麦邦数据远程传输型血糖仪临床测量准确性的评价研究丁星赵畅张海严蔡道章摘要：目的評价麦邦数据远程传输型血糖仪监测院外糖尿病患者血糖水平的准确性，为麦邦数据远程传输型血糖仪的临床使用提供数据参考。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广州市天河区已诊断为糖尿病的患者，共计210例，采用麦邦数据远程传输型血糖仪和我院内分泌科所使用的美国雅培辅理善越佳型血糖仪，分别测量受试者指端血的血糖浓度，并与静脉血生化血糖值进行比较，分别计算两种血糖仪的测量结果与生化仪血糖值的相关系数和测量偏倚。上述的血糖检测控制在20min内全部完成。结果两种便携式血糖仪与全自动生化仪所测结果的相关系数分别为r=0.98、0.97，相关性均较好，且呈线性相关；两种血糖仪与生化仪测量值差值95%的置信区间均在标准等效区间（-0.83，0.83）mmol/L内，均满足临床等效性要求；麦邦数据远程传输型血糖仪95.28%的数据在临床可接受范围内，高于国家标准的要求，而雅培辅理善越佳型血糖仪低于此标准；各组检测结果之间差异虽无统计学意义（P>0.05），但两种血糖仪检测的结果均高于生化仪检测的结果。结论通过等效性分析，麦邦数据远程传输型血糖仪可以用于临床血糖监测及个人血糖检测，但不能取代实验室血糖检测结果作为临床诊断标准；麦邦数据远程传输型血糖仪的数据传输功能，方便医生根据患者情况适时调整血糖控制方案，降低并发症的发生。关键词：便携式血糖仪；2型糖尿病；血浆血糖；指尖血糖：TP391.4；R714.256：ADOI：10.3969/j.issn.1006-1959.2018.15.020：1006-1959（2018）15-0064-04EvaluationofAccuracyofClinicalMeasurementofMaibangRemoteDataTransmissionGlucometerDINGXing，ZHAOChang，ZHANGHai-yan，CAIDao-zhang（DepartmentofArthroplasty，theThirdAffiliatedHospitalofSouthernMedicalUniversity，Guangzhou510630，Guangdong，China）Abstract：ObjectiveToevaluatetheaccuracyofbloodglucosemonitoringinpatientswithdiabetesmellitusbyMaibangremotedatatransmission，andtoprovideadatareferencefortheclinicaluseofremotedatatransmissionglucometer.MethodsApplyingtheequivalenceclinicaltrialdesignanddesign，accordingtotheinclusionexclusioncriteria，210patientswithdiabetesdiagnosedinTianheDistrictofGuangzhoucitywereselected，usingtheMaibangDataRemoteTransmissionGlucoseMeterandtheAmericanAbbottAuxiliaryGoodBloodGlucoseMeterusedbytheDepartmentofEndocrinology，thebloodglucoseconcentrationofthefingerbloodwasmeasuredandcomparedwiththevenousbloodbiochemicalbloodglucoselevel.Calculatethecorrelationcoefficientandmeasurementbiasofthemeasurementresultsofthetwobloodglucosemetersandthebloodglucoselevelofthebiochemicalanalyzer.Theabovebloodglucosedetectioncontrolwascompletedin20minutes.ResultsThecorrelationcoefficientbetweenthetwokindsofportablebloodglucoseanalyzerandtheautomaticbiochemicalinstrumentrwas0.98and0.97，withthegoodcorrelation，therewasalinearcorrelation.Theconfidenceintervalsof95%differencebetweenthetwobloodglucosemetersandbiochemicalinstrumentswerewithinthestandardequivalentinterval（-0.83，0.83）mmol/L，whichmettherequirementofclinicalequivalence95.28%ofthedataofMaibangdataremotetransmissionglucometerishigherthantherequirementofnationalstandardintheclinicalacceptablerange，buttheAmericanAbbottAssistantGoodHealthBloodglucometerislowerthanthisstandard.Althoughtherewasnosignificantdifferencebetweeneachgroup（P>0.05），theresultsoftwokindsofbloodglucoseanalyzerwerehigherthanthoseofbiochemicalapparatus.ConclusionBasedontheequivalenceanalysis，Maibangdataremotetransmissionglucometercanbeusedinclinicalbloodglucosemonitoringandpersonalbloodglucosedetection，butitcannotreplacetheresultsofbloodgluco...