Lipsky Benjamin A, Kuss Michael, Edmonds Michael, Reyzelman Alexander, Sigal Felix
Veterans Affairs Puget Sound Health Care System, University of Washington School of Medicine, Seattle, WA, USA.
J Am Podiatr Med Assoc. 2012 May-Jun;102(3):223-32. doi: 10.7547/1020223.
The aim of this pilot study was to determine the safety and potential benefit of adding a topical gentamicin-collagen sponge to standard of care (systemic antibiotic therapy plus standard diabetic wound management) for treating diabetic foot infections of moderate severity.
We randomized 56 patients with moderately infected diabetic foot ulcers in a 2:1 ratio to receive standard of care plus the gentamicin-collagen sponge (treatment group, n = 38) or standard of care only (control group, n = 18) for up to 28 days of treatment. Investigators performed clinical, microbiological, and safety assessments at regularly scheduled intervals and collected pharmacokinetic samples from patients treated with the gentamicin-collagen sponge. Test of cure was clinically assessed 14 days after all antibiotic therapy was stopped.
On treatment day 7, we noted clinical cure in no treatment patients and three control patients (P = .017). However, for evaluable patients at the test-of-cure visit, the treatment group had a significantly higher proportion of patients with clinical cure than did the control group (22 of 22 [100.0%] versus 7 of 10 [70.0%]; P =.024). Patients in the treatment group also had a higher rate of eradication of baseline pathogens at all visits (P ≤ .038) and a reduced time to pathogen eradication (P < .001). Safety data were similar for both groups.
Topical application of the gentamicin-collagen sponge seems safe and may improve clinical and microbiological outcomes of diabetic foot infections of moderate severity when combined with standard of care. These pilot data suggest that a larger trial of this treatment is warranted.
本初步研究的目的是确定在标准治疗（全身抗生素治疗加标准糖尿病伤口处理）基础上添加局部庆大霉素 - 胶原海绵治疗中度严重程度糖尿病足感染的安全性和潜在益处。
我们将56例中度感染的糖尿病足溃疡患者按2:1的比例随机分组，分别接受标准治疗加庆大霉素 - 胶原海绵治疗（治疗组，n = 38）或仅接受标准治疗（对照组，n = 18），治疗时间最长为28天。研究人员定期进行临床、微生物学和安全性评估，并从接受庆大霉素 - 胶原海绵治疗的患者中采集药代动力学样本。在所有抗生素治疗停止14天后进行临床治愈测试评估。
在治疗第7天，我们注意到治疗组无患者和3例对照组患者实现临床治愈（P = 0.017）。然而，在治愈测试访视时，对于可评估的患者，治疗组临床治愈的患者比例显著高于对照组（22例中的22例[100.0%]对10例中的7例[70.0%]；P = 0.024）。治疗组患者在所有访视时基线病原体的根除率也更高（P≤0.038），病原体根除时间缩短（P < 0.001）。两组的安全性数据相似。
局部应用庆大霉素 - 胶原海绵似乎是安全的，并且与标准治疗联合使用时可能改善中度严重程度糖尿病足感染的临床和微生物学结果。这些初步数据表明有必要对这种治疗方法进行更大规模的试验。
