Department of Anesthesiology, Baylor Scott and White Healthcare, Scott and White Memorial Hospital, Temple, Texas.
Shock. 2019 Oct;52(1S Suppl 1):65-69. doi: 10.1097/SHK.0000000000001063.
Perftoran, which has been rebranded as Vidaphor for marketing in North America, is an emulsion of perfluorocarbons in a surfactant and electrolyte mixture. It was developed in Russia as an oxygen-carrying intravenous plasma additive for hemorrhagic anemia and ischemic conditions from various etiologies. It was approved for clinical use in Russia in 1996 and used by the Russian Armed Forces and in civilian medical care. It was also approved in Mexico from 2005 to 2010. It has been reportedly administered to over 35,000 patients with significant evidence of benefit and relatively mild and manageable adverse effects. It may have significant potential for use in hemorrhagic shock if human red blood cells are not available, and for several other applications including treatment of vascular gas embolism, cerebral or spinal trauma, and regional ischemia. It is different from other perfluorocarbon preparations under development in the United States in that it uses a different primary perfluorocarbon (perfluorodecalin) and a surfactant (Proxanol 268) instead of egg-yok phospholipid as the emulsion vehicle. Perftoran has a much smaller particle size resulting in milder adverse effects. It has been safely administered to more patients than any oxygen carrier currently under development. A newly formed United States Corporation (FluorO2 Therapeutics, Inc.) intends to manufacture the product in the United States under GMP standards and make it available for clinical use in Mexico and Latin America and pursue research to support eventual approval in the United States for human and veterinary use. This article will briefly review key information about this product and provide references for the interested reader.
Perftoran(已在北美的市场中重新命名为 Vidaphor)是一种全氟碳化合物的乳液,包含表面活性剂和电解质混合物。它是在俄罗斯开发的,作为一种携带氧气的静脉内血浆添加剂,用于各种病因引起的出血性贫血和缺血性疾病。它于 1996 年在俄罗斯获得临床使用批准,并在俄罗斯军队和民用医疗保健中使用。它还于 2005 年至 2010 年在墨西哥获得批准。据报道,已有超过 35000 名患者接受了该药的治疗,疗效显著,且不良反应相对较轻,易于控制。如果没有人类红细胞,该药可能在出血性休克中有很大的应用潜力,并且在其他几个应用中也有潜力,包括治疗血管气体栓塞、脑或脊髓创伤和局部缺血。它与美国正在开发的其他全氟碳化合物制剂不同,因为它使用了不同的主要全氟碳化合物(全氟癸烷)和表面活性剂(Proxanol 268),而不是卵黄磷脂作为乳液载体。Perftoran 的颗粒尺寸更小,因此不良反应更轻。它已经在比任何正在开发的氧气载体更多的患者中安全使用。一家新成立的美国公司(FluorO2 Therapeutics,Inc.)打算按照 GMP 标准在美国生产该产品,并在墨西哥和拉丁美洲将其用于临床,并进行研究以支持最终在美国获得人类和兽医使用的批准。本文将简要回顾该产品的关键信息,并为感兴趣的读者提供参考。