【开放获取】凯普斯泰冷敷凝胶治疗成人轻中度特应性皮炎的随机双盲对照研究

【摘要】 目的 评价外用凯普斯泰冷敷凝胶治疗成人轻中度特应性皮炎（AD）的疗效和安全性。方法 采用随机、双盲、氢化可的松乳膏对照临床研究。2019年7月至2020年5月,于首都医科大学附属北京友谊医院收集80例成人轻中度AD患者,分为两组,每组40例。试验组外涂凯普斯泰冷敷凝胶,对照组外涂氢化可的松乳膏,每日3次,治疗4周。分别于治疗前和治疗1、2、4周随访,根据湿疹面积及严重程度指数（EASI）、视觉模拟标尺法（VAS）、研究者总体评估（IGA）评分等评价疗效,记录不良事件。主要采用重复测量的方差分析和χ2检验进行疗效和安全性比较。结果 AD患者80例,男43例、女37例,年龄（52.71 ± 16.71）岁。治疗前,两组患者性别、年龄、EASI评分、VAS评分、IGA评分差异均无统计学意义（均P > 0.05）。治疗1、2周时,试验组有效率分别为10.00%（4/40）、57.50%（23/40）,对照组有效率分别为15.00%（6/40）、52.50%（21/40）,两组差异均无统计学意义（均P > 0.05）。治疗4周,试验组有效率82.50%（33/40）,显著高于对照组57.50%（23/40,P < 0.05）。治疗1、2、4周时,试验组VAS评分均显著低于对照组（U = 1 253.00、1 121.00、1 091.50,均P < 0.05）。两组均无药物相关不良事件发生。结论 凯普斯泰冷敷凝胶治疗成人轻中度AD安全、有效,可用于临床。

Calcium-based antimicrobial peptide compounds cooling gel for the treatment of atopic dermatitis: a randomized,double-blind controlled clinical study

【Abstract】 Objective To evaluate clinical efficacy and safety of calcium-based antimicrobial peptide compounds cooling gel （CAPCS cooling gel） in the treatment of atopic dermatitis （AD）. Methods A randomized, double-blind, active-controlled clinical study was conducted. From July 2019 to May 2020, 80 adult patients with mild-to-moderate AD were enrolled from Beijing Friendship Hospital, Capital Medical University, and randomly and equally divided into 2 groups: test group topically treated with CAPCS cooling gel, control group topically treated with hydrocortisone cream, and the treatment was performed thrice a day for 4 consecutive weeks. Before, 1, 2 and 4 weeks after the start of treatment, efficacy was evaluated according to the Eczema Area and Severity Index （EASI）, Visual Analog Scale （VAS）, and Investigator′s Global Assessment （IGA） scores, and adverse events were recorded. Efficacy and safety were compared by using repeated measures analysis of variance and chi-square test. Results Of the 80 patients with AD, 43 were males and 37 were females, and the age was 52.71 ± 16.71 years. Before the treatment, there was no significant difference in gender, age, EASI, VAS or IGA scores between the two groups （all P > 0.05）. After 1- and 2-week treatment, there was no significant difference in the response rate between the test group （10.00% ［4/40］, 57.50% ［23/40］, respectively） and control group （15.00% ［6/40］, 52.50% ［21/40］ respectively, both P > 0.05）. After 4-week treatment, the response rate was significantly higher in the test group （82.50%, 33/40） than in the control group（57.50%, 23/40, P < 0.05）. Compared with the control group, the test group showed significantly decreased VAS scores after 1-, 2- and 4-week treatment（U = 1253.00, 1121.00, 1091.50, respectively, all P < 0.05）. No drug-related adverse events were observed in either of the groups. Conclusion CAPCS cooling gel is safe and effective in the treatment of mild-to-moderate AD in adults, and can be applied in clinic.