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聚乙二醇化重组人粒细胞集落刺激因子对淋巴瘤患者自体造血干细胞移植后造血重建的疗效及安全性

[Effect and safety of pegylated recombinant human G-CSF on hematopoietic reconstitution after autologous hematopoietic stem cell transplantation in lymphoma patients].

作者信息

Shen Y G, Ji M M, Zheng Z, Tang W, Zhao W L

机构信息

Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2022 Nov 14;43(11):940-945. doi: 10.3760/cma.j.issn.0253-2727.2022.11.010.

DOI:10.3760/cma.j.issn.0253-2727.2022.11.010
PMID:36709186
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9808863/
Abstract

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. 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. 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 (=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% 82.4% , =0.798) , but the duration was shorter in the PEG-rhG-CSF group (4.0 d 5.5 d, =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 (=0.247) , and the bloodstream infection incidence were 5.3% (4/75) and 9.5% (7/74) , respectively (=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 (<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) % (=0.638) , respectively, and the OS rates were 100.0% and (98.6±1.3) % (=0.312) , respectively. 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.

摘要

聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)对淋巴瘤患者自体造血干细胞移植(auto-HSCT)后促进造血恢复的疗效及安全性分析。2016年4月至2021年12月,上海交通大学医学院附属瑞金医院共纳入149例auto-HSCT术后患者。PEG-rhG-CSF组75例,于第1天和+8天皮下单次注射100 μg/kg;重组人粒细胞集落刺激因子(rhG-CSF)组74例,从+1天开始皮下注射,剂量为5-10 μg·kg⁻¹·d⁻¹,持续至中性粒细胞绝对值(ANC)超过1.5×10⁹/L。①PEG-rhG-CSF组3/4级粒细胞缺乏症及中性粒细胞植入时间与rhG-CSF组差异有统计学意义(P = 0.010、0.030、0.007)。两组间血小板植入时间、移植后1个月内贫血发生率及持续时间、血小板及红细胞输注情况差异无统计学意义。②PEG-rhG-CSF组粒细胞缺乏伴发热发生率与rhG-CSF组相似(84.0%对82.4%,P = 0.798),但PEG-rhG-CSF组持续时间较短(4.0天对5.5天,P = 0.005)。③PEG-rhG-CSF组和rhG-CSF组感染发生率分别为22.7%(17/75)和31.1%(23/74)(P = 0.247),血流感染发生率分别为5.3%(4/75)和9.5%(7/74)(P = 0.336)。④PEG-rhG-CSF组和rhG-CSF组平均住院时间分别为31.5(23-43)天和37(25-75)天(P<0.001)。⑤PEG-rhG-CSF组和rhG-CSF组无病生存率分别为(96.4±2.5)%和(94.7±2.6)%(P = 0.638),总生存率分别为100.0%和(98.6±1.3)%(P = 0.312)。淋巴瘤患者auto-HSCT后应用PEG-rhG-CSF可促进造血粒细胞重建并缩短住院时间,但对移植后感染发生率、无病生存及总生存无显著影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f98/9808863/8842f0d5cdb8/cjh-43-11-940-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f98/9808863/8842f0d5cdb8/cjh-43-11-940-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f98/9808863/8842f0d5cdb8/cjh-43-11-940-g001.jpg

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BuCyE can safely replace BEAM as a conditioning regimen for autologous stem cell transplantation in the treatment of refractory and relapsed lymphomas.BuCyE 可安全替代 BEAM 作为自体干细胞移植治疗难治性和复发性淋巴瘤的预处理方案。
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Use of pegfilgrastim primary prophylaxis and risk of infection, by chemotherapy cycle and regimen, among patients with breast cancer or non-Hodgkin's lymphoma.乳腺癌或非霍奇金淋巴瘤患者中,培非格司亭初级预防与化疗周期和方案相关的感染风险。
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