目的 利用美國食品藥品管理局不良事件呈報(bào)系統(tǒng)（FAERS）數(shù)據(jù)庫挖掘替瑞奇珠單抗相關(guān)不良事件的風(fēng)險(xiǎn)信號，預(yù)警其潛在的不良反應(yīng)，為替瑞奇珠單抗的臨床應(yīng)用和后續(xù)研究提供客觀資料。方法 查詢和提取FAERS數(shù)據(jù)庫2018年第1季度—2024年第2季度的原始數(shù)據(jù)，篩選出涉及替瑞奇珠單抗的不良事件報(bào)告，并采用比例失衡分析法中的報(bào)告比值比（ROR）和比例報(bào)告比值比法（PRR）作為信號檢測指標(biāo)，設(shè)定相應(yīng)的閾值條件，對不良事件進(jìn)行統(tǒng)計(jì)分析和系統(tǒng)分類。結(jié)果 共檢索到替瑞奇珠單抗相關(guān)不良事件報(bào)告1 599份，男性患者比例稍高于女性（43.0% vs 41.6%），45～64歲患者所占比例較高（14.8%）。共挖掘出57個(gè)有效信號，涉及13個(gè)系統(tǒng)器官分類（SOCs），其中有51個(gè)有效信號，涉及11個(gè)SOCs未在替瑞奇珠單抗國內(nèi)外藥品說明書中提及。主要集中的有效信號外陰陰道念珠菌病、上呼吸道分泌物黏度增加、輸尿管結(jié)石、原位惡性黑素瘤，其次為肥厚性心肌病、巴氏食管、支撐體質(zhì)量困難、主動(dòng)脈瓣關(guān)閉不全等；主要SOCs包括全身性疾病及給藥部位各種反應(yīng)（277例），感染及侵染類疾?。?96例），皮膚及皮下組織類疾?。?3例），良性、惡性及性質(zhì)不明的腫瘤（包括囊狀和息肉狀）（41例），心臟器官疾?。?6例）等。中位不良事件發(fā)生時(shí)間189 d（IQR：70～426.25），平均值302.69 d。結(jié)論 利用挖掘FAERS數(shù)據(jù)庫可較全面深入地分析研究替瑞奇珠單抗上市后的不良事件，為臨床安全合理用藥提供依據(jù)。需要關(guān)注不良事件高發(fā)的男性患者，發(fā)現(xiàn)一些新的不良事件，如外陰陰道念珠菌病、輸尿管結(jié)石、巴氏食管等，臨床應(yīng)用替瑞奇珠單抗時(shí)，應(yīng)密切關(guān)注，保證患者安全有效用藥。

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