药物心脏安全性评估与全面QT/QTc研究  

Cardiac safety evaluation of pharmaceuticals and thorough QT/QTc study

作　　者：佘飞[1] 李海燕[1] 

机构地区：[1]北京大学第三医院心血管内科,北京100191

出　　处：《中国临床药理学杂志》2011年第3期232-235,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：许多非抗心律失常药物可以导致心电图QT间期延长,甚至引发尖端扭转型室性心动过速。因此在新药上市前,进行的心脏安全性评估,应该包括药物对QT间期影响的特点。全面QT/QTc研究旨在通过测量QT间期,明确药物是否具有延长QT间期的作用,判断其引发恶性心律失常的风险,并为决定药物是否进入下一步研发提供数据支持。Many non-antiarrhythmic drugs could induce QT interval prolongation on the surface electrocardiogram,or even result in ventricular tachycardia,especially torsades de pointes.Therefore,an adequate pre-marketing cardiac safety evaluation of a new pharmaceutical agent should include rigorous characterization of its effects on the QT/QTc interval.Thorough QT/QTc study is designed to detect drug-induced QT interval prolongation,assess the risk of inducing malignant arrhythmia caused by research drugs,and provide data to decide whether to enter the next step of drug development.

关 键 词：心脏安全性评估 QT间期延长 全面QT/QTc研究 

分 类 号：R972.2[医药卫生—药品] R969.3[医药卫生—药学]