Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers - A phase III randomized placebo-controlled double-blind study
Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers - A phase III randomized placebo-controlled double-blind study
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DOI：
10.2337/diacare.21.5.822
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发表时间：
1998-05-01
期刊：
影响因子：
16.2
通讯作者：
Su, YC
中科院分区：
文献类型：
--
作者：
Wieman, TJ;Smiell, JM;Su, YC
比较局部应用重组人血小板源性生长因子-BE（rhPDGF-BB）（becaplermin）与安慰剂凝胶治疗下肢慢性糖尿病神经性溃疡患者的疗效和安全性。研究设计和方法-这一多中心双盲安慰剂对照III期试验包括382例1型或2型糖尿病和慢性溃疡至少8周的持续时间。溃疡彻底清创后，患者随机接受becaplermin凝胶30 μ g/g、becaplermin凝胶100 μ g/g或安慰剂凝胶，并联合良好伤口护理的标准化方案，直至伤口完全闭合或最多20周。湿盐水浸泡纱布敷料每日更换两次，由患者或护理人员在晚上换药时使用研究药物。通过监测不良事件（AE）和临床实验室评估来评估安全性。结果-与安慰剂凝胶相比，100 μ g/g becaplermin凝胶使伤口完全闭合的发生率显着增加了43%（50 vs. 35%，P = 0.007），达到伤口完全闭合的时间缩短了32%（86 vs. 127天;估计第35百分位数，P = 0.013）。治疗期间或3个月随访期间报告的AE在所有治疗组中的性质和发生率相似。结论-贝卡普勒明凝胶100 μ g/g，与良好的伤口护理相结合，显著增加了伤口完全闭合的发生率，并显著减少了慢性糖尿病神经性溃疡完全闭合的时间。贝卡普勒明凝胶的安全性与安慰剂凝胶相似。
OBJECTlVE -To compare the efficacy and safety of topically applied recombinant human platelet-derived growth factor-BE (rhPDGF-BB) (becaplermin) with placebo gel in patients with chronic diabetic neuropathic ulcers of the lower extremities.RESEARCH DESIGN AND METHODS -This multicenter double-blind placebo-controlled phase III trial included 382 patients with type 1 or type 2 diabetes and chronic ulcers of at least 8 weeks' duration. After sharp debridement of the ulcer, patients were randomized to receive becaplermin gel 30 mu g/g, becaplermin gel 100 mu g/g, or placebo gel, in conjunction with a standardized regimen of good wound care until complete wound closure was achieved or for a maximum of 20 weeks. Moist saline-soaked gauze dressings were changed twice daily with study medication applied by patients or caregivers at the evening dressing change. Safety was assessed by monitoring adverse events (AEs) and by clinical laboratory evaluations.RESULTS -Compared with placebo gel, becaplermin gel 100 mu g/g significantly increased the incidence of complete wound closure by 43% (50 vs. 35%, P = 0.007) and decreased the time to achieve complete wound closure by 32% (86 vs. 127 days; estimated 35th percentile, P = 0.013). AEs reported during treatment or during a 3-month follow-up period were similar in nature and incidence across all treatment groups.CONCLUSIONS -Becaplermin gel 100 mu g/g, in conjunction with good wound care, significantly increased the incidence of complete wound closure and significantly reduced the time to complete closure of chronic diabetic neuropathic ulcers, The safety profile of becaplermin gel was similar to that of placebo gel.