重组人粒细胞-巨噬细胞集落刺激因子Ⅰ期临床耐受性试验与疗效观察

Phase I study of recombinant human granulocyte-macrophageclony-stimulating factor in cancer patients

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：２５、５０、７５μｇ／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；２５、５０、７５μｇ／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。

Nine patients with malignant tumors were administrated with recombinant human granulocyte-macrophage colony-stimulating factor(rhGM-CSF)in phase I clinical tolerant trial and the relationship between doses and the enhancement of white blood cell counts was observed.The results showed that minimal toxicities consisting myalgia,chill,fever,local skin rash,sub-cutaneous node,skin swelling and local pain might occur after subcutaneous injection with 25,50,75 μg/kg doses of rhGM-CSF,but these toxic effects could disappear without any treatment.There were no toxic effect to hepatic function,renal function and cardiac function.The enhancements were seen in white blood cell counts and absolute neutrophil counts with doses of 25,50,75 μg/kg of rhGM-CSF,and the enhancements were larger with doses of 75 μg/kg than that of 25 μg/kg(and 5 μg/kg).