目的:比较聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)和重组人粒细胞集落刺激因子(rhG-CSF)预防化疗后中性粒细胞减少症的有效性和安全性.方法:采用随机开放、平行分组的方法,乳腺癌患者接受1个周期TAC方案化疗,随机分配到60、100、120 μg/kg PEG-rhG-CSF组和5μg/(kg·d)rhG-CSF组.结果:共入组12例,5μg/(kg·d)rhG-CSF对照组和60、100、120 μg/kg PEG-rhG-CSF试验组患者ANC＜ 1.5×109/L分别持续1、2、2和2.75 d,中性粒细胞减少症的发生率差异无统计学意义.受试药物的第2峰低于对照药物.结论:PEG-rhG-CSF一次给药的疗效和不良反应与rhG-CSF多次给药相似.%Objective: To compare the efficacy and safety of daily administration of recombinant human granulocyte colony - stimulating factor ( rhG - CSF) with single subcutaneous injection of pegylated recombinant human granulocyte colony - stimulating factor ( PEG - rhG - CSF) in patients with chemotherapy - induced neutropenia. Methods: In the randomized open - label study, 12 breast cancer patients receiving chemotherapy with TAC regimen were randomly divided into 4 groups. The patients in group A received a single subcutaneous injection of rhG - CSF from day 3 to 16. The patients in group B, C, D received subcutaneous injection of PEG - rhG - CSF (daily 60, 100 and 120(μg/kg respectively) on day 3. Results: The duration of neutropenia (absolute neutrophil count < 1. 5 ×109/L) in group A, B, C and D were 1, 2, 2 and 2. 75 days, respectively (P > 0. 05). Compared with group B, C and D, the profile of absolute neutrophil count exhibited the second peak in group A. Conclusion : A single subcutaneous injection of PEG - rhG - CSF provides neutrophil support and a safe profile comparable to regimen of daily subcutaneous injection of rhG - CSF in breast cancer patients receiving chemotherapy.
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