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有效性分析*

目的：比较每周期1 剂聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）与每日1 剂重组人粒细胞集落刺激因子（rhG-CSF ）预防癌症患者化疗后中性粒细胞减少的有效性。方法：合并分析PEG-rhG-CSF的2 期和3 期临床研究中的单中心数据，比较疗效与安全性指标。两项研究均为随机、自身交叉对照试验。56例初治恶性肿瘤患者接受2 个周期常用化疗方案治疗，且化疗方案相同，其中试验周期给予PEG-rhG-CSF100 μ g/kg 皮下注射，每个周期1 次；对照周期皮下注射rhG-CSF 5 μ g/kg ，
每日1 次。结果：2 个研究单中心共纳入56例患者，其中53例可进行疗效评价，PEG-rhG-CSF和rhG-CSF 各使用53个周期。在使用PEG-rhG-CSF的周期和使用rhG-CSF 的周期中，4 度外周血中性粒细胞绝对值（ANC ）减少未发生率均为94.3%（50/ 53），均未出现中性粒细胞减少性发热，抗生素使用率分别为7.5%（4/ 53）和3.8%（2/ 53，P = 0.678）。 全组患者中位应用rhG-CSF 天数为10（3～14）天。此两种药物的不良反应均为骨痛、注射部位疼痛、心悸、发热和乏力等。结论：1 剂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有效性与连续10剂常规重组人粒细胞集落刺激因子相似。

Efficacy analysis of pegylated filgrastim as prophylaxis for chemotherapy-induced neutropenia

Objective:To compare the efficacy of a single injection of pegylated filgrastim with daily doses of filgrastim as pro -phylaxis for chemotherapy-induced neutropenia in Chinese cancer patients. Methods:Single-institution data from a phase 2 study and a phase 3 trial on pegylated filgrastim were combined to analyze the efficacy and safety parameters. In the two randomized crossover tri-als, patients with previously untreated cancers received two cycles of chemotherapy with identical regimen. In the study cycle, the pa -tients received a single subcutaneous injection of pegylated filgrastim ( 100 μ g/kg), whereas those in the control cycle received daily subcutaneous injections of filgrastim ( 5 μ g/kg). Results:Among the 56patients enrolled, 53were evaluable for efficacy. These patients received one cycle with pegylated filgrastim prophylaxis and one cycle with filgrastim support each. Results indicated that 94.3% (50/53) of the cycles with pegylated filgrastim or filgrastim support did not develop grade 4 neutropenia. Moreover, febrile neutropenia did not occur in the cycles. The incidence rates of antibiotic administration were 7.5% (4/53) and 3.8% (2/53) in the pegylated filgrastim and filgrastim cycles, respectively (P=0.678). The median duration of filgrastim administration was 10days (3- 14days). Generally, the safety profile of pegylated filgrastim is similar to that of filgrastim, including skeletal pain, pain at the injection site, palpitation, fever, and fatigue. Conclusion:A single dose of pegylated filgrastim demonstrated comparable efficacy with10consecutive doses of filgras-tim as prophylaxis for chemotherapy-induced neutropenia.