目的 利用美国食品药品管理局不良事件呈报系统（FAERS）数据库挖掘替瑞奇珠单抗相关不良事件的风险信号，预警其潜在的不良反应，为替瑞奇珠单抗的临床应用和后续研究提供客观资料。方法 查询和提取FAERS数据库2018年第1季度—2024年第2季度的原始数据，筛选出涉及替瑞奇珠单抗的不良事件报告，并采用比例失衡分析法中的报告比值比（ROR）和比例报告比值比法（PRR）作为信号检测指标，设定相应的阈值条件，对不良事件进行统计分析和系统分类。结果 共检索到替瑞奇珠单抗相关不良事件报告1 599份，男性患者比例稍高于女性（43.0% vs 41.6%），45～64岁患者所占比例较高（14.8%）。共挖掘出57个有效信号，涉及13个系统器官分类（SOCs），其中有51个有效信号，涉及11个SOCs未在替瑞奇珠单抗国内外药品说明书中提及。主要集中的有效信号外阴阴道念珠菌病、上呼吸道分泌物黏度增加、输尿管结石、原位恶性黑素瘤，其次为肥厚性心肌病、巴氏食管、支撑体质量困难、主动脉瓣关闭不全等；主要SOCs包括全身性疾病及给药部位各种反应（277例），感染及侵染类疾病（196例），皮肤及皮下组织类疾病（43例），良性、恶性及性质不明的肿瘤（包括囊状和息肉状）（41例），心脏器官疾病（36例）等。中位不良事件发生时间189 d（IQR：70～426.25），平均值302.69 d。结论 利用挖掘FAERS数据库可较全面深入地分析研究替瑞奇珠单抗上市后的不良事件，为临床安全合理用药提供依据。需要关注不良事件高发的男性患者，发现一些新的不良事件，如外阴阴道念珠菌病、输尿管结石、巴氏食管等，临床应用替瑞奇珠单抗时，应密切关注，保证患者安全有效用药。

Objective To mine adverse drug event risk signals related to tildrakizumab using the FAERS database, and to warn potential adverse reactions of tildrakizumab, providing objective data for clinical application and subsequent research. Methods The original data of FAERS database from the first quarter of 2018 to the second quarter of 2024 were queried and extracted, and the adverse drug event reports involving tildrakizumab were screened out. The ROR and PRR were used as signal detection indicators, and the corresponding threshold conditions were set for statistical analysis and system classification of adverse drug event. Results A total of 1 599 adverse drug event reports related to tildrakizumab were retrieved, with the proportion of male patients slightly higher than that of female patients (43.0% vs 41.6%). The proportion of patients aged 45 — 64 was higher (14.8%). A total of 57 effective signals were mined, involving 13 system organ classes (SOCs), of which 51 effective signals involved 11 SOCs that were not mentioned in the domestic and foreign drug of tildrakizumab. The main effective signals were vulvovaginal candidiasis, increased viscosity of upper respiratory tract secretions, ureteral calculi, malignant melanoma in situ, followed by hypertrophic cardiomyopathy, Pap's esophagus, weight support difficulties, aortic insufficiency, etc. The main SOCs included systemic diseases and various reactions at the administration site (277 cases), infection and infectious diseases (196 cases), skin and subcutaneous tissue diseases (43 cases), benign, malignant and unknown tumors (including cystic and polyp) (41 cases), and heart organ diseases (36 cases). The median duration of adverse events was 189 d (IQR: 70 — 426.25) and the mean was 302.69 d. Conclusion Utilizing data mining of the FAERS database can provide a comprehensive and in-depth analysis of adverse drug events associated with tildrakizumab monoclonal antibody after its marketing, providing evidence for safe and rational drug use in clinical practice. Attention should be paid to male patients with a high incidence of adverse drug events, and new adverse drug event such as vulvovaginal candidiasis, ureteral stones, and Barrett's esophagus should be discovered, which should be closely monitored during clinical use of tildrakizumab monoclonal antibody to ensure the safety and effectiveness of drug use for patients.

R986