目的 基于美国食品药品管理局不良事件报告系统（FAERS），挖掘与分析克立硼罗的药物不良事件信号，为临床安全合理用药提供参考。方法 收集FAERS数据库中克立硼罗2016年第4季度—2026年第1季度的不良事件报告。采用比例失衡法中的报告比值比（ROR）法和比例报告比（PRR）法进行信息挖掘。结果 共检索到克立硼罗为首要怀疑药物的不良事件报告7 242例，经筛选后获得105个不良事件信号，主要累及10个器官系统分类（SOC），主要集中在皮肤及皮下组织类疾病、全身性疾病及给药各部位各种反应等方面。结论 除说明书提示常见不良事件外，建议临床用药期间关注外用药部位疼痛、病情恶化、超敏反应、接触性荨麻疹等不良反应信号，以减少用药风险。

Objective To explore and analyzed the drug adverse event signals of crisaborole based on the FAERS, providing a reference for safe and rational clinical drug use. Methods The event data of crisaborole from the fourth quarter of 2016 to the first quarter of 2026 were retrieved from FAERS. The ROR and PRR in the proportional imbalance method were used for signal mining. Results A total of 7 242 adverse drug event reports with crisaborole as the primary suspected drug were retrieved. After screening, 105 adverse drug event signals were obtained, mainly accumulating in 10 SOC systems, primarily focusing on skin and subcutaneous tissue diseases, systemic diseases, and various reactions at different drug administration sites. Conclusion In addition to the common adverse events indicated in the instructions, it is recommended to pay attention to adverse reaction signals such as application site pain, deterioration of the condition, hypersensitivity reactions, and contact urticaria during clinical medication.

R986

广西壮族自治区卫生健康委员会自筹经费科研课题（Z-A20231163）