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评估作为一个混合库储存的全血源性血小板的有效性:一项随机区组非劣效性试验。

Assessing the effectiveness of whole blood-derived platelets stored as a pool: a randomized block noninferiority trial.

作者信息

Heddle N M, Cook R J, Blajchman M A, Barty R L, Sigouin C S, Boye D M, Nelson E J, Kelton J G

机构信息

Department of Medicine and Pathology and Molecular Medicine, McMaster University, and the Canadian Blood Services, Hamilton, Ontario, Canada.

出版信息

Transfusion. 2005 Jun;45(6):896-903. doi: 10.1111/j.1537-2995.2005.04233.x.

DOI:10.1111/j.1537-2995.2005.04233.x
PMID:15934987
Abstract

BACKGROUND

Prestorage pooling of whole blood-derived platelets (PLTs) would simplify bacterial detection. This study evaluated the in vivo effect of the prestorage pooling of PLTs stored for up to 5 days, by assessing the corrected count increment (CCI) 18 to 24 hours after transfusion of the product.

STUDY DESIGN AND METHODS

A randomized block noninferiority design was used. Eligible patients had chemotherapy-induced thrombocytopenia and were considered likely to need at least six PLT transfusions. For every block of two transfusion events, one consisted of PLTs stored individually and then pooled before transfusion, and the other was a product pooled before storage. The primary outcome was categorized as a successful (>4.5) or unsuccessful (<or=4.5) 18- to 24-hour posttransfusion CCI analyzed with a matched pair score test. A mixed-effect linear model estimated the mean difference in CCI between the two types of storage.

RESULTS

Twenty-three eligible patients received a total of 189 PLT transfusions. The median number of PLT transfusions was 7 (range, 0-27). Eighty-five complete transfusion pairs were used in the primary analysis. The proportions of transfusions leading to a CCI of greater than 4.5 was identical for both routine and PLTs pooled before storage (45/85=52.9%; relative risk, 1.00; lower limit of the one-sided 95% confidence interval [CI], 0.83). The estimate of the mean difference in CCI between pooled and routine storage (pooled-routine) was -0.45 (95% CI, -2.23 to 1.33; p=0.63).

CONCLUSION

These results provide evidence that storage of PLTs as a pool for up to 5 days results in posttransfusion CCIs that are not inferior to PLTs stored individually.

摘要

背景

全血来源血小板(PLT)储存前合并可简化细菌检测。本研究通过评估产品输注后18至24小时的校正计数增加值(CCI),评价了储存长达5天的PLT储存前合并的体内效果。

研究设计与方法

采用随机区组非劣效性设计。符合条件的患者患有化疗诱导的血小板减少症,且被认为可能至少需要6次PLT输注。对于每两个输血事件的区组,一个由单独储存然后在输血前合并的PLT组成,另一个是储存前合并的产品。主要结局分类为输血后18至24小时CCI成功(>4.5)或不成功(≤4.5),采用配对评分检验进行分析。混合效应线性模型估计了两种储存类型之间CCI的平均差异。

结果

23名符合条件的患者共接受了189次PLT输注。PLT输注的中位数为7次(范围为0至27次)。在主要分析中使用了85对完整的输血。常规PLT和储存前合并的PLT导致CCI大于4.5的输血比例相同(45/85 = 52.9%;相对风险为1.00;单侧95%置信区间[CI]的下限为0.83)。合并储存与常规储存之间CCI的平均差异估计值(合并 - 常规)为 -0.45(95% CI,-2.23至1.33;p = 0.63)。

结论

这些结果表明,PLT合并储存长达5天导致的输血后CCI不劣于单独储存的PLT。

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