Burgos-Alonso Natalia, Lobato Igone, Hernández Igone, Sebastian Kepa San, Rodríguez Begoña, March Anna Giné, Perez-Salvador Adriana, Arce Veronica, Garcia-Alvarez Arturo, Gomez-Fernandez Maria Cruz, Grandes Gonzalo, Andia Isabel
Primary Care Research Unit of Bizkaia, BioCruces Health Research Institute, Bilbao, Spain, Preventive Medicine and Public Health Department, University of the Basque Country. Faculty of Medicine and Odontology. UPV/EHU.
Nurse, Enkarterrri-Ezkerraldea-Cruces Health Region, Basque Health Service (Osakidetza), Spain.
J Wound Care. 2018 Jun 1;27(Sup6):S20-S24. doi: 10.12968/jowc.2018.27.Sup6.S20.
To examine the potential efficacy and safety of autologous platelet-rich plasma (PRP) in comparison with the conventional treatment (standard care, SoC) for the treatment of leg ulcers in patients with chronic venous insufficiency, in a primary health-care setting.
A Phase I-II, open-label, parallel-group, multicentre, randomised pilot study was conducted. The outcome variables at baseline and at weeks five and nine included reduction in the ulcer area, Chronic Venous Insufficiency Quality of Life Questionnaire score, cost of the treatment for up to nine weeks and average weekly cure rate.
A total of eight patients, each with at least a six-month history of venous leg ulcer (VLUs), were included in the study. A total of 12 ulcers were treated with either autologous PRP or standard SoC. Patients treated with PRP required wound care only once per week. In the SoC group, patients required intervention 2-3 times per week. A reduction in the mean ulcer size in the PRP group was 3.9cm compared with the SoC group at 3.2cm , although the sample size was insufficient to reach statistical significance. Improvement in quality of life (QoL) score was observed in the patients in the PRP group.
This study offers proof-of-concept of the feasibility and safety of PRP treatment to inform larger clinical trials in patients with VLUs. Our preliminary results suggest that PRP delivers a safe and effective treatment for VLU care that can be implemented in primary health-care settings.
在初级卫生保健环境中，比较自体富血小板血浆（PRP）与传统治疗（标准护理，SoC）对慢性静脉功能不全患者腿部溃疡的潜在疗效和安全性。
进行了一项I-II期、开放标签、平行组、多中心随机试点研究。基线以及第5周和第9周的结局变量包括溃疡面积缩小、慢性静脉功能不全生活质量问卷评分、长达9周的治疗费用以及平均每周治愈率。
共有8名患者纳入研究，每名患者均有至少6个月的下肢静脉溃疡（VLUs）病史。总共12处溃疡接受了自体PRP或标准SoC治疗。接受PRP治疗的患者每周仅需进行一次伤口护理。在SoC组中，患者每周需要进行2-3次干预。PRP组的平均溃疡大小减少了3.9平方厘米，而SoC组为3.2平方厘米，尽管样本量不足以达到统计学显著性。PRP组患者的生活质量（QoL）评分有所改善。
本研究为PRP治疗的可行性和安全性提供了概念验证，为VLUs患者的更大规模临床试验提供了参考。我们的初步结果表明，PRP为VLU护理提供了一种安全有效的治疗方法，可在初级卫生保健环境中实施。
