利百多预防肿瘤化疗所致白细胞减少的随机对比Ⅱ期临床研究

来源 :中国肿瘤临床 | 被引量 : 0次 | 上传用户:jojochen812
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目的: 为观察利百多( 国产基因重组人粒细胞/ 巨噬细胞集落刺激因子,rhGM- CSF) 防治实体瘤化疗所致白细胞( WBC) 和中性粒细胞(ANC) 减少的临床效果及不良反应。方法:采用多中心随机分组、自身交叉对照方法,对68 例肿瘤化疗患者随机分成AB 组和BA 组。AB 组第一周期化疗加利百多治疗( 治疗组) , 第二周期单用化疗( 对照组) ;BA 组则第一周期单用化疗,第二周期化疗加利百多治疗。60 例可供临床疗效分析。结果:利百多可明显减轻化疗所致WBC 和ANC 下降程度, 缩短WBC 和ANC 降至正常值以下的持续时间,促进WBC 和ANC 的早日恢复,有助于化疗按期进行。结论:利百多对化疗所致白细胞减少有明显预防作用。主要不良反应有轻中度发热,注射部位疼痛,乏力。少数有寒战、流涕和皮疹,一般可以耐受。 OBJECTIVE: To observe the clinical effects and adverse effects of Rebaudioside (Domestic recombinant human granulocyte/macrophage colony stimulating factor, rhGM-CSF) on the prevention of leukocyte (WBC) and neutrophils (ANC) reduction caused by solid tumor chemotherapy reaction. Methods: Multicenter randomization and self-crossover control methods were used to randomly divide 68 patients with tumor chemotherapy into groups AB and BA. The first cycle of chemotherapy in group AB was treated with Galetodol (treatment group) and the second cycle was treated with chemotherapy alone (control group). In BA group, chemotherapy was administered in the first cycle and Galeride was administered in the second cycle. 60 cases available for clinical efficacy analysis. Results: Rebaudioid can significantly reduce the extent of chemotherapy-induced WBC and ANC reduction, shorten the duration of WBC and ANC reduction below normal values, and promote the early recovery of WBC and ANC, which is helpful for chemotherapy on schedule. Conclusion: Rebaudioside has a significant preventive effect on leukopenia induced by chemotherapy. The main adverse reactions were mild to moderate fever, pain at the injection site, and fatigue. Few chills, runny noses, and rashes are generally tolerable.
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