改良Bethesda方法、改良Nijmegen方法和空白法检测凝血因子Ⅷ抑制物及其影响因素  

Modified Bethesda, modified Nijmegen and blank assays for coagulation factor Ⅷ inhibitor detection and factors affecting the results

作　　者：冯厚梅[1] 李强[1] 许伟珊[1] 陈东妙 郑磊[1] 

机构地区：[1]南方医科大学南方医院检验科,广东广州510515

出　　处：《南方医科大学学报》2016年第4期592-594,F0003,共4页Journal of Southern Medical University

基　　金：南方医科大学南方医院新业务新技术课题资助项目(2013019);南方医科大学大学生创新项目(201512121254)

摘　　要：目的评价改良Bethesda方法、改良Nijmegen方法和空白法检测血友病A患者凝血因子Ⅷ抑制物的临床应用价值,并探讨凝血因子Ⅷ抑制物检测的影响因素。方法采用改良Bethesda方法、改良Nijmegen方法和以去离子水替代缓冲液或乏Ⅷ因子血浆的空白法,分别检测257例血友病A患者的抑制物水平,以抑制物滴度≥0.60 BU/m L判为阳性结果,并对3种方法检测结果的阳性率及抑制物滴度水平进行分析。结果改良Bethesda方法、改良Nijmegen方法和空白法的阳性率分别为79.38%、85.21%和72.37%。改良Bethesda方法与改良Nijmegen方法之间相关系数为0.996(P<0.001),两种方法的抑制物滴度水平之间有显著的统计学差异(P<0.001),阳性率无显著的统计学差异(P=0.105);改良Bethesda方法与空白法之间相关系数为0.994(P<0.001),抑制物滴度水平之间有显著的统计学差异(P<0.001),阳性率无显著的统计学差异(P=0.079);改良Nijmegen方法与空白法之间相关系数为0.994(P<0.001),抑制物滴度水平之间有显著的统计学差异(P<0.001),阳性率有显著的统计学差异(P=0.001)。结论改良Nijmegen方法具有较高的灵敏度,改良Bethesda方法次之,空白法最差。反应体系中各凝血因子活性水平的一致性是影响凝血因子Ⅷ抑制物检测的主要因素,而稳定的缓冲体系也是影响检测结果稳定性、灵敏度及特异性不可忽视的因素。Objective To evaluate the dinical value of modified Bethesda assay, modified Nijmegen assay and blank assay for detection of coagulation factor Ⅷ （FⅧ） inhibitors in patients with hemophilia A and analyze the factors that affect FⅧinhibitor detection. Methods The levels of FⅧ inhibitors in 257 patients with hemophilia A were detected using modified Bethesda assay modified Nijmegen assay and blank assay （in which the buffer or FⅧ-deficient plasma in the control mixture was replaced by deionized water）. The 3 methods were compared for positivity rates and FⅧ inhibitor titers based on the positive cut-off value of FⅧ inhibitors ≥0.60 BU/mL. Results The positive rates of modified Bethesda assay modified Nijmegen assay and blank assay were 79.38%, 85.21% and 72.37%, respectively. A strong correlation was found between the results by modified Bethesda assay and modified Nijrnegen assay （r=0.996, P〈0.001）, and FVIII inhibitor titers （P〈0.001） but not the positive rates （P=0.105） detected by the two methods differed significantly. The correlation coefficients between modified Nijmegen assay and blank assay was 0.994 （P〈0.O01）, and a significant difference was found in FVIII inhibitor titers （P〈0.001） but not the positivity rates （P=0.079） detected by the two methods. The correlation coefficient between modified Nijmegen assay and blank assay was 0.994 （r=0.994）, and the two methods yielded significantly different FVIII inhibitor titers and positivity rates （P=0.001）. Conclusion The modified Bethesda assay has a lower sensitivity than modified Nijmegen assay but has a higher sensitivity than blank assay. The consistency level of coagulation factors in the reaction system and stable buffer system are important factors that affect FⅧ-inhibitor detection.

关 键 词：改良Bethesda方法 改良Nijmegen方法 空白法 FⅧ抑制物 血友病A 

分 类 号：R554.1[医药卫生—血液循环系统疾病] R446.11[医药卫生—内科学]