酶法测定血清β-羟丁酸的方法学评价及其临床应用

Evaluation of Enzymatic Method for Determination of SerumBeta-hydroxybutyrate and Its Clinical Application

目的应用美国临床实验室标准化委员会(NCCLS)的标准化评价方案对酶法测定血清β-羟丁酸进行初步评价,并探讨β-羟丁酸对糖尿病酮症酸中毒诊断及治疗监测的意义。方法分析酶法测定血清β-羟丁酸的精密度、准确性、线性范围和干扰因素。测定60例正常人、50例糖尿病DM患者和34例糖尿病酮症酸中毒DKA患者血清β-羟丁酸浓度。结果酶法测定β-羟丁酸具有良好的精密度(批内、日间及总变异系数均小于5%)和准确度(回收率为98.5%～104.1%),检测线性范围为0～4.00mmol/L,基本不受溶血、黄疸和脂血干扰。DKA患者血清β-羟丁酸明显升高(P<0.01),血清β-羟丁酸测定阳性率高于尿酮体测定(P<0.05)。结论酶法测定血清β-羟丁酸快速、准确、精密度高,可用于DKA的早期特异、快速诊断及治疗监测。

To evaluate an enzymatic method for determining serum beta-hydroxybutyrate(β-HB) with the National Committee for Clinical Laboratory Standards(NCCLS)projects, and to discuss its clinical values in diabetic ketoacidosis(DKA). Methods The precision, accuracy, specificity, linearity and interference of the enzymatic method were analyzed. This method was used to determine serum β-HB in 60 cases of normals, 50 cases of diabetes, and 34 cases of DKA by autochemistry analyzer. Results Enzymatic β-HB assay was precise(within-run CV, day-to-day CV, and total CV< 5%). The linearity studies showed the method was linear up to 4 mmol/L. Recovery rate was 98.5% ～ 104.1%. Hemolysis(Hemoglobin up to 18.2 g/L), icteric samples with total bilirubin up to 224 μmol/L, and lipemia up to triglyceride concentration of 2.28 mmol/L did not interfere with the β-HB results in this method. Serum β-HB levels were significantly elevated in DKA patients compared with DM patients and controls(P < 0.01). Positive rate of serum β-HB in DKA patients was significantly higher than that of urinary ketone(P < 0.05). Conclusions Enzymatic method is convenient and reliable, allows full automation, and is rapid enough to be used for both routine and urgent determinations of serum β-HB. It can be used in diagnosing and monitoring treatment of DKA.