中华皮肤科杂志 ›› 2010, Vol. 43 ›› Issue (12): 867-870.

• 论著 • 上一篇    下一篇

异维A酸红霉素凝胶治疗寻常痤疮的多中心随机对照临床研究

刘伦飞1,严建良2,方红3,程浩4,潘卫利5,丁颖果3,陆威6,郑敏7   

  1. 1. 浙江大学医学院附属第二医院
    2. 浙江大学医学院附属第二医院皮肤科
    3. 浙江大学医学院附属第一医院皮肤科
    4. 杭州市浙江大学邵逸夫医院皮肤科
    5. 杭州市浙江省人民医院
    6. 杭州浙江大学医学院附属第二医院皮肤科
    7. 杭州：浙江大学医学院附属第二医院
  • 收稿日期:2010-05-25 修回日期:2010-07-09 出版日期:2010-12-15 发布日期:2010-12-13
  • 通讯作者: 刘伦飞 E-mail:liulunfei@medmail.com.cn

Isotretinoin erythromycin gel in the treatment of acne vulgaris: a multicenter randomized parallel-controlled clinical study

  • Received:2010-05-25 Revised:2010-07-09 Online:2010-12-15 Published:2010-12-13

PDF

233

赞

摘要：

目的 比较异维A酸红霉素凝胶与阿达帕林凝胶治疗轻中度寻常痤疮的疗效和安全性。方法 多中心、开放、随机、平行对照研究。按照中国痤疮治疗指南痤疮严重程度标准入选轻、中度（Ⅰ ~ Ⅲ级）寻常痤疮患者192例，纳入疗效分析169例，安全性分析190例。试验组86例，外用异维A酸红霉素凝胶；对照组83例，外用阿达帕林凝胶，均为每晚1次，共用药6周。在基线、治疗2、4和6周时分别记录患者白头粉刺、黑头粉刺、炎性丘疹、脓疱数，评价各时间点患者痤疮严重程度，同时记录皮肤局部耐受性以及其他不良反应。结果 随着治疗时间延长，两组的有效率逐渐提高，总体病情严重程度改善。在治疗6周时，试验组总有效率为51.16%，对照组为40.96%，两组差异无统计学意义（P > 0.05）；但在治疗4周及6周时，试验组患者脓疱及炎性皮损的疗效优于对照组（P < 0.05），同时试验组痤疮分级较对照组低（P < 0.01）。两组不良反应类似，均表现为局部刺激，可耐受。结论 异维A酸红霉素凝胶治疗轻、中度寻常痤疮总有效率与阿达帕林凝胶类似，对于炎性损害疗效优于阿达帕林凝胶，并且对患者总体严重程度降低更快。

关键词: 痤疮，寻常, 异维A酸, 红霉素, 随机对照试验

Abstract:

Objective To compare the clinical efficacy and safety of isotretinoin erythromycin gel, a gel containing isotretinoin （0.05%） and erythromycin （2%）, versus adapalene gel in the treatment of mild to moderate acne vulgaris． Methods A multicenter, randomized, open, parallel-controlled clinical study was conducted. A total of 192 patients with mild to moderate （Grade Ⅰ-Ⅲ） acne vulgaris were enrolled in this study according to the grading criteria for acne severity in guidelines for the treatment of acne in China. Efficacy analysis was carried out in 169 patients and safety analysis in 190 patients. The patients were classified into trial group （n = 86） and control group （n = 83） to be treated with isotretinoin erythromycin gel or adapalene gel once a night for 6 weeks. Patients were evaluated at the baseline, on week 2, 4 and 6 during the treatment for the count of comedones （both open and closed）, inflammatory papules and pustules, severity of acne and local or general adverse effects. Results After the start of treatment, the response rate gradually increased and severity of acne decreased in both groups. On week 6, the total response rate was 51.16% in the trial group and 40.96% in the control group （P > 0.05）, while a greater reduction in the count of pustules and inflammatory lesions was observed on week 4 and 6 in the trial group with a lower severity grade of acne compared with the control group （P < 0.05 or 0.01）. Adverse reactions were similar in both groups and manifested as tolerable local irritation. Conclusions The efficacy of isotretinoin erythromycin gel is similar to that of adapalene gel in the treatment of mild to moderate acne vulgaris, however, isotretinoin erythromycin gel seems superior to adapalene gel in reducing inflammatory lesions and rapidly improving severity of acne vulgaris.

Key words: Randomized controlled trials