Qin Nan, Bian Zhongliu, Chen Jingtao
Department of Propaganda and United Front Office, The First Hospital of Jilin University, Changchun, Jilin Province, China.
Department of Hepatobiliary and Pancreatic Surgery, General Surgery Center, The First Hospital of Jilin University, Changchun, Jilin Province, China.
Sci Rep. 2025 Aug 27;15(1):31602. doi: 10.1038/s41598-025-16848-y.
Nab-paclitaxel (albumin-bound paclitaxel) and traditional paclitaxel are both used in pancreatic cancer treatment, but their adverse event (AE) profiles may differ due to formulation differences. This study compares the safety profiles of Nab-paclitaxel and paclitaxel using the FDA Adverse Event Reporting System (FAERS) database. FAERS data from Q1 2004 to Q2 2024 were analyzed using disproportionality methods, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR), to detect significant AE signals. Adverse events were categorized by system organ classes, and key signals were identified and compared for each drug. Nab-paclitaxel was associated with a higher frequency of severe hematologic and hepatobiliary events, including neutropenia (ROR 44.63; PRR 23.86) and cholangitis (ROR 113.06). Additionally, Nab-paclitaxel had 539 reports of death (27.08%), while paclitaxel had 272 (9.68%). Paclitaxel was more frequently associated with infusion-related hypersensitivity reactions, with 172 cases of flushing and 116 hypersensitivity reactions. Time trends showed a steady increase in Nab-paclitaxel-related AEs, especially hematologic toxicities, suggesting greater risk accumulation over time. Nab-paclitaxel's nanoparticle formulation, while enhancing distribution and clearance properties, is linked to elevated hematologic and hepatic AEs in pancreatic cancer treatment, requiring vigilant patient monitoring.
纳米白蛋白结合型紫杉醇和传统紫杉醇均用于胰腺癌治疗，但由于制剂差异，它们的不良事件（AE）谱可能有所不同。本研究使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库比较纳米白蛋白结合型紫杉醇和紫杉醇的安全性概况。使用不成比例法分析2004年第一季度至2024年第二季度的FAERS数据，包括报告比值比（ROR）和比例报告比值比（PRR），以检测显著的AE信号。不良事件按系统器官类别分类，并对每种药物识别和比较关键信号。纳米白蛋白结合型紫杉醇与严重血液学和肝胆事件的发生率较高相关，包括中性粒细胞减少（ROR 44.63；PRR 23.86）和胆管炎（ROR 113.06）。此外，纳米白蛋白结合型紫杉醇有539例死亡报告（27.08%），而紫杉醇有272例（9.68%）。紫杉醇更常与输液相关的过敏反应相关，有172例潮红和116例过敏反应。时间趋势显示纳米白蛋白结合型紫杉醇相关AE呈稳步上升，尤其是血液学毒性，表明随着时间推移风险积累更大。纳米白蛋白结合型紫杉醇的纳米颗粒制剂虽然增强了分布和清除特性，但在胰腺癌治疗中与血液学和肝脏AE升高有关，需要对患者进行密切监测。
