高效液相色谱法同时测定人血浆中拉莫三嗪和奥卡西平活性代谢物血药浓度及其临床应用分析

Simultaneous determination of lamotrigine and monohydroxy carbamazepine in human plasma by HPLC and its clinical application

目的:建立HPLC法同时测定人血浆中拉莫三嗪和奥卡西平活性代谢物血药浓度的方法,应用于临床常规检测,为患者个体化用药提供依据。方法:采用反相高效液相色谱法建立同时测定人血浆中拉莫三嗪(LTG)和奥卡西平活性代谢物(MHD)血药浓度的方法,方法学验证合格后用于治疗药物浓度监测(TDM),2013年8月-2016年3月,共完成1 611人次LTG和MHD血药浓度的监测,并对监测结果进行统计分析。结果:991人次(61.51%)在有效血药浓度范围内,13例患者进行了多次LTG血药浓度监测,达有效血药浓度的比例从61.54%上升至84.62%;23例患者进行了多次MHD血药浓度监测,达有效血药浓度的比例从34.78%上升至91.30%。结论:该方法适用于癫痫患者服用拉莫三嗪和奥卡西平后临床常规的TDM,为患者个体化用药提供依据,提高临床疗效、降低不良反应。

OBJECTIVE To establish a HPLC method for simultaneous determination of Lamotrigine lamotrigine(LTG) and monohydroxy carbamazepine(MHD) in human plasma, apply for routine testing and provide the basis for individualized medication of patients. METHODS The HPLC method of simultaneous determination of LTG and MHD in human plasma was established and validated. Totally 1611 cases of therapeutic drug monitoring from August. 2013 to May. 2016 were completed and the results were analyzed. RESULTS The results of 1611 cases showed that the plasma concentration of 991 cases(61.51%) fell in the target therapeutic concentrations. Thirteen patients continued monitoring blood concentration of LTG and the percentage of target therapeutic concentrations increased from 61.54% to 84.62%. Twenty three patients continued monitoring blood concentration of MHD and the percentage of target therapeutic concentrations increased from 34.78% to 91.30%. CONCLUSION This method is suitable for epilepsy patients taking LTG and oxcarbazepine after clinical routine monitoring of therapeutic drug monitoring. It provides the basis for individualized medication, improves clinical efficacy and reduces adverse reactions.