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）挖掘利特希替尼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O(shè)penVigil 2.1數(shù)據(jù)平臺，收集2023年6月7日—2024年6月30日FAERS數(shù)據(jù)庫中利特昔替尼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(jié)果 共檢索到以利特替尼為主要懷疑對象的相關(guān)不良事件報告546份，經(jīng)過二次篩選得到17個不良事件信號。其中焦慮、糖尿病、食物過敏、嘔吐、疼痛、哮喘、血壓異常等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（38個信號、208例），全身性疾病及給藥部位各種反應(yīng)（30個信號、258例），各類檢查（28個信號、210例），胃腸系統(tǒng)疾病（22個信號、94例），精神病類（17個信號、64例），感染及侵染類疾?。?6個信號、58例），各類損傷、中毒及操作并發(fā)癥（11個信號、62例）等。結(jié)論 除說明書提示的常見不良事件外，還發(fā)現(xiàn)了利特昔替尼新的不良事件風(fēng)險信號。建議臨床在關(guān)注頭痛、腹瀉、嚴重感染、帶狀皰疹、惡性腫瘤、蕁麻疹、血栓栓塞事件等已知常見不良事件的同時，予以焦慮、抑郁、呼吸困難、糖尿病、關(guān)節(jié)痛等新的風(fēng)險信號更多關(guān)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

貴州省中醫(yī)藥管理局中醫(yī)藥、民族醫(yī)藥科學(xué)技術(shù)研究課題(QZYY-2021-099);貴州省衛(wèi)生健康委科學(xué)技術(shù)基金項目(gzwkj2022-330)