目的 挖掘侖卡奈單抗的藥品不良事件信號(hào)，為合理用藥提供參考。方法 通過(guò)美國(guó)食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)（FAERS）和世界衛(wèi)生組織藥品不良反應(yīng)報(bào)告數(shù)據(jù)庫(kù)（WHO-VigiAccess）收集2023年第1季度—2024年第4季度的侖卡奈單抗相關(guān)不良事件報(bào)告，利用比例失衡法中的報(bào)告比值比（ROR）法和比例報(bào)告比值（PRR）法進(jìn)行數(shù)據(jù)統(tǒng)計(jì)并分析。結(jié)果 在FAERS數(shù)據(jù)庫(kù)和WHO-VigiAccess數(shù)據(jù)庫(kù)分別涉及25、23種系統(tǒng)器官分類（SOC），主要為各類神經(jīng)系統(tǒng)疾病、全身性疾病及給藥部位各種反應(yīng)、精神病類。在FAERS數(shù)據(jù)庫(kù)中，報(bào)告例數(shù)排名靠前的不良事件信號(hào)涉及頭痛、淀粉樣蛋白相關(guān)性影像異常水腫/滲出型、淀粉樣蛋白相關(guān)性影像異常微出血和血鐵質(zhì)沉積型、寒戰(zhàn)和疲勞；而WHO-VigiAccess數(shù)據(jù)庫(kù)則為頭痛、寒戰(zhàn)、疲勞、淀粉樣蛋白相關(guān)性影像異常水腫/滲出型和輸液相關(guān)反應(yīng)。2個(gè)數(shù)據(jù)庫(kù)中信號(hào)強(qiáng)度排名靠前的不良事件信號(hào)均涉及淀粉樣蛋白相關(guān)性影像異常、淀粉樣蛋白相關(guān)性影像異常微出血和血鐵質(zhì)沉積型、淀粉樣蛋白相關(guān)性影像異常水腫/滲出型、中樞神經(jīng)系統(tǒng)表面鐵沉積癥和大腦微出血等首選術(shù)語(yǔ)。FAERS數(shù)據(jù)庫(kù)顯示，大多數(shù)病例發(fā)生不良事件是在給藥第1個(gè)月內(nèi)。結(jié)論 在使用侖卡奈單抗時(shí)，應(yīng)重點(diǎn)關(guān)注老年女性和長(zhǎng)期用藥患者，并要警惕感染、缺血性卒中等罕見(jiàn)的不良事件。同時(shí)也應(yīng)加強(qiáng)臨床用藥監(jiān)護(hù)，降低不良事件對(duì)患者預(yù)后以及生活質(zhì)量的影響。

Objective To provide reference for rational drug use through mining adverse drug event signals associated of lecanemab. Methods To collect adverse drug event reports of lecanemab from Q1 2023 to Q4 2024 in FAERS and WHO-VigiAccess databases. Data mining was performed using ROR and PRR methods in the proportional imbalance method. Results The FAERS database and WHO-VigiAccess database involved 25 and 23 SOC, respectively, mainly for various neurological diseases, systemic diseases, reactions at the drug administration site, and psychosis. In the FAERS database, the adverse drug event signals with the highest number of reported cases were related to headache, amyloid-associated imaging abnormality oedema/exudative type, amyloid-associated imaging abnormality microhaemorrhagic and haemoferritic type, chills, and fatigue, while in the WHO-VigiAccess database, they were headache, chills, fatigue, amyloid-associated imaging abnormality oedema/exudative type, and infusion-associated reactions. The top-ranked adverse drug event signals in both databases in terms of signal intensity were related to the preferred terms of amyloid-associated imaging abnormality, amyloid-associated imaging abnormality microhaemorrhagic and haemoferritic type, amyloid-associated imaging abnormality oedema/exudative type, central nervous system surface iron deposition disorders, and microhaemorrhages in the brain. The FAERS database showed that the occurrence of adverse drug event in most of the cases occurred within the first month of administration. Conclsion When using lencanumab, focus should be placed on elderly women and patients on long-term use of the drug, and be vigilant for rare adverse drug events such as infections, ischaemic stroke, etc. Clinical monitoring of the use of the drug should also be strengthened to reduce the impact of the adverse drug event on the patient’s prognosis as well as quality of life.

R971

山東省自然科學(xué)基金聯(lián)合基金資助項(xiàng)目（ZR2022LSW016）；濰坊市衛(wèi)生健康委員會(huì)科研項(xiàng)目（WFWSJK-2024-072）