0.1%阿达帕林凝胶预防和减轻寻常痤疮复发的多中心随机对照临床试验  

Effects on the prevention of 0.1% adapalene gel maintenance treatment and relieving relapse of acne vulgaris: a multi-center, randomized controlled clinical trial

作　　者：蔡林[1] 张建中[1] 李邻峰[2] 袁珊[2] 郑捷[3] 徐慧珍[3] 涂亚庭[4] 陈思远[4] 

机构地区：[1]北京大学人民医院皮肤科,北京100044 [2]北京大学第三临床医院皮肤科,北京100083 [3]上海第二医科大学附属瑞金医院皮肤科,上海200025 [4]同济医科大学附属协和医院皮肤科,湖北武汉430022

出　　处：《临床皮肤科杂志》2004年第1期45-47,共3页Journal of Clinical Dermatology

摘　　要：目的:评价0.1%阿达帕林凝胶维持治疗对于预防和减轻寻常痤疮复发的作用。方法:采用多中心、区组随机、开放、对照的方法,共入选患者246例,均为经过阿达帕林和克林霉素(特丽仙)联合治疗或特丽仙单独治疗获得有效改善≥25%的寻常痤疮患者,随机分为两组,一组外用0.1%阿达帕林凝胶,另一组不用药,均观察12周。结果:239例患者完成治疗和观察,阿达帕林组121例,对照组118例。治疗4周后阿达帕林组炎性皮损数的减少显著优于对照组(P<0.05),并维持至12周;治疗8周后阿达帕林组皮损总数和非炎性皮损数的减少也显著优于对照组(P<0.01),并维持至12周。治疗结束后,阿达帕林组总体改善率为66.9%对照组为4.2%(P<0.01)阿达帕林组总复发率为4.1%对照组为83.9%两组间差异有显著性(P<0.01)。阿达帕林组有个别病例有轻度局部刺激反应,两组间不良反应差异无显著性(P<0.05)。结论:阿达帕林凝胶可有效地治疗寻常痤疮,并维持治疗效果,且不增加局部刺激反应,对于减少病情复发具有显著效果。Objective: To assess the maintenance treatment of 0.1% adapalene gel, for acne vulgaris. Methods: A multi-center, randomized, open, controlled, parallel group clinical trial was conducted. A total of 246 subjects were enrolled in this study. All subjects had been successfully treated with 1% dalacin topical solution + 0.1% adapalene gel or dalacin topical solution alone. They were randomized to receive either 0.1% adapalene gel or no treatment for 12 weeks. Results: 239 patients completed the study, 121 patients in adapalene group and 118 patients in control group. The number of inflammatory lesion counts in adapalene group decreased significantly than those of control group from week 4 through week 12. The total number of lesion counts and non-inflammatory lesions counts in adapalene group decreased significantly than those of control group from week 8 through week 12( P < 0.01). The percentage of global improvement was 66.9% in adapalene group compared to 4.2% in control group (P < 0.01). The global relapse rate was 4.1% in adapalene group compared to 83.9% in control group (P < 0.01). There were a few mild local irritations. Conclusions: A maintenance therapy is really needed after partial or complete clearance of moderate to moderately severe acne. Adapalene gel 0.1% is effective and safe in the maintenance treatment for acne vulgaris without increase local irritation and can decrease relapse rate markedly

关 键 词：痤疮 寻常 阿达帕林 复发 

分 类 号：R758.733[医药卫生—皮肤病学与性病学]