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纳米晶体银敷料治疗烧伤后残余创面的多中心临床研究
Multi-center clinical study of Acticoat (nanocrystalline silver dressing) for the management of residual burn wounds
【摘要】 目的观察纳米晶体银敷料在治疗烧伤后残余创面、控制感染方面的疗效和安全性, 从而评价其临床应用价值。方法入选患者98例166个残余创面,采用随机、盲法、多中心、阳性平行对照的试验设计。在常规治疗的基础上,试验组(83处创面)参照伤口形状剪切大小合适的纳米晶体银敷料覆盖创面,对照组(83处创面)常规外用磺胺嘧啶银。观察至创面完全愈合或用药20d 时终止试验。比较两组患者创面愈合时间、愈合率及药物抗感染效果。结果试验组创面愈合时间为(12±5)d,较对照组(16±6)d明显缩短(P=0.005<0.01)。治疗总显效率试验组为97.05%, 较对照组的94.17%有升高趋势(P>0.05)。试验组用药后6、12 d累计细菌清除率分别为21.7%、 43.5%,较对照组明显增高(P<0.05)。用药后两组患者均未见明显不良反应。结论纳米晶体银敷料用于治疗烧伤后残余创面疗效确切,并可为进一步促进伤口愈合提供良好的基底。
【Abstract】 Objective To investigate the clinical efficacy and safety of Acticoat ( nanocrystalline silver dressing) for the treatment of residual burn wounds. Methods Ninety-eight patients with 166 residual burn wounds were enrolled in the multi-center randomized clinical trials. In addition to the routine treatment, Acticoat was applied onto the wounds of the trial group once a day if there was much exudation from the wound, or the dressing change was made every other two days when the wounds were clean. Silver sulfa-diazine (SD-Ag) was used in the control group of patients. The healing time was observed up to 20 days. The healing rate on the 15th day after treatment was taken as the percentage of healing. Results The average healing time was (12±5) days after the application of Acticoat, which was significantly shorter than that in control wounds with SD-Ag(16±6)days, ( P =0. 005 <0. 01 ). The total effective rate of the wounds for trial was 97.05% , which was higher than that in control(94. 17% ) group, but there was no statistically significant difference. The bacterial clearing rate of the Acticoat group on the 6th and 12th post treatment day was 21.7% and 43.5% respectively, which was significantly higher than that in control group. No side-effect was observed in the two groups during the study. Conclusion Acticoal with nanocrystalline silver can promote the healing of residual burn wounds effectively.
【Key words】 Burns; Residual wounds; Nanocrystalline silver dressing; Silver sulfadiazine;
- 【文献出处】 中华烧伤杂志 ,Chinese Journal of Burns , 编辑部邮箱 ,2006年01期
- 【分类号】R644
- 【被引频次】64
- 【下载频次】359