Vin F, Teot L, Meaume S
Hôpital Américain, Neuilly, France.
J Wound Care. 2002 Oct;11(9):335-41. doi: 10.12968/jowc.2002.11.9.26438.
To evaluate the healing rate of venous leg ulcers treated with Promogran.
Patients with stagnating venous leg ulcers were recruited. Target wounds were > or = 2 cm but < or = 10 cm in any one dimension. Subjects were randomly allocated to receive either Promogran or a non-adherent dressing (Adaptic) with a secondary dressing of gauze followed by short-stress compression (Biflex). Weekly wound assessments occurred over 12 weeks and dressings were changed twice weekly by the investigator and/or nurse team. Planimetry tracings and photographs were blindly reviewed and assessed by two independent investigators. An intent-to-treat analysis was performed.
Seventy-three patients were included. Thirty-seven were randomly allocated Promogran and 36 Adaptic. Twenty-nine patients completed the 12-week follow-up visit, 25 healed before week 12 and 19 stopped follow-up before week 12 for reasons unrelated to healing. Significantly more patients in the Adaptic group than in the Promogran group switched to another dressing (22.2% versus 5.4%; p = 0.035). Eleven venous leg ulcers healed in the control group (31%) and 15 in the Promogran group (41%) (p = 0.373). Overall, 15 venous leg ulcers healed or improved in the control group (42%) and 23 in the Promogran group (62%) (p = 0.079). Surface area decreased, on average, by 36.5 +/- 11.4% (median decrease: 44.6%) in the Adaptic group and by 54.4 +/- 10.9% (median decrease: 82.4%) in the Promogran group (p < 0.001). A < or = 20% surface area reduction was observed in 15 patients in the Adaptic group and in seven in the Promogran group (42% versus 19%; p = 0.034). No severe local adverse events were noted in either group, although poor tolerability caused a dressing switch in five patients in the control group and three in the Promogran group. Dressing acceptability was good or excellent in more than 60% of subjects in both groups.
The results suggest that Promogran may accelerate healing in venous leg ulcers and was well tolerated compared with the current standard of care.
评估使用普洛施康治疗下肢静脉性溃疡的愈合率。
招募患有下肢静脉淤滞性溃疡的患者。目标伤口在任何一个维度上≥2厘米但≤10厘米。受试者被随机分配接受普洛施康或不粘敷料（Adaptic），并辅以纱布二次敷料，随后进行短程压力包扎（Biflex）。在12周内每周进行伤口评估，研究者和/或护士团队每周更换两次敷料。由两名独立研究者对面积测量图和照片进行盲法审查和评估。进行意向性分析。
纳入73例患者。37例被随机分配接受普洛施康治疗，36例接受Adaptic治疗。29例患者完成了12周的随访，25例在第12周前愈合，19例在第12周前因与愈合无关的原因停止随访。Adaptic组更换为另一种敷料的患者明显多于普洛施康组（22.2%对5.4%；p = 0.035）。对照组11例下肢静脉性溃疡愈合（31%），普洛施康组15例愈合（41%）（p = 0.373）。总体而言，对照组15例下肢静脉性溃疡愈合或改善（42%），普洛施康组23例（62%）（p = 0.079）。Adaptic组的表面积平均减少36.5±11.4%（中位数减少：44.6%），普洛施康组减少54.4±10.9%（中位数减少：82.4%）（p < 0.001）。Adaptic组15例患者和普洛施康组7例患者的表面积减少≤20%（42%对19%；p = 0.034）。两组均未观察到严重的局部不良事件，尽管对照组有5例患者和普洛施康组有3例患者因耐受性差而更换了敷料。两组超过60%的受试者对敷料的接受度良好或极佳。
结果表明，与当前的护理标准相比，普洛施康可能会加速下肢静脉性溃疡的愈合，且耐受性良好。
