【摘要】 目的　观察国产重组人粒细胞集落刺激因子 (rhG CSF)瑞血新防治肺癌化疗所致白细胞(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、随机自身交叉对照试验方法将 6 7例入组的肺癌患者随机分成AB组和BA组。AB组第一周期为治疗周期 (A周期 ) ,采用化疗加瑞血新 ,第二周期为对照周期 (B周期 ) ,单纯化疗不加瑞血新。BA组第一周期单纯化疗 ,第二周期加瑞血新。比较两周期WBC和ANC变化 ,并观察其不良反应。结果　本组 6 7例患者中 ,6例因依从性等原因出组 ,1例因发热出组 ,余 6 0例可供临床疗效评价 ,6 1例可作不良反应分析。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) ;化疗第 2 1天时因WBC <4.0× 10 9/L而延迟化疗的发生率A周期显著低于B周期 (P <0 .0 1)。不良反应总发生率为 2 6 .2 % ,主要为注射部位疼痛、硬结、乏力 ,一般均为轻度 ,不需作特殊处理。结论　瑞血新可明显降低肺癌患者化疗所致WBC和ANC减少的程度 ,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 evaluate the effect and toxicity o f the domestic product of rhG CSF (Rui Xue Xin) in preventing leukopenia caused b y chemotherapy in patients with lung cancer. WTHZ Methodspatient s in multicenter were randomly devided into AB group and BA group. The first cyc le was a trial cycle (chemotherapy plus injection of Rui Xue Xin), and the seco nd cycle was a control cycle (chemotherapy alone) in AB group. On the contrast, the first cycle was a control cycle, and the second cycle was a trial cycle in B A group. The changes of white blood cell (WBC) and absolute neutrophil counts (A NC), and the side effect of Rui Xue Xin were observed and compared between the t rial cycle and control cycle. WTHZ Results〓 WTBZ Of the 67 patients, 6 cas es were out of the trial because of patient compliance, and the another one case due to fever, and the other 61 cases could be used to analyze and to evaluate t he effects and toxicity of Rui Xue Xin. The duration of leukopenia and neutropen ia in cycle A was significantly shorter than that in cycle B ( WTBX P WTBZ ＜0.01). The nadirs of WBC and ANC following chemotherapy were remarkably higher in cycle A than those in cycle B ( WTBX P WTBZ ＜0.01). The incidence of ch emotherapy delay due to WBC＜4.0×10 9／L on the 21st day after chemotherapy in cycle A was also significantly lower than that in cycle B ( WTBX P WTBZ ＜0.01). The total rate of side effects of Rui Xue Xin was 26.2％, including pain and scleroma on the injection sites, weakness, fe ver. But, all of them were mild and didn’t need to give any treatment. WTHZ C onclusion〓 WTBZ The results demonstrate that Rui Xue Xin is able to re duce the degree of leukopenia and neutropenia, and to shorten the duration of le ukopenia and neutropenia caused by chemotherapy in patients with lung cancer. Th e toxicity is also slight.更多还原