含牛油果树果脂等植物成分的保湿产品改善皮肤干燥的安全性及有效性评价  

Assessment of the safety and efficacy of a moisturizer containing Butyrospermum parkii butter for dry skin

作　　者：仲少敏[1] 那君 冯雪娇 于佳怡 王一宇 刘玮 霍唯 华薇[3] 李朝霞[3] 舒晓红[3] 汤莹 王曦[3] 邹琳 李利[3] 叶聪秀[4] 郑跃[4] 易金玲[4] 赖维[4] 吴艳[1] 朱学骏[1] ZHONG Shao-min;NA Jun;FENG Xue-jiao;YU Jia-yi;WANG Yi-yu;LIU Wei;HUO Wei;HUA Wei;LI Zhao-xia;SHU Xiao-hong;TANG Ying;WANG Xi;ZOU Lin;LI Li;YE Cong-Xiu;ZHENG Yue;YI Jin-ling;LAI Wei;WU Yan;ZHU Xue-jun(Department of Dermatology,Peking University First Hospital,Beijing,Key Laboratory of Molecular Diagnosis on Dermatoses,National Clinical Research Center for Shin and Immune Diseases,Beijing 100034,China)

机构地区：[1]北京大学第一医院皮肤科、北京市皮肤病分子诊断重点实验室、国家皮肤与免疫疾病临床医学研究中心,北京100034 [2]中国人民解放军空军特色医学中心皮肤科,北京100142 [3]四川大学华西医院皮肤科,四川成都610041 [4]中山大学附属第三医院皮肤科,广东广州510630

出　　处：《临床皮肤科杂志》2022年第3期142-146,共5页Journal of Clinical Dermatology

摘　　要：目的:探讨一种含牛油果树果脂等植物成分的保湿产品改善皮肤干燥的临床有效性和安全性。方法:采用前瞻性多中心自身前后对照试验进行研究,共收集196例受试者。受试者在双侧小腿胫前皮肤使用该保湿产品,每日1次,共14 d。分别在使用前、使用后1 h、4 h、24 h、7 d及14 d进行受试区皮肤生理指标检测及干燥程度的主观评分。结果:受试者单次使用研究产品后1 h、4 h及24 h,受试区皮肤角质层含水量较基线水平显著增加,分别升高17.11±6.72、13.98±6.36、10.79±6.28(P<0.001),保湿时效≥24 h。使用7 d和14 d后,角质层含水量分别为41.18±8.70和43.48±8.84,较基线水平(26.53±8.68)明显升高;经皮水分丢失分别为(6.48±2.33)g/h/m^(2)和(6.46±3.43)g/h/m^(2),较基线水平[(7.36±3.96)g/h/m^(2)]减少;pH值改变分别为5.28±0.60和5.37±0.53,较基线水平(5.51±0.70)降低并保持稳定;皮肤干燥程度主观评分显著降低,有2例(1.02%)受试者出现一过性轻度烧灼感和刺痛感,继续使用后消失。结论:该保湿产品可有效改善皮肤干燥且效果持久,无严重不良反应。Objective:To evaluate the clinical efficacy and safety of a moisturizer containing Butyrospermum parkii butter for dry skin.Methods:This is a prospective multicenter self-controlled trial with 196 cases enrolled.All subjects applied the moisturizer on the skin in front of pretibial area one time per day for 14 days,and were followed up at 1 h,4 h,24 h,7 days and 14 days.Skin physiological parameters including hydration,transepidermal water loss(TEWL),pH and side-reactions were recorded at each follow-up.Scoring of skin dryness was performed by the dermatologists and the subjects themselves.Results:After application of the moisturizer,the skin hydration was 43.64±8.06,40.50±9.26,37.32±9.69,41.18±8.70,43.48±8.84 at 1 h,4h,24 h,7 d,14 d,showing significant increases compared with that at baseline(26.53±8.68,P<0.001).The TEWL(6.48±2.33 g/h/m^(2) and 6.46±3.43 g/h/m^(2) at 7 d and 14 d,respectively)and pH(5.28±0.60 and 5.37±0.53 at 7 d and 14 d,respectively)were significantly decreased compared with those at baseline(TEWL 7.36±3.96 g/h/m^(2);pH 5.51±0.70)(P<0.01).Both the dermatologists and the subjects reported improvement in subjective score of the skin dryness(P<0.001).The moisturizing efficacy lasted up to 24 hours.Two subjects(1.02%)reported transient slight stinging and burning sensation,which disappeared after continuous use of the moisturizer.Conclusion:The application of this moisturizer containing Butyrospermum Parkii could effectively alleviate skin dryness with no serious adverse reactions and intolerance.

关 键 词：干性皮肤 皮肤屏障 保湿剂 

分 类 号：R322.99[医药卫生—人体解剖和组织胚胎学]