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两种血液成分分离机用于外周血干细胞采集的前瞻性随机交叉比较:一项多中心研究。

Prospective randomized and crossover comparison of two apheresis machines for peripheral blood stem cell collection: a multicenter study.

作者信息

Ikeda Kazuhiko, Minakawa Keiji, Muroi Kazuo, Fujiwara Shin-Ichiro, Yamada-Fujiwara Minami, Fujimori Yoshihiro, Tanosaki Ryuji, Ohto Hitoshi

机构信息

Department of Blood Transfusion and Transplantation Immunology, Fukushima Medical University, Fukushima, Fukushima, Japan.

Cell Therapy Committee, The Japan Society of Transfusion Medicine and Cell Therapy, Tokyo, Japan.

出版信息

Transfusion. 2016 Nov;56(11):2839-2847. doi: 10.1111/trf.13777. Epub 2016 Aug 29.

Abstract

BACKGROUND

Improving apheresis technology may lead to an efficient and safe peripheral blood stem cell (PBSC) collection. Recently, the Spectra Optia (Optia, Terumo BCT) was introduced as an automated apheresis instrument, but comparisons with other instruments have been few. This is the first randomized multicenter and crossover comparison of the Optia with the automated program of the established apheresis instrument, the Spectra (Spectra-Auto, Terumo BCT).

STUDY DESIGN AND METHODS

A total of 233 apheresis procedures performed in 46 autologous patients and 108 allogeneic donors were investigated. Apheresis performed in the first day for all subjects using the Spectra-Auto (n = 79) and the Optia (n = 75) were evaluated as first-day analysis. Seventy-nine subjects, who required another session on the second day, underwent apheresis using the other instrument than the first-day instrument and were compared with each other in a paired crossover analysis.

RESULTS

The two instruments processed similar volumes with comparable run times and volumes of acid-citrate-dextrose used. The volumes of collected products were greater in the Optia. Yields of mononuclear cells and CD34+ cells were not different, but collection efficiencies were higher in the Optia (p = 0.008 in CE1 of crossover analysis). Spectra-Auto-collected products contained more contaminating red blood cells (RBCs), whereas there was a trend of more contaminating platelets (PLTs) in the Optia-collected products. Slight reductions were noted in the RBC or PLT counts of subjects who underwent apheresis with the Spectra-Auto or the Optia, respectively.

CONCLUSION

The Optia is safe and more efficient in the PBSC collection compared with the Spectra-Auto.

摘要

背景

改进单采技术可能会实现高效、安全的外周血干细胞(PBSC)采集。最近,Spectra Optia(Optia,Terumo BCT公司)作为一种自动化单采仪器被推出,但与其他仪器的比较却很少。这是Optia与已有的单采仪器Spectra(Spectra-Auto,Terumo BCT公司)的自动化程序进行的首次随机多中心交叉比较。

研究设计与方法

对46例自体患者和108例异体供者进行的总共233次单采程序进行了研究。将所有受试者第一天使用Spectra-Auto(n = 79)和Optia(n = 75)进行的单采作为首日分析进行评估。79名需要在第二天进行另一次单采的受试者使用首日仪器以外的另一种仪器进行单采,并在配对交叉分析中相互比较。

结果

两种仪器处理的血量相似,运行时间和使用的枸橼酸-葡萄糖酸体积相当。Optia采集的产品量更大。单核细胞和CD34+细胞的产量没有差异,但Optia的采集效率更高(交叉分析的CE1中p = 0.008)。Spectra-Auto采集的产品含有更多污染的红细胞(RBC),而Optia采集的产品中污染的血小板(PLT)有增多趋势。分别接受Spectra-Auto或Optia单采的受试者的RBC或PLT计数略有下降。

结论

与Spectra-Auto相比,Optia在PBSC采集中更安全、更高效。

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