血清肌酐的特异性分析及新eGFR公式的适用性研究

Specificity analysis of serum creatinine and applicability research of the new eGFR formula

目的验证血清肌酐(Cr)参考区间的适用性及不同影响因素下Cr的分布特征,探讨不同估算肾小球滤过率(eGFR)公式在慢性肾脏病中的差异及新公式的验证。方法选取2020年9月1日至2023年8月31日该院实验室信息系统中健康体检者的数据。采用偏度-峰度法判断数据正态性,Box-Cox法转换偏态数据,四分位间距法剔除离群值。Mann-Whitney U检验、Kruskal-Wallis单因素方差分析及协方差分析比较Cr在性别、年龄及季节上的差异。参照我国行业标准对现行的Cr参考区间进行适用性验证。另选取同期住院的慢性肾脏病患者数据,以目前实验室在用的CKD-EPI Cr2009公式为标准,验证法国新开发的MMB-eGFR公式。Spearman相关、Deming回归及Bland-Altman图分析两种估算公式结果的相关性、线性关系与一致性。结果纳入健康体检者数据54710例。Cr在性别、年龄、季节间差异均有统计学意义:男性Cr水平明显高于女性(P<0.001);除20~<30岁与30~<40岁外,其余年龄段间差异有统计学意义(P<0.001),随年龄增长,Cr水平升高;男、女性Cr水平在四季之间变化呈“对号”形和“倒梯”形。上述数据均用于Cr参考区间的适用性验证,各亚组通过率均大于90%。筛选慢性肾脏病患者数据后,纳入研究336例,进行CKD-EPI Cr2009和MMB-eGFR结果间的比较,两种估算公式的结果呈正相关(r=0.943,P<0.001),并且存在线性关系,具有92.86%的一致性。结论血清Cr水平在年龄、性别、季节方面的差异均有统计学意义。行业标准中提供的Cr参考区间适用于长春地区。MMB-eGFR与CKD-EPI Cr2009公式一致性较高,适用于该地区。

Objective To verify the applicability of serum creatinine(Cr)reference interval and the distribution characteristics of Cr under different influencing factors,and to explore the difference of different formulas for estimating glomerular filtration rate(eGFR)in chronic kidney disease and to validate the new formula.Methods Data from the laboratory information system of the hospital on September 1,2022 to August 31,2023 on healthy examinees were retrieved.The Skewness-Kurtosis method was used to determine the normality of data,Box-Cox method was used to convert skewed data,and interquartile range method was used to remove outliers.Mann-Whitney U test,Kruskal-Wallis one-way ANOVA,and covariance analysis were used to compare differences in Cr by gender,age,and season.The applicability of the current Cr reference range was verified based on industry standards in China.Data of chronic kidney disease patients hospitalized during the same period were selected and the CKD-EPI Cr2009 formula currently in use in the laboratory was used as the standard to validate the newly developed MMB-eGFR formula in France.Spearman correlation,Deming regression,and Bland-Altman plot were used to analyze the correlation,linear relationship,and consistency of the results of two estimation formulas.Results Data of 54710 healthy subjects who underwent the physical examination were included.There were statistically significant differences in Cr between genders,ages,and seasons.Cr level in males was significantly higher than that in females(P<0.001).There were statistically significant differences among the age groups except for the age range of 20-<30 and 30-<40(P<0.001),and Cr level increased with age.The Cr levels in males and females varied in a"checkmark"and"inverted trapezoidal"pattern between the four seasons.The above data were all used for the applicability verification of the Cr reference interval,and the pass rates of each subgroup were greater than 90%.336 patients with chronic kidney disease were screened and included in the study for comparison between CKD-EPI Cr2009 and MMB-eGFR results.There was a significant correlation between the results of two estimation formulas(r=0.943,P<0.001),and there was a linear relationship with a consistency of 92.86%.Conclusion There are statistically significant differences in serum Cr levels in terms of age,gender,and season.The Cr reference range provided in the industry standards is applicable to the local area.The MMB-eGFR and CKD-EPI Cr2009 formulas have high consistency and are suitable for the local area.