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韩国非国家免疫规划疫苗相关特定关注不良事件的哨点安全监测系统

Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea.

作者信息

Hyun Hakjun, Heo Jung Yeon, Choi Yu Jung, Nham Eliel, Yoon Jin Gu, Noh Ji Yun, Song Joon Young, Kim Woo Joo, Choi Won Suk, Choi Min Joo, Seo Yu Bin, Lee Jacob, Cheong Hee Jin

机构信息

Department of Infectious Diseases, Ajou University School of Medicine, Suwon, Korea.

Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.

出版信息

J Korean Med Sci. 2025 Apr 28;40(16):e152. doi: 10.3346/jkms.2025.40.e152.

Abstract

South Korea's current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI. We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for pre-defined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.

摘要

韩国目前的疫苗接种政策在非国家免疫规划(NIP)疫苗方面存在监测缺口。在本研究中,我们提出了一种哨点监测方法来监测非NIP疫苗的安全性。通过回顾五所大学医院的电子病历,对因预先定义的特殊关注不良事件(AESI)住院的患者进行回顾性疫苗接种数据收集。该方法纳入专家评估以确定因果关系。我们确认在860例被诊断为AESI的患者中有16例接种了非NIP疫苗。我们得出结论,1例先兆子痫可能与破伤风-白喉-百日咳疫苗接种有关。我们提出一种基于多医院的、针对预先定义的AESI的回顾性评估系统,作为主动疫苗安全性监测方法的替代方案。这些努力有望提高韩国安全性监测的准确性和及时性。

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本文引用的文献

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