소아기 발병 난치성 뇌전증 환자에서 Rufinamide의 효용성과 안전성 = Rufinamide in Patients with Childhood Onset Intractable Epilepsy

국문 초록 (Abstract)

목적: 본 연구에서는 소아기에 발병한 난치성 뇌전증 환자를 대상으로 보조적 요법으로 사용한 rufinamide의 효용성과 안전성을 확인 해보고자 하였다. 방법: 서울아산병원 어린이병원에서 난치성 뇌전증으로 rufinamide를 처방받은 70명의 환자들의 의무기록을 후향적으로 분석하였다. 의무기록이 불완전한 2명의 환자를 제외한 68명의 환자가 연구에 참여하였다. Rufinamide는 기존의 항경련제에 보조요법으로 사용하였고 발작의 빈도는 rufinamide 투여 전 4주 간의 발작 횟수 와 투약 3개월, 12개월 후의 발작 횟수를 비교하여 평가하였다. 결과: 평균연령은 10.5세(범위, 1-24세)이었으며 남자가 43명, 여자는 25명이었다. 투여 3개월에 7.4%가 발작 완전 관해되었고, 발작 빈도가 50% 이상 감소한 반응군은 41.2% 이었다. 투여 12개월에는 10.3%가 발작 완전 관해되었고, 반응군은 42.6%였다. 약물 유지율 은 3개월에 75%, 12개월에 66.2%로 확인되었다. 부작용은 29명의 환자에서 보고되었으며 발작 악화, 기면, 불면, 감기 증상, 구역, 구토 순으로 많았다. 결론: Rufinamide가 레녹스-가스토 증후군에 특화된 약물이기는 하나 기타 소아기에 발생한 난치성 뇌전증 환자들에서도 효과적이고 안전하게 투여할 수 있는 약물이라는 것을 확인할 수 있었다.

다국어 초록 (Multilingual Abstract)

Purpose: This study is aimed to evaluate the effectiveness and tolerability of rufinamide as add-on therapy in patients with intractable epilepsies. Methods: We retrospectively reviewed the medical records of 70 patients treated with rufinamide in Asan Medical Center, children’s hospital. Two cases with incomplete medical records were excluded and total sixty-eight cases were enrolled. Rufinamide was added on the existing antiepileptic drugs and the total seizure frequency at pre-medication, 3 months and 12 months were examined. Results: The mean age of 68 patients (43 male) was 10.5 yrs (range, 1-24 yrs). At 3 months after rufinamide initiation, 5 patients achieved freedom from seizures and 28 (41.2%) achieved a ≥50% seizure reduction. At 12 months, 7 patients achieved seizure freedom and 29 (42.6%) achieved ≥50% seizure reduction. The retention rate was hold up to 75.0% at 3 months and 66.2% at 12 months of study. Total 29 patients reported adverse events in order of seizure aggravation, somnolence, insomnia, common cold, nausea and vomiting. Conclusion: In this study, rufinamide is effective and tolerable in patients with other intractable epilepsy of childhood onset as well as the patients with LGS. Further research is required to define the efficacy of rufinamide in intractable epilepsy other than LGS.

목차 (Table of Contents)

• 서론
• 대상 및 방법
• 결과
• 고찰

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