世界中医药Issue(9)：1132-1136,5.DOI:10.3969/j.issn.1673-7202.2014.09.006
主动监测在中药注射剂上市后临床安全性评价的应用及范例
Clinical Application and Example of Active Post-marketing Safety Surveillance of Traditional Chinese Medicine
摘要
Abstract
Objective:To explore and evaluate the post-marketing safety evaluation methods with the example of three heat-clearing and detoxifying injections of traditional Chinese medicine.Methods:We monitored patients taken the above injections based on active surveil-lance methods.It is a prospective,multi-center,large sample and nested case-controlled design,to investigate the incidence,character-istics and influencing factors of adverse reaction (ADR).Results:Among 10,029 patients monitored,26 patients had ADR,5 of them experienced allergic reactions.IgE of the 5 patients who had allergic reactions was elevated.Conclusion:The overall ADR incidence rate is 0.26% (0.1% ~1%)and allergic reactions are probably mediated by IgE.关键词
中药注射剂/安全性/主动监测/巢式病例对照/真实世界Key words
TCMinjections/Safety/Active Surveillance/Nested case-control design/Real world分类
医药卫生引用本文复制引用
王连心,谢雁鸣,常艳鹏,易丹辉..主动监测在中药注射剂上市后临床安全性评价的应用及范例[J].世界中医药,2014,(9):1132-1136,5.基金项目
国家中医药管理局中医药行业科研专项资助项目（编号200907001-5-6）；“重大新药创制”科技重大专项“中药上市后再评价关键技术研究”（编号2009ZX09502-030）；中国中医科学院科技创新团队建设项目 （）
