Center for Drug Evaluation and Research, Office of New Drugs, Division of Anti-Infective Products, US Food and Drug Administration, Silver Spring, Maryland.
Clin Infect Dis. 2012 Dec;55(11):1474-80. doi: 10.1093/cid/cis735. Epub 2012 Aug 23.
Addition of antibacterial drugs to interim antibacterial cement spacers (ACSs) is considered to be standard of care for surgical revision in prosthetic joint infections (PJIs). We reviewed published studies evaluating the choice and doses of antibacterials in spacers.
We conducted a PubMed search of all clinical study reports evaluating the use of ACSS in a 2-stage hip or knee arthroplasty for treatment of PJI (1988 through August 2011). The trial design, antibacterials used, and end points studied were analyzed.
No randomized trials were found comparing either ACSs with different concentrations of antibacterials or ACSs with or without antibacterials. Most of the studies were uncontrolled and used various time points to evaluate the outcome. Twenty publications that reported doses of antibacterials in spacers and had a follow-up of ≥ 24 months after the second stage were selected for review. Most ACSs included vancomycin and aminoglycosides. The doses of aminoglycosides and vancomycin ranged from 0.25 to 4.8 g and from 1 to 4 g, respectively, per 4 g of cement. No association between reported eradication of the infection and antibacterial load was found.
Published data do not allow evaluation of whether antibacterials in temporary cement spacers provide additional benefits in the treatment of PJI, compared with systemic antibacterials, and are not sufficient to support recommendations on dosages. Complications of ACSs have not been consistently analyzed. Prospective randomized trials comparing spacers with and without antibacterials or spacers with different loads of antibacterials are needed to evaluate the safety and efficacy of ACSs.
在临时抗菌水泥间隔物（ACS）中添加抗菌药物被认为是治疗假体关节感染（PJI）手术翻修的标准治疗方法。我们回顾了已发表的评估间隔物中抗菌药物选择和剂量的研究。
我们对所有评估在髋关节或膝关节 2 期置换术治疗 PJI（1988 年至 2011 年 8 月）中使用 ACS 的临床研究报告进行了 PubMed 搜索。分析了试验设计、使用的抗菌药物和研究的终点。
未发现比较不同浓度抗菌药物的 ACS 或带或不带抗菌药物的 ACS 的随机试验。大多数研究为非对照研究，使用了不同的时间点来评估结果。选择了 20 篇报告间隔物中抗菌药物剂量且在第 2 阶段后随访时间≥24 个月的出版物进行综述。大多数 ACS 包括万古霉素和氨基糖苷类药物。氨基糖苷类药物和万古霉素的剂量分别为每 4 克水泥 0.25 至 4.8 克和 1 至 4 克。未发现报告的感染清除率与抗菌负荷之间存在关联。
已发表的数据不允许评估与全身抗菌药物相比，临时水泥间隔物中的抗菌药物在治疗 PJI 方面是否提供了额外的益处，也不足以支持关于剂量的建议。ACS 的并发症尚未得到一致分析。需要进行比较带或不带抗菌药物的间隔物或具有不同抗菌药物负荷的间隔物的前瞻性随机试验，以评估 ACS 的安全性和疗效。
