中国医学装备
中國醫學裝備
중국의학장비
CHINA MEDICAL EQUIPMENT
2014年
1期
33-35
,共3页
便携式血糖仪%准确性%血糖%评价
便攜式血糖儀%準確性%血糖%評價
편휴식혈당의%준학성%혈당%평개
Portable blood glucose meters%Accuracy%Blood glucose%Assessment
目的：评价5种(A～E)不同品牌血糖仪测量血糖水平的准确性，为制定便携式血糖仪的临床使用管理规范提供数据参考。方法：应用等效性临床试验研究设计，按照纳入排除标准选取解放军总医院内分泌科受试者共230例，采用便携式血糖仪对其测量指端血的血糖浓度，并与静脉血生化血糖值进行比较，计算两种测量结果的相关系数r和测量偏倚。结果：受试者生化血糖值为2.19～19.95 mmol/L，平均生化血糖浓度为(6.77±2.65) mmol/L。血糖仪C与生化测量结果的差值均数最小，为0.08 mmol/L。血糖仪E与生化测量结果差值的95%置信区间为(-0.87，-0.68)mmol/L，差别超出了等效区间(-0.83，0.83)mmol/L范围，不满足临床等效性。其他血糖仪的差值在等效区间内，满足临床等效性。5种血糖仪测量的血糖值与生化测量值之间的测量误差≤±20%或者≤±0.83 mmol/L的比例均低于95%。结论：5种血糖仪测量血糖的准确性尚可作为患者日常血糖监测，但准确度有待提高，有必要加强血糖仪准确性的持续性监测。
目的：評價5種(A～E)不同品牌血糖儀測量血糖水平的準確性，為製定便攜式血糖儀的臨床使用管理規範提供數據參攷。方法：應用等效性臨床試驗研究設計，按照納入排除標準選取解放軍總醫院內分泌科受試者共230例，採用便攜式血糖儀對其測量指耑血的血糖濃度，併與靜脈血生化血糖值進行比較，計算兩種測量結果的相關繫數r和測量偏倚。結果：受試者生化血糖值為2.19～19.95 mmol/L，平均生化血糖濃度為(6.77±2.65) mmol/L。血糖儀C與生化測量結果的差值均數最小，為0.08 mmol/L。血糖儀E與生化測量結果差值的95%置信區間為(-0.87，-0.68)mmol/L，差彆超齣瞭等效區間(-0.83，0.83)mmol/L範圍，不滿足臨床等效性。其他血糖儀的差值在等效區間內，滿足臨床等效性。5種血糖儀測量的血糖值與生化測量值之間的測量誤差≤±20%或者≤±0.83 mmol/L的比例均低于95%。結論：5種血糖儀測量血糖的準確性尚可作為患者日常血糖鑑測，但準確度有待提高，有必要加彊血糖儀準確性的持續性鑑測。
목적：평개5충(A～E)불동품패혈당의측량혈당수평적준학성，위제정편휴식혈당의적림상사용관리규범제공수거삼고。방법：응용등효성림상시험연구설계，안조납입배제표준선취해방군총의원내분비과수시자공230례，채용편휴식혈당의대기측량지단혈적혈당농도，병여정맥혈생화혈당치진행비교，계산량충측량결과적상관계수r화측량편의。결과：수시자생화혈당치위2.19～19.95 mmol/L，평균생화혈당농도위(6.77±2.65) mmol/L。혈당의C여생화측량결과적차치균수최소，위0.08 mmol/L。혈당의E여생화측량결과차치적95%치신구간위(-0.87，-0.68)mmol/L，차별초출료등효구간(-0.83，0.83)mmol/L범위，불만족림상등효성。기타혈당의적차치재등효구간내，만족림상등효성。5충혈당의측량적혈당치여생화측량치지간적측량오차≤±20%혹자≤±0.83 mmol/L적비례균저우95%。결론：5충혈당의측량혈당적준학성상가작위환자일상혈당감측，단준학도유대제고，유필요가강혈당의준학성적지속성감측。
Objective:To assess the accuracy of the portable blood glucose meters. Methods:The study design was equivalent clinical trial. The participants were selected according to the inclusion and exclusion criteria from inpatients, outpatients and outpatient volunteers of the department of endocrinology. The fingertip blood glucose was measured by five portable blood glucose meters and compared with vein blood glucose measured by biochemistry. The measurement error was assessed by the mean difference with biochemical results. The correlation coefficient was calculated to test the correlation between fingertip and vein blood glucose. Results:there were 230 cases in total including 86 males and 144females. The average age was (50.6±13.5) years old. There were 73 fasting blood glucose and 157 postprandial blood glucose. The range of biochemical blood glucose value was from 2.19 to 19.95 mmol/L and the averaged biochemical blood glucose concentration was (6.77±2.65) mmol/L. The minimum measurement error was 0.08mmol/L measured by blood glucose meter C. However, there was one meter E whose 95%confidence interval of measurement error exceeds the equivalent interval (-0.83, 0.83) mmol/L range and the difference does not meet the clinical equivalence. The measurement bias was all lower than 95%. Conclusion:The blood glucose meters can be used as the day-to-day monitoring of blood glucose in patients. The accuracy needs to be improved and continuously monitored.
