摘要
目的基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库,分析艾加莫德α和依库珠单抗用于治疗重症肌无力(MG)的不良事件,为临床安全用药提供参考。方法以艾加莫德α或依库珠单抗为主要怀疑对象,提取两药美国上市至2024年12月31日FAERS数据库中适应证为MG的相关不良事件报告,采用报告比值比法(ROR)和比例报告比值比法(PRR)进行信号挖掘,并采用韦伯分布检验分析发生时间。结果艾加莫德α和依库珠单抗不良事件分别有14590、12979份,分别涉及3362、5048例患者。按报告例数排序,艾加莫德α前5位不良事件为呼吸困难、尿路感染、肺炎、背痛和窒息;依库珠单抗为关节痛、肌痛、颈痛、口咽痛和脱发。按信号强度排序,艾加莫德α前5位为窒息、眼睑痉挛、Graves病、前列腺炎和糖尿病足;依库珠单抗为抗体检测异常、肌肉骨骼疼痛、嗳气、血乳酸脱氢酶升高和恐惧。韦伯分布检验显示,艾加莫德α和依库珠单抗不良事件中位发生时间分别为102(27.00,260.25)d和71(14.00,257.25)d,多集中于用药早期。结论根据系统器官分类(SOC),两药涉及的SOC存在较多重叠,艾加莫德α更多涉及心脏器官疾病,而依库珠单抗则较多涉及精神病类不良事件。除已知不良反应外,本研究还发现新的不良事件信号,建议临床用药过程中强化动态观察,重点关注治疗初期可能出现的不良事件,以保障患者用药安全。
Objective To analyze adverse events associated with efgartigimod alfa and eculizumab in the treatment of myasthenia gravis(MG)using the US Food and Drug Administration Adverse Event Reporting System(FAERS)database,providing reference for safety of clinical drug use.Methods Adverse event reports on efgartigimod alfa and eculizumab with the indication of myasthenia gravis were extracted from the FAERS database from US market approval to December 31,2024,with these drugs as the primary suspects.Signal mining was conducted using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods.The time to onset was analyzed using the Weibull distribution test.Results There were 14590 and 12979 adverse events,involving 3362 and 5048 patients,respectively,with regard to the use of efgartigimod alfa and eculizumab.According to the number of reported cases,the top 5 adverse events of efgartigimod alfa were dyspnea,urinary tract infection,pneumonia,back pain,and asphyxia;eculizumab was associated with joint pain,muscle pain,neck pain,oropharyngeal pain,and hair loss.According to the signal intensity,the top 5 adverse events of efgartigimod alfa were asphyxia,blepharospasm,Graves’disease,prostatitis and diabetic foot;eculizumab was associated with abnormal antibody test,musculoskeletal pain,belching,elevated blood lactate dehydrogenase,and fear.According to the Weibull distribution test,the median occurrence time of adverse events related to efgartigimod alfa and eculizumab was 102(27.00,260.25)d and 71(14.00,257.25)d,respectively,and the adverse events were mostly concentrated in the early stages of medication.Conclusion According to the System Organ Class(SOC),the two drugs exhibit substantial overlap in their associated SOC.Efgartigimod alfa is associated with a higher incidence of cardiac disorders,whereas eculizumab demonstrates a greater frequency of psychiatric adverse events.Besides the adverse reactions already known,this study identifies novel safety signals.It is advised to enhance dynamic monitoring during clinical medication,particularly focusing on adverse events potentially arising in the initial treatment phase,in order to ensure medication safety.
作者
贺兰芝
周鹏翔
秦永洁
周欣
罗海坤
周甘平
He Lanzhi;Zhou Pengxiang;Qin Yongjie;Zhou Xin;Luo Haikun;Zhou Ganping(Department of Pharmacy,Jiangbin Hospital of Guangxi Zhuang Autonomous Region,Nanning 530021,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;Department of Pharmacy,Children's Hospital Affiliated to Capital Institute of Pediatrics,Beijing 100020,China)
出处
《实用药物与临床》
2025年第8期574-579,共6页
Practical Pharmacy and Clinical Remedies
基金
广西自然科学基金项目(2024GXNSFAA010166)
广西壮族自治区第三批药品临床综合评价主题和评价基地。
