目的 基于美國食品藥品監(jiān)督管理局（FDA）藥品不良事件報告系統(tǒng)（FAERS）數(shù)據庫，挖掘和分析塞利尼索藥物不良事件（ADE）信號，為臨床安全用藥提供參考。方法 采用報告比值比法（ROR）和比例報告比值法（PRR）挖掘2019年3季度—2023年3季度期間塞利尼索ADE報告，利用監(jiān)管活動醫(yī)學詞典（MedDRA）的首選系統(tǒng)器官分類（SOC）和首選術語（PT）對挖掘的信號進行分類和統(tǒng)計分析。結果 共檢索到以塞利尼索為首要懷疑藥物的ADE報告4 991例，涉及19 868個PT。經過計算篩選后得到塞利尼索ADE信號118個，涉及16個SOC。塞利尼索ADE信號與已知的相關安全性信息基本一致，ADE主要集中在胃腸系統(tǒng)疾病、全身性疾病及給藥部位各種反應、各類檢查、代謝及營養(yǎng)類疾病。另外還檢出藥品說明書未收錄的ADE信號53個，如便秘、跌倒、嗜睡和腎功能異常等。結論 基于FAERS的大數(shù)據可全面深入分析藥品上市后的ADE，提示臨床在治療初期應密切關注塞利尼索胃腸道毒性、血液學毒性以及說明書未提及的風險，并采取預防措施，從而保障臨床用藥安全。

Objective To mine the signals of adverse drug events (ADE) for selinexor based on the FAERS database, and to provide a reference for safe use of drugs in clinical. Methods The reported odds ratio (ROR) and proportional reported ratio (PRR) methods were used to mine selinexor adverse event reports between the second quarter of 2019 and the third quarter of 2023, and the mined signals were classified and statistically analyzed using the Medical Dictionary of Regulatory Activities (MedDRA) preferred system organ classification (SOC) and preferred termy (PT). Results A total of 4 991 adverse event reports involving 19 868 PTs with selinexor as the first suspected drug were retrieved. After computational screening, 118 selinexor ADE signals were obtained, involving 16 SOCs. Selinexor ADE signals were basically consistent with the known relevant safety information, and the adverse events were mainly focused on gastrointestinal system diseases, systemic diseases and various reactions at the drug administration site, various types of examinations, metabolic and nutritional diseases. In addition, 53 ADE signals not included in the drug specification were detected, such as constipation, fall, drowsiness, and abnormal renal function. Conclusion FAERS-based big data can provide a comprehensive and in-depth analysis of post-marketing adverse reactions of drugs, suggesting that the clinic should pay close attention to the gastrointestinal toxicity, hematological toxicity and risks not mentioned in the instruction manual of selinexor at the early stage of treatment, and take preventive measures so as to ensure the safety of clinical use.

R979.1

湖北省中醫(yī)藥管理局中醫(yī)藥科研立項項目（ZY2023F075）；十堰市科技局引導性科研項目（22Y78）