Clinical and Experimental Pediatrics

The Korean Pediatric Society (대한소아청소년과학회)
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Efficacy and safety of oxcarbazepine in epileptic children

소아 간질 환자에서 oxcarbazepine의 효용성과 안전성

  • 신혜경 (고려대학교 의과대학 소아과학교실) ;
  • 이윤 (고려대학교 의과대학 소아과학교실) ;
  • 이지연 (광명성애병원 소아청소년과) ;
  • 최욱선 (고려대학교 의과대학 소아과학교실) ;
  • 은소희 (고려대학교 의과대학 소아과학교실) ;
  • 은백린 (고려대학교 의과대학 소아과학교실) ;
  • 홍영숙 (고려대학교 의과대학 소아과학교실) ;
  • 이주원 (고려대학교 의과대학 소아과학교실)
  • Received : 2007.12.04
  • Accepted : 2008.01.05
  • Published : 2008.02.15
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Abstract

Purpose : Oxcabarzepine (OXC), newly recommended antiepileptic drug, has been prescribed for patients with partial seizures and generalized tonic clonic seizures in Korea from 1999. There are limited reports about an efficacy of OXC therapy in epileptic children in Korea. This study evaluated the efficacy and safety of OXC in the light of our experience. Methods : The patients, who had visited the pediatric neurology clinic of Korea University Guro Hospital from January 2001 to December 2006, were included. The data of 144 patients who were administrated OXC as monotherapy or polytherapy, was summarized retrospectively and we evaluated the efficacy and safety of OXC. Results : After 6 months of OXC therapy, 77 patients (53.5%, n=144) achieved seizure freedom, 48 patients (33.3%) experienced >50% improvement. After 12 months of OXC therapy, cessation of seizure was observed in 88 patients (61.1%, n=133), and 27 patients (18.8%) manifested an improvement. Monotherapy group showed superior efficacy to polytherapy one. The frequent side effects of OXC were drowsiness (20.1%), headache (12.5%), dizziness (9.7%) and rash (8.3%). They did not related to patient's age or sex, and dosage of OXC. Twenty four patients (16.7%) experienced hyponatremia, but which were neither symptomatic nor significant one. Conclusion : The efficacy and safety of OXC in our patients were excellent and had less significant side effects than established international one. We expect this report contributes toward OXC therapy in epileptic children.

목 적 : Oxcarbazepine(OXC)은 대표적인 부분간질의 치료제로 2001년 미국 식약청으로 부터 승인을 받았으며 1970년대 말부터 임상 보고가 시작되었고 소아를 대상으로 OXC의 효용성 및 안전성에 대한 다수의 보고가 있다. 국내에는 1999년부터 임상적 적용이 시작되었으나 국내 소아 대상의 연구 보고가 제한적이다. 방 법 : 2001년 1월부터 2006년 12월까지 6년간 고려대학교 의료원 구로병원 소아과에 내원하여 OXC 투약을 시행하였던 환자 144명을 대상으로 후향적 자료 분석을 통해 효용성과 안전성을 연구하였다. 결 과 : OXC 투약 6개월 후 회복군은 77명(53.5%, n=144), 호전군은 48명(33.3%), 유지군은 14명(9.7%), 그리고 악화군은 5명(3.5%)이었고, 치료 12개월 후에는 회복군은 88명(61.1%, n=133), 호전군은 27명(18.8%), 유지군은 8명(5.6%), 그리고 악화군은 8명(5.6%)이었다. 단일요법 군의 회복군은 6개월 치료 후에 63명(66.3%, n=95), 12개월 치료 후에는 86명(90.5%, n=95)였으며 복합요법 군에서 6개월 투약 후에 회복군은 14명(28.6%, n=49), 치료 12개월 후에는 45명(91.8%, n=49)으로 유의한 차이를 보였다. OXC 투약 기간동안 부작용이 발생한 경우는 73명으로, 그 중 졸림(20.1%), 두통(12.5%), 어지러움(9.7%), 발진(8.3%), 피로함(4.2%) 등이 관찰되었으며 나이, 성별 및 약물 용량과는 유의한 인과관계가 없었다. 혈액 검사상 저나트륨혈증이 관찰된 경우는 총 24명(16.7%)이며 그 외 투약 후 검사 상 이상소견은 유의하게 관찰되지 않았다. 반면 투약 이후 빈혈의 빈도가 감소하였는데 혈색소와 체중 간에 유의한 상관관계는 없었다. 결 론 : 본 연구 결과 OXC 의 효용성은 국외 보고와 비교하여 우수하거나 큰 차이가 없었으며, 위중한 부작용 사례는 없었다. 소아 간질 환자의 OXC 치료 시 참고가 되는 자료가 될 수 있을 것이다.

Keywords

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