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糖尿病患者中季节性流感疫苗接种效果测量的偏差。

Bias in the measure of the effectiveness of seasonal influenza vaccination among diabetics.

作者信息

Casanova Ludovic, Gobin Nirvina, Villani Patrick, Verger Pierre

机构信息

INSERM, UMR_S 912, «Sciences Economiques & Sociales de la Santé et Traitement de l'Information Médicale» (SESSTIM), F-13385 Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, F-13006 Marseille, France; Aix Marseille University, Department of General Practice, Marseille, France.

Aix Marseille University, Department of General Practice, Marseille, France.

出版信息

Prim Care Diabetes. 2016 Dec;10(6):398-406. doi: 10.1016/j.pcd.2016.05.005. Epub 2016 Jun 9.

Abstract

BACKGROUND

The influenza virus is an important cause of morbidity and mortality for diabetics. The seasonal influenza vaccine's immunologic effectiveness is proven within the type 1 and type 2 diabetic populations, but the level of evidence is low. This article presents a systematic review for the bias in the measure of the effectiveness of seasonal influenza vaccination among diabetics.

METHODS

Using systematic review methods, we searched three electronic databases for published literature (MEDLINE, EMBASE and the Cochrane Library) and two grey literature (SIGLE and NHS EED) databases, to identify studies published between 1997 and 2013, examining the effect of seasonal influenza vaccination, among diabetics, on any measure for influenza morbidity or mortality.

RESULTS

725 records were identified from the three databases and screening, short-listing was undertaken independently by two reviewers. After de-duplication, all records were screened by title and then abstract, and 34 short-listed records were reviewed in full, with 7 studies included: 4 cohort studies and 3 case-control studies, conducted in 7 countries. The most common outcome of interest in studies (n=4) was all-cause mortality among elderly diabetics (>65 years), with individual studies reporting reductions in risk of between 33% [95%CI: 4%-54%] and 68% [95%CI: 58%-75%]. We found only two studies for working-age adult diabetics: one reporting that vaccination prevented hospitalizations due to pneumonia or influenza (vaccine effectiveness [VE] 43%, [95%CI: 28%-54%]) and all-cause hospitalizations (VE: 28% [95%CI: 24%-32%]); and, another reporting no significant decrease in all-cause mortality for working-age adult diabetics. We have identified three major biases: the use of indirect health outcomes, a risk of selection bias (health-seeking bias), and no adjustment for participant pneumococcal vaccination status. The most recent included article finds that morbimortality is still lower during off-season influenza in both vaccinated and non-vaccinated diabetics, indicating important residual confounding.

CONCLUSION

To date, the strength of evidence supporting the routine use of seasonal influenza vaccination is low for diabetics older than 65, and very low for working-age diabetics.

摘要

背景

流感病毒是糖尿病患者发病和死亡的重要原因。季节性流感疫苗在1型和2型糖尿病患者群体中的免疫效果已得到证实,但证据水平较低。本文对糖尿病患者季节性流感疫苗接种效果衡量中的偏倚进行了系统评价。

方法

采用系统评价方法,我们检索了三个电子数据库(MEDLINE、EMBASE和Cochrane图书馆)以及两个灰色文献数据库(SIGLE和NHS EED),以识别1997年至2013年间发表的研究,这些研究考察了糖尿病患者中季节性流感疫苗接种对流感发病或死亡的任何衡量指标的影响。

结果

从三个数据库中识别出725条记录,由两名评审员独立进行筛选、入围。去重后,所有记录先按标题筛选,再按摘要筛选,对34条入围记录进行全文评审,纳入7项研究:4项队列研究和3项病例对照研究,在7个国家开展。研究中最常见的关注结局(n = 4)是老年糖尿病患者(>65岁)的全因死亡率,个别研究报告风险降低幅度在33%[95%CI:4%-54%]至68%[95%CI:58%-75%]之间。我们仅找到两项针对工作年龄成年糖尿病患者的研究:一项报告称接种疫苗预防了因肺炎或流感导致的住院(疫苗效力[VE]43%,[95%CI:28%-54%])以及全因住院(VE:28%[95%CI:24%-32%]);另一项报告称工作年龄成年糖尿病患者的全因死亡率无显著下降。我们识别出三个主要偏倚:使用间接健康结局、存在选择偏倚(就医偏倚)风险以及未对参与者的肺炎球菌疫苗接种状况进行调整。最新纳入的文章发现,在接种和未接种疫苗的糖尿病患者中,非流感季节的发病率和死亡率仍然较低,表明存在重要的残余混杂因素。

结论

迄今为止,支持65岁以上糖尿病患者常规接种季节性流感疫苗的证据力度较低,而对于工作年龄糖尿病患者则非常低。

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