论文部分内容阅读
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.