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目的:观察rbGM-CSF(重组人粒细胞-巨噬细胞集落刺激因子)预防和治疗肿瘤化疗所致白细胞(WBC)和中性粒细胞(ANC)减少的临床疗效和毒性反应。方法:采用随机自身交叉对照临床研究的方法,对64例病人进行化疗和rhGM-CSF治疗,每一例病人连续观察2个周期。AB组病人第1周期为治疗组(A周期),采用化疗加rhGM-CSF治疗,第2周期为对照组(B周期),采用单纯化疗;BA组病人第1周期为对照组(B周期)采用单纯化疗,第2周期为治疗组(A周期)采用化疗加rhGM-CSF治疗。结果:59例病人可评价疗效,治疗组WBC和ANC下降持续天数明显少于对照组,同时,WBC和ANC最低值也高于对照组,并且最低值时的中位化疗序日也比对照组明显提前,第21天时,治疗组WBC和ANC数值明显高于对照组,化疗延迟的例数治疗组明显少于对照组。结论:rhGM-CSF对化疗所致的白细胞和中性粒细胞减少具有明显的预防和治疗作用,保证化疗如期进行,不良反应可以耐受。
Objective: To observe the clinical efficacy and toxicity of rbGM-CSF (recombinant human granulocyte-macrophage colony stimulating factor) in preventing and treating the reduction of white blood cells (WBC) and neutrophils (ANC) caused by chemotherapy. METHODS: Sixty-four patients were treated with chemotherapy and rhGM-CSF using a randomized, self-crossover, controlled clinical study. Each patient was continuously observed for 2 cycles. The first cycle of the AB group was the treatment group (A cycle), treated with chemotherapy plus rhGM-CSF, the second cycle was the control group (B cycle), and chemotherapy alone; the first cycle of the BA group was the control group (B cycle) With chemotherapy alone, the second cycle of treatment group (A cycle) was treated with chemotherapy plus rhGM-CSF. RESULTS: A total of 59 patients could be evaluated for efficacy. The duration of WBC and ANC decline in the treatment group was significantly shorter than that in the control group. At the same time, the lowest WBC and ANC values were also higher than those in the control group, and the median of the lowest chemotherapy time was also higher than that of the control group. Obviously ahead of schedule, on the 21st day, WBC and ANC values in the treatment group were significantly higher than those in the control group. The number of delayed chemotherapy cases was significantly lower in the treatment group than in the control group. Conclusion: rhGM-CSF has obvious preventive and therapeutic effects on leucocyte and neutropenia induced by chemotherapy, ensuring that chemotherapy can be performed on schedule and adverse reactions can be tolerated.