痰热清注射液对常用临床生化检验项目的干扰研究

In vitro interference of Tanreqing injection on routine clinical biochemical assays

目的探讨痰热清注射液对8种常用临床生化检验项目的干扰。方法配制10倍治疗浓度的痰热清注射液的干扰血清样本,以注射用水配制对照组样本,分别测定8种临床生化项目,确定干扰情况。对存在干扰的项目进行剂量效应试验,确定干扰药物浓度及干扰强度。分别通过配对差异试验评估痰热清注射液对肌氨酸氧化酶法和碱性苦味酸法测定肌酐(Cr)的干扰情况。结果在配对差异试验中,当血清中痰热清注射液浓度为40mL/L,基础样本三酰甘油(TG)、尿酸(UA)及Cr(肌氨酸氧化酶法)分别为5.87mmol/L、502μmol/L和142μmol/L时,测定产生负干扰,与空白对照血清的偏差分别为-27.21%、-59.80%和-46.21%。剂量效应试验结果表明,引起TG、Cr和UA检测干扰的最低痰热清注射液浓度分别为17.06、1.47、3.06mL/L。配对差异试验表明痰热清注射液对碱性苦味酸法测定Cr无干扰。结论痰热清注射液对部分临床生化检验项目存在干扰。

Objective To investigate the interference of Tanreqing injection on8clinical biochemical assays.Methods The concentrations of8analytes were determined and prepared through mixed serum.10times of the therapeutic concentration of Tanreqing injection was prepared and used as the interference sample,and the control sample was injection water.The interference of the interference sample and the control sample were accessed through testing8clinical biochemical items respectively.Furthermore,dose effect test was conducted to determine the concentration and intensity of the interference drugs.Through the paired difference test,aevaluation on the Tanreqing injection interfering with the sarcosine oxidase and alkaline picric acid methods which were used to analyze serum creatinine was held.Results The paired difference tests showed negative interference when the concentration of Tanreqing injection in serum was40mL/L and the concentrations of TG,UA and Cr(enzymatic assay)in samples were5.87mmol/L,502μmol/L and142μmol/L,respectively.The deviations from drug-free serum were-27.21%,-59.80%and-46.21%.The dose effect tests were carried out on3negative interfering assays,which showed the lowest concentrations of Tanreqing injection that could cause interference on TG,Cr and UA detection were17.06,1.47and3.06mL/L respectively.The paired difference test showed Tanreqing injection had no interference to the determination of creatinine on basic picric acid method.Conclusion The interference of Tanreqing injection exists on some clinical biochemical assays.