| 引用本文: | 薛淑一,尹桂森,崔晓,张艳华,张关敏.基于OpenFDA对3种BTK抑制剂的不良事件信号分析[J].中国现代应用药学,2023,40(12):1630-1636. |
| XUE Shuyi,YIN Guisen,CUI Xiao,ZHANG Yanhua,ZHANG Guanmin.Adverse Event Signal Analysis of Three BTK Inhibitors Based on OpenFDA[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(12):1630-1636. |
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| 基于OpenFDA对3种BTK抑制剂的不良事件信号分析 |
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薛淑一1,2, 尹桂森1,3, 崔晓2, 张艳华1, 张关敏1
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1.北京大学肿瘤医院暨北京市肿瘤防治研究所药剂科, 恶性肿瘤发病机制及转化研究教育部重点实验室, 北京 100142;2.青岛大学附属青岛市中心医院, 青岛市肿瘤医院药学部, 山东 青岛 266042;3.烟台市中医医院药学部, 山东 烟台 264001
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| 摘要: |
| 目的 通过对伊布替尼、阿卡替尼和泽布替尼3种布鲁顿酪氨酸激酶(Bruton’s tyrosine kinase，BTK)抑制剂不良事件风险信号挖掘分析，为临床安全用药提供参考。方法 基于美国食品药品监督管理局公共数据开放项目(OpenFDA)，对3种BTK抑制剂2004年1月1日—2021年9月30日的不良事件上报数据进行检索。结果 FDA收到的伊布替尼、阿卡替尼和泽布替尼不良事件各为49 006，2 056，246份。采用比例失衡法检测，具有统计学意义的不良事件信号共计769个，主要集中于感染及侵染类、血液及淋巴系统、心脏器官疾病、皮肤及皮下组织类、血管与淋巴管类等，也挖掘到一些新的不良事件，如败血症、肺出血、指甲疾病、脆甲症、味觉障碍等。伊布替尼不良事件风险信号最多，三者各不良事件风险信号相关性有所区别。结论 利用OpenFDA数据库对3种BTK抑制剂多维度挖掘分析，提示临床医师在临床使用过程中警惕药物不良事件风险，及时对症处理，促进合理用药。 |
| 关键词: BTK抑制剂 OpenFDA 不良反应信号挖掘 报告比值比法 比例报告比值法 |
| DOI：10.13748/j.cnki.issn1007-7693.20223928 |
| 分类号:R969.3 |
| 基金项目:山东省第一批药品临床综合评价项目(2021YZ014)；青岛市医疗卫生临床重点专科建设项目(青卫政字[2022]6号) |
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| Adverse Event Signal Analysis of Three BTK Inhibitors Based on OpenFDA |
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XUE Shuyi1,2, YIN Guisen1,3, CUI Xiao2, ZHANG Yanhua1, ZHANG Guanmin1
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1.Department of Pharmacy, Peking University Cancer Hospital & Institute, Key laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing), Beijing 100142, China;2.Department of Pharmacy, Affiliated Qingdao Central Hospital of Qingdao University, Qingdao Cancer Hospital, Qingdao 266042, China;3.Department of Pharmacy, Yantai Hospital of Traditional Chinese Medicine, Yantai 264001, China
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| Abstract: |
| OBJECTIVE To provide reference for clinical safe drug use by mining and analyzing the risk signals of adverse events of three Bruton’s tyrosine kinase(BKT) inhibitors, ibrutinib, acalabrutinib and zanubrutinib. METHODS Based on the Public Data Open Project of the US Food and Drug Administration(OpenFDA), adverse event reporting data for three BTK inhibitors from January 1, 2004 to September 30, 2021 were retrieved. RESULTS According to the FDA, 49 006, 2 056 and 246 adverse events had been reported in relation to ibrutinib, acalabrutinib, and zanubrutinib, respectively. Using the proportional imbalance method for detection, there were a total of 769 adverse event signals with statistical significance, which were mainly focused on infection, blood and lymphatic system, heart diseases, skin and subcutaneous tissue, vascular and lymphatic vessel vessels, etc. In addition, new adverse events were observed, such as sepsis, pulmonary hemorrhage, nail disorder, brittle nails, taste disorder, etc. Compared to acalabrutinib and zanubrutinib, ibrutinib had the most adverse event risk signals, and the correlations of adverse event risk signals among them were diverse. CONCLUSION By conducting a multi-dimensional mining analysis of the three BTK inhibitors using the OpenFDA database, the study prompts clinical physicians to be alert to the risk of adverse drug events during clinical use, timely diagnose and treat corresponding symptoms, so as to promote rational drug use. |
| Key words: BTK inhibitors OpenFDA adverse reaction signal mining reporting odds ratio proportional reporting ratio |
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