U.S. Army Institute of Surgical Research, Ft. Sam Houston, San Antonio, Texas.
Israel Defense Forces Medical Corps.
Shock. 2019 Oct;52(1S Suppl 1):55-59. doi: 10.1097/SHK.0000000000001417.
Approximately 10 years ago, the development of hemoglobin-based oxygen carriers (HBOCs) was largely stalled after two large phase 3 clinical trials failed to achieve licensure primarily because the safety profile was viewed as unsatisfactory when HBOCs were compared with red cells. Concerns were also raised that HBOCs, as a class, had inherent toxicities. Since then, clinical experience with HBOCs in expanded access programs and under licensure in South Africa has demonstrated that HBOCs can be used safely and effectively. In recent years, clinical studies have demonstrated that prehospital blood transfusion improves survival in severely injured patients with hemorrhage, especially when transport times are longer than 20 to 30 min. Yet, logistical constraints still limit use of blood products in the prehospital setting. As the urgent need for oxygen-carrying capacity for trauma patients for whom red cells are not available is becoming much more apparent, it is imperative that we reexamine the possibility of using HBOCs when red blood cell transfusion is not an option.
大约 10 年前,血红蛋白类氧载体(HBOCs)的发展基本停滞不前,因为两项大型 3 期临床试验未能获得许可,主要是因为与红细胞相比,HBOCs 的安全性被认为不理想。人们还担心 HBOCs 作为一类药物具有固有的毒性。此后,在扩大准入计划和南非许可下使用 HBOCs 的临床经验表明,HBOCs 可以安全有效地使用。近年来,临床研究表明,院前输血可改善出血性严重创伤患者的存活率,尤其是在转运时间超过 20-30 分钟时。然而,物流限制仍然限制了在院前环境中使用血液制品。由于对于没有红细胞的创伤患者急需携氧能力,当不能进行红细胞输血时,我们必须重新考虑使用 HBOCs 的可能性。