“即刻法”卡马西平治疗药物监测的室内质量控制及药学实践  

“Instant Method”for Indoor Quality Control in Therapeutic Drug Monitoring of Carbamazepine and Pharmaceutical Care

作　　者：吴妍[1] 李会婷 张哲弢 史天陆 WU Yan;LI Huiting;ZHANG Zhetao;SHI Tianlu(Department of Pharmacy,the First Affiliated Hospital of USTC,Anhui Provincial Hospital,University of Science and Technology of China,Hefei 230001,China)

机构地区：[1]中国科学技术大学附属第一医院(安徽省立医院)药剂科,合肥230001

出　　处：《医药导报》2022年第4期548-553,共6页Herald of Medicine

摘　　要：目的探讨“即刻法”在卡马西平(CBZ)治疗药物监测(TDM)室内质量控制评价中的作用,并基于此开展药学服务实践。方法自制CBZ血浆质控品(标示浓度4μg·mL^(-1)),采用高效液相色谱-紫外法(HPLC-UV)分别测定2019年5月-2020年7月CBZ及随行质控品浓度,确定前3组质控品实测值后,分别计算均值(x)、标准差(SD)、离散指数(SI)上限(SI_(上限))、下限(SI_(下限))。参照SI界值表,采用“即刻法”进行室内质量控制评价。待完成20组质控品浓度测定后,回顾性应用Excel软件绘制室内质控图,验证“即刻法”室内质量控制评价效果。并对1例癫痫患者的CBZ血药浓度监测结果进行解读。结果第3~20组SI_(上限)及SI_(下限)均小于其对应SI界值表的N2s,提示血药浓度监测数据在控,且癫痫患者的CBZ血药浓度监测结果准确,这与20组质控品实测值的室内质控图验证结果一致。结论对于临床必需、监测频次较低的血药浓度监测项目,“即刻法”室内质量控制评价可有效提高监测结果的准确性。Objective To investigate the role of“instant method”in the evaluation of indoor quality control for therapeutic drug monitoring(TDM)of carbamazepine(CBZ)and to conduct pharmaceutical care analysis based on it.Methods Hospital made CBZ plasma control product with concentration of 4μg·mL^(-1) were prepared.High performance liquid chromatography-ultraviolet spectrometry(HPLC-UV)method was used to determine the concentrations of CBZ and hospital-made quality control products from May 2019 to July 2020,respectively.The mean value(x),standard deviation(SD),upper and lower limit of separation index(SI)were calculated respectively after measuring the values of the first 3 sets of hospital-made quality control products.The“instant method”was used to evaluate the indoor quality control according to SI boundary table.After 20 groups of quality control products were measured,excel software was used to draw indoor quality control chart to verify the role of“instant method”in indoor quality control.Then,the“instant method”for indoor quality control was used to interpret results of TDM on CBZ in an epileptic patient.Results The upper and lower limits of separation index from group 3 to 20 were all less than the corresponding N2s of the corresponding SI boundary table.This result suggests that the monitoring values of blood concentration were under control,and the monitoring result in epileptic patient was accurate,which was all consistent with the indoor quality control chart of the measured values of 20 groups of quality controls.Conclusion The“instant method”for indoor quality control can effectively improve the accuracy of those blood drug concentration monitoring projects which are clinically necessary and have low monitoring frequency.

关 键 词：卡马西平 即刻法 高效液相色谱-紫外法 室内质量控制 药学实践 

分 类 号：R971.4[医药卫生—药品] R749.17[医药卫生—药学]