目的 基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）挖掘利特希替尼的药品不良事件信号，为临床用药提供依据。方法 通过开放性OpenVigil 2.1数据平台，收集2023年6月7日—2024年6月30日FAERS数据库中利特昔替尼的药品不良事件报告。采用比例失衡法中的报告比值比（ROR）和比例报告比（PRR）进行信号挖掘。结果 共检索到以利特替尼为主要怀疑对象的相关不良事件报告546份，经过二次筛选得到17个不良事件信号。其中焦虑、糖尿病、食物过敏、呕吐、疼痛、哮喘、血压异常等37个不良事件信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含皮肤及皮下组织类疾病（38个信号、208例），全身性疾病及给药部位各种反应（30个信号、258例），各类检查（28个信号、210例），胃肠系统疾病（22个信号、94例），精神病类（17个信号、64例），感染及侵染类疾病（16个信号、58例），各类损伤、中毒及操作并发症（11个信号、62例）等。结论 除说明书提示的常见不良事件外，还发现了利特昔替尼新的不良事件风险信号。建议临床在关注头痛、腹泻、严重感染、带状疱疹、恶性肿瘤、荨麻疹、血栓栓塞事件等已知常见不良事件的同时，予以焦虑、抑郁、呼吸困难、糖尿病、关节痛等新的风险信号更多关注。

Objective Mining the adverse drug event signals of ritlecitinib based on the FAERS, to provide a basis for clinical medication. Methods The open OpenVigil 2.1 data platform was used to collect adverse drug event reports of ritlecitinib in FAERS database from June 7, 2023 to June 30, 2024. The ROR and PRR in the proportional imbalance method were used for signal mining. Results A total of 546 reports of adverse events related to ritlecitinib were retrieved, and 17 adverse drug event signals were obtained after secondary screening. Among them, 37 adverse drug event signals such as anxiety, diabetes, food allergy, vomiting, pain, asthma, and abnormal blood pressure were not mentioned in the drug package insert. The system organ categories with high signal number or cumulative number of cases included skin and subcutaneous tissue diseases (38 signals, 208 cases), systemic diseases and various reactions at the drug administration site (30 signals, 258 cases), various examinations (28 signals, 210 cases), gastrointestinal diseases (22 signals, 94 cases), psychiatric diseases (17 signals, 64 cases), and gastrointestinal diseases (22 signals, 94 cases). Infection and infectious diseases (16 signals, 58 cases), various types of injury, poisoning and operational complications (11 signals, 62 cases), etc. Conclusions In addition to the common adverse drug event indicated by the package insert, this study identified new risk signals for adverse events with ritlecitinib. It is recommended to pay more attention to the known common adverse drug event such as headache, diarrhea, severe infection, herpes zoster, malignant tumor, urticaria, and thromboembolism events, and to the new risk signals such as anxiety, depression, dyspnea, diabetes, and arthralgia.

R979.5

贵州省中医药管理局中医药、民族医药科学技术研究课题(QZYY-2021-099);贵州省卫生健康委科学技术基金项目(gzwkj2022-330)