聚乙二醇化重组人G-CSF促进淋巴瘤患者自体造血干细胞移植后造血重建的效果及安全性

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.