Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study.
Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study.
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DOI：
10.1371/journal.pone.0162520
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发表时间：
2016
期刊：
影响因子：
3.7
通讯作者：
Valentiner-Branth P
中科院分区：
文献类型：
--
作者：
Mølbak K;Hansen ND;Valentiner-Branth P
自2013年以来，向丹麦药品管理局（DMA）报告的四价人乳头瘤病毒（HPV）疫苗疑似不良反应的数量有所增加。由于公众对疫苗安全性的担忧，儿童疫苗接种计划中HPV疫苗的覆盖率有所下降。本研究的目的是确定怀疑对HPV疫苗有不良反应的女性在首次接种HPV疫苗前的就医情况。在这项基于登记的病例对照研究中，我们纳入了向DMA报告疑似严重不良反应的接种疫苗的女性病例。我们从丹麦疫苗接种登记处选择没有不良反应报告的对照组，并按接种年份、接种年龄和市政府进行匹配，并从丹麦国家患者登记处和国家健康保险服务登记处获得首次接种疫苗前两年的医疗保健使用史。我们通过逻辑回归分析数据，同时调整匹配变量。该研究包括2006年至2014年期间接受第一次HPV疫苗的316例病例。病例的年龄范围为11至52岁，高峰为12岁，这与接种疫苗的建议年龄相对应，另一个高峰为19至28岁，这与针对年轻妇女的追赶方案相对应。与163，910名对照组相比，在接受第一次HPV疫苗之前的两年内，寻求护理的病例有所增加。多变量模型显示，电话/电子邮件咨询（OR 1.9; 95% CI 1.2-3.2）、物理治疗（OR 2.1; 95% CI 1.6-2.8）和心理学家/精神科医生（OR 1.9; 95% CI 1.3-2.7）的使用率较高。病例更可能在ICD-10消化系统疾病章节中得到诊断（OR 1.6; 95% CI 1.0-2.4），肌肉骨骼系统（OR 1.6; 95% CI 1.1-2.2）、未分类的症状或体征（OR 1.8; 95% CI 1.3-2.5）以及损伤（OR 1.5; 95% CI 1.2-1.9）。在接受第一次HPV疫苗接种之前，怀疑有不良反应的女性有与匹配人群不同的症状和就医模式。在评价疫苗安全性信号时应考虑接种前发病率。
Since 2013 the number of suspected adverse reactions to the quadrivalent human papillomavirus (HPV) vaccine reported to the Danish Medicines Agency (DMA) has increased. Due to the resulting public concerns about vaccine safety, the coverage of HPV vaccinations in the childhood vaccination programme has declined. The aim of the present study was to determine health care-seeking prior to the first HPV vaccination among females who suspected adverse reactions to HPV vaccine. In this registry-based case-control study, we included as cases vaccinated females with reports to the DMA of suspected severe adverse reactions. We selected controls without reports of adverse reactions from the Danish vaccination registry and matched by year of vaccination, age of vaccination, and municipality, and obtained from the Danish National Patient Registry and The National Health Insurance Service Register the history of health care usage two years prior to the first vaccine. We analysed the data by logistic regression while adjusting for the matching variables. The study included 316 cases who received first HPV vaccine between 2006 and 2014. Age range of cases was 11 to 52 years, with a peak at 12 years, corresponding to the recommended age at vaccination, and another peak at 19 to 28 years, corresponding to a catch-up programme targeting young women. Compared with 163,910 controls, cases had increased care-seeking in the two years before receiving the first HPV vaccine. A multivariable model showed higher use of telephone/email consultations (OR 1.9; 95% CI 1.2–3.2), physiotherapy (OR 2.1; 95% CI 1.6–2.8) and psychologist/psychiatrist (OR 1.9; 95% CI 1.3–2.7). Cases were more likely to have a diagnosis in the ICD-10 chapters of diseases of the digestive system (OR 1.6; 95% CI 1.0–2.4), of the musculoskeletal system (OR 1.6; 95% CI 1.1–2.2), symptoms or signs not classified elsewhere (OR 1.8; 95% CI 1.3–2.5) as well as injuries (OR 1.5; 95% CI 1.2–1.9). Before receiving the first HPV vaccination, females who suspected adverse reactions has symptoms and a health care-seeking pattern that is different from the matched population. Pre-vaccination morbidity should be taken into account in the evaluation of vaccine safety signals.
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影响因子：
--
作者：
Reid, S;Wessely, S;Hotopf, M
通讯作者：
Hotopf, M
影响因子：
120.7
作者：
Scheller, Nikolai Madrid;Svanstrom, Henrik;Hviid, Anders
通讯作者：
Hviid, Anders
影响因子：
5.5
作者：
Donegan, Katherine;Beau-Lejdstrom, Raphaelle;Bryan, Philip
通讯作者：
Bryan, Philip
DOI：
10.1136/bmj.f5906
发表时间：
2013-10-09
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Arnheim-Dahlström L;Pasternak B;Svanström H;Sparén P;Hviid A
通讯作者：
Hviid A
影响因子：
5.5
作者：
Callreus, Torbjoern;Svanstroem, Henrik;Hviid, Anders
通讯作者：
Hviid, Anders