抗心律失常藥物作用于心肌細(xì)胞的離子通道，臨床使用時常產(chǎn)生致心律失常等風(fēng)險。藥物非臨床安全性評價過程中，除參考國內(nèi)外指導(dǎo)原則外，應(yīng)結(jié)合藥物作用機(jī)制和適應(yīng)癥的特點(diǎn)，追加心血管系統(tǒng)安全性相關(guān)試驗(yàn)，有針對地完善試驗(yàn)設(shè)計(jì)，為后續(xù)試驗(yàn)中風(fēng)險點(diǎn)的設(shè)置和臨床使用風(fēng)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.