中药槟榔及其制剂的安全性系统评价
投稿时间:2017-08-19    责任编辑:  点此下载全文
引用本文:孙露,宋海波,张力,黄举凯,王景霞,杨晓晖,孙桂波,高学敏,孙晓波.中药槟榔及其制剂的安全性系统评价[J].中国中药杂志,2017,42(21):4067.
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作者中文名作者英文名单位中文名单位英文名E-Mail
孙露 SUN Lu 北京中医药大学 东方医院, 北京 100078 Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China  
宋海波 SONG Hai-bo 国家食品药品监督管理总局 药品评价中心, 北京 100045 Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China  
张力 ZHANG Li 北京中医药大学 东方医院, 北京 100078 Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China yty0616@hotmail.com 
黄举凯 HUANG Ju-kai 北京中医药大学 东方医院, 北京 100078 Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China  
王景霞 WANG Jing-xia 北京中医药大学, 北京 100029 Beijing University of Chinese Medicine, Beijing 100029, China  
杨晓晖 YANG Xiao-hui 北京中医药大学 东方医院, 北京 100078 Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China  
孙桂波 SUN Gui-bo 中国医学科学院 药用植物研究所, 北京 100193 Institute of Medicinal Plants, Chinese Academy of Medical Sciences, Beijing 100193, China  
高学敏 GAO Xue-min 北京中医药大学, 北京 100029 Beijing University of Chinese Medicine, Beijing 100029, China  
孙晓波 SUN Xiao-bo 中国医学科学院 药用植物研究所, 北京 100193 Institute of Medicinal Plants, Chinese Academy of Medical Sciences, Beijing 100193, China  
基金项目:国家中医药管理局中医药行业科研专项(201507004-1)
中文摘要:该文通过全面查阅国内外文献,对槟榔的本草文献溯源及考证、古今文献毒性记载、临床不良事件案例、近年来相关毒性实验研究及食用与药用槟榔安全性风险差异等关键点,进行了系统回顾和分析,并对常用槟榔临床安全性病例报告进行了分析。初步总结了与槟榔及其制剂的安全性相关病例临床特点及潜在的风险因素,笔者提出药用槟榔的临床不良事件较少并具有可控性,但临床应用时仍应严格规范使用并合理配伍,同时加强安全性相关的基础与临床研究,以更好指导临床安全用药。
中文关键词:槟榔  不良反应  安全性评价  风险控制
 
Systematic evaluation for safety of traditional Chinese medicine Areca catechu and its preparations
Abstract:The authors systemically evaluated and analyzed the safety of Areca catechu from domestic and foreign literatures about the herbal origin, toxicity recorded in ancient/current documents, safety case reports of clinical A. catechu, experimental studies on toxicity in recent years, and differences of safety risk between edible and medicinal A. catechu. Subsequently, they proposed a preliminary summary about the clinical characteristics and potential risk factors of safety related cases of A. catechu and its preparations. According to the authors, although clinical adverse events of A. catechu were fewer and controllable, clinicians shall stillstrictly standardize its application,and rationally combine it with other herbs, while strengthening fundamental and clinical studies related to safety, so as to give better guidance to safety application of A. catechu in clinic.
keywords:Areca catechu  adverse reaction  safety evaluation  risk control
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