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评价 7 天储存后采用氨甲喋呤和长波紫外线法制备的去白细胞病毒灭活单采血小板。

Evaluation of amotosalen and UVA pathogen-reduced apheresis platelets after 7-day storage.

机构信息

Hoxworth Blood Center, Cincinnati, Ohio, USA.

Cerus Corporation, Concord, California, USA.

出版信息

Transfusion. 2022 Aug;62(8):1619-1629. doi: 10.1111/trf.17003. Epub 2022 Jul 9.

Abstract

BACKGROUND

Amotosalen/UVA pathogen-reduced platelet components (PRPCs) with storage up to 7 days are standard of care in France, Switzerland, and Austria. PRPCs provide effective hemostasis with reduced risk of transfusion-transmitted infections and transfusion-associated graft versus host disease, reduced wastage and improved availability compared with 5-day-stored PCs. This study evaluated the potency of 7-day PRPCs by in vitro characterization and in vivo pharmacokinetic analysis of autologous PCs.

STUDY DESIGN AND METHODS

The in vitro characteristics of 7-day-stored apheresis PRPCs suspended in 100% plasma or 65% platelet additive solution (PAS-3)/35% plasma, thrombin generation, and in vivo radiolabeled post-transfusion recovery and survival of 7-day-stored PRPCs suspended in 100% plasma were compared with either 7-day-stored or fresh autologous conventional platelets.

RESULTS

PRPCs after 7 days of storage maintained pH, platelet dose, in vitro physiologic characteristics, and thrombin generation when compared to conventional 7-day PCs. In vivo, the mean post-transfusion survival was 151.4 ± 20.1 h for 7-day PRPCs in 100% plasma (Test) versus 209.6 ± 13.9 h for the fresh autologous platelets (Control), (T-ΔC: 72.3 ± 8.8%: 95% confidence interval [CI]: 68.5, 76.1) and mean 24-h post-transfusion recovery 37.6 ± 8.4% for Test versus 56.8 ± 9.2% for Control (T-ΔC: 66.2 ± 11.2%; 95% CI: 61.3, 71.1).

DISCUSSION

PRPCs collected in both 100% plasma as well as 65% PAS-3/35% plasma and stored for 7 days retained in vitro physiologic characteristics. PRPCs stored in 100% plasma for 7 days retained in vivo survival. Lower in vivo post-radiolabeled autologous platelet recovery is consistent with reported reduced count increments for allogenic transfusion.

摘要

背景

在法国、瑞士和奥地利,保存期长达 7 天的氨甲喋呤/UVA 病原体减少血小板成分(PRPC)是标准护理。与保存 5 天的血小板相比,PRPC 可提供有效的止血效果,降低输血传播感染和输血相关移植物抗宿主病的风险,减少浪费,提高可用性。本研究通过对自体血小板的体外特征和体内药代动力学分析来评估 7 天 PRPC 的效力。

研究设计和方法

比较了保存 7 天的 100%血浆或 65%血小板添加剂溶液(PAS-3)/35%血浆悬浮的 7 天保存的机采 PRPC 的体外特征、血栓生成以及 100%血浆悬浮的 7 天保存的放射性标记的 PRPC 输注后的恢复和存活,与 7 天保存的或新鲜的自体常规血小板进行比较。

结果

与 7 天保存的常规血小板相比,保存 7 天后的 PRPC 维持 pH 值、血小板剂量、体外生理特性和血栓生成。在体内,100%血浆中 7 天 PRPC 的平均输注后存活时间为 151.4±20.1 h(试验),而新鲜自体血小板的平均存活时间为 209.6±13.9 h(对照)(T-ΔC:72.3±8.8%:95%置信区间[CI]:68.5,76.1),24 小时平均输注后恢复率为 37.6±8.4%(试验),而对照为 56.8±9.2%(T-ΔC:66.2±11.2%;95% CI:61.3,71.1)。

讨论

在 100%血浆和 65%PAS-3/35%血浆中收集并保存 7 天的 PRPC 保留了体外生理特性。在 100%血浆中保存 7 天的 PRPC 保留了体内存活。与所有同种异体输血报道的血小板计数增加减少一致,体内放射性标记的自体血小板恢复较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8bb3/9546462/2fade9f1e297/TRF-62-1619-g001.jpg

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