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[JAMA最新论文]:输注新鲜与标准红细胞对危重病患儿MODS的影响
2019年12月13日 时讯速递, 进展交流 暂无评论

Original Investigation December 10, 2019

Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial

Philip C. Spinella, Marisa Tucci, Dean A. Fergusson, et al

JAMA. 2019;322(22):2179-2190. doi:10.1001/jama.2019.17478

Importance 背景

The clinical consequences of red blood cell storage age for critically ill pediatric patients have not been examined in a large, randomized clinical trial.

红细胞储存期对于危重病患儿的临床结局尚未经过大规模随机临床试验的验证。

Objective 目的

To determine if the transfusion of fresh red blood cells (stored ≤7 days) reduced new or progressive multiple organ dysfunction syndrome compared with the use of standard-issue red blood cells in critically ill children.

与输注标准的红细胞相比,确定危重病患儿输注新鲜红细胞 (储存期 ≤7 天) 能否减少新发MODS或MODS进展。

Design, Setting, and Participants 试验设计,场景及研究人群

The Age of Transfused Blood in Critically-Ill Children trial was an international, multicenter, blinded, randomized clinical trial, performed between February 2014 and November 2018 in 50 tertiary care centers. Pediatric patients between the ages of 3 days and 16 years were eligible if the first red blood cell transfusion was administered within 7 days of intensive care unit admission. A total of 15 568 patients were screened, and 13 308 were excluded.

ABC-PICU试验是一项国际多中心、设盲、随机临床试验,从2014年2月至2018年11月在50个三级医学中心进行。入选标准为年龄在3天至16岁,且在入住ICU最初7天内接受首次输注红细胞。共筛查15568名患儿,13308名被排除。

Interventions 干预措施

Patients were randomized to receive either fresh or standard-issue red blood cells. A total of 1538 patients were randomized with 768 patients in the fresh red blood cell group and 770 in the standard-issue group.

入选患儿被随机分组,分别接受输注新鲜或标准红细胞。共有1538名患儿接受随机分组,768名患儿分至新鲜红细胞组,770名分至标准组。

Main Outcomes and Measures 主要预后指标

The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured for 28 days or to discharge or death.

主要预后指标为28天或出院或死亡时新发MODS或MODS进展。

Results 结果

Among 1538 patients who were randomized, 1461 patients (95%) were included in the primary analysis (median age, 1.8 years; 47.3% girls), in which there were 728 patients randomized to the fresh red blood cell group and 733 to the standard-issue group. The median storage duration was 5 days (interquartile range [IQR], 4-6 days) in the fresh group vs 18 days (IQR, 12-25 days) in the standard-issue group (P < .001). There were no significant differences in new or progressive multiple organ dysfunction syndrome between fresh (147 of 728 [20.2%]) and standard-issue red blood cell groups (133 of 732 [18.2%]), with an unadjusted absolute risk difference of 2.0% (95% CI, –2.0% to 6.1%; P = .33). The prevalence of sepsis was 25.8% (160 of 619) in the fresh group and 25.3% (154 of 608) in the standard-issue group. The prevalence of acute respiratory distress syndrome was 6.6% (41 of 619) in the fresh group and 4.8% (29 of 608) in the standard-issue group. Intensive care unit mortality was 4.5% (33 of 728) in the fresh group vs 3.5 % (26 of 732) in the standard-issue group (P = .34).

在 1538 名接受随机分组的患儿中,1461 名 (95%) 患儿纳入主要分析 (中位年龄, 1.8 岁; 47.3% 女孩),其中 728 名患儿随机分至新鲜红细胞组,733 名分至标准组。新鲜组红细胞中位储存期为 5 天 (四分位区间 [IQR], 4-6 天),标准组为 18 天 (IQR, 12-25 天) (P < .001)。新鲜红细胞组与标准红细胞组间新发或进展MODS无显著差异 (147/728 [20.2%] vs 133/732 [18.2%]),未校正风险差异 2.0% (95% CI, –2.0% to 6.1%; P = .33)。新鲜组全身性感染发生率为 25.8% (160/619),标准组为 25.3% (154/608)。新鲜组和标准组急性呼吸窘迫综合征发生率分别为 6.6% (41/619) 和 4.8% (29/608)。新鲜组ICU病死率为 4.5% (33/728),标准组为 3.5% (26/732) (P = .34)。

Conclusions and Relevance 结论

Among critically ill pediatric patients, the use of fresh red blood cells did not reduce the incidence of new or progressive multiple organ dysfunction syndrome (including mortality) compared with standard-issue red blood cells.

对于危重病患儿,与输注标准红细胞相比,输注新鲜红细胞不能减少新发或进展MODS(包括死亡)的发生率。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT01977547

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