探讨全血粘弹性凝血功能监测技术对川崎病患儿凝血功能检测的临床应用价值。

选择2024年1月至10月西南地区多家医院送检的拟诊为川崎病患儿血样标本中，经第3方(宝锐生物科技泰州有限公司)采用全血粘弹性凝血功能监测技术确诊为川崎病的168例患儿为研究对象。采用回顾性分析方法，根据患儿病程将其分别纳入急性期组(n＝114，病程≤10 d)与亚急性组(n＝54，10 d<病程≤21 d)。对2组川崎病患儿采取全血粘弹性凝血功能监测技术，检测全血样本的激活凝血时间(ACT)、凝血速率(CR)、血小板功能(PF)指数；采取凝血功能及PF常规检测方法，检测患儿血浆样本的活化部分凝血酶原时间(APTT)、纤维蛋白原(FIB)、血小板计数(PLT)等指标。采用成组t检验、配对χ²检验，对2组患儿上述检测指标进行统计学分析。采用Kappa一致性检验，评估全血粘弹性凝血功能监测技术与凝血功能及PF常规检测方法，对急性期川崎病患儿凝血功能评估结果的一致性；采用受试者工作特征(ROC)曲线，评估全血粘弹性凝血功能监测技术检测的凝血功能指标，对急性期及亚急性期川崎病患儿的临床鉴别诊断价值。本研究遵循的程序通过四川省第二中医医院伦理委员会审批[审批文号：202402(K)-02]。2组川崎病患儿年龄、性别构成比及人体质量指数(BMI)等一般临床资料比较，差异均无统计学意义(P>0.05)。

①急性期组川崎病患儿ACT、CR、PF指数，均显著高于亚急性期组，并且差异均有统计学意义(t＝5.29、5.26、6.14，P<0.001)，而PLT，则显著低于亚急性期组，并且差异亦有统计学意义(t＝10.05，P<0.001)，2组APTT、FIB分别比较，则差异均无统计学意义(P>0.05)。②急性期组川崎病患儿的ACT与APTT、CR与FIB评估结果分别进行比较显示，差异均有统计学意义(χ²＝6.81、9.00，P＝0.009、0.003)。上述2种方法对急性期川崎病患儿凝血功能指标ACT与APTT、CR与FIB、PF指数与PLT评估结果的一致性均较差(Kappa值为0.035、0.021、0.060，P>0.05)。③采取ROC曲线分析ACT、CR、PF指数各单一指标及3项指标联合，对鉴别诊断急性期与亚急性期川崎病患儿的结果显示，ACT、CR、PF指数单一指标及3项指标联合对鉴别诊断急性期与亚急性期川崎病患儿的曲线下面积(AUC)分别为0.733(95%CI：0.652～0.814)、0.728(95%CI：0.644～0.813)、0.772(95%CI：0.695～0.849)、0.864(95%CI：0.808～0.919)，差异均有统计学意义(P<0.001)。

相较于凝血功能及PF常规检查方法，全血粘弹性凝血功能监测技术对川崎病患儿凝血功能及PF判断可能更准确，可通过检测ACT、CR及PF指数，辅助诊断急性期与亚急性期川崎病患儿，指导临床对其尽早治疗。

To explore the clinical application value of whole blood viscoelasticity coagulation function monitoring technique in detection of coagulation function in children with Kawasaki disease.

A total of 168 children with suspected Kawasaki disease who were sent for examination by multiple hospitals in Southwest China from January to October 2024 and diagnosed with Kawasaki disease by whole blood viscoelastic coagulation function monitoring technique by the third-party company Baorui Biotechnology Taizhou Co. Ltd. were selected as the research subjects. According to the course of disease, they were divided into acute phase group (n=114, disease course≤10 d) and subacute phase group (n=54, 10 d<disease course≤21 d) by retrospective analysis method. The whole blood viscoelasticity coagulation function monitoring technique was performed on the two groups of children with Kawasaki disease to detect activated coagulation time (ACT), coagulation rate (CR) and platelet function (PF) index. The activated partial thromboplastin time (APTT), fibrinogen (FIB) and platelet count (PLT) of plasma samples were detected by coagulation function and PF routine examination method. These detection indicators between two groups were statistically compared by independent-samples t test or paired chi-square test. Kappa consistency test was used to evaluate the consistency of whole blood viscoelasticity coagulation function monitoring technique with coagulation function and PF routine detection method for coagulation function in children with acute Kawasaki disease. Receiver operating characteristic (ROC) curve was adopted to evaluate the clinical differential diagnosis value of coagulation function indicators detected by whole blood viscoelasticity coagulation function monitoring technique on children with acute and subacute Kawasaki disease. The procedures followed in this study were approved by the ethics committee of Sichuan Second Hospital of Traditional Chinese Medicine [Approval No. 202402(K)-02]. There were no statistical differences in general clinical data such as age, gender composition ratio and body mass index (BMI) between two groups (P>0.05).

①ACT, CR and PF index of Kawasaki disease children in acute phase group were higher than those in subacute phase group (t=5.29, 5.26, 6.14; P<0.001), while PLT was lower than that in subacute phase group (t=10.05, P<0.001), and APTT and FIB revealed no statistical differences between groups (P>0.05). ②Among children with Kawasaki disease in acute phase group, the evaluation results of ACT and APTT, CR and FIB were statistically different (χ²=6.81, 9.00; P=0.009, 0.003). The consistencies of ACT with APTT, CR with FIB, and PF index with PLT detected by the above two methods were poor (Kappa value=0.035, 0.021, 0.060, all P>0.05). ③ROC curve analysis of ACT, CR and PF index and the combination of the three indicators in the differential diagnosis of children with Kawasaki disease in acute phase and subacute phase showed that the area under the curve (AUC) of ACT, CR and PF index alone and in combination for differential diagnosis of children with acute and subacute Kawasaki disease were 0.733 (95%CI: 0.652-0.814), 0.728 (95%CI: 0.644-0.813), 0.772 (95%CI: 0.695-0.849), and 0.864 (95%CI: 0.808-0.919), respectively, and the differences were statistically significant (P<0.001).

Compared with coagulation function and PF routine examination method, whole blood viscoelasticity coagulation function monitoring technique may be more accurate in judging coagulation function and PF in children with Kawasaki disease, and it can assist in the diagnosis of children with acute and subacute Kawasaki disease by detecting ACT, CR and PF index, and guide clinical treatment as soon as possible.