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对血友病患者使用的凝血因子 VIII 制剂中的污染物分析。

Analysis of contaminants in factor VIII preparations administered to patients with hemophilia.

作者信息

Rock G A, Farrah G, Rozon G, Smiley R K, Cole R, Villeneuve D, Tittley P

出版信息

Can Med Assoc J. 1983 Feb 15;128(4):403-8.

PMID:6401585
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1875030/
Abstract

Cryoprecipitate and the more purified factor VIII concentrates are all heterogeneous preparations that contain not only a high concentration of factor VIII but also various other materials, some of which might be injurious, causing liver damage after long-term exposure. The efficiency of three standard cryoprecipitate filters, two microaggregate filters and the appropriate factor VIII concentrate filters in reducing the amount of particulate matter delivered to the patient was assessed. Filtration of cryoprecipitate through the standard filters removed less than 20% of the contaminating microaggregates and very few of the large number of intact platelets, although the total dose of factor VIII was delivered. Microaggregate filters were no better in reducing the platelet contamination, although the total number of particles delivered was halved. However, 25% of the factor VIII was retained in the bed volume of the filter. The concentrate preparations also contained significant amounts of particulate matter that was unrelated to factor VIII and was not removed following filtration through the designated filter. These findings indicate that a new filter should be developed for administration of factor VIII concentrate that would remove the particulate matter while delivering all of the factor VIII to the patient.

摘要

冷沉淀和更纯化的凝血因子VIII浓缩物都是异质制剂,不仅含有高浓度的凝血因子VIII,还含有各种其他物质,其中一些可能有害,长期接触后会导致肝损伤。评估了三种标准冷沉淀过滤器、两种微聚体过滤器和合适的凝血因子VIII浓缩物过滤器在减少输送给患者的颗粒物数量方面的效率。通过标准过滤器过滤冷沉淀,虽然输送了全部凝血因子VIII剂量,但去除的污染微聚体不到20%,大量完整血小板中只有极少数被去除。微聚体过滤器在减少血小板污染方面也没有更好的效果,尽管输送的颗粒总数减半。然而,25%的凝血因子VIII保留在过滤器的床体积中。浓缩制剂中也含有大量与凝血因子VIII无关的颗粒物,通过指定过滤器过滤后并未去除。这些发现表明,应该开发一种新的过滤器用于凝血因子VIII浓缩物的给药,该过滤器在将所有凝血因子VIII输送给患者的同时能够去除颗粒物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/ea1307ebc6af/canmedaj01385-0045-a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/a971abb233cc/canmedaj01385-0042-a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/be6fa365ede4/canmedaj01385-0043-a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/90c614e33ddc/canmedaj01385-0043-b.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/ea1307ebc6af/canmedaj01385-0045-a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/a971abb233cc/canmedaj01385-0042-a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/be6fa365ede4/canmedaj01385-0043-a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/90c614e33ddc/canmedaj01385-0043-b.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739c/1875030/ea1307ebc6af/canmedaj01385-0045-a.jpg

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Analysis of contaminants in factor VIII preparations administered to patients with hemophilia.对血友病患者使用的凝血因子 VIII 制剂中的污染物分析。
Can Med Assoc J. 1983 Feb 15;128(4):403-8.
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[Production of factor VIII preparations and their use in the substitution therapy of hemophilia A].
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Environ Health Perspect. 1986 Mar;65:309-16. doi: 10.1289/ehp.8665309.
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本文引用的文献

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The biological behaviour of a new synthetic anticoagulant (dextran sulphate) possessing heparin-like properties.一种具有肝素样特性的新型合成抗凝剂(硫酸葡聚糖)的生物学行为。
Br J Pharmacol Chemother. 1952 Sep;7(3):370-91. doi: 10.1111/j.1476-5381.1952.tb00705.x.
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Contamination of commercial blood products by di-2-ethylhexyl phthalate and mono-2-ethylhexyl phthalate.商业血液制品被邻苯二甲酸二(2-乙基己基)酯和邻苯二甲酸单(2-乙基己基)酯污染。
Vox Sang. 1981 May;40(5):317-22. doi: 10.1111/j.1423-0410.1981.tb00715.x.
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使用凝血因子 VIII 浓缩物后复发性急性肝炎。
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Filtration of cryoprecipitate: a microscopic assessment of filter depostion.冷沉淀的过滤:滤器沉积的微观评估
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Studies on the hepatic effects of orally administered di-)2-ethylhexyl) phthalate in the rat.大鼠口服邻苯二甲酸二(2-乙基己基)酯的肝脏效应研究。
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