Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF) -: results of a prospective randomised monocentre study
Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF) -: results of a prospective randomised monocentre study
复制标题
DOI：
10.1038/sj.bmt.1703136
复制
发表时间：
2001-08-01
影响因子：
4.8
通讯作者：
Nürnberger, W
中科院分区：
文献类型：
--
作者：
Bönig, H;Silbermann, S;Nürnberger, W
造血生长因子粒细胞集落刺激因子（G-CSF）的发现通过减轻化疗后中性粒细胞减少症降低了癌症患者感染相关的发病率。有两种重组人（rh）G-CSF制剂，一种糖基化，一种非糖基化。糖基化形式来格司亭在体外具有至少25%的生物活性。一些对该制剂动员造血干细胞潜力的比较研究表明了类似的优势。鉴于G-CSF的临床重要性，我们对化疗诱导的中性粒细胞减少症儿童进行了首次前瞻性、随机、交叉研究。化疗阻断后第1天开始给予G-CSF（250 mg/m2），连续3天直至WBC > 1500/穆尔。研究了11例患者（16例来格司亭，17例非格司亭）的33个G-CSF周期。对他们进行了非常严重（WBC < 500/穆尔，9 vs 9.5天，来格司亭vs非格司亭，中位数）和严重白细胞减少症（WBC < 1000/穆尔，11 vs 11天）、感染（CRP >5 mg/dl，5 vs 5.5天）、感染相关住院时间（11 vs 9天）和抗生素治疗（9 vs 9天）的研究。通过配对分析进行的统计学评价无法检测到治疗组之间的任何差异;所有终点的中位差异为零。总之，至少在250 μ g/ml时，就其对中性粒细胞减少症的临床作用而言，两种G-CSF制剂似乎具有相同的活性。
The discovery of the haematopoietic growth factor granulocyte colony-stimulating factor (G-CSF) has reduced infection-related morbidity in cancer patients by alleviating post-chemotherapy neutropenia. Two formulations of recombinant human (rh) G-CSF, one glycosylated and one non-glycosylated, are available. The glycosylated form, lenograstim, possesses at least 25% greater bioactivity in vitro. Some comparative studies into the preparation's potential to mobilise haematopoietic stem cells suggest a similar advantage. In the light of the great clinical importance of G-CSF, we have performed the first prospective, randomised, crossover study on children with chemotherapy-induced neutropenia. G-CSF (250 mg/m(2)) was started I day after the chemotherapy block, and was administered until a WBC > 1500/mul was achieved on 3 successive days. Thirty-three G-CSF cycles from 11 patients (16 lenograstim, 17 filgrastim) were studied. They were investigated for duration of very severe (WBC < 500/mul, 9 vs 9.5 days, lenograstim vs filgrastim, median) and severe leukopenia (WBC < 1000/mul, 11 vs 11 days), infections (CRP >5 mg/dl, 5 vs 5.5 days), infection-related hospital stay (11 vs 9 days) and antibiotic treatment (9 vs 9 days). Statistical evaluation by paired analysis could not detect any difference between treatment groups; the median difference for all end-points was zero. In summary, at least at 250 mug/ml, in terms of their clinical effect on neutropenia, the two G-CSF preparations appear to have identical activity.