人凝血酶原复合物中凝血因子Ⅸ效价测定影响因素的探讨
Study the influence on detection activity of coagulation factors Ⅸ in human prothrombin complex concentrates
栗景蕊 1高晓新 1胡宇驰1
作者信息
摘要
目的 探讨几种因素对人凝血酶原复合物中凝血因子Ⅸ效价测定的影响.方法 参照枟中国药典枠2010年版,采用不同厂家乏Ⅸ因子血浆、不同型号仪器、不同肝素中和方式、不同样品前处理方法测定人凝血酶原复合物中凝血因子Ⅸ效价,分析其对PCC 中凝血因子Ⅸ效价测定结果的影响.结果 不同厂家的乏Ⅸ因子血浆对凝血因子效价测定结果有显著性差异( P< 0.05).不同型号全自动凝血分析仪对凝血因子效价测定结果无显著性差异.当稀释倍数大于60倍时,是否中和肝素对凝血因子Ⅸ效价测定结果影响较小.当稀释倍数小于60倍时,中和肝素的检测结果高于不中和的检测结果,差异有统计学意义( P< 0.05).样品预温与否及是否复溶15分钟,凝血因子Ⅸ效价测定结果无显著性差异.结论 不同厂家乏Ⅸ因子血浆,不同稀释倍数的肝素中和方式,样品前处理方法均影响PCC制品凝血因子Ⅸ效价的测定,在检测过程中应予以重视.加强对乏因子血浆的质量控制及操作流程的规范化,建立PCC制品凝血因子检测的室间质量评价体系.
Abstract
Objective To study the influence factors on detection coagulation factors Ⅸ activity in human prothrombin complex concentrates(PCC).MethodsUsing Chinese Pharmacopoeia(2010)as reference,factor Ⅸ deficient plasma from different manufacturers,different types of instruments,different methods of heparin neutralization,different sample pretreatment methods were used to determine the activity of coagulation factor Ⅸ in PCC.The influence on the results of coagulation factor Ⅸ was analyzed.ResultsThere was a significant difference between factor Ⅸ deficient plasma from different manufacturers for the activity of coagulation factors Ⅸ(P<0.05).There was no significant difference between the results of coagulation factor Ⅸ measured by different types of Automatic Coagulation Analyzer.When the dilution ratio was more than 60 times,the neutralization of heparin had little effect on the coagulation factor Ⅸ activity.When the dilution ratio is less than 60 times,the detection results of coagulation factor Ⅸ by neutralization of heparin are higher than no neutralization of heparin,and the difference is significant(P<0.05).Samples for pre-temperature or not and whether dissolution for 15minutes or not,the coagulation factor Ⅸ activity showed no significant difference.Conclusion The coagulation factor Ⅸ activity in PCC was affected by factor Ⅸ deficient plasma from different manufacturers,different dilution times of heparin neutralization method and sample pre-treatment methods.It must be paid attention to in the detection process.Strengthen the quality control of the factor deficient plasma and the standardization of operation process are necessary.The External Quality Assessment for the detection of coagulation factors in PCC products should be edtablished.
关键词
人凝血酶原复合物/凝血因子Ⅸ/乏Ⅸ因子血浆Key words
human prothrombin complex concentrates/coagulation factors Ⅸ/factor Ⅸ deficient plasma引用本文复制引用
出版年
2017
NETL
NSTL
维普
万方数据