基于HIS"真实世界"数据仓库探索上市后中成药安全性评价方法
投稿时间:2011-08-06    责任编辑:  点此下载全文
引用本文:杨薇,谢雁鸣,庄严.基于HIS"真实世界"数据仓库探索上市后中成药安全性评价方法[J].中国中药杂志,2011,36(20):2779.
DOI:10.4268/cjcmm20112005
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作者中文名作者英文名单位中文名单位英文名E-Mail
杨薇 YANG Wei 中国中医科学院 中医临床基础医学研究所, 北京 100700 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China  
谢雁鸣 XIE Yanming 中国中医科学院 中医临床基础医学研究所, 北京 100700 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China zhinanb2010@yahoo.com.cn 
庄严 ZHUANG Yan 中国人民解放军海军总医院, 北京 100048 Navy General Hospital, Beijing 100048, China  
基金项目:国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0171)
中文摘要:临床使用的中成药品种繁多,不良反应时有发生,中成药上市后的安全性问题成为患者与医生所关注的问题。本研究选取10家医院的医院信息系统(hospital information system,HIS)临床数据,通过清理、整合形成海量真实世界数据仓库。从数据仓库中提取中成药单品种数据,选取理化检查指标中的血、尿、便常规,血生化检查中的血肌酐、血尿素氮、谷丙转氨酶、谷草转氨酶检查项目作为安全性实验室评价指标。比较用药前后上述指标的异常变化,应用数据挖掘的方法,与未应用该中成药的人群进行对比分析,对上市后中成药的安全性做出评价。本研究为基于真实世界数据仓库的上市后中成药安全性再评价提供新的思路与方法,为中成药的临床安全使用提供指导。
中文关键词:上市后中成药  安全性评价  HIS数据仓库  真实世界  数据挖掘
 
Explore method about post-marketing safety re-evaluation of Chinese patent medicines based on HIS database in real world
Abstract:There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals.Chinese patent medicine's safety problems are the most concerned by patients and physicians.At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China.However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems.HIS database in real world is a good resource with rich information to research medicine safety.This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures.This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database.A clear protocol has been completed as for the first step for the whole study.The protocol is as follows.First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database.Secondly, select some related laboratory tests indexes as the safety evaluating outcomes,such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests.Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines.Finally, judge the relationship between those abnormal changing and Chinese patent medicine.We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.
keywords:post-marketing  Chinese patent medicine  safety re-evaluation  HIS database  real world  data mining method
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