目的 基于美國食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)（FAERS）數(shù)據(jù)庫挖掘醛固酮受體拮抗劑依普利酮和螺內(nèi)酯的不良反應(yīng)（ADR）信號，對比和分析兩者ADR的相關(guān)情況，為臨床安全用藥提供參考依據(jù)。方法 基于FAERS數(shù)據(jù)庫，利用Open Vigil FDA分析工具提取2004年1月1日—2022年11月4日上報(bào)的目標(biāo)藥物依普利酮與螺內(nèi)酯相關(guān)的不良事件情況數(shù)據(jù)。采用報(bào)告比值比法進(jìn)行數(shù)據(jù)挖掘，按國際醫(yī)學(xué)用語詞典25.1版中的首選系統(tǒng)器官分類（SOC）和首選術(shù)語（PT）對不良事件進(jìn)行統(tǒng)計(jì)分類并分析。結(jié)果 共檢索到醛固酮受體拮抗劑依普利酮和螺內(nèi)酯相關(guān)的ADR報(bào)告112 518份，其中依普利酮ADR報(bào)告8 516份，風(fēng)險(xiǎn)信號50個(gè)，信號累及12個(gè)系統(tǒng)/器官；螺內(nèi)酯ADR報(bào)告104 002份，風(fēng)險(xiǎn)信號60個(gè)，信號累及13個(gè)系統(tǒng)器官分類；其中36個(gè)為重疊信號。依普利酮說明書未提及的有13個(gè)風(fēng)險(xiǎn)信號，主要涉及呼吸、胃腸等系統(tǒng)器官分類；螺內(nèi)酯說明書未提及的有19個(gè)風(fēng)險(xiǎn)信號，主要涉及血液及淋巴系統(tǒng)疾病、精神病類等系統(tǒng)器官分類。結(jié)論 臨床應(yīng)用醛固酮受體拮抗劑時(shí)，除重點(diǎn)關(guān)注說明書提及的ADR，還需對未提及的風(fēng)險(xiǎn)信號和原有疾病進(jìn)展情況引起重視。

Objective To mine the adverse drug reaction (ADR) signals of aldosterone receptor antagonists eplerenone and spironolactone based on the Food and Drug Administration adverse event reporting system (FAERS) database, compare and analyze their ADR related conditions, and provide a reference for clinical safe drug use. Methods Based on FAERS database, Open Vigil FDA analysis tool was used to extract the adverse events related to eplerenone and spironolactone reported from January 1, 2004 to November 4, 2022. The reporting ratio method was used for data mining, and the adverse events were statistical classification and analyzed according to the preferred system organ classification (SOC) and preferred term (PT) in the 25.1 edition of the International Dictionary of Medical Terms. Results A total of 112 518 ADR reports related to eplerenone and spironolactone, aldosterone receptor antagonists, were retrieved, including 8 516 ADR reports of eplerenone, 50 risk signals, and 12 systems/organs involved in eplerenone, and 104 002 ADR reports of spironolactone, 60 risk signals, involving 13 system organ classifications. Among them, 36 are overlapping signals. There are 13 risk signals that are not mentioned in the instruction manual of eplerenone, mainly involving the classification of respiratory, gastrointestinal and other systemic organs. There are 19 risk signals not mentioned in the instructions of spironolactone, which mainly involve the classification of blood and lymphatic system diseases, mental diseases and other system organs. Conclusion In the clinical application of aldosterone receptor antagonists, in addition to the ADR mentioned in the instructions, attention should also be paid to the risk signals not mentioned and the original disease progress.

R972

國家自然科學(xué)基金青年科學(xué)基金項(xiàng)目（82000842）；廣東省基礎(chǔ)與應(yīng)用基礎(chǔ)研究基金項(xiàng)目（2021A1515010151）；東莞市社會(huì)發(fā)展科技面上項(xiàng)目（20211800903072）