Preliminary validation of a new standard of efficacy for stored platelets
Preliminary validation of a new standard of efficacy for stored platelets
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DOI：
10.1046/j.0041-1132.2004.00604.x
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发表时间：
2004-01-01
期刊：
影响因子：
2.9
通讯作者：
Murphy, S
中科院分区：
文献类型：
--
作者：
AuBuchon, JP;Herschel, L;Murphy, S
背景：与RBC不同的是，血小板制备和储存系统缺乏一个客观的、绝对的性能标准来确定可接受性。最近，基于与放射性标记的新鲜血小板的恢复和存活率的配对比较，提出了一个标准，即恢复率=三分之二，存活率=新鲜血小板的一半。研究设计和方法：11名正常受试者使用一个标准的、经批准的系统捐献一单位去白细胞的分离血小板。他们在捐献后4到20小时收到一份标记有In-111或Cr-51(随机选择)的等量放射性核素，并在储存的第5天使用另一种放射性同位素。根据注射后的放射性计算回收率。采用多次打击模型确定存活率。结果：采集后20h内回输血小板回收率为74.7+/-12.3%，存活时间为7.5+/-1.1天。输注后第5天的恢复率为58.2±12.0%，存活时间为6.9±1.4天，分别为使用“新鲜”血小板观察值的77.9±9.5%和91.8±16.1%。使用第5天的血小板的曲线下面积是使用“新鲜”血小板的67.8+/-11.5%。结论：所提出的客观评价血小板制备和储存系统的标准似乎适用于一种普遍接受的方法，即在血浆中保存5天的去白细胞分离血小板，并适用于其他采集、处理和储存系统的价值评估。
BACKGROUND: Platelet preparation and storage systems, unlike those for RBC, lack an objective, absolute performance criterion to determine acceptability. Recently, a criterion based on paired comparison with the radiolabeled recovery and survival of "fresh" platelets has been proposed, namely, recovery = two-thirds and survival = half of "fresh" platelets.STUDY DESIGN AND METHODS: Eleven normal subjects donated a unit of leukoreduced apheresis platelets using a standard, approved system. They received an aliquot radiolabeled with In-111 or Cr-51 (random selection) 4 to 20 hours after donation and, using the other radioisotope, on Day 5 of storage. The recovery was calculated based on the injectate radioactivity. The survival was determined using the multiple-hit model. The area under the platelet survival curve was calculated using the COST program.RESULTS: Reinfusion of platelets less than 20 hours after collection resulted in a recovery of 74.7 +/- 12.3 percent and a survival time of 7.5 +/- 1.1 days. Reinfusion on Day 5 resulted in a recovery of 58.2 +/- 12.0 percent and a survival time of 6.9 +/- 1.4 days, values that were 77.9 +/- 9.5 percent and 91.8 +/- 16.1 percent of the observation using "fresh" platelets, respectively. The area under the curve using Day 5 platelets was 67.8 +/- 11.5 percent of that using "fresh" platelets.CONCLUSION: The proposed criterion for objective evaluation of platelet preparation and storage systems appears applicable to a commonly accepted approach, leukoreduced apheresis platelets stored in plasma for 5 days, and merits evaluation using other collection, treatment, and storage systems.