The Korean Journal of Medicine

The Korean Association of Internal Medicine (대한내과학회)
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Analysis of Drugs Causing Severe Cutaneous Adverse Reactions, Based on the Korean Database of Spontaneously Reported Adverse Drug Reactions

약물유해사례 자발보고자료를 통한 국내 중증피부유해반응 원인 약물 분석

  • Kim, Mi-Yeong (Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center) ;
  • Yang, Min-Suk (Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center) ;
  • Kang, Hye-Ryun (Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center) ;
  • Cho, Sang-Heon (Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center) ;
  • Min, Kyung-Up (Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center)
  • 김미영 (서울대학교 의학연구원 알레르기 및 임상면역연구소) ;
  • 양민석 (서울대학교 의학연구원 알레르기 및 임상면역연구소) ;
  • 강혜련 (서울대학교 의학연구원 알레르기 및 임상면역연구소) ;
  • 조상헌 (서울대학교 의학연구원 알레르기 및 임상면역연구소) ;
  • 민경업 (서울대학교 의학연구원 알레르기 및 임상면역연구소)
  • Received : 2013.10.04
  • Accepted : 2013.12.31
  • Published : 2014.06.01
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Abstract

Background/Aims: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) are severe cutaneous adverse reactions (SCARs) that also affect the internal organs with high mortality. However, there has been no previous nationwide study of SCARs in Korea. Methods: Cases of SCARs were recruited from the nationwide Korean Pharmacovigilance Research Network database, collected from June 2009 to December 2010, by a spontaneous reporting system. We analyzed age, gender, route of administration and the causative agents. We also reviewed previously published cases of SCARs in Korea. Results: In total, 100 cases of SJS (66 cases), TEN (7 cases), and DRESS (27 cases) were reported. The mean age of the patients was $54.1{\pm}19.8$ years and the proportion of males to females was 1:0.88. In total, 81 drugs were reported as causative agents: SJS (61 drugs), TEN (15 drugs), and DRESS (29 drugs). The most commonly reported causative drug was allopurinol (12 cases). Allopurinol (8 cases) and levofloxacin (2 cases) were the most commonly reported causative drugs for SJS and TEN, respectively. In DRESS, allopurinol (4 cases) and vancomycin (4 cases) were the two most common causative drugs. Anti-infective drugs were the most common drug category (75 cases). Carbamazepine was the most commonly reported causative drug according to published cases in Korea. Conclusions: Allopurinol in the spontaneous reporting system and carbamazepine in the published cases were the most common single causative drugs in SCARs in Korea. Anti-infectives were the most common drug category in the spontaneous reporting system.

목적: 스티븐스-존슨증후군(Stevens-Johnson syndrome, SJS), 독성표피괴사용해(toxic epidermal necrolysis, TEN) 그리고 호산구 증가증 및 전신 증상을 동반한 약물 반응(drug reaction with eosinophilia and systemic symptoms, DRESS)은 중증피부유해반응(severe cutaneous adverse reactions, SCARs)에 속하는 질환으로 내부 장기를 침범하고 사망률이 높다. 국내에는 지금까지 SCARs에 대한 범국가적인 연구가 없었다. 방법: 2009년 6월부터 2010년 12월까지 약물감시사업단을 통해 수집된 의약품 유해사례보고 자료 중 SCARs에 해당되는 사례들을 분석하였다. 보고자 나이, 성별, 투약 경로, 의심 약물의 종류에 대하여 분석하였다. 아울러 기존에 국내에서 발표된 SCARs 사례를 분석하였다. 결과: SJS은 66건, TEN은 7건 그리고 DRESS는 27건으로 총 100건의 SCAR가 보고되었다. 환자군의 평균 연령은 $54.1{\pm}19.8$였고, 남녀 비율은 1:0.88이었다. SJS 61가지, TEN 15가지, DRESS 29가지로 총 81가지의 약물이 보고되었다. 가장 빈번하게 보고된 의심 약물은 allopurinol (12건)이었다. SJS의 의심 약물로 allopurinol (8건)이 가장 빈번하였고 carbamazepine 이 5건으로 그 뒤를 따랐다. TEN에서는 levofloxacin이 2건으로 가장 많았다. DRESS에서 가장 빈번하게 보고된 의심 약물은 allopurinol (4건)과 vancomycin (4건)이었다. 가장 흔한 약물군은 전신적 항감염제(antiinfectives for systemic use, 75건, 46.6%)였다. 국내에서 보고된 증례에서 가장 빈번한 의심 약물은 carbamazepine이었다. 결론: 자발적 보고에서 가장 흔한 SCARs 원인은 개별약제로는 allopurinol, 약물군으로는 전신적 항감염제가 원인 약물이었다. 지금까지 국내에서 보고된 SCARs 증례를 분석한 결과 carbamazepine이 가장 높은 빈도를 차지하였다.

Keywords

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