소아청소년에서 공수병 예방접종 및 교상 후 조치 현황: 최근 5년간 국립중앙의료원에서의 경험

노진철,박향미,박종현,원연경,이창휴,김재윤,Noh, Jin Chul,Park, Hyang Mi,Park, Jong Hyun,Won, Youn Kyung,Lee, Chang Hyu,Kim, Jae Yoon 대한소아감염학회 2013 Pediatric Infection and Vaccine Vol.20 No.1

목 적 : 본 연구는 국립중앙의료원 단일기관에서 경험한 공수병 예방접종 및 교상 후 조치 현황에 대하여 기술하고 최근의 국외 및 국내 공수병 예방조치 지침과 비교하여 적절한 교상 후 조치가 이루어지고 있는지를 알아보았다. 방 법 : 2006년 11월부터 2011년 12월까지 공수병 예방접종 및 교상 후 조치를 위해 국립중앙의료원에 내원한 만 18세 이하 41명을 대상으로 하여 의무기록을 검토하여 나이, 성별, 상처부위, 물린 동물 종류, 물린 지역, 발생일로부터 내원일까지의 기간, 공수병 예방접종 및 면역글로불린 접종 실시 여부 등을 조사하였다. 결 과 : 연구기간 중 공수병 예방접종 및 교상 후 조치를 위해 본원에 방문한 만 18세 이하 소아는 41명이었고 교상 전 예방접종을 위해 내원한 소아 11명, 교상 후 예방조치를 위해 내원한 소아 30명이었다. 연령분포를 보면 6세 이후(83.3%)가 많았다. 물린 동물은 개에 의해 가장 많이 발생하여 전체 교상환자 30명 중 27명(90%)을 차지했다. 물린 부위는 다리(9명, 30%), 손(8명, 26.7%)에 많이 물렸다. 교상부위가 미파악된 경우는 전체 교상환자 30명 중 7명(23.3%)이었다. 전체 교상환자 중에서 동물에 대한 광견병 백신 접종을 받았는지 안 받았는지를 알 수 있는 경우는 30명중 10명이었고 이중 4명이 광견병 백신을 접종받은 동물에 의해 교상을 당하였다. 동물의 광견병 백신접종 여부에 따라 교상 후 치료형태를 나누어 보면 광견병 백신을 접종 받은 동물에 의한 교상환자 4명 중 1명(25%)이 상처소독 등의 1차적인 응급조치만 행해졌고 나머지 3명(75%)은 교상 후 조치(교상 후 조치 완료)를 받았다. 반면에 야생동물을 포함하여 광견병 백신접종을 받지 않았거나 백신접종 이력이 불명확한 동물에 의한 교상환자 26명중 9명(34.6%)이 응급조치만 하였으며 나머지 17명(65.4%)은 교상 후 조치 미완료 또는 교상 후 조치를 완료하였다. 결 론 : 이러한 결과는 야생동물을 포함하여 광견병 백신접종을 받지 않았거나 광견병 백신접종 이력이 불명확한 동물에 의한 교상환자에게 교상 후 조치를 실시하는 경우가 상대적으로 적었다는 것을 의미한다. 앞으로 국내에서 공수병 발생을 억제하기 위해서는 먼저 공수병 예방 및 관리 지침에 따른 교상 후 조치에 대한 올바른 이해가 필요하며 교상환자, 해당동물 및 교상지역에 관한 정보를 정확히 기록해야한다. Purpose : This study aims to investigate preexposure prophylaxis and postexposure prophylaxis of rabies that the National Medical Center (NMC) handled and to check whether appropriate measures were performed according to the recent domestic and overseas guidelines after animal bites. Methods : This study surveyed 41 people who were 18 years or under and received preexposure and postexposure prophylaxis of rabies at the NMC from November 2006 to December 2011. Their medical records were reviewed for their age, gender, the reason for preexposure prophylaxis, the body sites of animal bite, the kind of the animal that bit children, the region where the biting occurred and rabies vaccination and inoculation of immunoglobulin. Results : Eleven children took rabies vaccination for preexposure prophylaxis and 30 children received post exposure prophylaxis of rabies. Of patients who were bitten by unvaccinated animals including wild animals or by animals which were not certain to be vaccinated, 50% (13 of 26 children) received postexposure prophylaxis, while 75% (3 of 4 children) of patients who were bitten by vaccinated animals received postexposure prophylaxis of rabies. Ten of 30 bitten patients knew whether or not the biting animals had received rabies vaccination. Of them, four people (40%) were bitten by animals which had received rabies vaccination. Conclusion : To prevent the occurrence of rabies, people and health care providers need to correctly understand latest guideline for rabies preexposure and postexposure prophylaxis and the information for bitten patient, biting animal and area at bitten by animal should be accurately recorded.

