化疗后预防性使用重组人粒细胞集落刺激因子的持续时间及其影响因素

Duration of filgrastim prophylaxis for chemotherapy-induced neutropenia and its predictors

目的分析化疗后预防性使用重组人粒细胞集落刺激因子（rhG-CSF）的持续时间及影响因素。方法回顾性分析聚乙二醇化重组人粒细胞集落刺激因子（PEG—rhG—CSF）Ⅱ期和Ⅲ期临床研究中招募的受试者的临床病理特征。试验组患者皮下注射100仙g／kgPEG—rhG—CSF1次，对照组患者每天注射5I,Lg／kgrhG—CSF。结果在53个化疗周期中，rhG—CSF使用时间为（9．57±2．10）d；使用时间为7～11d者44例（83．0％）。体质指数和基线中性粒细胞绝对值（ANC）与rhG—CSF使用时间均有关（均P〈0．05）。多因素方差分析结果显示，基线ANC与rhG—CSF使用时间有关（P=0．019）。rhG—CSF最常见的不良反应为骨痛，不良反应均较轻，无因不良反应死亡患者。结论化疗后预防性使用rhG—CSF的中位时间为10d；基线ANC低的患者需要预防性应用rhG—CSF更长时间。临床试验注册美国临床注册中心。

Objective To analyze the duration of preventive filgrastim administration as support for chemotherapy and its affecting factors. Methods Single institutional data from a phase U clinical trial and a phase IlI clinical trial of pegylated filgrastim were combined. In the two randomized cross-over trials, patients with previously untreated cancer received two cycles of chemotherapy of the same regimen. In the study group, the patients received a single subcutaneous injection of 100 p^g/kg pegylated filgrastim, and in the control group, they received daily subcutaneous injections of 5 ~g/kg filgrastim. Results In 53 chemotherapy cycles, the median duration of filgrastim administration was （9.57_＋2.10）d. 83.0% （44/53） of them received filgrastim for 7-11 days. Patients with baseline absolute neutrophil count of 〈4x 109/L or body mass index less than 22 received a longer filgrastim prophylaxis （P 〈 0.05 ）. Results of muhivariate analysis showed that the baseline absolute neutrophil count is associated with the time of filgrastim administration（P=0.019）. The most common adverse event of rhG-CSF was skeletal pain, generally mild and no treatment-related death occurred. Conclusions The median duration of filgrastim support for chemotherapy was 10 days. Patients with lower baseline neutrophil count require a longer filgrastim prophylaxis. Trial registration： ClinicalTrials.gov identifier, NCT01285219