【摘要】 目的 :观察国产重组人粒细胞集落刺激因子 (rhG CSF)防治实体瘤化疗所致白细胞 (WBC)和中性粒细胞 (ANC)减少的临床疗效和不良反应。方法 :采用多中心、随机自身交叉对照方法将 6 9例入组的肿瘤化疗患者随机分成AB组和BA组。AB组第 1周期为治疗周期 (A周期 ) ,采用化疗加rhG CSF ,第 2周期为对照周期 (B周期 ) ,单纯化疗。BA组第 1周期单纯化疗 ,第 2周期化疗加G CSF。比较 2周期WBC和ANC变化并观察不良反应。结果 :6 0例可供疗效分析及评价不良反应。A周期WBC下降及ANC下降持续的天数明显少于B周期 (P <0 .0 1) ;A周期WBC ,ANC最低值显著高于B周期 (P <0 .0 1) ;化疗 2 1d时因WBC <4.0× 10 9·L-1而延迟化疗的发生率在A周期明显低于B周期 (P <0 .0 1)。国产rhG CSF不良反应总发生率 36 .7% ,主要为注射局部红肿疼痛、硬结、乏力和发热 ,一般为轻度。结论 :国产rhG CSF可明显减轻化疗所致WBC和ANC下降程度 ,缩短WBC和ANC下降的持续时间 ,促进WBC和ANC减少的早日恢复 ,有助于化疗按期进行 ,且不良反应轻微更多还原

【Abstract】 Objective:To observe the phase Ⅱ of clinical trials on efficacy and tolerability of domestic rhG CSF in preventing leucopenia caused by chemotherapy.Methods:The multicenter study was conducted in 69 patients with malignancies.They were randomized to receive cycles A and B therapy or cycles B and A therpay.In cycle A therapy,patients were treated with chemotherapy plus rhG CSF and in cycle B therapy,they were treated with chemotherapy alone.The changes in WBC(white blood cell) and ANC (absolute neutrophil count) in cycle A and B therapy were compared.Results:Shortening duration of leucopenia and neutropenia were more pronounce in cycle A therapy than in cycle B therapy.The minimum value of WBC and ANC were higher in cycle A therapy than in cycle B therapy.The incidence of delaying chemotherapy due to leucopenia was obviously lower in cycle A therapy.The side effect for domestie rhG GSF,including pain and scleroma at injection site,weakness,and fever,were mild.Conclusion:The results indicated that the domestic rhG CSF was able to alleviate the degree of leucopenia and neutropenia and to shorten the duration of leucopenia and neutropenia caused by chemotherapy with mild toxicity. [更多还原