致QT间期延长药物使用风险管理的初步探讨及启示

中国药物警戒 ›› 2018, Vol. 15 ›› Issue (9): 545-549.

致QT间期延长药物使用风险管理的初步探讨及启示

丁发明¹, 张新丽², 王琼^3*, 尹茂山¹

¹国家食品药品监督管理总局药品审评中心,北京 100022;
²青岛市黄岛区中心医院,山东青岛 266555;
³北京医院,北京100730

收稿日期:2018-11-02 修回日期:2018-11-02 出版日期:2018-09-20 发布日期:2018-11-02
通讯作者: 王琼,女,博士,主治医师,内科疾病诊治及临床研究。E-mail：qiongwang@163.com
作者简介:丁发明,男,博士,主治医师,药品注册和安全有效性评价。

Preliminary Discussion on the Risk Management of QT-prolonging Drugs Use and Its Implication

DING Faming¹, ZHANG Xinli², WANG Qiong^3*, YIN Maoshan¹

¹Center for Drug Evaluation, China Food and Drug Administration, Beijing 100022, China;
²Huangdao Center Hospital, Shandong Qingdao 266555, China;
³Beijing Hospital,Beijing 100730, China

Received:2018-11-02 Revised:2018-11-02 Online:2018-09-20 Published:2018-11-02

摘要/Abstract

摘要： 目的介绍美国用于致QT间期延长药物临床使用决策的重要工具-CredibleMeds网站信息,为我国上市后药物风险管理和安全使用提供借鉴。方法运用文献研究的方法,在概述diLQTS机制和导致TdP危险因素基础上,对基于CredibleMeds网站的药物危险分类、药物风险管理策略进行介绍。结果美国FDA通过优化资源配置,倡议由独立的教育与研究机构建设成立致QT间期延长药物风险管理平台,提高了安全性信息使用和风险管理效率。结论我国可参考美国药物风险管理经验,提高致QT间期延长药物风险管理能力。

关键词: 致QT间期延长药物, 尖端扭转型室性心动过速, 风险管理

Abstract: Objective To provide reference for the post-marketing risk management and safe use of QT-prolonging drugs in China by introducting CredibleMeds website, an important tool used by the United States to determine the clinical use of QT-prolonging drugs. Methods Literature study was used. Based on the overview of the diLQTS mechanism and factors contributing to risk of TdP, the risk categorization and risk management strategies for QT prolonging drugs were described according to the CredibleMeds website. Results With optimizing the allocation of resources, US FDA advocated the establishment of an independent QT-prolonging drugs risk management platform by an independent education and research institution and improved the utilization of safety information and drug risk management efficiency. Conclusion We should learn from the experience of drug risk management in the United States to improve the risk management capabilities of QT-prolonging drugs.

Key words: QT-prolonging drugs, torsade de pointes, risk management

中图分类号:

丁发明, 张新丽, 王琼, 尹茂山. 致QT间期延长药物使用风险管理的初步探讨及启示[J]. 中国药物警戒, 2018, 15(9): 545-549.

DING Faming, ZHANG Xinli, WANG Qiong, YIN Maoshan. Preliminary Discussion on the Risk Management of QT-prolonging Drugs Use and Its Implication[J]. Chinese Journal of Pharmacovigilance, 2018, 15(9): 545-549.

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