Kuan Jew W, Su Anselm T, Leong Chooi F
Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia.
Department of Community Medicine and Public Health, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia.
J Clin Apher. 2017 Dec;32(6):517-542. doi: 10.1002/jca.21550. Epub 2017 May 9.
Granulocyte-colony stimulating factor (G-CSF) mobilizes and increases the amount of hematopoietic stem cells in peripheral blood, enabling its harvest by few apheresis procedures. The pegylated G-CSF has longer half-life and is given once only, which is more comfortable for patients, whereas the non-pegylated requires multiple daily injection because of its short half-life. We summarized results of randomized trials comparing the efficacy and safety of pegylated and non-pegylated G-CSF for peripheral blood stem cell mobilization. We searched the Cochrane CENTRAL, MEDLINE, EMBASE, and two conference proceedings. Two authors made the selection, extracted data and evaluated methodological quality using GRADE independently. We used random-effects model for meta-analysis. We found 3956 records and retrieved 47 full texts. We included eight randomized trials with a total number of 554 randomized and 532 analyzed subjects. The meta-analysis included five trials because not all trials reported the same outcomes. Pooling data from two studies shows no evidence for a difference in the successful mobilization rate (CD34+ cell ≥ 2 × 10 /kg collected) between pegfilgrastim 6 mg (early administration) and filgrastim 5 µg/kg/day (147 participants; risk ratio (RR) 0.87, 95% confidence interval (95%CI) 0.67-1.11; P = .26). Pooling data from three studies shows no difference in the incidence of adverse events between pegylated and non-pegylated G-CSF (170 participants; RR 0.86, 95%CI 0.34-2.17; P = .75). No difference found on the quantity of CD34+ cells collected, number of apheresis procedure in successful mobilization, level of peak PB CD34+ cells achieved, and day of neutrophil and platelet engraftment.
粒细胞集落刺激因子（G-CSF）可动员并增加外周血中造血干细胞的数量，通过少量单采程序即可采集到造血干细胞。聚乙二醇化G-CSF半衰期更长，只需给药一次，对患者来说更舒适，而非聚乙二醇化G-CSF由于半衰期短则需要每日多次注射。我们总结了比较聚乙二醇化和非聚乙二醇化G-CSF在外周血干细胞动员方面的疗效和安全性的随机试验结果。我们检索了Cochrane中心对照试验注册库、医学期刊数据库、荷兰医学文摘数据库以及两个会议论文集。两位作者独立进行文献筛选、数据提取，并使用GRADE方法评估方法学质量。我们采用随机效应模型进行荟萃分析。我们共找到3956条记录，并获取了47篇全文。我们纳入了8项随机试验，共有554名受试者随机分组，532名受试者接受分析。荟萃分析纳入了5项试验，因为并非所有试验都报告了相同的结果。两项研究的数据合并显示，聚乙二醇化重组人粒细胞刺激因子6毫克（早期给药）与非聚乙二醇化重组人粒细胞刺激因子5微克/千克/天之间在成功动员率（采集的CD34+细胞≥2×10⁶/千克）上没有差异（147名参与者；风险比（RR）0.87，95%置信区间（95%CI）0.67 - 1.11；P = 0.26）。三项研究的数据合并显示，聚乙二醇化和非聚乙二醇化G-CSF在不良事件发生率上没有差异（170名参与者；RR 0.86，95%CI 0.34 - 2.17；P = 0.75）。在采集的CD34+细胞数量、成功动员时的单采程序次数、外周血中达到的CD34+细胞峰值水平以及中性粒细胞和血小板植入天数方面未发现差异。
