目的 利用美國食品藥品監(jiān)督管理局（FDA）不良事件報告系統(tǒng)（FAERS）挖掘艾立布林不良事件（ADE）風(fēng)險信號，為臨床安全用藥提供參考。方法 檢索FAERS數(shù)據(jù)庫中2010年12月15日—2022年3月31日的ADE報告數(shù)據(jù)，以“艾立布林”為目標(biāo)藥物，檢索關(guān)鍵詞為“eribulin”“eribulin mesylate”及“halaven”。采用WPS表格統(tǒng)計患者基本信息，包括性別、年齡、用藥原因、ADE上報人員和上報國家、ADE嚴(yán)重程度和類型等。采用《ICH國際醫(yī)學(xué)用語詞典》（MedDRA）中的首選系統(tǒng)器官分類（SOC）和首選術(shù)語（PT）對ADE進行描述、分類和統(tǒng)計。采用比值失衡測量法中的報告比值比法（ROR）和綜合標(biāo)準(zhǔn)法（MHRA）對艾立布林ADE報告進行數(shù)據(jù)挖掘。結(jié)果 共檢索到艾立布林ADE報告4159份，涉及26個SOC，其中嚴(yán)重ADE報告3898份。上報人員以醫(yī)務(wù)人員為主（91.92%），上報國家以日本為主（29.36%），患者年齡以18～64歲居多，性別以女性占比最高（87.67%）。采用ROR法和MHRA法共獲得150個ADE風(fēng)險信號，包括假性肝硬化、免疫球蛋白G4相關(guān)疾病及生殖器膿腫等新發(fā)不良反應(yīng)。結(jié)論 臨床在使用艾立布林時，除藥物說明書載入的不良反應(yīng)外，還應(yīng)重點關(guān)注假性肝硬化、免疫球蛋白G4相關(guān)疾病及生殖器膿腫等風(fēng)險，以保證患者安全用藥。

Objective To access the database of Food and Drug Administration Adverse Events Reporting System (FAERS) to mining risk signals of adverse drug events (ADE) of eribulin, so as to provide references for drug safety in clinical practices. Methods The ADE reports from December 15, 2010 to March 31, 2022 in FAERS database were retrieved and analyzed. With eribulin as the target drug, the search keywords were "eribulin""eribulin mesylate" and "halaven". The WPS form was used to count the basic information of patients, including gender, age, reason for medication, ADE reporting personnel and reporting country, ADE severity and type, etc. The preferred system organ classification (SOC) and preferred term (PT) in the Medical Dictionary for Regulatory Activities (MedDRA) were used to describe, classify and count adverse events. The reported odds ratio (ROR) and the medicines and healthcare products regulatory agency (MHRA) in the ratio imbalance measurement method were used to mine the data of ADE of eribulin. Results 4159 ADE reports of eribulin were retrieved,which involved 26 kinds of SOC, including 3 898 reports belonged to serious ADE. The reporting personnel are mainly healthcare professional (91.92%). The ADE mainly occurred in Japan (29.36%), the population was concentrated among 18—64 age groups, and female accounted for the highest proportion (87.67%). A total of 150 ADE risk signals were obtained by ROR and MHRA, including many new adverse reactions such as pseudocirrhosis, immunoglobulin G4 related diseases and genital abscess. Conclusion During clinical dosing of eribulin,in addition to adverse reactions in package inserts,great attention should be paid to pseudocirrhosis, immunoglobulin G4 related diseases and genital abscess to insure the safety of drug in clinic.

安徽省自然科學(xué)重點研究項目（KJ2021A1146）；亳州市第二批“首席專家工作室”（亳組辦字2020［2］號）；安徽省高校學(xué)科（專業(yè)）拔尖人才學(xué)術(shù)資助項目（gxbjZD2020095）