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可穿戴式新生儿黄疸仪安装条件及准确性的临床评估

Clinical evaluation of the installation conditions and accuracy of wearable neonatal jaundice meter.

作者信息

Uozumi Azusa, Ohara Ibuki, Shimamura Masaki, Iwama Kazuhiro, Fukuyama Ayako, Horiguchi Haruko, Isoda Yutaka, Kimura Fumiya, Ota Hiroki, Ito Shuichi

机构信息

Department of Pediatrics, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.

Department of Pediatrics, National Hospital Organization Yokohama Medical Center, 3-60-2, Harajyuku, Totsuka-ku, Yokohama, Kanagawa, 245-8575, Japan.

出版信息

Sci Rep. 2025 Apr 15;15(1):12909. doi: 10.1038/s41598-025-93776-x.

DOI:10.1038/s41598-025-93776-x
PMID:40234559
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12000441/
Abstract

Neonatal jaundice is a physiological phenomenon that occurs in newborns. However, because excess bilirubin can cause cytotoxicity, abnormal hyperbilirubinemia can lead to bilirubin encephalopathy. In the evaluation of neonatal jaundice, serum bilirubin concentrations are indirectly assessed via a transcutaneous bilirubinometer. However, commercially available transcutaneous bilirubinometers are expensive, especially in developing countries. Therefore, many newborns still suffer from bilirubin encephalopathy worldwide. We previously developed a prototype wearable jaundice meter. In this study, we aimed to investigate further improvements in this device and evaluate its measurement accuracy at different measurement sites and at different pressures. The bilirubin values of forty-eight newborns were measured at different sites (middle of the forehead and upper eyebrows) and with different pressures (1 and 2 newtons). The transcutaneous bilirubin values measured by the wearable bilirubin meter were strongly correlated with the transcutaneous bilirubin values measured by a commercially available bilirubin meter (r > 0.9) and the actual serum bilirubin values (> 0.84), even under different conditions. This wearable jaundice meter is much cheaper and smaller than commercially available jaundice meters and is a novel medical device that could be useful for evaluating neonatal jaundice.

摘要

新生儿黄疸是新生儿中出现的一种生理现象。然而,由于过量胆红素可导致细胞毒性,异常的高胆红素血症可导致胆红素脑病。在评估新生儿黄疸时,血清胆红素浓度通过经皮胆红素仪间接评估。然而,市售的经皮胆红素仪价格昂贵,尤其是在发展中国家。因此,全球仍有许多新生儿患有胆红素脑病。我们之前开发了一种可穿戴黄疸仪原型。在本研究中,我们旨在进一步研究该设备的改进之处,并评估其在不同测量部位和不同压力下的测量准确性。对48名新生儿在不同部位(前额中部和上眉)以及不同压力(1牛顿和2牛顿)下测量胆红素值。即使在不同条件下,可穿戴胆红素仪测得的经皮胆红素值与市售胆红素仪测得的经皮胆红素值(r>0.9)以及实际血清胆红素值(>0.84)密切相关。这种可穿戴黄疸仪比市售黄疸仪便宜得多且体积更小,是一种可用于评估新生儿黄疸的新型医疗设备。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/30e70eb43c7b/41598_2025_93776_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/a4f472c66733/41598_2025_93776_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/8d4447bbd416/41598_2025_93776_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/c08506f2cec7/41598_2025_93776_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/302e0867700d/41598_2025_93776_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/2123f756205b/41598_2025_93776_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/ea087dc69f83/41598_2025_93776_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/c5b8d96e759b/41598_2025_93776_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/30e70eb43c7b/41598_2025_93776_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/a4f472c66733/41598_2025_93776_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/8d4447bbd416/41598_2025_93776_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/c08506f2cec7/41598_2025_93776_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/302e0867700d/41598_2025_93776_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/2123f756205b/41598_2025_93776_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/ea087dc69f83/41598_2025_93776_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/c5b8d96e759b/41598_2025_93776_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0a4/12000441/30e70eb43c7b/41598_2025_93776_Fig8_HTML.jpg

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Skin color influences transcutaneous bilirubin measurements: a systematic in vitro evaluation.肤色影响经皮胆红素测量:一项系统性体外评估
Pediatr Res. 2025 Apr;97(5):1706-1710. doi: 10.1038/s41390-024-03081-y. Epub 2024 Feb 17.
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Accuracy and Reproducibility of BiliCare™ Transcutaneous Bilirubin Device.BiliCare™ 经皮胆红素测定仪的准确性和可重复性。
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Transcutaneous bilirubinometry versus total serum bilirubin measurement for newborns.经皮胆红素测定与新生儿总血清胆红素测定的比较。
Cochrane Database Syst Rev. 2023 May 9;5(5):CD012660. doi: 10.1002/14651858.CD012660.pub2.
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Management challenges in the treatment of severe hyperbilirubinemia in low- and middle-income countries: Encouraging advancements, remaining gaps, and future opportunities.低收入和中等收入国家重症高胆红素血症治疗中的管理挑战:令人鼓舞的进展、尚存的差距及未来机遇
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