[논문]의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색

백지원; 양보람; 최수빈; 신광희

doi:10.24304/kjcp.2021.31.4.324

의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색
Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database 원문보기

한국임상약학회지 = Korean journal of clinical pharmacy, v.31 no.4, 2021년, pp.324 - 331

백지원 (경북대학교 약학대학, 약학연구소) , 양보람 (충남대학교 약학대학) , 최수빈 (경북대학교 약학대학, 약학연구소) , 신광희 (경북대학교 약학대학, 약학연구소)

Abstract ▼ AI-Helper

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

주제어

참고문헌 (14)

Steers WD. 5alpha-reductase activity in the prostate. Urology 2001;58(6 Suppl 1):17-24.

상세보기
Nguyen DD, Marchese M, Cone EB, et al. Investigation of suicidality and psychological adverse events in patients treated with finasteride. JAMA Dermatol 2021;157(1):35-42.

상세보기
World Health Organization (WHO). VigiAccess TM . Available from http://www.vigiaccess.org. Accessed August 31, 2021.
Sica DA. Minoxidil: an underused vasodilator for resistant or severe hypertension. J Clin Hypertens (Greenwich) 2004;6(5):283-7.

상세보기
Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol 2004;150(2):186-94.

상세보기
Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol 2013;189(1 Suppl):S122-8.
Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidem Drug Saf 2001;10(6):483-6.

상세보기
Egberts AC, Meyboom RH, van Puijenbroek EP. Use of measures of disproportionality in pharmacovigilance: three Dutch examples. Drug Saf 2002;25(6):453-8.

상세보기
Lindquist M, Stahl M, Bate A, Edwards IR, Meyboom RH. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Saf 2000;23(6):533-42.

상세보기
Kim M-S, You S-H, Park HM, et al. Patterns of spontaneous adverse events reporting on human papillomavirus vaccines according to the applicability of Brighton Collaboration Criteria in Korea from 2008 to 2017. Korean J Clin Pharm 2020;30(1):19-30.

원문보기 상세보기
Baig MS, Kolasa-Wolosiuk A, Pilutin A, et al. Finasteride-induced inhibition of 5alpha-reductase type 2 could lead to kidney damage-animal, experimental study. Int J Environ Res Public Health 2019;16(10):1726.

상세보기
Traish AM. Health risks associated with long-term finasteride and dutasteride use: it's time to sound the alarm. World J Mens Health 2020;38(3):323-37.

상세보기
Irwig MS. Depressive symptoms and suicidal thoughts among former users of finasteride with persistent sexual side effects. J Clin Psychiatry 2012;73(9):1220-3.

상세보기
Melcangi RC, Caruso D, Abbiati F, et al. Neuroactive steroid levels are modified in cerebrospinal fluid and plasma of post-finasteride patients showing persistent sexual side effects and anxious/depressive symptomatology. J Sex Med 2013;10(10):2598-603.

상세보기

내보내기 구분	파일저장 인쇄 메일전송
구성항목	기본정보 상세정보 관리번호, 논문명, 저널/프로시딩명, 저자 , 발행년, 권, 호, 시작페이지, 끝페이지, 발행기관 관리번호, 논문명, 대등논문명, 저자 , 저널/프로시딩명, 발행기관, 발행년, 발행언어, 권, 호, 시작페이지, 끝페이지, ISBN, ISSN, 주제분야, 키워드, 초록(한글), 초록(영문), 저자(소속기관)
저장형식	Text(ASCII format) Excel format RefWorks Direct Export RIS format (for Reference Manager, ProCite, EndNote), Scholar's Aids, Mendeley
메일정보	받는사람 (필수) @ 보내는사람 (선택) @ 제목 내용 KISTI 검색결과 이메일 서비스
안내	총 건의 자료가 검색되었습니다. 다운받으실 자료의 인덱스를 입력하세요. (1-10,000) 검색결과의 순서대로 최대 10,000건 까지 다운로드가 가능합니다. 데이타가 많을 경우 속도가 느려질 수 있습니다.(최대 2~3분 소요) 다운로드 파일은 UTF-8 형태로 저장됩니다. 파일의 내용이 제대로 보이지 않을실 때는 웹브라우저 상단의 보기 -> 인코딩 -> 자동선택 여부를 확인하십시오. ~ Text(ASCII format) Excel format

연합인증

의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색
Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database 원문보기

Abstract ▼ AI-Helper

주제어

참고문헌 (14)

이 논문을 인용한 문헌

저자의 다른 논문 :

관련 콘텐츠

원문 보기

원문 URL 링크

오픈액세스(OA) 유형

이 논문과 함께 이용한 콘텐츠

AI-Helper ※ AI-Helper는 오픈소스 모델을 사용합니다.

선택된 텍스트

연합인증

의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색 Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database 원문보기

Abstract ▼ AI-Helper

주제어

참고문헌 (14)

이 논문을 인용한 문헌

저자의 다른 논문 :

신광희 (2)

관련 콘텐츠

원문 보기

원문 URL 링크

오픈액세스(OA) 유형

이 논문과 함께 이용한 콘텐츠

AI-Helper ※ AI-Helper는 오픈소스 모델을 사용합니다.

선택된 텍스트

의약품이상사례보고시스템 데이터베이스를 이용한 피나스테리드의 약물유해반응 실마리 정보 탐색
Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database 원문보기