Stryjewski Martin E, Graham Donald R, Wilson Samuel E, O'Riordan William, Young David, Lentnek Arnold, Ross Douglas P, Fowler Vance G, Hopkins Alan, Friedland H David, Barriere Steven L, Kitt Michael M, Corey G Ralph
Duke Clinical Research Institute, Durham, North Carolina, USA.
Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896.
Telavancin is an investigational, rapidly bactericidal lipoglycopeptide with a multifunctional mechanism of action.
We conducted 2 parallel, randomized, double-blind, active-control, phase 3 studies with a prespecified pooled analysis design. Patients aged > or = 18 years who had complicated skin and skin-structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin (10 mg/kg intravenously every 24 h) or vancomycin (1 g intravenously every 12 h).
A total of 1867 patients were randomized and received > or = 1 dose of study medication. In the clinically evaluable population, at 7-14 days after receipt of the last antibiotic dose, success was achieved in 88% and 87% of patients who received telavancin and vancomycin, respectively (95% confidence interval for the difference, -2.1 to 4.6). Methicillin-resistant Staphylococcus aureus was isolated at baseline from samples from 579 clinically evaluable patients. Among these patients with methicillin-resistant S. aureus infection, cure rates were 91% among patients who received telavancin and 86% among patients who received vancomycin (95% confidence interval for the difference, -1.1 to 9.3). Microbiologic eradication among patients infected with methicillin-resistant S. aureus was 90% in the telavancin treatment group and 85% in the vancomycin treatment group (95% confidence interval for the difference, -0.9 to 9.8). Therapy was discontinued because of adverse events in 8% and 6% of patients who received telavancin and vancomycin, respectively. Except for mild taste disturbance, nausea, vomiting, and serum creatinine concentration elevation in the telavancin treatment group and pruritus in the vancomycin treatment group, adverse events were similar between groups with regard to type and severity.
Telavancin given once daily is at least as effective as vancomycin for the treatment of patients with complicated skin and skin-structure infections, including those infected with methicillin-resistant S. aureus.
特拉万星是一种处于研究阶段的、具有快速杀菌作用的脂糖肽类抗生素，其作用机制具有多效性。
我们进行了2项平行、随机、双盲、活性对照的3期研究，并采用了预先设定的汇总分析设计。年龄大于或等于18岁、由疑似或确诊的革兰氏阳性菌引起复杂皮肤及皮肤结构感染的患者被随机分组，分别接受特拉万星（每24小时静脉注射10mg/kg）或万古霉素（每12小时静脉注射1g）治疗。
共有1867例患者被随机分组并接受了≥1剂研究药物治疗。在临床可评估人群中，在接受最后一剂抗生素治疗7 - 14天后，接受特拉万星和万古霉素治疗的患者成功率分别为88%和87%（差异的95%置信区间为-2.1至4.6）。从579例临床可评估患者的样本中，在基线时分离出耐甲氧西林金黄色葡萄球菌。在这些耐甲氧西林金黄色葡萄球菌感染患者中，接受特拉万星治疗的患者治愈率为91%，接受万古霉素治疗的患者治愈率为86%（差异的95%置信区间为-1.1至9.3）。在耐甲氧西林金黄色葡萄球菌感染患者中，特拉万星治疗组的微生物清除率为90%，万古霉素治疗组为85%（差异的95%置信区间为-0.9至9.8）。接受特拉万星和万古霉素治疗的患者分别有8%和6%因不良事件而停药。除特拉万星治疗组出现轻度味觉障碍、恶心、呕吐和血清肌酐浓度升高，以及万古霉素治疗组出现瘙痒外，两组不良事件在类型和严重程度方面相似。
每日给药1次的特拉万星在治疗复杂皮肤及皮肤结构感染患者（包括耐甲氧西林金黄色葡萄球菌感染患者）方面至少与万古霉素一样有效。
