약물유해사례 자발보고자료를 통한 국내 중증피부유해반응 원인 약물 분석
Analysis of Drugs Causing Severe Cutaneous Adverse Reactions, Based on the Korean Database of Spontaneously Reported Adverse Drug Reactions
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초록
Background/Aims: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia andsystemic symptoms (DRESS) are severe cutaneous adverse reactions (SCARs) that also affect the internal organs with highmortality. 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, collectedfrom June 2009 to December 2010, by a spontaneous reporting system. We analyzed age, gender, route of administration and thecausative 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 patientswas 54.1 ± 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 werethe most common drug category (75 cases). Carbamazepine was the most commonly reported causative drug according topublished cases in Korea. Conclusions: Allopurinol in the spontaneous reporting system and carbamazepine in the published cases were the most commonsingle causative drugs in SCARs in Korea. Anti-infectives were the most common drug category in the spontaneous reportingsystem.
Abstract
Background/Aims: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia andsystemic symptoms (DRESS) are severe cutaneous adverse reactions (SCARs) that also affect the internal organs with highmortality. 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, collectedfrom June 2009 to December 2010, by a spontaneous reporting system. We analyzed age, gender, route of administration and thecausative 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 patientswas 54.1 ± 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 werethe most common drug category (75 cases). Carbamazepine was the most commonly reported causative drug according topublished cases in Korea. Conclusions: Allopurinol in the spontaneous reporting system and carbamazepine in the published cases were the most commonsingle causative drugs in SCARs in Korea. Anti-infectives were the most common drug category in the spontaneous reportingsystem.
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