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[Lancet在线发表]:抗生素浸润脑室腹腔分流管降低感染导致分流失败率
2019年10月05日 时讯速递, 进展交流 暂无评论

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Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation

Conor L Mallucci, Michael D Jenkinson, Elizabeth J Conroy, et al

Lancet Published:September 12, 2019 DOI:https://doi.org/10.1016/S0140-6736(19)31603-4

Summary

Background 背景

Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection.

脑积水时置入脑室腹腔分流是全球最常见的神经外科操作。15%的患者植入分流管发生感染,导致住院日延长,需要多次手术,认知功能及生活质量降低。本研究目的在于确定与标准分流管相比,抗生素(利福平和克林霉素)或银浸润的分流管减少感染的临床疗效及成本效益比。

Methods 方法

In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281.

这项平行,多中心,单盲,随机对照试验在英国和爱尔兰21个区域成人和儿童神经外科中心进行,纳入任何原因引起的脑积水且首次植入脑室腹腔分流管的任何年龄患者。患者接受随机分组(1:1:1的比例,随机区组大小3或6),根据独立统计学家生成的随机顺序,分别使用标准分流管(标准分流组),抗生素浸润分流管(0·15%克林霉素和0·054%利福平;抗生素分流组)或银浸润分流管(银分流组)。分组情况对所有患者以及记录并分析数据的研究者隐藏,仅在手术时神经外科医生了解。植入分流管时无感染表现的患者随访至少6个月,最长时间不超过2年。主要预后指标为感染引起分流管失功的时间,根据意向治疗原则采用Fine和Gray生存回归模型进行竞争风险分析。试验注册号为ISRCTN 49474281。

Findings 结果

Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10–24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18–0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56–1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function.

从2013年6月26日至2017年10月9日,我们对3505名患者进行了评估,其中1605名年龄不超过91岁的患者接受随机分组,分别使用标准分流管 (n=536),抗生素浸润分流管 (n=538),或银浸润分流管 (n=531)。1594名患者植入分流管时没有感染征象(标准分流组533名,抗生素分流组535名,银分流组526名),中位随访时间22个月(IQR 10–24;53名患者随访期间撤除知情同意)。标准分流组533名患者中32名 (6%) 发生分流管感染,抗生素分流组535名患者中12名 (2%) (病因特异性风险比 [csHR] 0·38, 97·5% CI 0·18–0·80, p=0·0038),银分流组526名患者中31名 (6%) (0·99, 0·56–1·74, p=0·96) 发生分流管感染。标准分流组中135名患者 (25%),抗生素分流组中127名患者 (23%),及银分流组中134名患者 (36%)发生不良事件,但均非致命性,多数与单向阀或导管相关。

Interpretation 结论

The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection.

对于首次植入脑室腹腔分流管的英国患者而言,BASIC试验提供的证据支持采用抗生素浸润分流管。这一做法可以减少分流管感染的风险,从而使所有年龄患者获益。

Funding 资助

UK National Institute for Health Research Health Technology Assessment programme.

评论[仅代表个人观点]

  • 抗生素浸润的中心静脉导管在上个世纪九十年代曾经受到关注。临床研究显示,与普通中心静脉导管相比,抗生素浸润的中心静脉导管能够减少3/4的导管相关菌血症
  • 相信上述导管不再流行的原因之一在于抗生素的释放具有一定的时间期限。因此,后来的抗感染导管开始采用其他工艺,以期延长其抗感染效能。
  • 抗生素浸润的脑室分流管是否会重蹈覆辙呢?
  • 从另一角度讲,为何银浸润的导管没有作用呢?

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