Riess Jean G
MRI Institute, University of California at San Diego and Alliance Pharmaceutical Corp., San Diego, CA 92103, USA.
Artif Cells Blood Substit Immobil Biotechnol. 2006;34(6):567-80. doi: 10.1080/10731190600973824.
The basic properties of perfluorocarbons (PFCs) and PFC emulsions relevant to their use as oxygen delivery systems are briefly reviewed. The key issues related to the selection of an appropriate, readily excretable PFC and the engineering of a stable injectable PFC emulsion are discussed. Oxygent, a terminally heat-sterilized, injectable 60% w/v PFC emulsion made primarily of F-octyl bromide and a few percent of F-decyl bromide, with egg phospholipids as an emulsifier, has been developed. Its efficacy in avoiding and reducing red cell transfusion during surgery has been established during a Phase III clinical evaluation. Another Phase III clinical trial in cardiopulmonary bypass surgery, with a protocol that included both augmented-acute normovolemic hemodilution and intraoperative autologous donation, has, however, been interrupted following the observation of adverse events. Data analysis assigned these events to an inappropriate study protocol. A search for possible interactions between Oxygent and fluids present during cardiopulmonary bypass surgery detected no effect of the emulsion on hemostasis, hemolysis and blood rheology.
简要回顾了全氟化碳(PFCs)及其乳液作为氧输送系统使用时的基本特性。讨论了与选择合适的、易于排泄的全氟化碳以及制备稳定的可注射全氟化碳乳液相关的关键问题。已开发出Oxygent,这是一种经终端热灭菌的、可注射的60% w/v全氟化碳乳液,主要由氟代溴辛烷和百分之几的氟代溴癸烷制成,以鸡蛋磷脂作为乳化剂。在一项III期临床评估中已证实其在手术期间避免和减少红细胞输血方面的功效。然而,在一项体外循环心脏手术的III期临床试验中,观察到不良事件后,该试验被中断,该试验方案包括急性等容血液稀释和术中自体输血。数据分析将这些事件归因于不适当的研究方案。对Oxygent与体外循环心脏手术期间存在的液体之间可能的相互作用进行的研究未发现该乳液对止血、溶血和血液流变学有影响。