摘要
目的挖掘瑞波西利的不良反应信号,为临床安全用药提供参考。方法从美国FDA不良事件报告系统(FAERS)中下载2017年4月1日—2022年6月30日关于瑞波西利的报告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。结果使用ROR和PRR公式计算后,两种方法均得到瑞波西利的不良反应信号521个,2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338个完全重合信号。其中新的不良反应信号148个,主要集中在各类检查(29个)、血液和淋巴系统疾病(23个)、胃肠系统疾病(14个)、呼吸道、胸部和纵膈腔疾病(12个)及皮肤和皮下组织疾病(6个)等。信号强度排名前五中有3个为血液及淋巴系统疾病。结论通过ROR和PRR信号检测方法,发现瑞波西利药品说明书中未提及的148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,保证患者用药安全。
Objective To explore the adverse reaction signal of ribociclib and provide a reference for clinical safe drug use.Methods The reports on ribociclib from April 1,2017 to June 30,2022 were downloaded from the US FDA Adverse Event Reporting System(FAERS),and the reporting odds ratio method(ROR)and the proportional reported ratio method(PRR)in the proportional imbalance method were used for data mining.Results After calculation by using the ROR and PRR formulas,521 adverse reaction signals were obtained with the two methods,and 338 completely coincident signals were finally obtained after secondary screening and elimination of adverse reaction signals caused by tumor treatment failure.Of these,148 were new adverse reaction signals,mainly concentrated in various examinations(29),blood and lymphatic system diseases(23),gastrointestinal system diseases(14),respiratory tract,chest and mediastinal diseases(12),and skin and subcutaneous tissue diseases(6).Three of the top five in signal intensity were diseases of blood and lymphatic system.Conclusion Through the signal detection methods of ROR and PRR,148 new adverse reaction signals not mentioned in the drug instructions of ribociclib should be taken seriously.It is suggested that the possible adverse reactions should be considered and intervention measures should be taken to ensure the safety of patients’medication.
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,Guizhou Zunyi 563000,China)
出处
《合肥医科大学学报》
2023年第8期788-795,共8页
Journal of Zunyi Medical University
基金
合肥市科技计划项目[NO:遵市科合HZ字(2021)256号]。
关键词
瑞波西利
药物不良事件
报告比值比法
比例报告比值法
信号挖掘
ribociclib
adverse drug events
reporting ratio ratio method
proportional reporting ratio method
signal mining
