Poole P J, Chacko E, Wood-Baker R W, Cates C J
Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand.
Cochrane Database Syst Rev. 2000(4):CD002733. doi: 10.1002/14651858.CD002733.
Influenza vaccinations are currently recommended in the care of people with COPD, but these recommendations are based largely on evidence from observational studies with very few randomised controlled trials (RCTs) reported. Influenza infection causes excess morbidity and mortality in COPD patients but there is also the potential for influenza vaccination to cause adverse effects or not to be cost effective.
To evaluate the evidence from RCTs for a treatment effect of influenza vaccination in COPD subjects. Outcomes of interest were exacerbation rates, hospitalisations, mortality, lung function and adverse effects.
We searched the Cochrane Airways Group trials register and reference lists of articles. References were also provided by a number of drug companies we contacted.
RCTs that compared live or inactivated virus vaccines with placebo, either alone or with another vaccine in persons with COPD. Studies of people with asthma were excluded.
Two reviewers extracted data. All entries were double checked. Study authors and drug companies were contacted for missing information.
Nine trials were included but only four of these were specifically performed in COPD patients. The others were conducted on elderly and high-risk individuals, some of whom had chronic lung disease. In one study of inactivated vaccine in COPD patients there was a significant reduction in the total number of exacerbations per vaccinated subject compared with those who received placebo (weighted mean difference (WMD) -0.45, 95% confidence interval -0.75 to -0.15, p = 0.004). This difference was mainly due to the reduction in exacerbations occurring after 3 weeks (WMD -0.44, (95% CI -0.68 to -0.20, p<0.001). The number of patients experiencing late exacerbations was also significantly less (OR= 0.13, 95%CI 0.04 to 0.45, p=0.002). There was no evidence of an effect of intranasal live attenuated virus when this was added to inactivated intramuscular vaccination. In studies in elderly patients (only a minority of whom had COPD), there was a significant increase in the occurrence of local adverse reactions in vaccinees, but the effects were generally mild and transient.
REVIEWER'S CONCLUSIONS: It appears, from the limited number of studies performed, that inactivated vaccine may reduce exacerbations in COPD patients. The size of effect was similar to that seen in large observational studies, and was due to a reduction in exacerbations occurring three or more weeks after vaccination. In elderly, high risk patients there was an increase in adverse effects with vaccination, but these are seen early and are usually mild and transient.
目前建议慢性阻塞性肺疾病(COPD)患者接种流感疫苗,但这些建议主要基于观察性研究的证据,随机对照试验(RCT)报道极少。流感感染会导致COPD患者发病率和死亡率增加,但流感疫苗也有可能产生不良反应或不具有成本效益。
评估RCT中关于流感疫苗对COPD患者治疗效果的证据。感兴趣的结局指标为急性加重率、住院率、死亡率、肺功能和不良反应。
我们检索了Cochrane Airways Group试验注册库和文章的参考文献列表。我们联系的多家制药公司也提供了参考文献。
将活病毒或灭活病毒疫苗与安慰剂进行比较的RCT,单独使用或与另一种疫苗联合用于COPD患者。哮喘患者的研究被排除。
两名评价员提取数据。所有条目都进行了双重核对。联系研究作者和制药公司获取缺失信息。
纳入了9项试验,但其中只有4项是专门针对COPD患者进行的。其他试验是在老年人和高危个体中进行的,其中一些人患有慢性肺病。在一项针对COPD患者的灭活疫苗研究中,与接受安慰剂的患者相比,接种疫苗的患者每人急性加重的总数显著减少(加权平均差(WMD)-0.45,95%置信区间-0.75至-0.15,p = 0.004)。这种差异主要是由于接种后3周后急性加重次数的减少(WMD -0.44,(95%CI -0.68至-0.20,p < 0.)。出现晚期急性加重的患者数量也显著减少(OR = 0.13,95%CI 0.04至0.45,p = 0.002)。当将鼻内减毒活病毒添加到肌肉注射灭活疫苗中时,没有证据表明有效果。在老年患者的研究中(其中只有少数患有COPD),接种疫苗者局部不良反应的发生率显著增加,但这些影响通常较轻且为一过性。
从进行的有限数量的研究来看,灭活疫苗似乎可以减少COPD患者的急性加重。效果大小与大型观察性研究中所见相似,且是由于接种疫苗三周或更长时间后急性加重次数减少所致。在老年高危患者中,接种疫苗后不良反应增加,但这些反应出现较早,通常较轻且为一过性。