Hellstern P, Beeck H, Fellhauer A, Fischer A, Faller-Stöckl B
Institut für Transfusionsmedizin und Immunhämatologie, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany.
Thromb Res. 1997 Jun 15;86(6):493-504. doi: 10.1016/s0049-3848(97)00098-4.
We established reference ranges for factor VII clotting activity (FVII:C), factor VII amidolytic activity (FVII:AM), and activated factor VII (FVIIa) in 102 healthy individuals. The reference ranges were 65-160 U/100 ml, 70-165 U/100 ml, and 30-170 mU/ml, respectively (2.5 and 97.5 percentiles). Freezing and thawing of the plasma samples had no influence on the assay results. Due to the small sample size, the results were not influenced by gender, age, smoking habits, and oral contraceptive use. The plasma levels of FVII:C, FVII:AM, and FVIIa were significantly correlated with each other. The significant correlation between FVIIa and FVII:AM indicates that FVIIa is not completely independent of circulating FVII mass. There was also a significant, though weak, correlation between FVIIa and FVII:C/FVII:AM ratios. Sixteen batches of prothrombin complex concentrates (PCC) from 3 manufacturers were also analysed. FVIIa could be detected in all preparations, with considerable variations from batch to batch. In contrast to the results obtained in plasma from normal individuals, there was a close correlation between FVIIa and FVII:C/FVII:AM ratios. The preparations could be characterized by their FVII and FVIIa potencies and by their FVII:C/FVII:AM ratios. In PCC, FVII:C was very strongly correlated with FVIIa, whereas no significant correlation was observed between FVII:AM and FVII:C and between FVII:AM and FVIIa, respectively. These results demonstrate that the FVII:C assay used is sensitive for detecting FVIIa. Thus, we cannot confirm that FVIIa sensitivity of one-stage clotting assays for FVII:C is low when a rabbit thromboplastin and a non-adsorbed FVII-deficient plasma is used.
我们测定了102名健康个体的凝血因子VII凝血活性（FVII:C）、因子VII酰胺水解活性（FVII:AM）和活化因子VII（FVIIa）的参考范围。参考范围分别为65 - 160 U/100 ml、70 - 165 U/100 ml和30 - 170 mU/ml（第2.5和97.5百分位数）。血浆样本的冻融对检测结果无影响。由于样本量较小，结果不受性别、年龄、吸烟习惯和口服避孕药使用情况的影响。FVII:C、FVII:AM和FVIIa的血浆水平彼此显著相关。FVIIa与FVII:AM之间的显著相关性表明FVIIa并非完全独立于循环中的FVII量。FVIIa与FVII:C/FVII:AM比值之间也存在显著但较弱的相关性。我们还分析了来自3个制造商的16批凝血酶原复合物浓缩剂（PCC）。所有制剂中均能检测到FVIIa，批次间差异较大。与正常个体血浆中的结果相反，FVIIa与FVII:C/FVII:AM比值之间存在密切相关性。这些制剂可用其FVII和FVIIa效价以及FVII:C/FVII:AM比值来表征。在PCC中，FVII:C与FVIIa高度相关，而FVII:AM与FVII:C以及FVII:AM与FVIIa之间未观察到显著相关性。这些结果表明所使用的FVII:C检测方法对检测FVIIa敏感。因此，当使用兔组织凝血活酶和非吸附性FVII缺乏血浆时，我们不能证实FVII:C的一步凝血检测法对FVIIa的敏感性较低。
