Objective To evaluate the efficacy and safety of Bismuth Subgallate/Borneol (SuileTM) (BSB) dressing in the treatment of diabetic foot ulcers. Method s 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 gt; 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 gt; 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 gt; 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.
目的 研究银离子联合水凝胶敷料和传统敷料对术后感染伤口的治疗作用。方法 对我院普外科行手术治疗后伤口发生感染的患者进行前瞻性研究,随机纳入新型敷料组(银离子联合水凝胶)和传统敷料组,收集患者一般基线资料,比较2组的创面愈合率、创面愈合时间及换药费用。结果 根据纳入和排除标准,最终新型敷料组纳入42例患者,传统敷料组纳入58例患者,2组患者基线资料一致(P>0.05)。治疗6d后的创面愈合率新型敷料组明显高于传统敷料组(P<0.05);创面愈合时间新型敷料组明显短于传统敷料组(P<0.05);换药费用2组间比较差异无统计学意义(P>0.05)。结论 银离子联合水凝胶敷料具有较好的控制伤口感染、促进伤口的生长及促进伤口愈合的作用。