Giordano Philip, Song James, Pertel Peter, Herrington Janet, Kowalsky Steven
Orlando Regional Medical Center (ORMC), Orlando, FL, USA.
Int J Antimicrob Agents. 2005 Nov;26(5):357-65. doi: 10.1016/j.ijantimicag.2005.07.017. Epub 2005 Oct 17.
In this prospective, double-blind, multicentre trial, adult patients with complicated skin and skin structure infection (cSSSI) randomly received sequential intravenous (i.v.)/oral (p.o.) moxifloxacin (400 mg once a day) or a control regimen of i.v. piperacillin-tazobactam (3.0/0.375 g every 6 h) followed by p.o. amoxicillin-clavulanate (800 mg every 12 h), each for 7-14 days. Clinical cure rates at the test-of-cure visit (10-42 days post therapy) for the efficacy-valid population were 79% (143/180) for the moxifloxacin-treated group and 82% (153/187) for the control group (95% confidence interval, -12.04, 3.29). Bacteriological eradication rates for Staphylococcus aureus, the most prevalent organism, were 78% and 80%, respectively. The incidence of drug-related adverse events was similar for both groups (31% moxifloxacin, 30% control). Sequential i.v./p.o. moxifloxacin was as effective and well tolerated as i.v. piperacillin-tazobactam followed by p.o. amoxicillin-clavulanate in treating patients with cSSSI.
在这项前瞻性、双盲、多中心试验中，患有复杂性皮肤和皮肤结构感染（cSSSI）的成年患者被随机分配接受序贯静脉注射（i.v.）/口服（p.o.）莫西沙星（每日一次，400毫克）或静脉注射哌拉西林-他唑巴坦（每6小时3.0/0.375克）随后口服阿莫西林-克拉维酸（每12小时800毫克）的对照方案，各治疗7 - 14天。在疗效验证人群的治愈测试访视（治疗后10 - 42天）时，莫西沙星治疗组的临床治愈率为79%（143/180），对照组为82%（153/187）（95%置信区间，-12.04，3.29）。最常见的病原体金黄色葡萄球菌的细菌清除率分别为78%和80%。两组药物相关不良事件的发生率相似（莫西沙星组为31%，对照组为30%）。序贯静脉注射/口服莫西沙星在治疗cSSSI患者方面与静脉注射哌拉西林-他唑巴坦随后口服阿莫西林-克拉维酸一样有效且耐受性良好。
