聚乙二醇化重组人粒细胞集落刺激因子预防化疗后中性粒细胞减少的临床观察

Clinical observation of pegylated recombinant human granulocyte colony-stimulating factor in prevention chemotherapy-induced neutropenia

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。方法采用随机自身交叉对照,纳入42例初治恶性肿瘤患者,接受2个周期相同方案的化疗,其中试验周期给予PEG-rhG-CSF 100μg/kg皮下注射1次,对照周期皮下注射rhG-CSF5μg/(kg.d)直至外周血中性粒细胞绝对值(ANC)达低谷后连续2次检查≥5.0×109/L。结果 42例患者,在40个试验周期和44个对照周期中,ANC<2.0×109/L的发生率试验组和对照组分别为30%(12/40)和31.8%(14/44),持续时间分别为(3±1.155)d和(4±1.225)d;受试药和对照药的不良反应均主要为骨骼肌肉疼痛、乏力、发热、头晕等,发生率与严重程度相似。结论 PEG-rhG-CSF一次给药的疗效与与rhG-CSF多次给药相似,不良反应低。

Objective To compare the efficacy and safety of daily injection of recombinant human granulocyte colonystimulating factor （rbG-CSF） and a single subcutaneous injection of pegylated recombinant human granulocyte colony-stimulating factor （PEG-rhG-CSF） in chemotherapy-induced neutropenia. Methods In the present randomized, match and cross-over study, enrolled 42 patients with previously untreated cancer and with normal bone marrow function were randomly divided into 2 matched groups. Each patient received two cycles of chemotherapy of identical regimen. In tile study cycle, the patients received a single subcutaneous injection of PEG-rhG-CSF 100μg/kg; and in control cycle, daily subcutaneous infection of rhG-CSF 5 μg/kg/d and continued for 7 days or until the absolute neutrophil count （ANC） became ≥5.0 × 10 9/L. Results The rates of ANC 〈 2. 0 × 10 9/L in the 40 evaluable study cycles and 44 evaluable control cycles were 30.00% and 31.8% with the duration of （3 ± 1. 155 ）d and （4 ± 1. 225 ）d respectively. The safety profiles of the PEG-rhG-CSF and rhG-CSF groups were similar. Conclusion A single subcutaneous injection of PEG-rhG-CSF 100μg/kg provides neutrophil support and a safety profile comparable to regimen of daily subcutaneous injection of rhG-CSF 5 μg/（kg· d） in patients receiving a variety of myelosuppressive chemotherapy regimens