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首页> 外文期刊>BJOG: an international journal of obstetrics and gynaecology >Transfusion policy after severe postpartum haemorrhage: A randomised non-inferiority trial
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Transfusion policy after severe postpartum haemorrhage: A randomised non-inferiority trial

机译：严重产后出血的输血策略：一项随机性非劣效性试验

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Objective To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage. Design Randomised non-inferiority trial. Setting Thirty-seven Dutch university and general hospitals. Population Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities. Methods Women were allocated to RBC transfusion or non-intervention. Main outcome measures Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum. Results In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable. Conclusions Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.
机译：目的评估输血对急性贫血妇女产后出血后生活质量的影响。设计随机非劣效性试验。设置了三十七所荷兰大学和综合医院。人群患有严重贫血症状或严重合并症的急性贫血（血红蛋白4.8-7.9 g / dl [3.0-4.9 mmol / l] [3.0-4.9 mmol / l]产后12-24小时）的妇女。方法将女性分配给RBC输血或不干预。主要结局指标主要结局是产后3天的身体疲劳（多维疲劳量表，等级4-20; 20表示最大疲劳）。如果研究臂之间的身体疲劳差异最大为1.3，则表明非自卑。次要结果是与健康有关的生活质量和身体并发症。与健康相关的生活质量问卷在五个时间点完成，直到产后6周。结果总共有521名妇女被随机分配为不干预（n = 262）或RBC输血（n = 259）。调整基线和分娩方式后，产后第3天的平均身体疲劳评分在RBC输血组中降低了0.8（95％置信区间：0.1-1.5，P = 0.02），在产后1周降低了1.06（95％）置信区间：0.3-1.8，P = 0.01）。在RBC输血臂中输注了两个RBC单位的中位数。在非干预组，有33名妇女接受了RBC输血，主要是因为贫血症状。身体并发症相当。结论从统计学上讲，由于置信区间跨越了非劣效性边界，因此无法证明非劣效性。然而，由于身体疲劳只有很小的差异，而次要结局没有差异，因此实施限制性管理在临床上似乎是合理的。

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