儿童使用不含硫柳汞的hibitter®的不良结果检测。

IF 0.8 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Karl Jablonowski, Brian Hooker
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引用次数: 0

摘要

背景:b型流感嗜血杆菌(HIB)是一种革兰氏阴性致病菌,主要影响儿童和老年人群,有时导致永久性后遗症或死亡。目的:在本研究中,我们着手发现来自2003年1月至2007年6月佛罗里达医疗补助数据集(n = 277,484)的无硫柳汞hititer®疫苗的不良后果。方法:从佛罗里达医疗补助数据集中分离出接种HIB疫苗的儿童。使用其他HIB疫苗作为对照,我们分析了与HibTITER®疫苗相关的具有统计学意义的不良结局的诊断(结果中仅报告了p值显著性的最严格p值):研究显示在接种后30天内19个个体ICD-9编码与p值®疫苗呈正相关。在这些条件中,有14个有VAERS确证。这些疾病的严重程度从轻微到危及生命,涉及呼吸系统(如哮喘)、胃肠道、耳鼻喉科(如普通感冒)、皮肤病、全身性感染(如结核病)和其他疾病。结论:与接种其他HIB疫苗制剂的对照组相比,19种不同疾病的发生率显著升高。这些结果得到了VAERS数据库的证实,对估计有3500万年龄在16岁至33岁之间接种疫苗的美国人具有深远的医学意义。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse outcome detection of childhood administered thimerosal-free HibTITER®.

Background: Haemophilus influenzae type b (HIB) is a gram-negative pathogenic bacterium that mostly impacts the pediatric and geriatric population, sometimes resulting in permanent sequelae or death.

Objective: In this study we set out to discover adverse outcomes from the thimerosal-free HibTITER® vaccine derived from a Florida Medicaid dataset spanning from January 2003 to June 2007 (n = 277,484).

Methods: HIB vaccinated children were isolated from the Florida Medicaid dataset. Using other HIB vaccines as the control, we analyzed diagnoses for statistically significant adverse outcomes related to the HibTITER® vaccine (only the strictest p-value of <0.0001 was used in analyzing this dataset). We simultaneously and independently examined the statistical significance of symptoms reported to VAERS related to HIB vaccines to corroborate our findings (p-value significance was reported at <0.05, <0.001, and <0.0001).

Results: The study revealed 19 individual ICD-9 codes positively associated (p-value<0.0001 post Bonferroni correction) with recipients of the HibTITER® vaccine within 30-days of vaccination. Of these conditions, 14 have VAERS corroborators. The diseases span severity from mild to life-threatening and areas of respiration (e.g., asthma), gastrointestinal, otolaryngologic (e.g., common cold), dermatologic, generalized infections (e.g., tuberculosis), and other conditions.

Conclusion: Incidence of 19 different medical conditions was significantly higher compared to the control group who received other HIB vaccine formulations. These results were corroborated using the VAERS database, and have profound medical implications for the estimated 35 million Americans between the ages of 16 and 33 who received the vaccine.

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来源期刊
INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE
INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
2.20
自引率
17.60%
发文量
102
期刊介绍: The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed. This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety.
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