tailieunhanh - báo cáo khoa học: "Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Hypersensitivity reactions to anticancer agents: Data mining of the public version of the FDA adverse event reporting system, AERS | Kadoyama et al. Journal of Experimental Clinical Cancer Research 2011 30 93 http content 30 1 93 Journal of Experimental Clinical Cancer Research RESEARCH Open Access Hypersensitivity reactions to anticancer agents Data mining of the public version of the FDA adverse event reporting system AERS 1 2 2 1 1 13 Kaori Kadoyama Akiko Kuwahara Motohiro Yamamori JB Brown Toshiyuki Sakaeda and Yasushi Okuno Abstract Background 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. Methods 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 was applied to evaluate the susceptibility to hypersensitivity reactions and standardized official pharmacovigilance tools were used for quantitative detection of signals . 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. Results 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. Conclusions 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