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[NEJM发表论文]: 非洲非复杂性严重贫血儿童立即输血
2019年08月15日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Immediate Transfusion in African Children with Uncomplicated Severe Anemia

Kathryn Maitland, Sarah Kiguli, Peter Olupot-Olupot, et al.

N Engl J Med 2019; 381:407-419
DOI: 10.1056/NEJMoa1900105

Abstract

BACKGROUND 背景

The World Health Organization recommends not performing transfusions in African children hospitalized for uncomplicated severe anemia (hemoglobin level of 4 to 6 g per deciliter and no signs of clinical severity). However, high mortality and readmission rates suggest that less restrictive transfusion strategies might improve outcomes.

对于非复杂性严重贫血(血红蛋白水平4-6 g/dL且没有病情严重的临床表现)的非洲儿童,WHO推荐不予输血。然而,这些患儿的高病死率及再入院率提示,非限制性输血策略可能改善预后。

METHODS 方法

In this factorial, open-label, randomized, controlled trial, we assigned Ugandan and Malawian children 2 months to 12 years of age with uncomplicated severe anemia to immediate transfusion with 20 ml or 30 ml of whole-blood equivalent per kilogram of body weight, as determined in a second simultaneous randomization, or no immediate transfusion (control group), in which transfusion with 20 ml of whole-blood equivalent per kilogram was triggered by new signs of clinical severity or a drop in hemoglobin to below 4 g per deciliter. The primary outcome was 28-day mortality. Three other randomizations investigated transfusion volume, postdischarge supplementation with micronutrients, and postdischarge prophylaxis with trimethoprim–sulfamethoxazole.

在这项析因设计、开放标签、随机对照试验中,我们将伴有非复杂性严重贫血的2个月至12岁乌干达和马拉维儿童随机分组,接受立即输血20 ml或30 ml等量全血/kg(根据第二个随机分组),或非立即输血(对照组),即当出血病情加重的新体征或血红蛋白水平低于4 g/dL时输等量全血20 ml/kg。主要预后指标为28天病死率。其他3项随机分组包括输血量、出院后补充微量营养素及出院后使用复方新诺明预防。

RESULTS 结果

A total of 1565 children (median age, 26 months) underwent randomization, with 778 assigned to the immediate-transfusion group and 787 to the control group; 984 children (62.9%) had malaria. The children were followed for 180 days, and 71 (4.5%) were lost to follow-up. During the primary hospitalization, transfusion was performed in all the children in the immediate-transfusion group and in 386 (49.0%) in the control group (median time to transfusion, 1.3 hours vs. 24.9 hours after randomization). The mean (±SD) total blood volume transfused per child was 314±228 ml in the immediate-transfusion group and 142±224 ml in the control group. Death had occurred by 28 days in 7 children (0.9%) in the immediate-transfusion group and in 13 (1.7%) in the control group (hazard ratio, 0.54; 95% confidence interval [CI], 0.22 to 1.36; P=0.19) and by 180 days in 35 (4.5%) and 47 (6.0%), respectively (hazard ratio, 0.75; 95% CI, 0.48 to 1.15), without evidence of interaction with other randomizations (P>0.20) or evidence of between-group differences in readmissions, serious adverse events, or hemoglobin recovery at 180 days. The mean length of hospital stay was 0.9 days longer in the control group.

共有 1565 名患儿(中位年龄,26个月)接受随机分组,778 名分至立即输血组,787 名分至对照组;984 名患儿 (62.9%) 为疟疾。随访至180天,71 名 (4.5%) 患儿失访。在首次住院期间,立即输血组所有患儿均接受输血,对照组仅有 386 名 (49.0%) 患儿接受输血(至输血的中位时间,随机分组后 1.3 小时 vs. 24.9 小时)。立即输血组每名患儿平均 (±SD) 输血量 314±228 ml,对照组 142±224 ml。至28天时,立即输血组 7 名患儿 (0.9%) 死亡,对照组 13 名患儿 (1.7%) 死亡(风险比,0.54;95% 可信区间 [CI],0.22 to 1.36; P=0.19),180天时分别有 35 名 (4.5%) 和 47 名 (6.0%) 患儿死亡(风险比,0.75;95% CI, 0.48 to 1.15),且与其他随机分组没有交互作用的证据 (P>0.20),两组间180天时再住院率、严重不良事件或血红蛋白恢复情况没有显著差异。对照组平均住院日延长0.9天。

CONCLUSIONS 结论

There was no evidence of differences in clinical outcomes over 6 months between the children who received immediate transfusion and those who did not. The triggered-transfusion strategy in the control group resulted in lower blood use; however, the length of hospital stay was longer, and this strategy required clinical and hemoglobin monitoring.

接受立即输血与非立即输血的患儿6个月的临床预后没有显著差异。对照组根据临床表现的输血策略可以减少血液的使用;然而住院日较长,且需要监测临床表现及血红蛋白水平。

(Funded by the Medical Research Council and Department for International Development; TRACT Current Controlled Trials number, ISRCTN84086586opens in new tab.)

评论[仅代表个人意见]

  • 这项研究再度表明,如果异常的生理指标不伴随临床病情加重或失代偿表现,将其纠正到正常范围或接近正常范围可能并无意义
  • 对于临床医生而言,我们都知道,每位患者都可以耐受一定程度的生理指标异常而无需纠正。但是,最难的问题可能在于,对于某位患者而言,如何确定何种程度的异常可以耐受或不能耐受
  • 主要完成人Kathryn Maitland是个英国人,在非洲工作多年。相信前些年她主持完成的FEAST研究(证实对于感染合并低血压的非洲儿童,输液可能增加病死率)大家还记忆犹新
  • 明天介绍的仍然是Maitland及其同事的另一项研究结果
  • 我们总是抱怨没有临床研究的资源。真的是这样的吗?可能更多的是没有想法、意愿和付出

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