Li Pei, Zhang Guo-Yun, Zhu Pin, Wu Bei-Qian, Niu Qiang, Xie Yi
Department of Hematology, Huashan Hospital, Fudan University, Shanghai 200040, China.
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2007 Apr;15(2):348-51.
The study was aimed to observe the effect of recombinant human granulocyte-colony stimulating factors (rhG-CSF) in low dose on peripheral blood stem cell (PBSC) mobilization in unrelated healthy normal donors. G-CSF was administered at 5 microg/(kg x d) subcutaneously for successive 5 or 6 days to 56 unrelated donors. Stem cells were harvested on the fourth and fifth days or on the fifth and sixth days. The numbers of mononuclear cells (MNC), CD34(+) cells and Hb, Plt, and CD3(+), CD4(+), CD8(+) and CD20(+) cells were determined during the mobilization. The results showed that most common adverse events were bone pain (17.9%, 10/56), agrypnia (8.9%, 5/56) and lassitude (4.5%, 3/56) during rhG-CSF mobilization, but all donors were suffered less than grade II according to the WHO criteria, and did not need to stop the mobilization and not need to give special treatment. In harvest on day 4 - 5 and 5 - 6, MNC count was (5.95 +/- 1.52) x 10(8)/kg and (7.19 +/- 2.12) x 10(8)/kg; CD34(+) cells count was (3.03 +/- 1.09) x 10(6)/kg and (7.92 +/- 2.50) x 10(6)/kg. There were no significant differences in hemoglobin level and platelet count, the percentage of CD3(+) cells, CD4(+) cells, CD8(+) cells and CD20(+) cells between pre-mobilization and post-mobilization of rhG-CSF. It is concluded that the low dose of rhG-CSF 5 microg/(kg x d) for peripheral blood stem cell mobilization in unrelated healthy normal donors is safe and effective.
本研究旨在观察低剂量重组人粒细胞集落刺激因子（rhG-CSF）对无关健康正常供者外周血干细胞（PBSC）动员的效果。对56名无关供者皮下注射G-CSF，剂量为5μg/（kg·d），连续注射5或6天。在第4天和第5天或第5天和第6天采集干细胞。在动员期间测定单个核细胞（MNC）、CD34(+)细胞以及血红蛋白（Hb）、血小板（Plt）和CD3(+)、CD4(+)、CD8(+)和CD20(+)细胞的数量。结果显示，rhG-CSF动员期间最常见的不良事件为骨痛（17.9%，10/56）、失眠（8.9%，5/56）和乏力（4.5%，3/56），但根据世界卫生组织标准，所有供者的不良事件均低于Ⅱ级，无需停止动员，也无需给予特殊治疗。在第4 - 5天和第5 - 6天采集时，MNC计数分别为（5.95±1.52）×10⁸/kg和（7.19±2.12）×10⁸/kg；CD34(+)细胞计数分别为（3.03±1.09）×10⁶/kg和（7.92±2.50）×10⁶/kg。rhG-CSF动员前后血红蛋白水平、血小板计数、CD3(+)细胞、CD4(+)细胞、CD8(+)细胞和CD20(+)细胞百分比无显著差异。结论是，低剂量rhG-CSF 5μg/（kg·d）用于无关健康正常供者外周血干细胞动员是安全有效的。
