[關(guān)鍵詞]
[摘要]
2020年5月歐洲藥品管理局(EMA)發(fā)布了“掌葉大黃和藥用大黃及其根的評(píng)估報(bào)告”,根據(jù)大量文獻(xiàn)對(duì)大黃的活性成分、大黃及其制劑有效性和安全性以及臨床應(yīng)用做了全面和深入細(xì)致的討論。該報(bào)告特別指出大黃制劑僅限于偶發(fā)便秘短期應(yīng)用,有遺傳毒性風(fēng)險(xiǎn)和致癌性尚未完全排除,限制每日用量和給藥持續(xù)時(shí)間;該內(nèi)容與中醫(yī)藥理論對(duì)大黃的傳統(tǒng)評(píng)價(jià)不同。介紹EMA該評(píng)估報(bào)告的主要內(nèi)容,以期引起對(duì)這些不同認(rèn)識(shí)的關(guān)注與思考。
[Key word]
[Abstract]
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.
[中圖分類號(hào)]
R951
[基金項(xiàng)目]