医院药学致命性药物相互作用导致米贝拉地尔撤的简析与启示.PDF

现代药物与临床 Drugs Clinic 第 27 卷 第 6 期 2012 年 11 月 • 597 • • 医院药学 • 致命性药物相互作用导致米贝拉地尔撤市的简析与启示 贾友宏，李一石 中国医学科学院北京协和医学院 国家心血管病中心 阜外心血管病医院 临床药理中心 卫生部心血管药物临床研究重点 实验室，北京 100037 摘 要：盐酸米贝拉地尔是瑞士罗氏公司研制生产的T 型钙通道阻滞剂，初期适应症为高血压、冠心病心绞痛和心力衰竭。 1997 年相继在欧洲、美国、日本上市，由于其药物相互作用的严重不良反应，于 1998 年 6 月自愿撤市。简述盐酸米贝拉地 尔的药理学特性、临床研究、严重的药物相互作用以及上市后的调整过程，希望对我国的新药研发人员、临床医生等带来有 益的启示，从而加深对我国新药上市后临床评价研究的认识、重视和加强监控药物相互作用的不良反应等安全性评估，加快 我国的新药研发进程。 关键词：盐酸米贝拉地尔；致命性相互作用；不良反应；撤市 中图分类号：R969.2 文献标志码：A 文章编号：1674 - 5515(2012)06 - 0597 - 05 Analysis and inspiration from fatal drug interactions causing mibefradil withdrawn JIA You-hong, LI Yi-shi Key Laboratory of Clinical Trial Research in Cardiovascular Drugs Ministry of Health, Center for Clinical Pharmacology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China Abstract: Mibefradil is a new T-type calcium channel blocker for treating hypertension, coronary heart disease, angina, and heart failure, which is researched and produced by Switzerland Roche laboratory. It was approved in Europe, the United States, and Japan in 1997, but soon it was withdrawn from the market voluntarily in June 1998 due to its serious side effects. We now reviewed its pharmacological properties, clinical trial results, serious drug interactions, and the adjustment process after listing, hoping that it could give some useful inspiration for the new drug research and development, enhance their understanding for the study on the clinical evaluation of new drugs after listing, attach the importance, and strengthen the safety assessment of monitoring drug interactions, side effects, so as to accelerate the process of research and development of new drugs. Key wor