7种eGFR公式早期诊断CKD的性能评价

doi:10.3969/j.issn.1673-8640.2015.07.005

摘要/Abstract

摘要： 目的

评价慢性肾脏疾病流行病学协作组(CKD-EPI)公式、中国eGFR协作组公式和FQ-eGFR公式计算的估算肾小球滤过率(eGFR)在慢性肾病(CKD)中的早期诊断性能。

方法

测定283例住院成人CKD患者和9 307例门诊成人就诊者血清中半胱氨酸蛋白酶抑制剂C(Cys C)和肌酐(Cr)水平,计算3个CKD-EPI公式(Cr-、Cys C-和Cys C-C联合公式)、2个eGFR协作组公式(Cys C-和Cys C-C联合公式)和2个FQ-eGFR公式(Cys C-和Cys C-C联合公式)的eGFR,依次得到eGFR1~eGFR7。住院患者同时测定血浆^99m锝-二乙烯三胺五乙酸(^99mTc-DTPA)清除率[作为测量GFR(mGFR)],用于其eGFR差异性、一致性以及分析性能评价的金标准。然后回顾性分析了9 307例门诊成人就诊者中各eGFR预测CKD的相对发生率(IRR)。

结果

eGFR2、eGFR3与mGFR比较差异均有统计学意义(P均=0.000)。eGFR4、eGFR6和eGFR7与mGFR的一致性相关系数(ρ_c)值均明显高于eGFR1(P均<0.01)。对于mGFR<60 mL/(min·1.73 m²)患者,eGFR4、eGFR6和eGFR7的偏差、精密度和准确性无差异(P均>0.05),但与eGFR1比较差异均有统计学意义(P均<0.05)。相比之下,eGFR4的偏差更小[中位数(M)=0.3 mL/(min·1.73 m²)],eGFR6的精密度更高[标准四分位距(IQR)=7.7 mL/(min·1.73 m²)],eGFR7的准确性更好(1-P₃₀=13.8%)。应用eGFR4、eGFR6和eGFR7预测CKD的发生率高于eGFR1(P均<0.01),且年长者(>65岁)与65岁以下者相比其预测CKD发生率更高(P均=0.000)。

结论

对于GFR<60 mL/(min·1.73 m²)的中国成人CKD患者,CKD-EPI公式并不能提供更为准确的肾功能评估。相对而言,中国eGFR协作组Cys C公式、FQ-eGFR Cys C公式或FQ-eGFR Cys C-C联合公式更适用于中国成人CKD的疾病筛查和早期诊断,其中FQ-eGFR Cys C公式用于疾病筛查可尽可能地避免漏诊或误诊。

关键词: 估算肾小球滤过率, 肾小球滤过率, 早期诊断, 慢性肾病

Abstract: Objective

To evaluate the performance of chronic kidney disease epidemiology collaboration (CKD-EPI) equations, Chinese estimated glomerular filtration rate (eGFR) investigation collaboration equations and FQ-eGFR equations in the early diagnosis of chronic kidney disease (CKD).

Methods

Serum cystatin C(Cys C) and creatinine(Cr) concentrations were detected in 283 inpatients with CKD and 9 307 outpatients, and the eGFR of 3 CKD-EPI equations (Cr-, Cys C- and Cys C-C equations), 2 Chinese eGFR investigation collaboration equations (Cys C- and Cys C-C equations) and 2 FQ-eGFR equations (Cys C- and Cys C-C equations) were calculated as the order of eGFR1-eGFR7. Plasma ^99mtechnetium-diethylene triamine pentacetic acid (^99mTC-DTPA) clearance rate as measured glomerular filtration rate (mGFR) was detected in 283 inpatients with CKD, and was used as a gold standard for evaluating difference, consistency and performance of eGFR. The incidence rate ratio (IRR) of each eGFR predicting CKD was analyzed retrospectively in 9 307 outpatients.

Results

There were significant differences between eGFR2 and eGFR3 with mGFR (P=0.000). The concordance correlation coefficients (ρ_c)of eGFR4, eGFR6 and eGFR7 with mGFR were all significantly higher than that of eGFR1 (P<0.01). For the patients with mGFR<60mL/(min·1.73 m²), the deviation, precision and accuracy of eGFR4, eGFR6 and eGFR7 had quite correspondence(P>0.05), and had significant differences with those of eGFR1(P<0.05). In contrast, the deviation of eGFR4 was smaller [median (M)=0.3 mL/(min·1.73 m²)], the precision of eGFR6 was higher [standard interquartile range (IQR)=7.7 mL/(min·1.73 m²)], and the accuracy of eGFR7 was better (1-P₃₀=13.8%). The incidence rates of predicting CKD by eGFR4, eGFR6 and eGFR7 were higher than that by eGFR1 (P<0.01), and were greatly higher in elderly (>65 years old) compared with in under 65 years old (P=0.000).

