健康成人血浆凝血四项检测结果的分布及其参考区间的建立

目的初步建立连云港地区20~79岁健康成人血浆凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)和纤维蛋白原(FIB)的参考区间。方法采用完全随机化方法选取2018年6月至2018年12月连云港市第二人民医院体检中心收治的2436例健康志愿者,男1395例,女1041例,年龄范围为20~79岁。将志愿者按照性别分为男性组和女性组,按照年龄分为20~29岁组、30~39岁组、40~49岁组、50~59岁组、60~69岁组、70~79岁组。采用ACL TOP700全自动凝血分析仪及其配套试剂检测血浆中PT、APTT、TT和FIB的水平,并依据CLSI C28-A3和WS/T 402-2012《临床实验室检验项目参考区间的制定》推荐方法建立血浆凝血四项的参考区间。结果连云港地区健康成人血浆中PT、APTT、TT和FIB的结果分布在性别、年龄方面比较,差异无统计学意义(P>0.05),故本研究建立血浆凝血四项的参考区间,PT为10.0~13.6 s,APTT为25.2~37.8 s,TT为11.9~17.7 s,FIB为2.13~4.56 g/L。结论连云港地区健康成人血浆PT、APTT、TT和FIB参考区间的建立,能够为临床相关疾病的诊断、监测和预后评估提供重要的参考价值。

Distribution of plasm coagulation four indices and establishment of reference interval in healthy adults

Objective The reference intervals of plasma prothrombin time(PT),activated partial thromboplastin time(APTT),thrombin time(TT)and fibrinogen(FIB)in healthy adults aged 20 to 79 years of Lianyungang area were preliminarily established.Methods A total of 2436 healthy volunteers,including 1395 males and 1041 females,aged 20 to 79 from June 2018 to December 2018 were randomly selected.The volunteers were divided into male group and female group according to gender,and into 20 to 29 years old group,30 to 39 years old group,40 to 49 years old group,50 to 59 years old group,60 to 69 years old group and 70 to 79 years old group according to age.The levels of PT,APTT,TT and FIB in plasma were detected by ACL TOP700 automatic coagulation analyzer and its supporting reagents,and the four reference intervals of plasma coagulation were established according to the recommended methods of CLSI C28-A3 and WS/T 402-2012"Establishment of Reference Intervals of Clinical Laboratory Test Items".Results There was no significant difference in the distribution of PT,APTT,TT and FIB in the plasma of healthy adults in Lianyungang area in terms of gender and age(P>0.05).Therefore,this study established a reference interval for the four terms of plasma coagulation,PT was 10.0 to 13.6 s,APTT was 25.2 to 37.8 s,TT was 11.9 to 17.7 s,and FIB was 2.13 to 4.56 g/L.Conclusion The establishment of reference intervals of Plasm PT,APTT,TT and FIB in healthy adults in Lianyungang area can provide important reference value for diagnosis,monitoring and prognosis evaluation of clinically related diseases.