井沆 牛志杰 刘子砚

[摘要]目的 探討酚磺乙胺对酶法检测血清肌酐（CREA）的影响。方法 收集2019年10月于贵州省人民医院就诊患者的新鲜血清，配置成高、低浓度CREA混合血清各一份，参照美国临床和实验室标准化协会（CLSI）制定的EP7-A2文件，对酶法检测血清CREA进行干扰筛选实验和剂量效应实验，通过酚磺乙胺对不同浓度CREA检测的干扰效应来探索酚磺乙胺对酶法检测CREA的影响。结果 干扰筛选实验：实验组样本均值为166.28 μmol/L，对照组样本均值为403.44 μmol/L，实验组的干扰值（dabs）95%CI为（-237.16±1.82）μmol/L，dabs 95%CI最低下线值 >预设干扰实验的可接受标准（dmax）。剂量效应实验：酚磺乙胺对低值CREA样本的干扰效应回归曲线方程为：Y=-1.727e-6X3+0.0016X2-0.474X-5.285（F=406.080，R2=0.981，P=0.000），当酚磺乙胺浓度在1.174 mg/L以下时，dabs<干扰实验的dmax;而酚磺乙胺对高值CREA样本的回归方程为：Y=-5.105e-6X3+0.00499X2-1.632X-11.252（F=1483.642，R2=0.995，P=0.000），当酚磺乙胺浓度在9.727 mg/L以下时，dabs<干扰实验的dmax。结论 酚磺乙胺对酶法检测血清CREA存在负干扰，可能是检测原理的因素导致了结果上的差异。建议咨询患者是否服用酚磺乙胺药物，停药后重新抽血检测或者有条件时可选用其他原理的CREA测定法复核，同时本研究也为CREA的准确分析提供了一定参考。

[关键词]酚磺乙胺;酶法;血清肌酐;药物干扰

[中图分类号] R446.112          [文献标识码] A          [文章编号] 1674-4721（2020）8（c）-0009-04

[Abstract] Objective To investigate the effect of Ethamsylate on the enzymatic detection of serum creatinine （CREA）. Methods Fresh serum was collected from patients who came to Guizhou Provincial People′s Hospital in October 2019 and prepared the collected serum to be high and low concentrations of CREA mixed serum. The interference screening experiments and dose-effect experiments were conducted on enzymatic detection of serum CREA according to the EP7-A2 document developed by the Clinical and Laboratory Standards Institute （CLSI）. Then the interfering results at different concentrations were used to determine the effect of Ethamsylate on detection of CREA. Results Interference screening experiment： the average value of the experimental group sample was 166.28 μmol/L， and that of the control group was 403.44 μmol/L. The interference value （dabs） 95%CI of the experimental group was （-237.16±1.82） μmol/L， indicated the lowest offline value of the dabs 95%CI was greater than the acceptable standard （dmax） of the preset interference experiment. Dose-effect experiment： the regression curve equation of interference effect of enzymatic on low value CREA samples was Y=-1.727e-6X3+0.0016X2-0.474X-5.285 （F=406.080， R2=0.981， P=0.000）， when the concentration of ethamsylate was below 1.174 mg/L， the dabs was lower than the dmax for interference experiment. Meanwhile， the regression curve equation of Ethamsylate for high value CREA samples was Y=-5.105e-6X3+0.00499X2-1.632X-11.252 （F=1483.642， R2=0.995，P=0.000）， and the dabs was lower than the dmax when the concentration of Ethamsylate was below 9.727 mg/L. Conclusion Ethamsylate causes the negative interference on the serum CREA detection by enzymatic method which may be attribute to the factors of detection principle. It is suggest to consult the patients whether to take Ethamsylate drug， redraw blood after discontinuation of the drug， or use other principles of CREA assay to check if necessary. Meanwhile， this study also provides some references for the accurate analysis of CREA.

[Key words] Ethamsylate; Enzymatic method; Serum creatinine; Drug interference

肌酐（creatinine，CREA）作为高能量化合物磷酸肌酸的分解物，由肌肉组织及神经组织释放至血液中，血液中的CREA经肾小球滤过后大部分不被再吸收，而是直接由尿排出体外。血清中的CREA浓度会因肾功能不全、尿毒症而上升，CREA作为肾功能的监测指标在肾脏疾病的诊断及治疗过程中具有重要意义[1]。

酚磺乙胺又名止血敏，主要用于血小板功能不全引起的出血、胃肠道出血、脑出血及泌尿道出血等多种出血的预防和治疗[2]。已有文献资料报道称[3-4]，使用酚磺乙胺的患者在通过酶法检测血清CREA所得出的结果会大幅度波动，与患者的临床表现有较大差异，导致医生与患者对检验结果的准确性提出质疑，且不准确的结果还会造成对患者病情的误判，从而耽误治疗。通……