目的 利用美國食品藥品管理局（FDA）不良事件報告系統(tǒng)（FAERS）分析阿伐可泮在真實世界中發(fā)生的藥物不良事件，為臨床安全使用提供重要依據(jù)。方法 檢索FAERS中2021年第4季度—2025年第1季度的相關(guān)不良事件報告數(shù)據(jù)，采用報告比值比（ROR）法和比例報告比（PRR）法挖掘不良事件信號，采用國際醫(yī)學(xué)術(shù)語詞典（MedDRA術(shù)語）27.1中的首選語（PT）、系統(tǒng)器官分類（SOC）對相關(guān)不良事件名稱進行規(guī)范性表達(dá)。結(jié)果 共檢索得到阿伐可泮相關(guān)不良事件報告3 510例，報告年齡主要集中在50歲以上，美國報告例數(shù)最多（74.16%）。共挖掘到106個不良事件信號，累及至16個SOC。主要包括胃腸系統(tǒng)疾?。?4個）、感染及侵染類疾病（19個）、肝膽系統(tǒng)疾病（13個）等。不良事件報告數(shù)排名前3位的PT分別為腹瀉（187例）、惡心（182例）、感染性肺炎（96例）。不良事件信號強度排名前3位的PT（按ROR值）分別為膽管消失綜合征、疑似藥物性肝損傷、黃疸。結(jié)論 在阿伐可泮用藥期間，除關(guān)注藥品說明書中提及的不良事件外，還應(yīng)密切關(guān)注膽管消失綜合征、類固醇糖尿病、黃疸等潛在新的風(fēng)險信號，保障患者的用藥安全。

Objective To analyze the adverse drug events of avacopan in the real world using the FAERS database, and provide a reference for the safe clinical use of the drug. Methods The adverse event report data of the drug from the fourth quarter of 2021 to the first quarter of 2025 in FAERS were retrieved, and the ROR and PRR methods were used to mine adverse drug events signals. The PT and SOC in the International Medical Terminology Dictionary (MedDRA terminology) 27.1 were used to standardize the expression of related adverse drug events names. Results A total of 3 510 adverse drug events reports related to avcaopan were retrieved, and the reporting age was mainly concentrated in those over 50 years old, with the largest number of reports from the United States (74.16%). A total of 106 adverse drug events signals were mined, involving 16 SOC. Mainly including gastrointestinal system diseases (14), infections and infective diseases (19), hepatobiliary system diseases (13), etc. The top three PT in terms of adverse drug events reports were diarrhea (187 cases), nausea (182 cases), and infectious pneumonia (96 cases). The top three PT (by ROR value) adverse event signal intensities were biliary disappearance syndrome, suspected drug-induced liver injury, and jaundice. Conclusion During the administration of avacopan, in addition to monitoring the adverse event mentioned in the drug package insert, close attention should also be paid to potential new adverse reactions such as biliary disappearance syndrome, steroid diabetes, and jaundice to ensure patient safety.

R972

國家自然科學(xué)基金資助項目（72304007）；北京市自然科學(xué)基金資助項目（7244474）