目的 基于美國食品藥品監(jiān)督管理局（FDA）不良事件報告系統(tǒng)（FAERS）挖掘佩索利單抗注射液的的藥品不良事件信號，為臨床用藥提供依據(jù)。方法 通過開放性OpenVigil 2.1數(shù)據(jù)平臺，收集2022年9月1日—2024年9月30日FAERS數(shù)據(jù)庫中佩索利單抗注射液的藥品不良事件報告。采用比例失衡法中的報告比值比（ROR）和比例報告比（PRR）進行信號挖掘。結果 共檢索到以佩索利單抗注射液為主要懷疑對象的相關不良事件報告93份，經(jīng)過二次篩選得到7個不良事件信號。其中紅斑、皮疹、心力衰竭、膿毒癥、呼吸衰竭等37個不良事件信號在藥品說明書中未提及。信號數(shù)或累積例數(shù)較多的系統(tǒng)器官分類包含皮膚及皮下組織類疾病、感染及浸染類疾病、全身性疾病及給藥部位各種反應、各類損傷、中毒及操作并發(fā)癥、呼吸系統(tǒng)、胸及縱隔疾病、各類神經(jīng)系統(tǒng)疾病、心臟器官疾病、血管與淋巴管類疾病等。結論 除說明書提示的常見不良事件外，本研究發(fā)現(xiàn)了佩索利單抗注射液新的不良事件風險信號。建議臨床在關注感染、瘙癢和癢疹、菌血癥、呼吸困難等已知常見不良事件的同時，予以紅斑、皮疹、心力衰竭、膿毒癥、呼吸衰竭等新的風險信號更多關注。

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

貴州省中醫(yī)藥管理局中醫(yī)藥、民族醫(yī)藥科學技術研究課題(QZYY-2021-099); 貴州省衛(wèi)生健康委科學技術基金項目(gzwkj2022-330); 貴州中醫(yī)藥大學研究生教育創(chuàng)新計劃自然科學項目(YCXZR2021002)