Chang Yaping, Kennedy Sean Alexander, Bhandari Mohit, Lopes Luciane Cruz, Bergamaschi Cristiane de Cássia, Carolina de Oliveira E Silva Maria, Bhatnagar Neera, Mousavi S Mohsen, Khurshid Saqib, Petrisor Brad, Ren Melody, Sodhi Sukhmani K, Mirza Reza Donald, Guyatt Gordon H
Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4K1, Canada.
Michael G. DeGroote School of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4K1, Canada.
JBJS Rev. 2015 Jun 9;3(6). doi: 10.2106/JBJS.RVW.N.00088.
The purpose of the present study was to perform a systematic review and meta-analysis of the use of alternative antibiotic regimens-including (A) antibiotic prophylaxis versus no prophylaxis, (B) longer versus shorter duration of antibiotic prophylaxis, and (C) alternative drugs-for patients with open fracture of the extremities.
Data sources included CINAHL, EMBASE, MEDLINE, the Cochrane Central Registry of Controlled Trials (CENTRAL), and the Cochrane database of systematic reviews from 1965 to December 2013. All randomized controlled trials comparing the effectiveness of antibiotic prophylaxis in patients with open fracture of the extremities were eligible.
We identified 329 potentially eligible articles, of which seventeen proved to be eligible. In four randomized controlled trials involving 472 patients, we found a significantly lower infection rate in patients receiving antibiotic prophylaxis compared with those not receiving antibiotic prophylaxis (risk ratio = 0.37 [95% confidence interval, 0.21 to 0.66]; absolute risk reduction = 9.6% [95% confidence interval, 5.2% to 12.1%]). In three studies involving 1104 patients, we found no difference in the infection rate when a longer duration of antibiotics (three to five days) was compared with a shorter duration (one day) (risk ratio = 0.97; 95% confidence interval, 0.69 to 1.37). Confidence in the estimates for both questions was low to moderate. Individual comparisons of alternative drugs yielded estimates warranting only low to very low confidence.
Results of randomized controlled trials performed to date provide evidence that antibiotic prophylaxis reduces subsequent infection and that courses as short as one day are as effective as courses of three to five days, although the evidence warrants only low to moderate confidence. Given current practice, a large, multicenter, low risk of bias, randomized controlled trial enrolling representative populations and addressing the duration of antibiotics may be the next optimum step in investigation.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
本研究旨在对四肢开放性骨折患者使用替代抗生素方案进行系统评价和荟萃分析,这些方案包括:(A)抗生素预防与不预防;(B)抗生素预防的较长疗程与较短疗程;(C)替代药物。
数据来源包括CINAHL、EMBASE、MEDLINE、Cochrane对照试验中心注册库(CENTRAL)以及1965年至2013年12月的Cochrane系统评价数据库。所有比较四肢开放性骨折患者抗生素预防效果的随机对照试验均符合要求。
我们识别出329篇可能符合要求的文章,其中17篇被证明符合要求。在四项涉及472例患者的随机对照试验中,我们发现接受抗生素预防的患者感染率显著低于未接受抗生素预防的患者(风险比=0.37[95%置信区间,0.21至0.66];绝对风险降低=9.6%[95%置信区间,5.2%至12.1%])。在三项涉及1104例患者的研究中,我们发现较长疗程(三至五天)的抗生素与较短疗程(一天)相比,感染率没有差异(风险比=0.97;95%置信区间,0.69至1.37)。对这两个问题估计值的信心为低到中等。替代药物的个体比较得出的估计值仅具有低到非常低的可信度。
迄今为止进行的随机对照试验结果表明,抗生素预防可降低后续感染率,且一天的疗程与三至五天的疗程效果相同,尽管证据的可信度仅为低到中等。鉴于当前的实践情况,开展一项大型、多中心、低偏倚风险、纳入代表性人群并探讨抗生素疗程的随机对照试验可能是下一步最佳的研究步骤。
治疗性I级。有关证据水平的完整描述,请参阅作者指南。