基于FAERS数据库的氨吡啶缓释片不良反应信号挖掘分析

doi:10.19803/j.1672-8629.20220212

摘要/Abstract

摘要： 目的挖掘氨吡啶缓释片相关药品不良反应/不良事件（ADR/ADE）信号,为临床安全用药提供参考。方法基于美国食品药品监督管理局不良事件报告系统（FAERS）,采用报告比值比法（ROR）和信息成分法（IC）对系统中2013年1月1日至2021年6月30日上报的氨吡啶缓释片ADR/ADE进行数据挖掘,按国际医学用语词典（MedDRA）的首选术语（PT）和系统-器官分类（SOC）进行统计分析。结果以氨吡啶缓释片为首要怀疑药品的ADR/ADE报告141 768份,涉及患者47 486例,其中女性占大多数（72.39%）;41~70岁年龄段的患者占比最大（82.83%）;美国是主要报告国家（90.98%）;严重ADR/ADE共7 873例（16.58%）,主要为导致住院或住院时间延长（12.24%）。经筛选后共检测到ADR信号174个,其中说明书未记载的信号126个。报告例数前50位PT中可疑信号36个,说明书未记载的信号 30个。信号强度前50位的PT涉及SOC主要为各类检查（19个）、各类神经系统疾病（11个）、全身性疾病及给药部位各种反应（5个）等。ADR信号共涉及13个系统-器官,主要为全身性疾病及给药部位各种反应（28.53%）、各类神经系统疾病（26.03%）和精神病类（8.79%）等。结论对氨吡啶缓释片ADR/ADE进行真实世界数据分析,提示临床应严格遵循说明书用药尤其要关注癫痫病史及肾功能,另外还检出新的较强信号如T淋巴细胞、CD4淋巴细胞、B淋巴细胞等免疫细胞异常,临床应关注密切监测患者各类检查,以及神经系统疾病等说明书未提及的风险。

关键词: 氨吡啶缓释片, 美国食品药品监督管理局不良事件报告系统, 药品不良反应, 信号挖掘

Abstract: Objective To provide reference for clinical safe drug use via data mining of adverse drug events /adverse drug reaction (ADE/ADR) caused by fampridine sustained-release tablets. Methods Based on the FDA Adverse Event Reporting System (FAERS), the ADR/ADE reports of fampridine sustained-release tablets submitted between January 2013 and June 2021 were mined by using the reporting odds ratio (ROR) method and information component (IC) method. Statistical analysis was conducted according to the preferred terms (PT) and system organ classification (SOC) in the International Dictionary of Medical Terms (MedDRA). Results A total of 141 768 ADR/ADE were reported with fampridine sustained-release tablets as the primary suspected drug, involving 47 486 patients, most of whom were females (72.39%) and aged 41 to 70 (82.83%). The United States was the leading reporting country (90.98%). There were 7 873 serious ADR/ADE (16.58%), which mostly resulted in hospitalizations or prolonged hospitalizations (12.24%). A total of 174 positive signals were detected after screening, 126 of which were not recorded in the instructions. There were 36 PT positive signals in the top 50 cases of ADR/ADE reported, and 30 PTs not recorded in the instructions. The top 50 PTs in terms of signal intensity that involved SOC included various examinations (19 cases), neurological diseases (11 cases), systemic diseases and various reactions of sites of administration (5 cases). There were 13 system and organs involved in effective signals, involving general disorders and administration site conditions (28.53%). nervous system disorders (26.03%) and psychiatric disorders (8.79%). Conclusion The real-world data analysis of ADR/ADE caused by newly-marketed fampridine sustained-release tablets suggests that clinicians should strictly follow the instructions and care about the patients' history of epilepsy and renal function. Furthermore, some new and stronger signals have been detected, such as abnormal T cells, CD4 lymphocytes and B cells. Therefore, clinicians should closely monitor the results of examinations of patients and stay alert to risks unmentioned in instructions, such as neurological diseases.

Key words: aminopyridine sustained-release tablet, American FAERS database, adverse drug event/ reaction, data mining

中图分类号:

R994.11

赵稳华, 舒鹤, 倪晨明, 郭晋敏. 基于FAERS数据库的氨吡啶缓释片不良反应信号挖掘分析[J]. 中国药物警戒, 2023, 20(6): 684-690.

ZHAO Wenhua, SHU He, NI Chenming, GUO Jinmin. Data mining and analysis of adverse drug reaction signals of fampridine sustained-release tablets based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 684-690.

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