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输血对重症脓毒症患者死亡率及其他不良事件的影响:一项使用边际结构Cox模型的观察性研究

Effect of Transfusion on Mortality and Other Adverse Events Among Critically Ill Septic Patients: An Observational Study Using a Marginal Structural Cox Model.

作者信息

Dupuis Claire, Garrouste-Orgeas Maité, Bailly Sébastien, Adrie Christophe, Goldgran-Toledano Dany, Azoulay Elie, Ruckly Stéphane, Marcotte Guillaume, Souweine Bertrand, Darmon Michael, Cohen Yves, Schwebel Carole, Lacave Guillaume, Bouadma Lila, Timsit Jean-Francois

机构信息

UMR 1137-IAME Team 5-DeSCID: Decision SCiences in Infectious Diseases control and care Inserm/ Univ Paris Diderot, Sorbonne Paris Cité, Paris, France.

Medical and Infectious Intensive Care Unit, Bichat Claude Bernard University Hospital, AP-HP, Paris, France.

出版信息

Crit Care Med. 2017 Dec;45(12):1972-1980. doi: 10.1097/CCM.0000000000002688.

DOI:10.1097/CCM.0000000000002688
PMID:28906284
Abstract

OBJECTIVES

RBC transfusion is often required in patients with sepsis. However, adverse events have been associated with RBC transfusion, raising safety concerns. A randomized controlled trial validated the 7 g/dL threshold, but previously transfused patients were excluded. Cohort studies led to conflicting results and did not handle time-dependent covariates and history of treatment. Additional data are thus warranted to guide patient's management.

DESIGN

To estimate the effect of one or more RBC within 1 day on three major outcomes (mortality, ICU-acquired infections, and severe hypoxemia) at day 30, we used marginal structural models. A trajectory modeling, based on hematocrit evolution pattern, allowed identification of subgroups. Secondary analyses were performed into each of them.

SETTING

A prospective French multicenter database.

PATIENTS

Patients with sepsis at admission. Patients with hemorrhagic shock at admission were excluded.

INTERVENTIONS

None.

MEASUREMENTS AND MAIN RESULTS

Overall, in our cohort of 6,016 patients, RBC transfusion was not associated with death (hazard ratio, 1.07; 95% CI, 0.88-1.30; p = 0.52). However, RBC transfusion was associated with increased occurrence of ICU-acquired infections (hazard ratio, 2.77; 95% CI, 2.33-3.28; p < 0.01) and of severe hypoxemia (hazard ratio, 1.29; 95% CI, 1.14-1.47; p < 0.01). A protective effect from death by the transfusion was found in the subgroup with the lowest hematocrit level (26 [interquartile range, 24-28]) (hazard ratio, 0.72; 95% CI, 0.55-0.95; p = 0.02).

CONCLUSIONS

RBC transfusion did not affect overall mortality in critically ill patients with sepsis. Increased occurrence rate of ICU-acquired infection and severe hypoxemia are expected outcomes from RBC transfusion that need to be weighted with its benefits in selected patients.

摘要

目的

脓毒症患者常需输注红细胞。然而,红细胞输注与不良事件相关,引发了安全担忧。一项随机对照试验验证了7g/dL的阈值,但此前接受过输血的患者被排除在外。队列研究结果相互矛盾,且未处理时间依赖性协变量和治疗史。因此,需要更多数据来指导患者的管理。

设计

为了评估1天内输注一个或多个单位红细胞对第30天的三个主要结局(死亡率、重症监护病房获得性感染和严重低氧血症)的影响,我们使用了边际结构模型。基于血细胞比容演变模式的轨迹建模能够识别亚组,并对每个亚组进行了二次分析。

背景

一个前瞻性法国多中心数据库。

患者

入院时患有脓毒症的患者。入院时患有失血性休克的患者被排除。

干预措施

无。

测量指标和主要结果

总体而言,在我们纳入的6016例患者队列中,红细胞输注与死亡无关(风险比,1.07;95%置信区间,0.88 - 1.30;p = 0.52)。然而,红细胞输注与重症监护病房获得性感染发生率增加(风险比,2.77;95%置信区间,2.33 - 3.28;p < 0.01)和严重低氧血症发生率增加(风险比,1.29;95%置信区间,1.14 - 1.47;p < 0.01)相关。在血细胞比容水平最低(26[四分位间距,24 - 28])的亚组中发现输血对死亡有保护作用(风险比,0.72;95%置信区间,0.55 - 0.95;p = 0.02)。结论:红细胞输注对重症脓毒症患者的总体死亡率无影响。红细胞输注会导致重症监护病房获得性感染和严重低氧血症的发生率增加,但在特定患者中需要权衡其益处。

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