中药槟榔及其制剂的安全性系统评价  

Systematic evaluation for safety of traditional Chinese medicine Areca catechu and its preparations

作　　者：孙露[1] 宋海波[2] 张力[1] 黄举凯 王景霞[3] 杨晓晖[1] 孙桂波[4] 高学敏[3] 孙晓波[4] 

机构地区：[1]北京中医药大学东方医院,北京100078 [2]国家食品药品监督管理总局药品评价中心,北京100045 [3]北京中医药大学,北京100029 [4]中国医学科学院药用植物研究所,北京100193

出　　处：《中国中药杂志》2017年第21期4067-4073,共7页China Journal of Chinese Materia Medica

基　　金：国家中医药管理局中医药行业科研专项(201507004-1)

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。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 prelimi- nary summary about the clinical characteristics and potential risk factors of safety related cases of A. catechu and its preparations. Ac- cording to the authors, although clinical adverse events of A. catechu were fewer and controllable, clinicians shall stillstrictly standard- ize 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. catechuin clinic.

关 键 词：槟榔 不良反应 安全性评价 风险控制 

分 类 号：R282.71[医药卫生—中药学]