目的 基于美国食品药品管理局（FDA）不良事件报告系统（FAERS）分析肿瘤坏死因子-α（TNF-α）抑制剂甲状腺相关不良事件的风险信号，为临床安全用药提供参考。方法 利用Open Vigil 2.1工具从FAERS系统收集阿达木单抗、戈利木单抗、培塞利珠单抗、英夫利昔单抗、依那西普5种TNF-α抑制剂不良事件报告，采用报告比值比（ROR）法和比例报告比值比（PRR）法进行信号挖掘。结果 共检索到5种TNF-α抑制剂与13种甲状腺相关不良事件存在统计学关联，其中甲状腺肿块（阿达木单抗）报告数量最多、甲状腺癌症（英夫利昔单抗）风险信号最高；且5种药品均涉及各种内分泌良性肿瘤；4种药品涉及甲状腺类疾病、内分泌恶性及性质不明的肿瘤。结论 TNF-α抑制剂与甲状腺不良事件的风险存在一定关联，建议在长期治疗患者随访中关注甲状腺形态变化，并结合临床风险评估决定是否进行影像学检查，以保障患者的用药安全。

Objective To analyze the risk signals of thyroid-related adverse events associated with tumor necrosis factor-α (TNF-α) inhibitors based on the FAERS, and provide references for safe clinical medication. Methods Adverse event reports of five TNF-α inhibitors, including adalimumab, golimumab, certolizumab pegol, infliximab and etanercept, were collected from the FAERS system by using the Open Vigil 2.1 tool. Signal mining was conducted by using ROR method and PRR method. Results A total of 13 thyroid-related adverse events were statistically associated with the five TNF-α inhibitors. Thyroid mass (adalimumab) were reported the most frequently, and the risk signal for thyroid gland cancer (infliximab) was the highest. Five drugs were identified as showing positive signals for benign neoplasm of thyroid gland. Four drugs involved thyroid gland disorders and endocrine neoplasms malignant and unspecified. Conclusion There is a certain correlation between TNF-α inhibitors and the risk of thyroid adverse events. It is recommended to pay attention to the changes in thyroid morphology during the long-term follow-up of patients, and combine clinical risk assessment to decide whether to conduct imaging examinations, in order to ensure the safety of drug use for patients.

R982

安徽省卫生健康科研项目（ AHWJ2023BAc10009）