目的 利用美國FAERS數(shù)據(jù)庫挖掘瑞派替尼上市后的藥品不良事件信號，旨在評估其上市后在真實世界中的安全性并為臨床用藥提供參考。方法 提取FAERS數(shù)據(jù)庫2020年第2季度—2024年第2季度的數(shù)據(jù)，經(jīng)過數(shù)據(jù)清洗和標(biāo)準(zhǔn)化處理，挖掘出以瑞派替尼為主要懷疑藥物的不良事件報告。并采用ROR、PRR、BCPNN法聯(lián)合篩選其不良事件風(fēng)險信號。結(jié)果 收集到以瑞派替尼為首要懷疑藥物的不良事件報告共11 469份，涉及患者3 250例，男性患者的構(gòu)成比高于女性患者（54.28% vs 43.63%）。挖掘出相關(guān)不良事件風(fēng)險信號131個，報告數(shù)排名前5位的不良事件分別疲勞、脫發(fā)、死亡、疾病進展、進展性腫瘤。而說明書中未收載的藥品不良反應(yīng)信號報告數(shù)前5位為毛發(fā)結(jié)構(gòu)異常、肝轉(zhuǎn)移、牙齦出血、發(fā)聲困難、血鉀降低。結(jié)論 瑞派替尼在臨床應(yīng)用中雖存在潛在不良反應(yīng)信號，但基于FAERS數(shù)據(jù)庫的數(shù)據(jù)挖掘分析顯示，其整體安全性仍處于可接受范圍。然而，瑞派替尼可能引發(fā)的頻發(fā)不良反應(yīng)及說明書中未記載的不良反應(yīng)，如肝轉(zhuǎn)移、肝腫瘤等需要引起關(guān)注。因此，臨床藥師和醫(yī)生應(yīng)高度關(guān)注這些風(fēng)險，制定并實施有效的預(yù)防和管理措施，以確保瑞派替尼臨床使用的安全性和有效性。

Objective FAERS database was used to mine adverse drug event signals of ripretinib after marketing in order to evaluate its safety in the real world after marketing and provide reference for clinical use. Methods The data from the second quarter of 2020 to the second quarter of 2024 in the FAERS database were extracted, cleaned, and standardized. Adverse drug event reports with ripretinib as the main suspected drug were screened. The ROR, PRR, and BCPNN methods were used to jointly mine adverse drug event signals. Results A total of 11 469 adverse drug event reports with ripretinib as the primary suspected drug were collected, involving 3 250 patients, and the proportion of male patients was higher than that of female patients (54.28% vs 43.63%). A total of 131 risk signals related to adverse drug event were excavated, and the top 5 adverse drug event s were fatigue, alopecia, death, disease progression, and progressive tumors. The top 5 adverse drug reaction signals not included in the instructions were abnormal hair structure, liver metastasis, bleeding gums, dysphonia, and decreased serum potassium. Conclusion Although ripretinib exhibits potential adverse drug event signals in clinical applications, the overall safety analysis based on the FAERS database suggests that it remains within an acceptable range. However, the frequent adverse reactions that may be caused by ripretinib and adverse reactions not recorded in the label, such as liver metastases and liver tumors, need to be of concern. Therefore, clinical pharmacists and physicians should pay close attention to these risks and develop and implement effective prevention and management measures to ensure the safety and efficacy of ripretinib in clinical use.

R979.1

郴州市科技發(fā)展計劃項目(ZDYF2020228)