基于FDA报告系统的乌司奴单抗严重不良事件分析与探讨

Analysis and Discussion of Serious Adverse Events of Ustekinumab Based on FAERS

目的:运用美国食品药品监督管理局不良事件报告系统(FAERS)对乌司奴单抗上市后的不良事件进行数据挖掘和综合分析,为其临床安全用药提供参考依据。方法:利用报告比值比(ROR)法和比例报告比值比(PRR)法对FAERS数据库自2009年第4季度至2022年第1季度的乌司奴单抗相关不良事件进行数据挖掘及信号检测。结果:共得到乌司奴单抗相关药物警戒信号90个(116 311例次),同时满足ROR法及PRR法识别并排除同义合并、药物外不良事件,共得到38个药品不良信号(44 515例次),涉及12个系统器官分类,其中13个信号未在乌司奴单抗药品说明书中提及,涉及心脏器官疾病、胃肠系统疾病、各种肌肉骨骼及结缔组织疾病、全身性疾病及给药部位各种反应等;主要累积器官为全身性疾病及给药部位各种反应(9543例次)、肌肉骨骼及结缔组织疾病(9366例次)以及皮肤及皮下组织类疾病(5801例次)等;涉及死亡结局信号28个(811例次),按频次排序排名前二的分别为肺炎(95例次)和牛皮癣(60例次)。结论:应关注药品说明书中尚未涉及的严重的、新的药物警戒信号。用药治疗期间应密切关注给药部位、肌肉骨骼系统、皮肤系统及感染药物警戒信号,及早科学识别药品不良事件,做好相应防范,保障患者用药安全。

Objective: To mine and comprehensively analyze the adverse events of ustekinumab after marketing by using the FAERS database, so as to provide data support for the adverse events of ustekinumab and provide reference basis for clinical safe drug use. Methods: Reporting odds ratio(ROR)method and proportional report ratio(PRR) method were used to mine and detect the adverse events related to ustekinumab in FAERS database from the fourth quarter of 2009 to the first quarter of 2022.Results: A total of 90 ustekinumab related pharmacovigilance signals(116 311 cases) were obtained. After being identified and excluded by ROR and PRR methods, 38 pharmacovigilance signals(44 515 cases)involving 12 systematic organ classifications were obtained, 13 of which were not mentioned in the text of drug instruction manuals. The main accumulated organs were systemic diseases and various reactions at the administration site(9543 cases), musculoskeletal and connective tissue diseases(9366 cases), skin and subcutaneous tissue diseases(5801 cases), etc. There were 28 signals involving death outcome(811 cases),and the top two signals by frequency were pneumonia(95 cases) and psoriasis(60 cases). Conclusion: In the clinical use, attention should be paid to not only the common adverse reactions in the drug instructions, but also the serious and new pharmacovigilance signals not yet mentioned. During drug treatment, close attention should be paid to the administration site, musculoskeletal system, cutaneous system and infection pharmacovigilance signals, so as to scientifically identify the adverse drug events as early as possible, take corresponding precautions and ensure drug safety of patients.