亚甲蓝/光照法病毒灭活血浆的制备及应用评价

Preparation of Virus Inactivea Plasma by Methylene Blue Photochemical Method and Evaluation of Its Effect on Clinical Application

目的探讨亚甲蓝/光照法病毒灭活血浆的制备及其临床应用评价。方法随机抽取200份病毒灭活血浆,检测灭活前后的血浆容量、总蛋白、凝血因子及亚甲蓝的残余量;选取15 756人份HBsAg、抗-HCV、抗-HIV酶联免疫吸附法检测阴性者的血浆,在病毒灭活前后分别进行HBV、HCV、HIV的核酸检测;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。结果经亚甲蓝/光照法进行灭活处理的血浆,血浆容量达到(227.34±5.21)g,回收率达到(96.67±2.34)%;血浆总蛋白、血浆凝血因子(Ⅷ因子和纤维蛋白原)回收率分别达到(88.69±3.32)%,(86.84±2.16)%和(84.62±1.86)%,与处理前相比,差异无统计学意义(P>0.05);血浆经病毒灭活后亚甲蓝的残余量为(1.17±0.05)μmol/L,而过滤后残余量减少至(0.16±0.03)μmol/L,去除率达到86.32%;对15 756人份血浆进行HBV、HCV、HIV核酸检测,发现HBV阳性23例,HIV阳性1例,阳性率为1.52‰,进行病毒灭活后,HBV、HCV、HIV核酸检测均为阴性。病毒灭活血浆输注人体后无不良反应发生。结论采用亚甲蓝/光照法进行病毒灭活的血浆,临床使用较安全;病毒灭活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。

Objectives To observe biochemical changes of various plasma components during the methylene blue photochemical virus inactivation process and evaluate clinical application of virus inactived plasma. Methods A total of 200 virus inactivated blood samples, were randomly selected. The amount of plasma samples and the level of total protein, factor Ⅷ and fibrinogen were measued. We detected the concentration of methylene blue photochemistry. Plasma samples from 15 756 people, which have gotten negative results in HBsAg,anti-HCV and anti-HIV detecting with ELISA, were respectively detected the nucleic acid of HBV,HCV and HIV before and after virus inactivation. Furthermore, we randomly selected 200 patients who were transfused with virus inactivated plasma to invest ate if the adverse effects occurred more frequently after transfusion. Results After virus inactivating, the recovery rate of plasma volume, total protein, factor and fibrinogen were （96.67±2.34）%, （88.69±3.32） %, （86. 84±2.16）%//00 and （84. 62±1.86）% respectively. There were no significant differences before and after virus inactivation （P〉0.05）. Residual concentration of methylene blue was （0.16±0. 03） μmol/L after virus inacivation and filtration. The remove rate was 86.32%. When plasma from 15 756 people were detected nucleic acid of HBV, HCV and HIV before virus inactivating, plasma from 23 people were found positive results of HBV DNA and plasma from 1 people was found positive result of HIV RNA. The positive rate was 1.52 per mill. But after virus inactivating, we got negative results when detecting nucleic acid of HBV, HCV and HIV. Meanwhile, the adverse effects were not found after transfusion of virus inactivated plasma. Conclusion Virus inactivation plasma prepared by methylene blue photochemistry is one of blood transfusion safety measures and when they were transfused to patients, adverse effects were not found.