Ratilal Bernardo O, Costa João, Pappamikail Lia, Sampaio Cristina
Department of Neurosurgery, Hospital de São José, Rua José António Serrano, Lisboa, Portugal, 1150-199.
Cochrane Database Syst Rev. 2015 Apr 28;2015(4):CD004884. doi: 10.1002/14651858.CD004884.pub4.
Basilar skull fractures predispose patients to meningitis because of the possible direct contact of bacteria in the paranasal sinuses, nasopharynx or middle ear with the central nervous system (CNS). Cerebrospinal fluid (CSF) leakage has been associated with a greater risk of contracting meningitis. Antibiotics are often given prophylactically, although their role in preventing bacterial meningitis has not been established.
To evaluate the effectiveness of prophylactic antibiotics for preventing meningitis in patients with basilar skull fractures.
We searched CENTRAL (2014, Issue 5), MEDLINE (1966 to June week 1, 2014), EMBASE (1974 to June 2014) and LILACS (1982 to June 2014). We also performed an electronic search of meeting proceedings from the American Association of Neurological Surgeons (1997 to September 2005) and handsearched the abstracts of meeting proceedings of the European Association of Neurosurgical Societies (1995, 1999 and 2003).
Randomised controlled trials (RCTs) comparing any antibiotic versus placebo or no intervention. We also identified non-RCTs to perform a separate meta-analysis in order to compare results.
Three review authors independently screened and selected trials, assessed risk of bias and extracted data. We sought clarification with trial authors when needed. We pooled risk ratios (RRs) for dichotomous data with their 95% confidence intervals (CIs) using a random-effects model. We assessed the overall quality of evidence using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach.
In this update we did not identify any new trials for inclusion. We included five RCTs with 208 participants in the review and meta-analysis. We also identified 17 non-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention in patients with basilar skull fractures. Most trials presented insufficient methodological detail. All studies included meningitis in their primary outcome. When we evaluated the five included RCTs, there were no significant differences between antibiotic prophylaxis groups and control groups in terms of reduction of the frequency of meningitis, all-cause mortality, meningitis-related mortality and need for surgical correction in patients with CSF leakage. There were no reported adverse effects of antibiotic administration, although one of the five RCTs reported an induced change in the posterior nasopharyngeal flora towards potentially more pathogenic organisms resistant to the antibiotic regimen used in prophylaxis. We performed a subgroup analysis to evaluate the primary outcome in patients with and without CSF leakage. We also completed a meta-analysis of all the identified controlled non-RCTs (enrolling a total of 2168 patients), which produced results consistent with the randomised data from the included studies.Using the GRADE approach, we assessed the quality of trials as moderate.
AUTHORS' CONCLUSIONS: Currently available evidence from RCTs does not support prophylactic antibiotic use in patients with basilar skull fractures, whether there is evidence of CSF leakage or not. Until more research is available, the effectiveness of antibiotics in patients with basilar skull fractures cannot be determined because studies published to date are flawed by biases. Large, appropriately designed RCTs are needed.
由于鼻窦、鼻咽部或中耳内的细菌可能直接接触中枢神经系统(CNS),颅底骨折使患者易患脑膜炎。脑脊液(CSF)漏与患脑膜炎的风险增加有关。抗生素常被预防性使用,但其在预防细菌性脑膜炎中的作用尚未确定。
评估预防性使用抗生素对预防颅底骨折患者脑膜炎的有效性。
我们检索了Cochrane系统评价数据库(CENTRAL,2014年第5期)、医学期刊数据库(MEDLINE,1966年至2014年6月第1周)、荷兰医学文摘数据库(EMBASE,1974年至2014年6月)和拉丁美洲及加勒比地区健康科学数据库(LILACS,1982年至2014年6月)。我们还对美国神经外科医师协会会议记录(1997年至2005年9月)进行了电子检索,并手工检索了欧洲神经外科学会会议记录(1995年、1999年和2003年)的摘要。
比较任何抗生素与安慰剂或不进行干预的随机对照试验(RCT)。我们还识别了非随机对照试验以进行单独的荟萃分析,以便比较结果。
三位综述作者独立筛选和选择试验、评估偏倚风险并提取数据。必要时,我们向试验作者寻求澄清。我们使用随机效应模型汇总二分数据的风险比(RRs)及其95%置信区间(CIs)。我们使用GRADE(推荐分级、评估、制定与评价)方法评估证据的总体质量。
在本次更新中,我们未识别出任何新的纳入试验。我们在综述和荟萃分析中纳入了5项随机对照试验,共208名参与者。我们还识别了17项非随机对照试验,这些试验比较了不同类型的抗生素预防措施与颅底骨折患者的安慰剂或不进行干预。大多数试验提供的方法学细节不足。所有研究均将脑膜炎纳入其主要结局。当我们评估纳入的5项随机对照试验时,抗生素预防组与对照组在降低脑膜炎发生率、全因死亡率、脑膜炎相关死亡率以及脑脊液漏患者手术矫正需求方面无显著差异。未报告抗生素给药的不良反应,尽管5项随机对照试验之一报告了鼻咽后部菌群向对预防性使用的抗生素方案耐药的潜在致病性更强的微生物转变。我们进行了亚组分析以评估有或无脑脊液漏患者的主要结局。我们还对所有识别出的对照非随机对照试验(共纳入2168名患者)进行了荟萃分析,其结果与纳入研究的随机数据一致。使用GRADE方法,我们将试验质量评估为中等。
目前随机对照试验的现有证据不支持对颅底骨折患者预防性使用抗生素,无论是否有脑脊液漏的证据。在有更多研究之前,由于迄今为止发表的研究存在偏倚,无法确定抗生素对颅底骨折患者的有效性。需要进行大规模、设计合理的随机对照试验。