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大出血时全血与成分输血潜在危害的差异:随机对照试验的快速系统评价和荟萃分析

The Difference in Potential Harms between Whole Blood and Component Blood Transfusion in major Bleeding: A Rapid Systematic Review and Meta-Analysis of RCTs.

作者信息

Geneen Louise J, Brunskill Susan J, Doree Carolyn, Estcourt Lise J, Green Laura

机构信息

Systematic Review Initiative, NHS Blood and Transplant, John Radcliffe Hospital, Oxford, UK; Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, UK.

Systematic Review Initiative, NHS Blood and Transplant, John Radcliffe Hospital, Oxford, UK; Nuffield Division of Clinical Laboratory Sciences, Radcliffe Department of Medicine, University of Oxford, UK.

出版信息

Transfus Med Rev. 2022 Jan;36(1):7-15. doi: 10.1016/j.tmrv.2021.10.003. Epub 2021 Nov 3.

Abstract

Our aim was to assess whether there is a difference in outcomes of potential "all-cause" harm in the transfusion of whole blood (WB) compared to blood components (BC) for any bleeding patient regardless of age or clinical condition. We searched multiple electronic databases using a pre-defined search strategy from inception to 2 March 2021. 1 reviewer screened, extracted, and analysed data, with verification by a second reviewer of all decisions. We used Cochrane ROB1 and GRADE to assess the quality of the evidence. We used predefined subgroups of trauma and non-trauma studies in the analysis. We included six RCTs (618 participants) which compared WB and BC transfusion therapy in major bleeding, one trauma trial (n = 107), and 5 surgical trials (non-trauma) (n = 511). We GRADED evidence as very-low for all outcomes (downgraded for high and unclear risk of bias, small sample size, and wide confidence intervals around the estimate). Our primary outcome (all-cause mortality at 24-hours and 30-days) was reported in 3 out of 6 included trials. There was no evidence of a difference in mortality of WB compared to BC therapy (very-low certainty evidence). There may be a benefit of WB therapy compared to BC therapy in the non-trauma subgroup, with a reduction in the duration of oxygen dependence (1 study; n = 60; mean difference 5.9 fewer hours [95% Confidence Interval [CI] -10.83, -0.99] in WB group), and a reduction in hospital stay (1 study, n = 64, median difference 6 fewer days in WB group) (very-low certainty evidence). For the remaining outcomes (organ injury, mechanical ventilation and intensive care unit requirement, infection, arterial/venous thrombotic events, and haemolytic transfusion reaction) there was no difference between WB and BC therapy (wide CI, crossing line of no effect), though many of these outcomes were based on small single studies (very-low certainty evidence). In conclusion, there appears to be little to no difference in harms between WB and BC therapy, based on small studies with very low certainty of the evidence. Further large trials are required to establish the overall safety of WB compared to BC, and to assess differences between trauma and non-trauma patients.

摘要

我们的目的是评估对于任何出血患者,无论年龄或临床状况如何,输注全血(WB)与血液成分(BC)相比,在潜在“全因”伤害的结果上是否存在差异。我们使用预定义的检索策略,从数据库建立到2021年3月2日检索了多个电子数据库。由1名审阅者筛选、提取和分析数据,所有决策均由第二名审阅者进行核查。我们使用Cochrane ROB1和GRADE来评估证据的质量。在分析中,我们使用了创伤和非创伤研究的预定义亚组。我们纳入了6项随机对照试验(618名参与者),这些试验比较了大出血患者中WB和BC的输血治疗,1项创伤试验(n = 107),以及5项外科试验(非创伤)(n = 511)。我们将所有结局的证据质量评为极低(因高偏倚风险和不明确的偏倚风险、小样本量以及估计值周围较宽的置信区间而降级)。我们纳入的6项试验中有3项报告了我们的主要结局(24小时和30天的全因死亡率)。没有证据表明WB治疗与BC治疗在死亡率上存在差异(极低确定性证据)。在非创伤亚组中,与BC治疗相比,WB治疗可能有获益,氧依赖持续时间缩短(1项研究;n = 60;WB组平均差少5.9小时[95%置信区间[CI] -10.83,-0.99]),住院时间缩短(1项研究,n = 64,WB组中位数差少6天)(极低确定性证据)。对于其余结局(器官损伤、机械通气和重症监护病房需求、感染、动脉/静脉血栓形成事件以及溶血性输血反应),WB和BC治疗之间没有差异(置信区间宽,跨越无效应线),尽管其中许多结局基于小样本单研究(极低确定性证据)。总之,基于证据确定性极低的小研究,WB和BC治疗在伤害方面似乎几乎没有差异。需要进一步的大型试验来确定WB与BC相比的总体安全性,并评估创伤和非创伤患者之间的差异。

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