一个新的基于面板的估算肾小球滤过率模型，包含β-微球蛋白和β-痕迹蛋白，但不包括种族，在一个多样化的人群中建立。
A New Panel-Estimated GFR, Including β-Microglobulin and β-Trace Protein and Not Including Race, Developed in a Diverse Population.
机构信息
Division of Nephrology, Tufts Medical Center; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA.
Division of Nephrology, Tufts Medical Center; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA.
出版信息
Am J Kidney Dis. 2021 May;77(5):673-683.e1. doi: 10.1053/j.ajkd.2020.11.005. Epub 2020 Dec 7.
RATIONALE AND OBJECTIVE
Glomerular filtration rate (GFR) estimation based on creatinine and cystatin C (eGFR) is more accurate than estimated GFR (eGFR) based on creatinine or cystatin C alone (eGFR or eGFR, respectively), but the inclusion of creatinine in eGFR requires specification of a person's race. β-Microglobulin (B2M) and β-trace protein (BTP) are alternative filtration markers that appear to be less influenced by race than creatinine is.
STUDY DESIGN
Study of diagnostic test accuracy.
SETTING AND PARTICIPANTS
Development in a pooled population of 7 studies with 5,017 participants with and without chronic kidney disease. External validation in a pooled population of 7 other studies with 2,245 participants.
TESTS COMPARED
Panel eGFR using B2M and BTP in addition to cystatin C (3-marker panel) or creatinine and cystatin C (4-marker panel) with and without age and sex or race.
OUTCOMES
GFR measured as the urinary clearance of iothalamate, plasma clearance of iohexol, or plasma clearance of [Cr]EDTA.
RESULTS
Mean measured GFRs were 58.1 and 83.2 mL/min/1.73 m, and the proportions of Black participants were 38.6% and 24.0%, in the development and validation populations, respectively. In development, addition of age and sex improved the performance of all equations compared with equations without age and sex, but addition of race did not further improve the performance. In validation, the 4-marker panels were more accurate than the 3-marker panels (P < 0.001). The 3-marker panel without race was more accurate than eGFR (percentage of estimates greater than 30% different from measured GFR [1 - P] of 15.6% vs 17.4%; P = 0.01), and the 4-marker panel without race was as accurate as eGFR (1 - P of 8.6% vs 9.4%; P = 0.2). Results were generally consistent across subgroups.
LIMITATIONS
No representation of participants with severe comorbid illness and from geographic areas outside of North America and Europe.
CONCLUSIONS
The 4-marker panel eGFR is as accurate as eGFR without requiring specification of race. A more accurate race-free eGFR could be an important advance.
背景和目的
基于肌酐和胱抑素 C 的肾小球滤过率（GFR）估计（eGFR）比仅基于肌酐或胱抑素 C 的估计肾小球滤过率（eGFR 或 eGFR）更准确，但在 eGFR 中包含肌酐需要指定一个人的种族。β-微球蛋白（B2M）和β-痕迹蛋白（BTP）是替代的滤过标志物，它们似乎比肌酐受种族影响小。
研究设计
诊断试验准确性的研究。
研究地点和参与者
在 7 项研究的合并人群中进行了开发研究，该人群中有 5017 名患有和不患有慢性肾脏病的参与者。在另外 7 项研究的合并人群中进行了外部验证，该人群中有 2245 名参与者。
比较的测试
在包含胱抑素 C 的情况下，使用 B2M 和 BTP 加上肌酐和胱抑素 C（4 标志物组）或单独使用胱抑素 C（3 标志物组）的面板 eGFR，并结合年龄和性别或种族。
结果
使用碘海醇尿清除率、碘海醇血浆清除率或[Cr]EDTA 血浆清除率测量 GFR。
结果
在开发和验证人群中，平均测量的 GFR 分别为 58.1 和 83.2 mL/min/1.73 m，黑人参与者的比例分别为 38.6%和 24.0%。在开发过程中，与不包含年龄和性别的方程相比，添加年龄和性别可改善所有方程的性能，但添加种族并不能进一步改善性能。在验证中，4 标志物组比 3 标志物组更准确（估计值大于 30%的比例不同，与测量的 GFR[1-P]之间的差异为 15.6%比 17.4%；P=0.01），而无种族的 4 标志物组与 eGFR 一样准确（1-P 为 8.6%比 9.4%；P=0.2）。结果在亚组中基本一致。
局限性
没有代表患有严重合并症的参与者，也没有代表来自北美和欧洲以外地理区域的参与者。
结论
4 标志物组 eGFR 与无需指定种族的 eGFR 一样准确。一个更准确的无种族限制的 eGFR 可能是一个重要的进步。
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