改进Bethesda方法和Nijmegen方法检测凝血因子Ⅷ抑制物的比较

Comparison of Modified Bethesda Assay and Nijmegen Assay in Detecting FⅧ Inhibitor in Patients with Hemophilia A

目的比较改进的Bethesda方法与Nijmegen方法检测血浆凝血因子Ⅷ（FⅧ）抑制物的可靠性及实用性。方法自行改进Bethesda检测方法,将Nijmegen方法中的乏FⅧ血浆和Nijmegen正常混合血浆替换成缓冲液和通用参比血浆（UCRP）来制备标准曲线;在检测患者抑制物时将Nijmegen正常混合血浆替换成UCRP;以滴度≥0.6 BU/ml为抑制物阳性。分别采用改进Bethesda方法和Nijmegen方法对237例血友病A患者进行抑制物检测。结果改进Be-thesda方法和Nijmegen方法检测的阳性率分别为5.5%（13/237）和8.4%（20/237）,两者相比差异无统计学意义（P〉0.05）。对于滴度〉0.7 BU/ml的抑制物,两种方法具有很好的一致性。两种方法阳性结果不同的抑制物水平均在0.6~0.7 BU/ml。结论改进的标准Bethesda方法是一种简便、可行的检测方法,Nijmegen方法更有利于低滴度抑制物的检出。

Objective To compare the sensitivity and practicability of modified Bethesda assay and Nijmegen assay in detecting factor Ⅷ （FⅧ） inhibitor. Methods Modified Bethesda assay and Nijmegen assay were used to screen FⅧ inhibitors in 237 patients with hemophilia A. The buffer plus universal coagulation reference plasma （UCRP） was used to establish a standard curve for FⅧ ： C assay in modified Bethesda method, instead of Nijmegen plasma plus FⅧ deficiency plasma in Nijmegen method. The cutoff value for positive FⅧ inhibitors is ≥0.6BU/ml. Results The positive rate of FⅧ inhibitors was 5. 5 % （n=13） when using modified Bethesda assay and was 8.4% （ n = 20） when using Nijmegen assay （ P 〉 0.05 ）. Conclusion Modified standard Bethesda assay is a convenient and feasible method for detecting FⅧ inhibitors.