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马兜铃酸毒性研究进展及风险因素分析
引用本文:宋海波,任经天,杨乐,郭晓昕,杜晓曦. 马兜铃酸毒性研究进展及风险因素分析[J]. 中国中药杂志, 2014, 39(12): 2246-2250
作者姓名:宋海波  任经天  杨乐  郭晓昕  杜晓曦
作者单位:国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045;国家食品药品监督管理总局 药品评价中心, 北京 100045
基金项目:国家“重大新药创制”科技重大专项(2011ZX09304-08)
摘    要:马兜铃酸(aristolochic acids,AA)的肾毒性和致突变性,以及其对泌尿系统上尿路移行上皮的致癌性已广为人知。2003年以来,药品监管部门先后取消了青木香、关木通、广防己等含AA药材的质量标准,并对其他含AA的药材如朱砂莲、马兜铃、寻骨风等采取了加强监管、修订说明书或质量标准等措施,以控制其安全性风险。近年来,国内外对AA的研究内容主要包括AA毒性的作用机制及临床表现、早期诊断及治疗方法。该文对使用含AA药品的风险因素做了简要的归纳与评述,并提出了预防及控制AA毒性发生的措施及建议。

关 键 词:马兜铃酸  毒性  不良反应  风险因素
收稿时间:2014-01-28

Advance in studies on toxicity of aristolochic acid and analysis on risk factors
SONG Hai-bo,REN Jing-tian,YANG Le,GUO Xiao-xin and DU Xiao-xi. Advance in studies on toxicity of aristolochic acid and analysis on risk factors[J]. China Journal of Chinese Materia Medica, 2014, 39(12): 2246-2250
Authors:SONG Hai-bo  REN Jing-tian  YANG Le  GUO Xiao-xin  DU Xiao-xi
Affiliation:Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China;Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China
Abstract:The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.
Keywords:aristolochic acid  toxicity  adverse reaction  risky factor
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