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首页> 外文期刊>The Internet Journal of Infectious Diseases >Evaluation of long-term outcomes in patients with osteomyelitis treated with a daptomycin-containing regimen
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Evaluation of long-term outcomes in patients with osteomyelitis treated with a daptomycin-containing regimen

机译：含达托霉素方案治疗的骨髓炎患者的长期预后评估

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Objectives: Daptomycin is often used to treat patients with osteomyelitis. In this review, we describe the use of daptomycin for osteomyelitis. Material and methods: Inclusion criteria included patients ≥18 years, receipt of ≥2 weeks of daptomycin, and ≥6 months of follow-up. Outcomes and adverse events (AEs) were determined at end of therapy (EOT) and follow-up. Results: For this study, 29 patients met the inclusion criteria. A successful outcome was achieved in 86% of patients at EOT and 69% at follow-up. Conclusions: The most common pathogen was methicillin-resistant Staphylococcus aureus. The median daptomycin dosage was 4.2 mg/kg/day (3.5–7.1), and the median duration of therapy was 42 days (18–63). In all, 18 AEs were attributed to daptomycin in 9 patients; most were mild to moderate in severity. In a heavily pretreated cohort of patients, including those with prosthetic devices, daptomycin appeared to be effective for the treatment of osteomyelitis. Disclosures This study was sponsored by Cubist Pharmaceuticals, Inc., Lexington, MA.Proprietary StatementB.J.D., K.C.L., D.S.N., and L.V.F. are employees of and shareholders in Cubist Pharmaceuticals, Inc. L.B. received research funding for this project and travel support from Cubist Pharmaceuticals, Inc. to present these data.Institutional Review Board ApprovalUsing the US Department of Health and Human Services regulations found at 45 CFR 46.101 as a model, a central institutional review board (IRB) determined that this study was exempt from IRB review and oversight. Background Osteomyelitis is difficult to treat, requiring prolonged treatment with intravenous and/or oral antibiotics 12. The risk of recurrence is high and can lead to reduced limb function, amputation, or death. Staphylococcus aureus is the most common pathogen 1234. Vancomycin has been the drug of choice for the treatment of osteomyelitis due to methicillin-resistant S aureus (MRSA). However, recent literature suggests reduced efficacy of this agent, especially for infections caused by S aureus with a minimum inhibitory concentration (MIC) ≥2 μg/mL 56. In animal models of MRSA osteomyelitis, daptomycin has been shown to be as effective as vancomycin or clindamycin 789. Limited data exist about the efficacy and safety of daptomycin in patients with osteomyelitis. In case reports and small case series with limited follow-up, daptomycin appeared to be effective in patients with osteomyelitis [[[10-;17]]]. The objective of this study was to describe the use of daptomycin in patients with osteomyelitis. Material and methods A retrospective chart review was conducted in the United States from October 2005 through April 2006 from sites in Washington, DC, Orlando, FL, Charleston, SC, Denver, CO, Indianapolis, IN, and Munster, IN. Site investigators identified medical records of patients with osteomyelitis who had been treated with daptomycin and had follow-up for at least 6 months from the conclusion of therapy.Patients ≥18 years of age were eligible for inclusion if they were diagnosed with osteomyelitis by culture, radiography, histopathology, or clinical presentation, and had received at least 2 weeks of daptomycin therapy. Patients were excluded if they received daptomycin as part of a clinical trial or if their clinical outcomes had been previously presented or published. A standardized case report form (CRF) was used to capture data relevant to the diagnosis and management of osteomyelitis.Bacterial cultures obtained within 6 weeks before and up to 2 days after the initiation of daptomycin were included in the analysis. Concomitant use of other antibiotics with daptomycin also was recorded. If the patient record indicated the use of other antibiotics for the treatment of osteomyelitis prior to daptomycin, the antibiotics used and the reasons for discontinuation were recorded.Clinical outcomes, as assessed by the investigator at each study site, were evaluated at the end of therapy (EOT) with daptomycin and a
机译：目的：达托霉素通常用于治疗骨髓炎患者。在这篇综述中，我们描述了达托霉素用于骨髓炎的用途。材料和方法：纳入标准包括≥18岁的患者，接受达托霉素≥2周的患者以及≥6个月的随访。在治疗结束（EOT）和随访时确定结果和不良事件（AE）。结果：对于本研究，有29名患者符合纳入标准。 EOT患者中有86％的患者获得了成功的结果，随访时有69％的患者获得了成功的结果。结论：最常见的病原体是耐甲氧西林的金黄色葡萄球菌。达托霉素的中位剂量为4.2 mg / kg /天（3.5–7.1），中位治疗时间为42天（18–63）。总共9例患者中有18例AE归因于达托霉素。多数患者轻度至中度。在经过大量预处理的一组患者中，包括那些使用假体装置的患者，达托霉素似乎对治疗骨髓炎有效。披露本研究由马萨诸塞州列克星敦市的Cubist Pharmaceuticals，Inc.发起，所有权声明B.J.D.，K.C.L.，D.S.N。和L.V.F.是Cubist Pharmaceuticals，L.B.的雇员和股东。机构审查委员会批准以45 CFR 46.101的美国卫生与公共服务部法规为模型，由中央机构审查委员会（IRB）获得该项目的研究经费和Cubist Pharmaceuticals，Inc.提供的旅行支持以提供这些数据。确定该研究不受IRB审查和监督。背景骨髓炎难以治疗，需要长期使用静脉和/或口服抗生素治疗12。复发的风险很高，可能导致肢体功能下降，截肢或死亡。金黄色葡萄球菌是最常见的病原体1234。由于耐甲氧西林的金黄色葡萄球菌（MRSA），万古霉素已成为治疗骨髓炎的首选药物。但是，最近的文献表明该药的疗效降低，特别是对于最小抑菌浓度（MIC）≥2μg/ mL的金黄色葡萄球菌引起的感染。56.在MRSA骨髓炎的动物模型中，达托霉素已被证明与万古霉素一样有效或克林霉素789。关于达托霉素在骨髓炎患者中的疗效和安全性的数据有限。在病例报告和随访较少的小病例系列中，达托霉素似乎对骨髓炎患者有效[[10-; 17]]。这项研究的目的是描述达托霉素在骨髓炎患者中的使用。材料和方法自2005年10月至2006年4月，在美国华盛顿特区，佛罗里达州奥兰多市，佛罗里达州查尔斯顿市，南卡罗来纳州丹佛市，印第安纳州波利斯市和印第安纳州明斯特市进行了回顾性图表审查。现场调查人员确定了接受达托霉素治疗并在治疗结束后至少随访6个月的骨髓炎患者的病历.≥18岁的患者经培养被诊断出患有骨髓炎， X线摄影，组织病理学或临床表现，并已接受达托霉素治疗至少2周。如果患者作为临床试验的一部分接受了达托霉素治疗，或者以前曾发表或发表过临床结果，则排除在外。使用标准化病例报告表（CRF）来收集与骨髓炎的诊断和处理有关的数据。分析包括达托霉素启动前6周内和开始后2天以内的细菌培养物。还记录了其他抗生素与达托霉素的同时使用。如果患者记录表明在达托霉素治疗之前使用其他抗生素治疗骨髓炎，则应记录使用的抗生素和中止原因。在研究结束时，由研究人员在每个研究部位评估临床结果（EOT）与达托霉素和

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