目的 采用美國(guó)FDA不良事件自發(fā)呈報(bào)系統(tǒng)（FAERS）數(shù)據(jù)庫(kù)對(duì)阿哌沙班不良事件（AE）信號(hào)進(jìn)行挖掘，為臨床藥物治療監(jiān)測(cè)提供參考。方法 從FAERS數(shù)據(jù)庫(kù)中篩選2013年4月—2024年3月的阿哌沙班AE報(bào)告，完成數(shù)據(jù)清洗后采用報(bào)告比值比（ROR）、比例報(bào)告比（PRR）和貝葉斯可信傳播神經(jīng)網(wǎng)絡(luò)法（BCPNN） 3種方法對(duì)AE信號(hào)進(jìn)行挖掘和分析。結(jié)果 獲得了124 098份與阿哌沙班相關(guān)的AE報(bào)告，挖掘出AE 331個(gè)，涉及9個(gè)系統(tǒng)器官分類(lèi)（SOC），占比前3的SOC分別是各類(lèi)神經(jīng)系統(tǒng)疾?。?2.22%），各類(lèi)損傷、中毒及操作并發(fā)癥（11.72%）和胃腸系統(tǒng)疾?。?.78%）。出血及相關(guān)AE是阿哌沙班主要的AE，與說(shuō)明書(shū)描述一致。9個(gè)藥品說(shuō)明書(shū)未提到的AE：心瓣膜疾病、房顫、心臟疾病、二尖瓣疾病、跌倒、新型冠狀病毒肺炎（COVID-19）、感染性肺炎、癡呆和惡性腫瘤。結(jié)論 阿哌沙班在真實(shí)世界中發(fā)生的常見(jiàn)AE與說(shuō)明書(shū)一致，同時(shí)還存在部分新的AE信號(hào)，提示臨床用藥應(yīng)該密切關(guān)注，保證患者用藥安全。

Objective To conduct adverse event signal detection of apixaban using data from the US FDA Adverse Event Reporting System (FAERS) database, providing reference for clinical drug therapy monitoring. Methods Adverse event (AE) reports related to apixaban were extracted from the FAERS database covering the period from April 2013 to March 2024. After data cleaning, three methods—reporting odds ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN)—were employed to detect and analyze the adverse event signals. Results A total of 124 098 AE reports related to apixaban were obtained, uncovering 331 AEs, which were categorized into nine System Organ Classes (SOCs). The top three SOCs by proportion were Nervous System Disorders (12.22%), Injury, Poisoning and Procedural Complications (11.72%), and Gastrointestinal Disorders (8.78%). The results indicated that bleeding and related AEs were the primary adverse events for apixaban, consistent with the drug’s label information. In addition, this study identified nine AEs not mentioned in the drug’s label: valvular heart disease, atrial fibrillation, cardiac disorders, mitral valve disease, falls, COVID-19, infectious pneumonia, dementia, and malignant tumors. Conclusion The common AEs of apixaban observed in the real world were consistent with the drug’s label, but there were also several new AE signals. This suggests that close monitoring is essential in clinical practice to ensure patient safety.

R973

湖北省自然科學(xué)基金面上項(xiàng)目（2022CFB092）;吳階平醫(yī)學(xué)基金會(huì)臨床科研專(zhuān)項(xiàng)（320.6750.2023-25-5）