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高剂量流感疫苗在老年人中的疗效和安全性:一项系统评价和荟萃分析。

Efficacy and safety of high-dose influenza vaccine in elderly adults: A systematic review and meta-analysis.

作者信息

Wilkinson Krista, Wei Yichun, Szwajcer Andrea, Rabbani Rasheda, Zarychanski Ryan, Abou-Setta Ahmed M, Mahmud Salaheddin M

机构信息

Department of Community Health Sciences, College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada; Public Health Branch, Manitoba Health, Healthy Living and Seniors, Winnipeg, Manitoba, Canada.

Public Health Branch, Manitoba Health, Healthy Living and Seniors, Winnipeg, Manitoba, Canada.

出版信息

Vaccine. 2017 May 15;35(21):2775-2780. doi: 10.1016/j.vaccine.2017.03.092. Epub 2017 Apr 18.

DOI:10.1016/j.vaccine.2017.03.092
PMID:28431815
Abstract

INTRODUCTION

Older adults are prioritized for influenza vaccination but also have lowered antibody responses to the vaccine. Higher-doses of influenza antigen may increase immune response and thus be more effective. Our objectives were to compare the efficacy and safety of the high-dose influenza vaccine to the standard-dose influenza vaccine in the elderly (age>65).

METHODS

Data sources: Randomized trials (RCTs) from Medline (Ovid), EMBASE (Ovid), Cochrane Library (Wiley), ClinicalTrials.gov, reference lists of relevant articles, and gray literature.

STUDY SELECTION

Two reviewers independently identified RCTs comparing high-dose influenza vaccine (60μg of hemagglutinin per strain) to standard-dose influenza vaccine (15μg of hemagglutinin per strain) in adults over the age of 65years.

DATA EXTRACTION

Two reviewers independently extracted trial-level data including population characteristics, interventions, outcomes, and funding sources. Risk of bias was assessed using the Cochrane Risk of Bias tool.

RESULTS

We included seven eligible trials; all were categorized as having a low (n=3) or unclear (n=4) risk of bias. Patients receiving the high-dose vaccine had significantly less risk of developing laboratory-confirmed influenza infections (Relative Risk 0.76, 95%CI 0.65 to 0.90; I 0%, 2 trials, 41,141 patients). Post-vaccination geometric mean titres and seroprotection rates were also higher in high-dose vaccine recipients. There were no protocol-defined serious adverse events in the included trials in either group.

CONCLUSIONS

In elderly adults, the high-dose influenza vaccine was well-tolerated, more immunogenic, and more efficacious in preventing influenza infections than the standard-dose vaccine. Further pragmatic trials are needed to determine if the higher efficacy translates into higher vaccine effectiveness in adults over the age of 65.

摘要

引言

老年人被优先推荐接种流感疫苗,但他们对疫苗的抗体反应也较低。更高剂量的流感抗原可能会增强免疫反应,从而更有效。我们的目标是比较高剂量流感疫苗与标准剂量流感疫苗在老年人(年龄>65岁)中的疗效和安全性。

方法

数据来源:来自Medline(Ovid)、EMBASE(Ovid)、Cochrane图书馆(Wiley)、ClinicalTrials.gov的随机试验(RCT)、相关文章的参考文献列表以及灰色文献。

研究选择

两名评审员独立识别将高剂量流感疫苗(每株60μg血凝素)与标准剂量流感疫苗(每株15μg血凝素)用于65岁以上成年人的RCT。

数据提取

两名评审员独立提取试验水平的数据,包括人群特征、干预措施、结果和资金来源。使用Cochrane偏倚风险工具评估偏倚风险。

结果

我们纳入了七项符合条件的试验;所有试验的偏倚风险均被分类为低(n = 3)或不明确(n = 4)。接受高剂量疫苗的患者发生实验室确诊流感感染的风险显著降低(相对风险0.76,95%置信区间0.65至0.90;I² = 0%,2项试验,41,141名患者)。高剂量疫苗接种者接种后的几何平均滴度和血清保护率也更高。在纳入的试验中,两组均未出现方案定义的严重不良事件。

结论

在老年人中,高剂量流感疫苗耐受性良好,比标准剂量疫苗更具免疫原性,在预防流感感染方面更有效。需要进一步的实用试验来确定更高的疗效是否能转化为65岁以上成年人更高的疫苗效力。

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