摘要
目的挖掘和评价国内3种急性髓系白血病靶向治疗药物上市后不良反应信号。方法利用OpenVigil数据平台,从美国FDA不良事件报告系统分别获取维奈克拉、吉瑞替尼、艾伏尼布上市后药物不良反应(adverse drug reaction,ADR)报告。采用比例报告比法和报告比值比法检测维奈克拉、吉瑞替尼、艾伏尼布ADR信号,并分别按照发生频次和信号强度进行排序。结果共收集以维奈克拉首要怀疑药物的ADR报告14193份,ADR信号219个;吉瑞替尼ADR报告1885份,ADR信号125个;艾伏尼布ADR报告699份,ADR信号41个。从ADR报告的基本情况来看,3种药物的患者人群均为男性比例高于女性,患者的年龄分布均集中在60~74岁。维奈克拉、吉瑞替尼、艾伏尼布发生频次最高ADR分别为“死亡”“血小板计数减少”“疲乏”;信号强度最高ADR分别为“FLT3基因突变”“原始粒细胞计数增加”“分化综合征”。3种药物发生频次前20的ADR信号共累及系统器官10个,包括各类检查、血液及淋巴系统疾病、感染及侵染类疾病等。维奈克拉与吉瑞替尼发生频次前20的ADR占比最高的系统器官为“血液及淋巴系统疾病”,艾伏尼布发生频次前20的ADR占比最高的系统器官为“各类检查”。结论建议临床应对维奈克拉致心房颤动,吉瑞替尼致脓毒症等ADR给予关注。
OBJECTIVE To excavate and evaluate the post-marketing adverse reaction signals of three domestic targeted therapeutic drugs for acute myeloid leukemia.METHODS Using the OpenVigil data platform,post-marketing adverse drug reaction(ADR)reports for venetoclax,gilteritinib,and ivosidenib from the US FDA Adverse Event Reporting System was obtained.The proportional reporting ratio method and reporting odds ratio method were used to detect ADR signals for venetoclax,gilteritinib,and ivosidenib,and the signals were sorted according to their occurrence frequency and signal strength,respectively.RESULTS A total of 14193 ADR reports were collected for venetoclax with 219 ADR signals;1885 ADR reports were collected for gilteritinib with 125 ADR signals;and 699 ADR reports were collected for ivosidenib with 41 ADR signals.Based on the basic information of the ADR reports,the patient population for all three drugs had a higher male-to-female ratio,and the age distribution of the patients was concentrated mainly between 60 and 74 years old.The most frequent ADRs for venetoclax,gilteritinib,and ivosidenib were"death""decreased platelet count"and"fatigue"respectively.The ADRs with the highest signal strength were"FLT3 gene mutation""increased blast cell count"and"differentiation syndrome"respectively.The top 20 ADR signals for the three drugs involved a total of 10 system organs,including various tests,blood and lymphatic system diseases,infectious and infectious diseases,etc.For venetoclax and gilteritinib,the system organ with the highest proportion of the top 20 ADRs by frequency was"blood and lymphatic system diseases".For ivosidenib,the system organ with the highest proportion of the top 20 ADRs by frequency was"various tests".CONCLUSION It is recommended that clinical attention should be paid to ADRs such as atrial fibrillation caused by venetoclax and sepsis caused by gilteritinib.
作者
郑园
李云
闫晨
李彬
李正翔
袁恒杰
ZHENG Yuan;LI Yun;YAN Chen;LI Bin;LI Zhengxiang;YUAN Hengjie(Department of Pharmacy,Tianjin Medical University General Hospital,Tianjin 300052,China)
出处
《中国现代应用药学》
北大核心
2025年第3期437-444,共8页
Chinese Journal of Modern Applied Pharmacy
基金
天津市卫生健康委员会科技项目(JWJ2022QN010)。
