Gastrointestinal Bleeding Unit, Department of Gastroenterology, Hospital de Sant Pau, Autonomous University, Barcelona, Spain.
N Engl J Med. 2013 Jan 3;368(1):11-21. doi: 10.1056/NEJMoa1211801.
The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial. We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy.
We enrolled 921 patients with severe acute upper gastrointestinal bleeding and randomly assigned 461 of them to a restrictive strategy (transfusion when the hemoglobin level fell below 7 g per deciliter) and 460 to a liberal strategy (transfusion when the hemoglobin fell below 9 g per deciliter). Randomization was stratified according to the presence or absence of liver cirrhosis.
A total of 225 patients assigned to the restrictive strategy (51%), as compared with 61 assigned to the liberal strategy (14%), did not receive transfusions (P<0.001) [corrected].The probability of survival at 6 weeks was higher in the restrictive-strategy group than in the liberal-strategy group (95% vs. 91%; hazard ratio for death with restrictive strategy, 0.55; 95% confidence interval [CI], 0.33 to 0.92; P=0.02). Further bleeding occurred in 10% of the patients in the restrictive-strategy group as compared with 16% of the patients in the liberal-strategy group (P=0.01), and adverse events occurred in 40% as compared with 48% (P=0.02). The probability of survival was slightly higher with the restrictive strategy than with the liberal strategy in the subgroup of patients who had bleeding associated with a peptic ulcer (hazard ratio, 0.70; 95% CI, 0.26 to 1.25) and was significantly higher in the subgroup of patients with cirrhosis and Child-Pugh class A or B disease (hazard ratio, 0.30; 95% CI, 0.11 to 0.85), but not in those with cirrhosis and Child-Pugh class C disease (hazard ratio, 1.04; 95% CI, 0.45 to 2.37). Within the first 5 days, the portal-pressure gradient increased significantly in patients assigned to the liberal strategy (P=0.03) but not in those assigned to the restrictive strategy.
As compared with a liberal transfusion strategy, a restrictive strategy significantly improved outcomes in patients with acute upper gastrointestinal bleeding. (Funded by Fundació Investigació Sant Pau; ClinicalTrials.gov number, NCT00414713.).
对于急性胃肠道出血的患者，输注红细胞的血红蛋白阈值存在争议。我们比较了限制输血策略与自由输血策略的疗效和安全性。
我们纳入了 921 例严重急性上消化道出血患者，并将其中 461 例随机分配至限制输血组（血红蛋白水平降至每分升 7 克以下时输血），460 例随机分配至自由输血组（血红蛋白水平降至每分升 9 克以下时输血）。随机化按有无肝硬化分层。
与自由输血组（61 例，14%）相比，接受限制输血策略的 225 例患者（51%）未接受输血（P<0.001）[校正]。限制输血组的 6 周生存率高于自由输血组（95% vs. 91%；限制输血策略死亡风险比为 0.55；95%置信区间[CI]为 0.33 至 0.92；P=0.02）。限制输血组再次出血的发生率为 10%，而自由输血组为 16%（P=0.01），不良事件的发生率为 40%，而自由输血组为 48%（P=0.02）。在与消化性溃疡相关出血的患者亚组中，限制输血策略的生存率略高于自由输血策略（风险比为 0.70；95%CI 为 0.26 至 1.25），在肝硬化且 Child-Pugh 分级为 A 或 B 的患者亚组中显著更高（风险比为 0.30；95%CI 为 0.11 至 0.85），但在肝硬化且 Child-Pugh 分级为 C 的患者亚组中无显著差异（风险比为 1.04；95%CI 为 0.45 至 2.37）。在最初的 5 天内，自由输血组的门静脉压力梯度显著升高（P=0.03），而限制输血组无此变化。
与自由输血策略相比，限制输血策略可显著改善急性上消化道出血患者的结局。（由 Fundació Investigació Sant Pau 资助；ClinicalTrials.gov 编号，NCT00414713。）
