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目的:探讨基于半胱氨酸蛋白酶抑制素C(Cys C)建立的肾小球滤过率(GFR)估算公式在我国2型糖尿病患者肾功能评估中的适用性。方法:采用颗粒增强散射免疫比浊法(PENIA)和颗粒增强透射免疫比浊法(PETIA),对Cys C检测进行方法学比较。收集158例2型糖尿病患者的相关资料,行核素99m锝-二乙三胺五乙酸(99mTc-DTPA)肾动态显像检测肾小球滤过率(iGFR)作为GFR的参考标准。PETIA和PENIA检测血清Cys C浓度,并应用Grubb公式、Stevens公式、Rule公式及Macisaac公式估算GFR,结果与iGFR进行一致性、偏差程度和15%、30%、50%符合率的比较。结果:PENIA与PETIA这2种方法间的检测结果呈显著相关(r=0.986),且医学决定水平浓度处的系统误差在临床可接受范围。158例2型糖尿病患者的iGFR为(96.42±28.93)mL·min-1·(1.73m2)-1,血清Cys C质量浓度中位数为0.85 mg/L(0.46～4.32 mg/L)。各公式的肾小球滤过率估算值(eGFR)与iGFR均存在相关,将eGFR与iGFR分别进行Bland-Altman分析,Rule公式及Macisaac公式较Grubb公式和Stevens公式与iGFR的偏离度较小(P>0.05),存在良好的一致性。4个公式eGFR与iGFR15%、30%和50%符合率不尽相同,Macisaac公式在iGFR≥90 mL·min-1·(1.73m2)-1时15%符合率超过65%。结论:4个基于Cys C建立的GFR估算公式估算2型糖尿病患者肾功能水平时存在差异;临床应考虑估算公式建立初的研究人群,综合种族、年龄、病种等多方面因素选择合适的估算公式,才能更好地评估患者的肾功能水平。
Objective: To investigate the applicability of the estimating formula of glomerular filtration rate (GFR) based on caspase C (Cys C) in the assessment of renal function in type 2 diabetic patients in China. Methods: The Cys C test was compared with the method of particle-enhanced immunosorbent assay (PENIA) and particle-enhanced transmission immunoassay (PETIA). We collected 158 cases of type 2 diabetes in patients with relevant information, line 99m technetium - diethylenetriamine pentaacetic acid (99mTc-DTPA) renal dynamic imaging detection of glomerular filtration rate (iGFR) as a reference standard for GFR. PETIA and PENIA serum Cys C concentrations, and the application of Grubb formula, Stevens formula, Rule formula and Macisaac formula GFR, with iGFR consistency, deviation and 15%, 30%, 50% coincidence rate comparison. RESULTS: The results of PENIA and PETIA were significantly correlated (r = 0.986), and the systematic error at the level of medical decision was within the clinically acceptable range. The iGFR of 158 type 2 diabetic patients was (96.42 ± 28.93) mL · min-1 · (1.73m2) -1, and the median serum Cys C concentration was 0.85 mg / L (0.46 to 4.32 mg / L). The estimated glomerular filtration rate (eGFR) of each formula correlates with iGFR, and the Bland-Altman analysis of eGFR and iGFR respectively, the deviation of Rule formula and Macisaac formula from that of Grubb formula and Stevens formula is smaller than that of iGFR P> 0.05), there is good consistency. The four formulas eGFR and iGFR 15%, 30% and 50% compliance rates vary, Macisaac formula iGFR ≥ 90 mL · min-1 · (1.73m2) -1 15% coincidence rate of more than 65%. CONCLUSIONS: Four GFR estimation formulas based on Cys C are used to estimate the difference of renal function in patients with type 2 diabetes. The clinical population should be considered in formulating the initial study population, and appropriate estimates should be made based on various factors such as race, age, disease type, etc. Formula, in order to better assess the patient’s renal function level.