紫杉烷类药物相关心脏器官不良事件信号挖掘研究

目的 对美国食品和药品管理局不良反应报告系统（FAERS）中紫杉烷类药物相关心脏不良事件（ADE）数据进行挖掘，为临床合理用药提供参考。方法 自FAERS数据库提取2017年第一季度至2021年第四季度紫杉烷类药物ADE报告，从中筛选出累及心脏器官疾病报告，采用报告比值比法（ROR）和英国药品和保健品管理局综合标准法（MHRA）检测信号。结果 高位组语（HLGT）层面，紫杉醇的信号有报告744份，分布于心律失常类疾病，心肌类疾病，各类心脏衰竭、心脏相关疾病，症状和体征，冠状动脉类疾病和心包类疾病；多西他赛的信号有报告74份，分布于心肌类疾病和各类心脏衰竭、心脏相关疾病；紫杉醇（白蛋白结合型）的信号有报告85份，分布于心律失常类疾病，心肌类疾病，各类心脏衰竭和心包类疾病。结论 心脏器官相关ADE中，紫杉醇和紫杉醇（白蛋白结合型）多见心律失常、心脏传导阻滞和心肌缺血，多西他赛多见左心室功能障碍和心肌缺血，可供临床参考。

A study on signal mining of taxane-related cardiac organs adverse events

Objective To mine the signals of taxane-related cardiac adverse events (ADE) in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), and to provide reference for clinical rational drug use.Methods The adverse event reports of taxane drugs from the first quarter of 2017 to the fourth quarter of 2021 were extracted from the FAERS database, and the reports of diseases involving cardiac organs were screened out. The reporting odds ratio (ROR) and Medicines and Healthcare Products Regulation Agency (MHRA) method were used to analyze the signals.Results In the high level group term (HLGT) level, there were 744 reports of paclitaxel signals, and they were distributed in arrhythmia diseases, myocardial diseases, various types of heart failure and heart-related diseases, symptoms and signs, coronary artery diseases and pericardial diseases. There were 74 reports of docetaxel signals, and they were distributed in myocardial diseases, and various heart failure and heart-related diseases. And there were 85 reports of the signals of paclitaxel (albumin-bound). They were distributed in arrhythmia diseases, myocardial diseases, various heart failure and pericardial disease.Conclusion Among the cardiac organ-related ADEs, the most common paclitaxel and paclitaxel (albumin-bound)-involved ADEs were arrhythmia, heart block and myocardial ischemia, while the most common docetaxel-involved ADEs were left ventricular dysfunction and myocardial ischemia. All could be for clinical reference.