摘要
目的为临床安全使用阿法替尼提供参考。方法基于美国食品和药物管理局不良事件报告系统(FAERS)挖掘阿法替尼相关不良反应(ADR)信号,采用报告比值比(ROR)法及比例报告比值(PRR)法对FAERS数据库中2013年第3季度至2019年第3季度的ADR报告进行数据挖掘。结果筛选出报告25007035份,其中以阿法替尼为首要怀疑药物的ADR报告19710份,经ROR法和PRR法分析后,得到阿法替尼ADR信号325个,二次筛选并去除考虑肿瘤治疗无效引起的ADR信号后,得到完全重合信号190个,主要集中在胃肠道系统(47个),皮肤及皮下组织(41个),呼吸系统、胸及纵隔(22个),感染及侵染类疾病(19个),113个新的ADR信号也主要集中在上述系统/疾病。结论发现阿法替尼药品说明书未涉及的新的ADR信号113个,有必要进行信号评价和验证,以便在临床应用中决定是否采取相关风险防范措施。
Objective To provide a reference for clinical safe use of afatinib.Methods Based on the FDA Adverse Event Reporting System(FAERS),the adverse drug reaction(ADR)signals related to afatinib were mined.The ADR reports from the third quarter of 2013 to the third quarter of 2019 in the FAERS database were mined by the reporting odds ratio(ROR)method and proportional reporting ratio(PRR)method.Results A total of 25007035 reports were screened out,including 19710 ADR reports induced by afatinib as the primary suspected drug.Totally 325 ADR signals of afatinib were detected by both ROR method and PRR method,after secondary screening and removing ADR signals caused by ineffective tumor treatment,190 completely coincident signals were obtained by the two methods,which were mainly concentrated in the gastrointestinal system(47 signals),skin and subcutaneous tissue(41 signals),respiratory system,thoracic and mediastinal disorders(22 signals),infection diseases(19 signals),and 113 new ADR signals were also mainly concentrated in the above systems/diseases.Conclusion A total of 113 new ADR signals are obtained,which are not involved in the instructions of afatinib.It is necessary to evaluate and verify the signals in order to decide whether corresponding risk preventive measures should be taken in clinical application.
作者
郑冬妮
周后凤
任常谕
钟科
吴逢波
ZHENG Dongni;ZHOU Houfeng;REN Changyu;ZHONG Ke;WU Fengbo(The Fifth People’s Hospital of Chengdu,Chengdu,Sichuan,China 611130;West China Hospital,Sichuan University,Chengdu,Sichuan,China 610041)
出处
《中国药业》
CAS
2021年第14期90-93,共4页
China Pharmaceuticals
基金
四川省卫生健康委员会科研课题[19PJ018]。
