马兜铃酸毒性研究及思考.docVIP

马兜铃酸毒性研究及思考 　　[摘要]2017年10月18日，Science Translational Medicine?l布题为“Aristolochic acids and their derivatives are widely implicated in liver cancers in Taiwan and throughout Asia”的研究论文，该文指出含马兜铃酸的草药可通过诱导特异性的“马兜铃酸突变指纹”诱发肝癌，并建议公众避免摄入含有马兜铃酸的草药。我国自2000年始，针对含马兜铃酸的中草药，国家食品药品监督管理总局（CFDA）陆续取消了关木通、广防己和青木香等的药用标准，并通知加强相关药物监管；《中国药典》中也逐渐取消一系列相关中草药的记载。此文发表后，国家中医药管理局快速启动了关于马兜铃酸的“毒性”问题研讨会，与会专家对国内外关于马兜铃酸的毒性研究进行了充分讨论，发现暴露史、致癌剂量和潜伏期不明确，乙肝等关键影响因素未纳入分析，样本量小、混杂因素多，证据链不完整，数据间巨大差异缺少解析，基础研究论据不足等是目前研究存在的主要问题。为了正确认识马兜铃酸的毒性和致癌风险、指导临床安全合理用药，专家们提出如下建议：①尽快完善马兜铃酸致癌性的系统评价，科学阐明马兜铃酸与肝癌发生的关系；②制定含马兜铃酸类药物安全用药风险警示，进一步加大监管力度；③深化中药毒性的临床研究，逐步明确所有中药的临床不良反应。 　　[关键词]马兜铃酸； 毒性； 基因突变； 肝癌 　　[Abstract]On October 18th， 2017， a research article named Aristolochic acids and their derivatives are widely implicated in liver cancers in Taiwan and throughout Asia was published on Science Translational Medicine This article pointed out that herbs containing aristolochic acids could cause liver cancer by inducing the specific aristolochic acids mutational signature The public was also suggested to avoid the intake of herbs containing aristolochic acids Since 2000， CFDA has gradually abolished the medicinal standards for herbs containing aristolochic acids such as caulis aristolochiae manshuriensis， aristolochia heterophylla and radix aristolochiae Related drugs have been strengthened supervision since then Chinese Pharmacopoeia has also removed the records of a series of related herbs State Administration of Traditional Chinese Medicine held a conference on the toxicity of aristolochic acids as soon as the article was published After a discussion of the studies on the toxicity of aristolochic acids， experts attending the meeting discovered several problems， including the unclearness of exposure history， tumorproducing dose and latent period， the absence of some key factors such as hepatitis B， the small sample size， miscellaneous factors， incomplete evidence chains， the missing of analyses between data with huge differences