亚甲蓝病毒灭活血浆1年保存期质量调查研究

The quality research of Methylene blue virus inactivated plasma within 1 year storage period

目的探讨亚甲蓝光化学法(MBP)病毒灭活血浆在1年保存期内不同时间点成分的质量变化。方法 30人份全血制备新鲜血浆和病毒灭活新鲜血浆,同一人份制备的新鲜血浆分两组留样,一组为不灭活的新鲜血浆,另一组为病毒灭活后新鲜血浆,分别检测每组样本保存不同时间后的凝血因子活性和纤维蛋白原(Fib)含量的变化。结果病毒灭活前后FⅡ:C、FⅤ:C、FⅦ:C、FⅧ:C、FⅨ:C、FⅩ:C的含量比较发现,灭活前后血浆凝血因子差异无统计学意义(P>0.05),Fib的含量在病毒灭活前后有差异。同时还发现,FⅡ:C、FⅤ:C、FⅦ:C和FⅩ:C的含量在冻存期间呈缓慢下降趋势,在冻存12个月时含量还能维持在70%以上。而FⅧ:C和FⅨ:C在冻存后含量迅速下降,在冻存12个月时含量仅维持在30%～50%。Fib在冻存期间的含量也呈逐渐下降趋势,在冻存12个月时含量约维持在60%。结论作者认为应加强对病毒灭活血浆质量标准及血制品冻存等操作规程的研究,在保证输血安全的同时应确保输注血浆成分的疗效。

Objective To observe the effects of methylene blue photochemical（MBP） virus inactivation to blood plasma components at different time points during one year. Methods A total of 30 blood samples were randomly selected. Fresh plasma from whole blood was prepared two parts,one was reserved,another was sterilely connected with MBP virus inactivation. The amounts of FⅡ ：C,FⅤ ：C,FⅦ ：C,FⅧ ：C,FⅨ ：C,FⅩ ：C and the content of fibrinogen（Fib） were detected in the plasma samples exposure MBP or not at different time points. Results The amounts of FⅡ C,FⅤ ： C, FⅦ ： C, FⅧ ： C, FⅨ ： C, F Ⅹ： C were not significantly different before and after exposure MBP. However, the content of Fib was significantly lower under exposure compared with non-exposure. At the mean while, the amounts of F Ⅱ ： C, F Ⅴ ： C, F Ⅶ： C, F Ⅹ ： C were decreased slowly and maintained about 70 % during 12 months. However,the amounts of FⅧ ：C and FⅨ ..C were decreased sharply and only maintained only 30% to 50 %fro during 12 months. The content of Fib was only maintained 60% during 1 year storage. Conclusion Ensuring the safety of blood transfusion and the curative effects of plasma components are needed to strengthen the study for the virus inactivation plasma quality standards,hematic products frozen storage and operation procedures.