摘要
目的评价"类人胶原蛋白疤痕修复硅凝胶"治疗增生期增生性瘢痕的临床效果。方法采用多中心随机对照临床研究方法,分析比较"类人胶原蛋白疤痕修复硅凝胶(可痕®)"与Silicone Gel(芭克硅凝胶软膏)对伤后或手术后4~6个月处于增生期的增生性瘢痕患者的临床治疗效果,并比较3~18岁未成年人和19~45岁成年人的疗效差别。2017年3月至2019年3月北京蔡景龙瘢痕医学研究中心(蔡景龙医疗美容门诊部)、南通大学附属医院、河南省人民医院就诊的88例患者,根据随机数字表法随机分为试验组(可痕治疗组)、对照组(芭克硅胶治疗组),每组又分成年和未成年2个亚组。试验组58例,其中成年组39例、未成年组19例;对照组30例,其中成年组20例、未成年组10例。观察、统计、分析治疗前及治疗后第4、8、12、24周各组瘢痕色泽、厚度、血管分布、柔软度、患者自觉症状、临床疗效评分及不良反应的差异。结果治疗前试验组和对照组指标评分,除试验组中未成年组的柔软度、成年组的厚度评分略高于对照组(P<0.05)外,其余参数的比较差异均无统计学意义(P>0.05)。试验组和对照组治疗后第4、8、12、24周的疗效评分指标比较,差异均有统计学意义(P<0.05),但未成年组与成年组2组间差异均无统计学意义(P>0.05);每个时间点各指标评分比较差异均存在统计学意义(P<0.05),疗效评价时间与用药分组和年龄分组均不存在交互作用(P>0.05),且不受组别或年龄分组的影响(P>0.05);各组均无不良反应发生。结论"类人胶原蛋白疤痕修复硅凝胶"治疗增生期增生性瘢痕安全有效,临床疗效非劣于对照组芭克硅凝胶软膏。
Objective To evaluate the clinical efficacy of human-like collagen scar repair gel in the treatment of proliferative hypertrophic scar.Methods The clinical effect of smear-like silicone ointment on patients with hypertrophic scars after prolonged injury or 4-6 months after surgery,the difference of curative effects between 3-18 years old juvenile group and 19-45 years old adult group,were analyzed by multicenter randomized controlled clinical study.Among them,58 cases were treated with human-like collagen scar repair gel,39 cases in adult group and 19 cases in minor group;30 cases were using Silicone Gel,20 cases in adult group and 10 cases in minor group.The differences in scar color,thickness,blood vessel distribution,softness,patient's self-conscious symptoms,clinical efficacy scores and adverse reactions were analyzed before and after application of the products at 4,8,12 and 24 weeks.Results The scores of the two groups before treatment were slightly higher than those of the control group except the softness and thickness score test group(P<0.05).There was no significant difference in the remaining parameters(P>0.05).The efficacy scores at the 4th,8th,12th and the 24th week after application of the two groups showed that there were significant differences in the therapeutic indicators after treatment for different time(P<0.05)and age grouping.There was no significant difference between juvenile group and adult group(P>0.05).There was a statistically significant difference in the time points of different clinical evaluation scores(P<0.05).There was no interaction between the evaluation time and the experimental control group and age group(P>0.05);and not affected by group or age grouping(P>0.05),no adverse reactions occurred in either group.Conclusions Human-like collagen scar repair gel is safe and effective in the treatment of proliferative hypertrophic scar,and the clinical efficacy is not inferior to Silicone gel.
作者
蔡景龙
陈晓栋
李雪莉
许攀
崔晓美
张春阳
吴华娟
李云飞
Cai Jinglong;Chen Xiaodong;Li Xueli;Xu Pan;Cui Xiaomei;Zhang Chunyang;Wu Huajuan;Li Yunfei(Clinic of Cai Jinglong Medical Beauty,Beijing Cai Jinglong Scar Research Center,Beijing 100144,China;Department of Dermatology,Nantong University Affiliated Hospital,Nantong 226001,China;Department of Dermatology,Henan Provincial People’s Hospital,Zhengzhou University People’s Hospital,Henan University People’s Hospital,Zhengzhou 450003,China)
出处
《中华整形外科杂志》
CAS
CSCD
北大核心
2020年第4期423-428,共6页
Chinese Journal of Plastic Surgery
