目的 基于FAERS數據庫對原發(fā)性免疫球蛋白A（IgA）腎病新型藥物布地奈德腸溶膠囊不良事件信號進行挖掘與分析。方法 檢索并提取FAERS數據庫2021年第4季度—2025年第1季度收錄以目標藥物通用名“budesonide”及商品名“Tarpeyo^®、Kinpeygo^®、Nefecon^®”為首要懷疑對象的不良事件報告，利用ROR法和BCPNN法對布地奈德腸溶膠囊的相關報告進行數據挖掘和分析，并利用MedDRA醫(yī)學用語詞典進行漢化及系統(tǒng)歸類。結果 納入分析15 969 959份不良事件報告中，以布地奈德腸溶膠囊相關名稱為首要懷疑藥物的不良事件報告3 581份。發(fā)現該藥不良反應信號涉及多個系統(tǒng)，具有臨床參考意義的高風險信號包括高血壓亞急癥、類庫欣綜合征、體質量增加等等；另檢測出高風險且說明書中未提及的安全警戒信號如牙齒感覺敏感和尿異常。結論 布地奈德腸溶膠囊長期使用需關注如高血壓、類庫欣綜合征、體質量高增加等不良安全信號。此外用藥期間還需注意口腔健康，必要時應及時就醫(yī)。

Objective To mine and analyze adverse events related to the Budesonide Enteric Capsules for treating IgA nephropathy based on the FAERS database. Methods The FAERS database was searched and extraced the adverse event reports with the target drug generic name “budesonide” and brand names “Tarpeyo^®, Kinpeygo^®, Nefecon^®” as the primary suspects from Q4 of 2021 to Q1 of 2025. The ROR method and BCPNN method were employed for data mining and analysis of Budesonide Enteric Capsules-related reports. The MedDRA medical terminology was used for localization and systematic classification. Results Among the 15 969 959 adverse event reports included in the analysis, 3 581 adverse event reports were related to the name of Budesonide Enteric Capsules as the primary suspected drug. It was found that the adverse reaction signals of this drug involve multiple systems. High-risk signals with clinical reference significance include subacute hypertension, Cushing’s syndrome, weight gain, etc. In addition, high-risk safety warning signals not mentioned in the instruction manual were detected, such as tooth sensitivity and abnormal urine. Conclusion Long-term use of Budesonide Enteric Capsules requires attention to adverse safety signals such as hypertension, Cushing’s syndrome, and increased body weight. In addition, during the medication period, oral health should be paid attention to. If necessary, medical attention should be sought in a timely manner.

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