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一项配对试验,比较两台机器采集单核细胞后通过在线或离线体外光化学疗法进行进一步灭活的情况。

A paired trial comparing mononuclear cell collection in two machines for further inactivation through an inline or offline extracorporeal photopheresis procedure.

作者信息

Bueno José-Luis, Alonso Rosalía, Gonzalez-Santillana Clara, Naya Daniel, Romera Irene, Alarcón Ana, Aguilar Myriam, Bautista Guiomar, Duarte Rafael, Ussetti Piedad, Cabrera José Rafael

机构信息

Blood Transfusion & Therapeutic Apheresis Unit, Hematology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.

Lung Transplant Unit, Neumology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.

出版信息

Transfusion. 2019 Jan;59(1):340-346. doi: 10.1111/trf.14975. Epub 2018 Oct 4.

DOI:10.1111/trf.14975
PMID:30284302
Abstract

BACKGROUND

Extracorporeal photopheresis (ECP) is an effective treatment. However, protocols differ widely, and some questions, such as the number of cells to be collected or the number of ECP treatment days per treatment cycle, are still unsolved. The aim of this study was to compare a multistep (offline) (Spectra Optia and Macogenic G2) against an integrated (inline) ECP system (Therakos Cellex system) with respect to mononuclear cell (MNC) collection.

STUDY DESIGN AND METHODS

The number and quality parameters of the MNC products collected were evaluated together with some machine parameters, such as collection time. Comparisons were made through paired sample analysis with the t test.

RESULTS

Fourteen patients underwent 15 double-paired procedures using both ECP protocols. The average MNC collected in the multistep procedure was 77.4 × 10 , four times more than in the integrated procedure (18.5 × 10 ). MNC purity (84.4% vs. 63.8%) and enrichment (27.9 vs. 5.9) in the product collected were also higher in the multistep procedure. The whole ECP time was higher in the multistep than in the integrated procedure (272 vs. 106 min), but the calculated time to collect 25 × 10 MNCs in the multistep was shorter compared with the one-step procedure (77.8 vs. 172 min). All these differences between the two protocols were statistically significant.

CONCLUSIONS

These two ECP protocols are different with respect to MNC collection and length of procedure. Some unresolved questions, such as the better MNC dose to inactivate or the number of consecutive days that ECP should be performed for optimal clinical efficacy, require further review.

摘要

背景

体外光化学疗法(ECP)是一种有效的治疗方法。然而,治疗方案差异很大,一些问题,如每次治疗周期要采集的细胞数量或ECP治疗天数,仍未得到解决。本研究的目的是比较多步骤(离线)(Spectra Optia和Macogenic G2)与集成(在线)ECP系统(Therakos Cellex系统)在单核细胞(MNC)采集方面的差异。

研究设计与方法

评估采集的MNC产品的数量和质量参数以及一些机器参数,如采集时间。通过配对样本分析和t检验进行比较。

结果

14例患者使用两种ECP方案进行了15次双配对操作。多步骤操作中采集的平均MNC为77.4×10⁶,是集成操作(18.5×10⁶)的四倍。多步骤操作中采集产品的MNC纯度(84.4%对63.8%)和富集度(27.9对5.9)也更高。多步骤操作的整个ECP时间比集成操作更长(272对106分钟),但多步骤操作中采集25×10⁶个MNC的计算时间比单步骤操作更短(77.8对172分钟)。两种方案之间的所有这些差异均具有统计学意义。

结论

这两种ECP方案在MNC采集和操作时长方面存在差异。一些未解决的问题,如更好的MNC灭活剂量或为达到最佳临床疗效应连续进行ECP的天数,需要进一步研究。

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