Spence R K, Norcross E D, Costabile J, McCoy S, Cernaianu A C, Alexander J B, Pello M J, Atabek U, Camishion R C
Medical University of South Carolina, Charlestown 29425-2270.
Artif Cells Blood Substit Immobil Biotechnol. 1994;22(4):955-63. doi: 10.3109/10731199409138794.
Clinical testing of perfluorocarbons (PFC) as blood substitutes began in the early 1980's in the form of Fluosol DA-20% (FDA), a mixture of perfluorodecalin and perfluorotripropylamine emulsified with Pluronic F68. We have treated 55 patients (Treatment (T) = 40; Control (C) = 15) with intravenous infusions of 30 cc/kg of FDA as part of either a randomized, clinical trial or a humanitarian protocol. All patients were Jehovah's Witnesses who refused blood transfusion and were severely anemic (mean hemoglobin = 4.6 g/d). FDA successfully increased dissolved or plasma oxygen content (P1O2 in ml/dl), but not overall oxygen content (T group: P1O2 baseline = 1.01 +/- .27, P1O2 12hrs = 1.58 +/- .47 [p = < .0001, t-test]; P1O2 12 hrs: T = 1.58 +/- .47, C = 1.00 +/- .31, p = < .0002, t-test). This effect persisted for only 12 hours post infusion, and had no apparent effect on survival. FDA is an ineffective blood substitute because of low concentration and short half-life. Improved emulsion design may resolve these problems, thereby producing a more effective agent. Our discussion will include a review of our data plus a summary of other reports of FDA efficacy as a blood substitute.
全氟化碳(PFC)作为血液替代品的临床试验始于20世纪80年代初,以Fluosol DA - 20%(FDA)的形式进行,它是全氟萘烷和全氟三丙胺与普朗尼克F68乳化而成的混合物。作为随机临床试验或人道主义方案的一部分,我们对55例患者(治疗组(T)= 40;对照组(C)= 15)静脉输注30 cc/kg的FDA。所有患者均为拒绝输血且严重贫血的耶和华见证会信徒(平均血红蛋白 = 4.6 g/d)。FDA成功提高了溶解氧或血浆氧含量(P1O2,单位为ml/dl),但未提高总体氧含量(治疗组:P1O2基线 = 1.01 ± 0.27,输注12小时后P1O2 = 1.58 ± 0.47 [p = < 0.0001,t检验];输注12小时后的P1O2:治疗组 = 1.58 ± 0.47,对照组 = 1.00 ± 0.31,p = < 0.0002,t检验)。这种效果在输注后仅持续12小时,对生存率没有明显影响。由于浓度低和半衰期短,FDA是一种无效的血液替代品。改进的乳化设计可能会解决这些问题,从而产生一种更有效的制剂。我们的讨论将包括对我们数据的回顾以及其他关于FDA作为血液替代品疗效报告的总结。