补骨脂的安全性评价与风险控制措施探讨
投稿时间:2017-08-19    责任编辑:  点此下载全文
引用本文:田文杨,兰姗,张力,孙露,黄举凯,杨晓晖,孙桂波,高学敏,孙晓波.补骨脂的安全性评价与风险控制措施探讨[J].中国中药杂志,2017,42(21):4059.
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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
田文杨 TIAN Wen-yang 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  
兰姗 LAN Shan 四川省食品药品审查评价及安全监测中心, 四川 成都 610017 Sichuan Center for Food and Drug Evaluation, Inspection and Monitorin, Chengdu 610017, 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 
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  
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  
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:该文通过全面系统的国内外文献和信息研究,对补骨脂进行本草溯源及考证、追溯古今文献关于补骨脂的毒性记载、分析与补骨脂用药相关的临床不良事件案例报道以及近年来补骨脂相关的毒性实验研究,从而对补骨脂及相关制剂的安全性进行了系统分析,初步总结了与补骨脂及其制剂的安全性相关病例的临床特点及潜在的风险因素;研究发现,84例补骨脂临床不良事件病例报道的患者,其损伤主要表现为肝损害(55.95%)和光毒性接触性皮炎(38.10%),提示补骨脂可能存在肝损害和光毒性的安全性问题;毒性试验研究发现,补骨脂制剂可能存在生殖毒性和肾损害的安全性问题,但目前尚未发现相关的临床病例报告;补骨脂的成分复杂,目前其毒性成分和机制尚不明确;并提出临床应用补骨脂类制剂时应严格规范使用并合理炮制、配伍,加强医师的指导作用,加强补骨脂及相关制剂的安全性监测、积极开展安全性相关的基础和临床研究,以更好指导临床安全用药,充分发挥疗效规避用药风险。
中文关键词:补骨脂  安全性评价  不良反应  风险控制
 
Safety evaluation and risk control measures of Psoralea corylifolia
Abstract:Through a systematic and comprehensive study of domestic and foreign literatures and information, this study aims to trace the herbal origin and the toxicity recorded in ancient and current documents, analyze the safety case reports of Psoralea corylifolia and experimental studies on toxicity in recent years, and make a preliminary summary about the clinical characteristics and potential risk factors of cases related to the safety of P. corylifolia and its preparations. The study involved 84 patients in the safety case reports of P. corylifolia. The adverse events were mainly liver damage (55.95%) and light toxic contact dermatitis (38.10%), sugguesting that P. corylifolia may lead to liver damage and phototoxicity. However, reproductive toxicity and renal damage were only reported in animal studies, but not in clinical reports. Because of its complicated ingredients, the toxic components and mechanisms of P. corylifolia havenot been clear at present. Therefore, the authors proposed to strictly apply P. corylifolia in clinic, use it rationally and combine it with other medications. Besides, efforts shall be made to strength the guidance for doctors, the safety monitoring of P. corylifolia and relevant preparations, and actively carry out safety-related basic and clinical studies, so as to give a better guidance to safe medication, full exert the efficacy and avoid the medication risk.
keywords:Psoralea corylifolia  safety evaluation  adverse drug reaction  risk control
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