Cardinal Matthew, Eisenbud David E, Phillips Tania, Harding Keith
Advanced BioHealing, New York, NY 10016, USA.
Wound Repair Regen. 2008 Jan-Feb;16(1):19-22. doi: 10.1111/j.1524-475X.2007.00328.x.
This study was undertaken to determine if healing rates are reliable early predictors of ultimate complete wound closure in venous leg ulcers and diabetic foot wounds. We conducted a retrospective analysis of 306 venous leg ulcers and 241 diabetic foot ulcers enrolled in two large controlled, prospective, randomized pivotal trials to compare topical wound treatments, to determine whether certain early markers of healing could be correlated with later total wound closure. Two-sided tests at 95% confidence demonstrated that wound margin advance, initial healing rate, percent wound surface area reduction, and wound healing trajectories (all p<0.001) were powerful predictors of complete wound healing at 12 weeks. Wounds with poor healing progress by these criteria at 4 weeks were highly likely to remain unhealed after 8 additional weeks of treatment. Analysis of the diabetic foot ulcers and venous leg ulcers subgroups separately demonstrated consistent statistical test results with high significance; similarly, the results remained valid independent of the topical treatment used. The early prediction of eventual wound healing or nonhealing using early healing rates may enable more efficient triage of patients to advanced healing technologies. We believe that these surrogate markers are robust predictors of healing regardless of wound etiology and that they merit wider use in clinical trials and routine patient care.
本研究旨在确定愈合率是否是下肢静脉溃疡和糖尿病足伤口最终完全愈合的可靠早期预测指标。我们对两项大型对照、前瞻性、随机关键试验中纳入的306例下肢静脉溃疡和241例糖尿病足溃疡进行了回顾性分析,以比较局部伤口治疗方法,确定某些早期愈合指标是否与后期伤口完全闭合相关。95%置信度的双侧检验表明,伤口边缘进展、初始愈合率、伤口表面积减少百分比和伤口愈合轨迹(均p<0.001)是12周时伤口完全愈合的有力预测指标。按照这些标准,4周时愈合进展不佳的伤口在额外8周的治疗后极有可能仍未愈合。分别对糖尿病足溃疡和下肢静脉溃疡亚组进行分析,结果显示统计检验结果一致且具有高度显著性;同样,无论使用何种局部治疗方法,结果均有效。利用早期愈合率对最终伤口愈合或不愈合进行早期预测,可能会使患者能更有效地接受先进的愈合技术治疗。我们认为,无论伤口病因如何,这些替代指标都是愈合的有力预测指标,值得在临床试验和常规患者护理中更广泛地应用。