少腹逐瘀颗粒联合左氧氟沙星治疗慢性盆腔炎的临床研究

欧洲药品管理局（EMA）于2007年10月颁布了《欧白芷Angelica archangelic L.制剂中含有的呋喃香豆素相关的风险评估报告》,建议了关于草药中呋喃香豆素的风险管理策略。欧盟当局及其成员国往往要求申报者依据该评估报告对含当归的草药制剂进行安全性评估。介绍该评估报告的主要内容,并勘误了关于当归Angelica sinensis的2处错误,阐述了笔者的观点,期望对中国含当归的中成药进入欧洲市场有所启示。

Clinical study on Shaofu Zhuyu Granules combined with levofloxacin in treatment of chronic pelvic inflammation

The European Medicines Agency released "Reflection Paper on the Risk Associated with Furocoumarins Contained in Preparations of Angelica archangelica L." in October 2007, which proposed risk-management strategy for furocoumarins contained in herbal preparations. The European Union or Member States authorities often require applicants to conduct safety assessments of relevant herbal preparations containing Angelica based on the reflection paper. This paper introduces the main contents of the reflection paper, corrects two errors about Angelica sinensis, states the author''s opinions in conclusion and discussion, and is expected to give some enlightenment for Chinese herbal preparations containing Angelica to enter the European market.