OBJECTIVE To use data mining method to detect the adverse event signal of benalizumab after marketing,and to provide clinical reference for drug use.METHODS To conduct data mining and signal detection for benalizuzuma-related ADE reports in the U.S.FDA Adverse Event Reporting System(FAERS)with a reported number of≥3 from Q4 2017 to Q2 2023.RESULTS After data clearing,21 616 ADE reports of US FAERS with benalizumab as the primary suspected drug were obtained,involving a total of 8 020 patients,4 931 female patients(61.48％)and 2 151 male patients(26.82％)were reported.The main reporting country was the United States(71.57％).216 ADE positive signals were found,mainly involving diseases of respiratory system,chest and mediastinum(28.57％),as well as systemic diseases and various reactions at the drug administration site(26.65％),covering a total of 21 different categories of systemic organs.A total of 67 high-risk signals were identified,of which 25 were benalizumab drug labels explicitly mentioned or related adverse drug reactions,and 42(such as asthmatic crises,sputum changes,sleep disorders,etc.)were new high-risk signals.CONCLUSION In clinical use of benalizumab,in addition to paying close attention to the adverse reactions mentioned in the drug instructions such as cough,headache,dyspnea,hypersensitivity,etc.,we should also be alert to the changes in the nature of sputum,sleep disorders,sinus diseases and other potential ADEs to ensure drug safety.
关键词
美国不良事件报告系统/贝那利珠单抗/药品不良事件/信号检测/数据挖掘
Key words
American adverse event reporting system/benalizumab/adverse drug events/signal detection/data mining
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万方数据