Department of Surgery, University of Cincinnati Medical Center, Cincinnati, Ohio 45267-0558, USA.
Clin Infect Dis. 2010 Apr 15;50(8):1120-6. doi: 10.1086/651264.
Many trials have been carried out to determine the effectiveness of antimicrobial agents in treating skin and soft tissue infections. The results of these studies are often utilized to make determinations about the use of these antimicrobials against other types of infections. Despite the importance of these trials in determining clinical care, we hypothesized that many of these studies failed to include a variety of infections of significant enough severity to effectively draw objective conclusions about antimicrobial efficacy.
We conducted a modified PubMed search to identify studies of antimicrobial agents in treating soft tissue infections that were published from 1998 through 2008. We then evaluated these trials for specific recommended study criteria, which were based on published US Food and Drug Administration guidelines for the conduct of trials of antimicrobials for soft tissue infection.
Seventeen studies were identified for inclusion in the trial. Upon review, only 30% of trials required both local and systemic signs of infection for inclusion in the trial. One trial stratified results on the basis of operative intervention, less than half reported patient comorbidities, and only 53% provided a specific definition for "cure."
Our meta-analysis of current trials evaluating antimicrobial therapy for skin and soft tissue infections revealed substantial shortcomings in the design of most of these trials. These data provide evidence for the importance of designing specialist panels to objectively evaluate studies and photographs of included infections to ensure that conclusions drawn from these trials concerning clinical practice are justified.
许多试验已经进行，以确定抗菌药物在治疗皮肤和软组织感染的疗效。这些研究的结果通常被用来确定这些抗菌药物对其他类型感染的使用。尽管这些试验对于确定临床护理非常重要，但我们假设，其中许多研究未能包括各种严重程度足以有效得出关于抗菌疗效的客观结论的感染。
我们进行了一项改良的 PubMed 检索，以确定 1998 年至 2008 年期间发表的关于治疗软组织感染的抗菌药物的研究。然后，我们根据已发表的美国食品和药物管理局关于抗菌药物治疗软组织感染试验的指南，对这些试验进行了具体推荐研究标准的评估。
确定了 17 项研究纳入试验。经审查，只有 30%的试验要求局部和全身感染的迹象纳入试验。有一项试验根据手术干预进行分层结果，不到一半的报告患者合并症，只有 53%的试验提供了“治愈”的具体定义。
我们对当前评估抗菌治疗皮肤和软组织感染的试验的荟萃分析显示，这些试验的设计存在严重缺陷。这些数据为设计专门小组客观评估研究和包括感染的照片提供了证据，以确保从这些临床试验中得出的关于临床实践的结论是合理的。
