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의약품부작용보고시스템 데이터베이스를 이용한 졸피뎀 약물 유해반응 실마리 정보 검출 / 한준우 외

9 보건의료 조회 수 350 추천 수 0 2019.04.30 13:17:28

도서관사서 *.121.130.253 https://www.nibp.kr/xe/info4_3/139482

발행년 :	2018
구분 :	국내학술지
학술지명 :	보건의료기술평가
관련링크 :	http://www.riss.kr/link?id=A106112451

의약품부작용보고시스템 데이터베이스를 이용한 졸피뎀 약물 유해반응 실마리 정보 검출

= Signal Detection of Adverse Drug Reaction of Zolpidem Using the Korea Adverse Event Reporting System Database

저자[authors] 한준우,김선지,고영진,박병주
학술지명[periodical name] 보건의료기술평가
권호사항[Volume/Issue] Vol.6No.1[2018]
발행처[publisher] 한국보건의료기술평가학회
자료유형[Document Type] 학술저널
수록면[Pagination] 43-49
언어[language] Korean
발행년[Publication Year] 2018

다국어 초록[Multilingual Abstract]

Objectives: To detect signals of adverse drug reactions of zolpidem by data mining using the Korea Adverse Events Reporting System (KAERS) database. Methods: This study used the Korea Institute of Drug Safety KAERS Database (KIDS-KD) reported from December 1988 to December 2015 through KAERS. Among them, signals were detected by data mining on the adverse events of zolpidem. In this study, we defined a signal that satisfies all three indices: proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC). And we checked whether the detected signals exist in drug labels in Korea, the United States, the United Kingdom, Germany, France, and Japan. Results: A total of 3012517 adverse event-drug pairs were reported from 1988 to 2015, of which 11814 were associated with zolpidem. Fifty nine signals were satisfying the criteria (PRR, ROR, and IC). Based on this, the detected signals were compared with the drug labels of six countries. As a result, 17 signals were not included in all the drug labels of 6 countries. Schizophrenic reaction, paronychia, dry eyes, intervertebral disc disorder, duodenal ulcer, extravasation, lactation nonpuerperal, lymphoedema, carcinoma squamous, hypercalcaemia, brain neoplasm benign, colon carcinoma, colitis ulcerative, renal papillary necrosis, ovarian cyst, hyperphosphataemia, and fluid overload. Conclusion: We identified 17 new signals of zolpidem that do not exist in drug labels in six countries. However, further pharmacoepidemiological studies should be needed to evaluate the causality of the signals with zolpidem.

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