공중보건 위기대응 의료제품의 개발 촉진 및 긴급 공급을 위한 특별법 고찰 및 FDA와 EMA의 유사 법안 비교 분석

김선영(Sunyoung Kim),한연경(YeonGyeong Han),문은희(EunHui Moon),강석연(SeokYeon Kang),강원구(Wongu Kang),원정우(Jeongwoo Won),정시연(Si-Yeon Jeong) 대한약학회 2022 약학회지 Vol.66 No.3

Since the outbreak of the new strain of coronavirus (SARS-CoV-2, COVID-19) was first reported, regulatory authorities worldwide have issued various regulatory guidelines and recommendations. Global authorities are committed to supporting developers of potential vaccines and treatments for COVID-19. This study reviewed the guidelines and regulatory procedures instituted by authorities in the United States and Europe to understand the current perspectives of regulatory agencies worldwide and derive implications for public health emergency responses. The Act on Encouragement of Development and Emergency Circulation of Medical Countermeasures for public health emergencies enacted in 2021 established the Ministry of Food and Drug Safety (MFDS) to oversee policies for public health emergencies. In the US, the Public Law 113-5, the PHS Act, the PREP Act and the FD&C Act grant authorities emergency use power with respect to medical countermeasures needed during public health emergencies. The FDA can also facilitate the use of those medical countermeasures. The EMA has accelerated regulatory procedures in place for expediting the development and approval of medicinal products for COVID-19. The EMA’s rapid procedure includes rolling review, accelerated assessment and conditional marketing authorisation. Based on the review of foreign policies and practices regarding public health emergencies, this study showed that the Act on Encouragement of Development and Emergency Circulation of Medical Countermeasures for public health emergency responses has made important advances in public health emergency preparedness and response.

전국 146개 응급실에 내원한 급성 세기관지염 환자에 대한 통계적 관찰

노의정 ( Eui Jung Roh ),원연경 ( Youn Kyung Won ),이미희 ( Mi Hee Lee ),정은희 ( Eun Hee Chung ) 대한천식알레르기학회 2015 Allergy Asthma & Respiratory Disease Vol.3 No.5

Purpose: This study was aimed to investigate the clinical and epidemiological characteristics of the patients with acute bronchiolitis who visited in 146 Emergency Departments (EDs) in Korea in 2012. Methods: We used the NEDIS (National Emergency Department Information System) database to obtain all children with acute bronchiolitis who visited ED under the age of 3 between January 1, 2012 and December 31, 2012. Results: Totally 18,313 children with acute bronchiolitis were enrolled at this study. The male to female ratio was 1.55:1 and mean age was 10 months. The peak proportion was 17.3% in November during the whole year. The most common chief complaints were fever (38.5%), cough (37.4%), dyspnea (9.5%), gastrointestinal symptom (6.7%), and wheezing (2.5%). The most common accompanying disease was pneumonia (13.3%). The rate of hospital admission and intensive care unit admission were 34.5% and 0.3%, respectively. A predictor for admission via ED was respiratory difficulty. Conclusion: These data expand our understanding of clinical characteristics of patients with acute bronchiolitis who visited all ED in Korea in 2012. (Allergy Asthma Respir Dis 2015;3:334-340)

단일 의료기관에서 진단된 아나필락시스 환자의 임상적 특성

박향미,노진철,박종현,원연경,황세희,김재윤,김유영,노의정,정은희 대한 소아알레르기 호흡기학회 2012 Allergy Asthma & Respiratory Disease Vol.22 No.3

