基于FDA不良事件报告系统数据库对帕唑帕尼上市后不良事件信号的挖掘与分析  

Mining and analysis of adverse event signals of pazopanib after market launch based on the FDA adverse event reporting system database

作　　者：唐斌 胡颖 罗明波 丁乔 李建萍 TANG Bin;HU Ying;LUO Mingbo;DING Qiao;LI Jianping(Department of Neurology and Critical Care Medicine,The Third Affiliated Hospital of Zunyi Medical University,Zunyi First People's Hospital,Zunyi,Guizhou 563000,China)

机构地区：[1]遵义医科大学第三附属医院·遵义市第一人民医院神经重症医学科,贵州遵义563000

出　　处：《社区医学杂志》2024年第6期194-199,205,共7页Journal Of Community Medicine

基　　金：遵义市科技计划[遵市科合HZ字(2021)256号]。

摘　　要：目的挖掘帕唑帕尼的不良反应信号,为临床安全用药提供参考。方法从美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中下载2017-03-01-2022-12-31关于帕唑帕尼的报道并采用比例失衡法中的报告比值比法(ROR)和比例报告比值法(PRR)进行数据挖掘。分别计算ROR、PRR值和95%可信区间(95%CI)确定有无信号。对有信号的药品不良反应(ADR)采用ROR/PRR值与其标准误进行比较来确定ADR信号强度。结果使用ROR和PRR公式计算后,2种方法均得到帕唑帕尼的不良反应信号376个,二次筛选并清除考虑肿瘤治疗无效引起的不良反应信号后,最终得到184个完全重合信号。涉及16个系统,不良反应发生例数较多的有全身性疾病及给药部位各种反应、胃肠系统疾病及各类检查,在良性、恶性及性质不明的肿瘤中,有52.68%(1653/3138)发生了转移;不良反应发生频次较高的主要集中在死亡、腹泻、高血压、乏力和恶心想吐等,信号较强的主要发生在皮肤和皮下组织疾病中;同时发现了57个未收录于说明书中的不良反应,如眼球突出、低蛋白血症、咯血、食物不耐受和腔静脉血栓形成等。结论通过ROR和PRR信号检测方法,发现帕唑帕尼药品说明书中未提及的57个新的不良反应信号应引起重视,建议临床用药时考虑其可能引起的不良反应并采取干预措施。Objective To investigate the pazopanib adverse reaction signals and offer guidance for safe clinical medication.Methods Reports about pazopanib from March 1,2017,to December 31,2022,were acquired from the Food and Drug Administration's(FDA)adverse event reporting system(FAERS),and the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods were utilized for data mining.To ascertain whether a signal exists,the ROR,PRR,and95%confidence intervals(95%CI)were calculated.The intensity of the adverse drug reaction(ADR)signal was determined by comparing the ROR/PRR values with their standard errors.Results After calculations using the ROR and PRR formulas,both methods identified 376 adverse reaction signals for pazopanib.After a second screening and the exclusion of signals potentially caused by ineffective tumor treatment,a final total of 184 completely overlapping signals were obtained.Involving 16 systems,systemic diseases and various reactions at the administration site,gastrointestinal diseases,and various examinations had a higher incidence of adverse reactions.Among benign,malignant,and unknown tumors,52.68%(1653/3138)had metastasized.The frequency of adverse reactions was mainly concentrated in death,diarrhea,hypertension,fatigue,and nausea and vomiting,while those with strong signals mainly occured in skin and subcutaneous tissue diseases.At the same time,57 adverse reactions were found that were not included in the instructions,such as exophthalmos,hypoproteinemia,hemoptysis,food intolerance,and caval vein thrombosis,etc.Conclusions Through the ROR and PRR signal detection methods,57 new adverse reaction signals not mentioned in the pazopanib product leaflet were identified and should be paid attention to.It is recommended that healthcare professionals consider the possible adverse reactions caused by pazopanib and take intervention measures when using the drug clinically.

关 键 词：帕唑帕尼 食品药品监督管理局不良事件报告系统 报告比值比法 比例报告比值法 信号挖掘 

分 类 号：R969.3[医药卫生—药理学]