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用于治疗恶性伤口的全身性抗生素。

Systemic antibiotics for treating malignant wounds.

作者信息

Ramasubbu Darshini A, Smith Valerie, Hayden Fiona, Cronin Patricia

机构信息

Dental Department, HSE, Kilbarrack Dental Clinic, Foxfield Crescent, Dublin, Ireland, D5.

出版信息

Cochrane Database Syst Rev. 2017 Aug 24;8(8):CD011609. doi: 10.1002/14651858.CD011609.pub2.

Abstract

BACKGROUND

Malignant wounds are a devastating complication of cancer. They usually develop in the last six months of life, in the breast, chest wall or head and neck regions. They are very difficult to treat successfully, and the commonly associated symptoms of pain, exudate, malodour, and the risk of haemorrhage are extremely distressing for those with advanced cancer. Treatment and care of malignant wounds is primarily palliative, and focuses on alleviating pain, controlling infection and odour from the wound, managing exudate and protecting the surrounding skin from further deterioration. In malignant wounds, with tissue degradation and death, there is proliferation of both anaerobic and aerobic bacteria. The aim of antibiotic therapy is to successfully eliminate these bacteria, reduce associated symptoms, such as odour, and promote wound healing.

OBJECTIVES

To assess the effects of systemic antibiotics for treating malignant wounds.

SEARCH METHODS

We searched the following electronic databases on 8 March 2017: the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library, 2017, Issue 3), Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus. We also searched the clinical trial registries of the World Health Organization (WHO) International Clinical Trials Registry Platform (apps.who.int/trialsearch) and ClinicalTrials.gov on 20 March 2017; and OpenSIGLE (to identify grey literature) and ProQuest Dissertations & Theses Global (to retrieve dissertation theses related to our topic of interest) on 13 March 2017.

SELECTION CRITERIA

Randomised controlled trials that assessed the effects of any systemic antibiotics on malignant wounds were eligible for inclusion.

DATA COLLECTION AND ANALYSIS

Two review authors independently screened and selected trials for inclusion, assessed risk of bias and extracted study data. A third reviewer checked extracted data for accuracy prior to analysis.

MAIN RESULTS

We identified only one study for inclusion in this review. This study was a prospective, double-blind cross-over trial that compared the effect of systemic metronidazole with a placebo on odour in malignant wounds. Nine participants with a fungating wound and for whom the smell was troublesome were recruited and six of these completed both the intervention and control (placebo) stages of the trial. Each stage lasted fourteen days, with a fourteen day gap (washout period) between administration of the metronidazole and the placebo.The study, in comparing metronidazole and placebo, reported on two of this review's pre-specified primary outcomes (malodour and adverse effects of the treatment) and on none of the review's pre-specified secondary outcomes.MalodourThe mean malodour (smell) scores for the metronidazole group was 1.17 (standard deviation (SD) 1.60) and the mean for the placebo group was 3.33 (SD 0.82). It is unclear if systemic antibiotics were associated with a difference in malodour (1 study with 6 participants; MD -2.16, 95% CI -3.6 to -0.72) as the quality of the evidence (GRADE) was very low for this outcome. The study was downgraded due to high risk of attrition bias (33% loss to follow-up) and very serious imprecision due to the small sample size.Adverse effectsNo adverse effects of the treatment were reported in either the intervention or control group by the trial authors.

AUTHORS' CONCLUSIONS: It is uncertain whether systemic metronidazole leads to a reduction in malodour in patients with malignant wounds. This is because we were only able to include a single study at high risk of bias with a very small sample size, which focused only on patients with breast cancer. More research is needed to substantiate these findings and to investigate the effects of systemic metronidazole and other antibiotics on quality of life, pain relief, exudate and tumour containment in patients with malignant wounds.

摘要

背景

恶性伤口是癌症的一种毁灭性并发症。它们通常在生命的最后六个月出现,多见于乳房、胸壁或头颈部区域。这些伤口很难成功治愈,晚期癌症患者常伴有疼痛、渗液、恶臭和出血风险等症状,极其痛苦。恶性伤口的治疗和护理主要是姑息性的,重点在于缓解疼痛、控制伤口感染和异味、处理渗液以及保护周围皮肤防止进一步恶化。在恶性伤口中,随着组织降解和坏死,厌氧菌和好氧菌都会大量繁殖。抗生素治疗的目的是成功清除这些细菌,减轻相关症状,如异味,并促进伤口愈合。

目的

评估全身使用抗生素治疗恶性伤口的效果。

检索方法

我们于2017年3月8日检索了以下电子数据库:Cochrane伤口专业注册库、Cochrane对照试验中心注册库(CENTRAL;Cochrane图书馆,2017年第3期)、Ovid MEDLINE、Ovid Embase和EBSCO CINAHL Plus。我们还于2017年3月20日检索了世界卫生组织(WHO)国际临床试验注册平台(apps.who.int/trialsearch)和ClinicalTrials.gov的临床试验注册库;并于2017年3月13日检索了OpenSIGLE(以识别灰色文献)和ProQuest Dissertations & Theses Global(以检索与我们感兴趣的主题相关的学位论文)。

入选标准

评估任何全身使用抗生素对恶性伤口效果的随机对照试验均符合纳入标准。

数据收集与分析

两位综述作者独立筛选并选择纳入试验,评估偏倚风险并提取研究数据。第三位综述作者在分析前检查提取数据的准确性。

主要结果

我们仅确定了一项研究纳入本综述。该研究是一项前瞻性、双盲交叉试验,比较了全身使用甲硝唑与安慰剂对恶性伤口异味的影响。招募了9名有溃疡型伤口且异味困扰严重的参与者,其中6名完成了试验的干预和对照(安慰剂)阶段。每个阶段持续14天,在使用甲硝唑和安慰剂之间有14天的间隔期(洗脱期)。该研究在比较甲硝唑和安慰剂时,报告了本综述预先设定的两个主要结局(恶臭和治疗的不良反应),但未报告任何预先设定的次要结局。

恶臭

甲硝唑组的平均恶臭(气味)评分为1.17(标准差(SD)1.60),安慰剂组为3.33(SD 0.82)。尚不清楚全身使用抗生素是否与恶臭差异有关(1项研究,6名参与者;MD -2.16,95%CI -3.6至-0.72),因为该结局的证据质量(GRADE)非常低。由于失访偏倚风险高(33%失访)且样本量小导致非常严重的不精确性,该研究被降级。

不良反应

试验作者在干预组或对照组均未报告治疗的不良反应。

作者结论

全身使用甲硝唑是否能降低恶性伤口患者的恶臭尚不确定。这是因为我们仅能纳入一项偏倚风险高且样本量非常小的研究,且该研究仅关注乳腺癌患者。需要更多研究来证实这些发现,并调查全身使用甲硝唑和其他抗生素对恶性伤口患者生活质量、疼痛缓解、渗液和肿瘤控制的影响。

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