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一项关于白细胞单采量(8升与12升)疗效评估的随机试验。

A randomized trial of assessment of efficacy of leukapheresis volumes, 8 liters vs 12 liters.

作者信息

Demirer T, Dagli M, Ilhan O, Ayli M, Haznedar R, Fen T, Gunel N, Genc Y, Arat M, Ozcan M, Arslan O, Seyrek E, Dincer S, Ustun T, Ustael N, Koc H, Muftuoglu O, Akan H

机构信息

Ankara Numune Hospital, Bone Marrow Transplant Unit, Ankara, Turkey.

出版信息

Bone Marrow Transplant. 2002 Jun;29(11):893-7. doi: 10.1038/sj.bmt.1703571.

DOI:10.1038/sj.bmt.1703571
PMID:12080353
Abstract

It is logical to expect that large-volume leukapheresis may be able to collect adequate numbers of PBSC with fewer procedures. To date, there is no agreement on the optimal volume of leukapheresis. Therefore, in this study we compared 8 l volume with 12 l and assessed whether a 50% increase in the blood volume processed would decrease the number of leukaphereses each patient needed to collect > or =2.5 x 10(6) CD34(+) cells/kg in normal mobilizers. PBSC mobilization was done with cyclophosphamide etoposide followed by rhG-CSF in all patients. Forty patients were randomized to undergo 8 l leukaphereses (n = 20 patients) or 12 l leukaphereses (n = 20). The median numbers of leukaphereses required in order to collect > or =2.5 x 10(6) CD34(+) cells/kg in patients processed with 8 l and 12 l were 1 (range 1-5) and 1 (1-4), respectively (P = 0.50). The median number of total nucleated cells (TNC) collected per patient was greater for the 12 l group (7.47 x 10(8)/kg vs 3.90 x 10(8)/kg, P < 0.001), as was the median number of total mononuclear cells (TMNC) (4.26 x 10(8)/kg vs 2.16 x 10(8)/kg, P < 0.001), whereas there was no difference between the two groups for the median number of CD34(+)cells collected per patient (8.94 x 10(6)/kg vs 8.60 x 10(6)/kg, P = 0.85). The TNCs and TMNCs collected per leukapheresis were again greater for the 12 l group (3.64 x 10(8)/kg vs 1.91 x 10(8)/kg, P = 0.001 and 2.17 x 10(8)/kg vs 0.88 x 10(8)/kg, P < 0.001), whereas there was no difference between the two groups for the median number of CD34(+) cells collected per leukapheresis (3.98 x 10(6)/kg vs 3.26 x 10(6)/kg, P = 0.90). This study showed that there is no difference between 8 l and 12 l volumes in regard to collected CD34(+) cells/kg and also the use of a 12 l leukapheresis volume did not decrease the number of leukaphereses performed compared with a 8 l leukapheresis volume. In fact, the use of the larger leukapheresis volume had the disadvantage of adding 60 min to the time the patient was on the machine.

摘要

可以合理预期,大容量白细胞单采术或许能够通过较少的程序采集到足够数量的外周血干细胞(PBSC)。迄今为止,对于白细胞单采术的最佳容量尚无定论。因此,在本研究中,我们将8升容量与12升容量进行了比较,并评估了在正常动员剂作用下,处理血量增加50%是否会减少每位患者采集≥2.5×10⁶个CD34⁺细胞/千克所需的白细胞单采次数。所有患者均先使用环磷酰胺和依托泊苷进行PBSC动员,随后使用重组人粒细胞集落刺激因子(rhG-CSF)。40例患者被随机分为接受8升白细胞单采术组(n = 20例患者)或12升白细胞单采术组(n = 20例)。接受8升和12升处理的患者为采集≥2.5×10⁶个CD34⁺细胞/千克所需的白细胞单采次数中位数分别为1次(范围1 - 5次)和1次(1 - 4次)(P = 0.50)。12升组每位患者采集的有核细胞总数(TNC)中位数更高(7.47×10⁸/千克 vs 3.90×10⁸/千克,P < 0.001),总单核细胞(TMNC)中位数也是如此(4.26×10⁸/千克 vs 2.16×10⁸/千克,P < 0.001),而两组每位患者采集的CD34⁺细胞中位数无差异(8.94×10⁶/千克 vs 8.60×10⁶/千克,P = 0.85)。每次白细胞单采采集的TNC和TMNC同样是12升组更多(3.64×10⁸/千克 vs 1.91×10⁸/千克,P = 0.001和2.17×10⁸/千克 vs 0.88×10⁸/千克,P < 0.001),而每次白细胞单采采集的CD34⁺细胞中位数两组无差异(3.98×10⁶/千克 vs 3.26×10⁶/千克,P = 0.90)。本研究表明,就采集的CD34⁺细胞/千克而言,8升和12升容量之间没有差异,并且与8升白细胞单采容量相比,使用12升白细胞单采容量并未减少白细胞单采的次数。事实上,使用更大的白细胞单采容量存在使患者上机时间增加60分钟的缺点。

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