摘要
中药注射剂是近几年中药新药研发的热点之一,但其临床发生的严重不良反应引起了全社会的广泛关注,对其开展上市后安全性监测具有紧迫性。本研究根据中药注射剂发生安全性问题的原因及药品不良反应监测的发展趋势,阐述了药物警戒在中药注射剂上市后安全性监测中应用的必要性,并简要介绍了运用数据挖掘技术对自发呈报系统数据库进行快速信号检测的方法。
Traditional Chinese medicine （TCM） injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It＇ s very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance＇ s necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2008年第5期612-614,共3页
China Journal of Chinese Materia Medica
关键词
中药注射剂
药物警戒
安全性监测
traditional Chinese medicine injections
pharmacovigilance
safety monitoring
