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Mirasol®
病原体灭活技术 (PRT) 系统
概述 工作原理 资料
积极主动去提高血液安全

无论您身在何处,由于频繁的旅行、气候变化、病原体进化、新发流行病以及医疗保健措施的推进均使全球的血液安全处于行业最前沿的关注领域。

随着所有这些变化,现在是时候采取积极主动的方法去防止病人来自于捐赠血液的潜在风险。

Mirasol PRT 系统可以帮助您减少各种致病病毒、细菌和寄生虫的病原体负荷。

该系统还可灭活血液产品中残留的白细胞,这可能有助于减少病人的输血反应。

强大、可靠而拥有巨大的潜力

Mirasol PRT 系统是在人类临床试验中显示可减少输血传播性感染 (TTI) 疾病的一种 PRT 系统,可使疟疾 TTI 降低 87%。1

为更好的血液去做正确的平衡

我们相信,在保证病人需要的血液成分供应的同时,更好的血液安全能够提供效用与易用之间的正确平衡。Mirasol PRT 系统是一个简单的系统,其能够提供更好的病人关怀,减少了与救命的血液制品相关的风险。

Mirasol PRT 系统

您比任何人都清楚 - 这是充满挑战的时代。Mirasol PRT 系统使您可以通过优化血液制品成本、效用和安全性之间的平衡,从而满足您的业务需求。2,3

安全

Mirasol PRT 系统是一种具有以下优势的 PRT 系统:

  • 显示能降低人类输血传播性疾病的发生率1
  • 使用核黄素(维生素 B2;一种无毒性非致突变化合物)灭活病原体和白细胞1,5,6,7

简便

Mirasol 工艺的步骤比其他 PRT 方法的步骤更少,并且该设备可用于处理血小板、血浆和全血。这种简便性有助于减少受操作的影响。8,9,10

有效

Mirasol PRT 系统可有效防范各种新发的已检测出和未检测出的病原体,包括细菌、寄生虫以及包膜和无包膜病毒;其也能灭活白细胞,为病人额外提供一重安全性。采用 Mirasol PRT 系统处理的血液制品可保持其效用,并有助于挽救病人的生命。11,12,13,14,15,16,17,18,19

经济实惠

Mirasol PRT 系统处理可替代一些安全规程,不会给操作员或病人带来新的风险。20,21,22 Mirasol PRT 系统处理有助于降低血液中心的产品丢弃率,和降低医院的输血总成本。2,3,8,9

值得信赖的伙伴

Mirasol PRT 系统系血液成分技术领域全球综合方案提供商 Terumo BCT 出品。

工作原理

提高血液安全性的正确途径:安全、简便、有效

Mirasol PRT 系统使用核黄素(维生素 B2;一种无毒性无致突变的化合物)结合特定的紫外 (UV) 光谱照射来灭活所采集血液制品中可能存在的病毒、细菌、寄生虫和白细胞。

Mirasol PRT 系统由三个主要部分组成:

  • 一次性使用套件 - 包括一个照射/储存袋和无菌核黄素溶液
  • Mirasol 照射器 - 为 Mirasol 处理提供紫外光照射及震荡
  • Mirasol 管理软件 - 集成和管理数据报告及存储
在处理过程中,将血液制品与核黄素溶液混合,并置于照射器中,使之暴露于紫外光下。无需去除核黄素或其光产物;照射后,经处理的制品即可进行输注或放置入库。

作用机理

Mirasol PRT 系统使病毒、细菌、寄生虫和白细胞的 RNA 和 DNA 出现不可逆转的改变,阻止其复制和引发疾病。

核黄素 + 紫外光 = 病原体和白细胞的不可逆灭活

流程:血小板、血浆和新鲜全血都是三个简单步骤

Mirasol PRT 系统符合医疗器械指令。

Mirasol PRT 系统尚未获批在美国销售,仅在选定市场有售。

Mirasol PRT 系统已获得血小板、血浆和全血应用的 CE 标志。

1Allain JP, et al., "Prevention of Transfusion-Transmitted Malaria by Treatment of Whole Blood With the Mirasol PRT System."Blood 2015; 126 (23): 770.

2Custer B, et al., "The Cost-Effectiveness of Pathogen Reduction Technology as Assessed Using a Multiple Risk Reduction Model."Transfusion 2010; 50 (11): 2461–2473.

