Validation of the modification of diet in renal disease formula for estimating GFR with special emphasis on calibration of the serum creatinine assay
Validation of the modification of diet in renal disease formula for estimating GFR with special emphasis on calibration of the serum creatinine assay
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DOI：
10.1053/j.ajkd.2004.03.027
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发表时间：
2004-07-01
影响因子：
13.2
通讯作者：
Johnsen, H
中科院分区：
文献类型：
--
作者：
Hallan, S;Åsberg, A;Johnsen, H
背景：在欧洲和美国的肾小球滤过率（GFR）评估指南中，推荐使用肾脏疾病饮食修正（MDRD）配方。然而，这个公式的准确性在一些研究中受到质疑。我们的目标是评估MDRD公式的性能，特别强调血清肌酐的实验室间校准差异降低公式准确性的可能性。方法：对MDRD和其他7种常用公式进行偏倚、精密度和准确度评价。纳入的215名成人包括慢性肾脏疾病患者、潜在的肾脏供体以及在肾毒性化疗前转诊的患者。采用动态Jaffe法测定血清肌酐（日立917，日立，东京，日本；试剂来自罗氏诊断公司，曼海姆，德国）。血浆中铬51标记的EDTA （Cr-EDTA）清除率的GFR范围为3至162 mL/min/1.73 m(2)。结果：MDRD公式偏倚严重，但其准确性仍明显优于其他公式。在重新校准我们的血清肌酐值（血清肌酐[mg/dL] = -0.215 + 1.08 *血清肌酐）后，大大减少了系统偏差，获得了更好的准确性：45.6%的结果与Cr-EDTA差异小于15%，64.2%差异小于30%，81.4%差异小于50%。重新校准肌酐值的公式基于可追溯参考方法的数据和敏感性分析。结论：MDRD公式似乎是估计GFR的最佳公式，但它基于血清肌酐方法，校准后的值比大多数实验室低得多，导致轻度肾功能不全的GFR被低估。
Background: The Modification of Diet in Renal Disease (MDRD) formula is recommended by European and American guidelines for estimating glomerular filtration rate (GFR). However, the accuracy of the formula has been questioned in several studies. Our objective is to evaluate the performance of the MDRD formula with special emphasis on the possibility that interlaboratory calibration differences for serum creatinine reduce the accuracy of the formula. Methods: The MDRD and 7 other commonly used formulae were evaluated regarding bias, precision, and accuracy. The 215 adults included were patients with chronic kidney disease, potential kidney donors, and patients referred before nephrotoxic chemotherapy. Serum creatinine was measured by means of a kinetic Jaffe method (Hitachi 917, Hitachi, Tokyo, Japan; reagents from Roche Diagnostics, Mannheim, Germany). GFR, measured as plasma clearance of chromium 51-labeled EDTA (Cr-EDTA), ranged from 3 to 162 mL/min/1.73 m(2). Results: The MDRD formula was heavily biased, but it still had significantly better accuracy than the other formulae tested. After recalibrating our serum creatinine values (serum creatinine [mg/dL] = -0.215 + 1.08 * serum creatinine), systematic bias was greatly reduced and better accuracy was achieved: 45.6% of results differed less than 15% from Cr-EDTA, 64.2% differed less than 30%, and 81.4% differed less than 50%. The equation for recalibrating creatinine values was based on data with traceability to reference methods and on sensitivity analysis. Conclusion: The MDRD formula seems to be the best formula available for GFR estimating, but it is based on a serum creatinine method calibrated to give much lower values than most laboratories, leading to underestimation of GFR in mild renal insufficiency.