摘要
目的建立人半胱氨酸蛋白酶抑制剂C(Cystatin C)和血肌酐(Scr)的参考值,比较两者与^99mTc-DTPA清除率测定的肾小球滤过率(GFR)的相关性及其在诊断慢性肾脏病(CKD)患者肾小球滤过功能下降中的敏感度和特异性。方法研究对象包括1201名健康人和265例CKD患者。血清Cystatin C采用颗粒增强散射免疫比浊法测定,Scr采用苦味酸动力学法测定,以^99mTc-DTPA清除率测得的GFR作为评价的金标准,用受试者工作特征(ROC)曲线评价两指标检测肾小球滤过功能下降的敏感度和特异度。结果健康人群血清Cystatin C、Scr各年龄组之间差异无统计学意义(P〉0.05)。以99%双侧范围为标准,Cystatin C的参考值范围:男性为0.60~1.02mg/L,女性为0.47~0.97mg/L;Scr的参考值范围男性为63~110μmol/L,女性为53~93μmol/L。265例慢性肾脏病患者相关分析结果显示Cystatin C与金标准的相关系数(r=-0.660,P〈0.001)大于Scr的相关系数(r=-0.534,P〈0.001)。不同CKD分期结果显示在GFR正常(≥80ml/min)时,Cystatin C已经有42.2%的异常,Scr的异常率仅为13.3%,轻、中度下降期Cystatin C诊断GFR下降的敏感度均优于Scr。ROC曲线分析显示Cystatin C、Scr的曲线下面积(AUC)分别为0.907、0.862,两者差异具有统计学意义(P〈0.05)。结论Cystatin C可准确反映肾脏滤过功能的改变,与Scr相比其对肾小球滤过功能受损的诊断具有理想的敏感度和特异度,推荐作为反映GFR的新的内源性检测指标。
Objective To establish the reference values of serum Cystatin C and creatinine (Scr) in healthy Chinese volunteer. Comparison of correlation and ROC curve between Cystatin C、Scr and plasma ^99mTc-DTPA clearance as standard method were studied to investigate the value of serum Cystatin C,Scr in the evaluation of glomerular filtration function(GFR) in chronic kidney disease(CKD) patients. Methods The concentration of serum Cystatin C was determined by particle-enhanced immunonephrology method. Scr was determined by alkaline kinetic method. The study was performed on 1 201 cases of healthy person and 265 cases of CKD patients, and GFR was estimated by the plasma clearance of ^99mTc-DTPA. The sensitivity and specificity for the diagnosis of renal impairment were calculated by the receiver operating characteristic curves (ROC). Results There was no statistically different between age groups for Cystatin C and Scr. The 99% double-sided was chosen to define reference range of healthy people for Cystatin C were 0. 60-1.02 mg/ L for men and 0. 47-0. 97 mg/L for women; Scr were 63-110 μmol/L for men and 53-93 μmol/L for women. Correlation coefficients with ^99mTc-DTPA were - 0. 660 for serum Cystatin C, - 0. 534 for serum creatinine (P all 〈 0. 001 ). Areas under the ROC curve (AUC) were 0. 907 for Cystatin C, 0. 862 for creatlnine. The area under the ROC was statistically different between serum Cystatin C and creatinine ( P 〈 0. 05 ). Conclusion Cystatin C can truly reflect the glomerular filtration function and is a more sensitive and specific maker for GFR.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2006年第11期970-974,共5页
Chinese Journal of Laboratory Medicine
关键词
半胱氨酸蛋白酶抑制剂
参考值
肾小球滤过率
Cysteine proteinase inhibitors
Reference values
Glomerular filtration rate