含有金盏花提取物的防晒乳对儿童皮肤防护作用的单中心、随机、平行对照临床研究  

Protective effects of a sunscreen lotion containing Calendula extracts on children′s skin after sun exposure:a single-center,randomized,parallel controlled clinical study

作　　者：王珊[1] 焦磊[1] 刘盈[1] 赵牧童 申春平[1] 肖媛媛[1] 李丽[1] 梁源[1] 田晶[1] 汪洋[1] 马琳[1] Wang Shan;Jiao Lei;Liu Ying;Zhao Mutong;Shen Chunping;Xiao Yuanyuan;Li Li;Liang Yuan;Tian Jing;Wang Yang;Ma Lin(Department of Dermatology,Beijing Children′s Hospital,Capital Medical University,National Center for Children′s Health,Beijing 100045,China)

机构地区：[1]国家儿童医学中心、首都医科大学附属北京儿童医院皮肤科,北京100045

出　　处：《中华皮肤科杂志》2024年第6期562-566,共5页Chinese Journal of Dermatology

摘　　要：目的研究含有金盏花提取物的温和倍护防晒乳对儿童皮肤日晒的防护效果、安全性及耐受性。方法2022年7-8月以首都医科大学附属北京儿童医院为中心招募健康儿童,采用单中心、随机、平行对照临床研究方法,入组3~18岁健康儿童200例,按照1∶1的比例随机分为A组(左侧涂抹试验品、右侧涂抹对照品)或B组(右侧涂抹试验品、左侧涂抹对照品),涂抹后进行阳光暴露活动,在阳光暴露前后对颞部、上臂伸侧和前臂伸侧部位进行皮肤测试评估。试验品为含有金盏花提取物的温和倍护防晒乳[防晒系数(SPF)50+,长波紫外线防晒系数(PA)++++],对照品为含有甘草提取物的婴儿防晒霜(SPF35,PA++)。采用双侧差异量表评估日晒后症状,采用红斑评分评估晒后红斑情况,采用MPA10多功能皮肤测试平台检测评估部位黑色素及红斑值、含水量及经表皮失水量(TEWL)。观察记录相关不良事件。计量资料比较采用配对t检验或Wilcoxon配对样本秩和检验,计数资料比较采用卡方检验(Fisher精确检验)。结果198例受试者完成研究及访视,男100例(50.5%),女98例(49.5%);年龄3~17(8.11±0.23)岁,A组、B组各99例。颞部、前臂伸侧和上臂伸侧日晒后对照侧症状更明显的受试者例数多于试验品侧(颞部:11例比4例,上臂伸侧:16例比2例,前臂伸侧:33例比3例),两侧频次差异均有统计学意义(均P<0.001)。3个测试区域试验侧和对照侧红斑评分差异均无统计学意义(P>0.05)。上臂和前臂部试验侧日晒后与日晒前黑色素值差值[M(Q1,Q3):-0.33(-13.00,14.17)、1.17(-10.75,12.67)]均低于对照侧[9.83(-8.50,25.00)、5.50(-4.08,21.00)],角质层含水量差值[6.53(-2.12,21.65)、7.75(-4.08,19.23)]均高于对照侧[2.35(-8.51,14.44)、1.35(-7.80,12.37)],差异有统计学意义(均P<0.001)。3个测试区域试验侧和对照侧日晒后与日晒前红斑值、TEWL差值差异均无统计学意义(P>0.05)。研究期间1例(0.51%)Objective To investigate the protective effects of a sunscreen lotion containing Calendula extracts on children′s skin against sun exposure,as well as to evaluate its safety and tolerability when applied to children.Methods A single-center,randomized,split-body/face study was conducted on 200 healthy children aged 3-<18 years,who were enrolled from Beijing Children′s Hospital,Capital Medical University from July to August 2022.The participants were randomly and equally divided into Group A(the left side of the body/face applied with the test sunscreen,and the right side applied with the control sunscreen)or Group B(the right side of the body/face applied with the test sunscreen,and the left side applied with the control sunscreen)at a ratio of 1∶1.After applying the sunscreen,they were engaged in outdoor activities under sunlight.Skin tests were conducted on the temporal area,the extensor aspect of the upper arm and forearm before and after sun exposure.The test product was a mild sunscreen lotion containing Calendula extracts with the sun protection factor(SPF)being 50+and the long-wave ultraviolet protection factor(PA)being+++,and the control product was a baby sunscreen containing licorice extracts(SPF35,PA++).Bilateral differential scales were used to assess clinical symptoms after sun exposure,erythema values to clinically evaluate erythema after sun exposure,and the multifunctional skin testing platform MPA10 to measure melanin and erythema values,stratum corneum hydration,and transepidermal water loss(TEWL)at the tested sites.Related adverse events were observed and recorded during the study.The paired t-test or Wilcoxon signed-rank test was used for the comparison of quantitative data,and chi-square test(Fisher′s exact test)for the comparison of count data.Results Totally,198 children completed the study and visits,including 100 males(50.5%)and 98 females(49.5%),aged from 3 to 17 years(8.11±0.23 years),and there were 99 cases each in the Group A and Group B.The numbers of participants with more o

关 键 词：儿童 防晒剂 黑素类 红斑 防护 金盏花提取物 

分 类 号：R758.2[医药卫生—皮肤病学与性病学]