复方紫草油改善轻中度尿布皮炎临床症状的多中心、开放、随机对照临床研究

Compound oleum lithospermi in improving clinical symptoms of mild to moderate diaper dermatitis:a multicenter,open-labeled,randomized controlled clinical study

目的评价外用复方紫草油治疗轻中度尿布皮炎的临床疗效和安全性。方法2019年7月至2020年8月采用多中心、随机、阳性药平行对照的研究方法,在全国19家医院纳入0~12月龄轻中度尿布皮炎患儿,按随机数字表法分为试验组和对照组。试验组外用复方紫草油,对照组外用氧化锌乳膏,每日6~8次,观察期为7 d。分别于治疗第0、7天进行访视,评估总有效率、临床治愈时间,比较两组治疗前后皮肤病家庭生活质量评分(DFI)的变化,记录不良事件发生情况。两组间正态分布的连续性资料比较采用成组t检验,非正态分布的连续性资料比较采用Wilcoxon秩和检验;组间无序分类资料比较采用χ^(2)检验/Fisher确切概率法。对生存资料绘制生存曲线,两组间比较采用Log-Rank检验。结果343例尿布皮炎患儿中,31例违背方案,312例纳入符合方案分析集(试验组157例、对照组155例),均完成第0、7天访视。试验组总有效率87.26%(137/157),对照组总有效率78.71%(122/155),两组间比较差异有统计学意义(χ^(2)=4.04,P=0.044)。试验组和对照组中位临床治愈时间分别为5.33 d、6.13 d,差异有统计学意义(χ^(2)=4.67,P=0.025)。治疗7 d后,两组DFI均较治疗前下降,但两组间DFI差异无统计学意义(试验组4.02±6.96,对照组3.58±5.90,Z=-0.39,P=0.686)。试验组不良事件发生率为2.92%(5/171),对照组5.45%(9/165),两组间差异无统计学意义(χ^(2)=0.03,P=0.865)。结论复方紫草油可显著改善尿布皮炎患儿临床严重程度,提高总有效率,缩短临床治疗时间,提高患儿家庭生活质量,且安全性好。

Objective To evaluate clinical efficacy and safety of topical compound oleum lithospermi in the treatment of mild to moderate diaper dermatitis.Methods A multicenter,randomized,positive-drug parallel-controlled clinical trial was conducted in 19 hospitals from July 2019 to August 2020.Children aged 0-12 months with mild to moderate diaper dermatitis were enrolled and randomly divided into 2 groups using a random number table:test group topically treated with compound oleum lithospermi,and control group topically treated with zinc oxide cream.The treatment was carried out 6-8 times a day for 7 days.Visits were scheduled on days 0 and 7,and total response rate and clinical healing time were evaluated.Changes in the dermatitis family impact(DFI)score were compared between the test group and control group,and adverse events were recorded.Statistical analysis was carried out by using independent-sample t test for normally distributed continuous data,Wilcoxon rank sum test for non-normally distributed continuous data,and chi-square test or Fisher′s exact test for unordered categorical data;survival curves were drawn,and log-rank test was used for comparisons between two groups.Results A total of 343 children with diaper dermatitis were enrolled in this study.Among them,31 children violated the protocol,so 312 were included in the per protocol set,including 157 in the test group and 155 in the control group,and all completed the visits on days 0 and 7.The total response rate was significantly higher in the test group(87.26%,137/157)than in the control group(78.71%,122/155;χ^(2)=4.04,P=0.044).The clinical healing time was significantly shorter in the test group(5.33 days)than in the control group(6.13 days;χ^(2)=4.67,P=0.025).After 7-day treatment,the DFI score significantly decreased in both the 2 groups compared with that before the treatment,but there was no significant difference in the DFI score between the 2 groups(test group:4.02±6.96,control group:3.58±5.90,Z=-0.39,P=0.686).The incidence of adverse events was 2.92%(5/171)and 5.45%(9/165)in the test group and control group respectively,and there was no significant difference between the 2 groups(χ^(2)=0.03,P=0.865).Conclusion Compound oleum lithospermi can markedly reduce the clinical severity of diaper dermatitis,improve the total response rate,shorten the clinical treatment period,and improve the quality of life of children′s families with a favorable safety profile.