[국내논문]아세트아미노펜 사용 편의성 증가 후 중독발생 위험의 지속적 관리 필요성 Continuous Control of Acetaminophen Poisoning after Implementation of Regulation for Ease Access of Acetaminophen: Cohort Study from Emergency Department Based in-depth Injury Surveillance원문보기
Purpose: Since 2012, acetaminophen can be accessed easily not only at pharmacies but also at convenience stores. The relationship between the easy access of acetaminophen and the risk of poisoning has been controversial. Several studies also reported different results regarding the risk of acetamino...
Purpose: Since 2012, acetaminophen can be accessed easily not only at pharmacies but also at convenience stores. The relationship between the easy access of acetaminophen and the risk of poisoning has been controversial. Several studies also reported different results regarding the risk of acetaminophen poisoning after access to acetaminophen was relaxed. This study examined the long-term effects on the risk of acetaminophen poisoning after easy access to acetaminophen was implemented. Methods: This was a retrospective analysis of an emergency department (ED)-based in-depth Injury Surveillance Cohort by the Korea Center for Disease Control and prevention from 2011 to 2018. Poisoning cases were selected from the Cohort, and the incidence of acetaminophen poisoning and the characteristics of the cases of acetaminophen poisoning were analyzed. The purchase path and the amount of ingestion in acetaminophen poisoning were sub-analyzed from data of six EDs. Results: Of 57,326 poisoning cases, 4.0% (2,272 cases) were acetaminophen poisoning. Of 2,272 cases of acetaminophen poisoning, 42.8% (974 cases) required in-patient care after ED management. Two hundred and sixty-four of these 964 cases required intensive care. The rates of cases that required in-patient treatment and the rates of cases that required intensive care increased from 29.4% in 2011 to 48.1% in 2018, and from 3.1% in 2011 to 15.2% in 2018, respectively (p<0.001, p<0.001). In the poisoning group with in-depth toxic surveillance (n=15,908), the incidence and proportion of acetaminophen (AAP) poisoning increased from 55 cases per year to 187 cases per year and 4.9% to 6.1%, respectively (p=0.009, p<0.001, respectively). The most common age group of acetaminophen poisoning was teenagers, which is different from the most common age group of other pharmaceutical agents: the middle age group of 40-49 years (p<0.001). Of 15,908 in-depth toxic surveillance patients, 693 patients had AAP poisoning, of whom 377 cases (54.2%) purchased acetaminophen from a non-pharmacy. The proportions of the purchase path from non-pharmacy were 41.4% at 2011-12 and 56.4% (2013-18) (p=0.004). The amount of acetaminophen ingestion was 13.5±14.3 g at 2011-12 and 13.9±15.1 g at 2013-18 (p=0.794). Conclusion: Although the incidence of acetaminophen poisoning did not increase remarkably in the short term after the implementation of the new regulation, the incidence of acetaminophen poisoning has increased slightly during the study period of 2017-18. In addition, the proportion of the purchase path from non-pharmacies has increased since the emergence of new regulations for the easy access of acetaminophen in 2012. The incidence of acetaminophen poisoning might have been affected after the increasing accessibility of acetaminophen in convenience stores. Continuous control of acetaminophen poisoning is required. Furthermore, the prevention of acetaminophen poisoning should be focused on teenagers with specialized school education programs.
