何首乌及其制剂国外安全性信息的评价与思考

Evaluation and consideration on safety information abroad of Polygonum multiflorum and its preparations

通过对国外有关何首乌及其制剂安全性文献病例报告的具体用药和肝损害情况的回顾性分析,认为国外药政监管部门有关何首乌及其制剂的安全性信息报道和警示过程中存在缺乏深层次分析和调查的问题,提出不能人云亦云,从文献研究入手的追踪和调查、与国外药政监管部门建立相关安全性信息沟通与反馈机制、起草中草药合理使用指南是理性对待中草药安全性问题的重要途径。

This article retrospectively analyzed the safety reports published abroad regarding Polygonum multiflorum and its preparations in terms of drug use and liver damage. The authors found that the foreign drug regulatory authorities are lack of in-depth analysis and investigation on the safety information of P. multiflorum and its preparations in the process of reporting and warning. Therefore, the authors consider the following factors are significant for scientific evaluation of traditional Chinese medicine（TCM） safety： follow-up and investigation of the information based on literature study, establishment of the safety-related information communication and feedback mechanism with foreign drug regulatory authorities and drafting of the guidelines for rational use of TCM.