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。
Mibefradil is a new T-type calcium channel blocker for treating hypertension,coronary heart disease,angina,and heartfailure,which is researched and produced by Switzerland Roche laboratory.It was approved in Europe,the United States,and Japan in1997,but soon it was withdrawn from the market voluntarily in June 1998 due to its serious side effects.We now reviewed itspharmacological properties,clinical trial results,serious drug interactions,and the adjustment process after listing,hoping that it couldgive some useful inspiration for the new drug research and development,enhance their understanding for the study on the clinicalevaluation of new drugs after listing,attach the importance,and strengthen the safety assessment of monitoring drug interactions,sideeffects,so as to accelerate the process of research and development of new drugs.
出处
《现代药物与临床》
CAS
2012年第6期597-601,共5页
Drugs & Clinic
基金
国家科技重大专项基金资助项目(2011ZX09304)
