机构地区:[1]中国医学科学院北京协和医院检验科,北京100730 [2]中国医学科学院北京协和医院药剂科,北京100730
出 处:《检验医学》2016年第11期936-940,共5页Laboratory Medicine
基 金:首都卫生发展科研专题项目(首发2016-2-4017)
摘 要:目的探讨羟苯磺酸钙对6种酰基辅酶A合成酶(ACS)-过氧化物酶偶联法(简称ACS酶法)检测游离脂肪酸(FFA)的干扰及对临床的影响。方法用去离子水配制不同浓度羟苯磺酸钙溶液,添加到2种不同FFA浓度(550和1 200μmol/L)基础血清中,药物终浓度分别为0、2、4、8、16、32、64μg/m L。用6种ACS酶法试剂盒(以A、B、C、D、E、F随机顺序编号)测定添加了药物溶液的血清FFA浓度,计算与药物浓度为0μg/m L时的百分偏差,以±5%作为干扰可接受范围。采用高效液相色谱法(HPLC)监测志愿者服药前、后血清中羟苯磺酸钙浓度变化与时间[服药前及0(即药物浓度达稳态后的谷浓度)、1、2、3、4、6 h]的关系,并测定40例临床服用羟苯磺酸钙患者的血清药物浓度。结果羟苯磺酸钙药物稳态谷浓度(0 h)[中位数(四分位数间距)]为6.64(5.64~7.86)μg/m L;服药500 mg后,药物浓度在2~3 h达峰值,峰浓度为15.00(13.63~19.67)μg/m L,随后逐渐下降。40例服药患者血清中羟苯磺酸钙的平均浓度为11.92(5.45~19.22)μg/m L。在体外实验中,随着血清中羟苯磺酸钙浓度的增加,FFA检测结果的受干扰程度亦相应增强。当血清中羟苯磺酸钙浓度为8μg/m L时,6种试剂盒检测低浓度(550μmol/L)、高浓度(1 200μmol/L)FFA的偏差为-0.40%^-65.01%和-0.20%^-52.33%,除B、D 2种试剂盒外,其他4种试剂盒的干扰程度均在可接受范围内。当血清中的羟苯磺酸钙浓度为16μg/m L时,6种试剂盒检测低、高浓度FFA的偏差分别为-1.68%^-28.28%和-1.81%^-16.48%,除A试剂盒和C试剂盒(高浓度FFA)外,其他试剂盒及C试剂盒(低浓度FFA)的检测结果均明显超出了干扰可接受范围。干扰程度也与基础血清的FFA浓度有关,在同一药物浓度下,FFA浓度越低,干扰越明显。结论羟苯磺酸钙对ACS酶法检测FFA会产生不同程度的负干扰,应引起重视。Objective To investigate the interference of calcium dobesilate in the determination of free fatty acid(FFA) using 6 acetyl-coenzyme A synthetase (ACS)-peroxidase coupled assays and its influence. Methods Calcium dobesilate solution with different concentrations was prepared by pure water,and was added into sera with 2 different FFA concentrations(550 and 1 200μmol/L). Serum FFA levels with final concentrations of calcium dobesilate additions(0,2,4,8,16,32 and 64μg/mL) were determined using 6 ACS enzymatic assays (A,B,C,D,E and F,randomly). Bias(%) was calculated in serum FFA with final concentration of calcium dobesilate addition(0μg/mL). Taking ±5%as an acceptable range of interference,the changes in serum calcium dobesilate levels observed before and after calcium dobesilate administration [baseline,0 h(valley concentration of drug in the stable state),1 h,2 h,3 h,4 h and 6 h] in 40 participants were monitored by high performance liquidchromatography(HPLC). Serum calcium dobesilate levels in 40 participants from those taking calcium dobesilate were determined. Results The level of serum calcium dobesilate(0 h) [median(interquartile range)] was 6.64 (5.64-7.86)μg/mL. After taking 500 mg,the level of serum calcium dobesilate peaked at 2-3 h. The peak level of serum calcium dobesilate was 15.00(13.63-19.67)μg/mL,and then decreased gradually. The average level in 40 participants was 11.92(5.45-19.22)μg/mL. With the increase of serum calcium dobesilate level,the degree of interference in FFA determination also increased in in vitro experiment. For the low and high concentrations(550 and 1 200μmol/L) of serum FFA,the biases in 6 ACS enzymatic assays were-0.40%--65.01%and-0.20%--52.33%in 8μg/mL serum calcium dobesilate. The interference degrees of 4 ACS enzymatic assays can be accepted,except B and D. The biases in 6 ACS enzymatic assays were-1.68%--28.28%and-1.81%--16.48%in 16μg/mL serum calcium dobesilate. Except kit A and kit C(high concentrat
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