抗心律失常藥物作用于心肌細胞的離子通道，臨床使用時常產(chǎn)生致心律失常等風險。藥物非臨床安全性評價過程中，除參考國內(nèi)外指導原則外，應結(jié)合藥物作用機制和適應癥的特點，追加心血管系統(tǒng)安全性相關(guān)試驗，有針對地完善試驗設(shè)計，為后續(xù)試驗中風險點的設(shè)置和臨床使用風險的防控提供參考。

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.