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他扎罗汀乳膏与阿达帕林凝胶随机对照治疗寻常型痤疮多中心临床试验
引用本文:何志新,王宝玺,渠涛,胡兹嘉,张国毅,张怀亮,郝飞,钟华,杨希川. 他扎罗汀乳膏与阿达帕林凝胶随机对照治疗寻常型痤疮多中心临床试验[J]. 中国临床药理学杂志, 2003, 19(5): 330-333
作者姓名:何志新  王宝玺  渠涛  胡兹嘉  张国毅  张怀亮  郝飞  钟华  杨希川
作者单位:1. 北京协和医院,皮肤科,北京,100730
2. 中国医学科学院皮肤病研究所,江苏,南京,210042
3. 第三军医大学西南医院,皮肤科,重庆,400038
摘    要:目的 评价国产0.1%他扎罗汀乳膏治疗面部轻中度寻常型痤疮的疗效及安全性。方法 用多中心、随机单盲对照试验方法,0.1%他扎罗汀乳膏或0.1%阿达帕林凝胶局部外用每日1次,疗程8周。在治疗前、治疗2,4和8周进行观察。入选病例142例,其中0.1%他扎罗汀乳膏组71例,完成8周观察64例。0.1%阿达帕林凝胶组71例,完成8周观察67例。结果他扎罗汀乳膏组有效率72.3%,阿达帕林凝胶组有效率62.7%。两组之间无显著统计学差异。两组的不良反应均表现为轻度到中度的局部刺激,发生率分别为28.70%和23.50%。结论 他扎罗汀乳膏治疗寻常型痤疮安全有效。

关 键 词:他扎罗汀乳膏 阿达帕林凝胶 治疗 寻常型痤疮 临床试验 不良反应
文章编号:1001-6821(2003)05-0330-04

Randomized controlled multicenter clinical trial on tazarotene cream versus adapaline gel in the treatment of acne vulgaris
HE Zhi-xi,WANG Bao-xi,QU Tao,HUZi-jia,ZHANG Guo-yi,ZHANG Huai-liang,HAO Fei,ZHONG Hua,YANG Xi-chuan. Randomized controlled multicenter clinical trial on tazarotene cream versus adapaline gel in the treatment of acne vulgaris[J]. The Chinese Journal of Clinical Pharmacology, 2003, 19(5): 330-333
Authors:HE Zhi-xi  WANG Bao-xi  QU Tao  HUZi-jia  ZHANG Guo-yi  ZHANG Huai-liang  HAO Fei  ZHONG Hua  YANG Xi-chuan
Abstract:Objective To evaluate the efficacy and safety of topical tazarotene 0.1% cream in the treatment of acne vulgaris. Methods A multicenter randomized single-blind controlled clinical trial was conducted. The patients with mild-to-moderate facial acne vulgaris were treated with either 0.1 % tazarotene cream or 0.1 % adapaline gel once daily for 8 weeks. Study visits took place at baseline and week 2,4 and 8. A total of 142 patients were enrolled in present clinical study.Among them, 71 patients were topically treated with 0.1 % tazarotene cream, in whicd 64 patients were evaluable for safety and efficacy. Seventy-one patients were topically treated with 0.1 % adapaline gel, in which 67 patients were evaluable for safety and efficacy. Results The results showed that total effective rate was 72.3% for tazarotene cream group, 62.7% for adapaline gel group(P>0.05), respectively.Mild-to-moderate local skin irritation was found in 28.70% in tazarotene cream group and 23.50% in adapaline gel group(P>0.05), respectively.Conclusion The present study suggests that 0.1% tazarotene cream was effective and safe for the treatment of acne vulgaris.
Keywords:tazarotene cream  adapaline gel  acne vulgaris
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