Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open-label clinical evaluation of efficacy
Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open-label clinical evaluation of efficacy
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DOI：
10.1046/j.1524-475x.2000.00162.x
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发表时间：
2000-05-01
影响因子：
2.9
通讯作者：
Lau, CY
中科院分区：
文献类型：
--
作者：
Embil, JM;Papp, K;Lau, CY
局部应用重组人血小板源性生长因子-BB（becaplermin）是一种新的治疗慢性、神经性、下肢糖尿病溃疡的药物。在既往研究中，贝卡普勒明凝胶每日给药一次，但敷料每日更换两次。在目前对134例糖尿病和下肢全层溃疡患者的研究中，每天仅更换一次敷料，简化了治疗方案。疗效标准包括在20周治疗期内实现完全愈合的患者百分比、实现完全愈合的时间、愈合后6个月内溃疡复发率和治疗依从性。57.5%的患者溃疡完全愈合，平均闭合时间为63天，6个月时复发率为21%。在影响溃疡愈合的潜在因素中，只有药物依从性（p < 0.001）、敷料依从性（p <0.01）、感染的存在（p < 0.01）、基线溃疡面积（p < 0.05）和基线总伤口评估评分（p < 0.05）与愈合显著相关。本研究结果进一步证实了贝卡普勒明凝胶治疗下肢糖尿病溃疡的有效性和安全性。
Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new pharmacologically active therapy for chronic, neuropathic, lower extremity diabetic ulcers. In previous studies, becaplermin gel was administered once daily but dressings were changed twice daily. In the present study of 134 patients with diabetes mellitus and full thickness lower extremity ulcers, dressings were changed only once per day, simplifying the treatment regimen. Efficacy criteria included the percentage of patients achieving complete healing within the 20-week treatment period, the time to achieve complete healing, the rate of ulcer recurrence during the 6-month period following healing, and treatment compliance. Complete healing of ulcers was achieved in 57.5% of patients, with a mean time to closure of 63 days and a recurrence rate of 21% at 6 months. Of the potential factors affecting ulcer healing, only drug compliance (p < 0.001), dressing compliance (p < 0.01), the presence of infection (p < 0.01), baseline ulcer area (p < 0.05), and baseline total wound evaluation score (p < 0.05) were significantly associated with healing. Results of this study further confirm the efficacy and safety of becaplermin gel for the treatment of lower extremity diabetic ulcers.