Transfusion Volume for Children with Severe Anemia in Africa.
Transfusion Volume for Children with Severe Anemia in Africa.
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DOI：
10.1056/nejmoa1900100
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发表时间：
2019-08-01
期刊：
影响因子：
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通讯作者：
TRACT Group
中科院分区：
文献类型：
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作者：
Maitland K;Olupot-Olupot P;Kiguli S;Chagaluka G;Alaroker F;Opoka RO;Mpoya A;Engoru C;Nteziyaremye J;Mallewa M;Kennedy N;Nakuya M;Namayanja C;Kayaga J;Uyoga S;Kyeyune Byabazaire D;M'baya B;Wabwire B;Frost G;Bates I;Evans JA;Williams TN;Saramago Goncalves P;George EC;Gibb DM;Walker AS;TRACT Group
严重贫血（血红蛋白水平<6克/分升）是撒哈拉以南非洲儿童住院和死亡的主要原因。世界卫生组织建议，无论血红蛋白水平如何，贫血患者每公斤体重输注20 ml全血当量。在这项析因、开放标签试验中，我们随机分配了2个月至12岁的乌干达和马拉维儿童，他们的血红蛋白水平低于6 g/分升，并具有严重特征（例如，呼吸窘迫或意识减退）立即输血，输血量为每公斤20 ml或30 ml。另外三项随机分析研究了立即输血与不立即输血、出院后微量营养素给药和出院后甲氧苄啶-磺胺甲恶唑预防的比较。主要结局为28天死亡率。共有3196名符合条件的儿童（中位年龄为37个月; 2050名[64.1%]患有疟疾）被分配接受每公斤30 ml（1598名儿童）或每公斤20 ml（1598名儿童）的输血，并随访180天。高容量组共有1592名儿童（99.6%）开始输血，低容量组共有1596名儿童（99.9%）开始输血（中位数，随机化后1.2小时）。每名儿童的平均（±SD）输血总量分别为475±385 ml和353±348 ml;各组中分别有197名儿童（12.3%）和300名儿童（18.8%）接受了额外输血。总体而言，高容量组中有55名儿童（3.4%）和低容量组中有72名儿童（4.5%）在28天前死亡（风险比，0.76; 95%置信区间[CI]，0.54至1.08;对数秩检验P = 0.12）。这一发现掩盖了根据筛选时是否存在发热（>37.5°C）而导致的28天死亡率的显著异质性（Sidak校正后P = 0.001）。在1943例（60.8%）无发热的儿童中，输血量为30 ml/kg的死亡率低于输血量为20 ml/kg的死亡率（风险比，0.43; 95%CI，0.27 ~ 0.69）。在1253名发热儿童（39.2%）中，30 ml/kg组的死亡率高于20 ml/kg组（风险比，1.91; 95%CI，1.04 - 3.49）。没有证据表明随机组之间在再入院、严重不良事件或180天血红蛋白恢复方面存在差异。两种输血策略的总体死亡率无差异。（由英国医学研究理事会和国际发展部资助; TRACT当前对照试验编号，ISRCTN 84086586。）
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. 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. 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 réadmissions, serious adverse events, or hemoglobin recovery at 180 days. Overall mortality did not differ between the two transfusion strategies. (Funded by the Medical Research Council and Department for International Development, United Kingdom; TRACT Current Controlled Trials number, ISRCTN84086586.)