Tan A, Bhalla P, Smyth R
Neonatal Unit, Royal Women's Hospital, 132 Grattan Street, Melbourne, Victoria, Australia, 3053.
Cochrane Database Syst Rev. 2000(2):CD001753. doi: 10.1002/14651858.CD001753.
Viral respiratory tract infections in patients with cystic fibrosis have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for patients with cystic fibrosis.
To assess the effectiveness of influenza vaccination for patients with cystic fibrosis.
We have used the Cochrane Cystic Fibrosis and Genetic Disorders Group specialist trials register which comprises references identified from comprehensive electronic database searches, hand searching relevant journals and abstract books of conference proceedings and communication to the drug companies marketing influenza vaccines.
All randomised and pseudorandomised trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine.
Both reviewers independently assessed trial quality and extracted data. Additional information were obtained by contacting the investigators when it was indicated.
Three trials enrolling a total of 115 patients with cystic fibrosis (76 (66%) were children aged one to 13 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a sub unit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and one study compared a split virus to a sub unit vaccine (both intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48/201 (24%) for the intranasal live vaccine to 13/30 (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 trial reported other clinically important benefits.
REVIEWER'S CONCLUSIONS: There is currently no evidence from randomised studies that influenza vaccine given to patients with cystic fibrosis is of benefit to them. There is 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。
我们使用了Cochrane囊性纤维化和遗传疾病小组的专业试验注册库,该注册库包含通过全面电子数据库检索、手工检索相关期刊以及会议论文摘要书籍并与销售流感疫苗的制药公司沟通所确定的参考文献。
所有比较任何流感疫苗与安慰剂或与另一种流感疫苗的随机和半随机试验(已发表或未发表)。
两位综述作者独立评估试验质量并提取数据。如有需要,通过联系研究者获取额外信息。
本综述纳入了三项试验,共115例囊性纤维化患者(76例(66%)为1至13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活疫苗与肌肉注射灭活疫苗,一项研究比较了裂解病毒疫苗与亚单位疫苗(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。总不良事件发生率从鼻内活疫苗的48/201(24%)到裂解病毒疫苗的13/30(43%)不等。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。没有试验报告其他临床上重要的益处。
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。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。