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）挖掘佩索利单抗注射液的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2022年9月1日—2024年9月30日FAERS数据库中佩索利单抗注射液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 共检索到以佩索利单抗注射液为主要怀疑对象的相关不良事件报告93份，经过二次筛选得到7个不良事件信号。其中红斑、皮疹、心力衰竭、脓毒症、呼吸衰竭等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、感染及浸染类疾病、全身性疾病及给药部位各种反应、各类损伤、中毒及操作并发症、呼吸系统、胸及纵隔疾病、各类神经系统疾病、心脏器官疾病、血管与淋巴管类疾病等。结论 除说明书提示的常见不良事件外，本研究发现了佩索利单抗注射液新的不良事件风险信号。建议临床在关注感染、瘙痒和痒疹、菌血症、呼吸困难等已知常见不良事件的同时，予以红斑、皮疹、心力衰竭、脓毒症、呼吸衰竭等新的风险信号更多关注。

Objective Mining the adverse drug event signals of spesolimab 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 spesolimab in FAERS database from September 1, 2022 to September 30, 2024. The ROR and PRR in the proportional imbalance method were used for signal mining. Results A total of 93 reports of adverse events related to spesolimab were retrieved, and 7 adverse drug event signals were obtained after secondary screening. Among them, 37 adverse drug event signals such as erythema, rash, heart failure, sepsis and respiratory failure 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, infection and infectious diseases, systemic diseases and various reactions at the drug administration site, various types of injury, poisoning and operational complications, respiratory system, chest and mediastinal disorders, nervous system disorders, cardiac disorders, and vascular and lymphatic disorders. Conclusion In addition to the common adverse drug event indicated by the package insert, this study identify new risk signals for adverse events with spesolimab. It is recommended to pay more attention to the known common adverse drug event such as infection, pruritus and urticaria, bacteremia, and dyspnea events, and to the new risk signals such as erythema, rash, heart failure, sepsis, and respiratory failure.

R986

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); 贵州中医药大学研究生教育创新计划自然科学项目(YCXZR2021002)