Clinical Study On The Relation Between Oxcarbazepine (OXC) Serum Concentration And Epilepsy Therapy Efficacy

1. To determine the relationship between concentration of the active metabolit of oxcarbazepine (OXC),10-hydroxycarbamazepine (MHD) and dose to weight ratio.2. To investigate the relationships between dose or dose to weight ratio or MHD concentration and the clinical efficacy3. To investigate the clinic efficacy influencing factors during epilepsy treating process with OXC.Methods:98cases (patients18-64years of age) of OXC therapeutic drug monitoring were analyzed, prospectively. The serum trough steady state MHD concentration of post-dose samples was measured by high-performance liquid chromatography (HPLC). The relationship between dose to weight ratio and MHD concentration was observed, analyzed and discussed. The influence of OXC dose or dose to weight ratio or MHD concentration on the clinical efficacy and gender, age, course of disease, first attack, attack type of partial seizure on the clinical efficacy were discussed, respectively.Result:Serum trough steady state MHD concentration was highly correlated with the administered OXC dose per body weight, a linear relationship between dose to weight ratio and serum concentration was found (r=0.8157, R2=0.5672, P<0.001). There is a corresponding increase in the serum concentration of0.5327%with each additional dose to weight ratio of1%. The mutual relationships between each two of dose, dose to weight ratio and MHD concentration are in good correlation, with correlation index r bigger than0.7. Clinical efficacy is closely related to the concentration of the drug. When concentration of MHD increases1%, the clinical efficacy will be increased by0.194%. The clinical efficacy of epilepsy patients treated with OXC was not correlated with gender, age, course of disease, attack type of partial seizure and was negative correlated with the intracranial lesions.Conclusions:For adults, there are good correlations between dose, dose to body weight ratio and drug concentration. Due to the inter-individual differences, individual therapeutic concentration monitoring is necessary for those patients (children, elderly, during pregnancy, in renal insufficiency, or drug interactions or noncompliance), and routine monitoring is not necessary for adult. There are good correlations between dose, dose to body weight ratio and drug concentration, drug concentration affect the most on clinical efficacy. The higher concentration of serum MHD was, the better efficacy of epilepsy therapy was (with OXC300mg/d-1200mg/d). Intracranial lesions affect the clinical efficacy well (p<0.05). Age, gender, disease duration, the first attack and attack type of partial seizure have less influence on clinical efficacy.