A Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy And Safety Of Adjunctive Treatment With The Third Antiepileptic Drugs In Refractory Epilepsy Patients With Aged≥16Years

Objective: More than30percent of patients with epilepsy haveinadequate control of seizures with drug therapy, according to InternationalLeague Against Epilepsy (ILAE) about “Definition of drug resistantepilepsy”, those patients who have failure of adequate trails of two tolerated,appropriately chosen and used antiepileptic drug schedules(whether asmonotherapies or in combination) to achieve sustained seizure-free. Anoften-expressed view has recently arisen, extrapolating from the results oftherapy in patients, that epilepsy that does not respond to the first or secondantiepileptic drug will inevitably develop into refractory epilepsy. The aimof this study was to quantify the efficacy and safety of adjunctive treatmentwith the third antiepileptic drug in patients who have failure of twoantiepileptic drugs. Data and methods: this study is designed as randomized, double-blind,2-arm(1:1), parallel-group, placebo controlled clinical trail. Patients whomet the protocol were divided to two treatment group and control group. Theadjunctive drugs contained zonisamide, levetiracetam, lamotrigine,Pregabalin. The effect of therapy was devided seizure-free andnon-seizure-free.Results: A total of175patients met protocol,3patient withdrawedconsent to participate in study for personal reasons.155patients hadcompleted the trial.36(47.4%) patients in treatment group reachedseizure-free.13(16.5%) patients in placebo group reached seizure-free.Clinical factors associated with refractory epilepsy contains duration ofepilepsy, seizure type, frequency and etiological factor of epilepsy.Conclusions: This study provides that adjunctive treatment with thethird antiepileptic drugs in refractory epilepsy patients will improve seizurecontrol and quality of life. The rather nihilistic view that patient does notrespond to the first or second antiepileptic drug will inevitably develop intorefractory epilepsy is incorrect.