上海地区肌酐检测一致性探索及估算肾小球滤过率的临床初步应用

目的 探索上海地区血清Cr临床检测结果的一致性,进行表面健康人群的分布调查,并通过改良的适用于中国人群的MDRD公式计算eGFR,了解其分布情况,进一步评估eGFR的临床适用性.方法 每次实验前将自动化分析系统校准品(c.f.a.s.)中含有的根据IFCC推荐方法测得的Cr值传递到1份新鲜人混合血清,以此校准各参加医院检验科的Cr检测系统.14家医院检验科先后进行6次试验,并在检测结果基本一致后进行6 837名(男3 289名,女2 132名,儿童及青少年1 416名)、年龄段为0～99岁的表面健康人群Cr值测定及调查,并依据文献发表的适用于上海人群的GFR估算公式[eGFR=175×(血清Cr)-1.154×(年龄)-0.203×0.742(女性)×0.827]估算表面健康人群的eGFR值.结果 校准前各参加医院检验科之间的Cr检测值CV为3.1%～9.1%,校准后各医院之间检测值具有良好的一致性,CV降至5%以下.Cr人群分布调查后,得到结果为:成年男性63.0～102.8 μmol/L、成年女性:45.0～76.0 μmol/L;儿童及青少年:0～1岁11.0～77.0 μmol/L,＞1～＜3岁15.5～33.3 μmol/L,3～5岁19.0～42.0 μmol/L,6～19岁41.4～62.0μmol/L.成年男女间Cr存在差异,男性为(82.1±10.9)μmol/L、女性为(59.4±8.4)μmol/L,差异有统计学意义(t=94.3,P＜0.01);eGFR值可减小性别间的差异[男性为(79.1±13.5)ml·(min·1.73 m2)-1;女性为(79.2±13.6)ml·(min·1.73 m2)-1,差异无统计学意义,t=0.266,P＞0.05].成年人按年龄每10岁分组,统计显示Cr及eGFR年龄组间均存在差异(x2值分别为2601、1105,P均＜0.01).结论 采用新鲜人混合血清,可以使不同医院(不同检测系统)之间的Cr检测值差异明显减小;Cr人群分布应按性别、年龄加以区分;使用eGFR可减小性别差异,但无法消除年龄间差异.

Consistency of creatinine results in Shanghai and the preliminary clinical application of estimated glomerular filtration rate

Objective To explore the consistency of the clinical serum creatinine results in Shanghai district and investigate the population distribution of apparently healthy people, modified MDRD formula adapted to Chinese population was used to estimate glomerular filtration rate and its distribution for further assessment of the clinical applicability of the eGFR.Methods A fresh pooled human serum sample with given IFCC's creatinine level from c.f.a.s.(calibration for automatic system) ,was used to calibrate the creatinine detecting systems of each participating hospital laboratory before every examination. Fourteen hospital laboratories successively conducted 6 experiments, and the test results were almost identical.They tested and studied the creatinine values of 6 837 ( male 3 289, female 2 132, children and teenagers 1 416)apparently healthy individuals, age from 0 to 99 years old, and estimated eGFR value of these apparently healthy individuals according to the documented eGFR formula [ eGFR = 175 × (Scr) -1.154 × (age) -0.203 ×0.742 (female) × 0.827 ] which was applied especially to Shanghai people.Results Before calibration,the inter-laboratory CVs of creatinine results varied from 3.1％ -9.1％, and after calibration, CVs decreased to less than 5％.A good consistency of the creatinine results was established among all these hospitals.The result of population distribution study of creatinine for men was 63.0-102.8 μmol/L,for women was 45.0-76.0 μmol/L, and for children and teenagers was 0-1 year old 11.0-77.0 μmol/L, 2 years old 15.5-33.3 μmol/L,3-5 years old 19.0-42.0 μmol/L, 6-19 years old 41.4-62.0 μmol/L.The Cr value were different between the male and femal [ male: ( 82.1 ± 10.9 ) μmol/L, femal: ( 59.4 ± 8.4 ) μmol/L, t =94.3 ,P <0.01 ＝ ;The eGFR value could decrease the sexual difference[ male: (79.1 ± 13.5) ml · ( min ·1.73 m2 ) -1, femal: (79.2 ± 13.6) ml · ( min · 1.73 m2 ) - 1, t = 0.266, P > 0.05 ].The difference of Cr and eGFR could not be eliminated between the groups divided by every 10 years(x2Cr =2 601 ,P <0.01 ;x2eGFR2= 1 105 ,P <0.01 ＝.Conclusions The pooled patients' sera could be used as calibrator for harmonizing of creatinine results among the laboratories. The reference rang of Cr should be differentiated by age and sex.Although eGFR can decrease the difference of sex, it cannot eliminate the difference of age.