Pfizer, Inc., Collegeville, PA, USA.
Department of Pharmacy Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA.
Diagn Microbiol Infect Dis. 2014 Mar;78(3):295-301. doi: 10.1016/j.diagmicrobio.2013.11.001. Epub 2013 Nov 15.
Phase III randomized, clinical trials are primarily designed to evaluate overall treatment-outcome comparisons. Although valuable data are gained from such comparisons, it is difficult to draw meaningful inferences about potential outcomes differences in specific patient groups and infection types. It is well established that clinical outcomes are dependent on host, treatment- and pathogen-related factors and understanding which groups benefit from one treatment relative to another is of great importance. This study sought to determine if clinical success in the treatment of complicated skin and skin structure infections (cSSSI) caused by methicillin resistant Staphylocccus aureus (MRSA) with linezolid or vancomycin varied across subpopulations and infection type. Data from 3 prospective, randomized trials evaluating linezolid and vancomycin for the treatment of MRSA cSSSI were pooled. Treatment related differences in outcomes were found, on both the absolute and relative scales, for most subpopulations and infection types. Identifying treatment differences in outcome by patient subpopulation can enhance clinical decision making.
III 期随机临床试验主要旨在评估整体治疗效果的比较。虽然此类比较可以提供有价值的数据,但很难对特定患者群体和感染类型的潜在结果差异做出有意义的推断。众所周知,临床结果取决于宿主、治疗和病原体相关因素,了解哪些群体相对于另一些群体从一种治疗中获益是非常重要的。本研究旨在确定利奈唑胺或万古霉素治疗耐甲氧西林金黄色葡萄球菌(MRSA)引起的复杂性皮肤和皮肤结构感染(cSSSI)的临床疗效是否因亚人群和感染类型而异。汇总了 3 项评估利奈唑胺和万古霉素治疗 MRSA cSSSI 的前瞻性、随机试验的数据。在大多数亚人群和感染类型中,都发现了治疗结果在绝对和相对尺度上的差异。通过患者亚人群确定治疗结果差异可以增强临床决策。