脱痂软膏治疗深Ⅱ度烧伤的临床研究

目的评价脱痂软膏用于临床治疗深Ⅱ度烧伤患者的有效性和安全性。方法收集烧伤后7 d内的深Ⅱ度烧伤创面患者42例,分为试验组和对照组,试验组使用脱痂软膏,对照组使用清得佳。采用随机、单盲加盲法评定、阳性药自身对照、单中心、非劣效的临床试验。于首次用药后第3天进行第1次观测,之后每2天观测1次创面,记录创面愈合面积比值、创面愈合时间、创面坏死组织面积与创面总面积的比值、创面有无发生感染、皮疹、浸渍、瘙痒等,评定疼痛视觉模拟评分,最终第21天的观测结果用于该指标的评定。在首次用药前和创面愈合时评价安全性,检测血常规、肝肾功能和血钙。结果试验组创面愈合时间平均13.88 d,与对照组相比差异无统计学意义(P0.05),未出现与药物反应相关的血常规、肝肾功能和血钙明显改变。结论脱痂软膏促进深Ⅱ度烧伤患者愈合,疗效和安全性不弱于清得佳。

Clinical study on the treatment of deepⅡdegree burn with removing scab ointment

Objective To evaluate the efficacy and safety of the application of the scab she patients with deep Ⅱ degree burning. Methods Randomized,single blind,blinded,positive drug controlled,single center,non inferiority clinical trial. 42 patients with deep Ⅱ degree burn wound within 7 days of burning were observed and studied. The wounds were divided into experimental group and control group,the scab ointment was used in the experimental group,and the control group was treated with hydrogel. Beginning the observation on the third day after treatment,record every 2 days for healing area ratio,wound healing time,the ratio of necrotic tissue and total wound area,whether or not there was wound infection,erythra,maceration and pruritus,evaluation of the pain visual analogue scale. the results in 21 days as the end of observation to assess the above items. We also test the blood routine,liver and kidney function and serum calcium for safety evaluation at the beginning and the Wound healing. Results The average healing time in experimental group was 13.88 days,and there was no significant difference compared with the control group (P > 0.05). No drug related side effects on blood routine,liver and kidney function and serum calcium level. d ointment in the treatment of Conclusion Scab shed ointment can speed up the wound healing in the patients with deep Ⅱ degree burning. The efficacy and safety is not less than that of hydrogel.