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美国疾病预防控制中心/食品药品监督管理局疫苗不良事件报告系统(1990-2009 年)中接种肝炎疫苗后发生格林-巴利综合征的数据分析。

Analysis of data from the CDC/FDA vaccine adverse event reporting system (1990-2009) on Guillain-Barre syndrome after hepatitis vaccination in the USA.

机构信息

Department of Neurology, University of Medicine and Dentistry of New Jersey, Newark, NJ 07103, USA.

出版信息

J Clin Neurosci. 2012 Aug;19(8):1089-92. doi: 10.1016/j.jocn.2011.11.022. Epub 2012 Jun 15.

DOI:10.1016/j.jocn.2011.11.022
PMID:22705140
Abstract

We used data from the Vaccine Adverse Event Reporting System, supplemented by additional data provided by the Center for Biologics Evaluation and Research, to identify 189 patients with Guillain-Barré syndrome (GBS) reported after hepatitis vaccination with a mean age of 30.65 years, affecting men and women equally. Among vaccinated patients, 133 (70%) developed GBS within six weeks, 30 (15.9%) after six weeks, and for the remaining 26 (13.7%), the time between GBS occurrence and vaccination was not specified. The reporting rate of post-hepatitis vaccine GBS is approximately 3.4 cases per one million vaccinations, which is in the range expected in the general population. The unbalanced distribution of reports in the first six weeks after vaccination suggests that some cases of GBS may be triggered by vaccination. Nonetheless, the low incidence of hepatitis vaccine-associated GBS, and the dramatic incidence reduction of hepatitis and its complications after vaccination, support the current guidelines for vaccination.

摘要

我们使用了疫苗不良事件报告系统的数据,并补充了生物制品评价和研究中心提供的额外数据,鉴定了 189 例接种肝炎疫苗后发生的格林-巴利综合征(GBS)病例,这些病例的平均年龄为 30.65 岁,男女发病比例相当。在接种疫苗的患者中,133 例(70%)在接种后 6 周内发生 GBS,30 例(15.9%)在 6 周后发生,对于其余 26 例(13.7%),GBS 发生与接种之间的时间未作具体说明。接种肝炎疫苗后发生 GBS 的报告率约为每百万剂疫苗 3.4 例,这处于一般人群的预期范围内。接种后前 6 周报告的分布不均衡,提示有些 GBS 病例可能由疫苗接种引发。尽管如此,肝炎疫苗相关 GBS 的发病率较低,且接种后肝炎及其并发症的发病率显著降低,这支持了当前的疫苗接种指南。

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Analysis of data from the CDC/FDA vaccine adverse event reporting system (1990-2009) on Guillain-Barre syndrome after hepatitis vaccination in the USA.美国疾病预防控制中心/食品药品监督管理局疫苗不良事件报告系统(1990-2009 年)中接种肝炎疫苗后发生格林-巴利综合征的数据分析。
J Clin Neurosci. 2012 Aug;19(8):1089-92. doi: 10.1016/j.jocn.2011.11.022. Epub 2012 Jun 15.
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