目的 挖掘雷莫蘆單抗相關(guān)不良反應(yīng)風(fēng)險(xiǎn)信號(hào)，為其在臨床安全使用提供參考。方法 檢索美國(guó)食品藥品管理局不良事件報(bào)告系統(tǒng)（FAERS）數(shù)據(jù)庫中2014年1月1日—2023年2月1日雷莫蘆單抗報(bào)告的不良事件（AE）報(bào)告，采用報(bào)告比值比（ROR）法和比例報(bào)告比值比（PRR）法進(jìn)行聯(lián)合檢驗(yàn)，采用國(guó)際醫(yī)學(xué)用語詞典首選術(shù)語（PT）和系統(tǒng)器官分類（SOC）對(duì)AE進(jìn)行分類統(tǒng)計(jì)和描述性分析。結(jié)果 共收集到雷莫蘆單抗為首要懷疑藥物的AE報(bào)告1 786份，報(bào)告中患者中位年齡66歲，65歲以上患者占比60.46%；男性患者占絕大部分；主要上報(bào)國(guó)家是日本；部分患者為超說明書適應(yīng)癥用藥；嚴(yán)重AE占比54.82%。采用ROR法和PRR法分析，獲得123個(gè)PT信號(hào)，涉及18個(gè)SOC，其中有52個(gè)PT信號(hào)說明書中未記載。本研究挖掘的雷莫蘆單抗的主要AE與說明書記載一致，包括高血壓、蛋白尿、周圍性水腫、骨髓抑制、出血、穿孔等。而傷口愈合并發(fā)癥、化膿性肉芽腫、腦干出血、間質(zhì)性肺疾病、腹膜炎等說明書未記載的AE，其報(bào)告數(shù)較多、信號(hào)較強(qiáng)，臨床使用時(shí)應(yīng)加以警惕。結(jié)論 對(duì)數(shù)據(jù)庫中雷莫蘆單抗真實(shí)世界報(bào)告的AE信息進(jìn)行挖掘和分析，有助于發(fā)現(xiàn)新的AE風(fēng)險(xiǎn)信號(hào)，提示臨床對(duì)其加以關(guān)注，從而保障患者用藥安全。

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