PEG-G-CSF和G-CSF预防实体瘤或淋巴瘤化疗后中性粒细胞减少及相关事件的Meta分析  

PEG-G-CSF vs. G-CSF in the Prevention of Neutropenia and Related Events Following Solid Tumor or Lymphoma Chemotherapy: a Meta-analysis

作　　者：孙习鹏[1] 陈燕[1] 李星霞[1] 陆瑶华[1] 郭澄[1] Sun Xipeng;Chen Yan;Li Xingxia;Lu Yaohua;Guo Cheng(Department of Pharmcy,Shanghai Jiao Tong University Affiliated Sixth People's Hospital,Shanghai 200233,China)

机构地区：[1]上海交通大学附属第六人民医院药剂科

出　　处：《药物流行病学杂志》2019年第12期785-792,共8页Chinese Journal of Pharmacoepidemiology

基　　金：2018年上海市“医苑新星”青年医学人才培养资助计划

摘　　要：目的:系统评价聚乙二醇化重组人粒细胞刺激因子(PEG-G-CSF)和重组人粒细胞刺激因子(G-CSF)预防实体瘤或淋巴瘤化疗后中性粒细胞减少及相关事件的有效性和安全性。方法:计算机检索The Cochrane Library、PubMed、Embase、CNKI、VIP、WanFang Data和SinoMed数据库,搜集关于PEG-G-CSF和G-CSF预防实体瘤或淋巴瘤化疗后中性粒细胞减少及相关事件的随机对照试验(RCT),检索时限均为建库至2019年2月,由两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入18个RCTs,合计2517例患者。Meta分析结果显示,在主要结局指标方面,PEG-G-CSF与G-CSF相比,对化疗后第1周期中性粒细胞减少性发热(FN)发生率[RR=0.70,95%CI(0.46,1.06),P>0.05]和化疗后多周期FN发生率[RR=0.80,95%CI(0.61,1.04),P>0.05]的作用相当;在次要结局指标方面,PEG-G-CSF与G-CSF相比,可以降低化疗后第2周期3/4度中性粒细胞减少发生率[RR=0.80,95%CI(0.68,0.94),P=0.008]和化疗后第4周期4度中性粒细胞减少持续时间[MD=-0.23,95%CI(-0.42,0.04),P=0.02],对化疗后第1,3,4周期3/4度中性粒细胞减少发生率、化疗后第1,2,3周期4度中性粒细胞减少持续时间、中性粒细胞恢复时间、骨痛或骨骼肌肉痛发生率的作用相当(P>0.05)。结论:现有证据表明PEG-G-CSF和G-CSF预防化疗后中性粒细胞减少及相关事件的临床有效性和安全性相似,但PEG-G-CSF可以部分改善化疗后中性粒细胞减少的发生率和持续时间。Objective:To evaluate the effectiveness and safety of PEG-G-CSF or G-CSF in the prevention of neutropenia and related events following solid tumours or lymphoma chemotherapy.Methods:The Cochrane Library,PubMed,Embase,CNKI,VIP,WanFang and SinoMed databases were electronically searched to collect randomized controlled trial(RCT)of PEG-G-CSF or G-CSF in the prevention of neutropenia and related events following solid tumours or lymphoma chemotherapy from inception to February,2019.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies,then,Meta-analysis was performed by using RevMan 5.3 software.Results:A total of 18 RCTs involving 2517 patients were included.On the primary endpoint,the results of Meta-analysis showed that there was no significant difference in the incidence rate of FN for cycle one(RR=0.70,95%CI 0.46 to 1.06,P>0.05)and incidence rate of FN for all cycle(RR=0.80,95%CI 0.61 to 1.04,P>0.05)between PEG-G-CSF and G-CSF.On the secondary endpoint,there were significant difference in the incidence rate of grade 3/4 neutropenia for cycle two(RR=0.80,95%CI 0.68 to 0.94,P=0.008)and the duration of 4 neutropenia for cycle four(MD=-0.23,95%CI-0.42 to 0.04,P=0.02).The incidence rate of grade 3/4 neutropenia for cycle 1 or 3 or 4,duration of grade 4 neutropenia for cycle 1 or 2 or 3,the time to absolute neutrophil count recovery,bone or musculoskeletal pain did not exhibit any significant differences between PEG-G-CSF and G-CSF(P>0.05).Conclusion:Current evidence shows that PEG-G-CSF or G-CSF has similar efficacy and safety in preventing neutropenia and related events following chemotherapy,but PEG-G-CSF could partly reduce the incidence rate of grade 3/4 neutropenia and the duration of 4 neutropenia.

关 键 词：聚乙二醇化重组人粒细胞刺激因子 重组人粒细胞刺激因子 中性粒细胞减少 中性粒细胞减少性发热 META分析 随机对照试验 

分 类 号：R973.[医药卫生—药品]