Purpose: Since 2012, acetaminophen can be accessed easily not only at pharmacies but also at convenience stores. The relationship between the easy access of acetaminophen and the risk of poisoning has been controversial. Several studies also reported different results regarding the risk of acetaminophen poisoning after access to acetaminophen was relaxed. This study examined the long-term effects on the risk of acetaminophen poisoning after easy access to acetaminophen was implemented. Methods: This was a retrospective analysis of an emergency department (ED)-based in-depth Injury Surveillance Cohort by the Korea Center for Disease Control and prevention from 2011 to 2018. Poisoning cases were selected from the Cohort, and the incidence of acetaminophen poisoning and the characteristics of the cases of acetaminophen poisoning were analyzed. The purchase path and the amount of ingestion in acetaminophen poisoning were sub-analyzed from data of six EDs. Results: Of 57,326 poisoning cases, 4.0% (2,272 cases) were acetaminophen poisoning. Of 2,272 cases of acetaminophen poisoning, 42.8% (974 cases) required in-patient care after ED management. Two hundred and sixty-four of these 964 cases required intensive care. The rates of cases that required in-patient treatment and the rates of cases that required intensive care increased from 29.4% in 2011 to 48.1% in 2018, and from 3.1% in 2011 to 15.2% in 2018, respectively (p<0.001, p<0.001). In the poisoning group with in-depth toxic surveillance (n=15,908), the incidence and proportion of acetaminophen (AAP) poisoning increased from 55 cases per year to 187 cases per year and 4.9% to 6.1%, respectively (p=0.009, p<0.001, respectively). The most common age group of acetaminophen poisoning was teenagers, which is different from the most common age group of other pharmaceutical agents: the middle age group of 40-49 years (p<0.001). Of 15,908 in-depth toxic surveillance patients, 693 patients had AAP poisoning, of whom 377 cases (54.2%) purchased acetaminophen from a non-pharmacy. The proportions of the purchase path from non-pharmacy were 41.4% at 2011-12 and 56.4% (2013-18) (p=0.004). The amount of acetaminophen ingestion was 13.5±14.3 g at 2011-12 and 13.9±15.1 g at 2013-18 (p=0.794). Conclusion: Although the incidence of acetaminophen poisoning did not increase remarkably in the short term after the implementation of the new regulation, the incidence of acetaminophen poisoning has increased slightly during the study period of 2017-18. In addition, the proportion of the purchase path from non-pharmacies has increased since the emergence of new regulations for the easy access of acetaminophen in 2012. The incidence of acetaminophen poisoning might have been affected after the increasing accessibility of acetaminophen in convenience stores. Continuous control of acetaminophen poisoning is required. Furthermore, the prevention of acetaminophen poisoning should be focused on teenagers with specialized school education programs.
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문제 정의
data-checked="false">국내에서도안전상비약편의점판매제도시행후8년이지났으므로이 제도가중독발생에미치는영향을다시분석할필요가있다. 본연구의목적은질병관리본부응급실손상환자심층조사코 호트를이용하여안전상비약편의점판매제도시행후아세트 아미노펜중독발생의장기간변화양상을측정하는것이다. 이와함께, 편의성 증대와 함께 안전관리의 측면에서 고려되어야할특징들을분석해보고자한다.
본연구의목적은질병관리본부응급실손상환자심층조사코 호트를이용하여안전상비약편의점판매제도시행후아세트 아미노펜중독발생의장기간변화양상을측정하는것이다. 이와함께, 편의성 증대와 함께 안전관리의 측면에서 고려되어야할특징들을분석해보고자한다.
data-checked="false">위험성을줄이기위해안전상비약의품목확대에신중해야한다는주장부터안전상 비약의일회판매량을제한하므로써약물중독에의한위험성 은낮추고국민편의성은증대할수있으므로안전상비약품목 을확대해야한다는논쟁이현재도계속되고있다. 본 연구는 2012년11월15일안전상비약편의점판매제도실시후지난8 년간(2011-2018) 아세트아미노펜중독의 발생위험을 장기간 조사한연구이다. data-checked="false">아세트아미노펜중독발생위험은전체중독물질중아세트아미노펜이차지하는비율과발생건수를연도 별로조사분석하였고, 조사참여기관이연구기간중달라진점을 고려하여, data-checked="false">참여기관이연구기간중동일했던중독심층조사군에서도아세트아미노팬중독의비율과발생건수를조사하 였으며, 발생 건수의 경우 참여기관 1개소당 연간 발생건수를조사분석하였다.
중독심층조사군을대상으로3가지심층조사항목중아세트아미노펜의음독량과중독물질의출처를추출하여분석하였 다. 음독량eg 단위로분석하였으나, 한주먹, 한 모금 등의 경우 기존의 연구결과를 참고하여음독량을추정하였다9).
다. 음독량eg 단위로분석하였으나, 한주먹, 한 모금 등의 경우 기존의 연구결과를 참고하여음독량을추정하였다9). 아울러, 10 g을초과하여음독한경우를간 독성유발위험중독으로 정의하고, 제도 시행 전후 간독성 유발 위험군의 비율을비교하였다10).
