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预防老年人带状疱疹的疫苗。

Vaccines for preventing herpes zoster in older adults.

作者信息

Gagliardi Anna M Z, Andriolo Brenda N G, Torloni Maria R, Soares Bernardo G O

机构信息

Department of Geriatrics and Gerontology, Universidade Federal de São Paulo, Rua Professor Francisco de Castro 105, São Paulo, São Paulo, Brazil, 04020-050.

出版信息

Cochrane Database Syst Rev. 2016 Mar 3;3(3):CD008858. doi: 10.1002/14651858.CD008858.pub3.

Abstract

BACKGROUND

Herpes zoster, also known as 'shingles', is a neurocutaneous disease characterised by the reactivation of the latent varicella zoster virus (VZV), the virus that causes chickenpox when immunity to VZV declines. It is an extremely painful condition that can last many weeks or months and it can significantly compromise the quality of life of affected individuals. The natural process of aging is associated with a reduction in cellular immunity and this predisposes older people to herpes zoster. Vaccination with an attenuated form of VZV activates specific T cell production avoiding viral reactivation. The Food and Drug Administration has approved a herpes zoster vaccine with an attenuated active virus for clinical use among older adults, which has been tested in large populations. A new adjuvanted recombinant VZV subunit zoster vaccine has also been tested. It consists of recombinant VZV glycoprotein E and a liposome-based AS01B adjuvant system. This new vaccine is not yet available for clinical use.

OBJECTIVES

To evaluate the effectiveness and safety of vaccination for preventing herpes zoster in older adults.

SEARCH METHODS

For this 2015 update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9), MEDLINE (1948 to the 3rd week of October 2015), EMBASE (2010 to October 2015), CINAHL (1981 to October 2015) and LILACS (1982 to October 2015).

SELECTION CRITERIA

Randomised controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine with placebo or no vaccine, to prevent herpes zoster in older adults (mean age > 60 years).

DATA COLLECTION AND ANALYSIS

Two review authors independently collected and analysed data using a data extraction form. They also performed 'Risk of bias' assessment.

MAIN RESULTS

We identified 13 studies involving 69,916 participants. The largest study included 38,546 participants. All studies were conducted in high-income countries and included only healthy Caucasian individuals ≥ 60 years of age without immunosuppressive comorbidities. Ten studies used live attenuated varicella zoster virus (VZV) vaccines. Three studies tested a new type of vaccine not yet available for clinical use. We judged five of the included studies to be at low risk of bias.The incidence of herpes zoster, at up to three years of follow-up, was lower in participants who received the vaccine than in those who received a placebo: risk ratio (RR) 0.49; 95% confidence interval (CI) 0.43 to 0.56, risk difference (RD) 2%, number needed to treat to benefit (NNTB) 50; GRADE: moderate quality evidence. The vaccinated group had a higher incidence of mild to moderate intensity adverse events. These date came from one large study that included 38,546 people aged 60 years or older.A study including 8122 participants compared the new vaccine (not yet available) to the placebo; the group that received the new vaccine had a lower incidence of herpes zoster at 3.2 years of follow-up: RR 0.04, 95% CI 0.02 to 0.10, RD 3%, NNTB 33; GRADE: moderate quality evidence. The vaccinated group had a higher incidence of adverse events but most them were of mild to moderate intensity.All studies received funding from the pharmaceutical industry.

AUTHORS' CONCLUSIONS: Herpes zoster vaccine is effective in preventing herpes zoster disease and this protection can last three years. In general, zoster vaccine is well tolerated; it produces few systemic adverse events and injection site adverse events of mild to moderate intensity.There are studies of a new vaccine (with a VZV glycoproteic fraction plus adjuvant), which is currently not yet available for clinical use.

摘要

背景

带状疱疹,又称“缠腰龙”,是一种神经皮肤疾病,其特征为潜伏的水痘带状疱疹病毒(VZV)重新激活,该病毒在对VZV的免疫力下降时会引发水痘。这是一种极为疼痛的病症,可持续数周或数月,会严重影响患者的生活质量。自然衰老过程与细胞免疫功能下降相关,这使得老年人易患带状疱疹。接种减毒形式的VZV可激活特定T细胞生成,从而避免病毒重新激活。美国食品药品监督管理局已批准一种含减毒活性病毒的带状疱疹疫苗用于老年人临床,该疫苗已在大量人群中进行了测试。一种新型的佐剂重组VZV亚单位带状疱疹疫苗也已进行测试。它由重组VZV糖蛋白E和基于脂质体的AS01B佐剂系统组成。这种新型疫苗尚未用于临床。

目的

评估接种疫苗预防老年人带状疱疹的有效性和安全性。

检索方法

对于本次2015年更新,我们检索了Cochrane对照试验中心注册库(CENTRAL 2015年第9期)、MEDLINE(1948年至2015年10月第3周)、EMBASE(2010年至2015年10月)、CINAHL(1981年至2015年10月)和LILACS(1982年至2015年10月)。

入选标准

比较带状疱疹疫苗与安慰剂或不接种疫苗以预防老年人(平均年龄>60岁)带状疱疹的随机对照试验(RCT)或半随机对照试验。

数据收集与分析

两位综述作者使用数据提取表独立收集和分析数据。他们还进行了“偏倚风险”评估。

主要结果

我们识别出13项研究,涉及69916名参与者。最大的研究纳入了38546名参与者。所有研究均在高收入国家进行,且仅纳入年龄≥60岁、无免疫抑制合并症的健康白种人个体。10项研究使用了减毒活水痘带状疱疹病毒(VZV)疫苗。3项研究测试了一种尚未用于临床的新型疫苗。我们判定纳入的5项研究偏倚风险较低。在长达三年的随访中,接种疫苗的参与者带状疱疹发病率低于接受安慰剂的参与者:风险比(RR)0.49;95%置信区间(CI)0.43至0.56,风险差(RD)2%,需治疗获益人数(NNTB)50;证据质量分级:中等质量证据。接种疫苗组轻度至中度强度不良事件的发生率较高。这些数据来自一项纳入38546名60岁及以上人群的大型研究。一项纳入8122名参与者的研究将新型疫苗(尚未上市)与安慰剂进行了比较;在3.2年的随访中,接受新型疫苗的组带状疱疹发病率较低:RR 0.04,95%CI 0.02至0.10,RD 3%,NNTB 33;证据质量分级:中等质量证据。接种疫苗组不良事件的发生率较高,但大多数为轻度至中度强度。所有研究均获得制药行业的资助。

作者结论

带状疱疹疫苗在预防带状疱疹疾病方面有效,且这种保护作用可持续三年。总体而言,带状疱疹疫苗耐受性良好;很少产生全身性不良事件以及轻度至中度强度的注射部位不良事件。有关于一种新型疫苗(含VZV糖蛋白组分加佐剂)的研究,该疫苗目前尚未用于临床。

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