中药上市后再评价HIS“真实世界”集成数据仓库的构建与实现

Construction and realization of real world integrated data warehouse from HIS on re-evaluation of post-maketing traditional Chinese medicine

目的:构建中药上市后再评价HIS(hospital information system)集成数据仓库,为以中药适应症、剂量疗程、联合用药、合并疾病以及不良反应等为主要内容的中药上市后临床再评价关键技术研究提供数据支撑,为上市后中成药的安全性、有效性和经济性的回顾研究提供数据,同时也为前瞻性研究提供基础。方法:上市中药HIS集成数据仓库利用信息采集系统和数据仓库技术,将多家医院HIS系统的数据进行清洗和有机整合,形成结构标准化、数据规范化的统一的数据仓库,在此基础上开展上市中药再评价关键技术研究。结果:构建了围绕患者住院主记录、患者住院医嘱、患者疾病诊断以及检验指标和经济指标几个主题的包含海量数据的数据仓库和多个可供研究的子数据仓库。结论:建立的数据仓库和子数据仓库可以为中药上市后临床再评价课题提供研究数据并具有临床使用价值,同时也为进一步的研究指明了方向。

Objective： To construct real world integrated data warehouse on re-evaluation of post-marketing traditional Chinese medicine for the research on key techniques of clinic re-evaluation which mainly includes indication of traditional Chinese medicine, dosage usage, course of treatment, unit medication, combined disease and adverse reaction, which provides data for reviewed research on its safety, availability and economy, and provides foundation for perspective research. Method： The integrated data warehouse extracts and integrate data from HIS by information collection system and data warehouse technique and forms standard structure and data. The further research is on process based on the data. Result： A data warehouse and several sub data warehouses were built, which focused on patients＇ main records , doctor orders, diseases diagnoses, laboratory results and economic indications in hospital. Conclusion ： These data warehouses can provide research data for re-evaluation of post-marketing traditional Chinese medicine, and it has clinical value. Besides, it points out the direction for further research.