国产 rhG-CSF 预防肿瘤化疗所致白细胞减少的Ⅱ期临床研究

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目的:考察国产重组人粒细胞集落刺激因子(rhG-CSF)对化疗患者的中性粒细胞的影响。方法:96例经病理检查证实的恶性肿瘤,包括肺癌、恶性淋巴瘤、乳癌、卵巢癌等四种肿瘤病例,分别使用同样方案和剂量的化疗并采用交叉自身配对对照的方法,对这些化疗病例同时加用或不加用重组人粒细胞集落刺激因子注射液(吉粒芬)作对照研究,比较两组病人中性粒细胞绝对数(ANC)的动态变化。结果:192个疗程不同化疗方案治疗几种肿瘤,并用国产rhG-CSF者,粒细胞减少症持续天数,ANC减少(<2.0×109/L)的发生率,化疗后ANC最低值以及因ANC过低致下一疗程化疗推迟的发生率,均优于空白对照组。注射国产rhG-CSF24小时后ANC迅速升高,多于第10~14天ANC恢复至正常或更高水平。本组观察国产rhG-CSF除轻微肾瘤、肌肉痛外未见明显毒副反应。结论:国产rhG-CSF可减轻化疗后ANC降低的程度,缩短粒细胞缺乏症的持续时间,促进ANC的恢复,无明显毒副反应,可作为肿瘤化疗中有价值的辅助药物。 Objective: To investigate the effect of domestic recombinant human granulocyte colony-stimulating factor (rhG-CSF) on neutrophil in patients with chemotherapy. Methods: Ninety-six malignant tumors confirmed by pathological examination, including lung cancer, malignant lymphoma, breast cancer, and ovarian cancer, were treated with the same regimen and dose of chemotherapy and crossed self-matched controls. At the same time with or without the use of recombinant human granulocyte colony stimulating factor injection (Jifenfen) as a controlled study, the dynamic changes in the absolute number of neutrophils (ANC) were compared between the two groups of patients. Results: 192 different chemotherapy regimens were used to treat several types of tumors, with domestic rhG-CSF, the days of neutropenia, the incidence of ANC decrease (<2.0×109/L), and the lowest ANC value after chemotherapy. The incidence of delayed chemotherapy for the next course of chemotherapy was lower than the control group. After injection of domestically produced rhG-CSF for 24 hours, ANC rapidly increased, and ANC returned to normal or higher levels on day 10 to 14 after injection. Observed in this group of domestic rhG-CSF except minor renal tumor, muscle pain, no obvious side effects. Conclusion: Domestically produced rhG-CSF can reduce the degree of ANC reduction after chemotherapy, shorten the duration of agranulocytosis, promote the recovery of ANC, and have no obvious toxic and side effects. It can be used as a valuable adjuvant drug in cancer chemotherapy.
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