PCSK9抑制剂阿利罗库单抗不良事件信号发掘

doi:10.19803/j.1672-8629.2022.06.22

摘要/Abstract

摘要： 目的基于美国食品药品监督管理局公共数据项目（US Food and Drug Administration Public Data OpenProject, openFDA）数据库数据,分析真实世界阿利罗库单抗（alirocumab）的药品不良事件（adverse drug event, ADE）信号,为临床合理用药提供参考。方法下载openFDA中2004年1月1日至2020年5月7日ADE报告,使用报告比值比法（ROR）与综合标准法（MHRA）进行ADE信号挖掘。结果共得到提及阿利罗库单抗的ADE报告15 511份,56 912对组合。上报人多为消费者或非卫生专业人士（71.10%）。来自美国的报告占95.82%。筛选出阿利罗库单抗ADE信号163个。ADE信号主要分布在全身性疾病及给药部位各种反应,各种肌肉骨骼及结缔组织疾病,各类损伤、中毒及手术并发症,呼吸系统、胸及纵隔疾病4方面。常见药品不良反应（adverse drug reaction, ADR）分布在鼻咽、注射部位。结论阿利罗库单抗的ADE信号涵盖了20类系统-器官。对于女性患者、老年患者、有潜在心脏疾病的患者,应当尤其注意观察。

关键词: 美国食品药品监督管理局公共数据项目, 阿利罗库单抗, 波立达, 药品不良事件, 信号挖掘

Abstract: Objective s To analyze the signals of adverse drug events (ADE) induced by alirocumab in the real world based on openFDA in order to provide reference for clinical rational use of the drug. Methods All the data on ADE was retrieved from the openFDA database collected between January 1, 2004 and May 7, 2020. ADE signals were detected by ROR and MHRA. Results Totally, 15 511 cases and 56 912 combinations of alirocumab were reported. Most of the reporters were consumers or non-health care providers, accounting for 71.10%. Reports from the United States accounted for 95.82%. After screening, 163 positive signals of alirocumab were obtained. ADE were mainly manifested as systemic disorders, responses at the sites of administration, musculoskeletal and connective tissue disorders, injury, poisoning, complications, and respiratory, thoracic and mediastinal disorders. Common ADE occurred in the nasopharynx and at the sites of injection. Conclusion The ADE signals of alirocumab involve 20 SOCs. Special attention should be paid to female or elderly patients or those with underlying heart diseases.

Key words: openFDA, alirocumab, Praluent, adverse drug events, data mining

中图分类号:

R994.11

张弛. PCSK9抑制剂阿利罗库单抗不良事件信号发掘[J]. 中国药物警戒, 2022, 19(6): 684-691.

ZHANG Chi. Data mining of adverse drug events of alirocumab from openFDA[J]. Chinese Journal of Pharmacovigilance, 2022, 19(6): 684-691.

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