中国健康成年人群凝血四项指标参考区间的建立与探讨

Establishing reference intervals of four routine coagulation indicators in healthy Chinese adults

目的:建立适合中国人群的凝血四项指标[活化部分凝血酶原时间(activated partial thromboplastin time,APTT)、凝血酶原时间(prothrombin time,PT)、凝血酶时间(thrombin time,TT)、纤维蛋白原(fibrinogen,FIB)]参考区间。方法:收集来自上海市东方医院(南院)、北京积水潭医院、山东省临沂市中医医院共计668例中国健康成年人,采用cobas t 711平台检测其凝血四项指标,根据结果建立参考区间。结果:适合中国人群的凝血四项指标参考区间为,APTT 26.6~43.6 s,PT 7.67~10.5 s,TT 14.5~19.2 s,FIB 193~419 mg/dL(1 L=10 dL)。凝血四项指标在不同性别、年龄和地区人群间均具有统计学差异,性别分析中,PT差异最为显著(P<0.001),PT和APTT中位数在男性人群中较高(P<0.01),FIB中位数在女性人群中较高(P=0.001)。以50岁分组,≤50岁人群与>50岁人群间的PT、TT中位数差异无统计学意义(P>0.05),>50岁人群的APTT、FIB中位数高于≤50岁人群(P<0.005);不同地区(上海、北京、山东)间APTT、FIB、PT、TT中位数差异有统计学意义(P<0.001),APTT和FIB中位数在上海地区最高,PT中位数在北京地区最高,TT中位数在山东地区最高。结论:本研究建立了中国健康成年人群的凝血四项指标参考区间,而影响该参考区间的因素包括地区、年龄,而男、女间参考区间相近,提示实验室应根据自身情况及地区、年龄来建立适用的参考区间。

Objective To establish four coagulation indicators suitable for Chinese adults,including activated partial thromboplastin time(APTT),prothrombin time(PT),thrombin time(TT)and fibrinogen(FIB).Methods Representative medical institutions from East and North China were selected.A total of 668 Chinese healthy adults were enrolled from Shanghai Oriental Hospital(South Campus),Beijing Jishuitan Hospital and Linyi Hospital of Traditional Chinese Medicine in this study.The cobas t 711 platform was used to detect the four coagulation indicators,and reference intervals were established based on the results.Results The reference interval applicable to all enrolled population was established:APTT(s):26.6-43.6 s,PT(s):7.67-10.5,TT(s):14.5-19.2,FIB(mg/dL):193-419.The four coagulation indicators were statistically different in different regions,genders and ages.In the gender analysis,difference in PT was the most significant(P<0.001).PT and APTT were higher in the male group,and FIB was higher in the female group;Taking≤50 years as the cut-off age,APTT,FIB were statistically higher in the elderly group(>50 years old);There were statistical differences in APTT,FIB,PT,and TT in different regions(Shanghai,Beijing,and Shandong)(P<0.001).The median APTT and FIB were highest in Shanghai(P<0.001),the median PT was highest in Beijing(P=0.001),and the median TT was highest in Shandong.Conclu⁃sions The reference interval of four coagulation indicators suitable for Chinese healthy adult population is established.Factors that influencing the reference intervals include region and age.Reference intervals between male and female overlaps,and reference intervals establishment depends on laboratory conditions,influencing factors(region,and age)on coagulation management.