Kandasamy Jothy, Dwan Kerry, Hartley John C, Jenkinson Michael D, Hayhurst Caroline, Gatscher Sylvia, Thompson Dominic, Crimmins Darach, Mallucci Conor
Department of Paediatric Neurosurgery, Alder Hey, Royal Liverpool Children's University Hospital NHS Trust, Liverpool, UK.
Childs Nerv Syst. 2011 Apr;27(4):575-81. doi: 10.1007/s00381-010-1290-z. Epub 2010 Oct 17.
Ventriculoperitoneal shunt infection remains a significant problem. The introduction of antibiotic-impregnated shunt (AIS) systems in the prevention of shunt infection may represent a potential advance; however, there are no randomized controlled trials to establish a robust evidence-based practice. Previously published single-institution cohort studies have provided varying results on the efficacy of AIS systems in the prevention of shunt infection. In this study, we evaluate combined outcomes from three paediatric neurosurgical units in the use of AIS systems for paediatric patients with hydrocephalus.
The three units established independent databases with data collected from varying time frames. All procedures, where a complete AIS system or part was implanted into patients from 0-16 years in age, were included. The primary outcome measure was shunt infection rate. Shunt procedures were classified as de novo (DNS) and clean revision (CRS). An infant (<1 year) de novo insertion subgroup was also analyzed. AIS shunts were compared to a historical control of non-AIS shunts and results were analysed by centre using an odds ratio with a 95% confidence interval and combined across centres by meta-analysis.
A total of 581 AIS implantation procedures were performed in all three units. The comparative non-AIS historical cohort comprised of 1,963 procedures. The pooled effect estimate indicated a clinical advantage for AIS shunts compared to non-AIS shunts, odds ratio (OR), 0.60 (95% CI 0.38, 0.93). The de novo infant group comprised 153 AIS systems, and 465 de novo shunts in the historical non-AIS cohort. Again the pooled effect estimate indicated a clinical advantage for AIS shunts compared to non-AIS shunts, OR 0.38 (95% CI, 0.17; 0.85); however, there was a large overlap of confidence intervals in the results from the different sites indicating the uncertainty in the treatment effect estimates. Over 80% of organisms were gram positive in the infected AIS cohort with a median time to infection of 19 days. Two rifampicin-resistant organisms and three MRSA organisms were detected.
Data from this exclusively paediatric multi-centre historical control study suggest that AIS may significantly reduce infection rates in de novo and clean revision shunt implants. Although the possibility of bias cannot be excluded due to study design, this is the largest study on an exclusively paediatric cohort comparing standard shunts to AIS implants. Future double-blinded RCTs are needed to confirm AIS efficacy.
脑室腹腔分流感染仍然是一个重大问题。引入抗生素浸渍分流（AIS）系统来预防分流感染可能是一项潜在进展；然而，尚无随机对照试验来确立强有力的循证实践。此前发表的单机构队列研究对于AIS系统预防分流感染的疗效给出了不同结果。在本研究中，我们评估了三个儿科神经外科单元在将AIS系统用于小儿脑积水患者时的综合结果。
这三个单元建立了独立数据库，收集不同时间段的数据。纳入所有将完整AIS系统或其部件植入0至16岁患者的手术。主要结局指标是分流感染率。分流手术分为初次手术（DNS）和清洁翻修手术（CRS）。还对婴儿（<1岁）初次植入亚组进行了分析。将AIS分流与非AIS分流的历史对照进行比较，并通过中心使用比值比及95%置信区间进行结果分析，然后通过荟萃分析在各中心间进行合并。
所有三个单元共进行了581例AIS植入手术。比较的非AIS历史队列包括1963例手术。汇总效应估计表明，与非AIS分流相比，AIS分流具有临床优势，比值比（OR）为0.60（95%CI 0.38，0.93）。初次植入婴儿组包括153个AIS系统，历史非AIS队列中有465例初次分流。同样，汇总效应估计表明，与非AIS分流相比，AIS分流具有临床优势，OR为0.38（95%CI，0.17；0.85）；然而，不同部位结果的置信区间有很大重叠，表明治疗效果估计存在不确定性。在感染的AIS队列中，超过80%的病原体为革兰氏阳性，感染的中位时间为19天。检测到两种耐利福平病原体和三种耐甲氧西林金黄色葡萄球菌病原体。
这项专门针对儿科的多中心历史对照研究的数据表明，AIS可能显著降低初次手术和清洁翻修分流植入的感染率。尽管由于研究设计不能排除偏倚的可能性，但这是关于将标准分流与AIS植入进行比较的最大规模儿科队列研究。未来需要进行双盲随机对照试验来证实AIS的疗效。
