摘要
目的通过检测新鲜冰冻血浆病毒灭活前后Ⅷ因子含量及病毒灭活效果的变化,探讨病毒灭活新鲜冰冻血浆在增城地区临床应用的可行性。方法将300袋未灭活新鲜冰冻血浆作为对照组,进行Ⅷ因子含量检测;将病毒灭活后上述300袋新鲜冰冻血浆作为实验组,进行Ⅷ因子含量检测,计算病毒灭活后Ⅷ因子含量。将5袋确诊HBV和5袋确诊HCV的新鲜冰冻血浆采用荧光定量PCR检测方法检测亚甲蓝光化学疗法病毒灭活前后,病毒灭活效果的变化。临床随机抽取200例输注病毒灭活血浆的患者,观察病毒灭活血浆输注后是否出现输血不良反应。结果新鲜血浆病毒灭活前后血浆Ⅷ因子含量为(1.097±0.047)IU/m L(0.824±0.027)IU/m L;凝、血因子Ⅷ含量灭活前后差异有统计学意义(P<0.01);利用亚甲蓝光化学疗法血浆病毒灭活技术对凝血因子Ⅷ含量有一定的影响,但是均达到GB 18469-2012《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。标本病毒灭活后血浆HBV-DNA及HCV-RNA载量均为<1000copies/m L。病毒灭活血浆输注人体后无不良反应发生。结论临床使用较安全,病毒灭活新鲜冰冻血浆能够有效降低经输血传播疾病的危险性,且不良反应较小。在广州增城地区的临床应用是可行的。
Objective In order to investigate the safety and effectiveness of Virus inactivation by methylene blue photochemical method in Guangzhou Zengcheng area, the concentration difference of Factor Ⅷ before and after the virus inactivation process was measured. Methods The concentrations of Factor Ⅷ in three hundred bags of freshly frozen blood plasma without virus inactivation were measured and used as a control group. Then virus inactivation procedures were performed on the three hundred bags of freshly frozen blood plasma mentioned above and the concentration of Factor Ⅷ was measured again. The difference in the concentration of Factor Ⅷ before and after virus deactivation were calculated. Two groups of five bags of freshly frozen blood plasma, which were confirmed to contain Hepatitis B Virus（HBV） and Hepatitis C Virus （HCV） respectively, were analyzed with quantitative fluorescent Polymerase Chain Reaction （PCR） before and after methylene blue photochemical treatment to study the effectiveness in virus inactivation. Random testing was performed among 200 patients who received virus inactivated blood plasma transfusion. These patients were observed for abnormal response after the transfusion. Results The concentration of the factorⅧbefore and after virus inactivation were （1.097±0.047）IU/mL and （0.824±0.027）IU/mL respectively. The use of methylene blue photochemical treatment of plasma virus inactivation technology has some influence on the plasma composition, but meets the GB 18469-2012“Whole Blood and Blood Components Quality Requirements”for virus inactivation of freshly frozen plasma. After virus inactivation,HBV-DNA and HCV-RNA load in sample blood plasma were less than 1000 copies/mL. There is no abnormal response observed in patients who received virus inactivation blood plasma transfusion. Conclusion Experiments showed that the method is clinically safe and effective. Virus inactivation of freshly frozen blood plasma is proven to effectively reduce the potential safety ha
出处
《中国医药科学》
2015年第8期196-198,204,共4页
China Medicine And Pharmacy
基金
广东省广州市医药卫生科技项目(20131A041029)
