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主动脉或主-髂动脉周围动脉重建术中的感染预防

Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction.

作者信息

Cristino Mateus Ab, Nakano Luis Cu, Vasconcelos Vladimir, Correia Rebeca M, Flumignan Ronald Lg

机构信息

Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.

Cochrane Brazil, Universidade Federal de São Paulo, São Paulo, Brazil.

出版信息

Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.

DOI:10.1002/14651858.CD015192.pub2
PMID:40260835
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12012886/
Abstract

BACKGROUND

Peripheral arterial disease (PAD) results from the narrowing of arteries. Aortic aneurysms - abnormal dilatations in artery walls - are a related concern. For severe cases, arterial reconstruction surgery is the treatment option. Surgical site infections (SSIs) are a feared and common complication of vascular surgery. These infections have a significant global healthcare impact. Evaluating the effectiveness of preventive measures is essential.

OBJECTIVES

To assess the effects of pharmacological and non-pharmacological interventions, including antimicrobial therapy, antisepsis, and wound management, for the prevention of infection in people undergoing any open or hybrid aortic or aortoiliac peripheral arterial reconstruction.

SEARCH METHODS

The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases, and the World Health Organization International Clinical Trials Registry Platform, LILACS, and ClinicalTrials.gov up to 11 November 2024.

SELECTION CRITERIA

We included all randomised controlled trials (RCTs) with a parallel (e.g. cluster or individual) or split-body design, and quasi-RCTs, which assessed any intervention to reduce or prevent infection following aortic or aortoiliac procedures for the treatment of aneurysm or PAD. There were no limitations regarding age and sex.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methodological procedures. Two review authors independently extracted the data and assessed the risk of bias of the trials. A third review author resolved disagreements when necessary. We assessed the evidence certainty for key outcomes using GRADE.

MAIN RESULTS

We included 21 RCTs with 4952 participants. Fifteen studies were assessed as having a high risk of bias in at least one domain, and 19 studies had an unclear risk of bias in at least one domain. We analysed 10 different comparisons for eight different outcomes. The comparisons were antibiotic versus placebo or no treatment; short-duration antibiotics (≤ 24 hours) versus long-duration antibiotics (> 24 hours); different types of systemic antibiotics (one versus another); antibiotic-bonded implant versus standard implant; Dacron graft versus stretch polytetrafluoroethylene graft; prophylactic closed suction drainage versus undrained wound; individualised goal-directed therapy (IGDT) versus fluid therapy based on losses, standard haemodynamic parameters and arterial blood gas values (standard care); comprehensive geriatric assessment versus standard preoperative care; percutaneous versus open-access technique; and negative pressure wound therapy (NPWT) versus standard dressing. The primary outcomes were graft infection rate and SSI rate. The secondary outcomes included all-cause mortality, arterial reconstruction failure rate, re-intervention rate, amputation rate, pain resulting from the intervention, and adverse events resulting from the interventions to prevent infection. We did not assess all the outcomes across the different comparisons. The main findings are presented below. Antibiotic versus placebo or no treatment (five studies) Very low-certainty evidence from five included studies suggests that antibiotic prophylaxis reduces SSI (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.15 to 0.71; 5 studies, 583 participants; number needed to treat for an additional beneficial outcome (NNT) 9). With very low- to low-certainty evidence, there was little or no difference between the groups in the other assessed outcomes (graft infection rate, all-cause mortality, re-intervention rate, and amputation rate). We did not quantitatively assess other outcomes in this comparison. Short duration antibiotics (≤ 24 hours) versus long duration antibiotics (> 24 hours) (three studies) Very low-certainty evidence from three included studies suggests that there is little or no difference in graft infection rate (RR 2.74, 95% CI 0.11 to 65.59; 1 study, 88 participants) or SSI rate (RR 3.65, 95% CI 0.59 to 7.71; 1 study, 88 participants) between short- and long-duration antibiotic prophylaxis. We did not quantitatively assess other outcomes in this comparison. Different types of systemic antibiotics (one versus another) (seven studies) We grouped seven studies comparing one antibiotic to another into three subgroups that compared different classes of antibiotics amongst themselves. We found little or no difference between the groups analysed. Graft infection rate: beta-lactams versus cephalosporins (RR 0.36, 95% CI 0.02 to 8.71; 1 study, 88 participants; very low-certainty evidence); glycopeptides versus cephalosporins (RR 5.00, 95% CI 0.24 to 103.05; 1 study, 238 participants; low-certainty evidence); one cephalosporin versus another (RR not estimable, CI not estimable; 1 study; 69 participants; very low-certainty evidence); SSI rate: beta-lactams and cephalosporins (RR 0.27, 95% CI 0.03 to 2.53; 2 studies, 229 participants; very low-certainty evidence); glycopeptides versus cephalosporins (RR 2.17, 95% CI 0.65 to 7.23; 2 studies, 312 participants; very low-certainty evidence); and one cephalosporin versus another (RR 1.26, 95% CI 0.21 to 7.45; 3 studies, 625 participants; very low-certainty evidence). We could extract all-cause mortality data for the glycopeptide versus cephalosporin comparison; there was little or no difference between groups (RR 1.33, 95% CI 0.30 to 5.83; 1 study, 238 participants; low-certainty evidence). We did not quantitatively assess other outcomes in this comparison.

