난치성 전신성 뇌전증에서 루피나마이드의 효용성과 안전성
Efficacy and Tolerability of Rufinamide for Intractable Generalized Epilepsies
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목 적 : 본 연구에서는 난치성 전신성 뇌전증 환자를 대상으로 루피나마이드의 효용성과 안전성을 후향적으로 분석하였다. 이 결과를 토대로 난치성 전신성 뇌전증에서 보다 폭 넓게 루피나마이드를 사용할 수 있는 가능성에 대해 알아보고자 하였다. 방 법 : 총 18명의 난치성 전신성 뇌전증 환자를 대상으로 후향적 의무 기록 조사를 하였다. 루피나마이드를 기존의 항경련제에 추가로 투여하였고 시작 용량은 10 mg/kg/day였으며 2주 간격으로 증량하여 30.50 mg/kg/day으로 유지하였다. 루피나마이드 투여전과 최종 용량 투여 후에 각 4주간의 발작 빈도를 비교하여 효용성과 안전성을 확인하였다. 결 과 : 남자는 13명 여자는 5명이었으며 평균연령은 13.6±6.2세(범위:3.3-29.2 세)였다. 발작 빈도가 50% 이상 감소한 반응군은 39%였으며 완전히 발작이 없어진 환자는 2명이었다. 부작용은 6명의 환자에서 확인되었고 각각은 과다행동, 기면, 실조, 다한 이었다. 부작용이 있었던 환자들 중 4명은 루피나마이드 투여 초기에 증상을 호소하였다. 이전에 투여된 항경련제의 수(P=0.025)와 성별(P=0.026)이 반응군과 비반응군간에서 통계학적으로유의한 차이를 보였다. 결 론 : 본 연구를 통해 레녹스-가스토 증후군 외의 난치성 전신성 뇌전증에서도 루피나마이드를 효과적이고 안전하게 사용할 수 있다는 것을 발견하였다. 투약 초기에 경련의 악화 및 부작용이 나타나는 경우가 잦아 이에 대한 세심한 관찰이 필요하다.
Abstract
Purpose : The purpose of the study was to evaluate the efficacy and safety of rufinamide for intractable generalized epilepsies. Methods : Eighteen patients with intractable generalized epilepsies were included in the study. Their medical records were retrospectively reviewed. Rufinamide was administered as an add-on treatment for intractable epilepsies. The initial administered dose was 10 mg/kg/ day, which was subsequently titrated up to 30.50 mg/kg/day. The effectiveness was assessed by comparing the frequency of seizures after the treatment. The difference in number of seizures during 4 weeks was compared before and after reaching the final dose. Results : The study population consisted of 13 males and 5 females (mean age 13.6±6.2 years, range 3.3-29.2 years). The responder rate (≥50% in seizure frequency) was 39% and the seizure free rate was 11%. Retention rate was 44% and the reasons for withdrawal was adverse events (6/18 patients, 33%), aggravation of seizures (4/18 patients, 22%), and ineffectiveness (2/18 patients, 11%). Adverse events included hyperactivity, somnolence, ataxia and polyhidrosis. Adverse events and seizure aggravation occurred even at the starting dose of rufinamide treatment. Conclusion : Rufinamide can be used as an efficacious and safe adjunctive anticonvulsant for patients with intractable generalized epilepsy.
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