| アブストラクト | PURPOSE: Despite morbidities and fatalities, nationwide epidemiologic data for severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), are not widely available. We aimed to investigate SCAR epidemiology over the last two decades in Korea. MATERIALS AND METHODS: We analyzed individual case safety reports (ICSRs) of SCARs in the Korea Adverse Event Reporting System from 1988 to 2013. Administered drugs, demographic profiles, and causality assessment according to the World Health Organization-Uppsala Monitoring Center system were analyzed. RESULTS: A total of 755 SCAR cases (508 SJS/TEN, 247 DRESS) were reported. The number of SCAR ICSRs has been increasing with increasing ICSRs for overall adverse drug events. Since 2010, the number of SCAR ICSRs has increased up to 100 cases/year. Allopurinol was the most common causative drug (SJS/TEN: 10.2%; DRESS: 11.3%; SCAR ICSRs: 10.6%), followed by carbamazepine (SJS/TEN: 8.7%; DRESS: 9.7%; SCAR ICSRs: 8.6%). Regarding drug groups, antiepileptics (19.5%) and antibiotics for systemic use (12.7%) were common causative drug groups. Twenty SCAR-related deaths were recorded. Antibacterials were the most common causes of deaths (8 cases), followed by antiepileptics (5 cases). The potential risk of SCARs was not specified in the drug information leaflet for 40.2% of drugs causing SJS/TEN and 82.5% causing DRESS syndrome in Korea. CONCLUSION: The number of SCAR ICSRs has increased rapidly with recent active pharmacovigilance programs in Korea. Allopurinol and antiepileptics are the most common individual and categorical causative agents, respectively. |
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| 投稿者 | Kang, Min Gyu; Sohn, Kyung Hee; Kang, Dong Yoon; Park, Han Ki; Yang, Min Suk; Lee, Ju Yeun; Kang, Hye Ryun |
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| 組織名 | Institute of Allergy and Clinical Immunology, Seoul National University Medical;Research Center, Seoul, Korea.;Department of Internal Medicine, Chungbuk National University Hospital, Cheongju,;Korea.;Regional Pharmacovigilance Center, Chungbuk National University Hospital,;Cheongju, Korea.;Department of Internal Medicine, Kyung-Hee University Hospital, Seoul, Korea.;Regional Pharmacovigilance Center, Seoul National University Hospital, Seoul,;Drug Safety Monitoring Center, Seoul National University Hospital, Seoul, Korea.;Department of Internal Medicine, School of Medicine, Kyungpook National;University, Kyungpook National University Chilgok Hospital, Daegu, Korea.;Department of Internal Medicine, Seoul Metropolitan Government-Seoul National;University Boramae Medical Center, Seoul, Korea.;College of Pharmacy, Seoul National University, Seoul, Korea.;Division of Allergy and Clinical Immunology, Department of Internal Medicine,;Seoul National University College of Medicine, Seoul, Korea. helenmed@snu.ac.kr. |
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