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不同术前皮肤消毒剂预防手术部位感染的效果:系统评价、GRADE 评估和网络荟萃分析。

Efficacy of different preoperative skin antiseptics on the incidence of surgical site infections: a systematic review, GRADE assessment, and network meta-analysis.

机构信息

Amsterdam University Medical Center, Department of Surgery, University of Amsterdam, Amsterdam, Netherlands; Amsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam, Netherlands; Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Utrecht, Netherlands.

Dutch National Guideline Group for Prevention of Postoperative Surgical Site Infections, Utrecht, Netherlands.

出版信息

Lancet Microbe. 2022 Oct;3(10):e762-e771. doi: 10.1016/S2666-5247(22)00187-2. Epub 2022 Aug 16.

DOI:10.1016/S2666-5247(22)00187-2
PMID:35985350
Abstract

BACKGROUND

Surgical site infection (SSI) is the most common postoperative complication and substantially increases health-care costs. Published meta-analyses and international guidelines differ with regard to which preoperative skin antiseptic solution and concentration has the highest efficacy. We aimed to compare the efficacy of different skin preparation solutions and concentrations for the prevention of SSIs, and to provide an overview of current guidelines.

METHODS

This systematic review and network meta-analysis compared different preoperative skin antiseptics in the prevention of SSIs in adult patients undergoing surgery of any wound classification. We searched for randomised controlled trials (RCTs) in MEDLINE, Embase, and Cochrane CENTRAL, published up to Nov 23, 2021, that directly compared two or more antiseptic agents (ie, chlorhexidine, iodine, or olanexidine) or concentrations in aqueous and alcohol-based solutions. We excluded paediatric, animal, and non-randomised studies, and studies not providing standard preoperative intravenous antibiotic prophylaxis. Studies with no SSIs in both groups were excluded from the quantitative analysis. Two reviewers screened and reviewed eligible full texts and extracted data. The primary outcome was the occurrence of SSI (ie, superficial, deep, and organ space). We conducted a frequentist random effects network meta-analysis to estimate the network effects of the skin preparation solutions on the prevention of SSIs. A risk-of-bias and Grading of Recommendations, Assessment, Development, and Evaluation assessment were done to determine the certainty of the evidence. This study is registered with PROSPERO, CRD42021293554.

FINDINGS

Overall, 2326 articles were identified, 33 studies were eligible for the systematic review, and 27 studies with 17 735 patients reporting 2144 SSIs (overall incidence of 12·1%) were included in the quantitative analysis. Only 2·0-2·5% chlorhexidine in alcohol (relative risk 0·75, 95% CI 0·61-0·92) and 1·5% olanexidine (0·49, 0·26-0·92) significantly reduced the rate of SSIs compared with aqueous iodine. For clean surgery, we found no difference in efficacy between different concentrations of chlorhexidine in alcohol. Seven RCTs were at high risk of bias, 24 had some concerns, and two had low risk of bias. Heterogeneity across the studies was moderate (I=27·5%), and netsplitting did not show inconsistencies between direct and indirect comparisons. Five of ten studies that mentioned adverse events related to the skin preparation solutions reported no adverse events, and five reported a total of 56 mild events (mainly erythema, pruritus, dermatitis, skin irritation, or mild allergic symptoms); none reported a substantial difference in adverse events between groups.

INTERPRETATION

For adult patients undergoing a surgical procedure of any wound classification, skin preparation using either 2·0-2·5% chlorhexidine in alcohol or 1·5% olanexidine is most effective in the prevention of SSIs. For clean surgery, no specific concentration of chlorhexidine in alcohol can be recommended. The efficacy of olanexidine was established by a single randomised trial and further investigation is needed.

FUNDING

Dutch Association for Quality Funds Medical Specialists.

摘要

背景

手术部位感染(SSI)是最常见的术后并发症,会大幅增加医疗保健成本。已发表的荟萃分析和国际指南在预防 SSI 方面哪种术前皮肤消毒剂和浓度最有效的问题上存在差异。我们旨在比较不同皮肤准备溶液和浓度预防 SSI 的效果,并提供当前指南的概述。

方法

本系统评价和网络荟萃分析比较了接受任何伤口分类手术的成年患者中不同术前皮肤消毒剂预防 SSI 的效果。我们在 MEDLINE、Embase 和 Cochrane CENTRAL 中检索了截至 2021 年 11 月 23 日的随机对照试验(RCT),这些试验直接比较了两种或更多种抗菌剂(即洗必泰、碘或奥拉定)或水基和酒精基溶液中的浓度。我们排除了儿科、动物和非随机研究,以及未提供标准术前静脉内抗生素预防的研究。如果两组均未发生 SSI,则排除了研究进行定量分析。两位评审员筛选并审查了合格的全文并提取了数据。主要结局是 SSI 的发生(即浅表、深部和器官间隙)。我们进行了频率论随机效应网络荟萃分析,以估计皮肤准备溶液预防 SSI 的网络效果。我们进行了风险偏倚和推荐分级评估、制定与评价评估,以确定证据的确定性。本研究在 PROSPERO 注册,CRD42021293554。

结果

总共确定了 2326 篇文章,33 项研究符合系统评价标准,27 项研究(共 17735 名患者报告了 2144 例 SSI(总发生率为 12.1%))符合纳入定量分析的标准。只有 2.0-2.5%酒精洗必泰和 1.5%奥拉定(相对风险 0.75,95%CI 0.61-0.92)可显著降低 SSI 发生率,与水碘相比。对于清洁手术,我们发现不同浓度的酒精洗必泰在疗效方面没有差异。7 项 RCT 存在高偏倚风险,24 项存在一些关注,2 项存在低偏倚风险。研究之间的异质性为中度(I=27.5%),netsplitting 并未显示直接比较和间接比较之间的不一致。提到与皮肤准备溶液相关的不良事件的 10 项研究中有 5 项报告无不良事件,5 项报告了总共 56 例轻度事件(主要为红斑、瘙痒、皮炎、皮肤刺激或轻度过敏症状);两组之间均未报告不良事件有实质性差异。

解释

对于接受任何伤口分类手术的成年患者,使用 2.0-2.5%酒精洗必泰或 1.5%奥拉定进行皮肤准备可最有效地预防 SSI。对于清洁手术,不能推荐使用特定浓度的酒精洗必泰。奥拉定的疗效是由一项随机试验确定的,需要进一步研究。

资金

荷兰医疗专业质量基金协会。

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