陕西地区健康人群血栓弹力图参考区间的建立

Establishment of reference intervals for thromboelastography in Shaanxi healthy population

目的 建立陕西地区健康人群血栓弹力图(TEG)的参考区间,为临床精准输血工作服务。方法 依据《临床实验室检验项目参考区间的制定》(WS/T 402-2012)的标准方法,采集386例陕西地区入选者的外周静脉血,分别运用血凝仪测定常规凝血纤溶指标(PT、APTT、TT、FiB、FDP、DD)和TEG检测以下各项参数(R、K、Angle、MA、LY30、CI),并以95%CI确定TEG各项参数的参考区间。结果 386例健康志愿者常规凝血纤溶指标均正常。所有入选者TEG数据与TEG生产商提供的各项指标的参考区间相比,其中7.2%(28/386)被诊断为凝血病,检测特异性仅为44%(170/386)。此外,R减小者188例(48.7%),K增大者28例(7.3%),Angle减小者12例(3.1%)。男性与女性的R、MA和CI差异明显(P<0.05)。不同年龄区间的R和CI差异明显(P<0.05)。最终,所有入选者的TEG各个参数的正常参考范围设置为男性R:2.7~8.6,K:1.3~3.6,Angle:46.2~72.5,MA:49.5~69.3,LY30:0~8.0,CI:-3.2~3.6;女性R:2.7~9.2,K:1.2~3.4,Angle:46.2~72.5,MA:49.5~69.3,LY30:0~8.0,CI:-3.2~3.6。结论 陕西地区健康人群TEG参考区间与生产商提供的参考区间存在明显差异。本研究建立的TEG参考区间更为适应本地区人群的临床凝血特征,可更好地应用于临床诊疗服务。

Objective To establish the reference interval of thromboelastography(TEG)for healthy adults in Shaanxi province so as to serve clinical precision blood transfusion.Methods According to the standard method of“Establishment of Reference Interval for Clinical Laboratory Test Items”(WS/T 402-2012),peripheral venous blood was collected from 386 selected patients in Shaanxi.The conventional coagulation and fibrinolysis indexes(PT,APTT,TT,FiB,FDP,and DD)were detected by hemagglutinometer,and the following parameters(R,K,Angle,MA,LY30,CI)were determined by thrombolysis graph.The 95%confidence interval was used to determine the reference interval of each parameter of thrombolysis diagram.Results The routine coagulation and fibrinolysis indexes of the 386 healthy volunteers were normal.Compared with the reference intervals of various TEG indicators provided by the manufacturer of TEG,7.2%(28/386)were diagnosed with coagulopathy,and the test specificity was only 44%(170/386).Furthermore,there was decreased R in 188 subjects(48.7%),increased K in 28 subjects(7.3%),and decreased Angle in 12 subjects(3.1%).The significant differences in R,MA and CI were found between males and females(P<0.05).The significantly different R and CI were revealed in different age ranges(P<0.05).Finally,the normal reference range of each parameter of thrombus elastigram in 386 cases was set for males(R:2.7-8.6,K:1.3-3.6,Angle:46.2-72.5,MA:49.5-69.3,LY30:0-8.0,CI:-3.2-3.6)and females(R:2.7-9.2,K:1.2-3.4,Angle:46.2-72.5,MA:49.5-69.3,LY30:0-8.0,CI:-3.2-3.6).Conclusion The reference interval of thrombolysis map of healthy people in Shaanxi is significantly different from that provided by the manufacturer.The thrombolysis map reference interval established in this study is more suitable for the clinical coagulation characteristics of the local population and can be better applied in clinical diagnosis and treatment services.