本体OAE对我国上市疫苗相关不良反应表征研究的可行性分析  

Feasibility analysis on the use of Ontology of Adverse Events for characterization of adverse events associated with China-licensed vaccines

作　　者：谢江安 资文瑞 冉攀 张耀 周文梅 黄星荧 何勇群 XIE Jiangan;ZI Wenrui;RAN Pan;ZHANG Yao;ZHOU Wenmei;HUANG Xingying;HE Yongqun(School of Bioinformatics,Chongqing University of Posts and Telecommunications,Chongqing 400065,China;Medical School,University of Michigan,Ann Arbor 48109,MI,USA)

机构地区：[1]重庆邮电大学,生物信息学院,重庆400065 [2]密西根大学医学院,安娜堡,密西根州48109,美国

出　　处：《生物信息学》2020年第4期247-253,共7页Chinese Journal of Bioinformatics

基　　金：国家自然科学基金青年基金项目(No.61801067);重庆市自然科学基金基础研究与前沿探索项目(No.cstc2018jcyjAX0243).

摘　　要：从广义上来说,疫苗也是一种药物。由于疫苗是接种到成千上万的健康人群用来预防各类传染性疾病,因此对其安全性的要求要比传统药物更高。保证上市疫苗的安全性可以增强广大民众对疫苗的信心,提高疫苗接种的接受度和普及度,进而实现巨大的社会医疗经济效益。当前,我国疫苗年使用量超过世界任何一个国家或地区,但是受制于数据来源匮乏、研究方法缺失等客观因素,我国关于上市疫苗安全性及其相关不良反应的分析研究明显滞后与不足。本文,我们系统地介绍了时下不良反应研究领域热门的数据标准化与整合工具不良反应本体OAE及其在疫苗不良反应研究中的进展情况,并探讨将其引入到我国疫苗相关不良反应报告体系中的可行性,这将为未来我国上市疫苗安全监督体制的完善及后续科研分析带来极大的促进作用。Prophylactic vaccines must adhere to greater safety standards than many other drugs,principally because they are given to largely healthy populations with the intent to prevent,rather than treat diseases.Higher safety of licensed vaccines is likely to increase vaccine coverage rate,boost public confidence in vaccines,and create great social medical and economic benefits.At present,the annual use of vaccines in China exceeds that of any other countries or regions all over the world.However,the research on the safety and/or adverse events of these vaccines is obviously insufficient and lagging behind the developed countries due to lack of available data resource,research methods,and so on.In this study,we systematically introduced the Ontology of Adverse Events(OAE)and its research progress in vaccine adverse reactions,which is currently a hot tool of data standardization and integration in the research field of adverse events.Furthermore,we explored to introduce OAE into the reporting system of China-licensed vaccine associated adverse events,which will greatly promote the perfection of the management system in safety of China-licensed vaccines and facilitate follow-up scientific research and analysis.

关 键 词：疫苗 不良反应 本体 生物医学大数据 术语体系 标准化 

分 类 号：R318[医药卫生—生物医学工程]