抗心律失常药物的非临床心血管系统安全性评价研究进展

Progress in non-clinical cardiovascular system safety evaluation of antiarrhythmic drug

抗心律失常药物作用于心肌细胞的离子通道,临床使用时常产生致心律失常等风险。药物非临床安全性评价过程中,除参考国内外指导原则外,应结合药物作用机制和适应症的特点,追加心血管系统安全性相关试验,有针对地完善试验设计,为后续试验中风险点的设置和临床使用风险的防控提供参考。

Antiarrythmic drug showed pharmacological activity on the ion channels of myocardial cell,with potential risks for proarrythmia in clinical use.In order to provide more reference for clinical trial and use,non-clinical safety evaluation should not only refer the guidelines,but also supplement researches on cardiac safety and improve the design of experiments based on the mechanism and the indication of drugs.