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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 on the detection of free fatty acids (FFA) by six kinds of acyl-CoA synthase (ACS) -superoxidase coupling (ACS enzymatic method) and its clinical effect. Methods Different concentrations of calcium dobesilate solution were prepared with deionized water and added to two basic serums with different concentrations of FFA (550 and 1 200 μmol / L). The final drug concentrations were 0, 2, 4, 8, 16 and 32 , 64 μg / m L. The concentration of serum FFA with drug solution was determined by six kinds of ACS enzyme kit (numbered randomly A, B, C, D, E, F) to calculate the percentage deviation from the drug concentration of 0μg / m L, ± 5% as the interference acceptable range. The changes of serum calcium dobesilate concentration and time in serum before and after volunteers’ medication were monitored by high performance liquid chromatography (HPLC) [before and 0 (ie, the drug concentration reaches the trough concentration after steady state), 1, 2, , 4, 6 h], and serum concentrations of 40 patients clinically treated with calcium dobesilate were determined. Results The steady-state trough concentration of calcium dobesilate (0 h) [median (interquartile range)] was 6.64 (5.64-7.86) μg / m L; after taking 500 mg of drug, h peak, the peak concentration of 15.00 (13.63 ~ 19.67) μg / m L, and then gradually decreased. The average concentration of calcium dobesilate in 40 patients was 11.92 (5.45-19.22) μg / m L. In in vitro experiments, as the concentration of calcium dobesilate in serum increased, the interference degree of FFA test results also increased accordingly. When the concentration of calcium dobesilate in serum was 8μg / mL, the deviations of low concentration (550μmol / L) and high concentration (1200μmol / L) of 6 kinds of kits were -0.40% -65.01% and - 0.20% ~ -52.33%, in addition to B, D 2 kinds of kits, the other 4 kits interference levels were within acceptable range. When the concentration of calcium dobesilate in serum was 16 μg / mL, the deviations of low and high concentrations of FFA in the six kits were -1.68% -28.28% and -1.81% -16.48%, respectively. Except for A reagent Out of the box and the C kit (high concentration of FFA), other kits and C kit (low concentration of FFA) test results were significantly out of acceptable interference range. The degree of interference was also related to the concentration of FFA in the basal serum, and the lower the concentration of FFA at the same drug concentration, the more obvious the interference. Conclusions Calcium dobesilate can negatively affect the detection of FFA by ACS, which should be paid more attention.