何首乌安全用药指南  

Guidelines for safe use of Polygoni Multiflori Radix

作　　者：肖小河 王伽伯 宋海波 欧阳冬生[2] 邹正升 王睿林 何婷婷 景婧 郭玉明 柏兆方 湛小燕 牛明 马致洁 李春雨 中华中医药学会中成药分会 中华中医药学会肝胆病分会 中国药学会临床中药学专业委员会 中国药理学会药源性疾病学专业委员会肝病分委会 中国毒理学会临床毒理专业委员会 Xiaohe Xiao;Jiabo Wang;Haibo Song;Dongsheng Ouyang;Zhengsheng Zou;Ruilin Wang;Tingting He;Jing Jing;Yuming Guo;Zhaofang Bai;Xiaoyan Zhan;Ming Niu;Zhijie Ma;Chunyu Li;Branch of Chinese Patent Medicine,China Association of Chinese Medicine;Branch of Hepatobiliary Diseases,China Association of Chinese Medicine;Committee of Clinical Chinese Pharmacy,Chinese Pharmaceutical Association;Subcommittee of Liver Diseases,Committee of Drug-Induced Diseases,Chinese Pharmacological Society;Committee of Clinical Toxicology,Chinese Society of Toxicology(The Fifth Medical Center,Chinese PLA General Hospital,Beijing,China;Center for Drug Reevaluation,National Medical Products Administration,Beijing,China;Institute of Clinical Pharmacology,Central South University,Changsha,China;不详)

机构地区：[1]中国人民解放军总医院第五医学中心,北京 [2]中南大学临床药理研究所,长沙 [3]国家药品监督管理局药品评价中心,北京 [4]不详

出　　处：《Acupuncture and Herbal Medicine》2024年第2期151-158,I0001,共9页针灸和草药（英文）

基　　金：supported by the National Natural Science Foundation of China (82230118);the Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine (ZYYCXTD-C-202005)。

摘　　要：何首乌为常用中药,在临床治疗和日常保健中使用广泛,但近年来屡见有肝损伤报道,引起国内外广泛关注,部分含何首乌和首乌藤制剂肝损伤风险已被国家食品药品监督管理局多次通报。近年来相关研究已取得实质性进展,揭示了其特异质肝损伤的基本属性、主要成因、物质基础和分子机制,发现其易感人群的基本特征和生物标志物,表明何首乌仅对极少数特定人群有肝损伤风险,对绝大多数人群是安全的。研究成果为正确客观地认识何首乌致肝损伤、合理制定何首乌及相关制剂安全用药措施提供了科学依据。为此,中华中医药学会组织全国相关领域专家,起草制定了《何首乌安全用药指南》,旨在帮助国内外公众和相关机构,科学认识、评估和规避何首乌肝损伤风险,指导何首乌及相关制剂的合理使用,保障广大消费者的健康权益,同时促进何首乌及相关产业的健康持续发展。该指南已通过中华中医药学会的审核,并进行了发布,编号T/CACM 1328-2019。Polygoni Multiflori Radix(He Shou Wu)is a Chinese medicine widely used in clinical treatment and preventive healthcare.However,recently there have been frequent reports of liver injury caused by Polygoni Multiflori Radix and its related preparations,and some patients have serious adverse outcomes,attracting wide attention worldwide.The risk of liver damage caused by preparations containing Polygoni Multiflori Radix or Polygoni Multiflori Caulis has been repeatedly reported by the Chinese Food and Drug Administration.Fortunately,substantial progress has recently been made in revealing the basic properties,main causes,material basis,and molecular mechanism of Polygoni Multiflori Radix-related liver injury.The basic characteristics and biomarkers of susceptible people have been identified,indicating that Polygoni Multiflori Radix has the risk of inducing liver injury only in a few specific populations and is safe for most populations.This study provides a scientific basis for a correct and objective understanding of liver injury caused by Polygoni Multiflori Radix,and a reasonable formulation of safe medication measures for Polygoni Multiflori Radix and related preparations.The China Association of Chinese Medicine organized experts in relevant fields across the country to draft and formulate the“Guidelines for Safe Use of Polygoni Multiflori Radix”with the aim of helping the public and relevant institutions at home and abroad to scientifically understand,evaluate,and avoid the risk of liver injury;guide the rational use;protect the health rights and interests of consumers;and promote the healthy and sustainable development of Polygoni Multiflori Radix and related preparations.These guidelines were issued by the China Association of Chinese Medicine(No.T/CACM 1328-2019).

关 键 词：药物安全性 肝损伤 何首乌 合理使用 中药 

分 类 号：R285[医药卫生—中药学]