目的 基于美国食品药品管理局（FDA）不良事件报告系统（FAERS）分析艾拉司群的药品不良事件信号，为临床安全用药提供依据。方法 收集FAERS数据库中2023年第1季度至2024年第4季度的报告数据，筛选以艾拉司群为首要怀疑药物的报告。采用报告比值比进行不良事件信号分析。结果 共获取艾拉司群为首要怀疑药物的不良事件报告病例数6 635份，涉及17 744例次不良事件。共挖掘信号120个，涉及14个系统器官分类。报告例次数排名前5位的信号为恶心、疲劳、呕吐、腹泻和便秘。信号强度前5名的信号为食道灼伤、食道刺激、骨折疼痛、骨痛和腋窝肿块。发现新的不良事件如背痛、血钙升高、毛发生长异常等。艾拉司群为引起的药品不良事件发生时间中位数为44.5 d，42.06%的病例发生在治疗的第1个月内。结论 医务人员使用艾拉司群治疗时，应重点关注胃肠系统疾病和各种肌肉骨骼及结缔组织疾病等方面。还需警惕新的不良反应事件，保障患者安全用药。

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

南通市卫生健康委员会科研课题（MSZ2023016）