摘要
临床试验评价包含疗效和安全性评价,但是具有一定的局限性。对于药品安全性评价来说,需要一些特殊的研究方法。本文主要就不良反应信息收集和评价技术进行介绍,包括自发呈报法、集中监测法、因果关系判断方法及信号挖掘算法等;同时简述我国中医药安全性评价的现状和方法挑战。
Clinical trial is limited in drug safety evaluation,in which some special research methods should be involved.This study mainly introduces the data collection methods and evaluation techniques for the adverse drug reactions judgement,including spontaneous reporting,intensive monitoring,causal relationship judgment,signal detection etc.,and its application and challenge in Traditional Chinese medicines.
作者
冯硕
刘文佳
胡晶
张会娜
李博
FENG Shuo;LIU Wen-jia;HU Jing;ZHANG Hui-na;LI Bo(Beijing Hospital of Traditional Chinese Medicine of the Capital Medical University,Beijing 100010,China;Beijing Institute of Traditional Chinese Medicine,Beijing 100010,China;Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 255014,China)
出处
《中国合理用药探索》
CAS
2020年第1期28-31,共4页
Chinese Journal of Rational Drug Use
基金
国家自然科学基金资助项目(81774146)
关键词
不良反应
安全性评价
中药
adverse drug reaction
safety evaluation
traditional Chinese medicines
