基于FAERS数据库的胺碘酮相关视神经不良事件信号挖掘研究

Study on the data mining and analysis of amiodarone-related optic nerve adverse events based on FAERS database

目的基于FDA不良事件报告系统(FDA adverse event reporting system,FAERS)数据库对胺碘酮相关视神经不良事件进行信号挖掘,探索胺碘酮与视神经不良事件的相关性及发生特点,为胺碘酮的用药安全提供参考。方法通过检索FAERS数据库中2004年1月至2022年12月的胺碘酮相关视神经不良事件报告,利用报告比值比法、综合标准法、贝叶斯置信传播神经网络法和多项伽玛泊松分布缩减法进行信号检测。结果胺碘酮为首要怀疑药物的报告数为17234份,共报告了69727例次不良事件,其中视神经不良事件报告数为282份,共报告397例次。信号检测结果显示胺碘酮与视神经不良事件存在阳性信号,胺碘酮与视神经不良事件相关(ROR=14.59,95%CI=13.21~16.12)。报告中男性占73.76%,女性占21.28%,年龄≥65岁者占39.01%,口服给药途径比52.84%,注射占2.13%。胺碘酮相关视神经不良事件的中位诱发时间为143 d。患者预后结局中残疾(如失明)占31.20%。胺碘酮相关视神经不良事件信号检测存在性别差异,男性更容易出现缺血性视神经病变(ROR=2.79,95%CI=1.69~4.59)和视神经损伤(ROR=3.59,95%CI=1.50~8.57)。结论胺碘酮与视神经不良事件发生存在相关性,且不良事件信号存在性别差异,服用胺碘酮可能会增加患者发生视神经相关不良事件的风险。临床使用胺碘酮时应加强对长期口服用药人群、高龄人群及男性患者的眼科检查,以便及时采取干预措施。

Objective Based on FAERS database,signal mining of amiodarone related optic nerve adverse events was conducted to explore the correlation and occurrence characteristics between amiodarone and optic nerve adverse events,providing a reference basis for the safety of amiodarone administration.Methods By retrieving the amiodarone-related optic nerve adverse event reports from the FAERS database between January 2004 and December 2022,four signal detection methods were utilized,including the Reporting Odd Ratio(ROR),Medicines and Healthcare Products Regulatory Agency(MHRA),Bayesian Confidence Propagation Neural Network(BCPNN)and Multiple Item Empirical Bayesian Gamma-Poisson Shrinker(MGPS).Results The number of reports with amiodarone as the primary suspected drug was 17234,reporting a total of 69727 adverse event occurrences,including 282 reports and 397 cases of optic nerve adverse events.Signal detection showed a suspicious signal between amiodarone and optic nerve adverse events,indicating that amiodarone was associated with optic nerve adverse events(ROR=14.59,95%CI=13.21 to 16.12).Among the reports,73.76%were males,21.28%were females,39.01%of the patients were aged 65 or above,52.84%were administered orally,and 2.13%were administered by injection.The median induction time for amiodarone-related optic nerve adverse events was 143 days.Disability,such as blindness,accounted for 31.20%of the patients'prognostic outcomes.There were gender differences in the signal detection of amiodarone-related optic nerve adverse events,with males being more likely to experience ischemic optic neuropathy(ROR=2.79,95%CI=1.69 to 4.59)and optic nerve damage(ROR=3.59,95%CI=1.50 to 8.57).Conclusion There is a correlation between amiodarone and the occurrence of optic nerve adverse events,and there is a gender difference in the signal of adverse events,and the administration of amiodarone may increase a patient's risk of optic nerve-related adverse events.Clinical use of amiodarone should enhance ophthalmologic examination of long-term oral drug users,the elderly,and male patients for timely intervention.