目的 通過對嗎替麥考酚酯不良事件（ADE）的信號挖掘分析，為臨床安全用藥提供參考。方法 利用Open Vigil工具對美國食品藥品監(jiān)督管理局（FDA）不良事件報告系統(tǒng)（FAERS）中2004—2021年的嗎替麥考酚酯ADE數(shù)據(jù)進行分析。結(jié)果 在數(shù)據(jù)庫中以嗎替麥考酚酯作為首要懷疑藥物的ADE報告共52327例。采用比例失衡法提取到陽性信號2225個，累及24個系統(tǒng)和器官，ADE例次排序前50位中挖掘到9項說明書中未記錄的信號，其中血栓性微血管病（TMA）和可逆性后部腦部綜合征（RPLS）尤其值得關(guān)注。與硫唑嘌呤相比，嗎替麥考酚酯引起的總體骨髓抑制和肝功能異常均較輕，但更容易出現(xiàn)單純紅細胞再生障礙性貧血和膽纖維化。結(jié)論 嗎替麥考酚酯在臨床應(yīng)用中應(yīng)定期監(jiān)測相應(yīng)指標，及時采取干預(yù)措施，確保安全合理用藥。

Objective To provide reference for clinical safe drug use through the signal mining analysis of adverse drug event (ADE) of mycophenolate mofetil. Methods OpenVigil was used to analyze ADE data of mycophenolate mofetil from 2004 to 2021 in the US FDA adverse event reporting system (FAERS). Results There were 52327 ADE with mycophenolate mofetil as the primary suspected drug in the database. 2225 positive signals were extracted by using the disproportionality measurement, involving 24 systems organ classes. Among the top 50 signals of ADE, nine unrecorded signals were excavated, including thrombotic microangiopathy (TMA) and reversible posterior leukoencephalopathy syndrome (RPLS), which should be particularly concerned. Compared with azathioprine, mycophenolate mofetil caused less overall myelosuppression and severe liver function abnormalities, but was more prone to pure red cell aplasia and biliary fibrosis. Conclusion In clinical application of mycophenolate mofetil, corresponding indicators should be monitored regularly, and intervention measures should be taken in time to ensure safe and rational drug use.