@文章{信息:doi/10.2196/17446,作者=“刘志科张梁杨宇孟若谷方、婷董颖李宁徐国章詹思燕”,标题=“人乳头瘤病毒疫苗接种不良事件主动监测:基于宁波市区域卫生保健信息平台的可行性初步研究”,期刊=“J医学互联网研究”,年=“2020”,月=“6”,日=“1”,卷=“22”,数=“6”,页数=“e17446”,关键词=“安全性;人乳头状瘤病毒;人类乳头状瘤病毒;疫苗;背景:疫苗许可后的全面安全监测数据,特别是主动监测,可以指导管理部门和个人做出合理的疫苗接种决策。因此,我们设计了一项试点研究,以评估区域卫生保健信息平台积极监测新获许可疫苗安全性的能力。目的:本研究旨在基于该信息平台对人乳头瘤病毒(HPV)疫苗安全性进行主动监测。方法:2017年选择国内最成熟、数据联动优势的信息平台之一。制定结构化问卷和开放式访谈指南,以调查利用宁波市区域卫生保健信息平台进行HPV疫苗接种后主动监测的可行性。调查问卷通过电子邮件发送给参与者,并进行面对面访谈以确认细节或解决差异。 Results: Five databases that could be considered essential to active surveillance of vaccine safety were integrated into the platform starting in 2015. Except for residents' health records, which had a coverage rate of 87{\%}, the data sources covered more than 95{\%} of the records that were documented in Ningbo. All the data could be inherently linked using the national identity card. There were 19,328 women who received the HPV vaccine, and 37,988 doses were administered in 2017 and 2018. Women aged 30-40 years accounted for the largest proportion. Quadrivalent vaccination accounted for 73.1{\%} of total vaccination, a much higher proportion than that of bivalent vaccination. Of the first doses, 60 (60/19,328, 0.31{\%}) occurred outside Ningbo. There were no missing data for vaccination-relevant variables, such as identity card, vaccine name, vaccination doses, vaccination date, and manufacturer. ICD-10 coding could be used to identify 9,180 cases using a predefined list of the outcomes of interest, and 1.88{\%} of these cases were missing the identity card. During the 90 days following HPV vaccination, 4 incident cases were found through the linked vaccination history and electronic medical records. The combined incident rate of rheumatoid arthritis, optic neuritis, and Henoch-Schonlein purpura was 8.84/100,000 doses of bivalent HPV, and the incidence rate of rheumatoid arthritis was 3.75/100,000 doses of quadrivalent HPV. Conclusions: This study presents an available approach to initiate an active surveillance system for adverse events following HPV vaccination, based on a regional health care information platform in China. An extended observation period or the inclusion of additional functional sites is warranted to conduct future hypothesis-generating and hypothesis-confirming studies for vaccine safety concerns. ", issn="1438-8871", doi="10.2196/17446", url="//www.mybigtv.com/2020/6/e17446", url="https://doi.org/10.2196/17446", url="http://www.ncbi.nlm.nih.gov/pubmed/32234696" }
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