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[NEJM发表论文]:非洲严重贫血儿童的输血量
2019年08月17日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE

Transfusion Volume for Children with Severe Anemia in Africa

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

N Engl J Med 2019; 381:420-431
DOI: 10.1056/NEJMoa1900100

Abstract

BACKGROUND 背景

Severe anemia (hemoglobin level, <6 g per deciliter) is a leading cause of hospital admission and death in children in sub-Saharan Africa. The World Health Organization recommends transfusion of 20 ml of whole-blood equivalent per kilogram of body weight for anemia, regardless of hemoglobin level.

严重贫血(血红蛋白< 6 g/dL)是撒哈拉以南非洲地区儿童住院及死亡的首要原因。WHO推荐,无论血红蛋白水平水平,应当输注20 ml等量全血/kg治疗贫血。

METHODS 方法

In this factorial, open-label trial, we randomly assigned Ugandan and Malawian children 2 months to 12 years of age with a hemoglobin level of less than 6 g per deciliter and severity features (e.g., respiratory distress or reduced consciousness) to receive immediate blood transfusion with 20 ml per kilogram or 30 ml per kilogram. Three other randomized analyses investigated immediate as compared with no immediate transfusion, the administration of postdischarge micronutrients, and postdischarge prophylaxis with trimethoprim–sulfamethoxazole. The primary outcome was 28-day mortality.

在这项析因设计、开放标签试验中,我们将伴有血红蛋白水平低于6 g/L且有病情严重表现(如呼吸窘迫或意识障碍)的2个月至12岁乌干达和马拉维儿童随机分组,分别接受立即输血20 ml/kg或30 ml/kg。其他3项随机分析包括立即输血与非立即输血的比较,出院后补充微量营养素,以及出院后使用复方新诺明预防。主要预后指标为28天病死率。

RESULTS 结果

A total of 3196 eligible children (median age, 37 months; 2050 [64.1%] with malaria) were assigned to receive a transfusion of 30 ml per kilogram (1598 children) or 20 ml per kilogram (1598 children) and were followed for 180 days. A total of 1592 children (99.6%) in the higher-volume group and 1596 (99.9%) in the lower-volume group started transfusion (median, 1.2 hours after randomization). The mean (±SD) volume of total blood transfused per child was 475±385 ml and 353±348 ml, respectively; 197 children (12.3%) and 300 children (18.8%) in the respective groups received additional transfusions. Overall, 55 children (3.4%) in the higher-volume group and 72 (4.5%) in the lower-volume group died before 28 days (hazard ratio, 0.76; 95% confidence interval [CI], 0.54 to 1.08; P=0.12 by log-rank test). This finding masked significant heterogeneity in 28-day mortality according to the presence or absence of fever (>37.5°C) at screening (P=0.001 after Sidak correction). Among the 1943 children (60.8%) without fever, mortality was lower with a transfusion volume of 30 ml per kilogram than with a volume of 20 ml per kilogram (hazard ratio, 0.43; 95% CI, 0.27 to 0.69). Among the 1253 children (39.2%) with fever, mortality was higher with 30 ml per kilogram than with 20 ml per kilogram (hazard ratio, 1.91; 95% CI, 1.04 to 3.49). There was no evidence of differences between the randomized groups in readmissions, serious adverse events, or hemoglobin recovery at 180 days.

总共 3196 名符合入选标准的儿童(中位年龄,27个月;2050名 [64.1%] 为疟疾)接受随机分组,分别接受输血 30 ml/kg(1598 名儿童)或 20 ml/kg(1598 名儿童),随访至180天。高容量组 1592 名儿童 (99.6%) 与低容量组 1596 名儿童 (99.9%) 开始输血(中位时间,随机分组后1.2 小时)。每名患儿平均 (±SD) 输血量分别为 475±385 ml 和 353±348 ml;两组分别有 197 名患儿 (12.3%) 和 300 名患儿 (18.8%) 接受了额外输血。高容量组 55 名患儿 (3.4%) 与低容量组 72 名患儿 (4.5%) 在28天前死亡(风险比,0.76;95% 可信区间 [CI], 0.54 to 1.08;log-rank检验 P=0.12)。上述结果掩盖了筛查时是否发热 (>37.5°C) 伴随的28天病死率的显著差异性( Sidak校正后 P=0.001)。在没有发热的 1943 名患儿 (60.8%),与输血20 ml/kg相比,输血 30 ml/kg 组病死率显著降低(风险比 0.43;95% CI, 0.27 to 0.69)。对于 1253 名发热患儿 (39.2%) ,输血30 ml/kg组病死率高于 20 ml/kg组(风险比 1.91;95% CI, 1.04 to 3.49)。两组患儿180天内再入院率、严重不良事件或血红蛋白恢复情况无显著差异。

CONCLUSIONS 结论

Overall mortality did not differ between the two transfusion strategies.

两种不同的输血策略之间病死率并无差异。

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

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