摘要
目的调查不同估算肾小球滤过率（eGFR）公式的参考范围及其临床应用特性。方法测定健康人群血清肌酐（苦味酸法、酶法）及半胱氨酸蛋白酶抑制剂C（Cys C）,统计参考限。把肌酐及Cys C测定值代入不同的eGRF公式（美国2个、中国3个、日本3个、Cys C 4个）,统计其95%可信区间（CI）。测定83例肾功能异常患者（男43例、女40例）血清肌酐及Cys C,代入不同的eGRF公式,以相关分析观察其一致性。改变某一变量（测定浓度、年龄和干扰）,考核对eGFR模型的影响程度。综合归纳eGFR方法适用范围。结果肌酐苦味酸法95%CI男、女分别为73-120、55-97μmol/L;酶法分别为34-106、18-75μmol/L;Cys C为0.38-0.98 mg/L。肌酐苦味酸法、酶法99%CI分别为41-132、26-120μmol/L。全国推荐法、美国法、美国IDMS法、瑞金医院、中山医院、日本推荐法、日本苦味酸法、日本酶法、Cys C66.8、Cys C91.6、Cys C77.24、Cys C中山医院eGFR 95%CI分别为53-123、49-110、48-227、52-110、38-85、36-85、44-96、36-169、50-190、75-227、59-213、57-81 mL/（min.1.73 m^2）。全国推荐法与美国法及日本法男性组间差异无统计学意义（P〉0.05）,其余组有明显差异（P〈0.05）。回归方程分别为：Y美国法=2.65＋0.9X全国推荐法,R^2=1;Y美国IDMS法=-0.81＋1.5X全国推荐法,R^2=0.98;Y瑞金医院=8.33＋0.8X全国推荐法,R^2=0.99;Y中山医院=2.04＋0.7X全国推荐法,R^2=1;Y日本推荐法=2.63＋0.66全国推荐法,R^2=0.99;Y日本苦味酸法=2.31＋0.79X全国推荐法,R^2=1;Y日本酶法=-0.656＋1.11X全国推荐法,R^2=0.98;YCys C 66.8=-11.79＋1.41X全国推荐法,R^2=0.90;YCys C 91.6=-4.96＋1.67X全国推荐法,R^2=0.92;YCys C 77.24=-11.65＋1.58X全国推荐法,R^2=0.91;YCys C中山医院=32.52＋0.4X全国推荐法,R^2=0.95（P均〈0.001）。严重黄疸会使苦味酸法eGFR偏高,严重溶血、脂血会使酶法eGFR偏高,药物对eGFR的影响可忽略不计。eGFR的临界区域为45-53 mL/（min.1.73 m^2）,敏感区域为5-60 mL/（min.1.73 m^2）。结论不同eGFR公式的参考区间不同。肌酐eGFR的一致性优于Cys C。肌酐对eGFR的影响远高于年龄。eGFR的敏感区为5-60 mL/（min.1.73 m^2）,介于肌酐浓度90-1 000μmol/L之间。内源性干扰会引起eGFR假性增高,需重新认识eGFR临界区[45-53 mL/（min.1.73 m^2）]对临床的价值。
Objective To investigate the reference interval of different estimated glomerular filtration rate（eGFR） models and their clinical characteristics.Methods The concentrations of serum creatinine（Jaffe kinetic creatinine assay and enzymic method） and cystatin C（Cys C） were determined and the reference intervals were analyzed statistically in healthy subjects（eGFR algorithms：2 in American,3 in Chinese,3 in Japanese and 4 in Cys C）.The 95% confidence interval（CI） was analyzed statistically.The creatinine and Cys C levels in samples of 83 patients with renal disorder（43 males and 40 females） were determined.The harmonization of different eGFR results was observed according to the analysis of regression and correlation.The validation range of eGFR was deduced from the influence level of eGFR models by changing elements（concentration,age or interference）.Results 95% CI in males and females were 73-120 and 55-97 μmol/L for Jaffe kinetic creatinine assay;34-106 and 18-75 μmol/L for enzymic method;0.38-0.98 mg/L for Cys C.99% CI in Jaffe kinetic creatinine assay and enzymic method were 41-132 and 26-120 μmol/L respectively.95% CI of eGFR were 53-123,49-110,48-227,52-110,38-85,36-85,44-96,36-169,50-190,75-227,59-213 and 57-81 mL/（min·1.73 m^2） for National recommendation,American,American IDMS,Ruijin Hospital,Zhongshan Hospital,Japanese recommendation,Japanese Jaffe,Japanese enzyme,Cys C66.8,Cys C91.6,Cys C77.24and Cys CZhongshan Hospital,respectively.There was no significant difference among National,American and Japanese group for males（P〈0.05）.The others had significant difference（P0.05）.The regression equations were YAmerican=2.65＋0.9XNational,R 2=1;YAmerican IDMS=-0.81＋1.5XNational,R 2=0.98;YRuijin Hospital=8.33＋0.8XNational,R ^2=0.99;YZhongshan Hospital=2.04＋0.7XNational,R ^2=1;YJapanese recommendation=2.63＋0.66XNational,R ^2=0.99;YJapanese Jaffe=2.31＋0.79XNational,R ^2=1;YJapanese enzyme=-0.656＋1.11XNational,R ^2=0.98;YCys C 66.8=-11.79＋1.41XNational,R^ 2=0.90;YCys C 91.6=-4.96＋1.67XNational,R^ 2=0.92;YCys C 77.24=-11.65＋1.58XNational,R^ 2=0.91;YCys C Zhongshan Hospital=32.52＋0.4XNational,R^ 2=0.95（P〈0.001）.The results of eGFR would increase in Jaffe kinetic creatinine assay with serious icterus and in enzymic method with serious hemolysis and lipemia.There was negligible influence on eGFR with drugs.The critical region of eGFR was 45-53 mL/（min·1.73 m^2） and the sensitive region was 5-60 mL/（min·1.73 m^2）.Conclusions Reference intervals vary in different eGFR algorithms.The harmonization of eGFR models in creatinine is superior to Cys C.The influence of eGFR by creatinine is much more than that by age.The eGFR sensitive region which is 5-60 mL/（min·1.73 m^2） would be equal to the creatinine concentration 90-1 000 μmol/L.The interference in vivo increases false error of eGFR.The critical region 45-53 mL/（min·1.73 m^2） must be understood for clinical value again.
出处
《检验医学》
CAS
北大核心
2010年第4期266-271,共6页
Laboratory Medicine
