Meng Long, Huang Jing, Jia Yuntao, Huang Huali, Qiu Feng, Sun Shusen
Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Department of Respiratory, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Int J Clin Pract. 2019 May;73(5):e13331. doi: 10.1111/ijcp.13331. Epub 2019 Apr 25.
A recent large epidemiological study found fluoroquinolone use is associated with an increased risk of aortic aneurysm or dissection. We aimed to examine fluoroquinolone (ciprofloxacin, levofloxacin and moxifloxacin) associated aortic aneurysm or dissection through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Reports to the FAERS from 1 January 2004 to 31 December 2016 were analysed. Pharmacovigilance tools were used for quantitative detection of signals that is, drug-associated adverse events, including reporting odds ratio, proportional reporting ratio, information component given by a Bayesian confidence propagation neural network and empirical Bayes geometric mean. Sensitivity analyses that limited the data by gender and adverse event date also showed similar trends.
Based on 3721 adverse event reports, all three fluoroquinolones are associated with aortic aneurysm, and levofloxacin is associated with aortic dissection. The risk of aortic aneurysm is higher than the aortic dissection. Oral administration of fluoroquinolones is more likely to produce these adverse events.
The results obtained herein are consistent with clinical observations, suggesting the necessity for further clinical research on aortic aneurysm and dissection associated with fluoroquinolones.
最近一项大型流行病学研究发现，使用氟喹诺酮类药物会增加患主动脉瘤或主动脉夹层的风险。我们旨在通过挖掘美国食品药品监督管理局不良事件报告系统（FAERS）的数据，研究氟喹诺酮类药物（环丙沙星、左氧氟沙星和莫西沙星）与主动脉瘤或主动脉夹层的相关性。
分析了2004年1月1日至2016年12月31日期间向FAERS提交的报告。使用药物警戒工具对信号进行定量检测，即药物相关不良事件，包括报告比值比、比例报告比、贝叶斯置信传播神经网络给出的信息成分和经验贝叶斯几何均值。按性别和不良事件日期对数据进行限制的敏感性分析也显示出类似趋势。
基于3721份不良事件报告，所有三种氟喹诺酮类药物均与主动脉瘤相关，左氧氟沙星与主动脉夹层相关。主动脉瘤的风险高于主动脉夹层。口服氟喹诺酮类药物更易发生这些不良事件。
本文获得的结果与临床观察结果一致，提示有必要对氟喹诺酮类药物相关的主动脉瘤和主动脉夹层进行进一步临床研究。
