|
[1]
|
Heidenreich, P.A., Bozkurt, B., Aguilar, D., Allen, L.A., Byun, J.J., Colvin, M.M., et al. (2022) 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 145, e895-e1032. https://doi.org/10.1161/cir.0000000000001063
|
|
[2]
|
Groenewegen, A., Rutten, F.H., Mosterd, A. and Hoes, A.W. (2020) Epidemiology of Heart Failure. European Journal of Heart Failure, 22, 1342-1356. https://doi.org/10.1002/ejhf.1858
|
|
[3]
|
Martin, S.S., Aday, A.W., Allen, N.B., et al. (2025) 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data from the American Heart Association. Circulation, 151, e41-e660.
|
|
[4]
|
国家心血管病中心, 国家心血管病专家委员会心力衰竭专业委员会, 中国医师协会心力衰竭专业委员会, 等. 国家心力衰竭指南2023 [J]. 中华心力衰竭和心肌病杂志, 2023, 7(4): 215-311.
|
|
[5]
|
中华医学会心血管病学分会, 中国医师协会心血管内科医师分会, 中国医师协会心力衰竭专业委员会, 等. 中国心力衰竭诊断和治疗指南2024 [J]. 中华心血管病杂志, 2024, 52(3): 235-275.
|
|
[6]
|
Epstein, M., Reaven, N.L., Funk, S.E., et al. (2015) Evaluation of the Treatment Gap between Clinical Guidelines and the Utilization of Renin-Angiotensin-Aldosterone System Inhibitors. The American Journal of Managed Care, 21, S212-S220.
|
|
[7]
|
Miller, P.R., Xiao, X., Brener, I., Burckel, D.B., Narayan, R. and Polsky, R. (2014) Microneedle‐Based Transdermal Sensor for On‐Chip Potentiometric Determination of K+. Advanced Healthcare Materials, 3, 876-881. https://doi.org/10.1002/adhm.201300541
|
|
[8]
|
Salehan, P., Ensafi, A.A., Mousaabadi, K.Z., Ghasemi, J.B., Aghaee, E. and Rezaei, B. (2022) A Theoretical and Experimental Study of Polyaniline/GCE and DNA G-Quadruplex Conformation as an Impedimetric Biosensor for the Determination of Potassium Ions. Chemosphere, 292, Article ID: 133460. https://doi.org/10.1016/j.chemosphere.2021.133460
|
|
[9]
|
Baker, L.B. and Wolfe, A.S. (2020) Physiological Mechanisms Determining Eccrine Sweat Composition. European Journal of Applied Physiology, 120, 719-752. https://doi.org/10.1007/s00421-020-04323-7
|
|
[10]
|
Brasier, N., Frobert, O., De Ieso, F., Meyer, D., Kowatsch, T. and Ghaffari, R. (2024) The Potential of Wearable Sweat Sensors in Heart Failure Management. Nature Electronics, 7, 182-184. https://doi.org/10.1038/s41928-024-01136-w
|
|
[11]
|
Miura, Y., Higuchi, S., Kohno, T., Shiraishi, Y., Kitamura, M., Nagatomo, Y., et al. (2022) Association of Potassium Level at Discharge with Long-Term Mortality in Hospitalized Patients with Heart Failure. Journal of Clinical Medicine, 11, Article 7358. https://doi.org/10.3390/jcm11247358
|
|
[12]
|
Gettes, L.S. (1992) Electrolyte Abnormalities Underlying Lethal and Ventricular Arrhythmias. Circulation, 85, I70-I76.
