基于FAERS数据库的甲磺酸达拉非尼联合曲美替尼致药品不良事件信号挖掘  

Signal Mining of Adverse Events Induced by Dabrafenib Mesylate Combined with Trametinib Based on FAERS Database

作　　者：石亚飞 李艳慧 陈伟 薄明明 张铭予 孙伟銮 衡愉 李国辉 戴媛媛 SHI Yafei;LI Yanhui;CHEN Wei;BO Mingming;ZHANG Mingyu;SUN Weiluan;HENG Yu;LI Guohui;DAI Yuanyuan(Dept.of Pharmacy,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Dept.of Pharmacy,National Cancer Center/National Clinical Research Center for Cancer/Hebei Cancer Hospital,Chinese Academy of Medical Sciences,Hebei Langfang 065001,China;Dept.of Nursing,National Cancer Center/National Clinical Research Center for Cancer/Hebei Cancer Hospital,Chinese Academy of Medical Sciences,Hebei Langfang 065001,China)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院药剂科,北京100021 [2]国家癌症中心/国家肿瘤临床医学研究中心/河北中国医学科学院肿瘤医院药剂科,河北廊坊065001 [3]国家癌症中心/国家肿瘤临床医学研究中心/河北中国医学科学院肿瘤医院护理部,河北廊坊065001

出　　处：《中国医院用药评价与分析》2023年第4期492-497,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：中国医学科学院肿瘤医院管理研究课题资助(No.LC2021D04)。

摘　　要：目的:探讨甲磺酸达拉非尼联合曲美替尼上市后的药品不良事件信号,为临床安全用药提供参考。方法:利用OpenVigil 2.1-MedDRA平台,收集美国食品药品监督管理局不良事件报告系统(FAERS)数据库中有关甲磺酸达拉非尼与曲美替尼联合应用的不良事件数据,截至2022年第2季度。采用比例失衡算法分析不良事件信号,分析不良事件上报的人群特征以及频数较高和新发的不良事件信息。结果:共获取甲磺酸达拉非尼与曲美替尼联合应用的不良事件报告9712例,涉及男性患者4555例(占46.90%),女性患者3921例(占40.37%);18~<65岁患者较多(2503例,占25.77%);上报数据主要源于美国(4287例,占44.14%);严重的不良事件主要包括死亡(2100例,占21.62%)、导致住院或住院时间延长(1889例,占19.45%)。发生频数较高的不良事件主要有恶性肿瘤转移,发热和皮肤毒性等;新发的不良事件主要有吞咽困难、惊厥和脂膜炎等。结论:临床联合应用甲磺酸达拉非尼与曲美替尼时,应对发生频数较高以及新发的不良事件予以重视。在使用药物治疗前、治疗中及随访阶段,均应做好相关监测工作,有效保障患者用药安全。OBJECTIVES:To probe into the signal of adverse events of dabrafenib mesylate combined with trametinib after marketing,so as to provide reference for clinical safe drug use.METHODS:OpenVigil 2.1-MedDRA platform was used to collect adverse event data of dabrafenib mesylate combined with trametinib which reported in FDA adverse event reporting system(FAERS),as of the second quarter of 2022.Disproportionality analysis methods were used to mine the adverse events risk signals.Characteristics of the population reporting adverse events and information on frequent and new adverse events were analyzed.RESULTS:A total of 9712 adverse event reports related to dabrafenib combined with trametinib were screened,in which 4555 cases(46.90%)were males,3921 cases(40.37%)were females.Cases were major in age from 18 to<65 years(2503 cases,25.77%).Most of the cases were reported from America(4287 cases,44.14%).Severe adverse event reports were mainly in death(2100 cases,21.62%)and hospitalization-initial or prolonged(1889 cases,19.45%).Adverse events with high frequency mainly included malignant tumor metastasis,pyrexia,and skin toxicity.New adverse events mainly included dysphagia,convulsions and panniculitis.CONCLUSIONS:In clinical medication,attention should be paid to the high frequency and new signal of adverse events for dabrafenib mesylate combined with trametinib.Relevant monitoring should be done before,during and after drug treatment to effectively ensure the safety of patients’medication.

关 键 词：甲磺酸达拉非尼 曲美替尼 药品不良事件 信号挖掘 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]