Background: Estimation of glomerular filtration rate (GFR) is limited by differences in creatinine generation among ethnicities. Our previously reported GFR-estimating equations for Japanese had limitations because all participants had a GFR less than 90 mL/min/1.73 m~2 and serum creatinine was assayed in different laboratories.Study Design: Diagnostic test study using a prospective cross-sectional design. New equations were developed in 413 participants and validated in 350 participants. All samples were assayed in a central laboratory.Setting & Participants: Hospitalized Japanese patients in 80 medical centers. Patients had not participated in the previous study.Reference Test: Measured GFR (mGFR) computed from inulin clearance.Index Test: Estimated GFR (eGFR) by using the modified isotope dilution mass spectrometry (IDMS)-traceable 4-variable Modification of Diet in Renal Disease (MDRD) Study equation using the previous Japanese Society of Nephrology Chronic Kidney Disease Initiative (JSN-CKDI) coefficient of 0.741 (equation 1), the previous JSN-CKDI equation (equation 2), and new equations derived in the development data set: modified MDRD Study using a new Japanese coefficient (equation 3), and a 3-variable Japanese equation (equation 4).Measurements: Performance of equations was assessed by means of bias (eGFR - mGFR), accuracy (percentage of estimates within 15% or 30% of mGFR), root mean squared error, and correlation coefficient.Results: In the development data set, the new Japanese coefficient was 0.808 (95% confidence interval, 0.728 to 0.829) for the IDMS-MDRD Study equation (equation 3), and the 3-variable Japanese equation (equation 4) was eGFR (mL/min/1.73 m~2) = 194 x Serum creatinine~(-1.094) x Age~(-0.287) x 0.739 (if female). In the validation data set, bias was -1.3 +- 19.4 versus -5.9 +- 19.0 mL/min/1.73 m2 (P = 0.002), and accuracy within 30% of mGFR was 73% versus 72% (P = 0.6) for equation 3 versus equation 1 and-2.1 +- 19.0 versus -7.9 +- 18.7 mL/min/1.73 m~2(P< 0.001) and 75% versus 73% (P = 0.06) for equation 4 versus equation 2 (P = 0.06), respectively.Limitation: Most study participants had chronic kidney disease, and some may have had changing GFRs.Conclusion: The new Japanese coefficient for the modified IDMS-MDRD Study equation and the new Japanese equation are more accurate for the Japanese population than the previously reported equations.
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机译：背景：肾小球滤过率（GFR）的估计受到种族之间肌酐生成差异的限制。我们先前报道的日语GFR估计方程式存在局限性，因为所有参与者的GFR均小于90 mL / min / 1.73 m〜2，并且血清肌酐在不同实验室中进行了测定。研究设计：采用前瞻性横断面设计的诊断测试研究。在413名参与者中开发了新的方程式，并在350名参与者中进行了验证。所有样本均在中央实验室进行分析。参与者：80个医疗中心的日本住院患者。患者未参加先前的研究。参考测试：从菊粉清除率计算出的GFR（mGFR）指数测试：采用改良同位素稀释质谱法（IDMS）跟踪的4变量饮食法估算的GFR（eGFR）肾脏疾病（MDRD）研究方程式，使用了先前的日本肾脏病学会慢性肾脏病倡议（JSN-CKDI）系数0.741（方程式1），先前的JSN-CKDI方程式（方程式2）以及开发数据中得出的新方程式设置：使用新的日语系数（等式3）和3变量日语方程式（等式4）进行修正的MDRD研究。测量：通过偏差（eGFR-mGFR），准确性（估计值的百分比在结果：在开发数据集中，IDMS-MDRD研究方程的新日本系数为0.808（95％置信区间为0.728至0.829）（mGFR的15％或30％），结果均方根误差和相关系数。等价（3），且三变量日本方程（方程式4）为eGFR（mL / min / 1.73 m〜2）= 194 x血清肌酐〜（-1.094）x年龄〜（-0.287）x 0.739（如果是女性） 。在验证数据集中，偏差为-1.3 +-19.4与-5.9 +-19.0 mL / min / 1.73 m2（P = 0.002），mGFR在30％以内的准确度为73％对72％（P = 0.6）方程3与方程1和-2.1 +-19.0与-7.9 +-18.7 mL / min / 1.73 m〜2（P <0.001）和方程4与方程2的75％与73％（P = 0.06）（P =局限性：大多数研究参与者患有慢性肾脏疾病，有些人的GFR可能发生变化。结论：修改后的IDMS-MDRD研究方程式和新的日本方程式的新日语系数比日语人群更准确先前报告的方程式。
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