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2009-2010 年疫苗安全数据链接项目中单价流感 A(H1N1) 疫苗和季节性流感疫苗接种后确诊吉兰-巴雷综合征的风险。

Risk of confirmed Guillain-Barre syndrome following receipt of monovalent inactivated influenza A (H1N1) and seasonal influenza vaccines in the Vaccine Safety Datalink Project, 2009-2010.

机构信息

Department of Population Medicine, Harvard Medical School, Boston, Massachusetts, USA.

出版信息

Am J Epidemiol. 2012 Jun 1;175(11):1100-9. doi: 10.1093/aje/kws195. Epub 2012 May 11.

Abstract

An increased risk of Guillain-Barré syndrome (GBS) following administration of the 1976 swine influenza vaccine led to a heightened focus on GBS when monovalent vaccines against a novel influenza A (H1N1) virus of swine origin were introduced in 2009. GBS cases following receipt of monovalent inactivated (MIV) and seasonal trivalent inactivated (TIV) influenza vaccines in the Vaccine Safety Datalink Project in 2009-2010 were identified in electronic data and confirmed by medical record review. Within 1-42 days following vaccination, 9 cases were confirmed in MIV recipients (1.48 million doses), and 8 cases were confirmed in TIV-only recipients who did not also receive MIV during 2009-2010 (1.72 million doses). Five cases following MIV and 1 case following TIV-only had an antecedent respiratory infection, a known GBS risk factor; furthermore, unlike TIV, MIV administration was concurrent with heightened influenza activity. In a self-controlled risk interval analysis comparing GBS onset within 1-42 days following MIV with GBS onset 43-127 days following MIV, the risk difference was 5.0 cases per million doses (95% confidence interval: 0.5, 9.5). No statistically significant increased GBS risk was found within 1-42 days following TIV-only vaccination versus 43-84 days following vaccination (risk difference = 1.1 cases per million doses, 95% confidence interval: -3.1, 5.4). Further evaluation to assess GBS risk following both vaccination and respiratory infection is warranted.

摘要

1976 年猪流感疫苗接种后吉兰-巴雷综合征(GBS)风险增加,导致 2009 年引入针对新型甲型流感(H1N1)猪源病毒的单价疫苗时,对 GBS 的关注度提高。2009-2010 年疫苗安全数据链接项目中,在电子数据中确定了单价灭活(MIV)和季节性三价灭活(TIV)流感疫苗接种后发生的 GBS 病例,并通过病历审查进行了确认。在接种后 1-42 天内,9 例 MIV 接种者(148 万剂)确诊,8 例仅 TIV 接种者(2009-2010 年未接种 MIV)确诊,TIV 仅接种者未接种 MIV。在 MIV 后 5 例和 TIV 后 1 例中,有 1 例有前驱呼吸道感染,这是已知的 GBS 危险因素;此外,与 TIV 不同,MIV 给药与流感活动增加同时发生。在比较 MIV 接种后 1-42 天内 GBS 发病与 MIV 接种后 43-127 天内 GBS 发病的自我对照风险间隔分析中,风险差异为每百万剂 5.0 例(95%置信区间:0.5,9.5)。在 TIV 仅接种后 1-42 天内与接种后 43-84 天内,未发现 GBS 风险显著增加(风险差异=每百万剂 1.1 例,95%置信区间:-3.1,5.4)。需要进一步评估接种和呼吸道感染后 GBS 的风险。

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