AUTHORS' CONCLUSIONS: Very low-certainty evidence suggests that the use of prophylactic antibiotics may prevent SSIs in aortic or aortoiliac peripheral arterial reconstruction. We found no superiority amongst specific antibiotics or differences in extended antibiotic use (over 24 hours) compared with shorter use (up to 24 hours), with low-certainty evidence. For other interventions, very low- to moderate-certainty evidence showed little or no difference across various outcomes. We advise interpreting these conclusions with caution due to the limited number of events in all groups and comparisons.

摘要

背景

外周动脉疾病(PAD)是由动脉狭窄引起的。主动脉瘤——动脉壁的异常扩张——是一个相关问题。对于严重病例,动脉重建手术是治疗选择。手术部位感染(SSIs)是血管手术令人担忧且常见的并发症。这些感染对全球医疗保健有重大影响。评估预防措施的有效性至关重要。

目的

评估药物和非药物干预措施,包括抗菌治疗、防腐和伤口管理,对接受任何开放性或杂交性主动脉或主-髂外周动脉重建手术患者预防感染的效果。

检索方法

Cochrane血管信息专家检索了Cochrane血管专业注册库、CENTRAL、MEDLINE、Embase和CINAHL数据库,以及世界卫生组织国际临床试验注册平台、LILACS和ClinicalTrials.gov,检索截至2024年11月11日的数据。

入选标准

我们纳入了所有采用平行(如整群或个体)或分体设计的随机对照试验(RCTs)以及半随机对照试验,这些试验评估了任何用于减少或预防主动脉或主-髂手术治疗动脉瘤或PAD后感染的干预措施。年龄和性别不受限制。

数据收集与分析

我们采用标准的Cochrane方法学程序。两位综述作者独立提取数据并评估试验的偏倚风险。必要时由第三位综述作者解决分歧。我们使用GRADE评估关键结局的证据确定性。

主要结果

我们纳入了21项RCTs,共4952名参与者。15项研究被评估为至少在一个领域存在高偏倚风险,19项研究在至少一个领域存在不明确的偏倚风险。我们分析了针对8种不同结局的10种不同比较。这些比较包括抗生素与安慰剂或不治疗;短疗程抗生素(≤24小时)与长疗程抗生素(>24小时);不同类型的全身性抗生素(一种与另一种);抗生素涂层植入物与标准植入物;涤纶移植物与拉伸聚四氟乙烯移植物;预防性闭式吸引引流与未引流伤口;个体化目标导向治疗(IGDT)与基于液体丢失、标准血流动力学参数和动脉血气值的液体治疗(标准护理);综合老年评估与标准术前护理;经皮与开放入路技术;以及负压伤口治疗(NPWT)与标准敷料。主要结局是移植物感染率和SSI率。次要结局包括全因死亡率、动脉重建失败率、再次干预率、截肢率、干预引起的疼痛以及预防感染干预措施导致的不良事件。我们并未对所有不同比较中的所有结局进行评估。主要结果如下。抗生素与安慰剂或不治疗(五项研究):五项纳入研究的极低确定性证据表明,抗生素预防可降低SSI(风险比(RR)0.33,95%置信区间(CI)0.15至0.71;5项研究,583名参与者;额外获得有益结局所需治疗人数(NNT)9)。基于极低至低确定性证据,在其他评估结局(移植物感染率、全因死亡率、再次干预率和截肢率)方面,各组之间几乎没有差异。我们未对该比较中的其他结局进行定量评估。短疗程抗生素(≤24小时)与长疗程抗生素(>24小时)(三项研究):三项纳入研究的极低确定性证据表明,短疗程和长疗程抗生素预防在移植物感染率(RR 2.74,95%CI 0.11至65.59;1项研究,88名参与者)或SSI率(RR 3.65,95%CI 0.59至7.71;1项研究,88名参与者)方面几乎没有差异。我们未对该比较中的其他结局进行定量评估。不同类型的全身性抗生素(一种与另一种)(七项研究):我们将七项比较一种抗生素与另一种抗生素的研究分为三个亚组,这些亚组相互比较不同类别的抗生素。我们发现所分析组之间几乎没有差异。移植物感染率:β-内酰胺类与头孢菌素类(RR 0.36,95%CI 0.02至8.71;1项研究,88名参与者;极低确定性证据);糖肽类与头孢菌素类(RR 5.00,95%CI 0.24至103.05;1项研究,238名参与者;低确定性证据);一种头孢菌素与另一种头孢菌素(RR无法估计,CI无法估计;1项研究;69名参与者;极低确定性证据);SSI率:β-内酰胺类和头孢菌素类(RR 0.27,95%CI 0.03至2.53;2项研究,229名参与者;极低确定性证据);糖肽类与头孢菌素类(RR 2.17,95%CI 0.65至7.23;2项研究,312名参与者;极低确定性证据);以及一种头孢菌素与另一种头孢菌素(RR 1.26,95%CI 0.21至7.45;3项研究,625名参与者;极低确定性证据)。我们能够提取糖肽类与头孢菌素类比较的全因死亡率数据;各组之间几乎没有差异(RR 1.33,95%CI 0.30至5.83;1项研究,238名参与者;低确定性证据)。我们未对该比较中的其他结局进行定量评估。

作者结论

极低确定性证据表明,预防性使用抗生素可能预防主动脉或主-髂外周动脉重建中的SSIs。基于低确定性证据,我们发现特定抗生素之间没有优势,且与较短时间使用(长达24小时)相比,延长抗生素使用时间(超过24小时)也没有差异。对于其他干预措施,极低至中等确定性证据表明,在各种结局方面几乎没有差异。由于所有组和比较中的事件数量有限,我们建议谨慎解读这些结论。

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