限制与宽松输血策略对老年机械通气危重症患者的影响：一项随机先导试验。

Restrictive versus liberal transfusion strategies for older mechanically ventilated critically ill patients: a randomized pilot trial.

机构信息

1Department of Critical Care and Centre for Inflammation Research, Edinburgh University, Little France Crescent, Edinburgh, Scotland. 2Edinburgh Clinical Trials Unit, Western General Hospital, Edinburgh, Scotland. 3Better Blood Transfusion, National Blood Transfusion Service, Gartnavel, Glasgow, Scotland. 4Centre for Population Health Sciences, Edinburgh University, Edinburgh, Scotland. 5Barts and The London School of Medicine & Dentistry, Queen Marys University of London, London, UK. 6Department of Anaesthesia and Intensive Care, Western General Hospital, Crewe Toll, Edinburgh, Scotland. 7Department of Anaesthetics, Stirling Royal Infirmary, Stirling, Scotland. 8Department of Anaesthesia and Critical Care, Ninewells Hospital & Medical School, Dundee, Scotland. 9Guy's & St Thomas' NHS Foundation Trust, London, UK.

出版信息

Crit Care Med. 2013 Oct;41(10):2354-63. doi: 10.1097/CCM.0b013e318291cce4.

DOI:10.1097/CCM.0b013e318291cce4

PMID:23939351

Abstract

OBJECTIVES

To compare hemoglobin concentration (Hb), RBC use, and patient outcomes when restrictive or liberal blood transfusion strategies are used to treat anemic (Hb≤90 g/L) critically ill patients of age≥55 years requiring≥4 days of mechanical ventilation in ICU.

DESIGN

Parallel-group randomized multicenter pilot trial.

SETTING

Six ICUs in the United Kingdom participated between August 2009 and December 2010.

PATIENTS

One hundred patients (51 restrictive and 49 liberal groups).

INTERVENTIONS

Patients were randomized to a restrictive (Hb trigger, 70 g/L; target, 71-90 g/L) or liberal (90 g/L; target, 91-110 g/L) transfusion strategy for 14 days or the remainder of ICU stay, whichever was longest.

MEASUREMENTS AND MAIN RESULTS

Baseline comorbidity rates and illness severity were high, notably for ischemic heart disease (32%). The Hb difference among groups was 13.8 g/L (95% CI, 11.5-16.0 g/L); p<0.0001); mean Hb during intervention was 81.9 (SD, 5.1) versus 95.7 (6.3) g/L; 21.6% fewer patients in the restrictive group were transfused postrandomization (p<0.001) and received a median 1 (95% CI, 1-2; p=0.002) fewer RBC units. Protocol compliance was high. No major differences in organ dysfunction, duration of ventilation, infections, or cardiovascular complications were observed during intensive care and hospital follow-up. Mortality at 180 days postrandomization trended toward higher rates in the liberal group (55%) than in the restrictive group (37%); relative risk was 0.68 (95% CI, 0.44-1.05; p=0.073). This trend remained in a survival model adjusted for age, gender, ischemic heart disease, Acute Physiology and Chronic Health Evaluation II score, and total non-neurologic Sequential Organ Failure Assessment score at baseline (hazard ratio, 0.54 [95% CI, 0.28-1.03]; p=0.061).

CONCLUSIONS

A large trial of transfusion strategies in older mechanically ventilated patients is feasible. This pilot trial found a nonsignificant trend toward lower mortality with restrictive transfusion practice.

摘要

目的

比较在 ICU 中接受机械通气≥4 天且年龄≥55 岁、需要输血的贫血（Hb≤90g/L）危重症患者中，采用限制性或宽松性输血策略治疗时血红蛋白浓度（Hb）、红细胞使用量和患者结局的差异。

设计

平行分组随机多中心试验。

地点

2009 年 8 月至 2010 年 12 月，英国的 6 个 ICU 参与了此项研究。

患者

共 100 例患者（51 例限制性组和 49 例宽松性组）。

干预

患者被随机分配到限制性（Hb 触发值为 70g/L，目标值为 71-90g/L）或宽松性（90g/L，目标值为 91-110g/L）输血策略组，治疗 14 天或 ICU 住院时间最长者。

测量和主要结果

基线合并症和疾病严重程度较高，特别是缺血性心脏病（32%）。两组间 Hb 差值为 13.8g/L（95%CI，11.5-16.0g/L）；p<0.0001）；干预期间平均 Hb 分别为 81.9（标准差，5.1）和 95.7（6.3）g/L；随机分组后，限制性组接受输血的患者比例减少 21.6%（p<0.001），中位数输注 RBC 单位数减少 1 个（95%CI，1-2；p=0.002）。方案依从性高。在 ICU 期间和住院随访期间，未观察到器官功能障碍、通气时间、感染或心血管并发症的主要差异。随机分组后 180 天的死亡率趋势显示，宽松性组（55%）高于限制性组（37%）；相对风险为 0.68（95%CI，0.44-1.05；p=0.073）。在调整基线年龄、性别、缺血性心脏病、急性生理学和慢性健康评估 II 评分以及总非神经器官功能衰竭评估评分后，这种趋势仍存在于生存模型中（风险比，0.54[95%CI，0.28-1.03]；p=0.061）。