目的 对蔗糖羟基氧化铁咀嚼片相关不良事件风险信号进行挖掘分析，为临床合理使用提供参考。方法 从FAERS数据库中提取2013年第4季度—2026年第1季度的蔗糖羟基氧化铁咀嚼片相关不良事件数据。采用比例失衡法挖掘风险信号，使用监管活动医学词典（MedDRA）28.1中的首选系统器官（SOC）和首选术语（PT）对不良事件信号进行分类和描述，并对其发生时间进行分析。结果 共得到以蔗糖羟基氧化铁咀嚼片为首要怀疑药物的不良事件报告2 316份，分布于26个SOC。最终筛选出42个阳性风险信号，其中12个为严重信号，18个为新信号。常见信号如腹泻、便秘等已在药品说明书中列出，而未收录的严重信号包括死亡、胃肠出血、心脏停搏等，需引起警惕。蔗糖羟基氧化铁咀嚼片不良事件的中位发生时间为74 d（IQR 24～203 d），韦伯分布检验结果表明其为早期失败型曲线。结论 临床医务人员不仅应关注药品说明书中已记录的不良事件，还应警惕未收录严重的如胃肠出血、心脏停搏等不良事件，确保患者用药安全。

Objective To identify and analyze the adverse drug event risk signals related to Sucroferric Oxyhydroxide Chewable Tablets, and provide a reference for its rational clinical use. Methods Adverse drug events data related to Sucroferric Oxyhydroxide Chewable Tablets from FAERS database, spanning from the fourth quarter of 2013 to the first quarter of 2026, were extracted. Disproportionality measurement was used to mine the risk signals, and the SOC and PT in the MedDRA 28.1 were used to classify and describe adverse drug events signals, and the time to onset was analyzed. Results A total of 2 316 adverse drug events reports with Sucroferric Oxyhydroxide Chewable Tablets as the primary suspected drug were identified, covering 26 SOCs. Forty-two positive risk signals were eventually selected, including 12 serious signals and 18 noval signals. Common signals, such as diarrhea and constipation, are already listed in the drug label, while serious signals not included in the label, such as death, gastrointestinal bleeding, and cardiac arrest, warrant attention. The median time to adverse drug events occurrence was 74 days (interquartile range 24—203 days), and the Weibull distribution test indicated an early failure-type curve. Conclusion Clinical healthcare professionals should not only pay close attention to the adverse drug events listed on the drug label, but also maintain a state of constant vigilance regarding serious adverse drug events, such as gastrointestinal bleeding and cardiac arrest, and ensure the safe utilisation of medications.

R973

云南省医疗机构药师协会科研专项基金项目（2024YSXH06）；昆明市卫生科技人才培养“千工程”项目（2023-SW（后备）-84）；南通市科技计划指导性项目（MSZ2024054）；南通大学临床医学专项科研基金项目（2024LZ025）；2024年度南通市药学会一常州四药医院药学科研基金项目（ntxy2048）