中国药物警戒 ›› 2010, Vol. 7 ›› Issue (12): 719-721.

• 循证药学 • 上一篇    下一篇

中药与化学药交互作用不良反应的临床评价方法探讨

刘凯1, 罗辉2, 刘建平2   

  1. 1.甘肃中医学院,甘肃兰州730000；
    2.北京中医药大学循证医学中心,北京100029
  • 收稿日期:2010-06-05 修回日期:2016-03-09 出版日期:2010-12-08 发布日期:2016-03-09
  • 通讯作者: 刘建平,男,教授,循证中医药临床研究。E-mail: liujp@bucm.edu.cn
  • 作者简介:刘凯,男,主治医师,中西医结合临床。
  • 基金资助:
    国家重点基础研究发展计划（973计划；2006CB504602）；科技部国际合作项目（ 2009DFA31460）

Expl oration on Methodology of Clinical Evaluation about Adverse Drug Reaction of Interaction between Chinese Herbs and Western Drug

LIU Kai1 ,LUO Hui2, LIU Jian-ping2   

  1. 1.Gansu College of Traditional Chinese Medicine, Gansu Lanzhou 730000, China;
    2.Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2010-06-05 Revised:2016-03-09 Online:2010-12-08 Published:2016-03-09

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摘要： 根据中药、化学药交互作用不良反应的概念与特点,针对中药、化学药交互作用不良反应的研究,从不良反应因果关系的判定,临床研究设计方案的选择、交互作用的判断与分析、循证药学的研究方法等方面进行方法学探讨,以期提高中药、化学药交互作用不良反应临床研究的科学性、规范性及实用性,为中药、化学药交互作用不良反应评价研究提供高质量的证据,指导临床合理用药,提高中药、化学药合用的安全性。

关键词: 中药, 化学药, 交互作用, 不良反应, 临床方法学

Abstract: According to concept and characteristics of adverse drug reaction of the interaction between Chinese herbs and western drug, and targeting for existing research about adverse drug reaction of herb and drug interaction, this article explored the judgment of causality relationship, judgment and analysis of herb and drug interaction, using evidence -based pharmacology methodology and explain how to design clinical study protocol in order to improve scientific nature, standardization and practicability in interaction clinical study. At the same time, the research can also offer high quality research evidence for adverse drug reaction evaluation study in order to realize guiding reasonable clinical drug use and improve safety of Chinese herbs and western drug for simultaneous use.

Key words: Chinese herbs, western drug, interaction effect, adverse drug reaction(ADR), clinical methodology

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