Department of General Surgery, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Department of Vascular Surgery, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Vascular. 2023 Dec;31(6):1222-1229. doi: 10.1177/17085381221104629. Epub 2022 May 22.
to assess the safety and efficacy of platelet-rich plasma (PRP) as adjunctive to compression therapy for post-phlebitic venous ulcers.
This is a single-center randomized controlled trial on patients with persistent chronic post-phlebitic lower limb venous ulcers from March 2019 to March 2020. Patients were randomly allocated to one of two equal cohort groups. Patients group in which patients underwent combined PRP with compression therapy versus control group in which patients underwent placebo+ compression therapy alone. The primary endpoint of the study was the improvement in ulcer topographic measurement. Secondary endpoints included ulcer healing parameters, possible healing factors, reduction in pain score (VAS), and the achievement of complete healing.
Forty patients were available equally for randomization and analysis in both groups. The median number of PRP applications for every patient in the patient group was 6 (ranging from 3 to 6). There was a significant decline in the median length, width, and depth of ulcers in the patients group versus control group. Consequently, there was a significant decline of the median ulcer area, in the patient group versus control group (4 (3-9) cm vs. 10 (6-14) cm, = .036). Also, the median volume of the ulcers showed a significant decline in the patient group versus control group (1 (.7-3) cm vs 3 (2-6) cm, = .008). Complete healing was achieved in 45% of patient group. There was a significant decline in pain scores at 3- and 6 months from the therapy starting point in both groups (patient group: pre-VAS = 6.5 vs. post(3 months)-VAS = 1 vs. post(6 months)-VAS = 0.5) and (control group: pre-VAS = 6.4 vs. post(3 months)-VAS = 4.5 vs. post(6 months)-VAS = 2.2), ( < .0001 for each). On the other hand, the decline in pain scores between both groups was statistically significant in favor of the patient group, (post (3 months); PRP-VAS = 1 vs. control-VAS = 4.5, and post(6 months); PRP-VAS = 0.5 vs. control-VAS = 2.2), ( < .0001).
Platelet-rich plasma as an adjunct to compression therapy for chronic post-phlebitic venous ulcers is safe and effective as regards the ulcer healing and improvement of pain score. PRP may be useful adjunct in treatment of post-phlebitic venous ulcer. However, larger trials are warranted.
评估富含血小板的血浆（PRP）作为辅助加压治疗静脉炎后静脉溃疡的安全性和有效性。
这是一项单中心随机对照试验，纳入了 2019 年 3 月至 2020 年 3 月期间患有持续性慢性静脉炎后下肢静脉溃疡的患者。患者被随机分配到两组，每组各 20 例。患者组接受 PRP 联合加压治疗，对照组接受安慰剂联合单纯加压治疗。该研究的主要终点是评估溃疡的拓扑学测量改善情况。次要终点包括溃疡愈合参数、可能的愈合因素、疼痛评分（VAS）降低情况以及完全愈合的实现情况。
两组各有 20 例患者随机分组，均有 40 例患者可供分析。患者组中每位患者接受 PRP 的中位数为 6 次（范围为 3 至 6 次）。与对照组相比，患者组的溃疡长度、宽度和深度中位数均显著降低。因此，与对照组相比，患者组的溃疡面积中位数显著降低（4（3-9）cm 比 10（6-14）cm， =.036）。同样，与对照组相比，患者组的溃疡体积中位数也显著降低（1（.7-3）cm 比 3（2-6）cm， =.008）。患者组中有 45%完全愈合。两组在治疗开始后的 3 个月和 6 个月时，疼痛评分均显著下降（患者组：治疗前 VAS = 6.5 比治疗后 3 个月 VAS = 1 比治疗后 6 个月 VAS = 0.5；对照组：治疗前 VAS = 6.4 比治疗后 3 个月 VAS = 4.5 比治疗后 6 个月 VAS = 2.2）（均 <.0001）。另一方面，两组之间的疼痛评分下降在统计学上具有显著差异，且患者组更优（治疗后 3 个月：PRP-VAS = 1 比对照组 VAS = 4.5；治疗后 6 个月：PRP-VAS = 0.5 比对照组 VAS = 2.2）（均 <.0001）。
富含血小板的血浆作为静脉炎后慢性静脉溃疡加压治疗的辅助治疗方法，在溃疡愈合和疼痛评分改善方面是安全有效的。PRP 可能是静脉炎后静脉溃疡治疗的有用辅助手段，但仍需要更大规模的试验。
