基于FAERS的芦可替尼药品不良事件信号挖掘  

Signal Mining of Ruxolitinib-Related Adverse Drug Events Based on the FAERS

作　　者：吕楠 冯柯臻 岳宝森 崔玮 LYU Nan;FENG Kezhen;YUE Baosen;CUI Wei(Xi′an Hospital of Traditional Chinese Medicine,Xi′an,Shaanxi,China 710021;Shaanxi Second Provincial People′s Hospital,Xi′an,Shaanxi,China 710068)

机构地区：[1]陕西省西安市中医医院,陕西西安710021 [2]陕西省第二人民医院,陕西西安710068

出　　处：《中国药业》2024年第15期113-118,共6页China Pharmaceuticals

基　　金：陕西省公共卫生发展补助项目[陕中医药发[2021]2号]。

摘　　要：目的 为临床合理、安全使用芦可替尼提供参考。方法 检索美国食品和药物管理局不良事件报告系统(FAERS)2011年11月16日至2022年12月31日以芦可替尼为首要怀疑药物的药品不良事件(ADE)报告,联用报告比值比(ROR)法及贝叶斯置信区间递进神经网络(BCPNN)法挖掘其ADE信号。结果 共筛选出芦可替尼相关ADE报告13 885份,男女比例为1.24∶1,上报国家/地区以北美洲报告数量最多(68.78%)。共挖掘到195个ADE风险信号,涉及14个系统器官分类(SOC),主要包括各类检查(53个)、血液及淋巴系统疾病(45个)、感染及侵染类疾病(24个)等,主要表现为贫血(1486次)、血红蛋白降低(1330次)、血小板计数降低(1 312次)等。共挖掘到30个感染信号及20个肿瘤相关ADE风险信号,发生频次排名前3的感染信号为带状疱疹(288次)、结核病(127次)、疱疹病毒感染(26次),发生频次排名前3的肿瘤信号为第2种原发恶性肿瘤(298次)、皮肤癌(246次)、鳞状细胞癌(150次),在药品说明书中均已提及。结论 挖掘到的芦可替尼ADE信号、涉及SOC与药品说明书基本一致。临床使用芦可替尼前应做好患者感染、皮肤癌、淋巴瘤的风险评估及用药教育与指导工作,治疗过程中应密切监测血液系统、感染及肿瘤相关指标,通过调整药量、中断治疗避免发生严重ADE,保障临床用药安全。Objective To provide a reference for the rational and safe use of ruxolitinib in the clinic.Methods Adverse drug event(ADE) reports with Ruxolitinib as the primary suspected drug from November 16,2011 to December 31,2022 in the Food and Drug Administration Adverse Event Reporting System(FAERS) were retrieved,and the ADE signals were mined by the reported odds ratio(ROR) method and Bayesian confidence propagation neural network(BCPNN) method.Results A total of Ruxolitinib-related 13885 ADE reports were screened,with a male-to-female ratio of 1.24∶1.North America(68.78%) was the region with the highest number of ADE reports.A total of 195 ADE risk signals were identified,involving 14 system organ classificantion(SOC),mainly including various examinations(53 signals),blood and lymphatic system diseases(45 signals),infections and infectious diseases(24 signals),etc,and the main manifestations were anemia(1486 times),lower hemoglobin(1330 times),and lower platelet count(1312 times).A total of 30 infection-related signals and 20 tumor-related ADE risk signals were obtained.The top three infection signals in terms of frequency were herpes zoster(288 times),tuberculosis(127 times),and herpesvirus infection(26 times).The top three tumor signals in terms of frequency were the second primary malignant tumor(298 times),skin cancer(246 times),and squamous cell carcinoma(150 times),which were listed in the drug instructions.Conclusion The mined ruxolitinib-related ADE signals and the involved SOC are basically consistent with the drug instructions.The risk assessment of infection,skin cancer and lymphomas,as well as medication education and guidance for patients should be done before use of ruxolitinib in the clinic.During the treatment,hematologic,infection,and tumor-related indicators should be closely monitored.Measures such as adjusting the dosage and interrupting treatment should be taken to avoid the occurrence of serious ADE and to ensure the medication safety of patients.

关 键 词：芦可替尼 美国食品和药物管理局不良事件报告系统 药品不良事件 信号挖掘 报告比值比法 贝叶斯置信区间递进神经网络法 

分 类 号：R95[医药卫生—药学] R979.1