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溶剂/去污剂血浆:药学特性与临床经验

Solvent/detergent plasma: pharmaceutical characteristics and clinical experience.

作者信息

Liumbruno Giancarlo Maria, Franchini Massimo

机构信息

UOC di Immunoematologia e Medicina Trasfusionale e UOC di Patologia Clinica, San Giovanni Calibita Fatebenefratelli Hospital, Rome, Italy,

出版信息

J Thromb Thrombolysis. 2015 Jan;39(1):118-28. doi: 10.1007/s11239-014-1086-1.

DOI:10.1007/s11239-014-1086-1
PMID:24844804
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7088539/
Abstract

The solvent/detergent treatment is an established virus inactivation technology that has been industrially applied for manufacturing plasma derived medicinal products for almost 30 years. Solvent/detergent plasma is a pharmaceutical product with standardised content of clotting factors, devoid of antibodies implicated in transfusion-related acute lung injury pathogenesis, and with a very high level of decontamination from transfusion-transmissible infectious agents. Many clinical studies have confirmed its safety and efficacy in the setting of congenital as well as acquired bleeding disorders. This narrative review will focus on the pharmaceutical characteristics of solvent/detergent plasma and the clinical experience with this blood product.

摘要

溶剂/去污剂处理是一种成熟的病毒灭活技术,已在工业上应用于生产血浆衍生药物产品近30年。溶剂/去污剂处理的血浆是一种含有标准化凝血因子的药品,不含有与输血相关急性肺损伤发病机制有关的抗体,并且对输血传播感染因子的去污水平非常高。许多临床研究已证实其在先天性和获得性出血性疾病中的安全性和有效性。本叙述性综述将聚焦于溶剂/去污剂处理血浆的药学特性以及该血液制品的临床经验。

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Solvent/detergent plasma: pharmaceutical characteristics and clinical experience.溶剂/去污剂血浆:药学特性与临床经验
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2
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本文引用的文献

1
Oxygen removal during pathogen inactivation with riboflavin and UV light preserves protein function in plasma for transfusion.在使用核黄素和紫外线进行病原体灭活过程中去除氧气可保留用于输血的血浆中的蛋白质功能。
Vox Sang. 2014 May;106(4):307-15. doi: 10.1111/vox.12106. Epub 2013 Oct 29.
2
Eight years with haemovigilance in Norway. What have we learnt?挪威开展血液监测八年。我们学到了什么?
Transfus Apher Sci. 2013 Dec;49(3):548-52. doi: 10.1016/j.transci.2013.09.013. Epub 2013 Oct 10.
3
Serious Hazards of Transfusion (SHOT) haemovigilance and progress is improving transfusion safety.严重输血不良反应(SHOT)监测有助于提高输血安全性。
Br J Haematol. 2013 Nov;163(3):303-14. doi: 10.1111/bjh.12547. Epub 2013 Sep 14.
4
Update on the use of pathogen-reduced human plasma and platelet concentrates.关于病原体减少的人血浆和血小板浓缩物的应用进展。
Br J Haematol. 2013 Aug;162(4):442-54. doi: 10.1111/bjh.12403. Epub 2013 May 27.
5
Cost-effectiveness and budget impact study of solvent/detergent (SD) treated plasma (octaplasLG®) versus fresh-frozen plasma (FFP) in any patient receiving transfusion in Canada.加拿大接受输血的任何患者中,溶剂/去污剂(SD)处理血浆(OctaplasLG®)与新鲜冰冻血浆(FFP)的成本效益和预算影响研究。
Transfus Apher Sci. 2014 Aug;51(1):25-34. doi: 10.1016/j.transci.2013.04.045. Epub 2013 May 23.
6
[Clinical use of virally inactived plasma. The experience of Blood Transfusion Unit in Mantova, Italy].[病毒灭活血浆的临床应用。意大利曼托瓦输血科的经验]
Recenti Prog Med. 2013 Mar;104(3):106-11. doi: 10.1701/1255.13858.
7
Current methods for the reduction of blood-borne pathogens: a comprehensive literature review.当前减少血源性病原体的方法:一项全面的文献综述。
Blood Transfus. 2013 Jul;11(3):343-8. doi: 10.2450/2013.0218-12. Epub 2013 Mar 14.
8
Solvent detergent vs. fresh frozen plasma in cirrhotic patients undergoing liver transplant surgery: a prospective randomized control study.肝硬化患者行肝移植手术中使用溶剂洗涤剂与新鲜冷冻血浆的比较:一项前瞻性随机对照研究。
Vox Sang. 2013 Aug;105(2):137-43. doi: 10.1111/vox.12021. Epub 2013 Feb 28.
9
Monitoring drug residues in donor blood/plasma samples using LC-(MS)/MS--a pilot study.使用 LC-(MS)/MS 监测供体血液/血浆样本中的药物残留——一项初步研究。
Drug Test Anal. 2013 May;5(5):380-3. doi: 10.1002/dta.1457. Epub 2013 Jan 21.
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Transfusion. 2013 Sep;53(9):1906-17. doi: 10.1111/trf.12075. Epub 2013 Jan 16.