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  

Efficacy and safety of chitosan wound dressing for deep second-degree burn:a prospective,single-blind,randomized controlled trial

作　　者：刘琳娜[1] 李学拥[2] 赵聪颖[2] 关波[1] 吴晓春[3] 张甜[1] 李诗草[1] 

机构地区：[1]解放军第四军医大学唐都医院药学部药物临床试验机构,陕西省西安市710038 [2]解放军第四军医大学唐都医院烧伤整形科,陕西省西安市710038 [3]解放军第四医院药械科,青海省西宁市810014

出　　处：《中国组织工程研究》2017年第14期2222-2226,共5页Chinese Journal of Tissue Engineering Research

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,P>0.05],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。BACKGROUND： Chitosan wound dressing has been extensively used in the treatment of wounds and burns, not only because of its bacteriastasis, hemostasis and promoting the wound healing, but also its good biocompatibility, biodegradability and biological functions. OBJECTIVE： To evaluate the efficacy and safety of chitosan wound dressing for deep second-degree burn, thereby providing clinical basis for its registration. METHODS： Sixty patients with deep second-degree burn were randomly allotted to two groups, and then subjected to the external application of chitosan wound dressing （experimental group） or chitosan biomedical dressing （control group） respectively. Then, the therapeutic efficacy was evaluated through healing time, recovering rate and pain scores, and the safety was evaluated through the incidence of adverse reactions and laboratory indexes before and after treatment. RESULTS AND CONCLUSION： There were no significant differences in the wound healing time [（21.23±6.84） days vs. （23.77±4.26） days], recovery rate and pain scores between the experimental and control groups at 14, 21 and 28 days after treatment （P 〉 0.05）. The blood routine, liver function and kidney function indexes before and after treatment did not differ significantly between groups. Additionally, neither adverse nor Severe adverse events occurred in the two groups. These results indicate that the therapeutic efficacy and safety of the chitosan wound dressing are equivalent to the control product in the treatment of deep second-dearee burn.

关 键 词：壳聚糖 生物敷料 烧伤 组织工程 生物材料 材料相容性 护创敷料 深Ⅱ度烧伤 创面愈合 

分 类 号：R318[医药卫生—生物医学工程]