Weigelt John, Itani Kamal, Stevens Dennis, Lau William, Dryden Matthew, Knirsch Charles
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, USA.
Antimicrob Agents Chemother. 2005 Jun;49(6):2260-6. doi: 10.1128/AAC.49.6.2260-2266.2005.
Skin and soft tissue infections (SSTIs) are a common cause of morbidity in both the community and the hospital. An SSTI is classified as complicated if the infection has spread to the deeper soft tissues, if surgical intervention is necessary, or if the patient has a comorbid condition hindering treatment response (e.g., diabetes mellitus or human immunodeficiency virus). The purpose of this study was to compare linezolid to vancomycin in the treatment of suspected or proven methicillin-resistant gram-positive complicated SSTIs (CSSTIs) requiring hospitalization. This was a randomized, open-label, comparator-controlled, multicenter, multinational study that included patients with suspected or proven methicillin-resistant Staphylococcus aureus (MRSA) infections that involved substantial areas of skin or deeper soft tissues, such as cellulitis, abscesses, infected ulcers, or burns (<10% of total body surface area). Patients were randomized (1:1) to receive linezolid (600 mg) every 12 h either intravenously (i.v.) or orally or vancomycin (1 g) every 12 h i.v. In the intent-to-treat population, 92.2% and 88.5% of patients treated with linezolid and vancomycin, respectively, were clinically cured at the test-of-cure (TOC) visit (P=0.057). Linezolid outcomes (124/140 patients or 88.6%) were superior to vancomycin outcomes (97/145 patients or 66.9%) at the TOC visit for patients with MRSA infections (P<0.001). Drug-related adverse events were reported in similar numbers in both the linezolid and the vancomycin arms of the trial. The results of this study demonstrate that linezolid therapy is well tolerated, equivalent to vancomycin in treating CSSTIs, and superior to vancomycin in the treatment of CSSTIs due to MRSA.
皮肤及软组织感染（SSTIs）是社区和医院中发病的常见原因。如果感染已扩散至深层软组织、需要进行手术干预，或者患者有妨碍治疗反应的合并症（如糖尿病或人类免疫缺陷病毒），则SSTI被分类为复杂性感染。本研究的目的是比较利奈唑胺与万古霉素在治疗需要住院的疑似或确诊的耐甲氧西林革兰氏阳性复杂性皮肤及软组织感染（CSSTIs）中的疗效。这是一项随机、开放标签、对照、多中心、跨国研究，纳入了疑似或确诊耐甲氧西林金黄色葡萄球菌（MRSA）感染且累及大面积皮肤或深层软组织（如蜂窝织炎、脓肿、感染性溃疡或烧伤（<体表面积的10%））的患者。患者被随机（1:1）分组，每12小时静脉注射（i.v.）或口服利奈唑胺（600mg），或每12小时静脉注射万古霉素（1g）。在意向性治疗人群中，在治疗结束试验（TOC）访视时，接受利奈唑胺和万古霉素治疗的患者分别有92.2%和88.5%临床治愈（P=0.057）。在TOC访视时，对于MRSA感染患者，利奈唑胺的治疗结果（1 * 40例患者中的124例，即88.6%）优于万古霉素的治疗结果（145例患者中的97例，即66.9%）（P<0.001）。在试验的利奈唑胺组和万古霉素组中，报告的药物相关不良事件数量相似。本研究结果表明，利奈唑胺治疗耐受性良好，在治疗CSSTIs方面与万古霉素相当，而在治疗由MRSA引起的CSSTIs方面优于万古霉素。
