新生儿黄疸筛查手机软件临床交叉对照试验结果分析  

Analysis of clinical cross-control trial results of an smartphone application in screening neonatal jaundice

作　　者：黄迪 苏敏[1] 高翔羽[1] 李丽[1] 赵丹丹 王惠颖 杨波 任漪 雷红林 金宝[1] 张静[1] Huang Di;Su Min;Gao Xiangyu;Li Li;Zhao Dandan;Wang Huiying;Yang Bo;Ren Yi;Lei Honglin;Jin Bao;Zhang Jing(Department of Neonatology,Xuzhou Central Hospital(Xuzhou Clinical College of Xuzhou Medical University),Xuzhou 221009,Jiangsu Province,China)

机构地区：[1]徐州市中心医院(徐州医科大学徐州临床学院)新生儿科,江苏徐州221009

出　　处：《中华实用儿科临床杂志》2021年第20期1548-1554,共7页Chinese Journal of Applied Clinical Pediatrics

基　　金：江苏省青年医学人才(QNRC2016384);江苏省妇幼健康重点学科专项资金(1-2-2017.2.4)。

摘　　要：目的评价新生儿黄疸筛查手机软件基于图像胆红素值(IBB)与经皮胆红素值(TcB)相比的相关性、一致性及安全性。方法选择2018年7月至10月在徐州市中心医院新生儿科住院及产科病房的日龄≤28 d、胎龄≥35周,且未经蓝光治疗的新生儿,随机分组交叉对照检测胸骨前皮肤黄疸值。试验Ⅰ组先用试验器械(iPhone 6手机和哪吒保贝^(TM)手机软件),后用对照器械(JM-103经皮测黄疸仪);试验Ⅱ组先用对照器械;后用试验器械。记录性别、日龄、胎龄、出生体质量和连续检测3次的均值。采用积矩相关性分析、Bland-Altman图一致性分析、t检验及受试者工作特性曲线(ROC)进行统计学分析。结果共纳入185例新生儿,其中男99例、女86例,日龄中位数5 d(3~8 d),胎龄(37.6±1.7)周,出生体质量(2950±645)g。IBB与TcB有较好的相关性(r=0.860,P<0.05)和较强的一致性(95.1%的样本落在95%一致性区间内)。在不同性别、日龄、胎龄和出生体质量等亚组也均有较好的相关性和较强的一致性。≤7 d、>37周和>2500 g亚组的一致性相对更好。IBB预测TcB>256.5μmol/L的能力好于预测TcB>171.0μmol/L的能力,ROC曲线下面积为0.93,最佳预测界值为232.6μmol/L,敏感性96.7%、特异性82.6%。IBB与TcB检测3次的均值的差值,小于IBB与TcB第1次检测值的差值[(12.0±34.4)μmol/L比(14.4±38.6)μmol/L,P=0.038]。未出现医疗不良事件,未发生器械本身缺陷。结论IBB与TcB有较好的相关性及较强的一致性,IBB预测TcB>256.5μmol/L的能力好于预测TcB>171.0μmol/L的能力,使用安全。Objective To evaluate the correlation,consistency and safety of an smartphone application(APP)in screening neonatal jaundice using the smartphone based on the image-based bilirubin(IBB)and transcutaneous bilirubin(TcB).Methods From July to October 2018,neonates with the age≤28 d and gestational age≥35 weeks who were admitted to Department of Neonatal and Obstetrics,Xuzhou Central Hospital without blue light phototherapy were recruited.They were randomly divided into two groups to measure the jaundice value of skin in front of sternum by a cross-control analysis.Jaundice level in groupⅠwas first measured using the Nezhabaobei™APP in iPhone 6,and then measured using the JM-103 transcutaneous jaundice instrument as the control device.In groupⅡ,jaundice level was sequencially measured by the control device and the Nezhabaobei™APP.Sex,age,gestational age,birth weight and the mean value of three consecutive tests were recorded.The Pearson′s correlation analysis,Bland-Altman plots consistency analysis,t test and receiver operating characteristic(ROC)curve were used for statistical analysis.Results A total of 185 eligible neonates were enrolled,including 99 males and 86 females,with the median age of 5 d(3-8 d),gestational age of(37.6±1.7)weeks,and birth weight of(2950±645)g.There were good correlation(r=0.860,P<0.05)and consistency(95.1%of the samples fall within the 95%consistency interval)between IBB and TcB.Good correlation and consistency were also yielded in subgroup analyses based on the sex,age,gestational age and birth weight.The consistency was better in subgroups of≤7 d,>37 weeks and>2500 g.The ability of IBB to predict TcB>256.5μmol/L was better than that of TcB>171.0μmol/L.The area under the ROC curve was 0.93,the cut-off value was 232.6μmol/L,the sensitivity was 96.7%,and the specificity was 82.6%.The difference of the mean values of IBB and TcB detected for 3 times was significantly lower than that obtained in the first measurement of IBB and TcB[(12.0±34.4)μmol/L vs.(14.4±38.6)μmo

关 键 词：黄疸 婴儿 新生 手机软件 基于图像胆红素值 经皮胆红素值 

分 类 号：R722.17[医药卫生—儿科]