Ratilal Bernardo O, Costa João, Sampaio Cristina, Pappamikail Lia
Department of Neurosurgery, Hospital de São José, Rua José António Serrano, Lisboa, Portugal, 1150-199.
Cochrane Database Syst Rev. 2011 Aug 10(8):CD004884. doi: 10.1002/14651858.CD004884.pub3.
Basilar skull fractures (BSF) 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 is not established.
To evaluate the effectiveness of prophylactic antibiotics for preventing meningitis in patients with BSF.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1), which contains the Cochrane Acute Respiratory Infections (ARI) Group's Specialised Register, MEDLINE (1966 to February 2011), EMBASE (1974 to February 2011) and LILACS (1982 to February 2011). 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 to compare results.
At least two authors independently appraised trial quality and extracted data for each trial.
We identified five RCTs and 17 non-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention in patients with BSF. Most trials presented insufficient methodological detail. All studies included meningitis in their primary outcome. Overall, we evaluated 208 participants from the five RCTs that were considered suitable for inclusion in the meta-analysis. 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), producing results consistent with the randomised data.
AUTHORS' CONCLUSIONS: Currently available evidence from RCTs does not support prophylactic antibiotic use in patients with BSF, whether there is evidence of CSF leakage or not. Until more research is completed, the effectiveness of antibiotics in patients with BSF cannot be determined because studies published to date are flawed by biases. Large, appropriately designed RCTs are needed.
由于鼻窦、鼻咽或中耳中的细菌可能直接接触中枢神经系统(CNS),颅底骨折(BSF)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立。
评估预防性使用抗生素对预防BSF患者脑膜炎的有效性。
我们检索了Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2011年第1期),其中包含Cochrane急性呼吸道感染(ARI)小组的专业注册库、MEDLINE(1966年至2011年2月)、EMBASE(1974年至2011年2月)和LILACS(1982年至2011年2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摘要(1995年、1999年和2003年)。
比较任何抗生素与安慰剂或无干预措施的随机对照试验(RCT)。我们还确定了非RCT进行单独的荟萃分析以比较结果。
至少两名作者独立评估试验质量并为每个试验提取数据。
我们确定了5项RCT和17项非RCT,比较了不同类型的抗生素预防措施与安慰剂或无干预措施在BSF患者中的效果。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。总体而言,我们评估了5项RCT中被认为适合纳入荟萃分析的208名参与者。在脑膜炎发生率降低、全因死亡率、脑膜炎相关死亡率以及CSF漏患者的手术矫正需求方面,抗生素预防组与对照组之间无显著差异。未报告抗生素给药的不良反应,尽管5项RCT之一报告称,预防性使用的抗生素方案使鼻咽后部菌群向潜在更具致病性的耐药菌转变。我们进行了亚组分析以评估有或无CSF漏患者的主要结局。我们还对所有已识别的对照非RCT(共纳入2168例患者)进行了荟萃分析,结果与随机数据一致。
目前来自RCT的证据不支持在BSF患者中预防性使用抗生素,无论是否有CSF漏的证据。在完成更多研究之前,由于迄今为止发表的研究存在偏倚缺陷,无法确定抗生素对BSF患者的有效性。需要进行大规模、设计合理的RCT。