导入透明质酸猪脱细胞真皮基质的刺激性及致敏性研究  

Skin irritation and sensitization of swine acellular dermal matrix treated with hyaluronic acid

作　　者：宁少南[1] 赵筱卓[1] 王慧英[1] 张国安[1] 

机构地区：[1]北京积水潭医院烧伤科,100035

出　　处：《中华烧伤杂志》2012年第5期344-348,共5页Chinese Journal of Burns

摘　　要：目的评价导入透明质酸后猪ADM（SADM—HA）的刺激性及敏敏性。方法（1）皮肤刺激试验。将12只新西鼍兔按随机数字表法分为3组：SADM—HA组、异体皮组、异种（人）皮组，每组4只。每只免背部没4个刺激部位。每只兔取其中2个部位，均覆盖相应的SADM—HA、异体皮及异种皮，另取1个部化覆盖200g／L十二烷牲硫酸钠水溶液纱布作为阳性对照、1个部位覆盖生理盐水纱布作为阴性对照。计算各组敷料原发刺激指数和累积刺激指数。（2）迟发型超敏反应封闭贴敷试验。取60H豚鼠，其中6只设为阳性对照纰，以体积分数25％的己坫肉栳醛溶液诱导后激发。余下54只按随机数宇表法分为3组：SADM—HA组、异怵皮组、异种（人）皮组，每组18只。各组取12只豚鼠，分别以SADM—HA、异体皮、异种皮进行诱导后激发；另外6只以尢水乙醇浸透的敷贴片诱导后激发，作为组内刚性埘照。各组敷料激发后24、48h，采用Magnusson和Kligman等级评分标准进行评分，评估其致敏性。数据行独立样本的非参数检验。结果（1）皮肤刺激试验中，SADM—HA组、异体皮组、肄种皮组敷料的原发刺激指数分别为-0．04、0，13、0．08；累积刺激指数与组内阴性对照值相近，分别为0．27、0．10、0．25，皮肤刺激性均为极轻微型．（2）迟发型超敏反应封闭贴敷试验中，SADM．HA组、异体皮组、异种皮组敷料敛敏性评分为0～1分，前2组敷料评分与组内阴性对照相比，差异兄统计学意义（U值分别为188．00、90．00，P值均大于0．05）。3组敷料致敏性评分与阳性对照组比较，差异有统计学意义（U值分别为19．00、59．00、21，50，P值均小于0．01）。结论SADM-HA在刺激性及致敏性方面安全可靠，具有较广阔的临床应用前景。Objective To evaluate the skin irritation and sensitization potential of the swine aeellu- lar dermal matrix treated with hyaluronic acid （SADM-HA）. Methods （ I ） Skin irritatinn test. Twelve New Zealand rabbits were divided into SADM-HA group, allogeneie skin grnup, and （human） xeno-skin group according to the random number table, with 4 rabbits in each group. Four test sites were designed on the back of each rabbit. Two test sites of each rabbit in the three groups were covm＇ed with SADM-HA, allo- geneic skin, and xeno-skin, respectively. Another test site was covered with gauze containing 200 g/L sodi- um dodecyl sulfate soluliml as positive control. The last test site was covered with gauze containing normal saline as negative control. The primary irritation index and cumulative irritation index of each material were calculated. （2） Skin closed-patch test. Sixty guinea pigs were used. Fifty-four guinea pigs were divided into SADM-HA group, allogeneic skin group, and （human） xeno-skin group according to the random number ta- ble, with 18 guinea pigs in each group. Twelve guinea pigs in each of the three groups were correspondingly induced and stimulated by SADM-HA, allogeneie skin, and xeno-skin, with 6 guinea pigs in each group treated with ethanol-soaked gauze to serve as negative control. The remaining 6 guinea pigs were treated with gauze containing 25% α-hexylcinnamaldehyde ethanol solution as positive control. The rating scales of Mag- nusson and Kligman were used to grade the condition of skin after being treated with above-mentioned materi- als to evaluate skin sensitivity to them at post stimulation hour 24 and 48. Data were processed with the non- parametric test of independent samples. Results （ 1 ） In the skin irritation test, the primary irritation in- dexes of the three dressings in SADM-HA group, allogeneic skin grnup, and xeno-skin group were respec-tively -0.04, 0. 13, and 0. 08. The cumulative irritation indexes of the three dressings in SADM-HA group, allogeneic sk

关 键 词：透明质酸 皮肤刺激试验 皮肤致敏试验 猪脱细胞真皮基质 

分 类 号：R644[医药卫生—外科学]