음독량eg 단위로분석하였으나, 한주먹, 한 모금 등의 경우 기존의 연구결과를 참고하여음독량을추정하였다9). 아울러, 10 g을초과하여음독한경우를간 독성유발위험중독으로 정의하고, 제도 시행 전후 간독성 유발 위험군의 비율을비교하였다10). 코호트에서는중독물질의출처를본인의약, 가족 의약, 주위인의약, 약국구입(전문의약품), 약국구입(일반의약품), 기타, data-checked="false">모름으로조사하였으나본연구에서는약국구입(전문및일반의약품)과비약국구입(그외출처)으로단순정의하 여재분류하였다.
2). 아세트아미노펜중독 발생 건수는 2011년부터2015년까지는감소하는경향을보였고, 2016년부터 2018년까지는 다시 늘어나는추세를보였으며, 포아송회귀분석에서연구기간 (2011년부터2018년까지) 동안의미있게발생건수가증가하였다(p<0.001, 포아송회귀분석). data-checked="false">응급센터1개소당연간아세트아미노펜중독발생건수도연구기간동안전체발생건수의 변화량과유사한패턴을보였다(Fig.
본 연구는 2012년11월15일안전상비약편의점판매제도실시후지난8 년간(2011-2018) 아세트아미노펜중독의 발생위험을 장기간 조사한연구이다. data-checked="false">아세트아미노펜중독발생위험은전체중독물질중아세트아미노펜이차지하는비율과발생건수를연도 별로조사분석하였고, 조사참여기관이연구기간중달라진점을 고려하여, data-checked="false">참여기관이연구기간중동일했던중독심층조사군에서도아세트아미노팬중독의비율과발생건수를조사하 였으며, 발생 건수의 경우 참여기관 1개소당 연간 발생건수를조사분석하였다. data-checked="false">그결과중독심층조사군에서전체중독중아세트아미노펜중독의비율이연도별로의미있게증가하는 경향을보였으며, 발생 건수도 의미 있게 증가하는 결과를 보였다.
이는 연도변화에 따라 아세트아미노펜중독 발생이영향을받는다고해석할수있으나, 본연구의기간중편의점판매제도시행뿐 아니라, 코호트참여 기관의수가확대되어, 발생 수 증가가 안전상비약 판매제도에 의한 것으로해석할수없었다. 그래서, data-checked="false">본연구에서는참여기관당연간발생수로아세트아미노펜중독의발생빈도를간접 추정하였으며, 참여 기관이 2011-18년까지동일했던중독심층조사군에서도발생건수를분석하였다. 아울러, data-checked="false">전체중독물질중아세트아미노펜중독이차지하는비율을공통조사군과심 층조사군에서연도별로분석하였다.
그래서, data-checked="false">본연구에서는참여기관당연간발생수로아세트아미노펜중독의발생빈도를간접 추정하였으며, 참여 기관이 2011-18년까지동일했던중독심층조사군에서도발생건수를분석하였다. 아울러, data-checked="false">전체중독물질중아세트아미노펜중독이차지하는비율을공통조사군과심 층조사군에서연도별로분석하였다. 이상의 결과들을 종합할 때, 국내 아세트아미노펜중독의 발생 건수와 중독에서차지하는비중이증가하는경향이있다고해석하였다.
대상 데이터
2011년 1월부터 2018년 12월까지질병관리본부응급실손상환자심층조사코호트(이하손상코호트) 2, 116, 039건중중독물질코드가입력된57, 326건(2.7%)의 자료를 추출하여 연구대상으로하였다. 응급실손상환자심층조사코호트구축은 2006년부터20개응급센터가참여하여손상으로응급실에내 원하는환자에대한일반적특징과손상관련요소를전향적으 로수집하고있으며, 2018년에는 총 23개 응급센터가 참여하였다8).
