化妆品过敏原皮肤斑贴试验的临床研究

Clinical Study on Cosmetic Allergens by Skin Patch Test

研究的目的是查找出化妆品中易导致人体化妆品皮炎的原料成分,以减少化妆品皮炎的发生几率。采用临床试验筛选研制出的过敏原60种,然后将其中20种过敏原作为实验组和瑞典化学诊断试剂公司生产的"瑞敏"相同成分20种过敏原作为对照组,为临床疑因接触化妆品而导致的过敏性皮炎患者做斑贴试验。156例患者使用研制的60种过敏原斑贴试验有145例出现阳性反应,总阳性率92.95%;其中有9种过敏原斑贴试验的阳性率超过10%。50例患者用研制的20种过敏原与"瑞敏"20种相同成分过敏原对照斑贴试验,结果完全一致的37例,占74%。206例患者均没有出现不良反应。本试验的60种化妆品筛选过敏原用于临床斑贴试验安全、有效。

The purpose of the study is by examining potential allergens in cosmetics,to reduce incidence of dermatitis.Skin patch test was performed for the patients with cosmetic dermatitis by using clinically selected 60 candidate allergens.Among them,20 allergens were compared with the same allergens from Chemotechnique Diagnostics,Sweden.145 of 156 patients treated with the above 60 candidate allergens showed positive skin reactions,which counts for 92.95% of total patients examined.For 9 of 60 allergens,the rate of positive results exceeded 10%.Furthermore,skin patch test to 50 patients was performed with our own 20 allergens and with the same allergens purchased from Chemotechnique diagnostics,Sweden.The results showed that 37 of 50 patients（counting for 74%） have similar positive skin reaction to the same allergens from two different sources.None of the 206 patients had skin adverse reaction.The selected 60 different cosmetic candidate allergens for patch test are safe and effective for clinical use.