지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2020.1
- 수록면
- 243 - 250 (8page)
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초록· 키워드
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Purpose: We aimed to analyze the surveillance reports of adverse events (AEs) due to different types of pneumococcal vaccines,in addition to detecting and validating signals of pneumococcal vaccines by comparing AEs with labels. Materials and Methods: We analyzed the percentages of AEs according to vaccine type [pneumococcal polysaccharide vaccines(PPSVs) and pneumococcal conjugate vaccines (PCVs)] in children and adults using data from the Korea Adverse Event ReportingSystem (KAERS) database from 2005 to 2016. A signal was defined as an AE that met all three indices of data mining: proportionalreporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). We validated the detected signals bycalculating sensitivity, specificity, as well as positive and negative predictive values of the signals against label information. Results: Of the 39933 AE reports on vaccination, 5718 (7.0%) were related to pneumococcal vaccine. The most frequent AE aftervaccination with PPSV was fever (23.9%) in children and injection-site reaction in adults. The most frequent AE after vaccinationwith PCV in children was pharyngitis (26.2%). In total, 13 AEs met all three indices for signal detection. Among these, hypotension,apathy, sepsis, and increased serum glutamic oxaloacetic transaminase level were not listed on vaccine labels. In validation analysis,PRR and ROR performed slightly better than IC for adults who were vaccinated with PPSVs. Conclusion: Overall, 13 new signals of PPSVs, including four signals not listed on the labels, were detected. Further researchbased on additional AE reports is required to confirm the validity of these signals for children.
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