Jin Shumin, Chang Mengyuan, Feng Lei, Hao Yiping, Li Wei, Zhou Ying, Jia Ruinan, Li Wěi, Liu Tingting, Zhang Di, Jiang Huihui, Wang Jingtao, Zhao Chuanli, Ji Chunyan, Ye Jingjing, Ji Min
Department of Hematology, Cheeloo College of Medicine, Qilu Hospital, Shandong University, 107 West Culture Road, Lixia District, Jinan, 250012, P.R. China.
Laboratory of Artificial Intelligence for Hematology, Qilu Hospital, Shandong University, Jinan, 250012, P.R. China.
Ann Hematol. 2025 Feb;104(2):1039-1046. doi: 10.1007/s00277-025-06183-7. Epub 2025 Jan 8.
To compare the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) and rhG-CSF in the recovery of neutrophils after induction therapy in ALL patients, PEG-rhG-CSF was injected subcutaneously within 24 ~ 48 h after the end of intravenous infusion of daunorubicin/idarubicin during induction chemotherapy. In rhG-CSF group, patients were given rhG-CSF. The main outcome indexes were the incidence and duration of grade 4 chemotherapy-induced-neutropenia (CIN, ANC less than 0.5 × 10/L), the incidence of severe agranulocytosis (ANC less than 0.2 × 10/L). The incidence of grade 4 CIN in the PEG-rhG-CSF group was significantly lower than that in the rhG-CSF group (P = 0.007). There was no significant difference in the incidence of severe neutrophil deficiency and the median time of neutrophil deficiency in PEG-rhG-CSF group and rhG-CSF group. There was no significant difference in day 28 complete response (CR) rate of bone marrow cytology between the two groups (P = 0.985). Compared with rhG-CSF, PEG-rhG-CSF can reduce the incidence of agranulocytosis after induction chemotherapy in newly diagnosed ALL patients, without affecting the efficacy of chemotherapy. Meanwhile, it can reduce the pain of patients, with good safety and tolerance.
为比较聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)与重组人粒细胞集落刺激因子(rhG-CSF)在急性淋巴细胞白血病(ALL)患者诱导化疗后中性粒细胞恢复中的疗效和安全性,在诱导化疗期间柔红霉素/伊达比星静脉输注结束后24至48小时内皮下注射PEG-rhG-CSF。在rhG-CSF组,患者接受rhG-CSF治疗。主要观察指标为4级化疗诱导的中性粒细胞减少症(CIN,中性粒细胞绝对值[ANC]低于0.5×10⁹/L)的发生率和持续时间、严重粒细胞缺乏症(ANC低于0.2×10⁹/L)的发生率。PEG-rhG-CSF组4级CIN的发生率显著低于rhG-CSF组(P = 0.007)。PEG-rhG-CSF组和rhG-CSF组严重中性粒细胞缺乏症的发生率及中性粒细胞缺乏的中位时间无显著差异。两组骨髓细胞学28天完全缓解(CR)率无显著差异(P = 0.985)。与rhG-CSF相比,PEG-rhG-CSF可降低新诊断ALL患者诱导化疗后粒细胞缺乏症的发生率,且不影响化疗疗效。同时,它可减轻患者疼痛,安全性和耐受性良好。