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抗生素或银与标准脑室腹腔分流术治疗脑积水的疗效评估
作者:小柯机器人 发布时间:2019/9/18 14:38:43

英国阿尔德儿童医院Conor L Mallucci团队的一项最新研究,综合评估了抗生素或银与标准脑室腹腔分流术治疗脑积水的效果。该项研究成果2019年9月12日在线发表于《柳叶刀》。

课题组在英国和爱尔兰的21个区域性成人和儿科神经外科中心进行了一项平行、多中心、单盲、随机对照试验,招募全年龄的接受第一脑室-腹腔分流术的任何病因的脑积水患者。2013年6月26日至2017年10月9日,研究人员评估了3505名患者,其中1605名年龄低于91岁的患者被随机分组(1:1:1),536名接受标准分流术(标准分流术组),538名采用0.15%克林霉素和0.054%利福平进行抗生素浸润(抗生素分流术组),531名接受银浸润分流术(银分流术组)。

1594名患者分流时没有感染,其中标准分流术组533人,抗生素分流术组535人,银分流术组526人。平均随访22个月后,标准分流术组中有32名(6%)患者术后感染,抗生素分流术组中有12名(2%),病因特异性风险比为0.38,银分流术组中有31名(6%)。标准分流术组中有135例(25%),抗生素分流术组中有127例(23%),银分流术组中有134例(36%)患者发生不良反应,但均不危及生命,且多与瓣膜或导管功能有关。

研究结果支持首次行脑室腹腔分流术的患者采用抗生素分流术,以减少术后感染的风险和危害。

据介绍,脑室腹腔分流术治疗脑积水是世界上最常见的神经外科手术之一。然而,分流术后多达15%患者发生感染,导致住院治疗时间延长,多次手术,认知和生活质量降低。

附:英文原文

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

Author: Conor L Mallucci, Michael D Jenkinson, Elizabeth J Conroy, John C Hartley, Michaela Brown, Joanne Dalton, Tom Kearns, Tracy Moitt, Michael J Griffiths, Giovanna Culeddu, Tom Solomon, Dyfrig Hughes, Carrol Gamble

Issue&Volume: 12 September 2019

Summary: 

Background

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.

Methods

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.

Findings

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.

Interpretation

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.

DOI: 10.1016/S0140-6736(19)31603-4

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31603-4/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet