Yang F, Sun X D, Yuan L, Zhang J C, Hu J W, Liu N, Lou X, Su Y F, Yu Z Y, Chen J L, Li Y H, Hu L D, Chen H, Jiang M
Department of Hematopoietic Stem Cell Transplantation, Affiliated Hospital to Academy of Military Medical Sciences, Beijing 100071, China.
Zhonghua Xue Ye Xue Za Zhi. 2017 Oct 14;38(10):831-836. doi: 10.3760/cma.j.issn.0253-2727.2017.10.002.
To observe the efficacy and safety between Pegfilgrastim (PEG-rhG-CSF) and Recombinant human granulocyte colony stimulating factor (rhG-CSF) in hematological malignancy after allogeneic hematopoietic stem cell transplantation (allo-HSCT) . 157 patients after allo-HSCT were enrolled in this study from June 2015 to November 2016. Two agents of G-CSF were used to stimulate hematopoietic recovery after transplantation. There were 65 cases in PEG-rhG-CSF and 92 cases in rhG-CSF groups. Patients in PEG-rhG-CSF group were given a single subcutaneous dose of 6 mg on the first day and +8 d, while cases in rhG-CSF group were given in dose of 5 μg·kg(-1)·d(-1) by subcutaneous injection from +1 d continuing to neutrophils more than 1.5×10(9)/L, and then the indicators and survival rates in two groups after transplantation were compared. ①There were no significant differences of the neutrophil implantation time[13.5 (8-12) d 13 (9-24) d, =0.393] and platelet implantation time [14 (9-160) d 14 (9-92) d, =0.094] between PEG-rhG-CSF and rhG-CSF groups respectively. There were no significant differences in terms of neutropenia period (=0.435) , number of cases who got fever during neutropenia (=0.622) , and the median time of fever in neutropenia period (=0.460) , respectively between the two groups. There were no significant differences of erythrocyte and platelet transfusions (=0.074, =0.059) within 1 month after transplantation. ②There were no significant differences with regard to the incidences of acute GVHD[23.1% (15/65) 34.8% (32/92) , =0.115], chronic GVHD[20.0% (13/65) 32.6% (32/92) , =0.081], Ⅱ-Ⅳdegree of acute GVHD[30.0% (13/65) 30.4% (30/92) , =0.287] and extensive chronic GVHD[9.2% (6/65) 20.7% (19/92) , =0.135] between PEG-rhG-CSF and rhG-CSF groups. ③There were no significant differences in terms of disease free survival (DFS) (62.5% 61.4%, =0.478) and overall survival (OS) (67.4% 67.3%, =0.718) between PEG-rhG-CSF and rhG-CSF groups. ④There was no significant difference of the non-relapse mortality (NRM) between PEG-rhG-CSF and rhG-CSF groups[20.5% (95% 11.4%-37.0%) 32.6% (95% 22.2%-47.9%) , =0.141]. The relapse rate was not statistically significant[14.9% (95% 7.4%-29.8%) 10.0% (95% 5.0%-20.0%) , =0.299]. Compared with rhG-CSF, PEG-rhG-CSF could reduce the times of injection. There were no differences in terms of hematopoietic recovery, the incidence of GVHD, relapse rate, DFS and OS rates after allo-HSCT between two groups.
观察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）在异基因造血干细胞移植（allo-HSCT）后血液系统恶性肿瘤中的疗效及安全性。2015年6月至2016年11月，157例allo-HSCT术后患者纳入本研究。移植后使用两种G-CSF制剂刺激造血恢复。PEG-rhG-CSF组65例，rhG-CSF组92例。PEG-rhG-CSF组患者于第1天和+8天皮下注射单次剂量6mg，而rhG-CSF组患者从+1天开始以5μg·kg⁻¹·d⁻¹的剂量皮下注射，持续至中性粒细胞超过1.5×10⁹/L，然后比较两组移植后的指标及生存率。①PEG-rhG-CSF组与rhG-CSF组中性粒细胞植入时间[13.5（8 - 12）天对13（9 - 24）天，P = 0.393]和血小板植入时间[14（9 - 160）天对14（9 - 92）天，P = 0.094]分别无显著差异。两组在中性粒细胞减少期（P = 0.435）、中性粒细胞减少期发热病例数（P = 0.622）及中性粒细胞减少期发热中位时间（P = 0.460）方面均无显著差异。移植后1个月内红细胞和血小板输注量（P = 0.074，P = 0.059）也无显著差异。②PEG-rhG-CSF组与rhG-CSF组急性移植物抗宿主病（GVHD）发生率[23.1%（15/65）对34.8%（32/92），P = 0.115]、慢性GVHD发生率[20.0%（13/65）对32.6%（32/92），P = 0.081]、Ⅱ - Ⅳ度急性GVHD发生率[30.0%（13/65）对30.4%（30/92），P = 0.287]及广泛慢性GVHD发生率[9.2%（6/65）对20.7%（19/92），P = 0.135]均无显著差异。③PEG-rhG-CSF组与rhG-CSF组无病生存（DFS）率（62.5%对61.4%，P = 0.478）和总生存（OS）率（67.4%对67.3%，P = 0.718）无显著差异。④PEG-rhG-CSF组与rhG-CSF组非复发死亡率（NRM）无显著差异[20.5%（95%CI 11.4% - 37.0%）对32.6%（95%CI 22.2% - 47.9%），P = 0.141]。复发率无统计学意义[14.9%（95%CI 7.4% - 29.8%）对10.0%（95%CI 5.0% - 20.0%），P = 0.299]。与rhG-CSF相比，PEG-rhG-CSF可减少注射次数。两组在allo-HSCT后的造血恢复、GVHD发生率、复发率、DFS和OS率方面无差异。
