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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
引用本文:季素珍,李福秋,姜日花,吴艳,汪科,巫毅,丛宪玲,赵谊,朱学骏.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[J].中国临床药理学杂志,2006,22(2):100-102.
作者姓名:季素珍  李福秋  姜日花  吴艳  汪科  巫毅  丛宪玲  赵谊  朱学骏
作者单位:1. 北京大学第一医院,皮肤性病科,北京,100034
2. 吉林大学第二医院,吉林,长春,130041
3. 吉林大学中日联谊医院,吉林,长春,130031
4. 北京大学第一医院医学统计室,北京,100034
摘    要: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.

关 键 词:0.05%异维A酸凝胶  凝胶基质  寻常痤疮
文章编号:1001-6821(2006)02-0100-03
收稿时间:2005-05-23
修稿时间:2005-05-232005-11-14

Randomized double-blind placebo controlled multicenter clinical trial of isotretinoin gel in the treatment of acne vulgaris
JI Shu-zhen,LI Fu-qiu,JIANG Ri-hua,WU Yan,WANG Ke,WU Yi,CONG Xian-ling,ZHAO Yi,ZHU Xue-jun.Randomized double-blind placebo controlled multicenter clinical trial of isotretinoin gel in the treatment of acne vulgaris[J].The Chinese Journal of Clinical Pharmacology,2006,22(2):100-102.
Authors:JI Shu-zhen  LI Fu-qiu  JIANG Ri-hua  WU Yan  WANG Ke  WU Yi  CONG Xian-ling  ZHAO Yi  ZHU Xue-jun
Institution:1. Department of Dermatology and Venereology , First Hospital of Peking University , Beijing 100034, China ; 2. Second Hospital of Jilin University, Changchun 130041, China ; 3. The China Japan Unite Hospital, Jilin University, Changchun 130031 , China; 4. Department of Medical Statistics, First Hospital of Peking University, Beijing 100034, China
Abstract:Objective To evaluate the efficacy and safety of 0.05% isotretinoin gel in the treatment of acne vulgaris. 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 su-ggest that 0.05% isotretinoin gel is an effective and safety drug in the treatment of acne vulgaris.
Keywords:0  05% isotretinoin gel  placebo  acne vulgaris
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