荧光免疫层析法对4种药物开展治疗药物监测数据分析

Data analysis of the therapeutic drug monitoring of four drugs by fluorescence immunochromatography assay

目的 :回顾性分析对4种药物(丙戊酸钠、万古霉素、甲氨蝶呤、地高辛)进行治疗药物监测(TDM)的结果,并比较荧光免疫层析法(FICA)和LC-MS/MS测定丙戊酸钠的差异。方法 :372例患者(519份)的血浆样品应用FICA测定血药浓度、59例(60份)样品同时应用FICA和LC-MS/MS测定丙戊酸钠浓度,统计分析检测结果。结果:4种药物检测的患者比例依次为6.89%、6.36%、65.39%、15.53%;首次监测TDM在安全有效浓度范围内的患者比例分别为33.9%、13.64%、32.03%、39.13%;对首次监测不在安全有效浓度范围内的患者药师干预被采纳的占比分别为33.34%、5.27%、100%、44.05%。两种方法测定丙戊酸钠的结果无明显差异。结论 :我院开展TDM还存在一些问题,医生及患者须提升对TDM的认知,临床药师须进一步加强宣教,以实现精准化治疗。

Objective:To retrospectively analyze the results of therapeutic drug monitoring(TDM)of four drugs including sodium valproate,vancomycin,methotrexate and digoxin,and meanwhile the differences of sodium valproate concentrations determined by fluorescence immunochromatography assay(FICA)and LC-MS/MS were compared.Methods:The blood drug concentrations in the plasma samples from 372 patients were determined by FICA,and sodium valproate concentrations in 60 plasma samples were determined by both FICA and LC-MS/MS,and their results were statistically analyzed.Results:The proportions of patients tested for the 4 drugs in turn were 6.89%,6.36%,65.39%,15.53%.Proportion of patients whose TDM was within the safe and effective concentration range at first determination accounted for 33.9%,13.64%,32.03%,39.13%,respectively.Percentage of pharmacist interventions adopted by physician when TDM was not within the safe and effective concentration range at initial monitoring were 33.34%,5.27%,100%,44.05%,respectively.There were no significant differences in sodium valproate concentration by FICA and LC-MS/MS.Conclusion:There are still some problems in the implement of TDM in our hospital.Doctors and patients should improve their awareness of TDM and clinical pharmacists should further strengthen publicity and education so as to achieve precise treatment.