PEG-rhG-CSF与rhG-CSF预防肿瘤化疗相关中性粒细胞减少的有效性和安全性比较的系统评价和Meta分析

Systematic Review and Meta-Analysis on Efficacy and Safety of PEG-rhG-CSF and rhG-CSF in the Prevention of Chemotherapy-Related 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)与重组人粒细胞集落刺激因子(rhG-CSF)预防肿瘤化疗相关中性粒细胞减少的有效性和安全性。方法:检索PubMed、Embase、the Cochrane Library、中国知网、万方数据库和维普数据库,纳入PEG-rhG-CSF与rhG-CSF预防肿瘤化疗相关中性粒细胞减少(CIN)的随机对照试验(干预措施为使用PEG-rhG-CSF;对照措施为使用rhG-CSF),检索时间截至2023年5月。文献筛选和信息提取由2名研究者独立完成,并进行偏倚风险评估。采用RevMan 5.3统计软件对提取的数据进行Meta分析。结果:共纳入41篇文献。Meta分析结果显示,与rhG-CSF比较,PEG-rhG-CSF可以显著降低化疗后中性粒细胞减少伴发热(FN)发生率(OR=0.64,95%CI=0.51~0.81,P=0.0002)和Ⅲ/Ⅳ度中性粒细胞减少发生率(OR=0.49,95%CI=0.35~0.69,P<0.0001),差异均有统计学意义,但Ⅲ/Ⅳ度中性粒细胞减少持续时间(MD=-0.33,95%CI=-0.68~0.01,P=0.06)、中性粒细胞减少恢复时间(MD=-0.11,95%CI=-0.32~0.09,P=0.27)、骨痛或骨骼肌肉痛发生率(OR=0.81,95%CI=0.66~1.00,P=0.05)的差异均无统计学意义。结论:PEG-rhG-CSF预防化疗后FN及Ⅲ/Ⅳ度中性粒细胞减少的有效性明显优于rhG-CSF,PEG-rhG-CSF作为一级预防具有可行性。

OBJECTIVE:To compare the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor(PEG-rhG-CSF)and rhG-CSF in the prevention of chemotherapy-related neutropenia.METHODS:PubMed,Embase,the Cochrane Library,CNKI,Wanfang Data and VIP databases were retrieved to collect randomized controlled trials of PEG-rhG-CSF and rhG-CSF in the prevention of chemotherapy-related neutropenia(intervention measures were PEG-rhG-CSF,control measures were rhG-CSF)until May 2023.Literature screening,information extraction and bias risk assessment were carried out by two researchers independently.Meta-analysis was performed by RevMan 5.3 statistical software.RESULTS:A total of 41 studies were included.Meta-analysis showed that compared with rhG-CSF,PEG-rhG-CSF could significantly reduce the incidence of neutropenia with fever(FN)after chemotherapy(OR=0.64,95%CI=0.51-0.81,P=0.0002)and the incidence of gradeⅢ/Ⅳneutropenia(OR=0.49,95%CI=0.35-0.69,P<0.0001),the differences were statistically significant;however,differences in the duration of gradeⅢ/Ⅳneutropenia(MD=-0.33,95%CI=-0.68-0.01,P=0.06),the recovery time of neutropenia(MD=-0.11,95%CI=-0.32-0.09,P=0.27),the incidence of bone pain or skeletal muscle pain(OR=0.81,95%CI=0.66-1.00,P=0.05)were not statistically significant.CONCLUSIONS:The efficacy of PEG-rhG-CSF in the prevention of FN and gradeⅢ/Ⅳneutropenia after chemotherapy is significantly better than that of rhG-CSF,and PEG-rhG-CSF is feasible as primary prevention.