Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary care: a randomised controlled, pilot study
Autologous platelet-rich plasma in the treatment of venous leg ulcers in primary care: a randomised controlled, pilot study
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DOI：
10.12968/jowc.2018.27.sup6.s20
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发表时间：
2018-06-01
影响因子：
1.9
通讯作者：
Andia, Isabel
中科院分区：
文献类型：
--
作者：
Burgos-Alonso, Natalia;Lobato, Igone;Andia, Isabel
目的：探讨自体富血小板血浆（PRP）与常规治疗（标准护理，SoC）在初级卫生保健机构治疗慢性静脉功能不全患者腿部溃疡的潜在疗效和安全性。方法：进行一项I-II期、开放标签、平行组、多中心、随机的先导研究。基线、第5周和第9周的结果变量包括溃疡面积减少、慢性静脉功能不全生活质量问卷评分、长达9周的治疗费用和平均每周治愈率。结果：共有8名患者被纳入研究，每位患者至少有6个月的静脉性腿部溃疡（VLUs）病史。共有12例溃疡采用自体PRP或标准SoC治疗。接受PRP治疗的患者每周只需要一次伤口护理。在SoC组中，患者每周需要干预2-3次。与SoC组的平均溃疡大小3.2cm(2)相比，PRP组的平均溃疡大小减少了3.9cm(2)，尽管样本量不足以达到统计学意义。观察到PRP组患者生活质量（QoL）评分的改善。结论：本研究提供了PRP治疗的可行性和安全性的概念证明，为vlu患者的更大规模临床试验提供了信息。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，可以在初级卫生保健机构中实施。
Objective: 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.Method: 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.Results: 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(2) compared with the SoC group at 3.2cm(2), 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.Conclusion: 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.