避免药物不良反应发生的方法学研究进展  

Review of Methodological Study on Prevention of Adverse Drug Reactions

作　　者：张楠 郭晓昕 贾海忠 ZHANG Nan;GUO Xiaoxin;JIA Haizhong(Beijing Cifang Traditional Chinese Medicine Clinic Co.,Ltd,Beijing 100012,China;Drug Evaluation Center of State Drug Administration,Beijing 100022,China)

机构地区：[1]北京慈方中医诊所有限公司,北京100012 [2]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国药物警戒》2020年第1期56-62,共7页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项(2015ZX09501004-001-001)：基于SRS系统的动态、长效中药风险信号早期发现研究

摘　　要：关于药物不良反应的相关研究日益增多,目前研究的重点几乎放在药物不良反应发生率、类型、严重程度等方面,而如何避免不良反应的研究却寥寥无几,预防和减少药物不良反应一直是现代医学的瓶颈。中医的整体思维和辨证思维为避免药物不良反应发生的研究提供了重要的方法学指导,笔者整理了近年来运用辨证思维研究药物不良反应的相关文献,发现确实可以减少不良反应的发生,填补了现代医学的空白,但其结论仍缺乏全面性与严密性,原因在于缺乏一个客观、全面、严密的药物不良反应研究体系,本文将从目前的研究成果以及存在的问题进行讨论。There are an increasing number of researches on ADRs(adverse drug reactions).The current research focuses on the incidence,type,and severity of ADRs so how to prevent ADRs is little studied.Preventing and reducing adverse drug reactions has always been the bottleneck of modern medicine.The overall and dialectical thinking of TCM has provided an important methodological guide to the prevention of ADRs.The authors of this article have discovered that ADRs can really be reduced after reviewing the literature related to studies on ADRs using the dialectical thinking in recent years.The findings achieved so far have filled a gap of modern medicine,but the conclusions are not comprehensive and rigorous enough due to the lack of an objective,comprehensive and rigorous research system for ADRs.This paper discusses the findings of current research and existing problems.

关 键 词：药物不良反应 规律 方法学 研究 预防 西药中药化 适应证群 不适应证群 

分 类 号：R994.1[医药卫生—毒理学]