羟苯磺酸钙对尿肌酐测定的干扰分析
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中央高水平医院临床科研项目(2022-PUMCH-B-073)


Interference of calcium dobesilate in urinary creatinine assay
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    摘要:目的 评估羟苯磺酸钙对肌氨酸氧化酶法尿肌酐测定的干扰程度与特征。方法 收集服用羟苯磺酸钙患者的尿液样本,采用液相色谱-串联质谱法(LC-MS/MS)测定羟苯磺酸钙浓度。依据CLSI EP07-A3文件,留取尿肌酐浓度分别为6.0、9.0、13.0、18.0、22.0 mmol/L的样本,采用配对差异试验验证羟苯磺酸钙对尿肌酐测定干扰的存在;以系列浓度羟苯磺酸钙(0、250、500、1 125、2 250、3 375、4 500 mg/L)作为干扰物,进行剂量-效应试验评估其对尿肌酐检测的干扰效应。结果 共收集服用羟苯磺酸钙患者24 h尿样本22例、随机尿样本50例。24 h尿羟苯磺酸钙浓度为76~738 mg/L,中位浓度(四分位距)为243(161~328)mg/L;随机尿羟苯磺酸钙浓度为60~2 236 mg/L,中位浓度(四分位距)为370(195~667)mg/L。配对差异试验显示,4 500 mg/L羟苯磺酸钙可使5个浓度水平的尿肌酐测定值降低45.6%~59.4%,均超过最大允许误差(10.0%)。剂量-效应试验显示,随着尿样中羟苯磺酸钙浓度的升高,对尿肌酐检测的负干扰效应逐渐增大。结论 羟苯磺酸钙可导致肌氨酸氧化酶法尿肌酐测定结果显著偏低,干扰程度呈浓度依赖性。临床试验室应充分认识此干扰效应,对服药患者建议使用具有抗羟苯磺酸钙干扰能力的检测试剂,或停药至少48 h后再留取尿样检测。

    Abstract:

    Abstract: Objective To evaluate the degree and characteristics of interference by calcium dobesilate in urinary creatinine measure-ment. MethodsUrine samples were colected from the patients receiving calcium dobesilate. The concentration of calcium dobesilate in urine samples was determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS). In accordance with the CLSI EP07-A3 guideline,specimens with urinary creatinine concentrations 6.0,9.0,13.0, 18.0,and 22.0 mmol/L were selected. A paired-difference experiment was conducted to confirm the interference from calcium dobesilate in urinary creatinine determination. Subse-quently,a dose-response experiment was performed using a series of calcium dobesilate concentrations(O,250,50o,1 125,2 250,3 375, and 4 500 mg/L) as interfering agents to evaluate the interference efect on creatinine measurement. Results Twenty-two 24-hour urine samples and 50 spot urine samples were collected from the patients taking calcium dobesilate. The calcium dobesilate concentrations ranged from 76 to 738 mg/L(median: 243,interquartile range[161 to 328]mg/L) in 24-hour urine samples and 60 to 2 236 mg/L (median; 370,interquartile range[195 to 667]mg/L) in spot urine samples. The paired difference testing showed that 4 500mg/L calcium dobesilate caused a 45.6% to 59.4% reduction in urinary creatinine measurements across the five concentration levels,all of which exceeded the maximum allwable error (10.0%). The doe-response experiment showed that negative interference effect on urine creatinine detection increased progressively with increasing calcium dobesilate concentration in urine samples. Conclu-sionCalcium dobesilate was found to cause a significant decrease in sarcosine oxidase-based urinary creatinine determination results,with thedegree of interferenceexhibiting concentration-dependence.Clinical laboratoriesshould fullyrecognizethisinterferenceeffect.For the patients taking this medication,it is recommended to use the reagent kits that are resistant to interference from calcium dobesil-ate or to collect urine samples after a washout period of at least 48 hours following the drug cessation.

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郑铭奇,马晓丽,禹松林,王丹晨,张琪,国秀芝,许敬蓉,张葵,夏良裕.羟苯磺酸钙对尿肌酐测定的干扰分析[J].临床检验杂志,2026,44(05):321-324

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  • 收稿日期:2025-06-12
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  • 在线发布日期: 2026-07-06
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