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美国汇集全血来源与单采(机采)血小板的相对安全性:对不同风险的系统评价。

Relative safety of pooled whole blood-derived versus single-donor (apheresis) platelets in the United States: a systematic review of disparate risks.

机构信息

Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, California 90048, USA.

出版信息

Transfusion. 2009 Dec;49(12):2743-58. doi: 10.1111/j.1537-2995.2009.02338.x. Epub 2009 Aug 4.

Abstract

BACKGROUND

Risks of transfusion-transmitted infections (TTIs), transfusion-associated sepsis (TAS), and transfusion-related acute lung injury (TRALI) were compared between pooled whole blood-derived (PWBD) and single-donor platelets (PLTs) transfused in the United States.

STUDY DESIGN AND METHODS

The literature was searched for estimates of the risk of TTIs and TAS and of the effect on bacterial contamination of PLTs of process improvements, bacterial culture, and surrogate methods to detect bacteria. Seven studies published between January 2005 and December 2008 and comparing bacterial contamination frequency between PWBD and single-donor PLTs after implementing bacterial culture testing of both components were subjected to meta-analysis. The three retrieved studies diagnosing TRALI based on the 2004 consensus definition in settings transfusing both PWBD and single-donor PLTs were not amenable to meta-analysis and were assessed qualitatively.

RESULTS

Under a best-case scenario, if 100% (from the current 12.5%) of PLT doses were provided as PWBD PLTs, the number of additional transmissions of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, bacteria, or a novel pathogen annually could be 1.2, 1.3, 9.0, 105.3, or 69.2 to 252.6, respectively. Compared with single-donor PLTs, US PLT pools of five concentrates have a 5.6-fold higher risk of bacterial contamination (summary odds ratio, 5.58; 95% confidence interval, 2.60-11.98; p < 0.05). The three studies that diagnosed TRALI based on the consensus definition did not demonstrate a difference in risk between PWBD and single-donor PLTs.

CONCLUSIONS

TTIs and TAS determine the relative safety of PWBD versus single-donor PLTs. The available limited data do not support a higher risk of TRALI from single-donor (compared with PWBD) PLTs.

摘要

背景

在美国,比较了集中采集的全血衍生血小板(PWBD)和单供体血小板(PLT)输注的输血传播感染(TTI)、输血相关败血症(TAS)和输血相关急性肺损伤(TRALI)风险。

研究设计和方法

检索文献以获取 TTI 和 TAS 风险的估计值,以及过程改进、细菌培养和用于检测细菌的替代方法对 PLT 细菌污染的影响。对 2005 年 1 月至 2008 年 12 月期间发表的 7 项研究进行了荟萃分析,这些研究比较了在对两种成分均进行细菌培养测试后,PWBD 和单供体 PLT 之间的细菌污染频率。有 3 项检索到的研究根据 2004 年共识定义在输注 PWBD 和单供体 PLT 的情况下诊断 TRALI,但不适合进行荟萃分析,因此进行了定性评估。

结果

在最佳情况下,如果 100%(从目前的 12.5%)的 PLT 剂量作为 PWBD PLT 提供,则每年可能会额外传播 1.2、1.3、9.0、105.3 或 69.2 至 252.6 例人类免疫缺陷病毒、丙型肝炎病毒、乙型肝炎病毒、细菌或新型病原体。与单供体 PLT 相比,美国的 5 个浓缩物 PLT 池的细菌污染风险高 5.6 倍(汇总优势比,5.58;95%置信区间,2.60-11.98;p<0.05)。根据共识定义诊断 TRALI 的 3 项研究并未显示 PWBD 与单供体 PLT 之间的风险差异。

结论

TTI 和 TAS 决定了 PWBD 与单供体 PLT 相对安全性。可用的有限数据不支持来自单供体(与 PWBD 相比)PLT 的 TRALI 风险更高。

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