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新研究探讨非洲严重贫血儿童的输血量
作者:小柯机器人 发布时间:2019/8/1 18:52:49

英国伦敦帝国理工学院、贝尔法斯特女王大学等机构的科学家,在2019年8月1日出版的《新英格兰医学杂志》发表了一项新成果,探究了非洲严重贫血儿童的输血量。

在这项因子分析、开放标签试验中,研究人员随机分配2个月至12岁的乌干达和马拉维儿童接受即刻输血,入选儿童血红蛋白水平低于6 g/dl并伴有严重功能障碍(如呼吸窘迫或意识下降),接受输血20ml/kg或30ml/kg。其他三项随机分析作为对照,包括未立即输血、出院后服用微量营养素以及使用甲氧苄啶-磺胺甲恶唑进行出院后预防。主要结果是28天死亡率。
 
共有3196名符合条件的儿童(中位年龄,37个月;2050例(64.1%)患有疟疾)被分配接受每公斤30ml(1598名儿童)或每公斤20ml(1598名儿童)的输血,并随访180天。高容量组1592名儿童(99.6%)和低容量组1596名儿童(99.9%)开始输血(中位数,随机分组后1.2小时)。每名儿童的平均(±SD)输血量分别为475±385 ml和353±348 ml;每组分别有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55名儿童(3.4%)和低容量组中72名儿童(4.5%)在28天前死亡(危险比,0.76;95%置信区间[CI],0.54-1.08;对数秩检验P=0.12)。这一发现掩盖了28天死亡率的显著异质性(Sidak校正后P=0.001)根据筛查时是否有发热(>37.5°C)。在1943名没有发烧的儿童中(60.8%),输血量为30ml/kg的死亡率低于输血量为20ml/kg的死亡率(危险比,0.43;95%可信区间,0.27-0.69)。在1253名发热儿童(39.2%)中,输血量为每公斤30ml的死亡率高于每公斤20ml(危险比为1.91;95%可信区间为1.04-3.49)。两组患者在180天的再入院率、严重不良事件或血红蛋白恢复率方面无明显差异,两种输血策略的总死亡率无差异。
 
据了解,严重贫血(血红蛋白水平,<6 g/dl)是撒哈拉以南非洲儿童住院和死亡的主要原因。世界卫生组织建议贫血患者不论血红蛋白水平如何,每公斤体重输血20ml全血当量。

 

附:英文原文

Title: Transfusion Volume for Children with Severe Anemia in Africa

Author: Kathryn Maitland, M.D., Ph.D., Peter Olupot-Olupot, M.B., Ch.B., Ph.D., Sarah Kiguli, M.B., Ch.B., M.Med., George Chagaluka, M.D., Florence Alaroker, M.B., Ch.B., M.Med., Robert O. Opoka, M.B., Ch.B., M.Med., Ayub Mpoya, M.Sc., Charles Engoru, M.B., Ch.B., M.Med., Julius Nteziyaremye, M.B., Ch.B., Macpherson Mallewa, M.R.C.P.C.H., Ph.D., Neil Kennedy, M.D., Margaret Nakuya, M.B., Ch.B., et al., for the TRACT Group*

Issue&Volume: Vol.381 No.5, 2019

Abstract: 

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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, ISRCTN84086586opens in new tab.)


DOI:10.1056/NEJMoa1900100

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1900100

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home