过敏反应。在对任意药物名称进行修改并删除重复提交后，对涉及候选药物的AER进行了分析。应用国家癌症研究所不良事件通用术语标准4.0版来评估过敏反应的易感性，并使用标准化的官方药物警戒工具来定量检测信号，即药物相关不良事件的定量检测，包括比例报告比、报告优势比、贝叶斯信心传播神经网络给出的信息分量和经验贝叶斯几何平均值。基于2004年至2009年的1,644,220个AERs，检测了紫杉醇相关的轻度、重度和致命性超敏反应以及多西紫杉醇相关的致命性反应的信号。然而，使用丙卡巴肼、天冬酰胺酶、替尼平苷或依托泊苷发生的不良事件总数不足以检测到信号。FDA的不良事件报告系统AERS和本文使用的数据挖掘方法对于确认与药物相关的不良事件很有用，但同时发生的次数是信号检测中的一个重要因素。
Previously, adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) database were reviewed to confirm platinum agent-associated hypersensitivity reactions. The present study was performed to confirm whether the database could suggest the hypersensitivity reactions caused by anticancer agents, paclitaxel, docetaxel, procarbazine, asparaginase, teniposide, and etoposide. After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving candidate agents were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 was applied to evaluate the susceptibility to hypersensitivity reactions, and standardized official pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Based on 1,644,220 AERs from 2004 to 2009, the signals were detected for paclitaxel-associated mild, severe, and lethal hypersensitivity reactions, and docetaxel-associated lethal reactions. However, the total number of adverse events occurring with procarbazine, asparaginase, teniposide, or etoposide was not large enough to detect signals. The FDA's adverse event reporting system, AERS, and the data mining methods used herein are useful for confirming drug-associated adverse events, but the number of co-occurrences is an important factor in signal detection.
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