使用“离线”系统进行体外光化学疗法的单核细胞采集：COBE Spectra与Spectra Optia设备的比较研究。

Mononuclear cell collection for extracorporeal photopheresis by using the "off-line" system: A comparative study between COBE Spectra and Spectra Optia devices.

作者信息

Pascual Cristina, González-Arias Elena, Pérez-Corral Ana María, Bailén Rebeca, Gayoso Jorge, Besson Nelly, Serrano David, Kwon Mi, Anguita Javier, Díez-Martín José Luis

机构信息

Hemathology and Hemotherapy Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.

Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.

出版信息

J Clin Apher. 2019 Aug;34(4):359-366. doi: 10.1002/jca.21679. Epub 2018 Dec 14.

DOI:10.1002/jca.21679

PMID:30549092

Abstract

BACKGROUND

Extracorporeal photopheresis (ECP) is an efficient and established therapy to treat acute and chronic graft vs host disease (GVHD). Using an "off-line" method, the first step (mononuclear cell [MNC] collection) is decisive, as long as a high MNC yield and purity in the collected product is desirable. Two "off-line" devices were compared: the COBE Spectra and the Spectra Optia (Terumo BCT), using both continuous and intermittent protocols.

PATIENTS AND METHODS

Twelve patients with GvHD (7 acute/5 chronic) were enrolled between June 2014 and May 2015 and were alternatively assigned for each procedure to either the COBE Spectra or the Spectra Optia cell separator. Patients characteristics and procedure/product parameters were analyzed.

RESULTS

Two hundred procedures (100 per device) were included. The Spectra Optia system showed higher total nucleated cells and MNC collection efficiencies (18.6(10.2-29.7) vs 7.9(4.1-14.8)% and 43.6(20.3-59.5) vs 23.3(11.4-37.1)%, P < .001) and monocyte and lymphocyte collection efficiencies (55.2(17.7-83.2) vs 22.8(9-38.9)% and 38.3(26.7-53.4) vs 22.2(9-38.9)%, respectively, P < .001). Absolute platelet loss (PL) and PL per liter of blood processed were significantly lower in the Spectra Optia group (22.9(18.3-28.1) vs 33.6(26.5-41.1)%, P < .001 and 3.7(3.1-4.5) vs 4.3(3.5-4.2)%, P = .01, respectively). However, granulocyte contamination was higher (4.5(1.3-36) vs 1.2(0.4-5.7)%, P < .001) and a higher product haematocrit was obtained with the Spectra Optia (1(0.5-1.6) vs 0.3(0.2-0.5)%, P < .001), without an impact on irradiation time.

CONCLUSIONS

In our study, Spectra Optia proved to be safe and effective in collecting MNC with high yield and purity for ECP in GvHD.

摘要

背景

体外光化学疗法（ECP）是治疗急慢性移植物抗宿主病（GVHD）的一种有效且成熟的疗法。采用“离线”方法时，第一步（单核细胞[MNC]采集）至关重要，因为所采集产品中需要高MNC产量和纯度。比较了两种“离线”设备：COBE Spectra和Spectra Optia（Terumo BCT），采用连续和间歇方案。

患者和方法

2014年6月至2015年5月期间招募了12例GVHD患者（7例急性/5例慢性），并将他们交替分配到COBE Spectra或Spectra Optia细胞分离器进行每种操作。分析了患者特征和操作/产品参数。

结果

共纳入200次操作（每个设备100次）。Spectra Optia系统显示出更高的总核细胞和MNC采集效率（分别为18.6(10.2 - 29.7)% 对7.9(4.1 - 14.8)%以及43.6(20.3 - 59.5)% 对23.3(11.4 - 37.1)%，P <.001），单核细胞和淋巴细胞采集效率也更高（分别为55.2(17.7 - 83.2)% 对22.8(9 - 38.9)%以及38.3(26.7 - 53.4)% 对22.2(9 - 38.9)%，P <.001）。Spectra Optia组的绝对血小板损失（PL）和每升处理血液中的PL显著更低（分别为22.9(18.3 - 28.1)% 对33.6(26.5 - 41.1)%，P <.001以及3.7(3.1 - 4.5)% 对4.3(3.5 - 4.2)%，P =.01）。然而，粒细胞污染更高（4.5(1.3 - 36)% 对1.2(0.4 - 5.7)%，P <.001），并且Spectra Optia获得的产品血细胞比容更高（1(0.5 - 1.6)% 对0.3(0.2 - 0.5)%，P <.001），但对照射时间无影响。