复方维A酸凝胶治疗寻常痤疮的疗效及安全性研究

Compound Tretinoin Gel in the treatment of acne vulgaris of the efficacy and safety study

【目的】评价复方维A酸凝胶治疗寻常痤疮的疗效和安全性。【方法】选择符合要求的寻常痤疮受试者236例,随机分为实验组119例,对照组117例。实验组给予复方维A酸凝胶治疗,对照组给予维A酸霜。采用多中心、随机、双盲、阳性药物平行对照法。【结果】统计结果显示两组各种痤疮皮损计数均有明显下降,皮损总数目相应下降,严重程度分级降低。试验组和对照组治疗寻常痤疮的有效率分别为75.63%和64.10%,差别无统计学意义(P>0.05);对具有炎症性损害的痤疮,试验组和对照组有效率分别为78.99%、64.10%,差别有统计学意义(P<0.012)。【结论】复方维A酸凝胶治疗寻常痤疮安全有效,尤其对炎症性损害效果更佳。

[ Objective] Evaluation of compound - dimensional A acid gel in the treatment of acne vulgaris of the efficacy and safety. [Methods] Opt to meet the requirements of 236 cases of acne vulgaris subjects, the groups： experimental group, 119 cases, 117 eases of the control group. The experimental group given Compound A acid gel in the treatment of Victoria, Victoria A control group given acid cream. The evaluation methodology included multi - center, randomized, double- blind, parallel- positive drug control law. [ Results] Statistics showed that the two groups have a variety of acne lesions count decreased, total number of lesions decreased, the severity of lower grade. Test group and control group the treatment of acne vulgaris has the efficieney of 75.63%, respectively and 64.10%, the difference was not significant （ P 〉 0.05）; with inflammatory ache damage, the pilot group and the control group there is the efficiency of 78.99%, respectively, 64.10%, the difference has statistical significance （ P 〈 0.012） . [ Conclusions] Compotmd A acid- dimensional gel safe and effective treatment of aene vulgaris, particularly for inflammatory damage better.