聚乙二醇化重组人粒细胞刺激因子预防乳腺癌剂量密集化疗后的中性粒细胞减少

Pegylated Recombinant Human Granulocyte Colony Stimulating Factor Prevents Neutropenia in Breast Cancer Patients Receiving Dose-dense Chemotherapy

目的研究聚乙二醇化重组人粒细胞刺激因子在乳腺癌剂量密集辅助化疗中预防中性粒细胞减少症的有效性,为聚乙二醇化重组人粒细胞刺激因子的临床应用提供依据。方法选取37名乳腺癌女性患者,在乳腺癌根治手术后均接受表柔比星+环磷酰胺序贯双周紫杉醇(EC-T)化疗方案,化疗后随机分成接受PEG-rhG-CSF预防的试验组和接受rhG-CSF预防的对照组,监测各个化疗周期两组中性粒细胞减少发生率及持续时间,观察聚乙二醇化重组人粒细胞刺激因子的有效性。结果共纳入37例患者,其中试验组22例,对照组15例。各化疗周期中3度、4度中性粒细胞减少发生率,PEG-rhG-CSF组比rhG-CSF组低,且差别有统计学意义(P<0.05)。从化疗结束到中性粒细胞绝对值出现最低值的时间两组差异无统计学意义(P=0.51)。3度、4度中性粒细胞减少持续的时间两组差异无统计学意义(P=0.119)。两组生活质量无明显差异(P>0.05)。结论聚乙二醇化重组人粒细胞刺激因子在乳腺癌剂量密集辅助化疗中能够降低3度、4度中性粒细胞减少症的发生率,且疗效优于rhG-CSF,有一定的临床价值。

Objective To study the efficacy of pegylated recombinant human granulocyte stimulating factor(PEG-rhG-CSF)in the prevention of neutropenia in breast cancer patients for dose intensive adjuvant chemotherapy and to provide the evidence for the clinical application of PEG-rhG-CSF.Methods 37 women with breast cancer were randomly divided into two groups.The experimental group accepting PEG-rhG-CSF prevention after EC-T chemotherapy and the control group accepting rhG-CSF prevention.The efficiency of PEG-rhG-CSF,the incidence and duration of neutropenia in two groups during six cycles of chemotherapy were monitored.Results 37 patients(22 in the experimental group and 15 in the control group)were enrolled in the clinical observation.The incidence of degree 3 and 4 neutropenia in the experimental group was lower than that in the control group during each chemotherapy cycle,and the difference was statistically significant.The difference between the two groups of time from the end of chemotherapy to the lowest absolute value of neutrophils was not statistically significant(P=0.51).The difference between the two groups of the duration of degree3 and 4 neutropenia was not statistically significant(P=0.119).There was no significant difference in the quality of life between the two groups.Conclusion PEG-rhG-CSF can reduce the incidence of degree 3 or 4 neutropenia in breast cancer patients for dose intensive adjuvant chemotherapy and the efficacy is better than rhG-CSF,suggesting that PEG-rhG-CSF has the clinical value.