Graham Donald R, Lucasti Christopher, Malafaia Osvaldo, Nichols Ronald L, Holtom Paul, Perez Nora Quintero, McAdams Andrea, Woods Gail L, Ceesay T Paulette, Gesser Richard
Springfield Clinic, Springfield, IL, 62703, USA.
Clin Infect Dis. 2002 Jun 1;34(11):1460-8. doi: 10.1086/340348. Epub 2002 May 9.
We conducted a prospective, randomized, double-blind trial comparing ertapenem (1 g once daily) with piperacillin-tazobactam (3.375 g every 6 h) as parenteral treatment for 540 adults with complicated skin and skin-structure infections. The most common diagnoses were skin or soft-tissue abscesses and lower-extremity infections associated with diabetes. The mean duration (+/- standard deviation) of therapy was 9.1+/-3.1 days for ertapenem and 9.8+/-3.3 days for piperacillin-tazobactam. At the assessment of primary efficacy end point, 10-21 days after treatment, 82.4% of those who received ertapenem and 84.4% of those who received piperacillin-tazobactam were cured. The difference in response rates, adjusting for the patients' assigned strata, was -2.0% (95% confidence interval, -10.2% to 6.2%), indicating that the response rates in the 2 treatment groups were equivalent. Cure rates for the 2 treatment groups were similar when compared by stratum, diagnosis, and severity of infection. The frequency and severity of drug-related adverse events were similar in the treatment groups.
我们进行了一项前瞻性、随机、双盲试验，比较厄他培南（每日1次，每次1 g）与哌拉西林-他唑巴坦（每6小时3.375 g）作为540例患有复杂性皮肤及皮肤结构感染的成人肠外治疗药物的疗效。最常见的诊断为皮肤或软组织脓肿以及与糖尿病相关的下肢感染。厄他培南治疗的平均疗程（±标准差）为9.1±3.1天，哌拉西林-他唑巴坦治疗的平均疗程为9.8±3.3天。在治疗后10 - 21天评估主要疗效终点时，接受厄他培南治疗的患者中有82.4%治愈，接受哌拉西林-他唑巴坦治疗的患者中有84.4%治愈。根据患者分配的分层进行调整后，有效率差异为 -2.0%（95%置信区间为 -10.2%至6.2%），表明两个治疗组的有效率相当。按分层、诊断和感染严重程度比较时，两个治疗组的治愈率相似。治疗组中与药物相关不良事件的频率和严重程度相似。
