Dharmaraj Poonam, Smyth Rosalind L
Diabetes & Endocrinology, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool, UK, L12 2AP.
Cochrane Database Syst Rev. 2014 Mar 6;2014(3):CD001753. doi: 10.1002/14651858.CD001753.pub3.
Viral respiratory tract infections in people with cystic fibrosis have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for people with cystic fibrosis.
To assess the effectiveness of influenza vaccination for people with cystic fibrosis.
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 Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register: 08 July 2013.
All randomised and quasi-randomised trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine.
Two authors independently assessed study quality and extracted data. Additional information was obtained by contacting the investigators when it was indicated.
Four studies enrolling a total of 179 participants with cystic fibrosis (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 cystic fibrosis 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.
囊性纤维化患者发生的病毒性呼吸道感染会对其肺功能和疾病进展产生不良影响。因此,通常建议囊性纤维化患者每年接种流感疫苗。
评估流感疫苗对囊性纤维化患者的有效性。
我们检索了Cochrane囊性纤维化和遗传疾病小组试验注册库,该注册库包含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集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。Cochrane囊性纤维化和遗传疾病小组的囊性纤维化试验注册库的最新检索日期:2013年7月8日。
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)。
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更多信息。
本综述纳入了四项研究,共179名囊性纤维化患者(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疫苗或裂解病毒疫苗。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,所有报告的不良事件发生率都很高。总不良事件发生率范围从鼻内活疫苗组201名参与者中的48名(24%)到裂解病毒疫苗组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。
目前尚无随机研究证据表明给囊性纤维化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。