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Original Article
의약품부작용보고시스템 데이터베이스를 이용한 fluconazole 및 itraconazole 관련 이상사례 분석
Real-world Adverse Events Associated with Fluconazole and Itraconazole : Analysis of Nationwide Data Using a Spontaneous Reporting System Database
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- 발행기관
- 한국임상약학회 바로가기
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- 간행물
- 한국임상약학회지 KCI 등재 바로가기
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- 통권
- 제32권 제3호 (2022.09)바로가기
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- 페이지
- pp.204-214
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- 저자
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- 언어
- 영어(ENG)
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- URL
- https://www.earticle.net/Article/A418383
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원문정보
초록
- 영어
- Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.
목차
ABSTRACT
Methods
Data source
Analysis of AE reports
Statistical analysis
Results
Number of AE reports
Characteristics of AE reports and patients
DDI severity of the concomitant medications
Types of AEs
Types of AEs stratified by DDI severity
Factors involved in the occurrence of the specific type of AEs
Discussion
Conclusion
Acknowledgments
Conflict of interest
References
키워드
Adverse events drug-drug interaction fluconazole itraconazole저자
간행물 정보
발행기관
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- 발행기관명
- 한국임상약학회 [Korean College of Clinical Pharmacy]
- 설립연도
- 1
- 분야
- 의약학>약학
- 소개
- 합리적 약물치료(rational pharmacotherapy)의 보장 및 증진을 궁극목적으로 하며 이를 달성하기 위해 임상약학의 발전과 회원 상호간의 친목을 도모한다.
간행물
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- 간행물명
- 한국임상약학회지 [Korean Journal of Clinical Pharmacy]
- 간기
- 계간
- pISSN
- 1226-6051
- 수록기간
- 1991~2026
- 등재여부
- KCI 등재
- 십진분류
- KDC 518 DDC 615
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