Table2_Adverse event profile of albumin-bound paclitaxel: a real-world pharmacovigilance analysis.DOCX

BackgroundAbraxane plays a crucial role in the treatment of various types of cancer, despite the considerable attention it has garnered for its adverse drug events (ADEs). Nevertheless, there is currently a significant lack of comprehensive real-world pharmacovigilance studies on the ADEs associated with Abraxane.
MethodsWe conducted a retrospective analysis of ADEs associated with Abraxane using data mining from the FAERS database, analyzing data from 2005 to 2023. In a real-world setting, we quantified and visualized the signals of these ADEs using four pharmacovigilance algorithms.
ResultsThe FAERS database identified a total of 10,230 adverse event reports associated with Abraxane. The study revealed that Abraxane-related adverse drug events involved 27 system organ classes (SOC), with the strongest signals associated with the lymphatic and hematological systems and hepatobiliary disorders. Additionally, we identified 70 significant Preferred Terms (PT) signals, which included some critical adverse events not highlighted in the product labeling, such as cystoid macular edema. Further analysis of the timing of adverse reactions showed a median onset time of 41 days. Most adverse events (AEs) occurred within the first month of using Abraxane (43.5%), although some were still possible 1 year after treatment (3.5%). Gender-specific analysis indicated that high-risk AEs differed between females (nausea, vomiting, and erythema) and males (febrile neutropenia, disseminated intravascular coagulation, and upper gastrointestinal bleeding).
ConclusionThe examined results provide crucial recommendations for optimizing the administration of Abraxane, enhancing its effectiveness, and mitigating potential adverse effects. This knowledge will substantially facilitate the implementation of the substance in clinical settings.

背景 尽管白蛋白结合型紫杉醇（Abraxane）因不良药物事件（Adverse Drug Events, ADEs）受到广泛关注，但其在多种癌症的治疗中仍发挥着关键作用。然而，当前针对与Abraxane相关的不良药物事件，尚缺乏全面的真实世界药物警戒研究。
方法 本研究借助FAERS数据库（FDA Adverse Event Reporting System, FAERS）的数据挖掘技术，对2005年至2023年的相关数据开展回顾性分析以探究Abraxane相关不良药物事件；在真实世界场景下，本研究采用4种药物警戒算法对这些不良事件信号进行量化与可视化处理。
结果 FAERS数据库共收录10230份与Abraxane相关的不良事件报告。研究显示，Abraxane相关不良药物事件涉及27个系统器官分类（System Organ Classes, SOC），其中信号强度最高的为淋巴与血液系统、肝胆系统疾病。此外，本研究共识别出70个具有统计学意义的首选术语（Preferred Terms, PT）信号，其中包含部分未在产品说明书中明确标注的严重不良事件，如囊样黄斑水肿。对不良反应发生时间的进一步分析表明，中位发病时间为41天。多数不良事件（Adverse Events, AEs）发生在使用Abraxane后的首个月内（43.5%），虽有3.5%的不良事件可在治疗后1年出现。性别特异性分析显示，男女患者的高风险不良事件存在差异：女性为恶心、呕吐与红斑，男性则为发热性中性粒细胞减少症、弥散性血管内凝血与上消化道出血。
结论 本研究结果为优化Abraxane的临床给药方案、提升治疗效果以及降低潜在不良反应提供了重要参考依据，该研究成果将有力推动该药物在临床实践中的合理应用。