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聚合牛血红蛋白溶液作为心脏手术后同种异体红细胞输血的替代品:一项随机双盲试验的结果

Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: results of a randomized, double-blind trial.

作者信息

Levy Jerrold H, Goodnough Lawrence T, Greilich Philip E, Parr Grant V S, Stewart Robert W, Gratz Irwin, Wahr Joyce, Williams John, Comunale Mark E, Doblar Dennis, Silvay George, Cohen Marc, Jahr Jonathan S, Vlahakes Gus J

机构信息

Emory University Hospital, Atlanta, GA, USA.

出版信息

J Thorac Cardiovasc Surg. 2002 Jul;124(1):35-42. doi: 10.1067/mtc.2002.121505.

DOI:10.1067/mtc.2002.121505
PMID:12091806
Abstract

BACKGROUND

Blood loss leading to reduced oxygen-carrying capacity is usually treated with red blood cell transfusions. This study examined the hypothesis that a hemoglobin-based oxygen-carrying solution can serve as an initial alternative to red blood cell transfusion.

METHODS

In a randomized, double-blind efficacy trial of HBOC-201, a total of 98 patients undergoing cardiac surgery and requiring transfusion were randomly assigned to receive either red blood cell units or HBOC-201 (Hemopure; Biopure Corporation, Cambridge, Mass) for the first three postoperative transfusions. Patients were monitored before and after transfusion, at discharge, and at 3 to 4 weeks after the operation for subsequent red blood cell use, hemodynamics, and clinical laboratory parameters.

RESULTS

The use of HBOC-201 eliminated the need for red blood cell transfusions in 34% of cases (95% confidence interval 21%-49%). Patients in the HBOC group received a mean of 1.72 subsequent units of red blood cells; those who received red blood cells only received a mean of 2.19 subsequent units (P =.05). Hematocrit values were transiently lower in the HBOC group but were similar in the two groups at discharge and follow-up. Oxygen extraction was greater in the HBOC group (P =.05). Mean increases in blood pressure were greater in the HBOC group, but not significantly so.

CONCLUSION

HBOC-201 may be an initial alternative to red blood cell transfusions for patients with moderate anemia after cardiac surgery. In a third of cases, HBOC-201 eliminated the need for red blood cell transfusion, although substantial doses were needed to produce this modest degree of blood conservation.

摘要

背景

因失血导致氧携带能力下降通常采用输注红细胞进行治疗。本研究检验了基于血红蛋白的氧携带溶液可作为红细胞输注的初始替代方案这一假设。

方法

在一项关于HBOC - 201的随机、双盲疗效试验中,共有98例接受心脏手术且需要输血的患者被随机分配,在术后前三次输血时分别接受红细胞单位制剂或HBOC - 201(血红蛋白氧载体;百特纯;百特公司,马萨诸塞州剑桥)。在输血前后、出院时以及术后3至4周对患者进行监测,观察后续红细胞使用情况、血流动力学及临床实验室参数。

结果

使用HBOC - 201使34%的病例无需输注红细胞(95%置信区间21% - 49%)。HBOC组患者后续平均接受1.72单位红细胞;仅接受红细胞的患者后续平均接受2.19单位红细胞(P = 0.05)。HBOC组血细胞比容值短暂降低,但两组在出院时及随访时相似。HBOC组氧摄取更高(P = 0.05)。HBOC组血压平均升高幅度更大,但无显著差异。

结论

对于心脏手术后中度贫血患者,HBOC - 201可能是红细胞输注的初始替代方案。在三分之一的病例中,HBOC - 201无需输注红细胞,尽管需要大量剂量才能达到这种适度的血液保护效果。

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