异维A酸红霉素凝胶治疗寻常痤疮的多中心随机平行对照临床试验  

Isotretinoin erythromycin gel in treatment of acne vulgaris:a randomized parallel controlled multicenter clinical trial

作　　者：江文[1] 涂亚庭[2] 张国毅[3] 段逸群[4] 陈兴平[1] 冯爱平[2] 周展超[3] 王玮蓁[4] 

机构地区：[1]华中科技大学同济医学院附属同济医院皮肤科,湖北武汉430030 [2]华中科技大学同济医学院附属协和医院,湖北武汉430022 [3]中国医学科学院皮肤病研究所,江苏南京210042 [4]武汉中西医结合医院,湖北武汉430022

出　　处：《中国新药与临床杂志》2007年第12期891-894,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:评价异维A酸红霉素凝胶治疗轻、中度寻常痤疮的疗效和安全性。方法:采用多中心随机、盲法、阳性药平行对照试验设计。试验组予异维A酸红霉素凝胶,对照组予维A酸乳膏。均为每晚一次,涂抹在全部患处,疗程为8 wk,观察疗效及不良反应。结果:共入组240例病人,进入疗效分析226例,其中试验组111例,对照组115例。治疗后,试验组与对照组综合疗效有效率分别为87.4% (97/111)和81.7%(70/115),2组综合疗效无显著差异(P>0.05);不良反应发生率分别为10.2%和7.6%(P>0.05)。结论:异维A酸红霉素凝胶治疗轻、中度寻常痤疮安全有效。AIM： To evaluate the efficacy and safety of isotretinoin erythromycin gel mild to moderate acne vulgaris. METHODS： A randomized blind paralleled control multi in the treatment of center clinical trial was designed. The patients in the trail group were treated with isotretinoin erythromycin gel and the others in the control group were treated with tretinoin cream for a course of 8 weeks with each drug respectively smeared on the surface individually per night; and then the clinical efficacy and safety were investigated. RESULTS： Two hundred and forty patients were enrolled in the trial, with only 226 efficient for the evaluation, including 111 patients in the trail group and 115 in the control group. After treatment, the total effective rates were 87.4 % （97/111） for the trial group and 81.7 % （70/115） for the control group, with no significant difference between them （P 〉 0.05）. The adverse reactions were 10.2 % and 7.6 % （P 〉 0.05） in trial and control group respectively. CONCLUSION ： Isotretinoin erythromycin gel is an effective and safe drug in the treatment of mild to moderate acne vulgaris.

关 键 词：痤疮 寻常 异维A酸 红霉素 凝胶类 多中心研究 随机对照试验 

分 类 号：R758.733[医药卫生—皮肤病学与性病学] R986[医药卫生—临床医学]