江苏省连云港市健康成年人血清肌酐浓度的分布及其参考区间的建立

Distribution of serum creatinine and establishment of reference interval in healthy adults of Lianyungang,Jiangsu province

目的初步建立连云港市20~79岁健康成年人血清肌酐的参考区间.方法采用完全随机化原则从健康体检人群中筛选出符合要求的健康人34577例,应用AU5821全自动生化分析仪及其配套试剂测定血清肌酐的水平,并依据CLSI C28-A2和WS/T 402-2012《临床实验室检验项目参考区间的制定》推荐方法制定血清肌酐的参考区间.结果该地区健康成年人血清中肌酐的浓度分布在性别、年龄上的差异均有统计学意义(男性组:78[72~84]μmol/L,女性组:61[56~66]μmol/L;20~59岁男性组:78[72~84]μmol/L,60~79岁男性组:77[70~85]μmol/L;20~59岁女性组:60[56~65]μmol/L,60~79岁女性组:63[58~69]μmol/L)(Z=120.93,Z=31.53,Z=28.45;P<0.05),故该研究依据性别和年龄建立的血清肌酐参考区间为:男性(20~59岁):61~97μmol/L;男性(60~79岁):60~106μmol/L;女性(20~59岁):47~76μmol/L;女性(60~79岁):49~86μmol/L.结论血清肌酐参考区间的建立,能够在各种肾脏疾病的辅助诊断、进展和预后评估方面发挥重要的临床价值.

Objective To preliminarily establish the reference interval for serum creatinine in healthy adults aged 20-79 years in city of Lianyungang.Methods A total of 34577 cases of reference individuals were selected from physical examination population by using the principle of complete randomization,and the concentration of serum creatinine was detected by AU5821 automatic biochemical analyzer with its matching reagents.According to the stand-ards of CLSI C28-A3 and WS/T 402-2012"Clinical Laboratory Test Project Reference Interval Formulation",the reference interval of serum creatinine was established.Results There was statistically significant difference of serum creatinine in gender and age between healthy adults in this area(male group:78[72-84]μmol/L,female group:61[56-66]μmol/L;aged 20-59 of male group:78[72-84]μmol/L,aged 60-79 of male group:77[70-85]μmol/L;aged 20-59 of female group:60[56-65]μmol/L,aged 60-79 of female group:63[58-69]μmol/L)(Z=120.93,Z=31.53,Z=28.45;all P<0.05).Therefore,the reference interval of serum creatinine was estab-lished based on gender and age,and its reference interval was 61-97μmol/L(aged 20-59 of male),60-106μmol/L(aged 60-79 of male),47-76μmol/L(aged 20-59 of female)and 49-86μmol/L(aged 60-79 of female),respectively.Conclusion Establishment of reference interval in serum creatinine plays an important role in the auxiliary diagnosis,progression and prognosis evaluation of various kidney diseases.