Singh Ranjit, Ansari Majibullah, Rao Namrata, Chandra Abhilash, Verma Shashwat, Mishra Prabhaker, Lohiya Ayush
Department of Nephrology, Dr Ram Manohar Lohia Institute of Medical Sciences, 4th floor, OPD Block Vibhuti Khand, Lucknow, Uttar Pradesh, 226010, India.
Department of Nuclear Medicine, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, India.
Int Urol Nephrol. 2024 Mar;56(3):1137-1145. doi: 10.1007/s11255-023-03758-z. Epub 2023 Aug 31.
Serum creatinine-based glomerular filtration rate (GFR) estimating equations are imprecise and systemic overestimate GFR in chronic kidney disease (CKD) populations with low muscle mass. Bioimpedance devices can measure body cell mass (BCM), a surrogate for muscle mass which has been included in a published GFR estimating equation. This BCM GFR equation is validated and compared with MDRD and CKD-EPI 2021 equations in an Indian CKD population.
Patients with stable CKD stages 1-5 and voluntary kidney donors underwent measurement of serum creatinine, DTPA GFR and bioimpedance on the same day. BCM GFR was tested for consistency, agreement and performance with respect to DTPA GFR.
A total of 125 study participants were enrolled, including 106 patients with CKD (Stage 1: 8; stage 2: 32, stage 3: 42, stage 4: 20 and stage 5: 4 patients) and 19 voluntary kidney donors, with 66% males, and a mean age of 43.3 (± 16.5) years. The median bias of BCM GFR was 5.45 ml/min/1.73 m2 [95% confidence interval (CI) 4.2-8.3], absolute precision was 10.16 ml/min/1.73 m [95% CI 4.5-12.6], P30 was 59.1% [95% CI 50.0-67.7] and accuracy was 8.62% [95% CI 6.4-20.0]. Kappa measurement of agreement was the highest for BCM GFR-based staging (0.628 vs 0.545 for MDRD and 0.487 for CKD-EPI).
BCM-based GFR estimating equation performed better than MDRD and CKD-EPI equations in this Indian CKD population, and BCM GFR-based KDIGO staging was associated with lesser misclassification than the MDRD and CKD-EPI equations.
TRIAL REGISTRATION (PROSPECTIVE): Clinical Trials Registry of India (CTRI/2019/11/021850).
基于血清肌酐的肾小球滤过率(GFR)估算方程并不精确,在肌肉量低的慢性肾脏病(CKD)人群中会系统性高估GFR。生物阻抗设备可测量身体细胞质量(BCM),这是肌肉量的一个替代指标,已被纳入一个已发表的GFR估算方程中。本研究对该基于BCM的GFR方程进行验证,并在印度CKD人群中与MDRD方程和CKD-EPI 2021方程进行比较。
1-5期稳定CKD患者及自愿肾脏捐献者于同一天进行血清肌酐、二乙三胺五乙酸(DTPA)GFR和生物阻抗测量。对基于BCM的GFR与DTPA GFR进行一致性、吻合度和性能测试。
共纳入125名研究参与者,包括106例CKD患者(1期:8例;2期:32例,3期:42例,4期:20例,5期:4例)和19名自愿肾脏捐献者,男性占66%,平均年龄43.3(±16.5)岁。基于BCM的GFR的中位数偏差为5.45 ml/min/1.73 m²[95%置信区间(CI)4.2 - 8.3],绝对精密度为10.16 ml/min/1.73 m[95% CI 4.5 - 12.6],P30为59.1%[95% CI 50.0 - 67.7],准确度为8.62%[95% CI 6.4 - 20.0]。基于BCM的GFR分期的Kappa吻合度测量值最高(BCM GFR为0.628,MDRD为0.545,CKD-EPI为0.487)。
在该印度CKD人群中,基于BCM的GFR估算方程比MDRD方程和CKD-EPI方程表现更好,且基于BCM的GFR的肾脏病改善全球预后(KDIGO)分期与MDRD方程和CKD-EPI方程相比错误分类更少。
试验注册(前瞻性):印度临床试验注册中心(CTRI/2019/11/021850)