Lane Jordan D, Mugamba John, Ssenyonga Peter, Warf Benjamin C
Harvard Medical School;
J Neurosurg Pediatr. 2014 Feb;13(2):140-4. doi: 10.3171/2013.11.PEDS13394. Epub 2013 Dec 6.
Antibiotic-impregnated shunts have yet to find widespread use in the developing world, largely due to cost. Given potential differences in the microbial spectrum, their effectiveness in preventing shunt infection for populations in low-income countries may differ and has not been demonstrated. This study is the first to compare the efficacy of a Bactiseal shunt system with a non-antibiotic-impregnated system in a developing country.
The Bactiseal Universal Shunt (BUS) was placed in 80 consecutive Ugandan children who required a shunt. In this retrospective cohort study, the outcome for that group was compared with the outcome for the immediately preceding 80 consecutive children in whom a Chhabra shunt had been placed. The primary end points were shunt failure, shunt infection, and death. Shunt survival was analyzed using the Kaplan-Meier method. Significance of differences between groups was tested using the log-rank test, chi-square analysis, Fisher's exact test, and t-test.
There was no difference between groups in regard to age, sex, or etiology of hydrocephalus. Mean follow-up for cases of nonfailure was 7.6 months (median 7.8 months, interquartile range 6.5-9.5 months). There was no significant difference between groups for any end point. The BUS group had fewer infections (4 vs 11), but the difference was not significant (p = 0.086, log-rank test). Gram-positive cocci were the most common culturable pathogens in the Chhabra group, while the only positive culture in the BUS group was a gram-negative rod.
These results provide equipoise for a randomized controlled trial in the same population and this has been initiated. It is possible that the observed trends may become significant in a larger study. The more complex task will involve determining not only the efficacy, but also the cost-effectiveness of using antibiotic-impregnated shunt components in limited-resource settings.
抗生素浸渍分流管在发展中国家尚未得到广泛应用，主要原因是成本问题。鉴于微生物谱可能存在差异，其在低收入国家人群中预防分流感染的有效性可能不同，且尚未得到证实。本研究首次在一个发展中国家比较了Bactiseal分流系统与非抗生素浸渍系统的疗效。
连续80例需要分流的乌干达儿童植入了Bactiseal通用分流管（BUS）。在这项回顾性队列研究中，将该组的结果与前80例连续植入Chhabra分流管的儿童的结果进行了比较。主要终点是分流失败、分流感染和死亡。使用Kaplan-Meier方法分析分流存活情况。使用对数秩检验、卡方分析、Fisher精确检验和t检验来检验组间差异的显著性。
两组在年龄、性别或脑积水病因方面没有差异。未发生分流失败的病例平均随访7.6个月（中位数7.8个月，四分位间距6.5 - 9.5个月）。两组在任何终点方面均无显著差异。BUS组感染较少（4例对11例），但差异不显著（p = 0.086，对数秩检验）。革兰氏阳性球菌是Chhabra组最常见的可培养病原体，而BUS组唯一的阳性培养物是革兰氏阴性杆菌。
这些结果为在同一人群中进行随机对照试验提供了平衡，目前该试验已经启动。在更大规模的研究中，观察到的趋势有可能变得显著。更复杂的任务将不仅涉及确定疗效，还涉及在资源有限的环境中使用抗生素浸渍分流组件的成本效益。
