基于FAERS的胺碘酮相关失明不良事件信号挖掘研究

Data Mining and Analysis of Amiodarone Related Adverse Drug Events of Blindness Based on FAERS

关键词:  胺碘酮  失明  FAERS  不良事件  信号挖掘  报告比值比法  综合标准法

Key words:  amiodarone  blindness  FAERS  adverse events  signal mining  ROR  MHRA

摘要:

目的 基于FAERS对胺碘酮相关失明药物不良事件(adverse drug event,ADE)进行信号挖掘,探索相关失明ADE的发生特点以及胺碘酮与相关失明ADE的相关性。方法 提取FAERS 2016年第1季度-2021年第4季度共24个季度的胺碘酮相关失明ADE报告数据,利用报告比值比法和综合标准法进行数据挖掘。得到有效信号后,再利用MedDRA规范进行汉化及系统归类。结果 获得胺碘酮报告数39 166个,胺碘酮相关失明ADE报告503个,其中失明、单侧盲、黑朦、一过性黑朦4个首选语运用2种方法均提示生成可疑信号。在503份患者报告中,男性所占比例(64.41%)高于女性(31.22%),在已知年龄的患者中,年龄主要集中在 ≥ 65岁(6.16%)。报告人员以律师和消费者为主90.46%,医务人员占比较低;除给药途径未知的患者,其余所有患者给药途径为口服(66.80%)。胺碘酮相关失明ADE的中位发病时间为692 d(四分位间距422.5~1 045.75 d);占比最高的患者结局为其他严重的医疗事件,报告病例279例(55.47%),患者结局为死亡的报告病例73例(14.51%),居第3位。结论 需重视胺碘酮的失明风险,重点关注男性、>65岁老人、给药途径为口服的患者,加强用药前的眼科评估及用药中、用药后的眼部监测,及时诊断和治疗可防止相关失明ADE的发生。

Abstract:

OBJECTIVE To carry out the signal mining of adverse drug events(ADE) related to amiodarone based on FAERS, and to explore the occurrence characteristics of related blind ADE and the correlation between amiodarone and related blind ADE. METHODS Reporting odds ratio methods and medicines and healthcare products regulatory agency methods were used to mine the amiodarone related ADE of blindness based on the ADE report data of 24 quarters from the first quarter of 2016 to the fourth quarter of 2021 extracted from the FAERS. After valid signals were obtained, the MedDRA was used for translation and system organ classification. RESULTS A total of 39 166 amiodarone related reports were obtained, 503 amiodarone related ADEs of blindness were reported. Among them, the four preferred terms of blindness, unilateral blindness, amaurosis, and amaurosis transient used both methods to prompt the generation of suspicious signals. Among the 503 patient reports, the proportion of male(64.41%) was higher than that of female(31.22%), and among the patients of known age, the age was mainly concentrated in those ≥ 65 years old(6.16%). The reporters were mainly lawyers and consumers(90.46%), and the proportion of medical staff was relatively low; except for patients whose route of administration was unknown, all the patients were administered orally(66.80%). The median onset time of amiodarone-related blindness adverse events was 692 d(interquartile range 422.5-1 045.75 d); the highest proportion of patient outcomes was other serious medical events. A total of 279 cases (55.47%) were reported. There were 73 reported cases(14.51%) with the outcome of death, ranking the third. CONCLUSION Attention should be paid to the risk of blindness of amiodarone, focusing on males, elderly people over 65 years old, and patients with oral administration. Strengthen ophthalmic evaluation before medication and ocular monitoring during and after medication. Timely diagnosis and treatment can prevent occurrence of blindness related ADE.