|
|
[13]
|
Aldahl, M., Polcwiartek, C., Davidsen, L., Kragholm, K., Søgaard, P., Torp-Pedersen, C., et al. (2021) Short-Term Prognosis of Normalising Serum Potassium Following an Episode of Hypokalaemia in Patients with Chronic Heart Failure. European Journal of Preventive Cardiology, 28, 316-323. https://doi.org/10.1177/2047487320911154
|
|
[14]
|
Collins, A.J., Pitt, B., Reaven, N., Funk, S., McGaughey, K., Wilson, D., et al. (2017) Association of Serum Potassium with All-Cause Mortality in Patients with and without Heart Failure, Chronic Kidney Disease, and/or Diabetes. American Journal of Nephrology, 46, 213-221. https://doi.org/10.1159/000479802
|
|
[15]
|
Chung, M., Fortunato, G. and Radacsi, N. (2019) Wearable Flexible Sweat Sensors for Healthcare Monitoring: A Review. Journal of the Royal Society Interface, 16, Article ID: 20190217. https://doi.org/10.1098/rsif.2019.0217
|
|
[16]
|
Baker, L.B., Stofan, J.R., Hamilton, A.A. and Horswill, C.A. (2009) Comparison of Regional Patch Collection vs. Whole Body Washdown for Measuring Sweat Sodium and Potassium Loss during Exercise. Journal of Applied Physiology, 107, 887-895. https://doi.org/10.1152/japplphysiol.00197.2009
|
|
[17]
|
Taylor, N.A. and Machado-Moreira, C.A. (2013) Regional Variations in Transepidermal Water Loss, Eccrine Sweat Gland Density, Sweat Secretion Rates and Electrolyte Composition in Resting and Exercising Humans. Extreme Physiology & Medicine, 2, Article No. 4. https://doi.org/10.1186/2046-7648-2-4
|
|
[18]
|
Li, M., Li, G., Xu, T., Wang, Y., Xu, R., Zhang, X., et al. (2025) Multi-Biosensing Hairband for Emergency Health Assessment. Nature Communications, 16, Article No. 7224. https://doi.org/10.1038/s41467-025-62556-6
|
|
[19]
|
Vairo, D., Bruzzese, L., Marlinge, M., Fuster, L., Adjriou, N., Kipson, N., et al. (2017) Towards Addressing the Body Electrolyte Environment via Sweat Analysis: Pilocarpine Iontophoresis Supports Assessment of Plasma Potassium Concentration. Scientific Reports, 7, Article No. 11801. https://doi.org/10.1038/s41598-017-12211-y
|
|
[20]
|
国家市场监督管理总局, 国家标准化管理委员会. GB 9706.1-2020医用电气设备 第1部分: 基本安全和基本性能的通用要求[S]. 北京: 中国标准出版社, 2020.
|
|
[21]
|
Fathy, M.A. and Bühlmann, P. (2025) Next-Generation Potentiometric Sensors: A Review of Flexible and Wearable Technologies. Biosensors, 15, Article 51. https://doi.org/10.3390/bios15010051
|
|
[22]
|
Zhang, T., Kabandana, G.K.M., Terrell, J.A., Chen, H. and Chen, C. (2025) Recent Advances in Wearable Sweat Sensor Development. WIREs Nanomedicine and Nanobiotechnology, 17, e70006. https://doi.org/10.1002/wnan.70006
|
|
[23]
|
Gao, W., Emaminejad, S., Nyein, H.Y.Y., Challa, S., Chen, K., Peck, A., et al. (2016) Fully Integrated Wearable Sensor Arrays for Multiplexed in Situ Perspiration Analysis. Nature, 529, 509-514. https://doi.org/10.1038/nature16521
|
|
[24]
|
Li, C., Li, Z., Nguyen, T.D.D., Ingebrandt, S. and Vu, X.T. (2024) Real-Time and Multiplexed Detection of Sodium and Potassium Ions Using PEDOT:PSS OECT Microarrays Integrated with Ion-Selective Membranes. Electrochimica Acta, 507, Article ID: 145111. https://doi.org/10.1016/j.electacta.2024.145111
|
|
[25]
|
Pirovano, P., Dorrian, M., Shinde, A., Donohoe, A., Brady, A.J., Moyna, N.M., et al. (2020) A Wearable Sensor for the Detection of Sodium and Potassium in Human Sweat during Exercise. Talanta, 219, Article ID: 121145. https://doi.org/10.1016/j.talanta.2020.121145
|
|
[26]
|
Standardization IOF (2025) ISO 10993-1:2025 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process.
|
|
[27]
|
Terse-Thakoor, T., Punjiya, M., Matharu, Z., Lyu, B., Ahmad, M., Giles, G.E., et al. (2020) Thread-Based Multiplexed Sensor Patch for Real-Time Sweat Monitoring. npj Flexible Electronics, 4, Article No. 18. https://doi.org/10.1038/s41528-020-00081-w
|
|
[28]
|
Gao, F.P., Liu, C.X., Zhang, L.C., et al. (2023) Wearable and Flexible Electrochemical Sensors for Sweat Analysis: A Review. Microsystems & Nanoengineering, 9, Article No. 1.
|
|
[29]
|
Ibrahim, N.F.A., Sabani, N., Johari, S., Manaf, A.A., Wahab, A.A., Zakaria, Z., et al. (2022) A Comprehensive Review of the Recent Developments in Wearable Sweat-Sensing Devices. Sensors, 22, Article 7670. https://doi.org/10.3390/s22197670
|
|
[30]
|
Iyigun, U., Kerkutluoglu, M., Gunes, H., et al. (2026) Detection of Hypokalemia, Hyponatremia, and Hyperkalemia in Heart Failure Patients Using Artificial Intelligence Techniques via Electrocardiography. Turk Kardiyoloji Dernegi Arsivi-Archives of the Turkish Society of Cardiology, 54, 24-32.
