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更新:美国2005年6月至2006年9月接种Menactra脑膜炎球菌结合疫苗者中的吉兰-巴雷综合征

Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine--United States, June 2005-September 2006.

出版信息

MMWR Morb Mortal Wkly Rep. 2006 Oct 20;55(41):1120-4.

PMID:17060898
Abstract

In October 2005, reports indicating a possible association between Guillain-Barré Syndrome (GBS) and receipt of meningococcal conjugate vaccine (MCV4) (Menactra, Sanofi Pasteur, Inc., Swiftwater, Pennsylvania) were made to the Vaccine Adverse Event Reporting System (VAERS). GBS is a serious neurologic disorder involving inflammatory demyelination of the peripheral nerves. During March 2005-February 2006, eight confirmed cases had occurred within 6 weeks (i.e., the time window of elevated risk noted for GBS after administration of other vaccines) after MCV4 vaccination. This report summarizes nine additional GBS cases reported to VAERS during March-September 2006. This report also provides a preliminary analysis of data from VAERS and the Vaccine Safety Datalink (VSD) since MCV4 became available in the United States in March 2005 and includes all 17 cases of GBS reported since June 2005. Although these data suggest a small increased risk for GBS after MCV4 vaccination, the inherent limitations of VAERS and the uncertainty regarding background incidence rates for GBS require that these findings be viewed with caution. Because of the risk for meningococcal disease and the associated morbidity and mortality, CDC continues to recommend routine vaccination with MCV4 for adolescents, college freshmen living in dormitories, and other populations at increased risk.

摘要

2005年10月,向疫苗不良事件报告系统(VAERS)提交了报告,表明格林-巴利综合征(GBS)与接种脑膜炎球菌结合疫苗(MCV4)(Menactra,赛诺菲巴斯德公司,宾夕法尼亚州斯威夫特沃特)之间可能存在关联。GBS是一种严重的神经系统疾病,涉及周围神经的炎性脱髓鞘。在2005年3月至2006年2月期间,8例确诊病例在接种MCV4疫苗后的6周内(即接种其他疫苗后GBS风险升高的时间窗)出现。本报告总结了2006年3月至9月期间向VAERS报告的另外9例GBS病例。本报告还对自2005年3月MCV4在美国上市以来VAERS和疫苗安全数据链(VSD)的数据进行了初步分析,包括自2005年6月以来报告的所有17例GBS病例。尽管这些数据表明接种MCV4疫苗后GBS风险略有增加,但VAERS的固有局限性以及GBS背景发病率的不确定性要求谨慎看待这些发现。由于存在脑膜炎球菌病风险以及相关的发病率和死亡率,美国疾病控制与预防中心(CDC)继续建议对青少年、居住在宿舍的大学新生以及其他风险增加人群常规接种MCV4疫苗。

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