目的 挖掘雷莫芦单抗相关不良反应风险信号，为其在临床安全使用提供参考。方法 检索美国食品药品管理局不良事件报告系统（FAERS）数据库中2014年1月1日—2023年2月1日雷莫芦单抗报告的不良事件（AE）报告，采用报告比值比（ROR）法和比例报告比值比（PRR）法进行联合检验，采用国际医学用语词典首选术语（PT）和系统器官分类（SOC）对AE进行分类统计和描述性分析。结果 共收集到雷莫芦单抗为首要怀疑药物的AE报告1 786份，报告中患者中位年龄66岁，65岁以上患者占比60.46%；男性患者占绝大部分；主要上报国家是日本；部分患者为超说明书适应症用药；严重AE占比54.82%。采用ROR法和PRR法分析，获得123个PT信号，涉及18个SOC，其中有52个PT信号说明书中未记载。本研究挖掘的雷莫芦单抗的主要AE与说明书记载一致，包括高血压、蛋白尿、周围性水肿、骨髓抑制、出血、穿孔等。而伤口愈合并发症、化脓性肉芽肿、脑干出血、间质性肺疾病、腹膜炎等说明书未记载的AE，其报告数较多、信号较强，临床使用时应加以警惕。结论 对数据库中雷莫芦单抗真实世界报告的AE信息进行挖掘和分析，有助于发现新的AE风险信号，提示临床对其加以关注，从而保障患者用药安全。

Objective To mine and analyze the adverse events signals of ramucirumab by database, and to provide reference for its safe use in clinical practice. Method The reports of ramucirumab from January 1st, 2014 to February 1st, 2023 were extracted from the FDA adverse event reporting system (FAERS) database. The reporting odds ratio (ROR) and the proportional reporting ratio (PRR) methods were used to mine the signals. The Preferred term (PT) and System Organ Class (SOC) from the International Dictionary of Medical Terms (MedDRA) were used for classification and description. Results A total of 1 786 AE reports of ramucirumab were retrieved. The median age of patients was 66 years, and 60.46% of the patients were over 65 years old, the main drug use population was male, the main reporting country was Japan, some patients were used for off-label indications, and the severe AE accounted for 54.82%. Totally 123 PT signals were obtained, involving 18 SOC categories according to the positive screening criteria, of which 52 PT signals were not listed in the specification. Hypertension, proteinuria, peripheral oedema, bone marrow suppression, bleeding, perforation, and other AEs had high frequency and strong signals, which were the same as the common AEs in the instructions. In addition, wound healing complications, pyogenic granuloma, brainstem hemorrhage, interstitial lung disease, peritonitis and so on, which were not mentioned in the instructions, also showed strong signals, which need to be paid more attention to. Conclusion Mining and analyzing the real-world AE of ramucirumab using the database is helpful to find its potential AE signals, and clinical attention should be paid to ensure the safety of patients.

R979.1