Conclusions

CKD-EPI equations could not provide an accurate assessment of kidney function for Chinese adult patients with CKD, whose GFR<60 mL/(min·1.73 m²). In contrast, it would be more appropriate for the screening of diseases and early diagnosing used Cys C- equation, FQ-eGFR Cys C- equation or FQ-eGFR Cys C-C equation of Chinese eGFR investigation collaboration equations, in which it is as far as possible to prevent leak-diagnosis or misdiagnosis when FQ-eGFR Cys C- equation is used for the screening of diseases.

Key words: Estimated glomerular filtration rate, Glomerular filtration rate, Early diagnosis, Chronic kidney disease

中图分类号:

R446.1

陈贵英, 杨涛, 应军, 何晓华. 7种eGFR公式早期诊断CKD的性能评价[J]. 检验医学, 2015, 30(7): 684-690.

CHEN Guiying, YANG Tao, YING Jun, HE Xiaohua. Performance evaluation of seven eGFR equations for the early diagnosis of CKD[J]. Laboratory Medicine, 2015, 30(7): 684-690.

图/表 8

参考文献 16

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公式	公式来源	方程式	相关参数说明
eGFR1	CKD-EPI 2009 Cr公式^[5]	eGFR1=141×Min(Cr/k,1)^a×Max(Cr/k,1)-1.209×0.993^年龄(女性×1.108)	k=0.9(男性)/0.7(女性) a=-0.411(男性)/-0.329(女性)
eGFR2	CKD-EPI 2012 Cys C公式^[5]	eGFR2=133×Min(Cys C/0.8,1)^-0.499×Max(Cys C/0.8,1)^-1.328×0.996^年龄(女性×0.932)
eGFR3	CKD-EPI 2012 Cys C-Cr联合公式^[5]	eGFR3=135×Min(Cys C/0.8,1)^-0.375×Max(Cys C/0.8,1)^-711×Min(Cr/k,1)^a×Max(Cr/k,1)^-0.601×0.995^年龄(女性×0.969)	k=0.9(男性)/0.7(女性) a=-0.207(男性)/-0.248(女性)
eGFR4	中国eGFR协作组 Cys C公式^[6]	eGFR4=86×Cys C^-1.132
eGFR5	中国eGFR协作组 Cys C-Cr联合公式^[6]	eGFR5=169×Cr^-0.608×Cys C^-0.630×年龄^-0.157(女性×0.83)
eGFR6	FQ-eGFR Cys C公式^[7]	eGFR6=78.64×Cys C^-0.964
eGFR7	FQ-eGFR Cys C-Cr联合公式^[7]	eGFR5=173.9×Cr^-0.184×Cys C^-0.725×年龄^-0.193(女性×0.89)

公式	公式来源	方程式	相关参数说明
eGFR1	CKD-EPI 2009 Cr公式^[5]	eGFR1=141×Min(Cr/k,1)^a×Max(Cr/k,1)-1.209×0.993^年龄(女性×1.108)	k=0.9(男性)/0.7(女性) a=-0.411(男性)/-0.329(女性)
eGFR2	CKD-EPI 2012 Cys C公式^[5]	eGFR2=133×Min(Cys C/0.8,1)^-0.499×Max(Cys C/0.8,1)^-1.328×0.996^年龄(女性×0.932)
eGFR3	CKD-EPI 2012 Cys C-Cr联合公式^[5]	eGFR3=135×Min(Cys C/0.8,1)^-0.375×Max(Cys C/0.8,1)^-711×Min(Cr/k,1)^a×Max(Cr/k,1)^-0.601×0.995^年龄(女性×0.969)	k=0.9(男性)/0.7(女性) a=-0.207(男性)/-0.248(女性)
eGFR4	中国eGFR协作组 Cys C公式^[6]	eGFR4=86×Cys C^-1.132
eGFR5	中国eGFR协作组 Cys C-Cr联合公式^[6]	eGFR5=169×Cr^-0.608×Cys C^-0.630×年龄^-0.157(女性×0.83)
eGFR6	FQ-eGFR Cys C公式^[7]	eGFR6=78.64×Cys C^-0.964
eGFR7	FQ-eGFR Cys C-Cr联合公式^[7]	eGFR5=173.9×Cr^-0.184×Cys C^-0.725×年龄^-0.193(女性×0.89)

