异维A酸凝胶治疗寻常痤疮多中心随机双盲安慰剂对照临床研究

Randomized double-blind placebo controlled multicenter clinical trial of isotretinoin gel in the treatment of acne vulgaris

目的评价0.05%异维A酸凝胶(抗面部痤疮药)治疗寻常痤疮的疗效及安全性。方法用多中心随机双盲安慰剂对照试验设计,以凝胶基质为对照,2药分别外用患处,每日2次,疗程12周。结果0.05%异维A酸凝胶与凝胶基质比较,治疗寻常痤疮的有效率分别为78.5%和23.3%;2药的药物不良反应发生率分别为23.2%和15.6%(P>0.05)。结论0.05%异维A酸凝胶治疗寻常痤疮是安全有效的外用药物。

Objective To evaluate the efficacy and safety of 0.05% isotretinoin gel in the treatment of acne vulgafis. Methods A rando - mized ,double blind ,placebo controlled multicentre clinical trial was performed. Eight two patients were given 0.05% isotretinoin gel and the other 77 patients were given placebo. Both drugs were used on the surface of the skin twice per day for 12 weeks. Results The total effective rates were 78. 5% in isotretinoin gel group, and 23. 3% in placebo group, respectively. The adverse reactions were 23.2% and 15.6% in both groups respectivedy（P 〉 0.05 ）. Conclusion These results suggest that 0.05% isotretinoin gel is an effective and safety drug in the treatment of acne vulgaris.