凝固曲线波形分析参数参考区间的建立及其在鉴别获得性血友病A及狼疮抗凝物阳性中的应用  

Establishment of reference values for clot waveform analysis parameters and their clinical application in differentiating acquired hemophilia A from lupus anticoagulant positive conditions

作　　者：闫彬 崔梦超 温媛媛 武迪 茹露谊 邹辉鑫 胡天喜[1] 王瑞娟[2] 翟素平[1] 杜伟鹏[1] Yan Bin;Cui Mengchao;Wen Yuanyuan;Wu Di;Ru Luyi;Zou Huixin;Hu Tianxi;Wang Ruijuan;Zhai Suping;Du Weipeng(Department of Clinical Laboratory Medicine,Nanyang Central Hospital,Nanyang Key Laboratory of Thrombosis and Hemostasis,Nanyang Engineering Research Center for Precision Testing and Application of Laboratory Medicine,Nanyang 473000,China;Department of haematology,Nanyang Central Hospital,Nanyang 473000,China)

机构地区：[1]南阳市中心医院医学检验科,南阳市血栓与止血重点实验室,南阳市检验医学精准检测与应用工程技术研究中心,南阳473000 [2]南阳市中心医院血液内科,南阳473000

出　　处：《中华检验医学杂志》2025年第3期371-377,共7页Chinese Journal of Laboratory Medicine

基　　金：河南省重点研发与推广专项科技攻关项目(242102311077);河南省和国家卫健委省部共建青年项目(SBGJ202103109)。

摘　　要：目的建立凝固曲线波形分析(CWA)参考区间,探讨其在鉴别获得性血友病A(AHA)和狼疮抗凝物(LA)阳性患者中的诊断效能。方法回顾性病例对照研究。收集2023年1月6日至2024年10月10日在南阳市中心医院的391份表观健康人血浆标本,男性260名,女性131名,年龄(45.53±14.85)岁。检测凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)和凝血酶时间(TT)用于CWA参数最大反应速度(Min1)、最大凝血加速度(Min2)、最大凝血减速度(Max2)参考区间的建立。收集明确诊断的AHA和LA阳性患者共158例,年龄(42.46±14.83)岁,其中AHA患者34例,LA阳性患者124例,采用Mann Whitney U检验分析两组CWA参数之间的差异。利用受试者工作特征(ROC)曲线下面积(AUC)评估凝血常规CWA参数在鉴别AHA和LA阳性患者中的价值并计算截断值。结果PT-Min1、APTT-Min1、APTT-Min2、APTT-Max2、TT-Min1、TT-Min2、TT-Max2的参考区间分别为203.41~516.89、144.63~324.03、526.46~1190.03、-404.96±157.22、159.17±60.34、272.29~686.99、-289.47~-113.76。与AHA患者CWA参数相比,LA阳性患者的APTT-Max2较低,差异有统计学意义[-422.74(-577.50,-239.22)比-68.87(-92.85,30.28),Z=-7.43,P<0.01];而APTT-Min1和APTT-Min2均较高,差异有统计学意义[287.01(188.03,382.50)比107.45(90.20,151.39)、972.88(601.20,1351.19)比229.10(118.38,371.67),Z=6.68、6.69,P均<0.01]。ROC曲线分析显示,APTT-CWA参数对AHA患者的诊断效能较高(AUC均>0.900),且APTT-Min1和APTT-Max2也可用于对AHA和LA阳性伴APTT延长患者的鉴别(AUC分别为0.660、0.700)。结论成功建立了CWA参数的参考区间。APTT-CWA有助于AHA和LA阳性患者的鉴别,APTT-Max2对鉴别AHA和LA阳性伴APTT延长患者具有较好的诊断价值。Objective To establish reference values for clot waveform analysis(CWA)and analyze their diagnostic efficacy in distinguishing acquired hemophilia A(AHA)and lupus anticoagulant(LA)-positive patients.Methods Case-Control Study.A total of 391 healthy individuals(260 males and 131 females)with a mean age of 45.53±14.85 years were enrolled at Nanyang central Hospital between January 6,2023 and October 10,2024.Prothrombin time(PT),activated partial thromboplastin time(APTT),and thrombin time(TT)were measured to establish reference ranges for the CWA parameters,including maximal reaction velocity(Min1),maximal reaction acceleration(Min2),and maximal reaction deceleration(Max2).A total of 158 definitively diagnosed AHA and LA-positive patients(mean age:42.46±14.83 years),including 34 AHA patients and 124 LA-positive patients,were recruited.The Mann Whitney U test was used to analyze the differences in the CWA parameters between the two groups.The diagnostic efficacy of CWA parameters in distinguishing AHA and LA-positive patients was evaluated using the area under the receiver operating characteristic(ROC)curve AUC and the cut-off values were calculated.Results The reference values for PT-Min1,APTT-Min1,APTT-Min2,APTT-Max2,TT-Min1,TT-Min2,TT-Max2 were 203.41-516.89,144.63-324.03,526.46-1190.03,-404.96±157.22,159.17±60.34,272.29-686.99,and-289.47--113.76,respectively.Compared with the CWA parameters in AHA patients,APTT-Max2 was significantly lower in LA-positive patients[-422.74(-577.50,-239.22)vs.-68.87(-92.85,30.28),Z=-7.43,P<0.01],while PT-Min1,APTT-Min1,APTT-Min2,TT-Min1,TT-Min2 were significantly elevated[287.01(188.03,382.50)vs.107.45(90.20,151.39),972.88(601.20,1351.19)vs.229.10(118.38,371.67),Z=6.68,6.69,all P<0.01].ROC analysis demonstrated the APTT-CWA parameter exhibited high diagnostic efficacy in patients with AHA(AUC>0.900 for both).Additionally,APTT-Min1 and APTT-Max2 were found to be useful in distinguishing between AHA patients and those with LA-positive status accompanied by APTT prolongation(AUC=0

关 键 词：参考区间 凝固曲线波形分析 获得性血友病A 狼疮抗凝物 

分 类 号：R446.11[医药卫生—诊断学] R446.6[医药卫生—临床医学]