目的 基于美國食品藥品監(jiān)督管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫對瑞波西利不良事件（ADE）進行分析，為臨床安全用藥提供參考。方法 通過訪問FAERS數(shù)據(jù)庫，檢索2017年3月13日—2023年3月31日瑞波西利的ADE的數(shù)據(jù)。采用報告比值比（ROR）法聯(lián)合貝葉斯可信區(qū)間遞進神經(jīng)網(wǎng)絡(luò)法（BCPNN）進行信號挖掘，分析ADE的發(fā)生情況。結(jié)果 共獲得371個ADE信號，涉及23個系統(tǒng)器官類別（SOC），收集報告30 999份。主要上報國家是美國；涉及的SOC主要包括各類檢查、血液及淋巴系統(tǒng)疾病、全身性疾病及給藥部位各種反應(yīng)、良性與惡性及性質(zhì)不明的腫瘤、呼吸系統(tǒng)與胸及縱膈疾病等。最常報告的ADE信號包括中性粒細胞減少癥、白細胞計數(shù)降低、脫發(fā)、食欲減退、便秘等。說明書未收錄的ADE如大紅細胞癥、丹毒、日光性雀斑樣痣、免疫功能降低等26個可疑信號需給予關(guān)注。結(jié)論 瑞波西利在真實世界中常見的ADE與說明書一致，但也存在一些新的疑似ADE，臨床用藥時應(yīng)予以重視。

Objective To analyze the adverse events of ribociclib based on the adverse event (ADE) reporting system (FAERS) database of the united states food and drug administration, so as to provide reference for clinical safe use of drugs. Methods ADE in ribociclib from 13 March 2017 to 31 March 2023 were retrieved by accessing the FAERS database. The reported ratio ratio (ROR) method combined with Bayesian confidence interval progressive neural network (BCPNN) method was used for signal mining and the occurrence of ADE was analyzed. Results A total of 371 ADE signals were obtained involving 23 system organ classes (SOC), and 30 999 reports were collected. The main reporting countries are the United States, SOC involved mainly includes various examinations, blood and lymphatic system diseases, systemic diseases and various reactions at the administration site, benign and malignant tumors with unknown nature, respiratory system and thoracic and mediastinal diseases, etc. The most frequently reported ADE signals include neutropenia, decreased white blood cell counts, alopecia, anorexia, constipation, and others. Twenty-six suspicious signals of ADE such as erythrocytosis, erysipelas, freckle-like nevus solaris, and decreased immune function that were not included in the manual should be paid attention. Conclusion The common adverse reactions of ribociclib in the real world were consistent with the instructions, but there were some new suspected adverse reactions, which should be paid attention to during clinical medication.

山東省醫(yī)學(xué)會臨床科研資金-齊魯專項(YXH2022ZX02067)