0.1%阿达帕林凝胶与0.025%维甲酸凝胶治疗寻常痤疮的疗效及安全性比较：一项多中心试验

A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025% in the treatment of acne vulgaris: a multicenter trial.

作者信息

Shalita A, Weiss J S, Chalker D K, Ellis C N, Greenspan A, Katz H I, Kantor I, Millikan L E, Swinehart T, Swinyer L, Whitmore C, Baker M, Czernielewski J

机构信息

State University of New York Health Science Center, Brooklyn, USA.

出版信息

J Am Acad Dermatol. 1996 Mar;34(3):482-5. doi: 10.1016/s0190-9622(96)90443-0.

DOI:10.1016/s0190-9622(96)90443-0

PMID:8609263

Abstract

BACKGROUND

Adapalene is a new synthetic retinoid analogue developed for the topical treatment of acne vulgaris.

OBJECTIVE

The study was designed to compare the efficacy and safety and adapalene gel 0.1% with tretinoin gel 0.025% in the treatment of grade II to II facial acne vulgaris.

METHODS

Three hundred twenty-three patients were enrolled in this investigator-masked, randomized, parallel group, multicenter trial. Patients applied the test materials to the entire facial area daily, for a period of 12 weeks. Efficacy and cutaneous tolerance were assessed at baseline and weeks 2,4,8, and 12. Efficacy was determined by investigator counts of noninflammatory open and closed comedones, and inflammatory papules and pustules, as well as global improvement. Cutaneous tolerance was evaluated by erythema, scaling, and dryness, along with burning and pruritus.

RESULTS

Staring at weeks 2 and 4, adapalene gel produced numerically greater lesion reductions than did tretinoin gel for all lesion types. At week 12, the mean percent reduction in the different lesion counts was as follow: 49% versus 37% for total lesions (p<0.01); 46% versus 33% for noninflammatory lesions (p=0.02); 48% versus 38% for inflammatory lesions (p=0.06) in adapalene and tretinoin gel treatment groups, respectively. Cutaneous side effects were limited to a mild "retinoid dermatitis" occurring in both treatment groups; however, patients treated with adapalene gel tolerated this therapy significantly better than those treated with tretinoin gel. Laboratory test evaluations (hematology, blood chemistries, urinalysis) were performed in 54 patients before and after 3 months of treatment. No clinically significant changes were observed.

CONCLUSION

Adapalene gel 0.1% applied once daily was significantly more effective in reducing acne lesions and was better tolerated than tretinoin gel 0.025% in the treatment of acne vulgaris.

摘要

背景

阿达帕林是一种新开发的用于寻常痤疮局部治疗的合成类视黄醇类似物。

目的

本研究旨在比较0.1%阿达帕林凝胶与0.025%维甲酸凝胶治疗Ⅱ级至Ⅲ级面部寻常痤疮的疗效和安全性。

方法

323例患者参加了这项研究者设盲、随机、平行组、多中心试验。患者每天将受试材料涂抹于整个面部区域，持续12周。在基线以及第2、4、8和12周评估疗效和皮肤耐受性。疗效通过研究者对非炎性开放性和闭合性粉刺、炎性丘疹和脓疱的计数以及整体改善情况来确定。通过红斑、脱屑、干燥以及烧灼感和瘙痒来评估皮肤耐受性。

结果

从第2周和第4周开始，对于所有皮损类型，阿达帕林凝胶在减少皮损数量方面在数值上比维甲酸凝胶更有效。在第12周时，不同皮损计数的平均减少百分比如下：阿达帕林凝胶治疗组和维甲酸凝胶治疗组的总皮损分别为49%对37%（p<0.01）；非炎性皮损为46%对33%（p=0.02）；炎性皮损为48%对38%（p=0.06）。皮肤副作用仅限于两个治疗组中出现的轻度“类视黄醇皮炎”；然而，使用阿达帕林凝胶治疗的患者对该疗法的耐受性明显优于使用维甲酸凝胶治疗的患者。在54例患者治疗3个月前后进行了实验室检查评估（血液学、血液化学、尿液分析）。未观察到具有临床意义的变化。