Guidelines for safe use of Polygoni Multiflori Radix

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
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Abstract

Polygoni Multiflori Radix 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).
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何首乌安全使用指南
何首乌是一种广泛应用于临床治疗和预防保健的中药。然而,近来有关何首乌及其相关制剂导致肝损伤的报道屡见报端,部分患者出现了严重的不良后果,引起了世界各国的广泛关注。含有何首乌或何首乌的制剂引起肝损伤的风险已多次被中国食品药品监督管理局通报。所幸的是,近年来在揭示何首乌相关肝损伤的基本性质、主要原因、物质基础和分子机制方面取得了实质性进展。目前已确定易感人群的基本特征和生物标志物,表明何首乌仅对少数特定人群有诱发肝损伤的风险,对大多数人群是安全的。该研究为正确客观认识何首乌引起的肝损伤,合理制定何首乌及相关制剂的安全用药措施提供了科学依据。中国中药协会组织全国相关领域专家起草制定了《何首乌安全用药指导原则》,旨在帮助公众和国内外相关机构科学认识、评估和规避肝损伤风险,指导合理用药,保护消费者健康权益,促进何首乌及相关制剂的健康可持续发展。本指南由中国中药协会发布(编号:T/CACM 1328-2019)。
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