Harmoinen A P, Kouri T T, Wirta O R, Lehtimäki T J, Rantalaiho V, Turjanmaa V M, Pasternack A I
Department of Clinical Chemistry, Tampere University Hospital, Finland.
Clin Nephrol. 1999 Dec;52(6):363-70.
To evaluate plasma cystatin C as a marker of the glomerular filtration rate in patients with type 2 diabetes and their age and sex-matched controls.
Forty-seven patients with one decade of type 2 diabetes and 51 non-diabetic control subjects were studied. Plasma cystatin C was measured by particle-enhanced turbidimetric immunoassay in a new application for the Hitachi 704 analyzer. For comparison, plasma creatinine and creatinine clearance were measured. The plasma clearance of 51Cr-EDTA by the single injection method was utilized as reference.
In patients with type 2 diabetes the correlation coefficient between plasma cystatin C and the plasma clearance of 51Cr-EDTA was 0.774 (Spearman's coefficient) and that between plasma creatinine and the plasma clearance of 51Cr-EDTA was 0.556 (p = 0.001 for the difference). The correlation between creatinine clearance and the plasma clearance of 51Cr-EDTA was 0.411. In receiver operating characteristic (ROC) curve analysis the diagnostic accuracy of plasma cystatin C was significantly better than that of plasma creatinine (p = 0.047) or creatinine clearance (p = 0.001). The best diagnostic efficiency (98%) for cystatin C was obtained when the cut-off limit was set at 1.32 mg/l. In the control group the correlation coefficients were: between cystatin C and the plasma clearance of 51Cr-EDTA 0.627, between creatinine and the plasma clearance of 51Cr-EDTA 0.466 and between creatinine clearance and the plasma clearance of 51Cr-EDTA 0.416. The area under the ROC plot curve of cystatin C was also greatest in the control group, but the diagnostic accuracy of cystatin C was marginally better than that of either plasma creatinine (p = 0.05) or creatinine clearance (p = 0.08). Among the control subjects various non-renal causes may have interfered with cystatin C concentrations reducing the correlations.
Cystatin C measurement is a more sensitive and specific test for GFR in patients with type 2 diabetes than plasma creatinine or its clearance, when GFR is normal or only slightly reduced. If an elevated cystatin C concentration is found, non-renal factors have to be excluded. The turbidimetric application described here can easily be applied for most clinical chemistry analyzers and is therefore useful in daily clinical practice.
评估血浆胱抑素C作为2型糖尿病患者及其年龄和性别匹配的对照组肾小球滤过率标志物的情况。
研究了47例患有十年2型糖尿病的患者和51例非糖尿病对照者。采用颗粒增强比浊免疫分析法在日立704分析仪的新应用中测量血浆胱抑素C。为作比较,测量了血浆肌酐和肌酐清除率。采用单次注射法测定51Cr - EDTA的血浆清除率作为参考。
在2型糖尿病患者中,血浆胱抑素C与51Cr - EDTA血浆清除率之间的相关系数为0.774(Spearman系数),血浆肌酐与51Cr - EDTA血浆清除率之间的相关系数为0.556(差异p = 0.001)。肌酐清除率与51Cr - EDTA血浆清除率之间的相关性为0.411。在受试者工作特征(ROC)曲线分析中,血浆胱抑素C的诊断准确性显著优于血浆肌酐(p = 0.047)或肌酐清除率(p = 0.001)。当临界值设定为1.32mg/l时,胱抑素C的最佳诊断效率为98%。在对照组中,相关系数分别为:胱抑素C与51Cr - EDTA血浆清除率之间0.627,肌酐与51Cr - EDTA血浆清除率之间0.466,肌酐清除率与51Cr - EDTA血浆清除率之间0.416。胱抑素C的ROC曲线下面积在对照组中也最大,但胱抑素C的诊断准确性略优于血浆肌酐(p = 0.05)或肌酐清除率(p = 0.08)。在对照者中,各种非肾脏因素可能干扰了胱抑素C浓度,降低了相关性。
当肾小球滤过率正常或仅轻度降低时,对于2型糖尿病患者,测量胱抑素C对肾小球滤过率的检测比血浆肌酐或其清除率更敏感、更特异。如果发现胱抑素C浓度升高,必须排除非肾脏因素。本文所述的比浊法应用可轻松应用于大多数临床化学分析仪,因此在日常临床实践中很有用。