Efficacy and safety of epoetin alfa in critically ill patients
Efficacy and safety of epoetin alfa in critically ill patients
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DOI：
10.1056/nejmoa071533
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发表时间：
2007-09-06
影响因子：
158.5
通讯作者：
Corwin, Michael J.
中科院分区：
文献类型：
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作者：
Corwin, Howard L.;Gettinger, Andrew;Corwin, Michael J.
贫血在危重病人中很常见，通常采用红细胞输注治疗，但临床效果不佳。我们假设，重组人促红细胞生成素（促红细胞生成素α）的治疗可能会减少红细胞transfusions.MethodsIn这个前瞻性的，随机的，安慰剂对照试验，我们招募了1460内科，外科手术，或创伤患者入院后48和96小时之间的重症监护病房。每周给予依泊苷α（40，000 U）或安慰剂，最多持续3周;患者随访140天。主要终点是接受红细胞输注的患者百分比。次要终点是输注红细胞单位的数量、死亡率和血红蛋白浓度较基线的变化。结果与安慰剂组相比，依泊苷α治疗未导致接受红细胞输注的患者数量减少，（依泊苷α组与安慰剂组的相对风险为0.95; 95%置信区间[CI]，0.85 - 1.06）或平均（+/-SD）输注红细胞单位数（依泊苷α组为4.5 ± 4.6单位，安慰剂组为4.3 ± 4.8单位，P=0.42）。然而，第29天，依泊苷α组的血红蛋白浓度比安慰剂组增加更多（1.6+/-2.0 g/dl vs. 1.2+/-1.8 g/dl，P
BackgroundAnemia, which is common in the critically ill, is often treated with red-cell transfusions, which are associated with poor clinical outcomes. We hypothesized that therapy with recombinant human erythropoietin (epoetin alfa) might reduce the need for red-cell transfusions.MethodsIn this prospective, randomized, placebo-controlled trial, we enrolled 1460 medical, surgical, or trauma patients between 48 and 96 hours after admission to the intensive care unit. Epoetin alfa (40,000 U) or placebo was administered weekly, for a maximum of 3 weeks; patients were followed for 140 days. The primary end point was the percentage of patients who received a red-cell transfusion. Secondary end points were the number of red-cell units transfused, mortality, and the change in hemoglobin concentration from baseline.ResultsAs compared with the use of placebo, epoetin alfa therapy did not result in a decrease in either the number of patients who received a red-cell transfusion (relative risk for the epoetin alfa group vs. the placebo group, 0.95; 95% confidence interval [CI], 0.85 to 1.06) or the mean (+/-SD) number of red-cell units transfused (4.5+/-4.6 units in the epoetin alfa group and 4.3+/-4.8 units in the placebo group, P=0.42). However, the hemoglobin concentration at day 29 increased more in the epoetin alfa group than in the placebo group (1.6+/-2.0 g per deciliter vs. 1.2+/-1.8 g per deciliter, P