外用丁酸氢化可的松乳膏联合一种皮肤膏剂敷料治疗特应性皮炎的随机开放对照研究

Efficacy of topical hydrocortisone butyrate cream combined with a skin cream dressing in the treatment of atopic dermatitis:a randomized,open,controlled clinical study

目的评价外用丁酸氢化可的松乳膏联合一种皮肤膏剂敷料治疗轻中度特应性皮炎(AD)的疗效和安全性。方法2019年7月至2020年6月,于首都医科大学附属北京友谊医院入组60例轻中度AD患者,采用随机数字表法分为两组,试验组先搽一种皮肤膏剂敷料(商品名芙汭膏剂)后涂丁酸氢化可的松乳膏,对照组先搽上述皮肤膏剂敷料的基质,后搽丁酸氢化可的松乳膏,每日2次,治疗4周。分别于治疗前和治疗2、4周时随访,评估疗效并记录不良反应。采用重复测量的方差分析和χ^(2)检验进行两组间疗效和安全性比较。结果治疗前,两组患者严重程度指数(EASI)、视觉模拟评分法(VAS)、研究者总体评估(IGA)评分差异均无统计学意义(均P<0.05)。治疗2、4周时,试验组有效率分别为86.67%(26/30)、93.33%(28/30),均显著高于对照组[60.00%(18/30)、73.33%(22/30);χ^(2)值分别为5.455、4.320,均P<0.05]。治疗2、4周时,试验组瘙痒消失率(χ^(2)=4.320、4.022,均P<0.05)和治疗成功率(χ^(2)=6.667、15.429,均P<0.05)亦均高于对照组。两组均无药物相关性不良反应发生。结论丁酸氢化可的松乳膏联合芙汭皮肤膏剂敷料治疗轻中度AD安全、有效,可用于临床。

Objective To evaluate the clinical efficacy and safety of topical hydrocortisone butyrate cream combined with a skin cream dressing in the treatment of mild to moderate atopic dermatitis(AD).Methods From July 2019 to June 2020,a randomized,open,controlled clinical study was conducted in Beijing Friendship Hospital,Capital Medical University.Sixty patients with mild to moderate AD were enrolled into this study,and randomly divided into 2 groups by using a random number table.The patients in test group topically applied a skin cream dressing(trade name FORENéE)followed by hydrocortisone butyrate cream,and those in control group topically applied the vehicle of the cream dressing followed by hydrocortisone butyrate cream.The treatment was carried out twice a day for 4 weeks.Visits were scheduled at baseline and after 2 and 4 weeks of treatment,efficacy was evaluated,and adverse reactions were recorded.Repeated measures analysis of variance and chi-square test were used to compare efficacy and safety between the 2 groups.Results Before treatment,there was no significant difference in eczema area and severity index(EASI),visual analogue scale(VAS)or investigator global assessment(IGA)scores between the 2 groups(all P<0.05).After 2 and 4 weeks of treatment,the response rate was significantly higher in the test group(86.67%[26/30],93.33%[28/30],respectively)than in the control group(60.00%[18/30],73.33%[22/30];χ^(2)=5.455,4.320,respectively,both P<0.05).After 2 and 4 weeks of treatment,the remission rate of pruritus(χ^(2)=4.320,4.022,respectively,both P<0.05)and treatment success(IGA 0/1)rate(χ^(2)=6.667,15.429,respectively,both P<0.05)were significantly higher in the test group than in the control group.There was no drug-related adverse reactions in the 2 groups.Conclusion Hydrocortisone butyrate cream combined with FORENéE skin cream dressing is safe and effective in the treatment of mild to moderate AD,and can be applied to clinical practice.