鹽酸米貝拉地爾是瑞士羅氏公司研制生產(chǎn)的T型鈣通道阻滯劑，初期適應(yīng)癥為高血壓、冠心病心絞痛和心力衰竭。1997年相繼在歐洲、美國、日本上市，由于其藥物相互作用的嚴(yán)重不良反應(yīng)，于1998年6月自愿撤市。簡述鹽酸米貝拉地爾的藥理學(xué)特性、臨床研究、嚴(yán)重的藥物相互作用以及上市后的調(diào)整過程，希望對我國的新藥研發(fā)人員、臨床醫(yī)生等帶來有益的啟示，從而加深對我國新藥上市后臨床評價研究的認(rèn)識、重視和加強監(jiān)控藥物相互作用的不良反應(yīng)等安全性評估，加快我國的新藥研發(fā)進程。

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 It was approved in Europe, the United States, and Japan in 1997, but soon it was withdrawn from the market voluntarily in June 1998 due to its serious side effects.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.

國家科技重大專項基金資助項目（2011ZX09304）