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)（FDA adverse event reporting system，F(xiàn)AERS）數(shù)據(jù)庫對托法替尼的不良事件信息進行對比分析，挖掘其潛在的藥品不良反應(yīng)信號，以期為臨床安全合理用藥提供參考依據(jù)。方法 從FAERS數(shù)據(jù)庫中提取2011—2022年托法替尼的不良事件報告數(shù)據(jù)，利用報告比值比法（report the odds ratio，ROR）和比例報告比值法（proportional report ratio，PRR）對托法替尼的報告進行數(shù)據(jù)挖掘。利用國際醫(yī)學(xué)用語詞典術(shù)語集進行漢化及系統(tǒng)/器官（system organ class，SOC）歸類得到有效信號。結(jié)果 納入的65 535份報告中，女性患者多于男性，年齡主要集中在50～75歲，上報國家主要為美國；利用ROR和PRR法篩選后共得到545個信號，經(jīng)系統(tǒng)器官分類后主要集中在各類肌肉骨骼及結(jié)締組織病、各類神經(jīng)系統(tǒng)疾病、全身性疾病及給藥部位反應(yīng)、感染及侵染類疾病、呼吸系統(tǒng)、胸及縱膈疾病等，其中報告數(shù)較多的依次為疼痛、關(guān)節(jié)痛、狀態(tài)惡化、類風(fēng)濕性關(guān)節(jié)炎等，信號強度依次為硫嘌呤甲基轉(zhuǎn)移酶下降、沮喪、免疫恢復(fù)性葡萄膜炎、紅細胞沉降率異常等。同時本研究檢測到良性、惡性及性質(zhì)不明的腫瘤、心臟等方面安全信號。結(jié)論 有效利用ROR法和PRR法挖掘托法替尼的不良反應(yīng)信號可為臨床用藥提供一定的參考，有利于促進臨床合理用藥。

Objective Adverse event information of tofacitinib was analyzed and compared based on the FDA adverse event reporting system (FAERS) database, and potential adverse drug reaction signals of tofacitinib were explored. In order to provide reference for clinical safe and rational drug use. Methods Adverse event report data of tofacitinib from 2011 to 2022 were extracted from FAERS database, and proportional report ratio (ROR) and report the odds ratio (ROR) were applied. Effective signals were obtained by sinicization and system organ class (SOC) classification using the International Dictionary of Medical Terms. Results Among the 65 535 reports included, female patients were more than male patients, and the age group was mainly between 50 and 75 years old. The reporting countries were mainly the United States. A total of 545 signals were obtained after screening by ROR and PRR methods, which were mainly classified into various musculoskeletal and connective tissue diseases, nervous system diseases, systemic diseases and drug site reactions, infections and infective diseases, respiratory system, chest and mediastinum diseases, etc. Among them, pain, arthralgia, state deterioration, rheumatoid arthritis were the most reported, and the signal intensity was successively decreased thiopurine methyltransferase, depression, immune restorative uveitis, abnormal erythrocyte subsidence rate and so on. At the same time, benign, malignant, and unknown tumors, heart and other safety signals were detected in this study. Conclusions In this study, ROR method and PRR method were effectively used to excavate the adverse reaction signals of tofacitinib, which could provide certain reference for clinical drug use and promote rational clinical drug use.<

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