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应用重组人粒细胞-巨噬细胞集落刺激因子对9例肿瘤患者分3种剂量进行了Ⅰ期临床的耐受性试验,同时观察了用药剂量与促进白细胞增殖作用的关系。观察结果:25、50、75μg/kg剂量皮下给药,虽可出现骨肌肉痛、寒战、发热等轻度反应,注射部位局部皮肤可出现红斑、皮下硬结、肿胀、疼痛反应,但病人均可耐受。上述反应无需处理,均可自行缓解;重组人粒细胞-巨噬细胞集落刺激因子对肝功能、肾功能、心功能无影响;25、50、75μg/kg皮下给药,可使化疗后肿瘤患者外周血白细胞总数及中性粒细胞绝对值升高,75μg/kg剂量组的升高中性粒细胞作用强于25及50μg/kg剂量组
Using a recombinant human granulocyte-macrophage colony-stimulating factor, a phase I clinical trial was performed on 3 doses of 9 tumor patients. The relationship between the dose and the leukocyte proliferation was also observed. Observations: Subcutaneous administration at a dose of 2 5, 5 0, 7 5μg/kg, although mild reactions such as musculoskeletal pain, chills, and fever may occur, erythema, subcutaneous induration, swelling, and pain may occur on the local skin of the injection site. Response, but patients can tolerate. The above reaction can be relieved without any treatment; the recombinant human granulocyte-macrophage colony-stimulating factor had no effect on liver function, renal function, and cardiac function; it was administered subcutaneously at 2 5, 5 0, and 7 5 μg/kg. It can increase the total number of white blood cells and neutrophil in peripheral blood of tumor patients after chemotherapy, and the effect of increased neutrophils in the 75μg/kg dose group is stronger than that of 2.5 and 50μg/kg.