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

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...

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

【Abstract】 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］; χ2 = 5.455, 4.320, respectively, both P < 0.05）. After 2 and 4 weeks of treatment, the remission rate of pruritus （χ2 = 4.320, 4.022, respectively, both P < 0.05） and treatment success （ IGA 0/1） rate （χ2 = 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.