Shim Ye Jee, Lee Kun Soo, Kim Uk Hyun, Suh Jin Kyung, Baik Sae Yun, Hyun Shin Young
Department of Pediatrics, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.
Department of Pediatrics, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.
Blood Res. 2014 Dec;49(4):265-9. doi: 10.5045/br.2014.49.4.265. Epub 2014 Dec 23.
Continuous infusion of factor VIII (FVIII) is a more cost-effective method for treating hemophilia A than intermittent bolus injection. However, there is currently no specific data in Korea about the progress of in vitro FVIII coagulant activity (FVIII:C) after reconstitution from its lyophilized form.
Three commercial FVIII concentrate products (two recombinant FVIII and one plasma-derived) were used. In vitro FVIII:C was measured at 0, 2, 4, 6, and 8 hours following reconstitution in both the indoor light-exposed and light-shielded groups.
For the three drugs, in vitro FVIII:C decreased over the 8 hours following reconstitution (P<0.001). The decline of FVIII:C was linear (P<0.001). In vitro FVIII:C for the indoor light-exposed groups was 95.3±1.9% and 90.6±2.5% after 4 and 8 hours following reconstitution, respectively, compared to baseline activity. In the light-shielded group, FVIII:C was 95.4±1.1% and 90.9±1.7% of the baseline activity after 4 and 8 hours, respectively. There was no statistical difference between FVIII:C in the indoor light-exposed and light-shielded groups (P=0.849).
In vitro FVIII:C decreased after reconstitution, but activity was maintained at over 90% of the baseline value during 8 hours. Exposure to indoor light did not accelerate the loss of FVIII:C over the experimental time. This result indicates that CI with FVIII is available in 8-hour intervals, with no indoor light-exposure precautions needed.
对于甲型血友病的治疗，持续输注凝血因子VIII（FVIII）比间歇性大剂量注射更具成本效益。然而，目前韩国尚无关于冻干形式的FVIII复溶后体外FVIII凝血活性（FVIII:C）变化的具体数据。
使用三种市售FVIII浓缩剂产品（两种重组FVIII和一种血浆源性FVIII）。在室内光照组和避光组中，复溶后0、2、4、6和8小时测量体外FVIII:C。
对于这三种药物，复溶后8小时内体外FVIII:C均下降（P<0.001）。FVIII:C的下降呈线性（P<0.001）。与基线活性相比，室内光照组复溶后4小时和8小时的体外FVIII:C分别为95.3±1.9%和90.6±2.5%。在避光组中，复溶后4小时和8小时的FVIII:C分别为基线活性的95.4±1.1%和90.9±1.7%。室内光照组和避光组的FVIII:C之间无统计学差异（P=0.849）。
复溶后体外FVIII:C下降，但在8小时内活性维持在基线值的90%以上。在实验期间，暴露于室内光线下并未加速FVIII:C的损失。该结果表明，FVIII持续输注可每8小时间隔进行，无需采取室内避光措施。
