目的 基于美國(guó)食品藥品監(jiān)督管理局（FDA）不良反應(yīng)事件報(bào)告系統(tǒng)（FDA adverse event reporting system, FAERS）對(duì)厄達(dá)替尼得相關(guān)不良反應(yīng)事件進(jìn)行數(shù)據(jù)挖掘，為厄達(dá)替尼的臨床應(yīng)用提供參考依據(jù)。方法 挖掘FAERS數(shù)據(jù)庫(kù)2019年第2季度—2022年第2季度的厄達(dá)替尼的藥品不良事件數(shù)據(jù)，并采用報(bào)告比值法（ROR）和比例報(bào)告比值法（PRR）對(duì)挖掘的數(shù)據(jù)進(jìn)行分析。結(jié)果 共收集到以厄達(dá)替尼為首要懷疑藥物的不良時(shí)間報(bào)告593例。其中男性所占比例（50.08%）高于女性所占比例（35.08%）。年齡多集中在46～80歲。上報(bào)國(guó)家以美國(guó)為主（77.07%）。將無(wú)效信號(hào)排除后，共得到藥品不良事件信號(hào)71個(gè)，依據(jù)MedDRA對(duì)該71個(gè)信號(hào)的首選術(shù)語(yǔ)（PT）進(jìn)行分類，共涉及到16個(gè)系統(tǒng)器官分類（SOC），排名前5位的依次是全身性疾病及給藥部位各種反應(yīng)、皮膚及皮下組織類疾病、胃腸紊亂疾病、社會(huì)環(huán)境及感染及侵染類疾病。結(jié)論 厄達(dá)替尼常見(jiàn)的藥品不良事件與說(shuō)明書(shū)記載的無(wú)較大差異，具有一致性，但涉及到的SOC分類與說(shuō)明書(shū)具有一定的差異性，可為臨床安全用藥提供參考。

Objective To conduct data mining of adverse events related to erdafitinib based on the FDA adverse event reporting system (FAERS), so as to provide reference for future clinical application of erdafitinib. Methods Adverse drug event data of erdafitinib in FAERS database from second quarter of 2019 to 2022 were mined, and the mined data were analyzed by ROR and PRR methods. Results A total of 593 cases of adverse time reports with erdafitinib as the primary suspected drug were collected. The proportion of males (50.08%) was higher than that of females (35.08%). Most of them are 46 — 80 years old. The United States was the main reporting country (77.07%). After excluding invalid signals, a total of 71 adverse drug event signals were obtained, which were classified according to MedDRA’s preferred term (PT), involving 16 SOC. The top 5 were systemic diseases and reactions at the site of administration, skin and subcutaneous tissue diseases, gastrointestinal disorders, social environment, and infections and infections. Conclusion The common adverse drug event signals of erdafitinib are not significantly different from those recorded in the instructions and are consistent, but the SOC classification involved is somewhat different from the instructions, which can provide a reference for safe clinical use.

R979.1