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撤回:预防炭疽的疫苗。

WITHDRAWN: Vaccines for preventing anthrax.

作者信息

Jefferson T, Demicheli V, Deeks J, Graves P, Pratt M, Rivetti D

出版信息

Cochrane Database Syst Rev. 2007 Jul 18;1998(1):CD000975. doi: 10.1002/14651858.CD000975.pub2.

Abstract

BACKGROUND

Anthrax is a potentially fatal bacterial disease with cutaneous, inhalation, and gastrointestinal forms. Three anthrax vaccines are commercially available, but their comparative effectiveness and safety is not clear.

OBJECTIVES

To assess the effectiveness and safety of vaccines against human anthrax in relation to adverse effects and disease incidence.

SEARCH STRATEGY

We searched the Cochrane Infectious Diseases Group Specialized Register (March 2004), CENTRAL (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to September 2005), EMBASE (1988 to September 2005), Science Citation Index (1981 to September 2005), the U.S. National Institutes of Health (NIH; September 2005), and the reference lists of articles. We contacted the UK Ministry of Defence, US Department of Defense, and individual researchers in the field.

SELECTION CRITERIA

Prospective randomized, quasi-randomized, and cluster randomized controlled trials comparing anthrax vaccines with placebo, other (non-anthrax) vaccines, or no intervention.

DATA COLLECTION AND ANALYSIS

Six reviewers independently assessed trial methodological quality and extracted data. Adverse effects data was collected from the trials.

MAIN RESULTS

Two trials involving 16,052 people met the inclusion criteria. Both trials had methodological limitations. Compared to placebo, vaccination was associated with a reduced risk of contracting anthrax (Relative Risk 0.16; 95% confidence interval 0.07 to 0.35). In the one trial reporting adverse effects, the killed vaccine was associated with a higher incidence of adverse effects compared to the placebo (Peto odds ratio 5.15; 95% confidence interval 2.28 to 11.61). Just over 5% of participants in the vaccine group reported adverse effects. The effectiveness of the vaccine does not appear to be influenced by the route of inoculation (scarifaction compared to needless injection - odds ratio 1.61; 95% confidence interval 0.39 to 6.75).

AUTHORS' CONCLUSIONS: Killed anthrax vaccines appear to be effective in reducing the risk of contracting anthrax with low rate of adverse effects. Further research should be carried out on the short and long term safety effects of available vaccines and if possible their effectiveness.

摘要

背景

炭疽是一种潜在的致命性细菌疾病,有皮肤型、吸入型和胃肠型。有三种炭疽疫苗可供商业使用,但其相对有效性和安全性尚不清楚。

目的

评估抗人炭疽疫苗在不良反应和疾病发病率方面的有效性和安全性。

检索策略

我们检索了Cochrane传染病组专业注册库(2004年3月)、Cochrane系统评价数据库(2005年第3期)、MEDLINE(1966年至2005年9月)、EMBASE(1988年至2005年9月)、科学引文索引(1981年至2005年9月)、美国国立卫生研究院(2005年9月)以及文章的参考文献列表。我们联系了英国国防部、美国国防部以及该领域的个别研究人员。

选择标准

比较炭疽疫苗与安慰剂、其他(非炭疽)疫苗或无干预措施的前瞻性随机、半随机和整群随机对照试验。

数据收集与分析

六位评价员独立评估试验方法学质量并提取数据。从试验中收集不良反应数据。

主要结果

两项涉及16052人的试验符合纳入标准。两项试验均存在方法学局限性。与安慰剂相比,接种疫苗可降低感染炭疽的风险(相对风险0.16;95%置信区间0.07至0.35)。在一项报告不良反应的试验中,与安慰剂相比,灭活疫苗的不良反应发生率更高(Peto比值比5.15;95%置信区间2.28至11.61)。疫苗组中略超过5%的参与者报告有不良反应。疫苗的有效性似乎不受接种途径的影响(划痕接种与皮下注射相比——比值比1.61;95%置信区间0.39至6.75)。

作者结论

灭活炭疽疫苗似乎能有效降低感染炭疽的风险,不良反应发生率较低。应进一步研究现有疫苗的短期和长期安全性影响以及其有效性(如有可能)。

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引用本文的文献

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