目的 探讨瑞司美替罗上市后不良事件的发生特征及潜在风险信号，为临床安全用药及风险管理提供参考。方法 提取美国食品药品管理局不良事件报告系统（FAERS）数据库2024年第1季度—2026年第2季度的瑞司美替罗相关不良事件报告，并以同期FAERS全库报告数据作为不成比例分析的背景数据集。采用报告比值比（ROR）、比例报告比值（PRR）、贝叶斯置信传播神经网络（BCPNN）和经验贝叶斯几何均数（EBGM）4种不成比例分析方法挖掘瑞司美替罗相关不良事件风险信号，从系统器官分类（SOC）和首选术语（PT）层面分析其分布特征；同时对不良事件诱发时间进行性分析。结果 共获得瑞司美替罗相关FAERS报告1 728份。SOC分析显示，胃肠系统疾病相关不良事件频数最多，为1 100例（38.43%），其次为各类检查681例（23.79%）、肝胆系统疾病390例（13.63%）和皮肤及皮下组织类疾病294例（10.27%）。PT层面，不良事件频数居前的主要为腹泻、恶心、瘙痒、丙氨酸氨基转移酶升高、天门冬氨酸氨基转移酶升高等。信号强度分析显示，肝纤维化标志物增加、代谢功能障碍相关脂肪性肝病及疑似药物性肝损伤等具有较强报告信号；眼黄疸、皮肤黄染、肝硬化、肝纤维化、肝痛及甲状腺相关指标异常亦表现出较强报告关联。在172份具有完整治疗开始时间及不良事件发生时间信息的报告中，0～30 d发生者占57.56%。结论 临床应用瑞司美替罗过程中应加强治疗初期胃肠道症状、肝功能及皮肤表现的监测，并结合患者具体情况关注甲状腺功能变化。

Objective To investigate the characteristics and potential risk signals of adverse drug events associated with resmetirom after marketing, and to provide evidence for clinical medication safety and risk management. Methods Adverse event reports associated with resmetirom were extracted from the FAERS database from the first quarter of 2024 to the second quarter of 2026. All FAERS reports from the same period were used as the background dataset for disproportionality analysis. Four disproportionality analysis methods, including ROR, PRR, BCPNN, and EBGM were applied to identify potential adverse drug event signals associated with resmetirom. The distribution of adverse drug events was analyzed at the SOC and PT levels, and the time to onset of adverse drug events was descriptively analyzed. Results A total of 1 728 FAERS reports associated with resmetirom were identified. At the SOC level, gastrointestinal disorders had the highest frequency of reported adverse events, with 1 100 events (38.43%), followed by investigations (681, 23.79%), hepatobiliary disorders (390, 13.63%), and skin and subcutaneous tissue disorders (294, 10.27%). At the PT level, the most frequently reported adverse events were diarrhea, nausea, pruritus, alanine aminotransferase increased, and aspartate aminotransferase increased. Signal strength analysis identified strong reporting signals for increased liver fibrosis markers, metabolic dysfunction-associated steatotic liver disease, and suspected drug-induced liver injury. Ocular icterus, skin discoloration yellow, liver cirrhosis, liver fibrosis, liver pain, and thyroid-related laboratory abnormalities also showed strong reporting associations. Among the 172 reports with complete treatment initiation and adverse event onset dates, adverse drug events most commonly occurred within 0 to 30 days after treatment initiation, accounting for 57.56%. Conclusion During the clinical application of resmetirom, it is necessary to strengthen the monitoring of gastrointestinal symptoms, liver function and skin manifestations in the early stage of treatment, and pay attention to changes in thyroid function based on the specific conditions of the patients.

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