摘要
2020年5月欧洲药品管理局(EMA)发布了"掌叶大黄和药用大黄及其根的评估报告",根据大量文献对大黄的活性成分、大黄及其制剂有效性和安全性以及临床应用做了全面和深入细致的讨论。该报告特别指出大黄制剂仅限于偶发便秘短期应用,有遗传毒性风险和致癌性尚未完全排除,限制每日用量和给药持续时间;该内容与中医药理论对大黄的传统评价不同。介绍EMA该评估报告的主要内容,以期引起对这些不同认识的关注与思考。
EMA released the Assessment report on Rheum palmatum L.and Rheum officinale Baillon,radix in May 2020.According to a large number of literatures,the active ingredients of rhubarb,the efficacy and safety of rhubarb and its preparations,as well as the clinical application were comprehensively and thoroughly discussed.In particular,rhubarb preparation is limited to short-term use of occasional constipation;genotoxicity risk and carcinogenicity have not been fully excluded;daily dosage and administration duration are limited.This is different from the traditional evaluation of traditional Chinese medicine.This content is different from the traditional evaluation of rhubarb by TCM theory.This paper introduces the main contents of EMA evaluation report,in order to arouse the attention and thinking of these different understandings.
作者
萧惠来
XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《药物评价研究》
CAS
2021年第1期45-55,共11页
Drug Evaluation Research
