基于FAERS数据库的注射用紫杉醇（白蛋白结合型）不良事件真实世界研究★

Real-world study of adverse events of paclitaxel for injection (albumin bound) based on the FAERS database★

摘要:

目的 挖掘真实世界中注射用紫杉醇（白蛋白结合型）相关不良事件（ADE）信号，为临床安全合理用药提供参考。方法 在美国食品药品监督管理局不良事件报告系统（FAERS）中检索2004年第1季度至2023年第3季度注射用紫杉醇（白蛋白结合型）的ADE报告，采用报告比值比（ROR）法和贝叶斯可信区间递进神经网络（BCPPN）算法进行信号挖掘，分析其在真实世界中的ADE发生情况。结果 共检测到200个ADE信号，累及22个系统器官分类（SOC），合计报告5 061份，其中女性占比高于男性，年龄主要分布在45岁以上。累及SOC主要包括全身性疾病及给药部位各种反应（23.43%）、血液和淋巴系统疾病（18.55%）、胃肠系统疾病（10.06%）、各类检查（8.32%）、代谢与营养类疾病（5.97%）、各类神经系统疾病（5.10%）等。报告数较多的ADE信号包括嗜中性粒细胞减少症、贫血、血小板减少症、发热性中性粒细胞减少、周围神经病变、脓毒症等；相关性较强的ADE信号主要包括胆道感染、周围感觉神经病变、免疫介导性肝炎、胆管狭窄、黄斑水肿等。挖掘到30个说明书未记录的新型可疑不良反应（ADR），主要包括淋巴细胞减少、心理状态改变、高血糖症、食管炎、多发性神经病等。结论 注射用紫杉醇（白蛋白结合型）在真实世界中的常见不良反应与说明书具有一致性，但存在部分新发现的可疑不良反应，临床用药时应重点关注此类不良反应。

Abstract:

Objective To explore the adverse drug event (ADE) signals associated with paclitaxel for injection (albumin bound) in the real world, in order to provide references for clinically rational and safe medication.Methods ADE reports of paclitaxel for injection (albumin bound) from the first quarter of 2004 to the third quarter of 2023 were retrieved from the FDA Adverse Event Reporting System (FAERS). The reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) method were used to find signals and study how ADEs happen in the real world.Results A total of 200 ADE signals were detected, involving 22 system organ classes (SOC), with 5 061 reports in total. A higher proportion of reports were from females than from males, and the reports were mainly from individuals aged 45 and above. The accumulated SOCs mainly included general disorders and administration site conditions (23.43%), blood and lymphatic system disorders (18.55%), gastrointestinal disorders (10.06%), various examinations (8.32%), metabolic and nutritional disorders (5.97%), and various neurological disorders (5.10%), etc. Neutropenia, anemia, thrombocytopenia, febrile neutropenia, peripheral neuropathy, and sepsis were the ADE signals that were reported the most. On the other hand, ADE signals with strong correlation mainly included biliary infection, peripheral sensory neuropathy, immune-mediated hepatitis, bile duct stenosis, macular edema, etc. A total of 30 new suspected adverse reactions (ADR) not recorded in the drug instruction were found, mainly including lymphopenia, changes in mental status, hyperglycemia, esophagitis, multiple neuropathies, etc.Conclusion The common adverse reactions of paclitaxel for injection (albumin bound) in the real world were consistent with those listed in the drug instruction, but there were some newly discovered suspected adverse reactions. These should be paid special attention to in clinical medication.