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用于预防慢性阻塞性肺疾病患者肺炎球菌感染的注射用疫苗。

Injectable vaccines for preventing pneumococcal infection in patients with chronic obstructive pulmonary disease.

作者信息

Walters Julia Ae, Smith Sabin, Poole Phillippa, Granger Robert H, Wood-Baker Richard

机构信息

Menzies Research Institute, University of Tasmania, MS1, 17 Liverpool Street, PO Box 23, Hobart, Tasmania, Australia, 7001.

出版信息

Cochrane Database Syst Rev. 2010 Nov 10(11):CD001390. doi: 10.1002/14651858.CD001390.pub3.

DOI:10.1002/14651858.CD001390.pub3
PMID:21069668
Abstract

BACKGROUND

As chronic obstructive pulmonary disease (COPD) progresses, exacerbations can occur with increasing frequency. One goal of therapy is to prevent these exacerbations, thereby reducing morbidity and associated healthcare costs. Pneumococcal vaccinations are one strategy for reducing the risk of infective exacerbations.

OBJECTIVES

To determine the safety and efficacy of pneumococcal vaccination in COPD. The primary outcomes assessed were episodes of pneumonia and acute exacerbations. Secondary outcomes of interest included hospital admissions, adverse events related to treatment, disability, change in lung function, mortality, and cost effectiveness.

SEARCH STRATEGY

We searched the Cochrane Airways Group COPD trials register and the databases CENTRAL, MEDLINE and EMBASE using pre-specified terms. The latest searches were performed in March 2010.

SELECTION CRITERIA

Randomised controlled trials assessing the effects of injectable pneumococcal vaccine in people with COPD were included.

DATA COLLECTION AND ANALYSIS

Two review authors independently extracted data and three review authors independently assessed trial quality.

MAIN RESULTS

Seven studies were identified that met the inclusion criteria for this review and were included in the 2010 review update. Two older trials used a 14-valent vaccine and five more recent trials used a 23-valent injectable vaccine.In six studies involving 1372 people, the reduction in likelihood of developing pneumonia with pneumococcal vaccination compared to control did not achieve statistical significance, the odds ratio (OR) was 0.72 (95% confidence interval (CI) 0.51 to 1.01), with moderate heterogeneity present between studies. The reduction in likelihood of acute exacerbations of COPD from two studies involving 216 people was not statistically significant (Peto OR 0.58; 95% CI 0.30 to 1.13).Of the secondary outcomes for which data were available there was no statistically significant effect for reduction in hospital admissions (two studies) or emergency department visits (one study). There was no significant reduction in pooled results from three studies involving 888 people for odds of all-cause mortality for periods up to 48 months post-vaccination (OR 0.94; 95% CI 0.67 to 1.33), or for death from cardiorespiratory causes (OR 1.07; 95% CI 0.69 to 1.66).

AUTHORS' CONCLUSIONS: The limited evidence from randomised controlled trials (RCTs) included in this review suggests that, while it is possible that injectable polyvalent pneumococcal vaccines may provide some protection against morbidity in persons with COPD, no significant effect on any of the outcomes was shown. Further large RCTs in this population would be needed to confirm effectiveness of the vaccine suggested by results from longitudinal studies.

摘要

背景

随着慢性阻塞性肺疾病(COPD)的进展,急性加重的发生频率可能会增加。治疗的一个目标是预防这些急性加重,从而降低发病率和相关的医疗费用。肺炎球菌疫苗接种是降低感染性急性加重风险的一种策略。

目的

确定肺炎球菌疫苗接种在COPD中的安全性和有效性。评估的主要结局为肺炎发作和急性加重。感兴趣的次要结局包括住院、与治疗相关的不良事件、残疾、肺功能变化、死亡率和成本效益。

检索策略

我们使用预先指定的检索词在Cochrane Airways Group慢性阻塞性肺疾病试验注册库以及CENTRAL、MEDLINE和EMBASE数据库中进行检索。最近一次检索于2010年3月进行。

入选标准

纳入评估注射用肺炎球菌疫苗对COPD患者影响的随机对照试验。

数据收集与分析

两名综述作者独立提取数据,三名综述作者独立评估试验质量。

主要结果

共识别出7项符合本综述纳入标准的研究,并纳入2010年综述更新。两项较早的试验使用了14价疫苗,另外五项较新的试验使用了23价注射用疫苗。在涉及1372人的6项研究中,与对照组相比,肺炎球菌疫苗接种降低患肺炎可能性的结果未达到统计学显著性,比值比(OR)为0.72(95%置信区间(CI)0.51至1.01),研究之间存在中度异质性。在涉及216人的两项研究中,COPD急性加重可能性的降低无统计学显著性(Peto比值比0.58;95%CI 0.30至1.13)。对于有数据的次要结局,在降低住院率(两项研究)或急诊就诊率(一项研究)方面没有统计学显著效果。在涉及888人的三项研究中,接种疫苗后长达48个月的全因死亡率(OR 0.94;95%CI 0.67至1.33)或心肺原因导致的死亡率(OR 1.07;95%CI 0.69至1.66)的汇总结果没有显著降低。

作者结论

本综述中纳入的随机对照试验(RCT)的有限证据表明,虽然注射用多价肺炎球菌疫苗可能为COPD患者提供一定的发病预防作用,但对任何结局均未显示出显著效果。需要在该人群中开展进一步的大型RCT,以证实纵向研究结果所提示的疫苗有效性。

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