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预防霍乱的疫苗。

Vaccines for preventing cholera.

作者信息

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

机构信息

SPC Pacific Regional Vector-Borne Diseases Project, PO Box R272, Honiara, Solomon Islands.

出版信息

Cochrane Database Syst Rev. 2000(4):CD000974. doi: 10.1002/14651858.CD000974.

Abstract

BACKGROUND

Oral cholera vaccines are newer alternatives to the parenteral vaccines which have been thought to confer only moderate and short-term immunity.

OBJECTIVES

The objective of this review was to assess the effect of cholera vaccines in preventing cases of cholera and preventing deaths.

SEARCH STRATEGY

We searched the Cochrane Infectious Diseases Group trials register, Medline, Embase and reference lists of articles. We handsearched the journal Vaccine, contacted researchers in the field and manufacturers.

SELECTION CRITERIA

Randomised and quasi-randomised studies comparing cholera vaccines (killed or live) with placebo, control vaccines or no intervention, or comparing types, doses or schedules of cholera vaccine. We included adults and children irrespective of immune status or special risk category.

DATA COLLECTION AND ANALYSIS

Data extraction and assessment of trial quality was done independently by two reviewers.

MAIN RESULTS

Twenty-five trials were included. Eighteen efficacy trials of relatively good quality, testing parenteral and oral killed whole cell vaccines and involving over 2.6 million adults, children and infants were included. No randomised efficacy trials of live vaccines were available and therefore this review is restricted to killed vaccines only. Eleven safety trials have been conducted for both types of killed whole cell vaccines and have involved 9,342 people. For killed whole cell vaccines compared to placebo, the relative risk of contracting cholera at 12 months was 0.49, 95% confidence interval 0.41 to 0.59 (random effects model). This translates to an efficacy of 51%, 95% confidence interval 41% to 59%. Both parenteral and oral administration were relatively efficacious, but significant protection extended into the third year for oral killed whole cell vaccines. Children under 5 were only protected for up to a year, while older children or adults were protected for up to three years. Parenteral killed whole cell vaccines were associated with increased systemic and local adverse effects compared to placebo, while oral killed whole cell vaccines were not.

REVIEWER'S CONCLUSIONS: Cholera killed whole cell vaccines appear to be relatively effective and safe. Protection against cholera appears to persist for up to two years following a single dose of vaccine, and for three to four years with an annual booster.

摘要

背景

口服霍乱疫苗是注射用疫苗的较新替代方案,注射用疫苗被认为只能提供中等程度的短期免疫力。

目的

本综述的目的是评估霍乱疫苗在预防霍乱病例和预防死亡方面的效果。

检索策略

我们检索了Cochrane传染病组试验注册库、Medline、Embase以及文章的参考文献列表。我们手工检索了《疫苗》杂志,联系了该领域的研究人员和制造商。

选择标准

比较霍乱疫苗(灭活或活疫苗)与安慰剂、对照疫苗或无干预措施的随机和半随机研究,或比较霍乱疫苗的类型、剂量或接种程序的研究。我们纳入了成人和儿童,无论其免疫状态或特殊风险类别如何。

数据收集与分析

由两名审阅者独立进行数据提取和试验质量评估。

主要结果

纳入了25项试验。包括18项质量相对较好的疗效试验,测试了注射用和口服灭活全细胞疫苗,涉及超过260万成人、儿童和婴儿。没有活疫苗的随机疗效试验,因此本综述仅限于灭活疫苗。针对两种类型的灭活全细胞疫苗都进行了11项安全性试验,涉及9342人。与安慰剂相比,灭活全细胞疫苗在12个月时感染霍乱的相对风险为0.49,95%置信区间为0.41至0.59(随机效应模型)。这相当于51%的效力,95%置信区间为41%至59%。注射和口服给药都相对有效,但口服灭活全细胞疫苗的显著保护作用可延续至第三年。5岁以下儿童仅在一年内得到保护,而大龄儿童或成人则在三年内得到保护。与安慰剂相比,注射用灭活全细胞疫苗会增加全身和局部不良反应,而口服灭活全细胞疫苗则不会。

审阅者结论

霍乱灭活全细胞疫苗似乎相对有效且安全。单剂量疫苗接种后对霍乱的保护作用似乎可持续长达两年,每年加强接种一次则可持续三至四年。

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