目的 基于美國(guó)食品藥品管理局（FDA）不良事件報(bào)告系統(tǒng)（FAERS）挖掘福他替尼的藥品不良事件信號(hào)，為臨床用藥提供依據(jù)。方法 收集FAERS中福他替尼2018年第2季度—2024年第4季度的數(shù)據(jù)，采用報(bào)告比值比（ROR）法、比例報(bào)告比值法（PRR）、貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)（BCPNN）法和多項(xiàng)經(jīng)驗(yàn)貝葉斯伽馬泊松分布縮減法（MGPS）進(jìn)行信號(hào)挖掘，分析其不良事件發(fā)生情況。結(jié)果 共得到報(bào)告5 083份，上報(bào)年份以2024年為主，上報(bào)國(guó)家以美國(guó)為主。不良事件信號(hào)64個(gè)，累及15個(gè)系統(tǒng)器官分類（SOC）。累及的SOC主要包括各類檢查，其次為各類損傷、中毒及操作并發(fā)癥，胃腸系統(tǒng)疾病，各種手術(shù)及操作等；報(bào)告數(shù)較多的不良事件信號(hào)包括腹瀉、血小板計(jì)數(shù)異常、血壓升高等。結(jié)論 福他替尼在用藥過(guò)程中發(fā)生的常見不良反應(yīng)與說(shuō)明書有較高一致性，臨床用藥時(shí)需警惕不良反應(yīng)發(fā)生。

Objective To mine the adverse drug event signals of fostamatinib based on the FAERS, to provide a basis for clinical drug use. Methods The data of blinatumomab in FAERS from the second quarter of 2018 to the fourth quarter of 2024 were collected, and the signal mining was performed by using the reported odds ratio (ROR) method, proportional reporting ratio (PRR) method, bayesian confidence interval progressive neural network (BCPNN) method, and multi-item gamma poisson shrinker (MGPS) method to analyze the occurrence of adverse drug event. Results A total of 5 083 reports were obtained, with 2024 as the main reporting year and the United States as the main reporting country. There were 64 adverse drug event signals, involving 15 system organ classifications (SOC). The SOC involved mainly included various examinations, followed by various injuries, poisoning, and operational complications, gastrointestinal diseases, various surgeries and operations, etc. Adverse drug event signals with a high number of reports included diarrhea, abnormal platelet count and elevated blood pressure. Conclusion The common adverse reactions that occur during the use of fostamatinib are highly consistent with the instructions, and caution should be exercised when using it clinically.

R973