rhPDGF凝胶治疗神经性糖尿病足疗效和安全性系统评价

Efficacy and safety of recombinant human platelet-derived growth factor gel for diabetic neuropathic foot ulcers: a Meta-analysis

目的 系统评价重组人血小板源性生长因子（rhPDGF）凝胶治疗神经性糖尿病足的临床疗效和安全性.方法 采用Cochrane系统评价的方法,电子检索Medline（～ 2014.1）,EMBase（～ 2014.1）,CBM（～2014.1）,按照Cochrane系统评价的方法,逐一评价纳入研究的质量,提取有效数据.采用RevMan 5软件进行Meta分析.结果 共纳入5个临床随机对照试验（共1 035例）.Meta分析结果显示：100μg/g剂型的rhPDGF凝胶可以提高神经性糖尿病足的治愈率[RR 1.36,95％ CI（1.16,1.61）],而30μg/g剂型的rhPDGF凝胶作用不明显[RR 1.32,95％ CI（0.66,2.63）].rhPDGF凝胶可能会缩短溃疡的愈合时间,更有效地使溃疡面缩小.此外,rhPDGF凝胶没有明显的不良反应,使用比较安全.结论 在传统治疗的基础上加用rhPDGF凝胶治疗神经性糖尿病足,可以增加治愈率,缩短治愈时间,有利于使溃疡面的面积缩小.rhPDGF凝胶没有明显的不良反应.

Objective To assess the efficacy and safety of recombinant human platelet-derived growth factor （rhPDGF） gel for diabetic neuropathie foot （DNF）. Methods We electronically searched Medline （ - 2014.1 ） , EMBASE （ - 2014.1 ） , CBM （ - 2014. 1 ） for ran- domized controlled trials （ RCTs ）. Mata-analysis were performed with the RevMan software from Cochrane Collaboration. Results Five RCTs involving 1 035 patients were included. Meta-analysis showed that, compared with controls, patients treated with rhPDGF at 100 ug/g had a significantly increase in complete healing rate [ RR 1.36,95% CI （ 1.16,1.61 ） ] , while patients with rhPDGF at 30 ug/g didn＇ t show an increased rate [ RR 1.32,95 % CI（0. 66,2.63） ]. rhPDGF gel was likely to decrease the time to complete healing and reduces the size of the ulcer more effectively. Moreover,rhPDGF gel did not cause apparent adverse effects and was relatively safe for use. Conclusion The currently available evidence indicates that rhPDGF gel can increase complete healing rate of DNF, shorten the time of complete healing and be helpful to shrink ulcer surface, rhPDGF gel has no apparent adverse effects.