Shimizu Sayaka, Kagimura Tatsuo, Maruyama Shoichi, Narita Ichiei
Department of Research, Patient Driven Academic League (PeDAL), Kyoto, JPN.
Section of Clinical Epidemiology, Department of Community Medicine, Graduate School of Medicine, Kyoto University, Kyoto, JPN.
Cureus. 2025 Apr 28;17(4):e83159. doi: 10.7759/cureus.83159. eCollection 2025 Apr.
Introduction Timely diagnosis of iron deficiency is crucial for managing anemia in patients with non-dialysis-dependent chronic kidney disease (ND-CKD). However, iron status results are not always immediately available. We aimed to examine the performance of mean corpuscular volume (MCV) in diagnosing iron deficiency as a primary objective and of iron status in predicting the onset of iron deficiency as a secondary objective. Methods This retrospective cohort study included adult patients with ND-CKD from the BRIGHTEN (oBservational clinical Research In chronic kidney disease patients with renal anemia: renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis-stimulating agents, darbepoetiN alfa) trial (enrolled from June 2014 to September 2016) in Japan who were started on darbepoetin-alpha for renal anemia and patients who were not started on iron supplementation during weeks 0-24. Diagnostic performance analysis assessed the MCV at week 24 and changes in MCV from week 12 to 24 for diagnosing iron deficiency (ferritin < 100 ng/mL) at week 24, using receiver operating characteristic curves, area under the curve (AUC), sensitivity, and specificity. For the patients without iron deficiency at week 12, ferritin levels at week 12 were assessed by predictive performance analysis to predict new-onset iron deficiency at week 24. Results A total of 796 participants were included in the diagnostic performance analysis (mean age, 70.0 years; mean estimated glomerular filtration rate, 19.2 mL/min/1.73 m²), and 338 were included in the predictive performance analysis. Diagnostic performance analysis revealed an AUC for MCV of 0.55 (95% confidence interval (CI), 0.51-0.59); for MCV changes, it was 0.52 (95% CI, 0.48-0.57). Prognostic performance analysis revealed that ferritin at week 12 demonstrated an AUC of 0.77 (95% CI, 0.67-0.86), with a sensitivity of 83% and a specificity of 66% at a cutoff of 131.5 ng/mL. Conclusion Neither MCV nor the changes in MCV could reliably diagnose iron deficiency in patients with ND-CKD. Ferritin level < 130 ng/mL could predict new-onset iron deficiency within 12 weeks.
引言 及时诊断缺铁对于管理非透析依赖性慢性肾脏病(ND-CKD)患者的贫血至关重要。然而,铁状态结果并非总能立即获得。我们旨在将平均红细胞体积(MCV)诊断缺铁的性能作为主要目标进行研究,并将铁状态预测缺铁发生的性能作为次要目标进行研究。
方法 这项回顾性队列研究纳入了来自日本BRIGHTEN(慢性肾脏病肾性贫血的观察性临床研究:对促红细胞生成素刺激剂低反应性贫血患者的肾脏预后,达贝泊汀α)试验(2014年6月至2016年9月入组)中开始使用达贝泊汀α治疗肾性贫血的成年ND-CKD患者,以及在0至24周未开始补充铁剂的患者。诊断性能分析使用受试者工作特征曲线、曲线下面积(AUC)、敏感性和特异性,评估第24周时的MCV以及第12周与第24周之间MCV的变化,以诊断第24周时的缺铁(铁蛋白<100 ng/mL)。对于第12周时无缺铁的患者,通过预测性能分析评估第12周时的铁蛋白水平,以预测第24周时新发缺铁情况。
结果 诊断性能分析共纳入796名参与者(平均年龄70.0岁;平均估计肾小球滤过率19.2 mL/min/1.73 m²),预测性能分析纳入338名参与者。诊断性能分析显示,MCV的AUC为0.55(95%置信区间(CI),0.51-0.59);MCV变化的AUC为0.52(95%CI,0.48-0.57)。预后性能分析显示,第12周时的铁蛋白AUC为0.77(95%CI,0.67-0.86),在临界值为131.5 ng/mL时,敏感性为83%,特异性为66%。
结论 MCV及其变化均不能可靠地诊断ND-CKD患者的缺铁情况。铁蛋白水平<130 ng/mL可预测12周内新发缺铁情况。