亚甲蓝光化学疗法血浆病毒灭活技术的应用分析

目的根据2012年颁发的GB18469—2012《全血及成分血质量要求》中对病毒灭活新鲜冰冻血浆质量控制项目和要求，分析亚甲蓝光化学疗法血浆病毒灭活技术在血浆灭活过程中对血液成分和功能的影响，探讨亚甲蓝光化学疗法血浆病毒灭活技术的疗效及安全性，为进一步广泛推广应用提供临床参考依据。方法采用称重法、双缩脲法、磁珠法、比色法、荧光定量PCR检测方法检测亚甲蓝光化学疗法病毒灭活前后的血浆量、血浆蛋白含量、凝血因子Ⅷ含量、亚甲蓝残留量、病毒灭活效果的变化。结果新鲜血浆病毒灭活前后血浆容量分别为（235±15．51）g、（230±14．17）g；Ⅷ因子含量为（1．084±0．045）IU／ml、（0．826±0．029）IU／mk血浆蛋白含量为（83．71±3．24）g／L、（79．09±3．21）g/L；凝血因子Ⅷ含量灭活前后差异有统计学意义（P〈0．01）；血浆容量和血浆蛋白在灭活前后无统计学意义（P〉0．05），亚甲蓝的残留率为（0．0638±0．013）μmol／L；标本病毒灭活后血浆HBV—DNA及HCV—RNA载量均为〈1000copies／ml。结论利用亚甲蓝光化学疗法血浆病毒灭活技术对血浆成分有一定的影响，但均达到GB18469—2012《全血及成分血质量要求》对病毒灭活新鲜冰冻血浆的质量要求。亚甲蓝光化学疗法简便、无毒、能最大程度的减少新鲜冰冻血浆病毒等显著特点，可有效消除临床输血带来的安全隐患。

Application of methylene blue photochemical therapy plasma virus inactivation technology

Objective Virus inactivation of plasma could be achieved by methylene blue （MB） photochemical method as Whole Blood and Blood Components Quality Requirements, 2012 issue （GB 18469- 2012） had advised. To investigate the safety and effectiveness of the method and the effect on biochemical functions of plasma components, we designed this experiment. Methods The virus inactivation method was performed on single donor plasma, then gravimetrie method, biuret method, beads method, eolorimetry, fluorescence quantitative PCR method were used to study the virus inactivation efficacy and the qualily Of plasma components by MB photochemical methods. Results The volume of fresh plasma before and after virus inactivation were （235 ± 15.51） g and （230 ± 14.17） g respectively, without statistically significant difference （P 〉 0.05）; the activities of the factor Ⅷ before and after virus inactivation were （1.084 ± 0.045） IU/ml and （0.826 ± 0.029） IU/ml, with statistically significant difference （P 〈 0.01）; the content of plasma protein before and after virus inactivation were （83.71 ± 3.24） g/L and （79.09 ± 3.21） g/L, without statistically significant difference （P 〉 0.05）. Residual methylene blue was （0.0638 ± 0.013） μ mol/L. HBV-DNA and HCV-RNA load were both lower than 1000 copies/ml after virus inactivation. Conclusions Methylene blue photochemical therapy plasma virus inactivation technology has a certain effect on plasma components, but reaches GB 18469-2012 Whole Blood and Blood Components Quality Requirements for virus inactivation of fresh frozen plasma quality requirements, with efficacy and safety. Methylene blue photochemical therapy is simple and non-toxic, can reduce fresh frozen plasma virus at the greatest extent and effectively eliminate potential safety hazard caused by clinical blood transfusion.