Jahr Jonathan S, Walker Valeri, Manoochehri Katayoon
Department of Anesthesiology, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA.
Curr Opin Anaesthesiol. 2007 Aug;20(4):325-30. doi: 10.1097/ACO.0b013e328172225a.
To discuss the development and current status of blood substitutes, including hemoglobin-based oxygen carriers (HBOCs) and perfluorocarbons. Research in this field offers an important view into the future of transfusion medicine in the operating room, as well as in trauma and combat arenas.
A pivotal multinational phase III trial of the Biopure product HBOC-201 (Hemopure) has been completed in orthopedic surgery patients. HBOC-201 consists of polymerized bovine hemoglobin and has already been well tolerated in patients undergoing cardiopulmonary bypass and abdominal aortic reconstruction. Polyheme is a polymerized human hemoglobin in early phase III clinical trials with trauma patients, having infused up to 10,000 ml, with efficacy apparently demonstrated in phase II. The Sangart product, Hemospan, is currently undergoing phase II trials.
Polymerized hemoglobin preparations have proven most successful in clinical trials due to their improved side-effect profile. The goal is to evaluate blood substitutes with enhanced intravascular retention, reduced osmotic activity, and attenuated hemodynamic derangements such as vasoconstriction. Although not without substantial morbidity and mortality, the current safety of allogeneic blood transfusion demands that comparative studies show minimal adverse effects, as well as efficacy and potential for novel applications.
讨论血液替代品的发展及现状,包括基于血红蛋白的氧载体(HBOCs)和全氟碳化合物。该领域的研究为手术室、创伤及战场输血医学的未来提供了重要视角。
Biopure公司的产品HBOC - 201(Hemopure)在骨科手术患者中完成了一项关键的跨国III期试验。HBOC - 201由聚合牛血红蛋白组成,在接受体外循环和腹主动脉重建的患者中已表现出良好的耐受性。Polyheme是一种聚合人血红蛋白,正处于针对创伤患者的III期临床试验早期阶段,已输注达10,000毫升,在II期试验中已显示出疗效。Sangart公司的产品Hemospan目前正在进行II期试验。
聚合血红蛋白制剂因其改善的副作用表现,在临床试验中已被证明最为成功。目标是评估具有增强血管内留存、降低渗透活性以及减轻诸如血管收缩等血流动力学紊乱的血液替代品。尽管同种异体输血目前并非没有严重的发病率和死亡率,但鉴于其安全性,对比研究应显示出最小的不良反应,以及疗效和新应用的潜力。