3Agapova M, et al., "Introducing Pathogen Reduction Technology in Poland: A Cost Utility Analysis."Transfus Med Hemother 2015; 42 (3): 158–165.

4Goodrich RP and MS Platz, "The Design and Development of Selective, Photoactivated Drugs for Sterilization of Blood Products."Drugs of the Future 1997; 22 (2): 159–171.

5Mundt JM, et al., "Chemical and Biological Mechanisms of Pathogen Reduction Technologies."Photochemistry and Photobiology 2014; 90 (5): 957–964.

6Reddy HL, et al., "Toxicity Testing of a Novel Riboflavin-Based Technology for Pathogen Reduction and White Blood Cell Inactivation."Transfusion Medicine Reviews 2008; 22 (2): 133–153.

7Goodrich RP, et al., Chapter 5: "The Antiviral and Antibacterial Properties of Riboflavin and Light: Applications to Blood Safety and Transfusion Medicine."Flavins: Photochemistry and Photobiology, 2006; Royal Society of Chemistry.

8Jimenez-Marco T, "The Benefits of Working With Mirasol PRT."4th Mirasol International Users Meeting, Estoril, Portugal, 2014.

9Bautista AM, "Logistics and Economical Aspects of Mirasol Implementation."5th Mirasol International Users Meeting, Palma de Mallorca, Spain, 2015.

10Jimenez-Marco T, et al., "Role of Riboflavin- and UV Light-Treated Plasma in Prevention of Transfusion-Related Acute Lung Injury."Transfusion Medicine and Hemotherapy 2014; 41 (3): 172–175.

11Marschner S and R Goodrich, "Pathogen Reduction Technology of Platelets, Plasma and Whole Blood Using Riboflavin and UV-Light."Transfusion Medicine and Hemotherapy 2011; 38 (1): 8–18.

12Keil SD, et al., "Inactivation of Viruses in Platelet and Plasma Products Using a Riboflavin-and-UV-based Photochemical Treatment."Transfusion 2015; 55 (7): 1736–1744.

13Keil SD, et al., "Treatment of Platelet Products With Riboflavin and UV Light: Effectiveness Against High Titer Bacterial Contamination."J Vis Exp 2015; (102): 52820.

14Yañez Izquierdo M, et al., "Performance of Buffy Coat Platelets in Plasma Treated With Riboflavin and UV Light: In Vitro and In Vivo Evaluation."Transfusion 2009; 49 (Suppl.): 84A.

15Yañez M, et al., "Clinical Evaluation of Platelets Treated With Riboflavin and UV Light in the Presence of Platelet Additive Solution in Thrombocytopenic Patients."Vox Sanguinis 2011; 101 (Suppl. 1): 148.

16Coene GC, et al., "In Vitro and In Vivo Evaluation of Mirasol Pathogen Reduction Technology Treated Platelets Stored in SSP+."Vox Sanguinis 2011; 101 (Suppl. 1): 188–189.

17Mirasol Clinical Evaluation Study Group and RP Goodrich, "A Randomized Controlled Clinical Trial Evaluating the Performance and Safety of Platelets Treated With Mirasol Pathogen Reduction Technology."Transfusion 2010; 50 (11): 2362–2375.

18Trakhtman P, "Efficacy and Safety of Pathogen-Reduced Platelet Concentrates in Children With Cancer: A Retrospective Cohort Study."Transfusion 2016; 56 (Suppl. 1): S24–S28.

19Kaplan A, et al., "Evaluation of the Post-Transfusion Platelet Increment and Safety of Riboflavin-Based Pathogen Reduction Technology (PRT) Treated Platelet Products Stored in Platelet Additive Solution for 5 Days or Less Versus 6-7 Days."Transfusion and Apheresis Science 2015; 54 (2): 248–252.

20Fast LD, et al., "Inactivation of Human White Blood Cells in Platelet Products After Pathogen Reduction Technology Treatment in Comparison to Gamma-Irradiation."Transfusion 2011; 51 (7): 1397–1404.

21Fast LD, et al., "Treatment of Whole Blood With Riboflavin Plus Ultraviolet Light, an Alternative to Gamma Irradiation in the Prevention of Transfusion-Associated Graft-Versus-Host Disease?"Transfusion 2013; 53 (2): 373–381.

22Goodrich RP, et al., "A Laboratory Comparison of Pathogen Reduction Technology Treatment and Culture of Platelet Products for Addressing Bacterial Contamination Concerns."Transfusion 2009; 49: 1205-1216.

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