Senet Patricia, Vicaut Eric, Beneton Nathalie, Debure Clelia, Lok Catherine, Chosidow Olivier
Service de Dermatologie, Hôpital Tenon, 4 rue de la Chine, 75970 Paris CEDEX 20, France.
Arch Dermatol. 2011 Aug;147(8):926-30. doi: 10.1001/archdermatol.2011.84. Epub 2011 Apr 11.
To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers.
Randomized, double-blind, parallel-assignment, controlled study.
Ambulatory or hospitalized patients from 17 dermatology departments.
Among 64 consecutive randomized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria, 59 received the allocated intervention, and findings were analyzed.
Becaplermin gel (human recombinant platelet-derived growth factor-BB, 0.1%, in hydrogel) or hydrogel dressing was applied, both in doses of 1 cm/cm(2), once daily for 8 weeks. Follow-up continued for 4 weeks beyond the final gel application.
The primary end point was complete wound closure rate after 8 weeks of treatment. Secondary end points were percentages of patients with complete wound closure at week 12; changed ulcer area after treatment vs baseline; and changed ulcer-related pain and health-related quality of life during the study.
Complete wound closure rates were comparable after 8 weeks for becaplermin (5 of 28 patients) and hydrogel (3 of 31 patients) (8 percentage-point difference; 95% confidence interval, -10% to 26%). No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12, changed ulcer area at week 8, or changed ulcer-related pain and quality of life during the study (P > .05 for all comparisons).
Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure. Surgical management by grafting remains the most promising treatment strategy but requires further evaluation. Trial Registration clinicaltrials.gov Identifier: NCT00970697.
确定外用贝卡普勒明凝胶与水凝胶敷料对高血压性腿部溃疡的愈合效果。
随机、双盲、平行分组、对照研究。
来自17个皮肤科的门诊或住院患者。
在64例连续随机分组的、患有1处或多处高血压性腿部溃疡且符合所有纳入标准的患者中，59例接受了分配的干预措施，并对结果进行了分析。
应用贝卡普勒明凝胶（水凝胶中含0.1%人重组血小板衍生生长因子-BB）或水凝胶敷料，剂量均为1 cm/cm²，每日1次，共8周。在最后一次应用凝胶后继续随访4周。
主要终点是治疗8周后的完全伤口闭合率。次要终点是第12周时完全伤口闭合的患者百分比；治疗后溃疡面积相对于基线的变化；以及研究期间溃疡相关疼痛和健康相关生活质量的变化。
8周后，贝卡普勒明组（28例患者中有5例）和水凝胶组（31例患者中有3例）的完全伤口闭合率相当（相差8个百分点；95%置信区间为-10%至26%）。两组在第12周的完全闭合百分比、第8周溃疡面积的变化或研究期间溃疡相关疼痛和生活质量的变化方面均未观察到统计学上的显著差异（所有比较P>0.05）。
外用贝卡普勒明凝胶在高血压性腿部溃疡伤口闭合方面并不优于水凝胶敷料。通过移植进行手术治疗仍然是最有前景的治疗策略，但需要进一步评估。试验注册 clinicaltrials.gov标识符：NCT00970697。
