Henkel-Honke Thad, Oleck Mark
Froedtert Hospital, Milwaulkee, Wis, USA.
AANA J. 2007 Jun;75(3):205-11.
Artificial oxygen carriers are not blood substitutes. They serve to carry oxygen to tissues and are either hemoglobin based or perfluorocarbon based. Driving the development of artificial oxygen carriers are concerns involving both the safety and quantity of the blood supply. No artificial oxygen carriers are currently approved for clinical use in the United States. Hemopure has been approved for use in South Africa. The companies producing Hemopure and PolyHeme, both of which are hemoglobin-based oxygen carriers, have filed a Biologic License Application in the United States. Phase III trials have been completed for Hemopure, while PolyHeme is currently undergoing phase III trials in the PolyHeme Urban Ambulance Trial. No North American trials are under way for perfluorocarbons.
人工氧载体并非血液替代品。它们用于将氧气输送到组织,可分为基于血红蛋白的和基于全氟化碳的两类。推动人工氧载体发展的因素包括对血液供应安全性和数量的担忧。目前在美国,尚无人工氧载体被批准用于临床。Hemopure已获批准在南非使用。生产Hemopure和PolyHeme(二者均为基于血红蛋白的氧载体)的公司已在美国提交生物制品许可申请。Hemopure已完成III期试验,而PolyHeme目前正在“PolyHeme城市救护车试验”中进行III期试验。全氟化碳在北美尚无正在进行的试验。