摘要
中药药物警戒研究需要融合多元的方法来进行全面、客观的评价。伴随着医疗大数据时代的到来,医学研究与之深度融合,以医院信息系统(hospital information system,HIS)为代表的真实世界研究(real world study,RWS)为中药药物警戒提供了数据基础。处方序列分析(prescription sequence analysis,PSA)及在其基础上发展来的处方序列对称分析(prescription sequence symmetry analysis,PSSA),为中成药上市后临床安全性评价等提供方法学支撑。该文通过梳理HIS、PSA、PSSA相关研究,结合使用倾向性评分匹配法(propensity score matching,PSM)和巢式病例对照研究(nested case control study,NCCS),形成了一套真实世界中基于HIS、PSA、PSSA的中成药临床安全性评价方法技术体系,以期为未来中药药物警戒研究提供方法学示范。
Multiple methods should be incorporated into the research on pharmacovigilance of traditional Chinese medicine(TCM)for a comprehensive and objective evaluation. The arrival of the era of medical big data allows it to be deeply integrated into medical research. The real world study(RWS) represented by hospital information system(HIS) provides a data basis for exploring the pharmacovigilance of TCM. Prescription sequence analysis(PSA) and prescription sequence symmetry analysis(PSSA) developed based on the former serve as a methodological basis for clinical safety evaluation of Chinese patent medicines after marketing. By collating the related studies of HIS, PSA and PSSA and employing the propensity score matching(PSM) method and nested case-control study(NCCS), this paper formed a HIS-, PSA-and PSSA-based technical system for clinical safety evaluation of Chinese patent medicines in the real world, in order to provide a methodological demonstration for the future research on the pharmacovigilance of TCM.
作者
吕健
王连心
谢雁鸣
LYU Jian;WANG Lian-xin;XIE Yan-ming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第21期5468-5474,共7页
China Journal of Chinese Materia Medica
基金
国家重点研发计划项目(2018YFC1707400)
中国中医科学院博士研究生创新人才培养基金项目。
关键词
中药药物警戒
医院信息系统
处方序列分析
处方序列对称分析
方法技术体系
pharmacovigilance of traditional Chinese medicine
hospital information system
prescription sequence analysis
prescription sequence symmetry analysis
technical system
