Gould S A, Moore E E, Hoyt D B, Burch J M, Haenel J B, Garcia J, DeWoskin R, Moss G S
University of Illinois, Chicago, USA.
J Am Coll Surg. 1998 Aug;187(2):113-20; discussion 120-2. doi: 10.1016/s1072-7515(98)00095-7.
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.
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.
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.
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.
人聚合血红蛋白（PolyHeme）是一种通用兼容、无疾病的携氧复苏液。这是第一项直接比较PolyHeme与异体红细胞（RBC）在治疗急性失血中治疗效果的前瞻性随机试验。
44例年龄在19 - 75岁之间、平均损伤严重度评分（ISS）为21±10的创伤患者（33例男性，11例女性）被随机分为两组，一组接受红细胞（n = 23），另一组接受最多6单位（300 g）的PolyHeme（n = 21），作为创伤后及急诊手术期间的初始血液替代品。
未发生与PolyHeme相关的严重或意外不良事件。输注4.4±2.0单位（均值±标准差）的PolyHeme导致血浆血红蛋白浓度（[Hb]）为3.9±1.3 g/dL，占总循环[Hb]的40%。输注前两组的总[Hb]无差异（对照组10.4±2.3 g/dL，试验组9.4±1.9 g/dL）。输注结束时，试验组红细胞[Hb]降至5.8±2.8 g/dL，而对照组为10.6±1.8 g/dL（p < 0.05），尽管两组间总[Hb]与输注前相比无差异。到第1天，对照组和试验组异体红细胞输注总量分别为10.4±4.2单位和6.8±3.9单位（p < 0.05），到第3天分别为11.3±4.1单位和7.8±4.2单位（p = 0.06）。
PolyHeme在急性失血中是安全的，尽管红细胞[Hb]显著下降，但仍能维持总[Hb]以替代红细胞，并减少异体血的使用。PolyHeme似乎是一种临床上有用的血液替代品。
