摘要
借鉴循证医学既有证据分类、分级的成功经验,探索中药上市后安全性证据评价、分类和分级标准并形成安全性证据评价的基本框架,从点、线、面、体多个角度综合不同证据源,构建中药上市后安全性证据体,为今后该领域证据体系的研究提供方法学和技术支撑。
There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm ev- idence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and in- dicative for evidence evaluation for harm.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2015年第24期4723-4727,共5页
China Journal of Chinese Materia Medica
基金
中央级公益性科研院所基本业务费项目(Z0406
PY1303)
2014年第七批博士后特别项目(2014T70202)
国家"重大新药创制"科技重大专项(2009ZX09502-030)
关键词
安全性证据
上市后中药
证据分级
循证医学
body of evidence
postmarteting traditional Chinese medicine
evidence grading
evidence based medicine
