Objective: Efficacy and safety analysis of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in promoting hematopoietic recovery after autologous hematopoietic stem cell transplantation (auto-HSCT) in patients with lymphoma. Methods: A total of 149 patients after auto-HSCT in Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine were enrolled in this study from April 2016 to December 2021. There were 75 cases in the PEG-rhG-CSF group who were given a single subcutaneous dose of 100 µg/kg on the first day and +8 d, while 74 cases in the rhG-CSF group were given a dose of 5-10 µg·kg(-1)·d(-1) by subcutaneous injection from +1d continuing to an absolute value of neutrophil (ANC) of more than 1.5×10(9)/L. Results: ①The time of grade 3/4 agranulocytosis and neutrophil implantation in the PEG-rhG-CSF group were significantly different from that in rhG-CSF group (P=0.010, 0.030, 0.007) . There were no significant differences in the platelet implantation time, anemia incidence and duration, and platelet and red blood cell infusion within 1 month after transplantation between groups. ②The agranulocytosis with fever incidence in PEG-rhG-CSF group was similar to that in rhG-CSF group (84.0% vs 82.4% , P=0.798) , but the duration was shorter in the PEG-rhG-CSF group (4.0 d vs 5.5 d, P=0.005) . ③The incidence of infection in the PEG-rhG-CSF and the rhG-CSF groups were 22.7% (17/75) and 31.1% (23/74) , respectively (P=0.247) , and the bloodstream infection incidence were 5.3% (4/75) and 9.5% (7/74) , respectively (P=0.336) . ④The PEG-rhG-CSF group and rhG-CSF group's mean length of hospital stay were 31.5 (23-43) days and 37 (25-75) days, respectively (P<0.001) . ⑤The PEG-rhG-CSF group and rhG-CSF group's disease-free survival rates were (96.4±2.5) % and (94.7±2.6) % (P=0.638) , respectively, and the OS rates were 100.0% and (98.6±1.3) % (P=0.312) , respectively. Conclusion: PEG-rhG-CSF application after auto-HSCT in patients with lymphoma can promote hematopoietic granulocyte reconstruction and shorten hospital stay, but has no significant effect on the incidence of infection, disease-free survival, and overall survival after transplantation.
目的： 观察聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）在淋巴瘤患者自体造血干细胞移植（auto-HSCT）后促进造血重建的效果及安全性。 方法： 对2016年4月至2021年12月上海交通大学医学院附属瑞金医院149例接受auto-HSCT的淋巴瘤患者进行回顾性分析。75例于移植后第1、8天分别给予PEG-rhG-CSF 100 μg/kg皮下注射1次；74例于移植后第1天开始予以重组人粒细胞集落刺激因子（rhG-CSF）5~10 µg·kg(-1)·d(-1)皮下注射，至中性粒细胞绝对计数（ANC）>1.5×10(9)/L持续3 d停药。 结果： ①PEG-rhG-CSF组、rhG-CSF组中性粒细胞植入时间分别为9.5（7~17）d、10（8~22）d（P＝0.007），3级粒细胞缺乏持续时间分别为2（0~7）d、1.5（0~4）d（P＝0.030），4级粒细胞缺乏持续时间分别为9（5~16）d、9.5（6~23）d（P＝0.010）；血小板植入时间、Ⅳ级贫血发生率及持续时间及移植后1个月内血小板输注量、红细胞输注量差异均无统计学意义（P值均>0.05）。②PEG-rhG-CSF组、rhG-CSF组粒细胞缺乏伴发热的发生率分别为84.0%（63/75）、82.4%（61/74）（P＝0.798），中位持续时间分别为4（1~10）d、5.5（1~24）d（P＝0.005）。③PEG-rhG-CSF组、rhG-CSF组感染发生率分别为22.7%（17/75）、31.1%（23/74）（P＝0.247），血流感染发生率分别为5.3%（4/75）、9.5%（7/74）（P＝0.336）。④PEG-rhG-CSF组、rhG-CSF组住院天数分别为31.5（23~43）d、37（25~75）d（P<0.001）。⑤PEG-rhG-CSF组、rhG-CSF组移植后6个月无病生存（DFS）率分别为（96.4±2.5）%、（94.7±2.6）%（P＝0.638），总生存（OS）率分别为100.0%、（98.6±1.3）%（P＝0.312）。 结论： 淋巴瘤患者auto-HSCT后应用PEG-rhG-CSF在促进中性粒细胞植入、缩短粒细胞缺乏伴发热持续时间方面优于rhG-CSF，移植后感染发生率、移植后6个月DFS率及OS率与rhG-CSF无显著差异。.
Keywords: Autologous stem cell transplantation; Lymphoma; Pegylated Recombinant human colony-stimulating factor; Recombinant human colony-stimulating factor.