复方丹参注射液对部分临床生化项目体外干扰研究

Vitro Interference of Salviae Mtltiorrhizae Compound Injection in Common Clinical Biochemical Tests

目的研究复方丹参注射液对部分临床生化项目的体外干扰.方法严格按照临床实验室标准化委员会(CLSI)推荐的EP7-A2干扰实验程序,设计配对差异实验和剂量效应实验,研究复方丹参注射液对GLU,UA,CHOL,TG,CR,LDH,HBDH是否存在干扰,并明确其干扰程度和药物浓度之间的关系.结果复方丹参注射液对CREA存在负干扰,对UA,CHOL,TG,GLU,HBDH不存在干扰,CREA测定的干扰效应与复方丹参浓度的关系式为y=-1.2-17.8x.结论复方丹参对CREA测定的最小干扰浓度为3.28 mL/L.

Objective To study vitro interference of Salviae Mtltiorrhizae Compound Injection in some common clinical biochemical tests.Method In strict accordance with EP7-A2 interference experiment program recommended by clinical and laboratory standards institute（CLSI）,paired-difference testing and dose-response experiment were designed to identify if Salviae Mtltiorrhizae Compound Injection would interfere with GLU,UA,CHOL,TG,LDH and HBDH assay,and determine the relationship between the degree of interference and the serum concentration of drug.Results Salviae Mtltiorrhizae Compound Injection showed a negative interference with CREA assay,but no interference with UA,CHOL,TG,GLU and HBDH assays.The relation between the degree of interference of Salviae Mtltiorrhizae Compound Injection in CREA test and the serum concentration of it was y =-1.2-17.8x.Conclusion The minimum interferent concentration of Salviae Mtltiorrhizae Compound Injection in CREA test was 3.28 mL/L.