我国肾小球滤过率测量与估算应用现状的初步调查
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北京市自然科学基金-昌平创新联合基金资助项目(L234058)


Current status of glomerular filtration rate measurement and estimation in China: A preliminary study
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    摘要:

    摘要:目的调查我国临床实验室中肾小球滤过率测量(mGFR)与估算(eGFR)的应用现状。方法通过国家卫生健康委临床检验中心网站发布调查问卷,收集486家临床实验室的相关信息。调查内容主要为4个方面:(1)mGFR检测所用方法;(2) eGFR计算所用公式;(3)eGFR公式的验证及其与mGFR结果比对情况;(4)GFR在临床中的报告方式。结果共28.4%的实验室开展mGFR检测,其中以Cr清除率法为主(88.6%)。在384家开展eGFR计算的实验室中,仅14.3%在临床应用前对公式进行了验证。基于肌酐(Cr)的eGFR公式最为常用(86.2%),以CKD-EPI公式为主(56.6%~62.2%)。在基于半胱氨酸蛋白酶抑制剂C(CysC)和Cr-CysC联合公式中,CKD-EPI公式同样最常用(分别为27.6%与42.5%)。Cr检测主要采用酶法(86.0%),使用酶法和苦味酸法的溯源到SI单位的比例分别为76.4%和71.4%。CysC检测多采用颗粒增强透射比浊法(69.9%),该方法溯源到标准物质的比例为61.1%,而颗粒增强散射比浊法的溯源比例仅为19.4%。mGFR的报告率为100%,eGFR的报告率为85.4%。结论我国临床实验室在GFR评估方面普遍存在mGFR开展率低、eGFR公式验证不足以及检测溯源性有待提升等问题。

    Abstract:

    Abstract: Objective To investigate the current status of measurement (mGFR) and estimation (eGFR) for glomerular filtration rate (GFR)in the clinical laboratories across China.Methods A nationwide questionnaire survey was distributed via the website of the National Center for Clinical Laboratories. The information was collected from 486 clinical laboratories. The survey addressed four key domains:(1) the methods used for mGFR measurement;(2)the formulas applied for eGFR calculation;(3)verification of eGFR equations and comparison with mGFR; and (4) the approaches of reporting GFR in clinical practice. Results Among all participating laboratories,28.4% perfommed mGFR testing,of which 88.6% used the creatinine clearance method. Of the 384 laboratories applying eGFR, only 14.3% validated the equations before clinical implementation. Creatinine-based equations were the most frequently used (86.2%). Among these,CKD-EPI was the predominant formula(56.6% to 62.2%). For cystatin C-based and combined creatinine-cystatin C equations,CKD-EPIwas also the most used (27.6% and 42.5%,respectively). Creatinine was predominantly measured by enzymatic assays(86.0%),with traceability to SI units achieved in 76.4% of enzymatic methods and 71.4% of Jaffe methods.Cystatin C was primarily determined by particle-enhanced turbidimetric immunoassay (69.9%),with 61.1% of the results traceable to reference materials,while only 19.4% of particle-enhanced nephelometric immunoassay results could be traceable. The reporting rates for mGFR and eGFR were 1OO% and 85.4%,respectively. Conclusion Clinical laboratories in China show limited implementation of mGFR, in-adequate validation of eGFR equations, and insuficient traceability in creatinine and particularly for cystatin C measurements.

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刘阳,夏尔巴努·尼扎木丁,周伟燕,张茜,李旭,戴宁,张天娇,张莉,张江涛,赵海建,汪静,郑浩,曾洁,张传宝.我国肾小球滤过率测量与估算应用现状的初步调查[J].临床检验杂志,2026,44(02):129-137

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  • 收稿日期:2025-11-13
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  • 在线发布日期: 2026-04-16
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