Yang Wei, Xie Yanming, Zhuang Yan
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2779-82.
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.
临床实践中使用的中药种类繁多，临床专业人员已报告了许多不良事件。中药的安全性问题是患者和医生最为关注的。目前，国内外许多研究人员都在研究中药上市后安全性的再评价方法。然而，利用医院信息系统（HIS）的数据对上市后中药安全性问题进行再评价的情况却很少见。现实世界中的HIS数据库是研究药物安全性的丰富信息的良好资源。本研究计划分析从北京十家顶级综合医院选取的HIS数据，经过一系列数据清理和整合程序后，形成一个总计容量达100万例的现实世界大型HIS数据库。本研究可能是一个基于HIS数据库利用信息评估中药安全性的新项目。对于整个研究的第一步，已经完成了一个明确的方案。方案如下。首先，将总HIS数据库中存在的每一种中药分别作为一个单独的数据库。其次，选择一些相关的实验室检查指标作为安全性评估结果，如血常规、尿常规、粪便常规、凝血常规、肝功能、肾功能等检查。第三，使用数据挖掘方法分析那些在使用中药前后有异常变化的选定安全性结果。最后，判断这些异常变化与中药之间的关系。我们希望这种方法能为对中药安全性评价感兴趣的中药研究人员提供有用信息。
