摘要
目的:探讨国产无创血糖仪在不同高原红细胞压积(HCT)人群检测中的准确性,明确其临床应用的可行性。方法:按照国际标准化组织(ISO)15197:2013标准《体外诊断检测系统-用于糖尿病管理的自测用血糖监测系统通用技术要求》,选取来自高原不同红细胞压积(HCT)的人群140名,将其中高原正常HCT者纳入正常HCT组(90例),将高HCT的患者纳入高HCT组(50例),分别采用无创血糖仪、传统血糖仪(强生NovaStatStripXpress血糖仪和罗氏卓越金采型血糖仪)进行葡萄糖检测,以生化检测的血浆葡萄糖及两个传统有创血糖仪检测值为“金标准”,分析无创血糖仪检测正常HCT和高HCT的准确性,利用多元Logistic回归分析无创血糖检测仪测量偏差的影响因素。结果:在正常HCT组和高HCT组中无创血糖仪检测结果与生化检测、传统强生Nova血糖仪和罗氏卓越血糖仪的测试值均有相关性(r_(正常HCT组)=0.773,r=0.768,r=0.765;r_(高HCT组)=0.683,r=0.736,r=0.751;P<0.0001)。正常HCT组和高HCT组的无创血糖仪测试结果与生化检测、强生Nova血糖仪和罗氏卓越传统血糖仪检测值的总符合率分别为47.78%和46.00%。无创血糖仪检测值在两组人群中的测试结果集中于A区(临床准确区)和B区(临床可接受区)分别为96.66%和96.00%。多元线性回归分析显示,生化检测血糖水平和患者年龄为无创血糖仪测量偏差的影响因素。结论:无创血糖仪检测结果不受高原人群HCT水平的影响,有望对糖尿病患者管理产生重大改变,并将成为高原红细胞增多症患者血糖检测的科学选择,具有糖尿病患者血糖监测的依从性和可行性。
Objective:To investigate the accuracy of domestic non-invasive blood glucose meter in population with different high altitude hematocrit(HCT),and to clarify the feasibility of that in clinical application.Methods:A total of 140 persons with different HCT from plateau enrolled in this research according to<In vitro diagnostic test systems–General technical requirements for blood-glucose monitoring systems for self-testing>of<IOS 15197:2013,In vitro diagnostic test systems-requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus,NEQ>,which included 90 persons with normal HCT and 50 patients with high HCT.The non-invasive blood glucose meter and conventional blood glucose meters(Johnson&Johnson Nova StatStrip Xpress blood glucose meter,Roche Superior Gold Extraction type blood glucose meter)were respectively adopted to detect glucose,and the plasma glucose of biochemical detection and the detected results of the two conventional invasive blood glucose meters were used as the“gold standard”.The accuracy of non-invasive blood glucose meters was analyzed in detecting normal HCT and high HCT.Multiple Logistic regression was used to analyze the influence factors of the measurement deviation of non-invasive blood glucose meters.Results:In normal HCT group and high HCT group,the Pearson correlation analysis showed that the result of non-invasive blood glucose meter was significantly correlated with the test values of biochemical detection,conventional Johnson Nova blood glucose meter and Roche Superior Gold Extraction type blood glucose meter(r_(normal HCT group)=0.773,r=0.768,r=0.765,r_(high HCT group)=0.683,r=0.736,r=0.751,P<0.0001),respectively.The total consistent rates between the result of non-invasive blood glucose meter and the results of biochemical detection,Johnson Nova blood glucose meter and Roche Superior Gold Extraction type blood glucose meter in the normal HCT group and the high HCT group were respectively 47.78%and 46.00%.The detected results of non-invasive b
作者
孙曾梅
邬云红
张惠勤
董婷婷
代倩
王玲
罗金措
SUN Zeng-mei;WU Yun-hong;ZHANG Hui-qin(Department of Nurse,Hospital of Chengdu Office of the People’s Government of Xizang Autonomous Region,Chengdu 610041,China;不详)
出处
《中国医学装备》
2023年第11期30-35,共6页
China Medical Equipment
基金
四川省护理科研课题(H22016)“无创血糖仪在高原人群中的运用研究”。
