壳聚糖护创敷料用于深Ⅱ度烧伤创面的疗效和安全性:一项前瞻性、随机、单盲、阳性对照临床试验

发布时间：2018-06-14 00:35

本文选题：壳聚糖 + 生物敷料　；参考：《中国组织工程研究》2017年14期

【摘要】：背景:以壳聚糖为原料制备而成的护创敷料,不仅具有天然抑菌、止血、促进伤口愈合的作用,而且具有良好的生物相容性、生物可降解性和生物学功能,被广泛应用于外科创伤、烧伤等治疗。目的:评价试验产品——壳聚糖护创敷料用于深Ⅱ度烧伤创面的疗效和安全性,为试验产品的临床注册提供依据。方法:将60例深Ⅱ度烧伤患者随机分为2组,试验组创面外敷壳聚糖护创敷料,对照组创面外敷壳聚糖生物医用敷料。以创面愈合时间、创面愈合百分率和疼痛评分为有效性指标,以不良事件和严重不良事件发生率和治疗前后实验室指标为安全性指标,评价试验产品的疗效和安全性。结果与结论:(1)有效性指标:两组创面愈合时间比较差异无显著性意义[(21.23±6.84),(23.77±4.26)d,P0.05],两组治疗后14,21,28 d的创面愈合率比较差异无显著性意义;两组治疗后7,14,21,28 d的疼痛评分比较差异无显著性意义;(2)安全性指标:两组治疗前后的血常规、肝功能、肾功能各指标比较差异均无显著性意义;两组均未发生不良事件和严重不良事件;(3)结果表明,壳聚糖护创敷料治疗深Ⅱ度烧伤创面的疗效和安全性方面与对照产品相当。
[Abstract]:Background: the protective wound dressing prepared from chitosan has not only natural bacteriostatic, hemostatic and wound healing effects, but also good biocompatibility, biodegradability and biological function. It is widely used in the treatment of surgical trauma, burn and so on. Objective: to evaluate the efficacy and safety of chitosan wound dressing for deep second degree burn. Methods: sixty patients with deep second degree burn were randomly divided into two groups: the experimental group was treated with chitosan external dressing and the control group was treated with chitosan biomedical dressing. The efficacy and safety of the test products were evaluated by the effective indexes of wound healing time, wound healing percentage and pain score, and the incidence of adverse events and serious adverse events and laboratory indexes before and after treatment. Results and conclusion: there was no significant difference in wound healing time between the two groups (21.23 卤6.84) (23.77 卤4.26 d P 0.05), but there was no significant difference in wound healing rate between the two groups at 14 ~ 2128 d after treatment. There was no significant difference in pain score between the two groups on the 28th day after treatment: there was no significant difference in blood routine, liver function and renal function between the two groups before and after treatment. There were no adverse events and severe adverse events in both groups. The results showed that the efficacy and safety of chitosan wound dressing in treating deep second degree burn wounds were similar to those of the control.
【作者单位】：解放军第四军医大学唐都医院药学部药物临床试验机构;解放军第四军医大学唐都医院烧伤整形科;解放军第四医院药械科;
【分类号】：R318.08;R644

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