Aquacel-Ag吸收性敷料治疗难愈性创面的多中心临床研究

目的观察爱康肤(Aquacel-Ag)吸收性敷料在治疗难愈性创面的疗效和安全性,评估其临床使用价值。方法采用随机、盲法、多中心、阳性对照的研究设计。选择患者共60例,120个难愈性创面,随机分为试验组(60处创面),创面用爱康肤吸收性银离子敷料处理;对照组(60处创面),创面用磺胺嘧啶银(SD-Ag)霜处理,两组均是在常规治疗的基础上进行。观察至创面愈合或用药4周(实验终止)。比较两组创面愈合时间、愈合率、药物抗感染效果及安全性。结果试验组创面愈合时间为(13±4)天,较对照组(17±5)天缩短(p<0.01)。治疗有效率试验组为98.7%,较对照组94.6%高(p>0.05)。试验组用药后1周及2周累计细菌清除率分别为31.5%、47.6%,对照组为18.3%、26.5%,两组比较p<0.05。用药4周内两组患者及创面均未见明显不良反应。结论爱康肤银离子敷料治疗难愈性创面疗效确切且无不良反应。

MULTI-CENTER CLINICAL STUDY OF Aquacel-Ag DRESSING FOR THE MANAGEMENT OF DIFFICULT HEALING WOUND

Objective To study the clinical efficacy and safety of Aquacel-Ag for the treatment of difficult healing wound.Methods Sixty patients with 120 wound were enrolled in the multi-center randomized clinical trials.In addition to the routine treatment,Aquacel-Ag was applied onto the wound of the trial group once a day if there was much exudation from the wound,or the dressing change was made every two-three days when the wound were clean.Silver sulfa diazine（SD-Ag） was used in the control group.The healing time was observed up to 4 weeks.The healing rate on the 14th day after treatment was taken as the percentage of healing.Results The average healing time was （13±4）days after the application of Aquacel-Ag,which was significantly shorter than that in control group with SD-Ag（17±5）days（p〈0.01）.The total effective rate of the wound for trial group was 98.7%,which was higher than that in control group 95.6%（p〉0.05）.The bacterial cleanup rate of Aquacel-Ag on the 7th and 14th post treatment day was 31.5% and 47.6% respectively,which was significantly higher than in control group18.3%、26.5%,with increasing tendency （p〈0.05）.But there was no statistically significant difference between two groups.No side-effect was observed in the two groups during the 4 weeks.Conclusion Aquacel-Ag dressing can promote the healing of difficult wound effectively.