FDA药物说明书心脏安全性风险警示规则分析与建议  

Analysis and suggestions for the FDA drug labeling rules on cardiac safety risk warnings

作　　者：刘维[1,4] 邢晓清 任雨青 沈情 周月 张南 梁芙萌 王方芳[2,3] 李海燕 LIU Wei;XING Xiao-qing;REN Yu-qing;SHEN Qin;ZHOU Yue;ZHHANG Nan;LIANG Fu-meng;WANG Fang-fang;LI Hai-yan(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Drug Clinical Trial Center,Peking University Third Hospital,Beijing 100191,China;Department of Cardiology and Institute of Vascular Medicine,National Health Commission Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides,Key Laboratory of Molecular Cardiovascular Science,Ministry of Education,Beijing Key Laboratory of Cardiovascular Receptors Research,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Department of Pharmacy,Hebei General Hospital,Shijiazhuang 050057,Hebei Province,China;Department of Pharmacy,The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710004,Shaanxi Province,China;Department of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Department of Pharmacy,The Fifth Clinical Medical College of Henan University of Chinese Medicine/Zhengzhou People's Hospital,Zhengzhou 450003,Henan Province,China)

机构地区：[1]北京大学第三医院药学部,北京100191 [2]北京大学第三医院药物临床试验机构,北京100191 [3]北京大学第三医院心内科、血管医学研究所、国家卫生健康委心血管分子生物学与调节肽重点实验室、分子心血管学教育部重点实验室、心血管受体研究北京市重点实验室,北京100191 [4]北京大学医学部药物评价中心,北京100191 [5]河北省人民医院药学部,河北石家庄050057 [6]西安交通大学第二附属医院药学部,陕西西安710004 [7]中日友好医院药学部,北京100029 [8]河南中医药大学第五临床医学院、郑州人民医院药学部,河南郑州450003

出　　处：《中国临床药理学杂志》2025年第2期235-239,共5页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然科学基金资助项目(82104294);首都卫生发展科研专项基金资助项目(2022-2Z-40916);北京大学第三医院人才孵育基金资助项目(BYSYFY2021016)。

摘　　要：目的完善和细化我国药品说明书警示语的相关法规和指导原则。方法本文梳理了美国食品药品监督管理局(FDA)2005—2022年上市的小分子抗肿瘤药物的药品说明书,纳入说明书提及QT间期延长风险的药物,分析其临床研究开展的情况和QT研究结果,对其说明书的标识和警示规则进行整理。结果共纳入35个药物,有4个药物将QT间期延长风险写在黑框警告位置,21个药物写在警告和注意事项位置,有6个药物写在药品不良反应部分,有2个药物仅在临床药理项下进行了描述。根据药物引起QT间期的严重程度和是否发生严重临床后果,依次在说明书的警示语(黑框警告)、注意事项(警告和注意事项)以及药品不良反应几个栏目展示。结论该项工作可对国内药品生产企业和监管部门的说明书QT风险警示信息的撰写提供参考,建议明确临床研究中药品安全性的严重程度与说明书体现位置,并在上市后持续进行安全性监测,及时更新说明书。Objective To improve and refine the relevant regulations and guiding principles of warnings on drug instructions and labels in China.MethodssThis paper sorted out the drug instructions of small molecule anti-tumor drugs listed by the U.S.Food and Drug Administration(FDA)from 2005 to 2022,included the drugs mentioned in the QT interval prolongation risk,analyzed the clinical research and QT research results,and sorted out the identification and warning rules of the instructions.Results A total of 35 drugs were included,4 drugs wrote the risk of QT interval prolongation in the black box warning,21 drugs were wrote in the warning and precautions position,6 drugs were wrote in the adverse reaction section,and 2 drugs were only described under clinical pharmacology section.According to the severity of the QT interval prolongation caused by the drug and whether there were serious clinical consequences,they were displayed in the warnings(black box warnings),precautions(warnings and precautions)and adverse reactions in the instructions.Conclusion The aim of this article is to provide a reference for the writing of QT risk warning information of the instructions of domestic drug production enterprises and regulatory departments.It is recommended to clarify the severity of drug safety and the location of the instructions in clinical research,and continue to carry out safety monitoring and update the instructions in time after listing.

关 键 词：肿瘤药物 药品说明书 QT间期延长 心脏安全性 警示信息 

分 类 号：R979.1[医药卫生—药品]