目的 利用美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）挖掘艾立布林不良事件（ADE）风险信号，为临床安全用药提供参考。方法 检索FAERS数据库中2010年12月15日—2022年3月31日的ADE报告数据，以“艾立布林”为目标药物，检索关键词为“eribulin”“eribulin mesylate”及“halaven”。采用WPS表格统计患者基本信息，包括性别、年龄、用药原因、ADE上报人员和上报国家、ADE严重程度和类型等。采用《ICH国际医学用语词典》（MedDRA）中的首选系统器官分类（SOC）和首选术语（PT）对ADE进行描述、分类和统计。采用比值失衡测量法中的报告比值比法（ROR）和综合标准法（MHRA）对艾立布林ADE报告进行数据挖掘。结果 共检索到艾立布林ADE报告4159份，涉及26个SOC，其中严重ADE报告3898份。上报人员以医务人员为主（91.92%），上报国家以日本为主（29.36%），患者年龄以18～64岁居多，性别以女性占比最高（87.67%）。采用ROR法和MHRA法共获得150个ADE风险信号，包括假性肝硬化、免疫球蛋白G4相关疾病及生殖器脓肿等新发不良反应。结论 临床在使用艾立布林时，除药物说明书载入的不良反应外，还应重点关注假性肝硬化、免疫球蛋白G4相关疾病及生殖器脓肿等风险，以保证患者安全用药。

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.

安徽省自然科学重点研究项目（KJ2021A1146）；亳州市第二批“首席专家工作室”（亳组办字2020［2］号）；安徽省高校学科（专业）拔尖人才学术资助项目（gxbjZD2020095）