Gosselin R A, Roberts I, Gillespie W J
PO Box 1983, El Granada, California 94018, USA.
Cochrane Database Syst Rev. 2004;2004(1):CD003764. doi: 10.1002/14651858.CD003764.pub2.
Wound and bone infections are frequently associated with open fractures of the extremities and may add significantly to the resulting morbidity. The administration of antibiotics is routinely used in developed countries as an adjunct to a comprehensive management protocol that also includes irrigation, surgical debridement and stabilisation when indicated, and is thought to reduce the frequency of infections.
To quantify the evidence for the effectiveness of antibiotics in the initial treatment of open fractures of the limbs.
We searched the Cochrane Musculoskeletal Injuries Group specialised register (April 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library issue 1, 2003), MEDLINE (1966 to April 2003), EMBASE (1988 to April 2003), LILACS (1992 to June 2002) and reference lists of articles. Proceedings of meetings of the American Academy of Orthopaedic Surgeons (1980 to 2001), the Orthopaedic Trauma Association (1990 to 2001) and the Société Internationale de Chirurgie Orthopedique et Traumatologique (1980 to 2001) were hand searched. We also contacted published researchers in the field.
Randomised or quasi-randomised controlled trials involving: participants - people of any age with open fractures of the limbs; intervention - antibiotic administered before or at the time of primary treatment of the open fracture compared with placebo or no antibiotic; outcome measures - early wound infection, chronic drainage, acute or chronic osteomyelitis, delayed unions or non-unions, amputations and deaths.
Two reviewers independently screened papers for inclusion, assessed trial quality using an eight item scale, and extracted data. Additional information was sought from three trialists. Pooled data are presented graphically.
Data from 913 participants in seven studies were analysed. The use of antibiotics had a protective effect against early infection compared with no antibiotics or placebo (relative risk 0.41 (95% confidence interval (CI) 0.27 to 0.63); absolute risk reduction 0.08 (95% CI 0.04 to 0.12); NNT 13 (95% CI 8 to 25)). There were insufficient data in the included studies to evaluate other outcomes.
REVIEWER'S CONCLUSIONS: Antibiotics reduce the incidence of early infections in open fractures of the limbs. Further placebo controlled randomised trials are unlikely to be justified in middle and high income countries. Further research is necessary to the determine the avoidable burden of morbidity in countries where antibiotics are not used routinely in the management of open fractures.
伤口及骨感染常与四肢开放性骨折相关,可能显著增加由此导致的发病率。在发达国家,抗生素的使用是综合治疗方案的辅助手段,该方案还包括冲洗、手术清创以及必要时的固定,并且认为抗生素可降低感染发生率。
量化抗生素在四肢开放性骨折初始治疗中有效性的证据。
我们检索了Cochrane肌肉骨骼损伤组专业注册库(2003年4月)、Cochrane对照试验中央注册库(《Cochrane图书馆》2003年第1期)、MEDLINE(1966年至2003年4月)、EMBASE(1988年至2003年4月)、LILACS(1992年至2002年6月)以及文章的参考文献列表。人工检索了美国矫形外科医师学会会议记录(1980年至2001年)、矫形创伤协会会议记录(1990年至2001年)以及国际矫形与创伤外科学会会议记录(1980年至2001年)。我们还联系了该领域已发表研究的人员。
随机或半随机对照试验,涉及:参与者——任何年龄的四肢开放性骨折患者;干预措施——开放性骨折初次治疗前或治疗时使用抗生素与使用安慰剂或不使用抗生素进行比较;结局指标——早期伤口感染、慢性引流、急性或慢性骨髓炎、延迟愈合或不愈合、截肢及死亡。
两名评价员独立筛选纳入的论文,使用八项量表评估试验质量,并提取数据。向三位试验者寻求了额外信息。汇总数据以图表形式呈现。
分析了七项研究中913名参与者的数据。与不使用抗生素或使用安慰剂相比,使用抗生素对早期感染有保护作用(相对危险度0.41(95%可信区间(CI)0.27至0.63);绝对危险度降低0.08(95%CI 0.04至0.12);需治疗人数13(95%CI 8至25))。纳入研究中的数据不足以评估其他结局。
抗生素可降低四肢开放性骨折早期感染的发生率。在中高收入国家,进一步进行安慰剂对照随机试验可能不合理。有必要进一步研究以确定在开放性骨折治疗中不常规使用抗生素的国家中可避免的发病负担。