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牛痘免疫球蛋白:现行政策、防范措施以及产品安全性和有效性

Vaccinia immune globulin: current policies, preparedness, and product safety and efficacy.

作者信息

Wittek Riccardo

机构信息

Institut de Biotechnologie, University of Lausanne, CH-1015 Lausanne, Switzerland.

出版信息

Int J Infect Dis. 2006 May;10(3):193-201. doi: 10.1016/j.ijid.2005.12.001. Epub 2006 Mar 27.

DOI:10.1016/j.ijid.2005.12.001
PMID:16564720
Abstract

In 1980 the World Health Organization declared that smallpox was eradicated from the world, and routine smallpox vaccination was discontinued. Nevertheless, samples of the smallpox virus (variola virus) were retained for research purposes, not least because of fears that terrorist groups or rogue states might also have kept samples in order to develop a bioweapon. Variola virus represents an effective bioweapon because it is associated with high morbidity and mortality and is highly contagious. Since September 11, 2001, countries around the world have begun to develop policies and preparedness programs to deal with a bioterror attack, including stockpiling of smallpox vaccine. Smallpox vaccine itself may be associated with a number of serious adverse events, which can often be managed with vaccinia immune globulin (VIG). VIG may also be needed as prophylaxis in patients for whom pre-exposure smallpox vaccine is contraindicated (such as those with eczema or pregnant women), although it is currently not licensed in these cases. Two intravenous formulations of VIG (VIGIV Cangene and VIGIV Dynport) have been licensed by the FDA for the management of patients with progressive vaccinia, eczema vaccinatum, severe generalized vaccinia, and extensive body surface involvement or periocular implantation following inadvertent inoculation.

摘要

1980年,世界卫生组织宣布天花已在全球根除,常规天花疫苗接种也随之停止。然而,天花病毒(痘苗病毒)样本被保留用于研究目的,这主要是因为担心恐怖组织或流氓国家也可能留存了样本以研发生物武器。痘苗病毒是一种有效的生物武器,因为它会导致高发病率和高死亡率,且具有高度传染性。自2001年9月11日以来,世界各国已开始制定政策和准备计划以应对生物恐怖袭击,包括储备天花疫苗。天花疫苗本身可能会引发一些严重的不良事件,这些事件通常可用牛痘免疫球蛋白(VIG)进行处理。对于暴露前天花疫苗接种禁忌的患者(如患有湿疹者或孕妇),可能也需要使用VIG进行预防,尽管目前在这些情况下VIG尚未获得许可。两种静脉注射用VIG制剂(Cangene公司的VIGIV和Dynport公司的VIGIV)已获得美国食品药品监督管理局(FDA)许可,用于治疗进行性牛痘、牛痘性湿疹、严重全身性牛痘以及意外接种后广泛的体表受累或眼周植入的患者。

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