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단일 상급종합병원에서의 중대한 약물 유해반응의 임상 양상
서유리 ( Yuri Seo ),한예슬 ( Yeseul Han ),김수현 ( Soo Hyun Kim ),손은선 ( Eun Sun Son ),심다운 ( Da Woon Sim ),박경희 ( Kyung Hee Park ),박중원 ( Jung-won Park ) 대한내과학회 2017 대한내과학회지 Vol.92 No.4
Background/Aims: Several studies have reported on the clinical aspects of adverse drug reactions (ADRs). To date, no study has evaluated serious adverse drug reactions (SADRs) in Korea. The current study evaluates the clinical expression of SADRs in a Korean hospital. Methods: We reviewed a total of 3,386 cases of SADR occurring between March 2012 and November 2015 in a single tertiary care institution (Regional Pharmacovigilance Center). Results: When classified by organ system, the most common SADRs were white cell and reticuloendothelial system disorders (n = 511). Skin/appendage (n = 296) and gastrointestinal (n = 216) disorders were the fourth- and eighth-most common SADRs, respectively. The three most common single symptoms were leukopenia (n = 499 events), hypotension (n = 444) and anaphylaxis (n = 215). Leukopenia was mainly caused by anti-tumor drugs, followed by piperacilin/tazobactam (n = 28), vancomycin (n = 10) and methimazole (n = 6). Hypotension was most often caused by propacetamol injection (n = 145), while anaphylaxis was mainly caused by cefaclor (n = 19), ranitidine (n = 12), iopamidol (n = 10) and multi-vitamin infusion (n = 9). Conclusions: Significant differences were noted in the clinical aspects of ADRs and SADRs. Additional studies are warranted to further assess SADRs in response to frequently used causative drugs. (Korean J Med 2017;92:392-400)