Purpose:The studies concerning the clinical features of patients with anaphylaxis, who meet the newly established diagnostic criteria, are reported in Korea, but comparative studies regarding the clinical features of children and adult patients with anaphylaxis are lacking. The purpose of this study is to compare the clinical features of the children and adults with anaphylaxis, who meet the new diagnostic criteria at a single hospital. Methods:We reviewed the medical records of patients who were diagnosed with anaphylaxis, anaphylactic shock, urticaria, and angioedema, including inpatients, outpatients and emergency room visited patients, at the National Medical Center from July, 2005 to August, 2011. The clinical characteristics of children and adults, who met the new diagnostic criteria for anaphylaxis, were analyzed. Results:We identified 91 patients with anaphylaxis. Sixteen were children and 75 were adults. The sex ratio (male:female) and the mean age were 1:1.7 and 9.6 years among children, respectively, and 1:2.3 and 42.3 years, respectively, among adults. The most common cause of anaphylaxis based on clinical history was foods in 15 children (93.7%) and 35 adults (46.7%). Twelve children (75%) and 36 adults (48%) were rediagnosed with anaphylaxis. Patients with cardiovascular symptoms and severe severity were 1 (6.3%) and 1 (6.3%), respectively, among children, and 28 (37.3 %) and 23 (30.3%), respectively, among adults. Conclusion:We rediagnosed some cases of anaphylaxis, using the new diagnostic criteria and most of the cases were diagnosed initially as urticaria or angioedema. The adults had more severe and more cardiovascular symptoms than children. In the future, a nationwide, multiinstitutional research will be necessary for the prevalence and the clinical features of anaphylaxis by the new diagnostic criteria in Korea. 목 적:새롭게 정립된 진단 기준에 맞는 아나필락시스 환자들의 임상적 특성에 대한 연구가 국내에서 보고되고 있지만, 소아와 성인에 대한 아나필락시스의 임상적 특성을 비교한 연구는 드물다. 이에 저자들은 단일 의료기관에 내원한 환자들을 대상으로 새롭게 정립된 진단 기준을 적용하여 아나필락시스로 진단된 소아와 성인에 대한 임상적 특성을 비교하고자 한다. 방 법:2005년 7월부터 2011년 8월까지 국립중앙의료원에 입원하거나 응급실 및 외래를 통해 내원한 환자들을 대상으로 아나필락시스, 아나필락시스 쇼크, 두드러기, 혈관부종, 유해 반응 등으로 등록된 환자들 중에서 새롭게 정립된 아나필락시스 진단 기준에 합당한 환자들을 대상으로 임상적 특성을 의무기록을 통해 후향적으로 조사하였고, 소아와 성인에 대한 아나필락시스의 임상적 특성을 비교 분석하였다. 결 과:연구 기간 동안 아나필락시스 진단 기준에 합당한 경우는 총 91명이었다. 소아는 16명, 성인은 75명이었고, 성비(남:여)와 평균 연령은 소아에서 1:1.7, 9.6세, 성인에서 1:2.3, 42.3세였다. 임상 병력상 의심되는 원인 물질로 소아는 15명(93.7%), 성인은 35명(46.7%)으로 식품이 가장 많았다. 새롭게 정립된 진단 기준을 적용하여 아나필락시스로 새로 진단된 경우는 소아에서 12명(75%)과 성인에서 36명(48%)이었다. 심혈관계 증상은 소아는 1명(6.3%), 성인은 28명(37.3%)이었고, 중증은 소아에서 1명(6.3%), 성인에서 23명(30.3%)이었다. 결 론:본 연구에서는 새롭게 정립된 아나필락시스 진단 기준을 적용하여 두드러기와 혈관부종으로 진단되었던 환자들 중 상당수를 아나필락시스로 진단할 수 있었다. 소아보다 성인에서 심혈관계 증상이 많이 동반되었고, 중증의 빈도가 높았다. 본 연구는 단일 의료기관의 연구이고 연구 대상이 적은 한계가 있으며, 향후 아나필락시스의 유병률과 임상적 특성에 대한 연구를 위해 새로이 정립된 진단 기준을 적용한 전국적 다기관 조사가 필요하리라 사료된다.

단일 의료기관에서 진단된 아나필락시스 환자의 임상적 특성

박향미 ( Hyang Mi Park ),노진철 ( Jin Chul Noh ),박종현 ( Jong Hyun Park ),원연경 ( Youn Kyoung Won ),황세희 ( Se Hee Hwang ),김재윤 ( Jae Yoon Kim ),김유영 ( You Young Kim ),노의정 ( Eui Jung Roh ),정은희 ( Eun Hee Chung ) 대한소아알레르기호흡기학회(구 대한소아알레르기 및 호흡기학회) 2012 소아알레르기 및 호흡기학회지 Vol.22 No.3

Purpose: The studies concerning the clinical features of patients with anaphylaxis, who meet the newly established diagnostic criteria, are reported in Korea, but comparative studies regarding the clinical features of children and adult patients with anaphylaxis are lacking. The purpose of this study is to compare the clinical features of the children and adults with anaphylaxis, who meet the new diagnostic criteria at a single hospital. Methods: We reviewed the medical records of patients who were diagnosed with anaphylaxis, anaphylactic shock, urticaria, and angioedema, including inpatients, outpatients and emergency room visited patients, at the National Medical Center from July, 2005 to August, 2011. The clinical characteristics of children and adults, who met the new diagnostic criteria for anaphylaxis, were analyzed. Results: We identified 91 patients with anaphylaxis. Sixteen were children and 75 were adults. The sex ratio (male:female) and the mean age were 1:1.7 and 9.6 years among children, respectively, and 1:2.3 and 42.3 years, respectively, among adults. The most common cause of anaphylaxis based on clinical history was foods in 15 children (93.7%) and 35 adults (46.7%). Twelve children (75%) and 36 adults (48%) were rediagnosed with anaphylaxis. Patients with cardiovascular symptoms and severe severity were 1 (6.3%) and 1 (6.3%), respectively, among children, and 28 (37.3%) and 23 (30.3%), respectively, among adults. Conclusion: We rediagnosed some cases of anaphylaxis, using the new diagnostic criteria and most of the cases were diagnosed initially as urticaria or angioedema. The adults had more severe and more cardiovascular symptoms than children. In the future, a nationwide, multiinstitutional research will be necessary for the prevalence and the clinical features of anaphylaxis by the new diagnostic criteria in Korea.