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用于预防囊性纤维化患者流感的疫苗。

Vaccines for preventing influenza in people with cystic fibrosis.

作者信息

Dharmaraj Poonam, Smyth Rosalind L

机构信息

Diabetes & Endocrinology, Alder Hey Children's Foundation Trust, Eaton Road, Liverpool, UK, L12 2AP.

出版信息

Cochrane Database Syst Rev. 2009 Oct 7(4):CD001753. doi: 10.1002/14651858.CD001753.pub2.

Abstract

BACKGROUND

Viral respiratory tract infections in people with cystic fibrosis (CF) have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for people with CF.

OBJECTIVES

To assess the effectiveness of influenza vaccination for people with CF.

SEARCH STRATEGY

We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also contacted the companies which market the influenza vaccines used in the trials to obtain further information about randomised controlled trials.Date of the most recent search of the Cystic Fibrosis Trials Register: 05 March 2009.

SELECTION CRITERIA

All randomised and quasi-randomised trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine.

DATA COLLECTION AND ANALYSIS

Two authors independently assessed study quality and extracted data. Additional information was obtained by contacting the investigators when it was indicated.

MAIN RESULTS

Four studies enrolling a total of 179 participants with CF (143 (80%) were children aged 1 to 16 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a subunit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and the other two studies compared a split virus to a subunit vaccine and a virosome to a subunit vaccine (all intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48 out of 201 participants (24%) for the intranasal live vaccine to 13 out of 30 participants (43%) for the split virus vaccine. With the limitation of a statistical low power there was no significant difference between the study vaccinations. None of the events were severe. All study influenza vaccinations generated a satisfactory serological antibody response. No study reported other clinically important benefits.

AUTHORS' CONCLUSIONS: There is currently no evidence from randomised studies that influenza vaccine given to people with CF is of benefit to them. There remains a need for a well-constructed clinical study, that assesses the effectiveness of influenza vaccination on important clinical outcome measures.

摘要

背景

囊性纤维化(CF)患者的病毒性呼吸道感染会对其肺功能和疾病进展产生恶化影响。因此,通常建议CF患者每年接种流感疫苗。

目的

评估流感疫苗对CF患者的有效性。

检索策略

我们检索了Cochrane囊性纤维化和遗传疾病小组试验注册库,该注册库包括通过全面电子数据库检索以及对相关期刊和会议论文摘要书籍进行手工检索而识别出的参考文献。我们还联系了试验中使用的流感疫苗的生产公司,以获取有关随机对照试验的更多信息。囊性纤维化试验注册库的最新检索日期:2009年3月5日。

选择标准

所有比较任何流感疫苗与安慰剂或另一种流感疫苗的随机和半随机试验(已发表或未发表)。

数据收集与分析

两位作者独立评估研究质量并提取数据。如有需要,通过联系研究者获取额外信息。

主要结果

本综述纳入了四项研究,共179名CF患者(143名(80%)为1至16岁儿童)。没有研究比较疫苗与安慰剂或全病毒疫苗与亚单位或裂解病毒疫苗。两项研究比较了鼻内接种的活疫苗与肌肉注射的灭活疫苗,另外两项研究比较了裂解病毒疫苗与亚单位疫苗以及病毒体疫苗与亚单位疫苗(均为肌肉注射)。根据流感疫苗的类型,所有报告不良事件的发生率都很高。不良事件总发生率范围从鼻内活疫苗的201名参与者中的48名(24%)到裂解病毒疫苗的30名参与者中的13名(43%)。由于统计效力较低,各研究疫苗之间无显著差异。所有事件均不严重。所有研究中的流感疫苗接种均产生了令人满意的血清学抗体反应。没有研究报告其他具有临床重要意义的益处。

作者结论

目前尚无随机研究证据表明CF患者接种流感疫苗对他们有益。仍需要进行一项精心设计的临床研究,以评估流感疫苗接种对重要临床结局指标的有效性。

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