為了發(fā)現(xiàn)并判斷非抗心律失常藥所致的QT間期延長(zhǎng)，人用藥品技術(shù)要求協(xié)調(diào)國(guó)際會(huì)議（ICH）發(fā)布了E14《非抗心律失常藥致QT/QTc間期延長(zhǎng)及潛在致心律失常作用的臨床評(píng)價(jià)指導(dǎo)原則》。2008年ICH發(fā)布了該指導(dǎo)原則的問答（E14 Q&As），對(duì)一些具體問題做了說明，隨后又對(duì)問答做了第3次修訂，問答數(shù)較原版增加了1倍。美國(guó)食品藥品管理局（FDA）于2017年6月對(duì)第3次修訂版予以轉(zhuǎn)發(fā)。介紹該修訂版的詳細(xì)內(nèi)容，希望對(duì)我國(guó)非抗心律失常藥臨床評(píng)價(jià)相關(guān)方面的研究和監(jiān)管工作有益。

To detect and determine the QT interval prolongation caused by non antiarrhythmic drugs, ICH released the E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs and released E14's questions and answers (ICH E14 Q&As) in 2008 which explained some specific questions. Subsequently, This Q&As were revised third times and in June 2017 forwarded by FDA. The number of questions and answers in the revised edition doubled compared with the original. This article introduces the details of this revised edition, and hopes to be helpful to the research and supervision in China.