Steed David L
Department of Surgery, University of Pittsburgh, UPMC Presbyterian Hospital, Pittsburgh, Pa 15213, USA.
Plast Reconstr Surg. 2006 Jun;117(7 Suppl):143S-149S; discussion 150S-151S. doi: 10.1097/01.prs.0000222526.21512.4c.
Diabetic foot ulcer is a major health care problem that leads to amputation.
Patients with full-thickness diabetic neurotrophic foot ulcers present for longer than 8 weeks without healing were entered into one of five randomized, prospective, blinded clinical trials comparing treatment with platelet-derived growth factor (PDGF) or placebo gel for up to 20 weeks. The purpose of these trials was to assess the safety and efficacy of PDGF used with good wound care. Each patient had an adequate arterial blood supply, was free of infection, was off-loaded, and was extensively débrided. The ulcers had been present for at least 8 weeks.
A total of 922 patients were entered into the study. Analysis of ulcers with a baseline area of less than 10 cm (95 percent of patients) showed that patients treated with PDGF at 100 mug/g had a significant increase in complete healing compared with patients given placebo (50 percent versus 36 percent, p < 0.007). PDGF also decreased the time to complete healing by 30 percent (14 weeks versus 20 weeks, p = 0.01). Adverse events were similar in both treatment groups, as were recurrent ulcer rates.
PDGF applied once daily was effective in healing chronic diabetic neurotrophic foot ulcers when used in conjunction with good wound care.
糖尿病足溃疡是一个导致截肢的主要医疗保健问题。
全层糖尿病神经病变性足溃疡持续超过8周未愈合的患者被纳入五项随机、前瞻性、盲法临床试验之一，比较使用血小板衍生生长因子（PDGF）或安慰剂凝胶治疗长达20周的效果。这些试验的目的是评估联合良好伤口护理使用PDGF的安全性和有效性。每位患者均有充足的动脉血供，无感染，减压，并进行了广泛清创。溃疡已存在至少8周。
共有922名患者进入研究。对基线面积小于10平方厘米的溃疡（95%的患者）进行分析显示，与接受安慰剂治疗的患者相比，接受100微克/克PDGF治疗的患者完全愈合率显著提高（50%对36%，p<0.007）。PDGF还使完全愈合时间缩短了30%（14周对20周，p=0.01）。两个治疗组的不良事件相似，复发性溃疡率也相似。
当与良好的伤口护理联合使用时，每日一次应用PDGF对愈合慢性糖尿病神经病变性足溃疡有效。
