凝血项目参考区间建立中直接法与间接法的比较及应用  

Comparison and application of direct and indirect methods in establishing reference intervals for coagulation tests

作　　者：郑静 王萍[1] 李江[1] 曹沁梅 曹永彤[1] Zheng Jing;Wang Ping;Li Jiang;Cao Qinmei;Cao Yongtong(Department of Clinical Laboratory,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[1]中日友好医院检验科,北京100029

出　　处：《中华预防医学杂志》2025年第3期359-364,共6页Chinese Journal of Preventive Medicine

基　　金：北京市临床重点专科项目(2020年度)。

摘　　要：本研究建立基于CN-6000全自动凝血分析仪的成人凝血功能项目参考区间,并比较直接法与间接法在不同人群中的适用性。本文采用横断面研究和回顾性研究相结合的方法。直接法纳入2023年4—12月中日友好医院西院区肛肠科、皮肤科患者及Ⅰ期临床试验健康受试者,按年龄分为中青年组(18~64岁)和老年组(≥65岁),进行凝血功能检测并建立参考区间。间接法利用refineR拟合法分析同期非ICU患者的凝血功能数据,推导参考区间。同时比较两种方法在健康人群、相对健康人群和疾病人群中的适用性。结果显示,直接法建立的APTT、PT及TT参考区间在中青年组与老年组差异较小,合并参考区间分别为23.7~31.2 s、10.4~12.8 s和14.7~17.5 s。但Fib在组间存在显著差异(U=1052023,P<0.01),分别建立参考区间:中青年组为1.7~4.5 g/L,老年组为2.1~4.6 g/L。间接法推导的参考区间与直接法结果相近,APTT、PT及TT分别为23.8~31.4 s、10.4~13.0 s和14.5~17.4 s,Fib分别为1.8~4.3 g/L(中青年组)和2.1~4.5 g/L(老年组)。在相对健康人群中,两种方法结果一致性较高,但在疾病人群中间接法的参考区间与直接法存在较大差异。综上,本研究建立了基于CN-6000全自动凝血分析仪的本地化参考区间,间接法在健康及相对健康人群中可作为直接法的替代,但在疾病人群中适用性有限,需结合临床背景谨慎使用。This study aimed to establish adult reference intervals for coagulation parameters using the CN-6000 fully automated coagulation analyzer.It also compared the applicability of direct and indirect methods in different populations.A cross-sectional and retrospective design was employed.The direct method included patients from the colorectal surgery and dermatology departments,as well as healthy participants from phase I clinical trials,admitted to the West Campus of China-Japan Friendship Hospital from April to December 2023.Participants were divided into two age groups:younger adults(18-64 years)and older adults(≥65 years).Coagulation parameters were tested,and reference intervals were determined.The indirect method applied the refineR algorithm to analyze coagulation data from non-ICU patients during the same period.The performance of both methods was evaluated in healthy participants,relatively healthy patients,and patients with high disease prevalence.The results showed that the direct method yielded similar reference intervals for APTT,PT,and TT in younger and older groups,with combined intervals of 23.7-31.2 seconds,10.4-12.8 seconds,and 14.7-17.5 seconds,respectively.However,the Fib showed a significant difference between the two groups(U=1052023,P<0.01),and separate reference intervals were established:1.7-4.5 g/L for the younger group and 2.1-4.6 g/L for the older group.The reference intervals derived by the indirect method are similar to those from the direct method:APTT 23.8-31.4 seconds,PT 10.4-13.0 seconds,TT 14.5-17.4 seconds,and Fib 1.8-4.3 g/L(18-64 years)and 2.1-4.5 g/L(≥65 years).In relatively healthy patients,the reference intervals obtained by both methods were comparable,but significant differences were observed in patients with high disease prevalence.In conclusion,this study established localized reference intervals for the CN-6000 fully automated coagulation analyzer.The indirect method can serve as an alternative to the direct method in healthy and relatively healthy populations.However

关 键 词：凝血功能 参考区间 直接法 间接法 

分 类 号：R446.11[医药卫生—诊断学]