中华皮肤科杂志 ›› 2003, Vol. 36 ›› Issue (6): 310-312.

• 论著 • 上一篇    下一篇

阿达帕林凝胶联合过氧苯甲酰凝胶治疗寻常痤疮的多中心随机对照研究

傅雯雯1, 方丽1, 顾军2, 孙建方3, 余碧娥1, 李泉2, 胡兹嘉3, 张国毅3, 周展超3, 张怀亮3   

  1. 1. 上海复旦大学附属华山医院皮肤科 200040;
    2. 上海第二军医大学附属长海医院皮肤科;
    3. 中国医学科学院皮肤病研究所
  • 收稿日期:2002-04-02 出版日期:2003-06-15 发布日期:2003-06-15

Clinical Efficacy and Safety of 5% Benzoyl Peroxide Gel Combined with 0.1% Adapalene Gel in the Treatment of Acne Vulgaris:A Multicenter,Randomised Study

FU Wen-wen1, FANG Li1, GU Jun2, SUN Jian-fang3, YU Bi-e1, LI Quan2, HU Zi-jia3, ZHANG Guo-yi3, ZHOU Zhan-chao3, ZHANG Huai-liang3   

  1. Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040, China
  • Received:2002-04-02 Online:2003-06-15 Published:2003-06-15

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摘要： 目的 评价阿达帕林凝胶联合过氧苯甲酰凝胶治疗轻中度寻常痤疮的疗效和安全性。方法 随机、多中心、开放、平行对照研究。按照痤疮严重程度国际改良标准入选轻、中度寻常痤疮患者。试验组早晨外用5%过氧苯甲酰凝胶1次,晚睡前外用0.1%阿达帕林凝胶1次;对照组仅晚睡前外用0.1%阿达帕林凝胶1次。共用药12周,在基线、2、4、8和12周时记录炎性皮损、非炎性皮损和总皮损数,皮肤局部刺激反应如红斑、脱屑、干燥、烧灼/刺痛的评分,以及其他不良反应。结果 3个中心共入选150例患者。试验组、对照组的总有效率在第8周分别为74.6%和56.7%(P<0.05);在第12周时分别为81.3%和68.9%(P>0.05)。局部刺激反应评分除烧灼/刺痛在第4、8周时两组间的差异有显著性外,其余差异均无显著性。另外,两组各有2例发生接触性皮炎。结论 0.1%阿达帕林凝胶合用5%过氧苯甲酰治疗轻中度寻常痤疮较0.1%阿达帕林凝胶单用疗效显著,见效快,病程短,未增加不良反应。

关键词: 痤疮, 寻常, 阿达帕林, 过氧化苯甲酰

Abstract: Objective To assess the clinical efficacy and safety of the combination therapy of 5% benzoyl peroxide(BPO)gel with 0.1% adapalene gel in patients with mild to moderate acne vulgaris.Methods Randomized,multicenter,open and parallel controlled study.Combined therapy group received 0.1% adapalene gel(once daily in the evening)plus BPO gel 5%(once daily in the morning),and the control group received 0.1% adapalene gel(once daily in the evening)for 12 weeks.Results 150 patients were enrolled in 3 centers.At week 8,a reduction of 74.6% and 56.7%(defined as markedly improved or clear in the clinical assessment)in total lesion counts in the combined therapy group and the control group was observed,respectively(P<0.05).At week 12,the figures were 81.3% and 68.9%,respectively.Mild dryness,scaling,stinging or burning,erythema and pruritus occurred,but no significant difference was found between the two groups,except stinging or burning at week 4 and 8.Conclusions 0.1% adapalene gel combined with 5% BPO gel therapy is more effective than0.1%adapalene alone in mild to moderate acne cases,with a rapid response and similar adverse reactions.

Key words: Acne vulgaris, Adapalene, Benzoyl peroxide