|
|
[31]
|
Standardization IOF (2019) ISO 14117:2019 Active Implantable Medical Devices—Electromagnetic Compatibility—EMC Test Protocols for Implantable Cardiac Pacemakers, Implantable Cardioverter Defibrillators and Cardiac Resynchronization Devices.
|
|
[32]
|
国家药品监督管理局医疗器械技术审评中心. 医疗器械网络安全注册审查指导原则(2022年修订版)(2022年第7号)[EB/OL]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20220309085900737.html, 2022-03-09.
|
|
[33]
|
国家药品监督管理局医疗器械技术审评中心. 人工智能辅助检测医疗器械(软件)临床评价注册审查指导原则(2023年第38号)[EB/OL]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20231116154535183.html, 2023-11-07.
|
|
[34]
|
Song, Y., Min, J., Yu, Y., Wang, H., Yang, Y., Zhang, H., et al. (2020) Wireless Battery-Free Wearable Sweat Sensor Powered by Human Motion. Science Advances, 6, eaay9842. https://doi.org/10.1126/sciadv.aay9842
|
|
[35]
|
Fang, J., Jia, Y., Liao, Z., Qi, B. and Huang, T. (2025) A Mechanical-Electrochemical Dual-Model E-Skin for the Monitoring of Cardiovascular Healthcare. Biosensors, 15, Article 5. https://doi.org/10.3390/bios15010005
|
|
[36]
|
Mukherjee, S., Pietrosemoli Salazar, S., Saha, T., Dickey, M.D. and Velev, O.D. (2024) Capillary-Osmotic Wearable Patch Based on Lateral Flow Assay for Sweat Potassium Analysis. Sensors and Actuators B: Chemical, 419, Article ID: 136383. https://doi.org/10.1016/j.snb.2024.136383
|
|
[37]
|
Fu, J., Wang, Y., Ding, Y., Wang, J., Deng, S., Jiang, Z., et al. (2025) Wearable Ring Sensor for Monitoring Biomarkers of Atherosclerosis in Sweat. Talanta, 287, Article ID: 127608. https://doi.org/10.1016/j.talanta.2025.127608
|
|
[38]
|
Cai, X., Xia, R., Liu, Z., Dai, H., Zhao, Y., Chen, S., et al. (2024) Fully Integrated Multiplexed Wristwatch for Real-Time Monitoring of Electrolyte Ions in Sweat. ACS Nano, 18, 12808-12819. https://doi.org/10.1021/acsnano.3c13035
|
|
[39]
|
Mo, L., Ma, X., Fan, L., Xin, J.H. and Yu, H. (2023) Weavable, Large-Scaled, Rapid Response, Long-Term Stable Electrochemical Fabric Sensor Integrated into Clothing for Monitoring Potassium Ions in Sweat. Chemical Engineering Journal, 454, Article ID: 140473. https://doi.org/10.1016/j.cej.2022.140473
|
|
[40]
|
Solar, H., Fernández, E., Tartarisco, G., Pioggia, G., Cvetković, B., Kozina, S., et al. (2013) A Non Invasive, Wearable Sensor Platform for Multi-Parametric Remote Monitoring in CHF Patients. Health and Technology, 3, 99-109. https://doi.org/10.1007/s12553-013-0045-8
|
|
[41]
|
Vijayan, V., Connolly, J.P., Condell, J., McKelvey, N. and Gardiner, P. (2021) Review of Wearable Devices and Data Collection Considerations for Connected Health. Sensors, 21, Article 5589. https://doi.org/10.3390/s21165589
|
|
[42]
|
Costa, P.D., Reis, A.H. and Rodrigues, P.P. (2013) Clinical and Economic Impact of Remote Monitoring on the Follow-Up of Patients with Implantable Electronic Cardiovascular Devices: An Observational Study. Telemedicine and e-Health, 19, 71-80. https://doi.org/10.1089/tmj.2012.0064
|
|
[43]
|
医疗器械注册与备案管理办法(国家市场监督管理总局令第47号)[EB/OL]. https://www.nmpaic.org.cn/yjzcfg/202109/t20210903_302408.html, 2021-08-26.
|
|
[44]
|
Jalal, N.R., Madrakian, T., Ahmadi, M., Afkhami, A., Khalili, S., Bahrami, M., et al. (2024) Wireless Wearable Potentiometric Sensor for Simultaneous Determination of Ph, Sodium and Potassium in Human Sweat. Scientific Reports, 14, Article No. 11526. https://doi.org/10.1038/s41598-024-62236-3
|
|
[45]
|
Sempionatto, J.R., Jeerapan, I., Krishnan, S. and Wang, J. (2020) Wearable Chemical Sensors: Emerging Systems for On-Body Analytical Chemistry. Analytical Chemistry, 92, 378-396. https://doi.org/10.1021/acs.analchem.9b04668
|