Objective The aim of this study was to investigate the clinical significance of serum homocysteine (Hcy) as a biomarker for early diagnosis of diabetic nephropathy (DN) in type 2 diabetes mellitus (T2DM) patients. Methods Fifty-five T2DM patients with DN and 51 T2DM patients without DN were prospectively recruited from January 2016 to May 2020 in our hospital. The serum Hcy was tested by electrochemiluminescence assay in DN and T2DM groups and compared. The diagnostic efficacy of serum Hcy as a biomarker for early diagnosis of DN was evaluated by calculating the diagnostic sensitivity, specificity and area under the ROC curve (AUC). Results The serum levels of Hcy were 15.49 ± 5.40 and 9.23 ± 3.15 μmol/L for DN and T2DM patients, respectively, with statistical difference ( t = 7.21, P < 0.001). In the DN group, the serum Hcy levels for patients with hyperfiltration, intermittent proteinuria, microalbuminuria, macroalbuminuria and uremic were 10.99 ± 2.57, 13.90 ± 2.86, 15.38 ± 4.77, 18.98 ± 4.36 and 23.31 ± 5.22 μmol/L, respectively, which indicated that serum Hcy levels in DN were higher than those of T2DM patients and correlated with patient’s renal damage. Using the serum Hcy level as the reference, the diagnostic sensitivity, specificity and AUC were 84.31 (71.41–92.98)%, 74.55 (61.00–85.33)% and 0.85 (0.78–0.92)%, respectively, with the cutoff value of 12.08 between DN and T2DM. The serum Hcy also had relatively good differential diagnostic efficacy between different DN stages with high sensitivity, specificity and AUC. Conclusion Serum Hcy was obviously elevated in DN compared to T2MD and correlated with the renal damage severity, which can be applied as a potential serological marker for early diagnosis of DN.

中文翻译：

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血清同型半胱氨酸作为2型糖尿病患者糖尿病肾病早期诊断的生物标志物的临床意义

目的本研究旨在探讨血清高半胱氨酸（Hcy）作为早期诊断2型糖尿病（T2DM）糖尿病肾病（DN）的生物标志物的临床意义。方法回顾性分析2016年1月至2020年5月在我院收治的25例DN的T2DM患者和51例无DN的T2DM患者的临床资料。通过电化学发光法检测DN和T2DM组的血清Hcy，并进行比较。通过计算诊断敏感性，特异性和ROC曲线下面积（AUC），评估血清Hcy作为DN早期诊断的生物标志物的诊断功效。结果DN和T2DM患者血清Hcy水平分别为15.49±5.40和9.23±3.15μmol/ L，差异有统计学意义（t = 7.21，P <0.001）。在DN组中，超滤，间歇性蛋白尿，微量白蛋白尿，巨蛋白尿和尿毒症患者的血清Hcy水平分别为10.99±2.57、13.90±2.86、15.38±4.77、18.98±4.36和23.31±5.22μmol/ L，表明DN高于T2DM患者，且与患者的肾脏损害相关。以血清Hcy水平为参考，诊断敏感性，特异性和AUC分别为84.31（71.41–92.98）％，74.55（61.00–85.33）％和0.85（0.78–0.92）％，两者之间的截断值为12.08。 DN和T2DM。血清Hcy还具有较高灵敏度，特异性和AUC的不同DN阶段之间相对较好的鉴别诊断功效。结论与T2MD相比，DN中血清Hcy明显升高，与肾脏损害严重程度相关;