是否有循证依据支持采用抗菌（三氯生）涂层缝线技术来降低手术部位感染的风险？：一项荟萃分析。

Is there an evidence-based argument for embracing an antimicrobial (triclosan)-coated suture technology to reduce the risk for surgical-site infections?: A meta-analysis.

机构信息

Department of Surgery, Medical College of Wisconsin, Milwaukee, WI 53226, USA.

出版信息

Surgery. 2013 Jul;154(1):89-100. doi: 10.1016/j.surg.2013.03.008.

DOI:10.1016/j.surg.2013.03.008

PMID:23809487

Abstract

BACKGROUND

It has been estimated that 750,000 to 1 million surgical-site infections (SSIs) occur in the United States each year, causing substantial morbidity and mortality. Triclosan-coated sutures were developed as an adjunctive strategy for SSI risk reduction, but a recently published systematic literature review and meta-analysis suggested that no clinical benefit is associated with this technology. However, that study was hampered by poor selection of available randomized controlled trials (RCTs) and low patient numbers. The current systematic review involves 13 randomized, international RCTs, totaling 3,568 surgical patients.

METHODS

A systematic literature search was performed on PubMed, Embase/Medline, Cochrane database group (Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Health Economic Evaluations Database/Database of Health Technology Assessments), and www.clinicaltrials.gov to identify RCTs of triclosan-coated sutures compared with conventional sutures and assessing the clinical effectiveness of antimicrobial sutures to decrease the risk for SSIs. A fixed- and random-effects model was developed, and pooled estimates reported as risk ratio (RR) with a corresponding 95% confidence interval (CI). Publication bias was assessed by analyzing a funnel plot of individual studies and testing the Egger regression intercept.

RESULTS

The meta-analysis (13 RCTs, 3,568 patients) found that use of triclosan antimicrobial-coated sutures was associated with a decrease in SSIs in selected patient populations (fixed effect: RR = 0.734; 95% CI: 0.590-0.913; P = .005; random-effect: RR = 0.693; 95% CI: 0.533-0.920; P = .011). No publication bias was detected (Egger intercept test: P = .145).

CONCLUSION

Decreasing the risk for SSIs requires a multifaceted "care bundle" approach, and this meta-analysis of current, pooled, peer-reviewed, randomized controlled trials suggests a clinical effectiveness of antimicrobial-coated sutures (triclosan) in the prevention of SSIs, representing Center for Evidence-Based Medicine level 1a evidence.

摘要

背景

据估计，每年美国有 75 万至 100 万例手术部位感染（SSI），导致大量发病率和死亡率。三氯生涂层缝线被开发为降低 SSI 风险的辅助策略，但最近发表的系统文献综述和荟萃分析表明，该技术没有临床获益。然而，该研究受到可用随机对照试验（RCT）选择不佳和患者数量低的限制。目前的系统综述涉及 13 项随机、国际 RCT，共有 3568 名手术患者。

方法

在 PubMed、Embase/Medline、Cochrane 数据库组（中央对照试验注册中心、Cochrane 系统评价数据库、卫生经济学评价数据库/卫生技术评估数据库）和 www.clinicaltrials.gov 上进行了系统文献检索，以确定三氯生涂层缝线与传统缝线的 RCT，并评估抗菌缝线降低 SSI 风险的临床效果。采用固定效应和随机效应模型，以风险比（RR）和相应的 95%置信区间（CI）报告汇总估计值。通过分析单个研究的漏斗图和检验 Egger 回归截距来评估发表偏倚。

结果

荟萃分析（13 项 RCT，3568 名患者）发现，在选定的患者人群中，使用三氯生抗菌涂层缝线可降低 SSI 的发生（固定效应：RR=0.734；95%CI：0.590-0.913；P=0.005；随机效应：RR=0.693；95%CI：0.533-0.920；P=0.011）。未发现发表偏倚（Egger 截距检验：P=0.145）。