데이터처리
코호트에서는중독물질의출처를본인의약, 가족 의약, 주위인의약, 약국구입(전문의약품), 약국구입(일반의약품), 기타, data-checked="false">모름으로조사하였으나본연구에서는약국구입(전문및일반의약품)과비약국구입(그외출처)으로단순정의하 여재분류하였다. 제도시행전후비약국구입의 비율을 분석하였으며, 연도별비약국구입의비율을카이검정과선형대선형 관계 검정법으로 분석하였다.
7%)였다. 중독 손상 중 가장 흔한 물질은 치료약물에 의한중독으로26, 807건 (46.8%)였고, 치료약물중아세트아미노펜중독은총2, data-checked="false">277건으로전체64개세부중독물질중아세트아미노펜은6번째로 흔한중독물질이었다(Fig. 1). 남자가488명, 여자가1, 789명이었고 평균연령은 25±15세였다.
data-checked="false">아세트아미노펜중독발생위험은전체중독물질중아세트아미노펜이차지하는비율과발생건수를연도 별로조사분석하였고, 조사참여기관이연구기간중달라진점을 고려하여, data-checked="false">참여기관이연구기간중동일했던중독심층조사군에서도아세트아미노팬중독의비율과발생건수를조사하 였으며, 발생 건수의 경우 참여기관 1개소당 연간 발생건수를조사분석하였다. data-checked="false">그결과중독심층조사군에서전체중독중아세트아미노펜중독의비율이연도별로의미있게증가하는 경향을보였으며, 발생 건수도 의미 있게 증가하는 결과를 보였다. 이런본연구의결과는기존결과와차이를보인다.
data-checked="false">본연구결과에서보여준국내아세트아미노펜중독의발생건수와중독에서차지하는비중이증가하는 경향을안전상비약편의점판매제도때문이라단정할수는없 으나, data-checked="false">이연구에서보여진아세트아미노펜중독환자에서비약국구입의비중이점차늘어나고있는점등을고려할때향후 안전상비약판매후지속관리를위한국가차원의대책을수 립할계기되었으면한다. 본 연구에서는 특히 2015년도에 발생 건수가적었는데이는MERS CoV에의한영향일가능성이높다. 응급 의료 통계 연보를 살펴보면 2015년 전체응급의료기관방문자수가타연도에비해적었다11, 12).
아울러, data-checked="false">전체중독물질중아세트아미노펜중독이차지하는비율을공통조사군과심 층조사군에서연도별로분석하였다. 이상의 결과들을 종합할 때, 국내 아세트아미노펜중독의 발생 건수와 중독에서차지하는비중이증가하는경향이있다고해석하였다. 둘째, data-checked="false">본연구에서약물의출처와음독량은6개응급센터수집된자료만을 제한적으로사용하여아세트아미노펜중독전체를대변하는데 제한이있을수 있다.
그러나, data-checked="false">본연구에서아세트아미노펜중독전체환자군과세부분석을위해사용된6개응급센터중독 환자의인구학적특성과의도성분포, 응급실 진료 결과에서 의미 있는 차이가 없었다. 셋째, data-checked="false">손상코호트는아세트아미노펜의구입출처구분에서편의점의항목이없어아세트아미노펜 중독빈도의증가가편의점판매때문인지직접확인하기어려 웠다. 그러나, 본 연구에서 아세트아미노펜구입 출처에서‘본인의약, 가족의약, 주위인의약, data-checked="false">기타’를비약국으로분류하였으나이들약제가모두편의점에서구입되었다고보기어렵 다.
후속연구
본 연구에서 제도시행전후아세트아미노펜평균음독량에서도모두간독성을유발할수있는음독량을초과하였고, 비록 통계적 차이는 없었으나, 간 독성유발위험중독의비율이제도시행후다소증가하였으며, data-checked="false">이런결과는입원율의증가와특히중환자실입원율의증가와일정관련이있을수있으 므로, 안전상비의약품판매제도시행후상시관리제도의강화가필요할것으로판단한다.
특히 10대에서 의 아세트아미노펜중독의 발생이뚜렷하였다. 안전상비약 판매 후상 시적 관리 및 감독제도의강화뿐아니라, data-checked="false">10대의대부분이초중고학생이므로학교보건교육에서아세트아미노펜오남용및과량복용의 위험성에대한특화된교육이아세트아미노펜중독의예방에 서주요하게고려되어야할것이다.
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