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의약품부작용보고시스템(KAERS)을 활용한 예방접종 이상반응 분석
차혜경(Cha, Hye-gyeong) 한국웰니스학회 2016 한국웰니스학회지 Vol.11 No.3
본 연구의 목적은 예방접종 이상반응의 보고사례 분석을 통해 보다 안전한 예방접종을 위한 인과성 연구 및 정책마련에 기초 자료를 제공하기 위함이다. 이를 위해 한국의약품안전관리원의 의약품부작용보고시스템(KAERS)에 2013월 1월부터 12월까지 보고된 3,217건의 의약품부작용원시자료(KIDS KAERS database, KIDS-KD)를 SPSS 22.0 통계 프로그램을 통해 분석하였다. 연구결과 예방접종 이상반응은 투여부위 이상반응, 전신 이상반응, 위장계 이상반응 순으로 많이 나타났으며, 백신별로는 Flu(Influenza) 백신, PCV(Pneumococcal Vaccines), Hib(Haemophilus influenzae type B) 백신, HPV(Human papillomavirus) 백신 순으로 나타났고, 48건의 심각한 예방접종 이상반응의 사례도 보고되었다. 향후 안전한 예방접종이 되기 위해서는 예방접종 이상반응 영향요인을 규명하기 위한 연구가 이루어져야 하며, 이를 위하여 대상자의 일반적 특성 및 질병관련 특성을 포함한 구체적인 보고가 되어야 하고, 예방접종 이상반응에 대한 의료인의 보고를 확대하여 지속적인 모니터링이 이루어져야 한다. The purpose of this study was to provide basic materials for causal research and policy preparation for safer vaccination by investigating information on adverse events following immunization(AEFI). This study employed KIDS KAERS database(KIDS-KD) of 3,217 cases reported between January 2013 and December 2013 through the Korea Adverse Event Reporting System(KAERS) in the Korea Institute of Drug Safety & Risk Management(KIDS). Data were analyzed with a statistical program SPSS 22.0. From the results of this study, AEFI were found in application site disorders, body as a whole-general disorders and gastrointestinal system disorders in order of incidence. As for classification of vaccine, the largest number of adverse events was found in Flu vaccine. The second was PCV, and adverse events of Hib vaccine and HPV vaccine were found in order of incidence. As a whole, serious 48 AEFI were reported. For safer vaccination, it is necessary to carry out research related to factors influencing on AEFI, to make close reports including general characteristics and diseases-related characteristics of the subjects to this end, and to continue to monitor AEFI with the extended reports of medical personnel.
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자발적 의약품 부작용 보고자료를 이용한 성별에 따른 부작용 발현 차이
연하림(Ha Rim Yeon),강상오(Sang Oh Kang),민경현(Kyung Hyun Min),최윤정(Yunjeong Choi),황보영(Boyoung Hwang),김현정(Hyun Jeong Kim),이경은(Kyung Eun Lee) 대한약학회 2020 약학회지 Vol.64 No.1
The aim of this study was to assess and characterize sex differences in adverse drug reactions (ADRs) reported to the Korea Institute of Drug Safety and Risk Management (KIDS). This retrospective pharmacoepidemiological study was performed using the Korea Adverse Event Reporting System (KAERS) database from the KIDS in 2014-2018. Variables used in the analyses include sex and age of patients, suspected drug, type and severity of ADR, and severity of ADR. A ratio of reports concerning women and men was calculated for ADRs reported. A dataset of 22 drugs selected from the FDA label and UpToDate?? database were requested to KIDS. Among 22 drugs, 17 of them were reported as suspected drugs to cause ADR and these were further analyzed in detail. The total reported number of ADRs was 241,974 and reports from female patients comprised of 54.5%. Aprepitant had the highest number of ADR reports (n=179,716), followed by fluorouracil (n=17,807), oxycodone (n=14,643) and cisplatin (n=14,191). Reports of serious adverse events were mostly from aprepitant and evidently high in female patients in aprepitant. Sex differences exist in ADRs based on KIDS-KAERS database which varies among drugs and type of ADRs. Further studies are warranted to examine details of clinical information of patients to conclude gender differences in adverse drug reactions.
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