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为了发现并判断非抗心律失常药所致的QT间期延长,人用药品技术要求协调国际会议(ICH)发布了E14《非抗心律失常药致QT/QTc间期延长及潜在致心律失常作用的临床评价指导原则》。2008年ICH发布了该指导原则的问答(E14Q&As),对一些具体问题做了说明,随后又对问答做了第3次修订,问答数较原版增加了1倍。美国食品药品管理局(FDA)于2017年6月对第3次修订版予以转发。介绍该修订版的详细内容,希望对我国非抗心律失常药临床评价相关方面的研究和监管工作有益。
In order to identify and determine the prolongation of the QT interval due to non-antiarrhythmic drugs, the International Conference on Technical Requirements Coordination of Human Medicines (ICH) published the E14 “prolongation of QT / QTc interval due to non-antiarrhythmic drugs and potential arrhythmic effects Clinical Evaluation Guidelines. ” In 2008, the ICH released E14Q & As, which explained some specific issues and then revised the question and answer again for the third time, doubling the number of questions and answers from the original version. The United States Food and Drug Administration (FDA) in June 2017 for the third revision to be forwarded. This revision is introduced in detail, hoping to study and supervise the related aspects of clinical evaluation of non-anti-arrhythmic drugs in our country.