In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution
In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution
复制标题
DOI：
10.1111/j.1537-2995.2012.03841.x
复制
发表时间：
2013-05-01
期刊：
影响因子：
2.9
通讯作者：
Razatos, Anna
中科院分区：
文献类型：
--
作者：
Dumont, Larry J.;Cancelas, Jose A.;Razatos, Anna
背景技术背景：储存在添加剂溶液（PAS）中的血小板（PLT）可降低几种血浆相关不良输血反应的风险，如过敏反应和潜在的输血相关肺损伤。本研究的目的是确定储存在新PAS中的单采血小板（AP）的体外特征和体内放射性标记回收率和存活率，并将后者与美国食品药品监督管理局（FDA）标准进行比较。研究设计和方法：在一项配对交叉研究中，从健康受试者中收集高浓度AP，该研究比较了PAS（35%血浆）和100%血浆储存的AP（第1部分）长达7天，并在第2部分中，与新鲜PLT对照相比，测定了PAS储存的AP在5天时的体内回收率和存活率。按照标准方法进行体外和体内测定。结果：分别有66名和25名可评价受试者成功完成了第1部分和第2部分。PAS AP的pH保持在6.6以上，储存5天。P-选择素值与已发表的常用输血PLT产品的值一致。PAS体内PLT回收率（54.3 +/-8.1%）为新鲜对照的86.7%，存活率（6.4 +/-1.3天）为新鲜对照的78.0%，均符合FDA性能标准。结论：储存在PAS中的AP（血浆残留率为35%）在储存5天内保持pH值，符合放射性标记回收率和存活率的现行FDA标准。在临床实践中使用PAS储存单供体PLT是一种可接受的输血产品，可减少与PLT输血相关的血浆体积。
BACKGROUND: Platelets (PLTs) stored in additive solutions (PASs) may reduce the risk of several plasma-associated adverse transfusion reactions such as allergic reactions and potentially transfusion-associated lung injury. The objective of this study was to determine the in vitro characteristics and the in vivo radiolabeled recovery and survival of apheresis PLTs (APs) stored in a new PAS and compare the latter to Food and Drug Administration (FDA) criteria. STUDY DESIGN AND METHODS: Hyperconcentrated APs were collected from healthy subjects in a paired crossover study comparing PAS (35% plasma) and 100% plasma-stored APs (Part 1) up to 7 days and, in Part 2, to determine the in vivo recovery and survival of PAS stored AP at 5 days compared to fresh PLT controls. In vitro and in vivo assays were performed following standard methods. RESULTS: Sixty-six and 25 evaluable subjects successfully completed Parts 1 and 2, respectively. pH for PAS AP was maintained above 6.6 for 5 days of storage. P-selectin values were consistent with published values for commonly transfused PLT products. The PAS in vivo PLT recovery (54.3 +/- 8.1%) was 86.7% of the fresh control, and survival (6.4 +/- 1.3 days) was 78.0% of the fresh control, both meeting the FDA performance criteria. CONCLUSION: APs stored in PAS with 35% plasma carryover maintained pH over 5 days of storage and met current FDA criteria for radiolabeled recovery and survival. The use of PAS for storage of single-donor PLTs in clinical practice represents an acceptable transfusion product that reduces the volume of plasma associated with PLT transfusion.