对我国非抗心律失常创新药QT间期延长的心脏安全性临床研究的考虑  

Considerations about clinical research strategy of cardiac safety for QT internal prolongation induced by new non-antiarrhythmic drugs in China

作　　者：耿莹[1] 赵德恒[1] 杨焕[1] 杨志敏[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2015年第16期1816-1819,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项"大品种药物Ⅳ期临床试验及新药临床试验审评研究技术平台"(2011ZX09304-001)

摘　　要：心脏安全性是创新药研发中十分关注的重要问题之一。QT间期延长导致的心脏安全性问题是贯穿药物全生命周期的关注内容。ICH已在10年前发布了关于全面QT的评价要求,我国暂无该方面的管理规范。为了适应我国创新药研发迅速发展的需要,无论是药物研发单位、临床研究机构还是药品监管部门,都需要不断积累有关心脏安全性临床研究方面的知识和经验。本文通过分析国外情况和国内现状,从新药审评的角度,提出对现阶段我国非抗心律失常创新药QT间期延长的心脏安全性临床研究的考虑。Cardiac safety is one of the concerned issues in new drug development. The problem of heart safety induced by QT interval prolongation is the focus during the entire life cycle of a drug. Ten years ago, ICH issued guidance about cardiac safety evaluation with thorough QT study, but China has not yet published any standards on this problem. In order to meet the needs of the rapid development, pharmaceutical companies, clinical research institutes as well as the authorities in China need to continually accumulate knowledge and experience about the cardiac safety evaluation. Analyzing current international consensus and the local situation, we discussed the clinical research strategy of cardiac safety for QT internal prolongation induced by new nonntiarrhythmic drugs, which is adaptable in China.

关 键 词：创新药 QT间期延长 心脏安全性临床研究 Ⅰ期临床试验中的心电图监测加强 

分 类 号：R95[医药卫生—药学]