ICH-E14指导下QT间期测量的方法学  

Methodology of QT interval measurement guided by ICH-E14 Guidelines

作　　者：曹春歌[1] 王红宇[1] CAO Chunge;WANG Hongyu(Department of Electrocardiogram Diagnosis,the Second Hospital of Shanxi Medical University,Taiyuan Shanxi 030001,China)

机构地区：[1]山西医科大学第二医院心电诊断科,山西太原030001

出　　处：《实用心电学杂志》2023年第4期243-247,共5页Journal of Practical Electrocardiology

摘　　要：QT间期显著延长易导致恶性心律失常,在新药研发中应高度重视对QT间期延长的评估。ICH-E14指南作为新药研发的指导原则,以行业规范的形式规定了非抗心律失常新药上市前必须经过致QT/QTc间期延长作用的评估。这就意味着心电监测将在此类药物安全性评价中发挥重要作用。为了高标准、高质量地完成心电数据的采集与QT/QTc间期的全面分析,本文从QT间期测量时对仪器和人员的要求、测量导联的选择、QT间期起点与终点的确定、特殊情况下QT间期的测量、不同的QT间期校正方法及数据测量的注意事项等方面,对QT/QTc间期测量的方法学进行介绍。Significant prolongation of QT interval would easily cause malignant arrhythmias,and therefore in the research and development of new drugs,great importance should be attached to the evaluation of QT interval prolongation.As a necessary guiding principle for new drug research and development,ICH-E14 Guidelines,in the form of industry norms,stipulates that new non-antiarrhythmic drugs must be evaluated for QT/QTc interval prolongation before marketing.It means that electrocardiogram(ECG)monitoring will play an important role in the safety evaluation of this kind of drugs.In order to complete the collection and comprehensive analysis of ECG data with high standards and quality,this paper focuses on the methodology of QT/QTc interval measurement from several aspects.It introduces the requirements for instruments and personnel during QT interval measurement,the selection of measurement leads,the determination of QT interval starting and end points,QT interval measurement under different circumstances,different correction methods for QT intervals,and notes during data measurement.

关 键 词：ICH-E14指南 QT间期 致心律失常作用 新药研发 药物安全性评价 

分 类 号：R541.7[医药卫生—心血管疾病] R540.4[医药卫生—内科学]