摘要
目的 针对单克隆抗体药物利妥昔单抗(rituximab)和阿达木单抗(adalimumab),使用美国食品药品监督管理局公共数据库(the US food and drug administration public data open project,OpenFDA)中药品不良事件(adverse drug events,AE)进行检索,对其药品不良事件的具体情况进行对比分析,比较2种药物在安全性上的差异。方法在OpenFDA数据库,使用端点交互式图表板块中的应用程序接口(application programming interface,API)功能对利妥昔单抗和阿达木单抗在2004年4月1日至2021年10月15日的药品不良事件数据进行详细检索。采用报告比值比(reporting odds ratio,ROR)法进行风险信号挖掘,同时多角度分析两种药物的不良事件的情况。结果 共得到提及利妥昔单抗的不良事件报告131 408例(包含不良反应信号376 203例次),阿达木单抗的不良事件报告515782例(包含不良反应信号1 238 760例次)。利妥昔单抗上报人多为其他卫生系统人员,阿达木单抗多为消费者或非卫生系统人员。因不良反应信号较多,本研究仅筛选出利妥昔单抗和阿达木单抗排名前9位的不良反应信号进行分析,包含利妥昔单抗9 379例次和阿达木单抗6 441例次,其中利妥昔单抗不良事件信号最强的是感染和侵染类疾病,阿达木单抗不良事件信号最强的是皮肤和皮下组织疾病。结论 对OpenFDA数据库中关于利妥昔单抗和阿达木单抗的药品不良事件数据进行挖掘和深入分析,为临床安全用药提供参考,对2种药物的不良事件进行关注,可有助于采取相应的预防措施,促进临床合理用药。
Objective To search and evaluate the adverse drug events(AE) of monoclonal antibody drugs rituximab and adalimumab in the database of the US Food and drug administration public data open project(OpenFDA),and to compare and analyze their AE.Methods The reporting odds ratio(ROR) method was used for quantitative detection of signals from the API module in the interactive chart section in OpenFDA database,the AE report data of rituximab and adalimumab from January 1,2004 to October 15,2021 were detailed retrieval.The profile of AE of both drugs was also analyzed from multiple perspectives simultaneously.Results A total of 131 408 adverse event reports referring to rituximab(including 376 203 adverse reaction signals) and 515 782 adverse event reports of adalimumab(including 1 238 760 adverse reaction signals) were obtained.Most of the reported persons of rituximab were personnel of other health systems,and most of adalimumab were consumers or non health system personnel.Due to the large number of adverse reaction signals,this study only screened the top 9 adverse reaction signals of rituximab and adalimumab for analysis.There were 9 379 cases of rituximab and 6 441 cases of adalimumab.The strongest signal of adverse events of rituximab was infectious and infectious diseases,and the strongest signal of adverse events of adalimumab was skin and subcutaneous tissue diseases.Conclusion In-depth analysis of the adverse drug event data of rituximab and adalimumab in the OpenFDA database would provide reference for clinical safe drug use.Paying attention to the adverse events of the above two drugs would help to take corresponding preventive measures and promote clinical rational drug use.
作者
任娱亲
李歆
余敏
苏钰文
REN Yuqin;LI Xin;YU Min;SU Yuwen(School of Pharmacy,Nanjing Medical University,Nanjing Jiangsu 211166,China;Center for Global Health,School of Public Health,Nanjing Medical University,Nanjing Jiangsu 211166,China)
出处
《中国药物警戒》
2022年第7期752-756,共5页
Chinese Journal of Pharmacovigilance
基金
国家自然科学基金资助项目(72074123,716731471)
江苏省政策引导类计划(软科学研究)(BR2020043)。
