The first randomized trial of human polymerized hemoglobin as a blood substitute in acute trauma and emergent surgery
The first randomized trial of human polymerized hemoglobin as a blood substitute in acute trauma and emergent surgery
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DOI：
10.1016/s1072-7515(98)00095-7
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发表时间：
1998-08-01
影响因子：
5.2
通讯作者：
Moss, GS
中科院分区：
文献类型：
--
作者：
Gould, SA;Moore, EE;Moss, GS
背景：人聚合血红蛋白（PolyHeme）是一种通用的、无病的、携氧复苏液。这是第一个前瞻性随机试验，直接比较聚血红素与同种异体红细胞（RBC）在治疗急性失血中的治疗益处。研究设计：44名外伤患者（33名男性，11名女性），年龄19-75岁，平均损伤严重度评分（ISS）为21 +/- 10，随机接受红细胞（n = 23）或高达6 U（结果：21例患者在创伤后和急诊手术中首次使用聚血红素（300 g）进行血液置换，未发生与聚血红素相关的严重或非预期不良事件。4.4 +/- 2.0单位（平均值+/- SD）的聚血红素输注导致血浆[Hb]为3.9 +/- 1.3 g/dL，占总循环[Hb]的40%。输注前，两组之间的总[Hb]无差异（对照组为10.4 +/- 2.3 g/dL，实验组为9.4 +/- 1.9 g/dL）。在输注结束时，实验RBC [Hb]降至5.8 +/- 2.8 g/dL，对照组为10.6 +/- 1.8 g/dL（p < 0.05），尽管两组之间或输注前的总[Hb]没有差异。对照组和实验组的同种异体红细胞输注总数分别为10.4 +/- 4.2单位和6.8 +/- 3.9单位（p < 0.05）至第1天，11.3 +/- 4.1单位vs. 7.8 +/- 4.2单位（p = 0.06）至第3天。结论：PolyHeme在急性失血中是安全的，尽管RBC [Hb]显着下降，但仍能维持总[Hb]而不是红细胞，并减少同种异体血液的使用。PolyHeme似乎是临床上有用的血液替代品。（美国科尔外科杂志1998;187：113-122。(C)1998年美国外科医生学会）
Background: Human polymerized hemoglobin (PolyHeme) is a universally compatible, disease-free, oxygen-carrying resuscitative fluid. This is the first prospective, randomized trial to compare directly the therapeutic benefit of PolyHeme with that of allogeneic red blood cells (RBCs) in the treatment of acute blood loss.Study Design: Forty-four trauma patients (33 male, 11 female) aged 19-75 years with an average Injury Severity Score (ISS) score of 21 +/- 10 were randomized to receive red cells (n = 23) or up to 6 U (300 g) of PolyHeme (n = 21) as their initial blood replacement after trauma and during emergent operations.Results: There were no serious or unexpected adverse events related to PolyHeme. The PolyHeme infusion of 4.4 +/- 2.0 units (mean +/- SD) resulted in a plasma [Hb] of 3.9 +/- 1.3 g/dL, which accounted for 40% of the total circulating [Hb]. There was no difference in total [Hb] between the groups before infusion (10.4 +/- 2.3 g/dL control vs. 9.4 +/- 1.9 g/dL experimental). At end-infusion the experimental RBC [Hb] fell to 5.8 +/- 2.8 g/dL vs. 10.6 +/- 1.8 g/dL (p < 0.05) in the control, although the total [Hb] was not different between the groups or from pre-infusion. The total number of allogeneic red cell transfusions for the control and experimental groups was 10.4 +/- 4.2 units vs. 6.8 +/- 3.9 units (p < 0.05) through day 1, and 11.3 +/- 4.1 units vs. 7.8 +/- 4.2 units (p = 0.06) through day 3.Conclusions: PolyHeme is safe in acute blood loss, maintains total [Hb] in lieu of red cells despite the marked fall in RBC [Hb], and reduces the use of allogeneic blood. PolyHeme appears to be a clinically useful blood substitute. (J Am Coll Surg 1998;187:113-122. (C) 1998 by the American College of Surgeons)