Corwin Howard L, Gettinger Andrew, Fabian Timothy C, May Addison, Pearl Ronald G, Heard Stephen, An Robert, Bowers Peter J, Burton Paul, Klausner Mark A, Corwin Michael J
Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA.
N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.
BACKGROUND: Anemia, 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. METHODS: In 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. RESULTS: As 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<0.001). Mortality tended to be lower at day 29 among patients receiving epoetin alfa (adjusted hazard ratio, 0.79; 95% CI, 0.56 to 1.10); this effect was also seen in prespecified analyses in those with a diagnosis of trauma (adjusted hazard ratio, 0.37; 95% CI, 0.19 to 0.72). A similar pattern was seen at day 140 (adjusted hazard ratio, 0.86; 95% CI, 0.65 to 1.13), particularly in those with trauma (adjusted hazard ratio, 0.40; 95% CI, 0.23 to 0.69). As compared with placebo, epoetin alfa was associated with a significant increase in the incidence of thrombotic events (hazard ratio, 1.41; 95% CI, 1.06 to 1.86). CONCLUSIONS: The use of epoetin alfa does not reduce the incidence of red-cell transfusion among critically ill patients, but it may reduce mortality in patients with trauma. Treatment with epoetin alfa is associated with an increase in the incidence of thrombotic events. (ClinicalTrials.gov number, NCT00091910 [ClinicalTrials.gov].).
背景：贫血在重症患者中很常见，常采用红细胞输血治疗，但这与不良临床结局相关。我们推测，重组人促红细胞生成素（阿法依泊汀）治疗可能会减少红细胞输血的需求。 方法：在这项前瞻性、随机、安慰剂对照试验中，我们纳入了1460例入住重症监护病房48至96小时后的内科、外科或创伤患者。阿法依泊汀（40,000单位）或安慰剂每周给药一次，最多给药3周；对患者随访140天。主要终点是接受红细胞输血的患者百分比。次要终点是输注的红细胞单位数量、死亡率以及血红蛋白浓度相对于基线的变化。 结果：与使用安慰剂相比，阿法依泊汀治疗并未使接受红细胞输血的患者数量减少（阿法依泊汀组与安慰剂组的相对风险为0.95；95%置信区间[CI]为0.85至1.06），也未使输注的红细胞单位平均数量（±标准差）减少（阿法依泊汀组为4.5±4.6单位，安慰剂组为4.3±4.8单位，P = 0.42）。然而，阿法依泊汀组在第29天时血红蛋白浓度的升高幅度大于安慰剂组（分别为每分升1.6±2.0克和每分升1.2±1.8克，P<0.001）。接受阿法依泊汀治疗的患者在第29天时死亡率倾向于更低（调整后的风险比为0.79；95%CI为0.56至1.10）；在预先设定的创伤诊断分析中也观察到了这种效应（调整后的风险比为0.37；95%CI为0.19至0.72）。在第140天时也观察到了类似的模式（调整后的风险比为0.86；95%CI为0.65至1.13），尤其是在创伤患者中（调整后的风险比为0.40；95%CI为0.23至0.69）。与安慰剂相比，阿法依泊汀与血栓形成事件的发生率显著增加相关（风险比为1.41；95%CI为1.06至1.86）。 结论：阿法依泊汀的使用并未降低重症患者红细胞输血的发生率，但可能降低创伤患者的死亡率。阿法依泊汀治疗与血栓形成事件发生率的增加相关。（ClinicalTrials.gov编号，NCT00091910 [ClinicalTrials.gov]。）
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