PEG-rhG-CSF与rhG-CSF预防肿瘤化疗相关发热性中性粒细胞减少症的临床疗效及安全性比较的Meta分析

摘要

目的:系统分析比较聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)与重组人粒细胞刺激因子(rhG-CSF)预防肿瘤化疗相关发热性中性粒细胞减少症(FN)的有效性及安全性,旨为临床提供循证参考.方法:计算机检索Cochrane Library、PubMed、EMBase、中国生物医学文献数据库、中国期刊全文数据库、维普数据库、万方数据库(各数据库检索时间均从建库至2017年12月21日),收集比较PEG-rhG-CSF与rhG-CSF预防FN的随机对照试验(RCT),对符合纳入标准的研究提取资料并进行质量评价,采用RevMan 5.3软件对数据进行Meta分析.结果:共纳入RCT文献10篇.Meta分析结果显示, PEG-rhG-CSF组与rhG-CSF组,化疗第1周期FN发生率OR = 0.58,95%CI[0.34,1.00];总FN发生率OR = 0.76,95%CI[0.52, 1.11];Ⅳ度粒细胞减少发生率第1周期OR = 0.93,95%CI[0.62,1.39],第2周期OR = 0.77,95%CI[0.50,1.20],第3周期OR = 0.65, 95%CI[0.23,1.78],第4周期OR = 0.79,95%CI[0.51,1.22];Ⅳ度粒细胞减少持续时间第1周期MD = – 0.01, 95%CI[– 0.28,0.26],第2周期MD = – 0.14,95%CI[– 0.54,0.26],第3周期MD = – 0.21,95%CI[– 0.99,0.57],第4周期MD = – 0.22, 95%CI[– 0.61,0.17];骨痛发生率OR = 0.81,95%CI[0.60,1.09];两组间各项结局指标均无统计学差异.结论:肿瘤化疗患者每周期使用1次PEG-rhG-CSF与连续使用rhG-CSF预防用药相比,FN发生率、Ⅳ度粒细胞发生率及持续时间、骨痛发生率均相当.%Objective: To compare the clinical efficacy and safety of PEG-rhG-CSF and rhG-CSF used in patients with solid tumors and malignant lymphomas for the prevention of febrile neutropenia (FN) associated with chemotherapy. Methods:Randomized controlled trials (RCTs) focusing on the efficacy and safety comparison of PEG-rhG-CSF versus rhG-CSF were searched in databases including Cochrane Library, PubMed, EMBase, CBM, CNKI, VIP and Wanfang database from construction to December 21st, 2017. Meta-analysis was conducted by the RevMan 5.3 software. Results: A total of 10 RCTs were enrolled in this study. A single dose of PEG-rhG-CSF per cycle versus daily rhG-CSF, meta analysis results were as follows: the incidence rate of FN: OR = 0.58, 95%CI[0.34, 1.00] for cycle one and OR = 0.76, 95%CI[0.52, 1.11] for all cycles. The incidence rate of grade Ⅳneutropenia rates: OR = 0.93, 95%CI[0.62, 1.39] for cycle one, OR = 0.77, 95%CI[0.50, 1.20] for cycle two, OR = 0.65, 95%CI[0.23, 1.78] for cycle three and OR = 0.79, 95%CI[0.51, 1.22] for cycle four. Duration of grade Ⅳ neutropenia:MD = – 0.01, 95%CI[– 0.28, 0.26] for cycle one, MD = – 0.14, 95%CI[– 0.54, 0.26] for cycle two, MD = – 0.21, 95%CI[– 0.99, 0.57] for cycle three and MD = – 0.22, 95%CI[– 0.61, 0.17] for cycle four. Incidence of bone pain: OR = 0.81, 95%CI[0.60, 1.09]. There were no significant differences in outcome indexes between two groups. Conclusion: Both single dose of PEG-rhG-CSF and continunous daily injection of rhG-CSF for patients undergoing myelosuppressive chemotherapy had equivalent incidence rate of FN, grade Ⅳ neutropenia and duration bone pain.