自体富血小板凝胶与标准疗法治疗糖尿病难治性皮肤溃疡的随机对照研究

目的评价自体富血小板凝胶（APG）治疗糖尿病难治性皮肤溃疡的有效性和安全性。方法2007年4月至2008年2月在我科住院治疗的糖尿病皮肤溃疡患者46例，随机分人APG治疗组（23例）和标准治疗组（23例）。两组患者均使用胰岛素控制血糖，严格控制血压、血脂，同时给予抗血小板、改善微循环、抗感染等一般治疗和局部溃疡创面标准处理。APG治疗组患者根据创面体积／面积用自制APG并外敷速愈乐敷料；标准治疗组直接外敷速愈乐敷料。疗程直至创面愈合、行皮瓣移植手术或12周满。结果除标准治疗组失访1例，其余患者均完成试验。APG治疗组溃疡愈合率为22／23（95．7％），总有效率为100％；标准治疗组溃疡愈合率为13／23（56．5％），总有效率为73．9％，两组比较差异有统计学意义（P值分别为0．002，0．009）；Kaplan-Meier溃疡时间愈合曲线和窦道闭合曲线分析提示P〈0．05，显示APG治疗明显优于标准治疗；治疗过程中未发现APG治疗相关副作用发生。结论APG治疗糖尿病难治性皮肤溃疡优于标准治疗法，且治疗伴窦道的溃疡更有优势；APG治疗糖尿病难治性皮肤溃疡是安全、有效、可行的。

A prospective randomized controlled study on topical autologous platelet-rich plasma gel for the treatment of diabetic non-healing dermal ulcers

Objective To compare the safety and effectiveness between treatments with autologous platelet gel （APG） versus standard care for treating refractory diabetic dermal ulcers. Methods The 46 patients with proved nonhealing diabetic dermal ulcers were enrolled. Eligible for the study were patients with grade Ⅱ/Ⅲ ulcers according to Wagner, lasting for at least 2 weeks and with no signs of infection at recruitment. Patients were given their informed consent document and randomly assigned to two groups： standard care （ST, n= 23） or standard care plus topic application of APG （APG, n = 23） for twelve weeks. The treatment of blood glucose, blood pressure and lipids was optimized and the empiric antibiotic treatment was further adjusted according to the results of culture and sensitivity testing in all patients. APG treatment consisted of wound dressing with APG, followed by topical washing and cleaning. The APG was then covered with vaseline gauze for 72 hours, after which the ulcers were treated by standard care. Participants were seen thrice a week, twice a week, or at weekly intervals. Twelve weeks observation was set as the end point. Results The would of APG group were improved in 22 patients with ulcers healed completely and 1 case with would area reduced. In the ST group, 13 ulcers were healed, 6 worsened and 4 with would area reduced. The cumulative rate of ulcer healing was 95.7% in the APG group versus 56.5% in the ST group （P= 0. 002）. The total effective rate in APG vs ST group was 100. 0% vs 73. 9% （P = 0. 009）. By Kaplan-Meier analysis, the time-to-healing of ulcer and time-to- lutation of sinus were significantly different between two groups （log-rank, P = 0.006, 0.000, respectively）. No treatment-related adverse events were observed. Conclusions Treatment with APG in addition to standard care results in a significantly faster and better healing for a refractory diabetic dermal ulcer and does not raise any safety concerns. So APG treatment can be a valuable and effective aid i