Demicheli V, Rivetti D, Deeks J J, Jefferson T O
Servizo Sovrazonale di Epidemiologia, ASL 20, Via Venezia 6, Alessandria, Piemonte, Italy, 15100.
Cochrane Database Syst Rev. 2004(3):CD001269. doi: 10.1002/14651858.CD001269.pub2.
Three different types of influenza vaccines are currently produced worldwide. None is traditionally targeted to healthy adults. Despite the publication of a large number of clinical trials, there is still substantial uncertainty about the clinical effectiveness of influenza vaccines and this has negative impact on the vaccines acceptance and uptake.
To assess the effects of vaccines on influenza in healthy adults. To assess the effectiveness of vaccines in preventing cases of influenza in healthy adults. To estimate the frequency of adverse effects associated with influenza vaccination in healthy adults.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 1, 2004) which contains the Cochrane Acute Respiratory Infections Group trials register; MEDLINE (January 1966 to December 2003); and EMBASE (1990 to December 2003). We wrote to vaccine manufacturers and first or corresponding authors of studies in the review.
Any randomised or quasi-randomised studies comparing influenza vaccines in humans with placebo, control vaccines or no intervention, or comparing types, doses or schedules of influenza vaccine. Live, attenuated or killed vaccines or fractions thereof administered by any route, irrespective of antigenic configuration were considered. Only studies assessing protection from exposure to naturally occurring influenza in healthy individuals aged 14 to 60 (irrespective of influenza immune status) were considered.
Two reviewers independently assessed trial quality and extracted data.
Twenty five reports of studies involving 59,566 people were included. The recommended live aerosol vaccines reduced the number of cases of serologically confirmed influenza by 48% (95% confidence interval (CI) 24% to 64%), whilst recommended inactivated parenteral vaccines had a vaccine efficacy of 70% (95% CI 56% to 80%). The yearly recommended vaccines had low effectiveness against clinical influenza cases: 15%(95% CI 8% to 21%) and 25% (95% CI 13% to 35%) respectively. Overall the percentage of participants experiencing clinical influenza decreased by 6%. Use of the vaccine significantly reduced time off work but only by 0.16 days for each influenza episode (95% CI 0.04 to 0.29 days); Analysis of vaccines matching the circulating strain gave higher estimates of efficacy, whilst inclusion of all other vaccines reduced the efficacy.
REVIEWERS' CONCLUSIONS: Influenza vaccines are effective in reducing serologically confirmed cases of influenza. However, they are not as effective in reducing cases of clinical influenza and number of working days lost. Universal immunisation of healthy adults is not supported by the results of this review.
目前全球生产三种不同类型的流感疫苗。传统上没有一种是针对健康成年人的。尽管发表了大量临床试验,但流感疫苗的临床效果仍存在很大不确定性,这对疫苗的接受度和接种率产生了负面影响。
评估疫苗对健康成年人流感的影响。评估疫苗在预防健康成年人流感病例方面的有效性。估计健康成年人接种流感疫苗相关不良反应的发生率。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆,2004年第1期),其中包含Cochrane急性呼吸道感染组试验注册库;MEDLINE(从1966年1月至2003年12月);以及EMBASE(从1990年至2003年12月)。我们写信给疫苗生产商以及综述中研究的第一作者或通讯作者。
任何将人类流感疫苗与安慰剂、对照疫苗或不干预进行比较,或比较流感疫苗类型、剂量或接种程序的随机或半随机研究。无论抗原构型如何,通过任何途径接种的活疫苗、减毒疫苗、灭活疫苗或其组分均予以考虑。仅考虑评估14至60岁健康个体(无论流感免疫状态如何)免受自然发生的流感感染的研究。
两名评价员独立评估试验质量并提取数据。
纳入了涉及5956人的25项研究报告。推荐的活气溶胶疫苗使血清学确诊的流感病例数减少了48%(95%置信区间(CI)24%至64%),而推荐的灭活注射疫苗的疫苗效力为70%(95%CI 56%至80%)。每年推荐的疫苗对临床流感病例的有效性较低:分别为15%(95%CI 8%至21%)和25%(95%CI 13%至35%)。总体而言,发生临床流感的参与者百分比下降了6%。使用疫苗显著减少了误工时间,但每次流感发作仅减少0.16天(95%CI 0.04至0.29天);对与流行毒株匹配的疫苗分析得出的效力估计值更高,而纳入所有其他疫苗则降低了效力。
流感疫苗在减少血清学确诊的流感病例方面是有效的。然而,它们在减少临床流感病例和误工天数方面效果不佳。本综述结果不支持对健康成年人进行普遍免疫。