[關(guān)鍵詞]
[摘要]
目的 基于美國(guó)食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)(FAERS)數(shù)據(jù)庫(kù)對(duì)瑞波西利不良事件(ADE)進(jìn)行分析,為臨床安全用藥提供參考。方法 通過(guò)訪問(wèn)FAERS數(shù)據(jù)庫(kù),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(bào)告比值比(ROR)法聯(lián)合貝葉斯可信區(qū)間遞進(jìn)神經(jīng)網(wǎng)絡(luò)法(BCPNN)進(jìn)行信號(hào)挖掘,分析ADE的發(fā)生情況。結(jié)果 共獲得371個(gè)ADE信號(hào),涉及23個(gè)系統(tǒng)器官類別(SOC),收集報(bào)告30 999份。主要上報(bào)國(guó)家是美國(guó);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(bào)告的ADE信號(hào)包括中性粒細(xì)胞減少癥、白細(xì)胞計(jì)數(shù)降低、脫發(fā)、食欲減退、便秘等。說(shuō)明書未收錄的ADE如大紅細(xì)胞癥、丹毒、日光性雀斑樣痣、免疫功能降低等26個(gè)可疑信號(hào)需給予關(guān)注。結(jié)論 瑞波西利在真實(shí)世界中常見(jiàn)的ADE與說(shuō)明書一致,但也存在一些新的疑似ADE,臨床用藥時(shí)應(yīng)予以重視。
[Key word]
[Abstract]
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.
[中圖分類號(hào)]
[基金項(xiàng)目]
山東省醫(yī)學(xué)會(huì)臨床科研資金-齊魯專項(xiàng)(YXH2022ZX02067)