Santa Casa de Misericórdia de Belo Horizonte, Santa Efigênia, Belo Horizonte-MG, Brazil.
Diagn Microbiol Infect Dis. 2010 Oct;68(2):140-51. doi: 10.1016/j.diagmicrobio.2010.05.012.
To compare efficacy and safety of a tigecycline regimen with an imipenem/cilastatin regimen in hospital-acquired pneumonia patients, a phase 3, multicenter, randomized, double-blind, study evaluated 945 patients. Coprimary end points were clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure. Cure rates were 67.9% for tigecycline and 78.2% for imipenem (CE patients) and 62.7% and 67.6% (c-mITT patients), respectively. A statistical interaction occurred between ventilator-associated pneumonia (VAP) and non-VAP subgroups, with significantly lower cure rates in tigecycline VAP patients compared to imipenem; in non-VAP patients, tigecycline was noninferior to imipenem. Overall mortality did not differ between the tigecycline (14.1%) and imipenem regimens (12.2%), although more deaths occurred in VAP patients treated with tigecycline than imipenem. Overall, the tigecycline regimen was noninferior to the imipenem/cilastatin regimen for the c-mITT but not the CE population; this difference appears to have been driven by results in VAP patients.
为了比较替加环素方案与亚胺培南/西司他丁方案在医院获得性肺炎患者中的疗效和安全性，一项 3 期、多中心、随机、双盲研究评估了 945 例患者。主要复合终点为治愈期时临床可评估（CE）和临床改良意向治疗（c-mITT）人群的临床应答。替加环素的治愈率为 67.9%，亚胺培南为 78.2%（CE 患者）和 62.7%和 67.6%（c-mITT 患者）。在呼吸机相关性肺炎（VAP）和非 VAP 亚组之间发生了统计学相互作用，与亚胺培南相比，替加环素 VAP 患者的治愈率显著降低；而非 VAP 患者中，替加环素与亚胺培南相比非劣效。替加环素组（14.1%）和亚胺培南组的总死亡率无差异（12.2%），但替加环素治疗的 VAP 患者死亡人数多于亚胺培南。总体而言，替加环素方案在 c-mITT 人群中与亚胺培南/西司他丁方案非劣效，但在 CE 人群中并非如此；这种差异似乎是由 VAP 患者的结果驱动的。
