异种脱细胞真皮基质膜修复全层皮肤损伤的疗效和安全性分析--多中心、随机、对照试验  

Efficacy and safety of acellular collagen matrix on treatment of full-thickness skin deficiency wounds: A multicenter randomized controlled trial

作　　者：王志勇[1] 窦懿[1] 廖镇江[1] 朱雄翔[2] 胡大海[2] 刘毅[3] 

机构地区：[1]上海交通大学医学院附属瑞金医院灼伤整形科,上海市烧伤研究所,上海市200025 [2]解放军第四军医大学西京医院烧伤科,陕西省西安市710032 [3]解放军兰州军区兰州总医院烧伤整形科,甘肃省兰州市730050

出　　处：《中国组织工程研究与临床康复》2008年第40期7837-7840,共4页Journal of Clinical Rehabilitative Tissue Engineering Research

摘　　要：背景:目前,国内尚无批准上市的植入性异种真皮基质。目的:评价异种脱细胞真皮基质修复真皮组织缺损创面的疗效和安全性。设计、时间及地点:多中心、随机、空白自身对照。选择2006-03/2007-07来自上海交通大学附属瑞金医院灼伤整形科、解放军第四军医大学西京医院烧伤科、解放军兰州军区兰州总医院烧伤整形科3个研究中心72例患者。对象:72例真皮层缺损患者,男61例,女11例,其中火焰烧伤35例、电击伤11例、化学烧伤4例、烫伤9例、整形美容1例、其他12例。平均年龄(35.6±10.7)岁,修复的缺损面积平均(59.2±33.8)cm2。采用随机数字表法创面分为试验区或对照区,各72个创面。脱细胞真皮基质由烟台正海生物技术有限公司生产并提供。方法:试验区进行脱细胞真皮基质及自体薄皮片复合移植;对照区单纯自体薄皮片移植。主要观察指标:试验区、对照区复合移植成活率及移植后3、6个月瘢痕增生情况。结果:移植后4周,试验区植皮成活率为(98.4±11.8)%;对照区植皮成活率为(99.2±5.9)%。两者疗效差异无显著性(P=0.992)。随访病例移植后3,6个月温哥华瘢痕评分中,试验区各项评分及总分均显著低于对照区(P<0.05,P<0.01)。移植后6个月试验区各项评分及总分均显著低于3个月时(P<0.05),移植后6个月对照区色泽、色素评分及总分均显著低于3个月时(P<0.05)。试验过程中未见与材料有关的实验室检查异常及其他不良反应。结论:该异种脱细胞真皮基质可作为安全的真皮替代物,与自体薄皮片复合移植后有利于真皮组织缺损的修复,减轻创面愈合后瘢痕增生。BACKGROUND： At present, there is no implantable xeno-dermal matrix that has the permission to go on market. OBJECTIVE： To evaluate the efficacy and safety of acellular collagen matrix for repairing full-thickness skin defects. DESIGN, TIME AND SETTING： A multicenter, randomized, blank self-control trial was conducted. A total of 72 patients were recruited from Department of Burns and Plastic Surgery in Ruijin Hospital Affiliated to Shanghai Jiao Tong University, Department of Burns in Xijing Hospital of the Fourth Military Medical University of Chinese PLA and Department of Burns and Plastic Surgery in Lanzhou General Hospital, Lanzhou Military Medical University of Chinese PLA from March 2006 to July 2007. PARTICIPANTS： There were 72 patients （male 61, female 11） were involved in this study. The cause of injury was flame burn （35）, electric injury （11）, chemical burn （4）, scald （9）, cosmetological operation （1） and others （12）. The average age was （35.6±10.7） years old. The average area of skin defects was （59.2±33.8） cm^2. The wound was randomly divided to treated area and control area. Acellular dermal matrix was a product of Yantai Zhenghai Biotechnology Inc. METHODS： In the treated area, the wound was cografted by xeno-acellular dermal matrix and thin split-thickness autograft. In the control area, the wound was treated by thin split-thickness autograft. MAIN OUTCOME MEASURES： The survival rate of cografts and scar hyperplasy at 3 and 6 months after transplantation were determined in both treated area and control area. RESULTS： At 4 weeks, the survival rate of the graft in treated area was similar with the control group [（98.4±11.8）%, （99.2±5.9）%, P=0.992]. At months 3 and 6, Vancouver scar scale in treated area was significantly lower than that in control area （P 〈 0.05, P 〈 0.01）. There were significant differences at month 3 and at month 6 in the item score and total scores of treated area （P 〈 0.05）. The color score, pigment scor

关 键 词：皮肤移植 脱细胞真皮基质 多中心研究 

分 类 号：R617[医药卫生—外科学]