| 引用本文: | 郑园,李云,闫晨,李彬,李正翔,袁恒杰.基于美国FAERS数据库的3个AML靶向治疗药物不良反应信号挖掘[J].中国现代应用药学,2025,42(3):107-114. |
| ZHENG Yuan,LI Yun,Yan Chen,LI Bin,LI Zheng-xiang,YUAN Heng-jie.Data mining of adverse drug reaction signals for 3 AML targeted therapy drugs based on FAERS database[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(3):107-114. |
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| 摘要: |
| 目的 挖掘和评价国内上市的3个急性髓系白血病(AML)靶向治疗药物上市后不良反应信号,以期指导临床合理用药。方法 利用OpenVigil数据平台从美国FDA不良事件报告系统(FAERS)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(ADR)报告。采用比例报告比(PRR)和报告比值比(ROR)方法检测维奈克拉、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14 193份,ADR信号219个；吉瑞替尼ADR报告1 885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,三个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岁区间。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。 |
| 关键词: 急性髓系白血病 不良反应信号 维奈克拉 吉非替尼 艾伏尼布 |
| DOI： |
| 分类号:R985 |
| 基金项目:天津市卫生健康委员会科技项目(JWJ2022QN010) |
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| Data mining of adverse drug reaction signals for 3 AML targeted therapy drugs based on FAERS database |
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ZHENG Yuan, LI Yun, Yan Chen, LI Bin, LI Zheng-xiang, YUAN Heng-jie
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Tianjin Medical University General Hospital
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| Abstract: |
| ABSTRACT: OBJECTIVE To excavate and evaluate the adverse reaction signals of 3 kinds of imported molecular targeted drugs of acute myeloid leukemia, and to guide rational drug use in clinic. METHODS Using OpenVigil and FDA adverse drug event reporting system (FAERS) database to obtain the adverse event reports of venetoclax, gilteritinib, ivosidenib from being approved by FDA to the Sep. 30th, 2022. The ADR signals were detected by frequency method and sorted according to the occurrence frequency and signal strength respectively. RESULTS As the primary suspected drug, 14 193 reports of adverse events and 269 signals of ADR of venetoclax were collected. With the same, 1885 reports and 132 signals of ADR of gilteritinib were collected. And 699 reports and 55 signals of ADR of ivosidenib were collected. Generally speaking, the gender distribution was more males than females, and the age distribution was mainly in the range of 60-74 years old. According to the occurrence frequency, the most frequent ADRs of venetoclax, gilteritinib and ivosidenib were “death”, “platelet count decreased”, “fatigue”, respectively. According to the signal strength, the strongest ADRs signal of venetoclax, gilteritinib and ivosidenib were “fLT3 gene mutation”, “myeloblast count increased”, “differentiation syndrome”, respectively. The top 20 frequent ADRs of all three drugs involved 10 system organs, mainly focused on “Blood and lymphatic system disorders”, “investigations” and “infections and infestations” etc. CONCLUSION It is suggested that attention should be paid not only to the most common ADRs of blood and lymphatic system caused by these three drugs, but also to the ADRs not reported in the drug instructions such as atrial fibrillation of venetoclax and sepsis of gilteritinib. |
| Key words: acute myeloid leukemia adverse reaction signals venetoclax gilteritinib ivosidenib |
