Research Of Carbamazepine Therapeutic Drug Monitoring And Its Application In Clinic

Background Carbamazepine,the most commonly prescribed anti-epileptic drugs at present,which are one of the choice drugs treatment for generalized tonic-clonic seizures and focal seizures,can control various types of epileptic seizures effectively.It’s necessary to do therapeutic drug monitoring(TDM)of carbamazepin because of its characteristics such as narrow effective serum concentration(4 ~ 12 mg·L-1),significant individual differences in body and severe adverse reactions.There were many reports about the most common method which is the Cmin determination of carbamazepin in plasma.However,the reports how to design individual treatment programs based on the TDM result of carbamazepine serum concentration,and then evaluate the effect of this method,are rare.Objective To establish a rapid and accurate determination method for the TDM of carbamazepine and evaluate its effect in the treatment of epilepsy.Methods First of all,a determination method was established for the content of carbamazepine tablet and related substances to carry out the quality control of clinical common carbamazepine tablet with high performance liquid chromatography(HPLC).And another determination method was established for the Cmin of carbamazepine in plasma,by using dichloromethane as extraction agent with twice extraction,with high performance liquid chromatography(HPLC),too.Chromatographic conditions: chromatographic column was Hypersil BDS C18(4.6 mm×250 mm,5 μm),mobile phase was methanol-0.05 mol/L KH2PO4(75:25,V/V),detection wavelength was at 238 nm,velocity of flow was 1.0 m L/min,column temperature was 30℃,sample size was 20μL.At last,this TDM method was applied in clinic.The TDM of carbamazepine was employed in the observation group,but not in the control group.By comparing the efficiency of treatment, the incidence of adverse drug reactions and the patient satisfaction between the two groups,evaluate the efficacy of the TDM of carbamazepine in epilepsy treatment.Results The HPLC method established in the research can control the quality of Carbamazepine tablets and determinate the drug concentration of Carbamazepine in plasma rapidly and accurately.The total effective rate of the observation group is 91.45%,higher than that of the control group which is 78.95%.The difference between the groups is statistically significant.The incidence rate of adverse drug reactions of the observation group is lower than that of the control group.The difference in the incidence of irregular breath is statistically significant.The patients’ satisfaction rate of the observation group is higher than the control group,which is also significant in statistics.Conclusion The TDM of carbamazepin can improve patients with epilepsy disease efficiently,reduce the incidence rate of adverse drug reactions and increase patients’ satisfaction.It is worth popularizing application in clinic.