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Original Article

의약품부작용보고시스템을 이용한 바레니클린의 이상사례 실마리정보 도출

원문정보

Signal detection for adverse event of varenicline in Korea Adverse Event Reporting System

장민교, 구현진, 김준우, 신광희

피인용수 : 0(자료제공 : 네이버학술정보)

초록

영어

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

목차

ABSTRACT
연구 방법
자료원과 연구약제
이상사례의 정의
데이터마이닝을 이용한 실마리정보
통계분석
연구 결과
바레니클린의 보고된 모든 이상사례 현황
바레니클린 처방 환자 이상사례의 인구학적 및 임상적 특성
금연 치료 처방에 미치는 이상사례 파악을 위한 데이터마이닝 지표 분석
고찰
결론
참고문헌

저자정보

  • 장민교 Min-Gyo Jang. 경북대학교 약학대학, 약학연구소
  • 구현진 Hyun-Jin Gu. 경북대학교 약학대학, 약학연구소
  • 김준우 Junwoo Kim. 대구보건대학교병원 가정의학과
  • 신광희 Kwang-Hee Shin. 경북대학교 약학대학, 약학연구소

참고문헌

자료제공 : 네이버학술정보

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