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全氟化合物全血代用品(氟碳代血液)的临床研究:186例总结

Clinical studies of a perfluorochemical whole blood substitute (Fluosol-DA) Summary of 186 cases.

作者信息

Mitsuno T, Ohyanagi H, Naito R

出版信息

Ann Surg. 1982 Jan;195(1):60-9. doi: 10.1097/00000658-198201001-00010.

DOI:10.1097/00000658-198201001-00010
PMID:7034658
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1352405/
Abstract

After the experimental and phase one studies of our so-called "artificial blood," Fluosol-DA (20%), an emulsified mixture of perfluorodecalin and perfluorotripropylamine, were successfully completed, phase two and three clinical studies were carried out on 186 patients in Japan. The initial dose was 20 ml/Kg body weight (BW), and additional 10 ml/Kg BW doses were applied as needed. Oxygen-supplying and plasma-extending effects were established. No untoward reaction was observed in any of the 186 cases except in a case that involved long-term repeated administration. Initial studies on FLuosol-DA suggest reasonable safety; however, additional clinical trials appear warranted.

摘要

在我们所谓的“人造血液”全氟萘烷双乳剂(20%),即全氟萘烷和全氟三丙胺的乳化混合物的实验研究和一期研究成功完成后,在日本对186名患者进行了二期和三期临床研究。初始剂量为20毫升/千克体重,必要时追加10毫升/千克体重的剂量。已证实其具有供氧和扩容作用。在这186例患者中,除1例长期重复给药的病例外,未观察到任何不良反应。对全氟萘烷双乳剂的初步研究表明其安全性合理;然而,似乎仍有必要进行更多的临床试验。

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本文引用的文献

1
Hemodynamic and oxygen transport effects of a perfluorochemical blood substitute, fluosol-DA (20%).全氟化学血液代用品氟碳乳剂(20%)的血液动力学及氧运输效应
Crit Care Med. 1980 Dec;8(12):738-41. doi: 10.1097/00003246-198012000-00009.
2
Clinical use of a blood substitute.血液替代品的临床应用。
N Engl J Med. 1980 Aug 14;303(7):391-2. doi: 10.1056/NEJM198008143030710.