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Original Article

국내 사람유두종바이러스백신 접종 후 자발적 이상반응 보고사례의 Brighton Collaboration 기준 활용 가능성 연구

원문정보

Patterns of Spontaneous Adverse Events Reporting on Human Papillomavirus Vaccines according to the Applicability of Brighton Collaboration Criteria in Korea from 2008 to 2017

김묘송, 유승훈, 박혜민, 이민택, 강예진, 구현지, 정선영

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초록

영어

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

목차

ABSTRACT
연구방법
자료원 및 연구대상 백신
연구대상 이상사례 용어 정의
통계분석
연구결과
고찰 및 결론
감사의 말씀
참고문헌

저자정보

  • 김묘송 Myo-Song Kim. 중앙대학교 약학대학
  • 유승훈 Seung-Hun You. 중앙대학교 약학대학
  • 박혜민 Hye Min Park. 중앙대학교 약학대학
  • 이민택 Min-Taek Lee. 중앙대학교 약학대학
  • 강예진 Ye-Jin Kang. 중앙대학교 약학대학
  • 구현지 Hyunji Koo. 중앙대학교 약학대학
  • 정선영 Sun-Young Jung. 중앙대학교 약학대학

참고문헌

자료제공 : 네이버학술정보

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