智能手机应用软件在新生儿高胆红素血症检测中的应用研究  

Application of a mobile app in the detection of neonatal hyperbilirubinemia

作　　者：方舒 吴跃进[1] 干军花 包玉丽 石文静 FANG Shu;WU Yuejin;GAN Junhua;BAO Yuli;SHI Wenjing(Department of Pediatrics,Jinshan Branch of Shanghai Sixth People’s Hospital,Shanghai 201599,China)

机构地区：[1]上海市第六人民医院金山分院儿科,上海201599 [2]上海市第六人民医院

出　　处：《上海医学》2024年第2期88-92,共5页Shanghai Medical Journal

基　　金：金山区卫生健康委员会青年项目课题(JSKJ-KTQN-2019-13)。

摘　　要：目的研究、评估基于一款通过拍摄新生儿皮肤照片获取其胆红素值(automated image-based bilirubin,AIB)的智能手机应用软件(APP)监测新生儿胆红素情况的准确度,及其操作的便捷性。方法本研究为前瞻性研究,选择2020年1月—2021年8月在上海市第六人民医院金山分院产科分娩的新生儿。经样本量计算,本研究共纳入250例新生儿样本。所纳入新生儿经黄疸检测仪测得的经皮胆红素值(transcutaneous bilirubin,TcB)均>5 mg/dL(1 mg/dL=17.1μmol/L),并已采集静脉血检测血清总胆红素值(total serum bilirubin,TSB),且胎龄均≥35周。采集新生儿静脉血检测新生儿TSB。应用新生儿黄疸检测仪测量患儿额部和胸部的胆红素值,并取平均值获得TcB。应用智能手机APP拍摄、计算新生儿胆红素值,取平均值为AIB。将AIB与TcB进行非劣效性分析,AIB与TSB进行相关性和等效性分析。AIB的预测价值采用线性回归分析。结果新生儿AIB为(219.54±57.50)μmol/L,TcB为(220.42±57.91)μmol/L,TSB为(213.41±58.62)μmol/L。在自由度为500时,t分布的97.5%分位数为1.96。非劣效性检验结果分析显示,t=2.48,P=0.007,AIB非劣效于TcB。AIB与TSB相关性分析结果显示r=0.96,P<0.001,有较强的相关性;95%CI为-0.54~0.66,在-2~2范围内,故AIB与TSB测量新生儿胆红素结果具有等效性。AIB与TSB在检测时日龄为<3 d、3~<7 d的新生儿中相关性较强(r=0.95、0.96,P值均<0.001),且其95%CI分别为-0.50~1.51、-0.33~0.94,均在-2~2范围内,故AIB与TSB在检测时日龄为<3 d、3~<7 d的新生儿中测量结果等效。AIB与TSB在检测时日龄≥7 d的新生儿中相关性较强(r=0.99,P<0.001),但其95%CI为-2.44~2.89,不在-2~2范围内,故AIB与TSB在检测时日龄≥7 d的新生儿中测量结果非等效。AIB与TSB在胎龄35~<37周的新生儿中相关性较强(r=0.96,P<0.001),其95%CI为-1.65~2.76,不在-2~2范围内,故AIB与TSB在胎龄35~<37周的新生儿中测量结果非等效。AIB与TSB在胎Objective To evaluate the accuracy and convenience of a mobile app in detection of neonatal bilirubin by automated image-based bilirubin(AIB).Methods A total of 250 neonates(gestational age≥35 weeks)born in the Jinshan Branch of Shanghai Sixth People’s Hospital from January 2020 to August 2021 were selected and enrolled in this prospective study.The transcutaneous bilirubin(TcB)values measured by the jaundice detector in the included newborns were all>5 mg/dL(1 mg/dL=17.1μmmol/L)with a gestational age of≥35 weeks.Venous blood was collected to detect total serum bilirubin(TSB).Meanwhile,the bilirubin levels of the forehead and chest were measured with neonatal jaundice detector,and the average value was taken as TcB.The photos(the photographing part is the same as the measurement part of neonatal jaundice detector)was taken by the mobile app,and the average value of neonatal bilirubin was calculated as AIB.The non-inferiority analysis was conducted between AIB and TcB.The correlation and equivalence were analyzed between AIB and TSB.Linear regression analysis was used to investigate the accuracy of AIB in predicting TSB.Results The average AIB was(219.54±57.50)μmol/L,TcB was(220.42±57.91)μmol/L,and TSB was(213.41±58.62)μmol/L.At a degree of freedom of 500,the 97.5%percentile of t distribution was 1.96.Non-inferiority analysis showed that AIB was not inferior to TcB(t=2.48,P=0.007).The correlation analysis showed that there was a good correlation between AIB and TSB(r=0.96,P<0.001).If 95%CI is set between-2 to 2,it is regarded as equivalent.AIB and TSB were equivalent in the detection of neonatal bilirubin(95%CI:-0.54 to 0.66).There was a good correlation and equivalence between AIB and TSB in newborns aged 0-3 d and 3 to<7 d(r=0.95,P<0.001,95%CI:-0.50 to 1.51;r=0.96,P<0.001,95%CI:-0.33 to 0.94).There was a good correlation between AIB and TSB in newborns aged≥7 d(r=0.99,P<0.001),but the equivalence was poor(95%CI:-2.44 to 2.89).In newborns with gestational age of 35 to<37 weeks,there was a strong co

关 键 词：高胆红素血症 智能手机 应用软件 新生儿 胆红素值 

分 类 号：R722[医药卫生—儿科]