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

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

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。

Objective To assess the clinical efficacy and safety of the combination therapy of5%benzoyl peroxide(BPO)gel with0.1%adapalene gel in patients with mild to moderate acne vulgaris.Meth-ods Randomized,multi-center,open and parallel controlled study.Combined therapy group received0.1%adapalene gel(once daily in the evening)plus BPO gel5%(once daily in the morning),and the control group received0.1%adapalene gel(once daily in the evening)for12weeks.Results150patients were en-rolled in3centers.At week8,a reduction of74.6%and56.7%(defined as markedly improved or clear in the clinical assessment)in total lesion counts in the combined therapy group and the control group was ob-served,respectively(P<0.05).At week12,the figures were81.3%and68.9%,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 week4and8.Conclusions0.1%adapalene gel combined with5%BPO gel therapy is more effective than0.1%adapalene alone in mild to moderate acne cases,with a rapid response and similar adverse reactions.