速愈乐^(TM)愈伤敷料治疗糖尿病足溃疡的临床研究

CLINICAL STUDY ON TOPICAL Bismuth Subgallate/Borneol (Suile^(TM)) DRESSING FOR TREATMENT OF DIABETIC FOOT ULCERS

目的评价速愈乐TM愈伤敷料[Bismuth Subgallate/Borneol(SuileTM),BSB]治疗糖尿病足(diabeticfoot,DF)溃疡的有效性和安全性。方法研究为两个中心、随机、阳性敷料[清得佳(Intrasite gel,IG)水凝胶]的开放性对照(2∶1)试验。2005年9月-2006年11月,共纳入Wagner 2～3级DF溃疡患者35例,其中试验组(BSB组)25例,对照组(IG组)10例。两组患者基线资料差异无统计学意义(P>0.05),具有可比性。两组患者均在DF综合治疗基础上加用相应敷料局部治疗。观察期间每周测量溃疡面积,观察创面出血情况,询问患者接受程度,同时记录不良事件至溃疡愈合或第12周试验结束。结果除BSB组3例和IG组2例敷料脱落外,其余患者均顺利完成试验。意向性治疗分析显示:BSB组患者溃疡完全愈合19例(76%),显效3例(12%),有效1例(4%),无效2例(8%);IG组完全愈合8例(80%),有效1例(10%),无效1例(10%)。符合方案分析显示:BSB组患者溃疡完全愈合19例(86%),显效3例(14%);IG组8例均完全愈合(100%)。两种分析结果两组间比较差异均无统计学意义(P>0.05)。治疗期间两组溃疡面积变化趋势一致,各时间点两组间的止血作用无明显差异(P>0.05),患者更倾向于接受BSB敷料(P<0.05)。未出现与两种敷料有关的不良事件。结论 BSB愈伤敷料治疗DF溃疡疗效及安全性与IG敷料相当,可为DF局部治疗提供新的选择。

Objective To evaluate the efficacy and safety of Bismuth Subgallate/Borneol （Suile？） （BSB） dressing in the treatment of diabetic foot ulcers. Methods A two-center, randomized controlled parallel-group comparison study was conducted. Between September 2005 and November 2006, 35 patients with nonhealing diabetic foot ulcer （Wagner 2-3 grade） were recruited and divided randomly into the test group （BSB group, n=25） and control group （IG group, n=10）. There was no significant difference in general data between 2 groups （P 〉 0.05）. Based on the comprehensive therapy of diabetic foot, ulcers were topically treated by SuileTM dressing and Intrasite gel in the BSB group and IG group, respectively. The ulcer area was measured once a week. Ulcer bleeding was observed and acceptance of the dressing was inquired each week. Results Of the patients, 22 patients in the BSB group and 8 in the IG group completed the clinical trial. Intention to treat （ITT） analysis indicated that the results were excellent in 19 （76%） cases, good in 3 cases （12%）, fair in 1 case （4%）, and poor in 2 cases （8%） in the BSB group. In the IG group, the results were excellent in 8 cases （80%） cases, fair in 1 case （10%）, and poor in 1 case （10%）. Per-protocol （PP） analysis showed that the results were excellent in 19 cases （86%） and good in 3 cases （14%） in the BSB group, and were excellent in 8 cases （100%） in the IG group. The results of ITT and PP analysis all showed no significant difference between 2 groups （P 〉 0.05）. The change trend of ulcer areas in the BSB group was similar to that in the IG group. There was no significant difference in the hemostatic effect between 2 groups （P 〉 0.05） and the patients were more likely to accept BSB dressings. Conclusion BSB dressings is an effective, safe, and generally well-tolerated therapy dressing in the treatment of diabetic foot ulcers.