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重组人粒细胞-巨噬细胞集落刺激因子(rhGM-CSF)是通过基因工程方法产生的细胞因子,对肿瘤化疗、放疗引起的粒细胞减少症,继发感染与免疫功能低下具有明显的治疗作用。为考察国产rhGM-CSF的毒性反应及耐受剂量,初步了解治疗白细胞减少的疗效,对13例住院的肿瘤患者进行了国产rhG-M-CSF的Ⅰ期临床试验。试验设置1.25μg/kg、2.5μg/kg、5μg/kg、7.5μg/kg四个剂量组,每例用药7天。共用药91人次,观察到10种不良反应,但均可以耐受。同时初步观察到2.5、5.0、7.5μg/kg三个剂量组都有不同程度的升高白细胞作用。
Recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) is a cytokine produced by genetic engineering methods and has a significant therapeutic effect on tumor neutropenia caused by chemotherapy and radiotherapy, and secondary infection and immune dysfunction. . To investigate the toxic response and tolerated dose of domestic rhGM-CSF, a preliminary understanding of the efficacy of leukopenia treatment was performed. A phase I clinical trial of domestic rhG-M-CSF was performed on 13 patients with inpatients with cancer. Tests were conducted in four dose groups of 1.25 μg/kg, 2.5 μg/kg, 5 μg/kg, and 7.5 μg/kg, each for 7 days. There were 91 common drugs and 10 adverse reactions were observed but all were tolerable. At the same time, it was initially observed that the 2.5, 5.0, and 7.5 μg/kg dose groups had different degrees of increased leukocyte activity.