目的 基于美國食品藥品管理局（FDA）不良事件報告系統(tǒng)（FAERS）分析艾拉司群的藥品不良事件信號，為臨床安全用藥提供依據(jù)。方法 收集FAERS數(shù)據(jù)庫中2023年第1季度至2024年第4季度的報告數(shù)據(jù)，篩選以艾拉司群為首要懷疑藥物的報告。采用報告比值比進行不良事件信號分析。結(jié)果 共獲取艾拉司群為首要懷疑藥物的不良事件報告病例數(shù)6 635份，涉及17 744例次不良事件。共挖掘信號120個，涉及14個系統(tǒng)器官分類。報告例次數(shù)排名前5位的信號為惡心、疲勞、嘔吐、腹瀉和便秘。信號強度前5名的信號為食道灼傷、食道刺激、骨折疼痛、骨痛和腋窩腫塊。發(fā)現(xiàn)新的不良事件如背痛、血鈣升高、毛發(fā)生長異常等。艾拉司群為引起的藥品不良事件發(fā)生時間中位數(shù)為44.5 d，42.06%的病例發(fā)生在治療的第1個月內(nèi)。結(jié)論 醫(yī)務(wù)人員使用艾拉司群治療時，應(yīng)重點關(guān)注胃腸系統(tǒng)疾病和各種肌肉骨骼及結(jié)締組織疾病等方面。還需警惕新的不良反應(yīng)事件，保障患者安全用藥。

Objective To analyze the adverse drug event signals of elacestrant based on the FAERS, to provide a basis for safe clinical use of the drug. Methods To collect reported data from the first quarter of 2023 to the fourth quarter of 2024 by FAERS database, screen reports with elacestrant as the first suspected drug, and perform adverse event signaling analysis by using the ratio of reports to ratios. Results A total of 6 635 reported cases of adverse events with elacestrant as the first suspected drug were obtained, involving 17 744 adverse events. A total of 120 signals were mined, involving 14 system-organ classifications. The top 5 signals in terms of number of reported cases were nausea, fatigue, vomiting, diarrhea, and constipation. The top 5 signals in terms of signal strength were esophageal burning, esophageal irritation, fracture pain, bone pain and axillary mass. New adverse events such as back pain, elevated blood calcium, and abnormal hair growth were identified. The median duration of adverse drug events caused by elacestrant as was 44.5 d, with 42.06% of cases occurring within the first month of treatment. Conclusions Medical personnel should pay attention to gastrointestinal diseases and various musculoskeletal and connective tissue diseases when using elacestrant treatment. It is also necessary to be alert to new adverse events to ensure patient safety.

R979.1

南通市衛(wèi)生健康委員會科研課題（MSZ2023016）