CAJ | 학술논문

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/mL、（0.824±0.027）IU/mL；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/mL。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。
목적：통과검측신선빙동혈장병독멸활전후Ⅷ인자함량급병독멸활효과적변화，탐토병독멸활신선빙동혈장재증성지구림상응용적가행성。방법장300대미멸활신선빙동혈장작위대조조，진행Ⅷ인자함량검측；장병독멸활후상술300대신선빙동혈장작위실험조，진행Ⅷ인자함량검측，계산병독멸활후Ⅷ인자함량。장5대학진HBV화5대학진HCV적신선빙동혈장채용형광정량PCR검측방법검측아갑람광화학요법병독멸활전후，병독멸활효과적변화。림상수궤추취200례수주병독멸활혈장적환자，관찰병독멸활혈장수주후시부출현수혈불량반응。결과신선혈장병독멸활전후혈장Ⅷ인자함량위（1.097±0.047）IU/mL、（0.824±0.027）IU/mL；응혈인자Ⅷ함량멸활전후차이유통계학의의（P＜0.01）；이용아갑람광화학요법혈장병독멸활기술대응혈인자Ⅷ함량유일정적영향，단시균체도GB 18469-2012《전혈급성분혈질량요구》대병독멸활신선빙동혈장적질량요구。표본병독멸활후혈장HBV-DNA급HCV-RNA재량균위＜1000copies/mL。병독멸활혈장수주인체후무불량반응발생。결론림상사용교안전，병독멸활신선빙동혈장능구유효강저경수혈전파질병적위험성，차불량반응교소。재엄주증성지구적림상응용시가행적。
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 hazard caused by clinical blood transfusion. It is feasible to implement this method in Guang Zhou Zeng Cheng region.