Qu Ying, Zuo Li'an, Zhang Shuting, Zhou Wanyi, Chen Rong
Department of Pharmacy, The First People's Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, ChangZhou, Jiang Su, 213003, China.
Department of Pharmacy, The First People's Hospital of Changzhou/The Third Affiliated Hospital of Soochow University, ChangZhou, Jiang Su, 213003, China.
Clin Ther. 2025 Aug;47(8):624-630. doi: 10.1016/j.clinthera.2025.04.017. Epub 2025 May 22.
Granulocyte-colony stimulating factor (G-CSF) is widely acknowledged for its efficacy in managing chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN), albeit accompanied by a spectrum of potential adverse effects. This study conducted a comprehensive analysis utilizing real-world data sourced from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, spanning the years 2004 to 2023, to assess and compare adverse events (AEs) associated with recombinant human G-CSF (rhG-CSF) and its polyethylene glycol-modified form (PEG-rhG-CSF).
A comprehensive analysis was conducted using FAERS data to evaluate the reporting proportion of AEs, gender-based disparities, and specific AEs such as bone pain. Statistical analyses included Reporting Odds Ratio (ROR) calculations and comparisons of median time to AE onset between PEG-rhG-CSF and rhG-CSF.
The study revealed that PEG-rhG-CSF was associated with a significantly higher number of adverse events (AEs) compared to rhG-CSF (76,155 vs. 10,953 cases). Female patients experienced a higher reporting proportion of AEs than males for both treatments, with PEG-rhG-CSF showing 54.2% of cases in females and rhG-CSF showing 46.1%, compared to 27.1% and 34.7% in males, respectively. Bone pain emerged as the most common AE, with PEG-rhG-CSF linked to 2,473 cases and rhG-CSF to 581 cases, and a higher reporting odds ratio (ROR = 1.17, 95% CI: 1.07-1.29) for PEG-rhG-CSF. Additionally, the median time to onset of AEs was shorter for PEG-rhG-CSF (3 days, IQR: 1-9) than for rhG-CSF (9 days, IQR: 2-42). Delayed AEs, such as splenomegaly, capillary leak syndrome, interstitial lung disease, and lung infiltration, were also identified, emphasizing the importance of close patient follow-up.
The study highlights significant differences in AE reporting proportion, gender disparities, and onset timing between PEG-rhG-CSF and rhG-CSF. These findings emphasize the need for close patient monitoring, especially for delayed AEs that may manifest after discharge. Further assessment of real-world data is warranted.
粒细胞集落刺激因子（G-CSF）在治疗化疗引起的中性粒细胞减少症（CIN）和发热性中性粒细胞减少症（FN）方面的疗效已得到广泛认可，尽管它会伴随一系列潜在的不良反应。本研究利用来自美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库的真实世界数据进行了全面分析，该数据库涵盖2004年至2023年，以评估和比较与重组人G-CSF（rhG-CSF）及其聚乙二醇修饰形式（PEG-rhG-CSF）相关的不良事件（AE）。
使用FAERS数据进行全面分析，以评估AE的报告比例、基于性别的差异以及特定的AE，如骨痛。统计分析包括报告比值比（ROR）计算以及PEG-rhG-CSF和rhG-CSF之间AE发作中位时间的比较。
研究表明，与rhG-CSF相比，PEG-rhG-CSF相关的不良事件数量显著更多（76,155例对10,953例）。两种治疗中，女性患者的AE报告比例均高于男性，PEG-rhG-CSF女性患者占54.2%，rhG-CSF女性患者占46.1%，而男性分别为27.1%和34.7%。骨痛是最常见的AE，PEG-rhG-CSF有2,473例，rhG-CSF有581例，PEG-rhG-CSF的报告比值比更高（ROR = 1.17，95% CI：1.07 - 1.29）。此外，PEG-rhG-CSF的AE发作中位时间（3天，IQR：1 - 9）比rhG-CSF（9天，IQR：2 - 42）更短。还发现了延迟出现的AE，如脾肿大、毛细血管渗漏综合征、间质性肺疾病和肺部浸润，这强调了密切随访患者的重要性。
该研究突出了PEG-rhG-CSF和rhG-CSF在AE报告比例、性别差异和发作时间方面的显著差异。这些发现强调了密切监测患者的必要性，特别是对于出院后可能出现的延迟AE。有必要进一步评估真实世界数据。
