Jørgensen Bo, Karlsmark Tonny, Vogensen Hanne, Haase Lone, Lundquist Rasmus
Bispebjerg University Hospital, Copenhagen, Denmark.
Int J Low Extrem Wounds. 2011 Dec;10(4):218-23. doi: 10.1177/1534734611426755. Epub 2011 Oct 18.
This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients' blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm(2) (median 2.3 cm(2)) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm(2) (range = 0-9.6cm(2)). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.
这项前瞻性、非对照性的试点研究评估了Leucopatch（一种无添加剂的自体富血小板纤维蛋白）在治疗顽固性慢性伤口方面的安全性和临床性能。15例患有16处不同病因的下肢慢性伤口的患者，每周接受一次Leucopatch治疗，共治疗6周，或直至伤口完全愈合。Leucopatch在护理点由患者捐献的血液制备而成。这些伤口已存在2至108个月（中位数为24个月），大小从0.4至15.7平方厘米（中位数为2.3平方厘米），且对先前的治疗均无反应。在符合方案的疗效分析中纳入的13处伤口（12例患者）中，4处完全愈合（31%）。伤口平均面积显著减少了65%（95%置信区间 = 45.6%至83.8%），最终伤口大小中位数为0.9平方厘米（范围 = 0 - 9.6平方厘米）。未发生严重不良事件。观察到两起不良事件，一起是不依从事件，一起是感染事件；两者均被认为与治疗无关。结果表明，Leucopatch在临床中易于制备和应用，安全且可能是治疗顽固性慢性伤口的一种临床有效方法。
