Becaplermin

Becaplermin
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DOI:
10.2165/00063030-199911050-00007
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发表时间:
1999-05-01
期刊:
影响因子:
6.8
通讯作者:
Noble, S
Noble, S
中科院分区:
医学2区
文献类型:
--
作者:
Balfour, JAB;Noble, S

文献摘要

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Becaplermin是一种重组人血小板衍生生长因子B链同源二聚体(rh-PDGF-BB),用于局部治疗全层糖尿病神经性溃疡和压力性溃疡。rh-PDGF-BB促进伤口愈合,可能通过细胞迁移和增殖增加肉芽组织形成,随后细胞外基质沉积。在健康和愈合受损的动物以及患有下肢糖尿病神经性溃疡和压力性溃疡的患者中已经证实了加速愈合。人体药代动力学研究表明,局部给药于溃疡后,becaplermin的全身吸收是最小的。与单独使用安慰剂或良好的伤口护理相比,每天一次联合良好的伤口护理显著增加了溃疡完全愈合的患者比例,并缩短了完全愈合的时间。在压疮患者中,Becaplermin也上级安慰剂。Becaplermin在临床试验中耐受性良好,因不良事件而停药的发生率与安慰剂接受者相似。2%的becaplermin接受者和2%的安慰剂接受者发生皮疹,可能归因于使用的溶剂。
Becaplermin is a recombinant human platelet-derived growth factor B-chain homodimer (rh-PDGF-BB) for topical treatment of full-thickness diabetic neuropathic ulcers and pressure ulcers.rh-PDGF-BB promotes wound healing, probably increasing granulation tissue formation via migration and proliferation pf cells, with subsequent extracellular matrix deposition. Accelerated healing has been demonstrated in healthy and healing-impaired animals and in patients with lower extremity diabetic neuropathic ulcers and pressure ulcers.Pharmacokinetic studies in humans have shown that systemic absorption of becaplermin after topical administration to ulcers is minimal.A clinical trial in patients with stage III or IV diabetic neuropathic ulcers of the lower extremities which had adequate perfusion showed that becaplermin 100 mu g/g applied once daily in conjunction with a programme of good wound care significantly increased the proportion of patients with complete healing of the ulcer and reduced the time to complete healing compared with placebo or good wound care alone. Becaplermin was also superior to placebo in patients with pressure sores.Becaplermin was well tolerated in clinical trials and the rate of discontinuation because of adverse events was similar to that among placebo:recipients. Rash, which occurred in 2% of becaplermin and 2% of placebo recipients, may be attributable to the vehicle used.