黄疸比色卡对新生儿高胆红素血症诊断效能的多中心评估

Multicenter evaluation of the diagnostic efficacy of jaundice color card for neonatal hyperbilirubinemia

目的评估父母使用黄疸比色卡(JCard)辅助目测识别新生儿高胆红素血症的准确性、诊断效能及应用价值。方法以诊断准确性研究报告标准(STARD)为指导,2019年10月至2021年9月在国内9家医院进行多中心前瞻性研究。纳入854例住院或门诊就诊因自身疾病需检测肝功能的出生胎龄≥35周、出生体重≥2000 g、年龄≤28日龄的新生儿。新生儿的父母使用JCard测量新生儿脸颊处的胆红素水平。在JCard测量后2 h内,研究人员使用JH20-1B黄疸仪测量胸骨处经皮胆红素(TcB)水平并采静脉血检测血清总胆红素水平。采用Pearson分析进行相关性分析,Bland-Altman法分析一致性,受试者工作特征(ROC)曲线分析JCard的诊断效能。结果854例新生儿中男445例、女409例;出生胎龄35~36周46例,≥37周808例;检测时年龄0~3日龄432例,4~7日龄236例,8~28日龄186例;总胆红素值为(227.4±89.6)μmol/L,范围23.7~717.0μmol/L;JCard值为(221.4±77.0)μmol/L,TcB值为(252.5±76.0)μmol/L。JCard和TcB值均与总胆红素有较好的相关性(r=0.77、0.80)和较强的一致性[分别有96.0%(820/854)和95.2%(813/854)的样本落在95%一致性界限内]。诊断效能分析显示,JCard值12识别总胆红素界值205.2μmol/L的灵敏度为0.93、特异度为0.75,识别总胆红素界值342.0μmol/L的灵敏度为1.00、特异度为0.35。TcB值205.2μmol/L识别总胆红素界值205.2μmol/L的灵敏度为0.97、特异度为0.60,识别总胆红素界值342.0μmol/L的灵敏度为1.00、特异度为0.26。JCard识别总胆红素界值153.9、205.2、256.5和342.0μmol/L的ROC曲线下面积(AUC)分别为0.96、0.92、0.83和0.83,TcB分别为0.94、0.91、0.86和0.87。当识别总胆红素界值153.9和205.2μmol/L时,JCard的AUC与TcB差异均无统计学意义(均P>0.05);当识别总胆红素界值256.5和342.0μmol/L时,JCard的AUC均低于TcB(均P<0.05)。结论JCard可以帮助父母判断新生儿高胆红素血症的程度,但诊断效能随着胆红素水平的升高而降低。当总胆红素≤205.2μmol/L时,JCard的诊断效能与JH20-1B黄疸仪相当。为了避免重度高胆红素血症的漏诊,建议使用JCard值12筛查重度高胆红素血症(总胆红素≥342.0μmol/L)。

Objective To evaluate the diagnostic efficacy and practicality of the Jaundice color card(JCard)as a screening tool for neonatal jaundice.Methods Following the standards for reporting of diagnostic accuracy studies(STARD)statement,a multicenter prospective study was conducted in 9 hospitals in China from October 2019 to September 2021.A total of 845 newborns who were admitted to the hospital or outpatient department for liver function testing due to their own diseases.The inclusion criteria were a gestational age of≥35 weeks,a birth weight of≥2000 g,and an age of≤28 days.The neonate′s parents used the JCard to measure jaundice at the neonate′s cheek.Within 2 hours of the JCard measurement,transcutaneous bilirubin(TcB)was measured with a JH20-1B device and total serum bilirubin(TSB)was detected.The Pearson′s correlation analysis,Bland-Altman plots and the receiver operating characteristic(ROC)curve were used for statistic analysis.Results Out of the 854 newborns,445 were male and 409 were female;46 were born at 35-36 weeks of gestational age and 808 were born at≥37 weeks of gestational age.Additionally,432 cases were aged 0-3 days,236 cases were aged 4-7 days,and 186 cases were aged 8-28 days.The TSB level was(227.4±89.6)μmol/L,with a range of 23.7-717.0μmol/L.The JCard level was(221.4±77.0)μmol/L and the TcB level was(252.5±76.0)μmol/L.Both the JCard and TcB values showed good correlation(r=0.77 and 0.80,respectively)and agreements(96.0%(820/854)and 95.2%(813/854)of samples fell within the 95%limits of agreement,respectively)with TSB.The JCard value of 12 had a sensitivity of 0.93 and specificity of 0.75 for identifying a TSB≥205.2μmol/L,and a sensitivity of 1.00 and specificity of 0.35 for identifying a TSB≥342.0μmol/L.The TcB value of 205.2μmol/L had a sensitivity of 0.97 and specificity of 0.60 for identifying TSB levels of 205.2μmol/L,and a sensitivity of 1.00 and specificity of 0.26 for identifying TSB levels of 342.0μmol/L.The areas under the ROC curve(AUC)of JCard for identifying TSB levels of 153.9,205.2,256.5,and 342.0μmol/L were 0.96,0.92,0.83,and 0.83,respectively.The AUC of TcB were 0.94,0.91,0.86,and 0.87,respectively.There were both no significant differences between the AUC of JCard and TcB in identifying TSB levels of 153.9 and 205.2μmol/L(both P>0.05).However,the AUC of JCard were both lower than those of TcB in identifying TSB levels of 256.5 and 342.0μmol/L(both P<0.05).Conclusions JCard can be used to classify different levels of bilirubin,but its diagnostic efficacy decreases with increasing bilirubin levels.When TSB level are≤205.2μmol/L,its diagnostic efficacy is equivalent to that of the JH20-1B.To prevent the misdiagnosis of severe jaundice,it is recommended that parents use a low JCard score,such as 12,to identify severe hyperbilirubinemia(TSB≥342.0μmol/L).