项目	例数	测定结果[M(范围), mL/(min·1.73 m²)]	偏差[M(95%CI), mL/(min·1.73 m²)]	一致性 [ρ_c(95%CI)]	准确性 (r值)	精密度 (Cb值)
mGFR	283	46.9(6.0~127.2)	-	-	-	-
eGFR1	283	40.9(2.4~139.1)	4.7(2.7~6.6)	0.726 3(0.671 6~0 .773 1)	0.755 6	0.961 3
eGFR2	283	34.9(5.7~121.2)^*	7.8(5.9~9.9)	0.812 9(0.771 1~0.847 7)	0.844 9	0.962 3
eGFR3	283	36.6(3.9~127.3)^*	5.2(2.4~7.1)	0.809 3(0.766 9~0.844 7)	0.832 4	0.972 2
eGFR4	283	43.7(8.1~135.3)	0.9(-1.3~2.1)	0.832 9(0.796 3~0.865 3)	0.834 0	0.998 7
eGFR5	283	41.3(4.9~155.9)	2.7(1.2~4.7)	0.791 0(0.747 7~0.827 6)	0.818 2	0.966 7
eGFR6	283	44.2(10.5~115.7)	2.1(0.3~3.7)	0.822 3(0.782 4~0.856 1)	0.832 6	0.988 1
eGFR7	283	45.7(11.8~120.9)	0.6(-1.4~2.0)	0.838 0(0.800 2~0.869 2)	0.841 3	0.996 2

项目	例数	测定结果[M(范围), mL/(min·1.73 m²)]	偏差[M(95%CI), mL/(min·1.73 m²)]	一致性 [ρ_c(95%CI)]	准确性 (r值)	精密度 (Cb值)
mGFR	283	46.9(6.0~127.2)	-	-	-	-
eGFR1	283	40.9(2.4~139.1)	4.7(2.7~6.6)	0.726 3(0.671 6~0 .773 1)	0.755 6	0.961 3
eGFR2	283	34.9(5.7~121.2)^*	7.8(5.9~9.9)	0.812 9(0.771 1~0.847 7)	0.844 9	0.962 3
eGFR3	283	36.6(3.9~127.3)^*	5.2(2.4~7.1)	0.809 3(0.766 9~0.844 7)	0.832 4	0.972 2
eGFR4	283	43.7(8.1~135.3)	0.9(-1.3~2.1)	0.832 9(0.796 3~0.865 3)	0.834 0	0.998 7
eGFR5	283	41.3(4.9~155.9)	2.7(1.2~4.7)	0.791 0(0.747 7~0.827 6)	0.818 2	0.966 7
eGFR6	283	44.2(10.5~115.7)	2.1(0.3~3.7)	0.822 3(0.782 4~0.856 1)	0.832 6	0.988 1
eGFR7	283	45.7(11.8~120.9)	0.6(-1.4~2.0)	0.838 0(0.800 2~0.869 2)	0.841 3	0.996 2

组别	mGFR	例数	eGFR1	eGFR2	eGFR3	eGFR4
A组	<60	189	5.5(3.2 ~ 7.7)^*	7.3(4.6 ~ 9,7)^*	5.8(3.8 ~ 8.0)^*	-0.2(-2.6 ~ 1.7)^#
B组	60~<90	65	2.6(-9.3 ~ 6.7)	8.6(5.1 ~ 13.0)^*,#	2.2(-2.4 ~ 6.6)	0.3(-3.9 ~ 3.3)
C组	≥90	29	1.3(-17.3 ~ 14.2)	13.5(4.7 ~ 23.0)^#	0.4(-6.4 ~ 15.2)	6.3(-0.5 ~ 15.7)
组别	mGFR	例数	eGFR5	eGFR6	eGFR7
A组	<60	189	4.7(1.9 ~ 6.6)^*	-1.0(-2.9 ~ 0.4)^#	-1.7(-4.3 ~ 0.0)^#
B组	60~<90	65	-1.7(-6.1 ~ 3.4)	5.2(1.4 ~ 9.5)	3.3(0.1 ~ 6.4)
C组	≥90	29	-6.0(-20.4 ~ 6.0)	17.3(11.6 ~ 26.1)^*,#	15.3(6.0 ~ 21.6)^*