浙江省便携式血糖仪的质量分析与比较  

Quality analysis and comparison of portable blood glucose meters in Zhejiang Province

作　　者：张洪瑞 叶雄伟[1] 程璐[1] 万晓晨[1] 沈月爽[1] 李萌[1] Zhang Hongrui;Ye Xiongwei;Cheng Lu;Wan Xiaochen;Shen Yueshuang;Li Meng(Department of Clinical Laboratory,Zhejiang Hospital,Hangzhou 310013,China)

机构地区：[1]浙江医院医学检验科,杭州310013

出　　处：《中华检验医学杂志》2025年第3期402-408,共7页Chinese Journal of Laboratory Medicine

基　　金：浙江省卫生健康重大科技计划重点项目(WKJ-ZJ-2412)。

摘　　要：目的浙江省医院及患者来源的便携式血糖仪的质量分析及现状调查。方法本研究为回顾性横断面研究,共纳入便携式血糖仪252台,包括2023年4月“浙江省便携式血糖仪飞行质量控制检查”项目抽调的35台便携式血糖仪(省级医院4台、市级医院29台、县级医院2台),2024年1月“浙江医院便携式血糖仪全院比对”126台,2021年至2023年“浙江医院居家便携式血糖仪便民服务”项目中收集的患者便携式血糖仪91台。通过与参比分析仪的血糖结果比较,分别比较医院来源和患者来源、进口和国产品牌便携式血糖仪的合格率,分析不合格便携式血糖仪的血糖浓度区间分布情况。对患者血糖仪使用情况进行调查问卷,分析患者对便携式血糖仪结果的信任度、质控执行率、比对知晓率和比对执行率。结果医院便携式血糖仪检测结果总体合格率(95.7%),高于患者便携式血糖仪(70.3%),差异有统计学意义(χ^(2)=31.94,P<0.001)。在不合格的血糖仪中,不合格的血糖浓度主要集中在高浓度区间(65.9%)。在进口品牌中,医院来源的血糖仪合格率(99.3%)高于患者来源(74.0%),差异具有统计学意义(χ^(2)=36.97,P<0.001),而在国产品牌中,医院来源便携式血糖仪合格率为45.5%,患者来源合格率为65.9%,差异无统计学意义(χ^(2)=1.53,P=0.217)。同时,调查问卷结果显示,75%的患者完全信任血糖仪的检测结果,但其仪器合格率为69%。患者对于便携式血糖仪比对的知晓率为73%,但患者对便携式血糖仪质控执行率和规范比对执行率均为0。结论浙江省医院来源的便携式血糖仪合格率较高,患者来源的便携式血糖仪合格率较低,患者对于便携式血糖仪质量控制意识和比对意识淡薄。Objective We conducted a quality analysis and a survey of current situation of portable blood glucose meters from hospitals and patient sources in Zhejiang Province..Methods The study is a retrospective cross-sectional study that included 252 portable blood glucose meters,of which 35 portable blood glucose meters(4 in provincial hospitals,29 in municipal hospitals,and 2 in county-level hospitals)selected for the"Zhejiang Province Portable Blood Glucose Meter Flight Quality Control Inspection"project in April 2023,126 portable blood glucose meters collected for the"Zhejiang Hospital Portable Blood Glucose Meter Whole Hospital Comparison"project in January 2024,and 91 portable blood glucose meters collected from patients in the"Zhejiang Hospital Home Portable Blood Glucose Meter Convenience Service"project from 2021 to 2023.By comparing the blood glucose results with the reference analyzer,evaluate the qualification rate of portable blood glucose meters between hospitals and patients,imported and domestic brands,and analyze the distribution of blood glucose concentration intervals for unqualified portable blood glucose meters.Conduct a survey questionnaire on the use of portable blood glucose meters by patients to analyze their trust in the results,quality control execution rate,comparison awareness rate,and comparison execution rate.Results The overall qualification rate of portable blood glucose meters in hospitals(95.7%)was higher than that of portable blood glucose meters use by patients(70.3%),and the difference was statistically significant(χ^(2)=31.94,P<0.001).Among the unqualified blood glucose meters,the unqualified blood glucose concentration is mainly concentrated in the high concentration range(65.9%).Among imported brands,the qualification rate of blood glucose meters from hospitals(99.3%)is higher than that from patients(74.0%),and the difference is statistically significant(χ^(2)=36.97,P<0.001).Meanwhile,75%of patients fully trust the detection results of the blood glucose meter,but its instrument

关 键 词：糖尿病 血糖 即时检测 便携式血糖仪 质量分析 

分 类 号：R587.1[医药卫生—内分泌]