Development of a perfluorochemical whole blood substitute (Fluosol-DA, 20%)--an overview of clinical studies with 185 patients.
Development of a perfluorochemical whole blood substitute (Fluosol-DA, 20%)--an overview of clinical studies with 185 patients.
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开发%20of%20a%20全氟化合物%20whole%20blood%20substitute%20(Fluosol-DA,%2020%)--%20概述%20of%20临床%20研究%20with%20185%20患者。
DOI：
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发表时间：
1981
期刊：
影响因子：
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通讯作者：
R. Naito
中科院分区：
文献类型：
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作者：
T. Suyama;K. Yokoyama;R. Naito
Fluosol-DA（20%）是一种全氟化学全血替代品，在日本 24 家医疗机构进行的 II 期和 III 期临床试验中，为 185 名患者输注了手术中丢失的血液或改善脑循环。其活性成分（全氟萘烷、全氟三丙胺、羟乙基淀粉和克雷布斯-林格碳酸氢盐溶液）使这种生物惰性乳液不仅具有血浆膨胀特性，而且具有高载氧能力（37℃时为7.2体积%；红细胞的载氧能力为17至20体积%）。给予患者的剂量范围为6至25毫升/公斤体重。对于动脉血氧分压、动脉血氧含量、血氧输送、耗氧量和酸碱平衡，失血后输注乳剂后通常观察到有益效果，特别是当吸入气体中氧分数浓度（FiO2）保持高于0.5时。该乳液还表现出对血流动力学（血压、脉搏率和中心静脉压）有益的血浆扩张器作用。在乳液输注期间或之后，没有观察到或报告任何过敏样反应或其他不良反应。尽管发现出血时间略有延长（杜克），但外科医生在手术期间或手术后从未经历过出血倾向。发现 SGOT 略有短暂升高，但 SGPT 和碱性磷酸酶水平保持正常。血液、血清和尿液中测量的所有其他血液学和生化参数均保持在正常范围内。
Fluosol-DA, 20%, a perfluorochemical whole blood substitute, was infused during Phase II and Phase III clinical trials at 24 medical institutions in Japan to 185 patients for replacement of blood lost during surgery or for improvement of cerebral circulation. Its active ingredients (perfluorodecalin, perfluorotripropylamine, hydroxyethyl starch and Krebs-Ringer bicarbonate solution) give this biologically inert emulsion not only plasma-expanding properties but also a high oxygen-carrying capacity (7.2 vol.% at 37 degrees C; the oxygen carrying capacity of red blood cells is 17 to 20 vol.%). Doses given to the patients ranged from 6 to 25 ml/kg body weight. With regard to arterial blood oxygen tension, arterial blood oxygen content, blood oxygen transport, oxygen consumption, and acid-base balance, beneficial effects were generally observed after infusion of the emulsion following blood loss especially when the fractional concentration of oxygen in inspired gas (FiO2) was kept higher than 0.5. The emulsion also manifested beneficial plasma-expander effects on hemodynamics (blood pressure, pulse rate, and central venous pressure). In no case was there any anaphylactoid or other untoward reaction observed or reported during or after infusion of the emulsion. Although a slight prolongation of bleeding time (Duke) was found, the surgeons never experienced and hemorrhagic tendencies during or after their operations. Slight and transient elevations of SGOT were found but SGPT and alkaline phosphatase levels remained normal. All other hematological and biochemical parameters measured in blood, serum and urine remained within normal ranges.