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2000-2014년 한국에서 수행된 백신 유용성 평가 연구
차지혜 ( Jihei Cha ),김한울 ( Han Wool Kim ),이소영 ( Soyoung Lee ),조혜경 ( Hye Kyung Cho ),안종균 ( Jong Gyun Ahn ),김경효 ( Kyung-hyo Kim ) 대한소아감염학회 2016 Pediatric Infection and Vaccine Vol.23 No.2
목적: 2000년부터 식품의약품안전처 주관 하에 국내 주요 백신의 안전성과 면역원성에 대한 임상평가자료를 확보하기 위한 백신 평가 연구를 시작하였다. 본 연구는 백신의 면역원성, 효능, 효과, 안전성 및 다른 평가분야에 대해 수행된 연구 및 보고서들을 고찰하여 각 백신 별 유용성 평가 자료를 찾아 분석하고자 하였다. 방법: 지난 2000년부터 2014년까지 여러 연구자들에 의해 “백신 유용성 평가” 과제가 수행되었다. 백신 유용성 평가 자료들의 결과 및 성과들을 고찰하여 향후 국내 백신 정책에 활용할 수 있는 가능성을 분석하였다. 각 백신은 백신 평가 영역에 따라 자료를 분석하고 체계화하였다. 결과: 2000년부터 2014년까지 주요 백신에 대해 총 83개의 연구과제가 수행되었다. 각 백신 별로는 BCG 8개, DTaP/Td 14개, 폴리오 1개, Hib 5개, 폐구균 3개, 인플루엔자 11개, A형 간염 3개, MMR11개, 수두 11개, 일본뇌염 16개였다. 평가 영역은 안전성, 면역원성, 면역도, 면역지속능, 효능평가, 효과평가, 유효성 평가기술, 품질평가 및 기타로 나누어 분석하였다. 결론: 우리나라에서 수행된 백신 유용성 평가 연구를 통해 유용한 자료가 도출되어 향후 국내 백신 평가 사업, 백신 정책 수립 및 대중/전문가 교육에 필요한 기초자료로 활용될 수 있을 것이다. Purpose: Vaccine evaluation studies were initiated from 2000 by the Ministry of Food and Drug Safety to produce proper data about the safety and immunogenicity of vaccines. The purpose of this study was to review studies and reports on evaluation of vaccine such as immunogenicity, efficacy, effectiveness, safety and other related topics in order to find and analyze the data on the usefulness of each vaccine. Methods: From 2000 to 2014, the project "The vaccine evaluation" had been performed by several researchers, and studies and reports of vaccine evaluation. We reviewed the results and outcomes of studies regarding the evaluation of vaccine’s usefulness and analyzed the possibilities of applying these data for establishing vaccine policies. For each vaccine, data analysis and organization were done according to evaluation fields. Results: A total of 83 studies were performed on vaccines from 2000 to 2014. For each vaccine, 8 studies were performed on BCG, 14 on DTaP/Td, 1 on poliovirus, 5 on Hib, 3 on pneumococcus, 11 on influenza, 3 on hepatitis A, 11 on MMR, 11 on varicella, and 16 on Japanese encephalitis. All studies were analyzed by the following evaluation area, such as safety, immunogenicity, seroprevalence, persistence of immunity, efficacy, effectiveness, vaccine evaluation methods, quality control product for vaccine, and others. Conclusions: Vaccine evaluation studies performed in Korea may be useful as references for establishing vaccination strategy and policy and could be used as baseline data for future studies on vaccine evaluation, vaccine policy establishment, and public/expert vaccine education in Korea.
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이상원,윤영민,차지혜,조안나 이화여자대학교 의과학연구소 2017 EMJ (Ewha medical journal) Vol.40 No.4
Objectives: To expand current knowledge on febrile seizures (FSs), the most common childhood seizure disorder, we investigated clinical features and risk factors of FS in the pediatric emergency department of a center in western Seoul. Methods: Children with FS that visited the pediatric emergency room of the Ewha Womans University Medical Center from January to December 2014 were included in this study. A retrospective medical record review was conducted for a total of 404 seizure events relative to 265 patients. Results: A total of 150 boys and 115 girls were enrolled. Children presenting their first FSs were 70.9% (n=188). Average age of FS onset was 28.9 months. Family history was reported in 95 children (36.8%) with higher relevance of paternal inheritance (44.2%, n=42/95). More than half of the seizures (56.4%, n=228/404) occurred on the first day of fever. The most common cause of fever was upper respiratory tract infection (65.8%, n=266/404). Children attending a daycare center had higher incidence of multiple FS compared to those cared for at home. Approximately one third of seizure events (31.7%, n=128/404) were admission cases, mainly because of prolonged fever. Conclusion: FS is a common neurologic disorder with relatively high admission rate among pediatric emergency department visits. Daycare attendance is associated with current increased incidence of multiple FS. Further study with long-term follow up is necessary to expand knowledge on improving clinical care strategy in FS.
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