CAJ | 학술논문

目的评价导入透明质酸后猪ADM(SADM-HA)的刺激性及致敏性.方法 (1)皮肤刺激试验.将12只新西兰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. 每只兔背部设4个刺激部位.每只兔取其中2个部位,均覆盖相应的SADMM-HA、异体皮及异种皮,另取1个部位覆盖200 g/L十二烷基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60只豚鼠,其中6只设为阳性对照组,以体积分数25％的己基肉桂醛溶液诱导后激发.余下5只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只以无水乙醇浸透的敷贴片诱导后激发,作为组内阴性对照.各组敷料激发后24、48 h,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、异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、异种皮组敷料致敏性评分为0～1分,前2组敷料评分与组内阴性对照相比,差异无统汁学意义(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,差异有统汁学意义(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.
목적 평개도입투명질산후저ADM(SADM-HA)적자격성급치민성.방법 (1)피부자격시험.장12지신서란토안수궤수자표법분위3조:SADM-HA조、이체피조、이충(인)피조,매조4지. 매지토배부설4개자격부위.매지토취기중2개부위,균복개상응적SADMM-HA、이체피급이충피,령취1개부위복개200 g/L십이완기류산납수용액사포작위양성대조、1개부위복개생리염수사포작위음성대조.계산각조부료원발자격지수화루적자격지수.(2)지발형초민반응봉폐첩부시험.취60지돈서,기중6지설위양성대조조,이체적분수25％적기기육계철용액유도후격발.여하5지안수궤수자표법분위3조:SADM-HA조、이체피조、이충(인)피조,매조18지.각조취12지돈서,분별이SADM-HA、이체피、이충피진행유도후격발；령외6지이무수을순침투적부첩편유도후격발,작위조내음성대조.각조부료격발후24、48 h,채용Magnusson화 Kligman등급평분표준진행평분,평고기치민성. 수거행독립양본적비삼수검험.결과 (1)피부자격시험중, SADM-HA조、이체피조、이충피조부료적원발자격지수분별위-0.04、0 13、0.08;루적자격지수여조내음성대조치상근,분별위0 27、0.10、0.25,피부자격성균위겁경미형. (2)지발형초민반응봉폐첩부시험중,SADM-HA조、이체피조、이충피조부료치민성평분위0～1분,전2조부료평분여조내음성대조상비,차이무통즙학의의(U치분별위188.00、90.00,P 치균대우 0.05).3조부료치민성평분여양성 대조조비교,차이유통즙학의의(U치분별위19.00、59.00、21.50,P치균소우0.01).결론 SADM-HA재자격성급치민성방면안전가고,구유교엄활적림상응용전경.
Objective To evaluate the skin irritation and sensitization potential of the swine acellular dermal matrix treated with hyaluronic acid (SADM-HA).Methods (1) Skin irritation test.Twelve New Zealand rabbits were divided into SADM-HA group,allogeneic skin group,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 covered with SADM-HA,allogeneic skin,and xeno-skin,respectively.Another test site was covered with gauze containing 200 g/L sodium dodecyl sulfate solution 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 table,with 18 guinea pigs in each group.Twelve guinea pigs in each of the three groups were correspondingly induced and stimulated by SADM-HA,allogeneic 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 Magnusson and Kligman were used to grade the condition of skin after being treated with above-mentioned materials to evaluate skin sensitivity to them at post stimulation hour 24 and 48.Data were processed with the nonparametric test of independent samples.Results (1) In the skin irritation test,the primary irritation indexes of the three dressings in SADM-HA group,allogeneic skin group,and xeno-skin group were respectively-0.04,0.13,and 0.08.The cumulative irritation indexes of the three dressings in SADM-HA group,allogeneic skin group,and xeno-skin group were respectively 0.27,0.10,and 0.25,which were close to those of negative control within the three groups.The skin irritation of each of the three materials was negligible.(2) In the skin closed-patch test,all scores of the three dressings in SADM-HA group,allogeneic skin group,and xeno-skin group were between 0 and 1.The scores of SADM-HA group and allogeneic skin group were close to those of negative control within the two groups (with U values respectively 188.00 and 90.00,P values both above 0.05).The differences were statistically significant between each material of the three groups and positive control (with U values respectively 19.00,59.00,21.50,P values all below 0.01).Conclusions The SADM-HA is safe and reliable without skin irritation and sensitization,and it has encouraging prospect in clinical application.