一种新的基于血红蛋白的氧载体在正常男性和女性受试者中的血液学影响。

G S Hughes, S F Francome, E J Antal, W J Adams, P K Locker, E P Yancey, E E Jacobs
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引用次数: 0

摘要

本研究的目的是评估铁代谢与基于血红蛋白的氧载体-201 (HBOC-201)的药代动力学之间的关系,HBOC-201是牛来源的聚合血红蛋白产物。采用随机、单盲、单剂量研究设计。这项研究是在密歇根州卡拉马祖的厄普约翰研究诊所进行的。四组健康男性和女性(n = 24),分别接受HBOC-201(9男9女)或对照溶液(林格氏乳酸)(3男3女)参与研究。所有受试者均行静脉切开术(约15%血容量),随后用乳酸林格液进行3:1血液稀释,静脉输注HBOC-201(最多45 gm或350 ml)或对照溶液(乳酸林格液)。在最初的24小时内,通过桡动脉导管和同步脉搏血氧仪进行了一系列动脉血气采样。在1个月的时间里,连续采集血清铁、铁蛋白、促红细胞生成素和血浆HBOC-201水平。在hboc -201治疗组,血清铁和铁蛋白水平升高。血清铁和铁蛋白水平峰值分别出现在8小时(高达220微克/分升)和48小时(高达180纳克/毫升)。血清铁水平与HBOC-201浓度平行。HBOC-201的血浆半衰期约为20小时。24小时血清促红细胞生成素比基线增加2 - 6倍(p < 0.001)。hboc -201组未检出尿血红蛋白。本研究表明,HBOC-201在男性和女性中产生的血清铁、铁蛋白和促红细胞生成素的升高与HBOC-201的血浆水平密切相关。
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Hematologic effects of a novel hemoglobin-based oxygen carrier in normal male and female subjects.

The objective of this study was to assess the relationship between iron metabolism and pharmacokinetics of hemoglobin-based oxygen carrier-201 (HBOC-201), a polymerized hemoglobin product of bovine origin. A randomized, single-blind, single-dose study design was used. The study was performed at the Upjohn Research Clinics in Kalamazoo, Michigan. Four groups of healthy men and women (n = 24), who either received HBOC-201 (9 men, 9 women) or a control solution (Ringer's lactate) (3 men, 3 women) participated in the study. All subjects had phlebotomy (approximately 15% blood volume) followed by 3:1 hemodilution with Ringer's lactate and an intravenous infusion of HBOC-201 (up to 45 gm or 350 ml) or control solution (Ringer's lactate). Serial arterial blood gas samples with a radial artery catheter and simultaneous pulse oximetry were done during the first 24 hours. Serial samples for serum iron, ferritin, erythropoietin, and plasma HBOC-201 levels were taken over a 1-month period. In the HBOC-201-treated groups, serum iron and ferritin levels increased. Peak serum iron and ferritin levels occurred by hours 8 (up to 220 micrograms/dl) and 48 (up to 180 ng/ml), respectively. Serum iron levels paralleled HBOC-201 concentrations. Plasma half-life of HBOC-201 was about 20 hours. Serum erythropoietin increased by twofold to sixfold over baseline (p < 0.001) at 24 hours. No urinary hemoglobin was detected in the groups with HBOC-201-treated subjects. This study demonstrates that HBOC-201 produces increases in serum iron, ferritin, and erythropoietin that closely parallel plasma levels of HBOC-201 in men and women.

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