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抗生素与安慰剂治疗急性细菌性结膜炎的对比

Antibiotics versus placebo for acute bacterial conjunctivitis.

作者信息

Sheikh Aziz, Hurwitz Brian, van Schayck Constant Paul, McLean Susannah, Nurmatov Ulugbek

机构信息

Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK.

出版信息

Cochrane Database Syst Rev. 2012 Sep 12(9):CD001211. doi: 10.1002/14651858.CD001211.pub3.

DOI:10.1002/14651858.CD001211.pub3
PMID:22972049
Abstract

BACKGROUND

Acute bacterial conjunctivitis is an infection of the conjunctiva. Both the palpebral and the bulbar ocular conjunctival surfaces are usually affected and typically become red and inflamed. Antibiotic therapy is widely used for the treatment of acute bacterial conjunctivitis. This Cochrane Review was first published in The Cochrane Library in 1999; updated in 2006 and again in 2012.

OBJECTIVES

To assess the benefits and harms of antibiotic therapy in the management of acute bacterial conjunctivitis.

SEARCH METHODS

We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), MEDLINE (January 1950 to July 2012), EMBASE (January 1980 to July 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 18 July 2012.

SELECTION CRITERIA

We included double-masked randomised controlled trials (RCTs) in which any form of antibiotic treatment had been compared with placebo/vehicle in the management of acute bacterial conjunctivitis. This included topical, systemic and combination (for example, antibiotics and steroids) antibiotic treatments.

DATA COLLECTION AND ANALYSIS

Two authors (UN and SM) independently checked and reviewed the titles and abstracts of identified studies. We assessed the full text of all potentially relevant studies. We graded the included RCTs for methodological quality using Cochrane methodology. We performed data extraction in a standardised manner. We performed random-effects meta-analyses using RevMan.

MAIN RESULTS

We identified 11 eligible RCTs which randomised a total of 3673 participants. One further trial, which was published in abstract form in 1990 but has yet to be reported fully, is currently 'awaiting assessment'. Six of the 11 included studies have been included for the first time in this latest (2012) update. The trials were heterogeneous in terms of their inclusion and exclusion criteria, the nature of the intervention, and the outcome measures assessed. We judged two of the trials to be of high quality and graded the remainder as poor quality.Meta-analyses of data on clinical and microbiological remission rates revealed that topical antibiotics were of benefit in improving 'early' (days two to five) clinical (risk ratio (RR) 1.36, 95% confidence interval (CI) 1.15 to 1.61) and microbiological (RR 1.55, 95% CI 1.37 to 1.76) remission rates. At the 'late' time point (days six to 10), antibiotics were found to still confer modest benefits in clinical remission (RR 1.21, 95% CI 1.10 to 1.33) and microbiological cure rates (RR 1.37, 95% CI 1.24 to 1.52). By days six to 10, 41% (95% CI 38 to 43) of cases had resolved in those receiving placebo. We found no data on the cost-effectiveness of antibiotics. No serious outcomes were reported in either the active or placebo arms of these trials, suggesting that important sight-threatening complications are an infrequent occurrence.

AUTHORS' CONCLUSIONS: Although acute bacterial conjunctivitis is frequently self limiting, the findings from this updated systematic review suggest that the use of antibiotic eye drops is associated with modestly improved rates of clinical and microbiological remission in comparison to the use of placebo. Use of antibiotic eye drops should therefore be considered in order to speed the resolution of symptoms and infection.

摘要

背景

急性细菌性结膜炎是结膜的一种感染。睑结膜和球结膜表面通常都会受到影响,典型表现为发红和发炎。抗生素疗法广泛用于治疗急性细菌性结膜炎。本Cochrane系统评价首次发表于1999年的《Cochrane图书馆》;2006年进行了更新,2012年再次更新。

目的

评估抗生素疗法治疗急性细菌性结膜炎的益处和危害。

检索方法

我们检索了Cochrane中心对照试验注册库(CENTRAL)(其中包含Cochrane眼科和视力组试验注册库)(《Cochrane图书馆》2012年第7期)、MEDLINE(1950年1月至2012年7月)、EMBASE(1980年1月至2012年7月)、OpenGrey(欧洲灰色文献信息系统)(www.opengrey.eu/)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。在电子检索试验时,我们未使用任何日期或语言限制。我们最近一次检索电子数据库的时间为2012年7月18日。

入选标准

我们纳入了双盲随机对照试验(RCT),这些试验将任何形式的抗生素治疗与安慰剂/赋形剂在急性细菌性结膜炎的治疗中进行了比较。这包括局部、全身和联合(如抗生素和类固醇)抗生素治疗。

数据收集与分析

两位作者(UN和SM)独立检查并审阅了已识别研究的标题和摘要。我们评估了所有潜在相关研究的全文。我们使用Cochrane方法对纳入的RCT进行方法学质量分级。我们以标准化方式进行数据提取。我们使用RevMan进行随机效应荟萃分析。

主要结果

我们识别出11项合格的RCT,共随机分配了3673名参与者。另一项试验于1990年以摘要形式发表,但尚未完整报告,目前正在“等待评估”。11项纳入研究中有6项是在此次最新(2012年)更新中首次纳入。这些试验在纳入和排除标准、干预性质以及评估的结局指标方面存在异质性。我们判定其中两项试验质量高,其余试验质量差。对临床和微生物学缓解率数据的荟萃分析显示,局部抗生素有助于提高“早期”(第2至5天)临床(风险比(RR)1.36,95%置信区间(CI)1.15至1.61)和微生物学(RR 1.55,95%CI 1.37至1.76)缓解率。在“晚期”时间点(第6至10天),发现抗生素在临床缓解(RR 1.21,95%CI 1.10至1.33)和微生物学治愈率(RR 1.37,95%CI 1.24至1.52)方面仍有适度益处。到第6至10天,接受安慰剂的患者中有41%(95%CI 38至43)的病例病情得到缓解。我们未找到关于抗生素成本效益的数据。这些试验的活性治疗组或安慰剂组均未报告严重结局,表明严重威胁视力的并发症很少发生。

作者结论

尽管急性细菌性结膜炎通常具有自限性,但此次更新的系统评价结果表明,与使用安慰剂相比,使用抗生素滴眼液可适度提高临床和微生物学缓解率。因此,为了加快症状缓解和感染的消退,应考虑使用抗生素滴眼液。

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