目的 基于美國(guó)食品藥品管理局不良事件報(bào)告系統(tǒng)（FAERS）分析呋喹替尼不良事件，為臨床安全用藥提供參考。方法 收集FAERS數(shù)據(jù)庫(kù)中2018年第1季度—2025年第1季度數(shù)據(jù)，篩選呋喹替尼為首要懷疑藥物的不良事件報(bào)告，使用報(bào)告比值比法（ROR）分析不良事件。結(jié)果 共獲取呋喹替尼為首要懷疑藥物的不良事件報(bào)告病例1 632份，適應(yīng)證結(jié)直腸癌（42.8%）最多，涉及3 073例不良事件，陽(yáng)性首選術(shù)語(yǔ)（PT）101個(gè)，涉及16個(gè)系統(tǒng)器官分類(lèi)。高發(fā)不良事件包括血壓升高、發(fā)聲困難、骨髓抑制等，與說(shuō)明書(shū)所收載不良事件一致。新的不良事件如便秘、周?chē)窠?jīng)病、脫水、腎局限性血栓性微血管病等。呋喹替尼引起藥品不良事件發(fā)生時(shí)間中位數(shù)為14 d，65.8%的不良事件發(fā)生在用藥前30天內(nèi)。結(jié)論 使用呋喹替尼應(yīng)重點(diǎn)關(guān)注胃腸、血液及皮膚等方面不良反應(yīng)，還需警惕新的不良反應(yīng)。

Objective To analyze adverse events of fruquintinib based on FAERS, to provide a reference for safe clinical medication. Methods Data from the first quarter of 2018 to the first quarter of 2025 in the FAERS database were collected. Adverse event reports of fruquintinib as the primary suspected drug were screened, and adverse events were analyzed using the report odds ratio (ROR) method. Results A total of 1 632 adverse event reports with fruquintinib as the primary suspected drug were obtained. Colorectal cancer (42.8%) was the most common indication, involving 3 073 adverse events and 101 positive PTs, covering 16 system and organ classifications. High-incidence adverse events include elevated blood pressure, difficulty in speaking, bone marrow suppression, etc., which are consistent with the adverse events recorded in the instructions. New adverse events such as constipation, peripheral neuropathy, dehydration, and localized thrombotic microangiopathy of the kidney, etc. The median occurrence time of adverse drug events caused by fruquintinib was 14 days, and 65.8% of the adverse events occurred within 30 days before medication. Conclusion When using fruquintinib, special attention should be paid to adverse reactions in the gastrointestinal tract, blood and skin, and new adverse reactions should also be vigilant.

R979.1

國(guó)家自然科學(xué)基金青年基金資助項(xiàng)目（82404600）；揚(yáng)州大學(xué)附屬醫(yī)院高層次人才引進(jìn)科研啟動(dòng)項(xiàng)目（2023BS-LJJ）