综合性离体致心律失常风险评估的研究进展

Advances in comprehensive in vitro proarrhythmia assay

药物心脏安全性研究一直都是药物安全性评价研究人员的关注重点。2013年7月23日,研究人员在美国食品和药物管理局(FDA)总部就一项新的药物心脏安全性评价规范——综合性离体致心律失常风险评估(Ci PA)的议案展开了讨论。Ci PA主要包含三个核心试验研究,分别是多离子通道研究、insilico模型研究和人源性干细胞分化心肌细胞(h SC-CMs)研究。本文主要对Ci PA的主要研究内容和研究进展进行了综述。

Drug cardiac safety evaluation has always been the focus of drug safety evaluation researchers. The comprehensive in vitro proarrhythmia assay （CiPA） as a new safety testing paradigm to assess drug-induced proarrhythmic risk was discussed at FDA headquarters on July 23, 2013. There are three core experiments including multiple ion channel research, in- silico model study and human pluripotent stem cells- derived c ardiomyocytes （hSC-CMs） study. This paper reviewed the main researches and advances of CiPA.