基于FAERS数据库尼达尼布心血管不良事件信号挖掘及分析

doi:10.6040/j.issn.1671-7554.0.2024.0090

摘要/Abstract

摘要： 目的旨在使用美国食品与药品管理局不良事件报告系统(food and drug administration adverse event reporting system, FAERS)数据库挖掘尼达尼布的不良反应信号并进行分析。方法收集FAERS数据库2014年7月至2023年9月以尼达尼布作为怀疑药物的不良事件报告病例17 547例,并使用世界卫生组织药品不良反应术语集进行标准化处理。采用报告比值比法(reporting odds ratio, ROR)、比例报告比值法(proportional reporting ratio, PRR)和多项伽玛分布法(multi-item gamma passion shrink-er, MGPS)进行不良反应信号的检测。结果在FAERS数据库中共提取17 547份以尼达尼布为主要怀疑药物的不良反应病例报告。男性患者占比最高(9 709例,55.3%),65~85岁患者最多(8 856例,50.5%),美国报告最多(10 209例,58.2%),而2022年报告最多(2 876例,17.46%)。利用ROR法、PRR法和MGPS法共计得到24个心血管不良反应信号。其中,阵发性心律失常、主动脉破裂、主动脉瓣钙化、心脏瓣膜手术和心导管插入的ROR值排名靠前。在报告数量方面,高血压(385例)、血压升高(291例)、心肌梗死(182例)、低血压(175例)和房颤(142例)居前。与现有说明书相比较,高血压和心肌梗死的不良反应信号与挖掘信号一致,但主动脉破裂、主动脉瓣钙化、房颤等不良反应尚未在说明书中提及。结论临床应用尼达尼布前应进行充分的用药评估,特别是对于存在血管疾病、缺血性心脏病和心律失常等高危患者,还需加强心电图、电解质、心脏超声等监测工作。临床医生也应关注不良反应信号,不仅限于说明书中的内容,以确保用药的安全性。

关键词: 尼达尼布, 不良事件报告系统, 真实世界研究, 数据挖掘, 心血管不良反应信号

Abstract: Objective To analyze the adverse reaction signals of nintedanib using the food and drug administration adverse event reporting system(FAERS)database. Methods Cases reported in the FAERS database from the July of 2014 to September of 2023 with nintedanib as suspected cause of adverse drug events were collected. After standardization of the WHO adverse drug reaction terminology, the reporting odds ratio method(ROR), proportional reporting ratio method(PRR)and multinomial gamma Posson distribution(MGPS)methods were used for adverse reaction signal detection. Results In total, 17,547 adverse reaction case reports listing nintedanib as the primary suspected drug were extracted from the FAERS database. Most patients were male(9,709 cases, 55.3%). The age mainly ranged from 65 to 85(8,856 cases, 50.5%). The majority of cases were reported from United States(10,209 cases, 58.2%), and the largest number of cases was reported in 2022(2,876 cases, 17.46%). In total, 24 cardiovascular adverse reaction signals were obtained through the ROR, PRR and MGPS methods, among which the RORs were highest for paroxysmal arrhythmia, aortic rupture, aortic valve calcification, heart valve surgery, and cardiac catheterization were ranked higher. The reported adverse reactions included hypertension(385 cases), elevated blood pressure(291 cases), myocardial infarction(182 cases), hypotension(175 cases), and atrial fibrillation(142 cases). The adverse reaction signals were consistent with the excavation signals, although adverse reactions such as aortic rupture, aortic valve calcification, and atrial fibrillation were not listed in the drug instructions. Conclusion Drug evaluation should be performed before the clinical use of nintedanib, especially for high-risk patients with cardiovascular diseases such as vascular disease, ischemic heart disease,and arrhythmia. Monitoring using electrocardiogram, electrolyte measurement, cardiac ultrasound, and other techniques should be strengthened, and clinicians should pay attention to adverse reactions beyond those listed in the instructions are included to ensure the safe use of this drug.

Key words: Nintedanib, Adverse event reporting system, Real-world research, Data mining, Cardiovascular adverse reaction signals

中图分类号:

R574

高雯,张鸽,魏来,苏琳. 基于FAERS数据库尼达尼布心血管不良事件信号挖掘及分析[J]. 山东大学学报 (医学版), 2024, 62(3): 47-53.

GAO Wen, ZHANG Ge, WEI Lai, SU Lin. Mining and analyzing cardiovascular adverse event signals for nintedanib based on the FDA Adverse Event Reporting System(FAERS)database[J]. Journal of Shandong University (Health Sciences), 2024, 62(3): 47-53.

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