The efficacy and safety of zonisamide as adjunctive therapy in patients with partial seizure: a multicenter, randomized, double-blinded, placebo-controlled trial

摘要

Objective To evaluate the efficacy and safety of zonisamide (ZNS) as adjunctive therapy in patients with partial seizure or secondary generalized seizure, generalized tonic-clonic seizure (GTCS), absence seizure. Methods In this multicenter, randomized, double-blinded, placebo-controlled trial, 240 patients with confirmed partial seizure were randomly distributed to either ZNS group or placebo group. After a 12-week baseline period, all patients entered a 3-week titration interval, in which the ZNS dose gradually increased from 100mg qd to 100 mg tid, and a 13-week maintenance period. The main criteria of efficacy was measured by control rates and response rates during the period between the fifth week to the sixteenth week. The adverse effects were also counted for the evaluation of safety. Results Thirty-two patients (32/94, 34.04%) in ZNS group and 14 (14/107, 13.08%) in placebo group achieved complete control of seizure; 70 (70/94, 74.47%) in ZNS group and 46 (46/107, 42.99%) in placebo group had seizure frequency decreased by more than 50% , the rate differences were both statistically significant (P = 0.000, for all). The most common adverse effects included: decreased appetite, drowsiness, fatigue, dizziness, abnormal liver function, et al. The incidence of adverse effects in ZNS group was significantly lower than that in placebo group (P = 0.003). Conclusion Zonisamide for adjunctive therapy is superior to placebo in patients with partial seizure, and is generally well tolerated. It can be a new selective antiepileptic drug. DOI：10.3969/j.issn.1672-6731.2011.04.008.